Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 19, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Entity Registrant Name | Minerva Neurosciences, Inc. | ||
Entity Central Index Key | 0001598646 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | NERV | ||
Security Exchange Name | NASDAQ | ||
Entity Tax Identification Number | 26-0784194 | ||
Entity File Number | 001-36517 | ||
Entity Address, Address Line One | 1500 District Avenue | ||
Entity Address, City or Town | Burlington | ||
Entity Address, State or Province | MA | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Postal Zip Code | 01803 | ||
City Area Code | 617 | ||
Local Phone Number | 600-7373 | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the Registrant’s Definitive Proxy Statement relating to the 2024 Annual Meeting of Stockholders to be filed pursuant to Regulation 14A with the Securities and Exchange Commission are incorporated by reference into Part III of this Report. Such proxy statement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the Registrant’s fiscal year ended December 31, 2023 . | ||
Document Annual Report | true | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 36.9 | ||
Entity Common Stock, Shares Outstanding | 6,993,406 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Interactive Data Current | Yes | ||
Document Financial Statement Error Correction [Flag] | false | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 34 | ||
Entity Registrant Name | Minerva Neurosciences, Inc. | ||
Auditor Name | Deloitte & Touche, LLP | ||
Auditor Location | Boston, Massachusetts |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 40,912,575 | $ 36,093,606 |
Restricted cash | 100,000 | 100,000 |
Refundable regulatory fee | 3,117,218 | |
Prepaid expenses and other current assets | 989,865 | 848,117 |
Total current assets | 42,002,440 | 40,158,941 |
Equipment, net | 10,884 | 16,326 |
Capitalized software, net | 17,027 | 42,567 |
Goodwill | 14,869,399 | 14,869,399 |
Total assets | 56,899,750 | 55,087,233 |
Current liabilities | ||
Accounts payable | 1,805,320 | 969,667 |
Accrued expenses and other current liabilities | 1,535,097 | 407,909 |
Total current liabilities | 3,340,417 | 1,377,576 |
Liability related to the sale of future royalties | 82,016,823 | 73,733,876 |
Total liabilities | 85,357,240 | 75,111,452 |
Commitments and contingencies (Note 9) | ||
Stockholders' (deficit) equity | ||
Preferred stock; $.0001 par value; 100,000,000 shares authorized; none issued or outstanding as of December 31, 2023 and 2022, respectively | ||
Common stock; $.0001 par value; 125,000,000 shares authorized; 6,993,406 and 5,340,193 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively | 699 | 534 |
Additional paid-in capital | 368,357,239 | 346,785,322 |
Accumulated deficit | (396,815,428) | (366,810,075) |
Total stockholders' (deficit) equity | (28,457,490) | (20,024,219) |
Total liabilities and stockholders' (deficit) equity | $ 56,899,750 | $ 55,087,233 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 100,000,000 | 100,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 6,993,406 | 5,340,193 |
Common stock, shares outstanding | 6,993,406 | 5,340,193 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Expenses | ||
Research and development | $ 12,705,253 | $ 14,649,087 |
General and administrative | 10,414,323 | 10,582,239 |
Total expenses | 23,119,576 | 25,231,326 |
Loss from operations | (23,119,576) | (25,231,326) |
Foreign exchange losses | (40,235) | (27,741) |
Investment income | 1,437,405 | 556,946 |
Non-cash interest expense for the sale of future royalties | (8,282,947) | (7,406,555) |
Net loss | $ (30,005,353) | $ (32,108,676) |
Net loss per share, basic | $ (4.61) | $ (6.01) |
Net loss per share, diluted | $ (4.61) | $ (6.01) |
Weighted average shares outstanding, basic | 6,506,372 | 5,340,194 |
Weighted average shares outstanding, diluted | 6,506,372 | 5,340,194 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 7,975,643 | $ 534 | $ 342,676,508 | $ (334,701,399) |
Balance (in shares) at Dec. 31, 2021 | 5,340,196 | |||
Stock-based compensation | 4,108,819 | 4,108,819 | ||
Adjustments due to the rounding impact from the reverse stock split for fractional shares | (5) | (5) | ||
Adjustments due to the rounding impact from the reverse stock split for fractional shares (in shares) | (3) | |||
Net loss | (32,108,676) | (32,108,676) | ||
Balance at Dec. 31, 2022 | $ (20,024,219) | $ 534 | 346,785,322 | (366,810,075) |
Balance (in shares) at Dec. 31, 2022 | 5,340,193 | 5,340,193 | ||
Issuance of common stock and warrants pursuant to a private placement | $ 19,999,994 | $ 142 | 19,999,852 | |
Issuance of common stock and warrants pursuant to a private placement (in shares) | 1,425,000 | |||
Costs related to issuance of common stock and warrants | (396,293) | (396,293) | ||
Vesting of performance-based restricted stock units | $ 23 | (23) | ||
Vesting of performance-based restricted stock units (in shares) | 228,213 | |||
Stock-based compensation | 1,968,381 | 1,968,381 | ||
Net loss | (30,005,353) | (30,005,353) | ||
Balance at Dec. 31, 2023 | $ (28,457,490) | $ 699 | $ 368,357,239 | $ (396,815,428) |
Balance (in shares) at Dec. 31, 2023 | 6,993,406 | 6,993,406 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows | 12 Months Ended | 35 Months Ended | |
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | |
Cash flows from operating activities: | |||
Net loss | $ (30,005,353) | $ (32,108,676) | |
Adjustments to reconcile net loss income to net cash used in operating activities: | |||
Depreciation and amortization | 5,442 | ||
Amortization of capitalized software | 25,540 | 8,513 | |
Stock-based compensation expense | 1,968,381 | 4,108,819 | |
Non-cash interest expense associated with the sale of future royalties | 8,282,947 | 7,406,555 | $ 22,016,823 |
Changes in operating assets and liabilities | |||
Refundable regulatory fee | 3,117,218 | (3,117,218) | |
Prepaid expenses and other current assets | (141,748) | 498,242 | |
Accounts payable | 835,653 | (883,548) | |
Accrued expenses and other current liabilities | 1,127,188 | (557,830) | |
Net cash used in operating activities | (14,784,732) | (24,645,143) | |
Cash flows from investing activities: | |||
Purchases of equipment | (16,326) | ||
Net cash used in investing activities | (16,326) | ||
Cash flows from financing activities: | |||
Proceeds from sales of common stock and warrants in private placement | 19,999,994 | ||
Costs paid in connection with private placements | (396,293) | ||
Fees paid in connection with the reverse stock split fractional shares | (5) | ||
Net cash provided by (used in) financing activities | 19,603,701 | (5) | |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 4,818,969 | (24,661,474) | |
Cash, cash equivalents, and restricted cash | |||
Beginning of period | 36,193,606 | 60,855,080 | |
End of period | 41,012,575 | 36,193,606 | 41,012,575 |
Reconciliation of the Condensed Consolidated Statements of Cash Flows to the Condensed Consolidated Balance Sheets | |||
Cash and cash equivalents | 40,912,575 | 36,093,606 | 40,912,575 |
Restricted cash | 100,000 | 100,000 | 100,000 |
Total cash, cash equivalents, and restricted cash | $ 41,012,575 | $ 36,193,606 | $ 41,012,575 |
Nature of Operations and Liquid
Nature of Operations and Liquidity | 12 Months Ended |
Dec. 31, 2023 | |
Nature Of Operations And Liquidity Disclosure [Abstract] | |
Nature of Operations and Liquidity | NOTE 1 — NATURE OF OPERATIONS AND LIQUIDITY Nature of Operations Minerva Neurosciences, Inc. (“Minerva” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases. The Company’s lead product candidate is roluperidone (f/k/a MIN-101), a compound the Company is developing for the treatment of negative symptoms in patients with schizophrenia. The Company holds the license to roluperidone from Mitsubishi Tanabe Pharma Corporation (“MTPC”) with the rights to develop, sell and import roluperidone globally, excluding most of Asia. In August 2022, the Company submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for its lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia. In October 2022, the Company received a refusal to file letter (“RTF”) from the FDA for the NDA for roluperidone. Subsequently, the Company requested a formal dispute resolution and appealed the RTF, following which, on April 27, 2023, the FDA filed the Company’s NDA for roluperidone. In May 2023, the FDA confirmed that the NDA for roluperidone was assigned a standard review classification and a Prescription Drug User Fee Act goal date of February 26, 2024. The FDA advised that it identified potential review issues that had been previously cited in the RTF decision letter, which included those discussed at the Type C meeting in March 2022. See the section titled “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Clinical and Regulatory Updates—Type C Meeting” for more information. The Company has exclusive rights to develop and commercialize MIN-301, a compound for the treatment of Parkinson’s disease. In addition, Minerva previously co-developed seltorexant (f/k/a MIN-202 or JNJ-42847922) with Janssen Pharmaceutica NV (“Janssen”) for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). During 2020, Minerva exercised its right to opt out of the joint development agreement with Janssen for the future development of seltorexant. As a result, the Company was entitled to collect royalties in the mid-single digits on potential future worldwide sales of seltorexant in certain indications, with no further financial obligations to Janssen. In January 2021, the Company sold its rights to these potential royalties to Royalty Pharma plc (“Royalty Pharma”) for a $ 60 million up front payment and up to $ 95 million in potential future milestone payments. Liquidity The accompanying financial statements have been prepared as though the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has limited capital resources and has incurred recurring operating losses and negative cash flows from operations since inception. As of December 31, 2023, the Company had an accumulated deficit of approximately $ 396.8 million and net cash used in operating activities was approximately $ 14.8 million during the year ended December 31, 2023. Management expects to continue to incur operating losses and negative cash flows from operations in the future. The Company has financed its operations to date from proceeds from the sale of common stock, warrants, loans, convertible promissory notes, collaboration agreements and royalty sales. As of December 31, 2023, the Company had cash, cash equivalents, and restricted cash of $ 41.0 million, which it believes will be sufficient to meet the Company ’ s operating commitments for the next 12 months from the date its financial statements are issued. The process of drug development can be costly and the timing and outcomes of clinical trials is uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon many factors, including, but not limited to, the design, timing and duration of future clinical trials, the progress of the Company’s research and development programs, the infrastructure to support a commercial enterprise, and the level of financial resources available. The Company can adjust its operating plan spending levels based on the timing of future clinical trials, which are predicated upon adequate funding to complete the trials. The Company routinely evaluates the status of its clinical development programs as well as potential strategic options. The Company will need to raise additional capital to continue to fund operations and fully fund any potential later stage clinical development programs. The Company believes that it will be able to obtain additional working capital through equity financings or other arrangements to fund future operations; however, there can be no assurance that such additional financing, if available, can be obtained on terms acceptable to the Company. If the Company is unable to obtain such additional financing, future operations would need to be scaled back or discontinued. Further, if the Company does not satisfy The Nasdaq Capital Market continued listing requirements, its common stock may be subject to delisting, which could impact the Company’s ability to complete additional equity financings on terms acceptable to the Company. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, planning and executing clinical trials and raising capital. Reverse Stock Split On June 17, 2022, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect a one-for-eight (1-for-8) reverse stock split of its outstanding common stock. The Amendment became effective at 5:00 p.m. Eastern Time on June 17, 2022. A series of alternate amendments to effect a reverse stock split was approved by the Company’s stockholders at the Company’s 2022 Annual Meeting of Stockholders on June 10, 2022, and the specific one-for-eight (1-for-8) reverse stock split was subsequently approved by the Company’s board of directors on June 10, 2022. The Amendment provided that, at the effective time of the Amendment, every eight (8) shares of the Company’s issued and outstanding common stock automatically combined into one issued and outstanding share of common stock, without any change in par value per share. The reverse stock split affected all shares of the Company’s common stock outstanding immediately prior to the effective time of the Amendment. As a result of the reverse stock split, proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options, restricted stock units and restricted stock awards issued by the Company and outstanding immediately prior to the effective time of the Amendment, which resulted in a proportionate decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, restricted stock units and restricted stock awards, and, in the case of stock options, a proportionate increase in the exercise price of all such stock options. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time of the Amendment was reduced proportionately. The reverse stock split did not affect the number of shares of common stock authorized for issuance under the Company’s Amended and Restated Certificate of Incorporation, which remained at 125,000,000 shares. No fractional shares were issued as a result of the reverse stock split. Stockholders of record who would otherwise have been entitled to receive a fractional share received a cash payment in lieu thereof. The reverse stock split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the reverse stock split results in any stockholder owning only a fractional share). As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock as of June 17, 2022 decreased from 42,721,566 (pre-split) shares to 5,340,193 (post-split) shares. All share and per share amounts in the accompanying financial statements, related footnotes, and management’s discussion and analysis have been adjusted retroactively to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented. The Company’s common stock began trading on The Nasdaq Global Market on a split-adjusted basis when the market opened on June 21, 2022. Effective September 12, 2022, the Company transferred the listing of its common stock from The Nasdaq Global Market to The Nasdaq Capital Market. Consolidation The accompanying consolidated financial statements include the results of the Company and its wholly-owned subsidiaries, Mind-NRG Sarl and Minerva Neurosciences Securities Corporation. Intercompany transactions have been eliminated. Significant risks and uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Cash and cash equivalents Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. Restricted cash Cash accounts with any type of restriction are classified as restricted. The Company maintained restricted cash balances as collateral for corporate credit cards in the amount of $ 0.1 million at December 31, 2023 and 2022 . Refundable regulatory fee On August 12, 2022, the Company paid $ 3,117,218 to the FDA for the NDA user fee related to roluperidone. The Company met the conditions of the Federal Food, Drug, and Cosmetic Act, as amended, for the small business waiver of the user fees and its request for a waiver of an application user fee was granted by the FDA on November 2, 2022. On January 26, 2023, the refund was received from the FDA. Research and development costs Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company and costs related to salaries, benefits, bonuses and stock-based compensation granted to employees in research and development functions. The Company determines expenses related to clinical studies based on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical studies on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. The expenses for some trials may be recognized on a straight-line basis if the anticipated costs are expected to be incurred ratably during the period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. In-process research and development In-process research and development (“IPR&D”) assets represent capitalized incomplete research projects that the Company acquired through business combinations. Such assets are initially measured at their acquisition date fair values. The initial fair values of the research projects are recorded as intangible assets on the balance sheet, rather than expensed, regardless of whether these assets have an alternative future use. The amounts capitalized are being accounted for as indefinite-lived intangible assets, subject to impairment testing, until completion or abandonment of research and development efforts associated with the project. An IPR&D asset is considered abandoned when it ceases to be used (that is, research and development efforts associated with the asset have ceased, and there are no plans to sell or license the asset or derive defensive value from the asset). At that point, the asset is considered to be disposed of and is written off. Upon successful completion of each project, the Company will make a determination about the remaining useful life of the intangible asset and begin amortization. The Company tests its indefinite-lived intangibles, IPR&D assets, for impairment annually and more frequently if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. When testing indefinite-lived intangibles for impairment, the Company may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the asset is impaired. Alternatively, the Company may bypass this qualitative assessment for some or all of its indefinite-lived intangibles and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. Impairment of MIN-301 In-process Research and Development Asset In 2021, the Company made the strategic decision to focus its limited resources on moving forward its lead drug candidate, roluperidone, and deferred the development of MIN-301 until additional resources become available. As a result of the Company’s limited resources and development deferral combined with the overall market conditions, it recognized a non-cash charge of $ 15.2 million as of December 31, 2021 related to the impairment of the intangible asset for MIN-301. The Company had previously recognized in-process research and development for MIN-301 in conjunction with the acquisition of MIN-301 during 2014. No updates were made in respect of the development of MIN-301 during 2023 . Stock-based compensation The Company recognizes compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, including grants of employee stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of stock-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, and expected life of the options. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur. The fair value of restricted stock units (“RSUs”) is equal to the closing price of the Company’s common stock on the date of grant. See Note 7 for information on the Company’s performance-based restricted stock units (“PRSU”) grants. The date of expense recognition for grants to non-employees is the earlier of the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or the date at which the counterparty’s performance is complete. The Company determines the fair value of stock-based awards granted to non-employees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, may be different. Foreign currency transactions The Company’s functional currency is the U.S. Dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in U.S. Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date an expense is recorded and the payment date is recorded as a foreign currency gain or loss. Loss per share Basic loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and warrants. Income taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Deferred tax assets are evaluated for realization based on a more-likely-than-not criterion in determining if a valuation allowance should be provided. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income tax expense. There was no interest or penalties related to income taxes for the years ended December 31, 2023 or 2022 . Income tax years beginning in 2019 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized. Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of corporate bonds, with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings. Equipment Equipment is stated at cost less accumulated depreciation. Equipment is depreciated on the straight-line basis over their estimated useful lives of three years . Expenditures for maintenance and repairs are charged to expense as incurred. Software The Company accounts for capitalized software in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350, Intangibles—Goodwill and Other (“ASC 350-40”), which provides guidance for computer software developed or obtained for internal use. The Company is required to continually evaluate the stage of the implementation process to determine whether costs are expensed or capitalized. Costs incurred during the preliminary project phase or planning and research phase are expensed as incurred. Costs incurred during the development phase, such as material and direct services costs, compensation costs of employees associated with the development and interest cost, are capitalized as incurred. Costs incurred during the post-implementation or operation phase, such as training and maintenance costs, are expensed as incurred. In addition, costs incurred to modify existing software that result in additional functionality are capitalized as incurred. Capitalized costs are amortized over the expected useful life of the asset. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . This new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Also, capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company has elected not to recognize on the balance sheet leases with terms of 12 months or less. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. The Company monitors its plans to renew its material leases on a quarterly basis. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in the Company’s leases is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term and in a similar economic environment. In transition to FASB ASC Topic 842, Leases (“ASC 842”), the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.). The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components by class of underlying asset where entities would account for each lease component and the related non-lease component together as a single component. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease and non-lease components for leases, for classes of all underlying assets, and allocate all of the contract consideration to the lease component only. Long-lived assets The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. If required, the Company compares the estimated undiscounted future net cash flows to the related asset’s carrying value to determine whether there has been an impairment. If an asset is considered impaired, the asset is written down to fair value, which is based either on discounted cash flows or appraised values in the period the impairment becomes known. The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2023 and 2022 . Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value. Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances. If the Company determines that an impairment has occurred, it is required to record a write-down of the carrying value and charge the impairment as an operating expense in the period the determination is made. In evaluating the recoverability of the carrying value of goodwill, the Company must make assumptions regarding estimated future cash flows and other factors to determine the fair value of the acquired assets. Changes in strategy or market conditions could significantly impact those judgments in the future and require an adjustment to the recorded balances. The Company has a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2023 and 2022. As of December 31, 2023 , $ 14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value. As the reporting unit had a positive fair value, there was no impairment associated with this reporting unit. Fair value of financial instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The following tables present information about the Company’s cash equivalents and marketable securities as of December 31, 2023 and 2022, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2023 Total Level 1 Level 2 Level 3 Cash equivalents $ 27,351,596 $ 27,351,596 $ — $ — Total fair value $ 27,351,596 $ 27,351,596 $ — $ — December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents $ 34,557,146 $ 34,557,146 $ — $ — Total fair value $ 34,557,146 $ 34,557,146 $ — $ — Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. The Company’s financial instruments consist of cash and cash equivalents, restricted cash, accounts payable, accrued expenses and liabilities related to the sale of future royalties. The carrying amounts of cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximate fair value because of their short-term nature. Revenue recognition The Company applies the revenue recognition guidance in accordance with ASC 606, Revenue from Contracts with Customers . Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable, and collectability is reasonably assured. The Company is a development stage company and has had no revenues from product sales to date. When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaborative Arrangements , the Company recognizes revenue as research and development is performed and its respective share of the expenses are incurred. The Company assesses whether the arrangement contains multiple elements or deliverables, which may include (1) licenses to the Company's technology, (2) research and development activities performed for the collaboration partner, and (3) participation on joint steering committees. Payments may include non-refundable, upfront payments, milestone payments upon achieving significant development events, and royalties on future sales. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price, and (iii) best estimate of selling price. The best estimate of selling price reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. The consideration allocated to each unit of accounting is then recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Supply or service transactions may involve the charge of a nonrefundable initial fee with subsequent periodic payments for future products or services. The up-front fees, even if nonrefundable, are recognized as revenue as the products and/or services are delivered and performed over the term of the arrangement. Liability related to the sale of future royalties The Company treats the sale of future royalties to Royalty Pharma as a debt financing, as the Company has significant continuing involvement in facilitating the transfer of royalties to Royalty Pharma and Royalty Pharma has recourse against the Company relating to the payments due from Janssen. As a result, the Company recorded the upfront payment of $ 60 million from this transaction as a liability related to the sale of future royalties, and up to an additional $ 95 million in potential milestone payments will also be recorded as a liability related to the sale of future royalties and amortized as interest expense over the estimated remaining life of the agreement. Under the terms of the agreement, all payments from Royalty Pharma to the Company, including the initial upfront payment of $ 60 million as well as amortized interest expense and potential milestone payments, are not repayable to Royalty Pharma in the event that Janssen discontinues the clinical development of seltorexant or ceases to pursue its commercialization at a future date for any reason. The liability related to sale of future royalties and the related interest expense is based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources. To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related non-cash interest expense. For further discussion of the sale of future royalties, please refer to Note 5, Sale of Future Royalties. Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief decision maker, who is the Chief Executive Officer, reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company views its operations and manages its business as one operating segment. Comprehensive loss The Company had no items of comprehensive loss other than its net loss for each period presented. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | NOTE 3 — ACCRUED EXPENSES AND OTHER LIABILITIES Accrued expenses and other liabilities consist of the following: Year Ended December 31, 2023 2022 Research and development costs and other accrued expenses $ 777,680 $ 279,434 Accrued bonus 590,769 14,832 Professional fees 166,648 113,643 Accrued expenses and other current liabilities $ 1,535,097 $ 407,909 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share of Common Stock | NOTE 4 — NET LOSS PER SHARE OF COMMON STOCK Diluted loss per share is the same as basic loss per share for all periods presented as the effects of potentially dilutive items were anti-dilutive given the Company’s net loss. Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding, plus potential outstanding common stock for the period. Potential outstanding common stock includes stock options and shares underlying RSUs, but only to the extent that their inclusion is dilutive. In June 2023, in connection with the Private Placement (as defined and described in Note 6, Stockholders’ Equity), the Company issued and sold pre-funded warrants exercisable for an aggregate of 575,575 shares of common stock. The purchase price of the pre-funded warrants is $ 9.99 per share, which was paid to the Company upon issuance of the pre-funded warrants. The exercise price of the pre-funded warrants is $ 0.01 per share. The pre-funded warrants are exercisable by the holders at any time and do not expire. As the remaining shares underlying the pre-funded warrants are issuable for nominal consideration of $ 0.01 per share, 575,575 shares of common stock underlying the unexercised pre-funded warrants were considered outstanding for purposes of the calculation of loss per share as of December 31, 2023. The following table sets forth the computation of basic and diluted loss per share for common stockholders: Year Ended December 31, 2023 2022 Net loss $ ( 30,005,353 ) $ ( 32,108,676 ) Weighted average shares of common stock outstanding 6,506,372 5,340,194 Net loss per share of common stock – basic and diluted $ ( 4.61 ) $ ( 6.01 ) The following securities outstanding at December 31, 2023 and 2022 have been excluded from the calculation of weighted average shares outstanding as their effect on the calculation of loss per share is antidilutive: Year Ended December 31, 2023 2022 Common stock options 1,157,229 700,929 Performance-based restricted stock units 228,209 456,422 Common stock warrants 5,099 5,099 In April 2023, the Compensation Committee of the Company’s board of directors certified the achievement of a performance condition occurring upon FDA acceptance of the NDA for roluperidone. As a result, 50 % of the shares of common stock underlying the PRSUs vested. As of December 31, 2023, 228,213 PRSUs have vested, 20,218 have been cancelled and 228,209 remain outstanding. |
Sale of Future Royalties
Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2023 | |
Sale Of Future Royalties [Abstract] | |
Sale of Future Royalties | NOTE 5 — SALE OF FUTURE ROYALTIES The Company had previously co-developed seltorexant with Janssen for the treatment of insomnia disorder and adjunctive treatment of MDD. During 2020, the Company exercised its right to opt out of the joint development agreement with Janssen for the future development of seltorexant and, as a result, the Company was entitled to collect royalties in the mid-single digits on potential future sales of seltorexant worldwide in certain indications, with no further financial obligations to Janssen. On January 19, 2021, the Company entered into an agreement with Royalty Pharma under which Royalty Pharma acquired the Company’s royalty interest in seltorexant for an upfront payment of $ 60 million and up to an additional $ 95 million in potential milestone payments. These milestone payments are contingent upon the achievement of certain clinical, regulatory and commercial milestones for seltorexant by Janssen or any other party in the event that Janssen sells seltorexant. Under the terms of the agreement, the Company has significant continuing involvement as Royalty Pharma has recourse against the Company relating to the payments due from Janssen. As such, the Company applied the debt recognition guidance under ASC 470, Debt, and recorded the upfront payment of $ 60 million as a liability related to the sale of future royalties (“Royalty Obligation”), which will be amortized under the interest method over the estimated life of the agreement. Under the terms of the agreement, all payments from Royalty Pharma to the Company, including the initial upfront payment of $ 60 million as well as amortized interest expense and potential milestone payments, are not repayable to Royalty Pharma in the event that Janssen discontinues the clinical development of seltorexant or ceases to pursue its commercialization at a future date for any reason. In addition, in accordance with ASC 470, Debt, the Company will account for any royalties received in the future as non-cash royalty revenue. As royalties are remitted from Janssen to Royalty Pharma, the balance of the Royalty Obligation will be effectively repaid over the life of the co-development and license agreement (the “Agreement”) with Janssen. In order to determine the amortization of the Royalty Obligation, the Company is required to estimate the total amount of future royalty payments to Royalty Pharma over the life of the Agreement. In addition to the $ 60 million upfront payment, up to an additional $ 95 million in potential milestone payments will also be recorded as a liability related to the sale of future royalties and amortized as interest expense over the estimated remaining life of the agreement. At execution, the Company’s estimate of this total interest expense resulted in an effective annual interest rate of approximately 10.5 %. As of December 31, 2023 , the Company estimated the effective annual interest rate to be approximately 10.97 %. This estimate contains significant assumptions, which are considered Level 3 fair value inputs, regarding the timing and amount of expected royalty and milestone payments that impact the interest expense that will be recognized over the royalty period. The Company will periodically assess the estimated royalty payments to Royalty Payments from Janssen and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect the amount and timing of royalty payments to Royalty Pharma from Janssen, and correspondingly, the amount of interest expense recorded by the Company, most of which are not within the Company’s control. Such factors include, but are not limited to, delays or discontinuation of development of seltorexant, regulatory approval, changing standards of care, the introduction of competing products, manufacturing or other delays, generic competition, intellectual property matters, adverse events that result in regulatory authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to Royalty Pharma are made in U.S. dollars (“USD”) while the underlying sales of seltorexant will be made in currencies other than USD, the ongoing COVID-19 pandemic, and other events or circumstances that are not currently foreseen. Changes to any of these factors could result in increases or decreases to both royalty revenues and interest expense. Janssen is currently conducting one Phase 3 study with seltorexant, completed a Phase 3 study during 2023, and discontinued a Phase 3 study during 2022. The following table shows the activity of the Royalty Obligation since the transaction inception through December 31, 2023: December 31, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 22,016,823 Liability related to the sale of future royalties $ 82,016,823 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | NOTE 6 — STOCKHOLDERS’ EQUITY Private Placement of Common Stock and Warrants On June 27, 2023 , the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors in a private placement (the “Private Placement”) (i) an aggregate of 1,425,000 shares (the “Shares”) of the Company’s common stock at a purchase price of $ 10.00 per Share, and (ii) in lieu of additional shares of common stock, pre-funded warrants to purchase an aggregate of 575,575 shares of common stock at a purchase price of $ 9.99 per pre-funded warrant. The price per pre-funded warrant represents the price of $ 10.00 per Share sold in the Private Placement, minus the $ 0.01 per share exercise price of each such pre-funded warrant. The pre-funded warrants are exercisable at any time after their original issuance and will not expire until exercised in full. The pre-funded warrants issued in the Private Placement provide that a holder of the pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants to the extent such holder, together with its affiliates, after giving effect to such exercise, would beneficially own in excess of the beneficial ownership limitation, as elected by such Investor, immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that each pre-funded warrant holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99 %. On June 30, 2023, the Private Placement closed and the Company received aggregate gross proceeds from the Private Placement of $ 20.0 million. The Company incurred approximately $ 0.4 million in offering expenses as of December 31, 2023, which have been included as a component of additional paid-in capital, resulting in net proceeds of $ 19.6 million as of December 31, 2023. Pursuant to the Securities Purchase Agreement, the Company filed a registration statement on Form S-3 (File No. 333-273686), which was declared effective by the SEC on August 9, 2023, covering the resale of the Registrable Securities (as such term is defined in the Securities Purchase Agreement). The Company has agreed to use its commercially reasonable efforts to keep such registration statement effective until the earlier of (i) the third anniversary of the effective date of the initial registration statement covering the Registrable Securities; (ii) the date all Shares and all shares of common stock underlying the pre-funded warrants may be sold under Rule 144 of the Securities Act of 1933, as amended, without being subject to any volume, manner of sale or publicly available information requirements; or (iii) immediately prior to the closing of a Change of Control (as such term is defined in the Securities Purchase Agreement). Pursuant to the Securities Purchase Agreement, in connection with the Private Placement, Boehringer Ingelheim International GmbH (“BI”), an Investor in the Private Placement, has the right to designate an observer to attend, subject to certain exceptions, meetings of the Company’s board of directors and its committees, until the earlier of (i) the occurrence of a Change of Control and (ii) the date that it and its affiliates collectively hold less than 10 % of the Company’s common stock (which shall be calculated by including in the amount of common stock held by such Investor and its affiliates any shares of common stock issuable upon exercise of any portion of the pre-funded warrant issued to such Investor and not yet exercised). BI designated a board observer on August 29, 2023. At-the-Market Equity Offering Program In September 2022 , the Company entered into an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which the Company may offer and sell, from time to time, through Jefferies shares of the Company ’s common stock, by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. During the twelve months ended December 31, 2023 , no shares of the Company’s common stock were issued or sold under the Sales Agreement. As of December 31, 2023 , an aggregate of $ 22.6 million was eligible for sale pursuant to the Sales Agreement under the Company’s effective registration statement on Form S-3 (File No. 333-267424). Term Loan Warrants In connection with the Company’s former Loan and Security Agreement with Oxford Finance LLC and Silicon Valley Bank (the “Lenders”), which provided for term loans to the Company in an aggregate principal amount of up to $ 15 million in two tranches on January 15, 2016, the Company issued the Lenders warrants to purchase 5,099 shares of common stock at a per share exercise price of $ 44.13 . The warrants were immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions, will expire on the ten-year anniversary of the date of issuance. The term loans were repaid in August 2018. All related warrants were outstanding and exercisable as of December 31, 2023 . |
Stock Award Plan and Stock-Base
Stock Award Plan and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Award Plan and Stock-Based Compensation | NOTE 7 — STOCK AWARD PLAN AND STOCK-BASED COMPENSATION In December 2013, the Company adopted the 2013 Equity Incentive Plan (as subsequently amended and restated, the “Plan”), which provides for the issuance of options, stock appreciation rights, stock awards and stock units. Stock Option Awards Stock option activity for employees and non-employees for the year ended December 31, 2023 is as follows: Shares Weighted- Weighted- Total Intrinsic Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted 483,800 $ 6.52 Exercised — $ — Cancelled/Forfeited ( 27,500 ) $ 36.60 Outstanding December 31, 2023 1,157,229 $ 11.36 8.5 $ 745 Exercisable December 31, 2023 389,767 $ 22.17 7.0 $ 213 Available for future grant 362,366 The weighted average grant-date fair value of stock options outstanding on December 31, 2023 was $ 8.31 per share. Total unrecognized compensation costs related to non-vested stock options at December 31, 2023 were approximately $ 3.6 million and are expected to be recognized within future operating results over a weighted-average period of 2.9 years. The total intrinsic value of the options exercised during the years ended December 31, 2023 and 2022 was zero . The expected term of the employee-related options was estimated using the “simplified” method as defined by the SEC’s Staff Accounting Bulletin No. 107, Share-Based Payment . The volatility assumption was determined by examining the historical volatility of the Company and volatilities for industry peer companies. The risk-free interest rate assumption is based on the U.S. Treasury instruments, the term of which was consistent with the expected term of the options. The dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has never paid dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable future. Accordingly, the Company has assumed no dividend yield for the purposes of estimating the fair value of the options. The Company uses the Black-Scholes model to estimate the fair value of stock options granted. For stock options granted during the years ended December 31, 2023 and 2022, the Company utilized the following assumptions: Year Ended December 31, 2023 2022 Expected term (years) 5.50 - 6.25 5.50 - 6.25 Risk free interest rate 4.68 % - 4.74 % 1.96 % - 3.62 % Volatility 115 % - 119 % 75 % - 97 % Dividend yield 0 % 0 % Weighted average grant date fair value per share of common stock $ 5.67 $ 3.48 Performance-Based Restricted Stock Units On August 6, 2021, options to purchase 953,980 shares of the Company’s common stock were exchanged for 476,640 PRSUs. Options surrendered in the one-time stock option exchange program (the “Exchange Program”) were cancelled and shares subject to the cancelled options again became available for issuance under the Plan. The Exchange Program was treated as a Type II modification (Probable-to improbable) under ASC 718. The Company used the pre-modification stock options for determining the compensation cost related to the PRSUs as the vesting conditions remain uncertain for the outstanding PRSUs. As of December 31, 2023 , the total unrecognized compensation cost related to non-vested pre-modification stock options was zero . On April 28, 2023, the Compensation Committee of the Company’s board of directors certified the achievement of a performance condition occurring upon FDA acceptance of the NDA for roluperidone. As a result, 50 % of the shares of common stock underlying the Company’s PRSUs vested. The remaining PRSUs vest upon roluperidone receiving FDA marketing approval, provided that such approval occurs within five years after the August 6, 2021 grant date. As of December 31, 2023 , 228,213 PRSUs have vested, 20,218 have been cancelled, and 228,209 remain outstanding. As a result of the PRSUs vesting, the Company recognized approximately $ 0.2 million in non-cash compensation expense for the period ending December 31, 2023 , representing 50 % of the incremental cost of the PRSUs granted under the Exchange Program. The incremental cost was measured as the excess of the fair value of each new PRSU, measured as of the date the new PRSUs were granted, over the fair value of the stock options surrendered in exchange for the new PRSU, measured immediately prior to the cancellation. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Year Ended December 31, 2023 2022 Research and development $ 909,845 $ 2,007,681 General and administrative 1,058,536 2,101,138 Total $ 1,968,381 $ 4,108,819 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 8 — INCOME TAXES The provision for federal, foreign and state income taxes for the years ended December 31, 2023 and 2022 are as follows: Year Ended December 31, 2023 2022 Current income tax provision (benefit) Federal $ — $ — Foreign — — State — — Deferred income tax provision (benefit) Federal — — Foreign — — State — — Total income tax provision (benefit) $ — $ — Net deferred tax assets (liabilities) as of December 31, 2023 and 2022 consist of the following: Year Ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 34,490,808 $ 26,695,408 Research and development tax credits 145,115 145,115 Capitalized research and development costs 27,901,874 29,527,069 Stock-based compensation 8,911,005 10,038,836 Deferred start-up and license costs 3,011,692 3,559,272 Sale of royalties 22,406,996 20,144,095 Total deferred tax assets 96,867,490 90,109,795 Deferred tax asset valuation allowance ( 96,867,059 ) ( 90,108,904 ) Net deferred tax assets 431 891 Deferred tax liabilities: Depreciation ( 431 ) ( 891 ) Total deferred tax liabilities ( 431 ) ( 891 ) Total $ — $ — A reconciliation between the Company’s effective tax rate and the federal statutory rate for the years ended December 31, 2023 and 2022 are as follows: Year Ended December 31, 2023 2022 Federal statutory rate 21.00 % 21.00 % Permanent differences ( 0.57 %) ( 0.08 %) State income taxes, net of federal benefit 0.00 % 0.00 % Valuation allowance ( 20.44 %) ( 20.92 %) Effective tax rate ( 0.00 %) 0.00 % In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based upon the level of historical losses and the uncertainty of future taxable income over the periods which the Company will realize the benefits of its net deferred tax assets, management believes it is more likely than not that the Company will not realize the benefits on the balance of its net deferred tax asset and, accordingly, the Company has established a full valuation allowance on its net deferred tax assets. The valuation allowance increased by approximately $ 6.8 million and $ 8.8 million during the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 , the Company had approximately $ 126.2 million of federal net operating losses that will begin to expire in 2036 , if not utilized. Of the total federal net operating loss, approximately $ 104.8 million has an unlimited carryforward and therefore will not expire. As of December 31, 2023 , the Company had approximately $ 7.7 million of New Jersey and approximately $ 116.3 million of Massachusetts operating losses that will begin to expire in 2029 and 2037 , respectively, if not utilized. As of December 31, 2023 , the Company had approximately $ 0.1 million of federal research and development credits that will begin to expire in 2027 , if not utilized. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2019 to present. As of December 31, 2023 and 2022 , the Company had no liability recorded for unrecognized tax benefit. The Company classifies penalties and interest expense related to income tax liabilities as an income tax expense. There were no interest and penalties recognized in the statements of operations for the years ended December 31, 2023 and 2022, or accrued on the balance sheets as of December 31, 2023 and 2022 . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 9 — COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of the Company’s business activities. The Company is not aware of any claim or litigation, the outcome of which, if determined adversely to the Company, would have a material effect on the Company’s financial position or results of operations. Leases On October 11, 2022, the Company entered into an office lease agreement with Regus to lease approximately 491 rentable square feet of office space located at 1500 District Avenue, Burlington, MA 01803. In January 2024, the Company renewed the month-to-month lease agreement commencing on February 1, 2024 , with a monthly payment of $ 8,697 . The Company has elected to not recognize the lease agreement on the balance sheet as the term of the agreement is 12 months or less. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | NOTE 10 — RELATED PARTY TRANSACTIONS None. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 11 — SUBSEQUENT EVENTS None. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. From its inception, the Company has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, planning and executing clinical trials and raising capital. |
Reverse Stock Split | Reverse Stock Split On June 17, 2022, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect a one-for-eight (1-for-8) reverse stock split of its outstanding common stock. The Amendment became effective at 5:00 p.m. Eastern Time on June 17, 2022. A series of alternate amendments to effect a reverse stock split was approved by the Company’s stockholders at the Company’s 2022 Annual Meeting of Stockholders on June 10, 2022, and the specific one-for-eight (1-for-8) reverse stock split was subsequently approved by the Company’s board of directors on June 10, 2022. The Amendment provided that, at the effective time of the Amendment, every eight (8) shares of the Company’s issued and outstanding common stock automatically combined into one issued and outstanding share of common stock, without any change in par value per share. The reverse stock split affected all shares of the Company’s common stock outstanding immediately prior to the effective time of the Amendment. As a result of the reverse stock split, proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options, restricted stock units and restricted stock awards issued by the Company and outstanding immediately prior to the effective time of the Amendment, which resulted in a proportionate decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, restricted stock units and restricted stock awards, and, in the case of stock options, a proportionate increase in the exercise price of all such stock options. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time of the Amendment was reduced proportionately. The reverse stock split did not affect the number of shares of common stock authorized for issuance under the Company’s Amended and Restated Certificate of Incorporation, which remained at 125,000,000 shares. No fractional shares were issued as a result of the reverse stock split. Stockholders of record who would otherwise have been entitled to receive a fractional share received a cash payment in lieu thereof. The reverse stock split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the reverse stock split results in any stockholder owning only a fractional share). As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock as of June 17, 2022 decreased from 42,721,566 (pre-split) shares to 5,340,193 (post-split) shares. All share and per share amounts in the accompanying financial statements, related footnotes, and management’s discussion and analysis have been adjusted retroactively to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented. The Company’s common stock began trading on The Nasdaq Global Market on a split-adjusted basis when the market opened on June 21, 2022. Effective September 12, 2022, the Company transferred the listing of its common stock from The Nasdaq Global Market to The Nasdaq Capital Market. |
Consolidation | Consolidation The accompanying consolidated financial statements include the results of the Company and its wholly-owned subsidiaries, Mind-NRG Sarl and Minerva Neurosciences Securities Corporation. Intercompany transactions have been eliminated. |
Significant Risks and Uncertainties | Significant risks and uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. |
Use of Estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and cash equivalents Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. |
Refundable regulatory fee | Refundable regulatory fee On August 12, 2022, the Company paid $ 3,117,218 to the FDA for the NDA user fee related to roluperidone. The Company met the conditions of the Federal Food, Drug, and Cosmetic Act, as amended, for the small business waiver of the user fees and its request for a waiver of an application user fee was granted by the FDA on November 2, 2022. On January 26, 2023, the refund was received from the FDA. |
Restricted Cash | Restricted cash Cash accounts with any type of restriction are classified as restricted. The Company maintained restricted cash balances as collateral for corporate credit cards in the amount of $ 0.1 million at December 31, 2023 and 2022 . |
Research and Development Costs | Research and development costs Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company and costs related to salaries, benefits, bonuses and stock-based compensation granted to employees in research and development functions. The Company determines expenses related to clinical studies based on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical studies on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. The expenses for some trials may be recognized on a straight-line basis if the anticipated costs are expected to be incurred ratably during the period. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. |
In-Process Research and Development | In-process research and development In-process research and development (“IPR&D”) assets represent capitalized incomplete research projects that the Company acquired through business combinations. Such assets are initially measured at their acquisition date fair values. The initial fair values of the research projects are recorded as intangible assets on the balance sheet, rather than expensed, regardless of whether these assets have an alternative future use. The amounts capitalized are being accounted for as indefinite-lived intangible assets, subject to impairment testing, until completion or abandonment of research and development efforts associated with the project. An IPR&D asset is considered abandoned when it ceases to be used (that is, research and development efforts associated with the asset have ceased, and there are no plans to sell or license the asset or derive defensive value from the asset). At that point, the asset is considered to be disposed of and is written off. Upon successful completion of each project, the Company will make a determination about the remaining useful life of the intangible asset and begin amortization. The Company tests its indefinite-lived intangibles, IPR&D assets, for impairment annually and more frequently if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. When testing indefinite-lived intangibles for impairment, the Company may assess qualitative factors for its indefinite-lived intangibles to determine whether it is more likely than not (that is, a likelihood of more than 50 percent) that the asset is impaired. Alternatively, the Company may bypass this qualitative assessment for some or all of its indefinite-lived intangibles and perform the quantitative impairment test that compares the fair value of the indefinite-lived intangible asset with the asset’s carrying amount. Impairment of MIN-301 In-process Research and Development Asset In 2021, the Company made the strategic decision to focus its limited resources on moving forward its lead drug candidate, roluperidone, and deferred the development of MIN-301 until additional resources become available. As a result of the Company’s limited resources and development deferral combined with the overall market conditions, it recognized a non-cash charge of $ 15.2 million as of December 31, 2021 related to the impairment of the intangible asset for MIN-301. The Company had previously recognized in-process research and development for MIN-301 in conjunction with the acquisition of MIN-301 during 2014. No updates were made in respect of the development of MIN-301 during 2023 . |
Stock-Based Compensation | Stock-based compensation The Company recognizes compensation cost relating to stock-based payment transactions using a fair-value measurement method, which requires all stock-based payments to employees, including grants of employee stock options, to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The Company determines the fair value of stock-based awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield, and expected life of the options. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur. The fair value of restricted stock units (“RSUs”) is equal to the closing price of the Company’s common stock on the date of grant. See Note 7 for information on the Company’s performance-based restricted stock units (“PRSU”) grants. The date of expense recognition for grants to non-employees is the earlier of the date at which a commitment for performance by the counterparty to earn the equity instrument is reached or the date at which the counterparty’s performance is complete. The Company determines the fair value of stock-based awards granted to non-employees similar to the way fair value of awards are determined for employees except that certain assumptions used in the Black-Scholes option-pricing model, such as expected life of the option, may be different. |
Foreign Currency Transactions | Foreign currency transactions The Company’s functional currency is the U.S. Dollar. The Company pays certain vendor invoices in the respective foreign currency. The Company records an expense in U.S. Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date an expense is recorded and the payment date is recorded as a foreign currency gain or loss. |
Loss Per Share | Loss per share Basic loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and warrants. |
Income Taxes | Income taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Uncertain tax positions are evaluated and if appropriate, the amount of unrecognized tax benefits are recorded within deferred tax assets. Deferred tax assets are evaluated for realization based on a more-likely-than-not criterion in determining if a valuation allowance should be provided. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company uses a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken, or expected to be taken, in a tax return. The Company has elected to treat interest and penalties, to the extent they arise, as a component of income tax expense. There was no interest or penalties related to income taxes for the years ended December 31, 2023 or 2022 . Income tax years beginning in 2019 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of corporate bonds, with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings. |
Equipment | Equipment Equipment is stated at cost less accumulated depreciation. Equipment is depreciated on the straight-line basis over their estimated useful lives of three years . Expenditures for maintenance and repairs are charged to expense as incurred. |
Software | Software The Company accounts for capitalized software in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350, Intangibles—Goodwill and Other (“ASC 350-40”), which provides guidance for computer software developed or obtained for internal use. The Company is required to continually evaluate the stage of the implementation process to determine whether costs are expensed or capitalized. Costs incurred during the preliminary project phase or planning and research phase are expensed as incurred. Costs incurred during the development phase, such as material and direct services costs, compensation costs of employees associated with the development and interest cost, are capitalized as incurred. Costs incurred during the post-implementation or operation phase, such as training and maintenance costs, are expensed as incurred. In addition, costs incurred to modify existing software that result in additional functionality are capitalized as incurred. Capitalized costs are amortized over the expected useful life of the asset. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract . This new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Also, capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. |
Leases | Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company has elected not to recognize on the balance sheet leases with terms of 12 months or less. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. The Company monitors its plans to renew its material leases on a quarterly basis. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in the Company’s leases is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term and in a similar economic environment. In transition to FASB ASC Topic 842, Leases (“ASC 842”), the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.). The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components by class of underlying asset where entities would account for each lease component and the related non-lease component together as a single component. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease and non-lease components for leases, for classes of all underlying assets, and allocate all of the contract consideration to the lease component only. |
Long-Lived Assets | Long-lived assets The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. If required, the Company compares the estimated undiscounted future net cash flows to the related asset’s carrying value to determine whether there has been an impairment. If an asset is considered impaired, the asset is written down to fair value, which is based either on discounted cash flows or appraised values in the period the impairment becomes known. The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2023 and 2022 . |
Goodwill | Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value. Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances. If the Company determines that an impairment has occurred, it is required to record a write-down of the carrying value and charge the impairment as an operating expense in the period the determination is made. In evaluating the recoverability of the carrying value of goodwill, the Company must make assumptions regarding estimated future cash flows and other factors to determine the fair value of the acquired assets. Changes in strategy or market conditions could significantly impact those judgments in the future and require an adjustment to the recorded balances. The Company has a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2023 and 2022. As of December 31, 2023 , $ 14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value. As the reporting unit had a positive fair value, there was no impairment associated with this reporting unit. |
Fair Value of Financial Instruments | Fair value of financial instruments The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels: Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The following tables present information about the Company’s cash equivalents and marketable securities as of December 31, 2023 and 2022, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2023 Total Level 1 Level 2 Level 3 Cash equivalents $ 27,351,596 $ 27,351,596 $ — $ — Total fair value $ 27,351,596 $ 27,351,596 $ — $ — December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents $ 34,557,146 $ 34,557,146 $ — $ — Total fair value $ 34,557,146 $ 34,557,146 $ — $ — Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk. The Company’s financial instruments consist of cash and cash equivalents, restricted cash, accounts payable, accrued expenses and liabilities related to the sale of future royalties. The carrying amounts of cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximate fair value because of their short-term nature. |
Revenue Recognition | Revenue recognition The Company applies the revenue recognition guidance in accordance with ASC 606, Revenue from Contracts with Customers . Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable, and collectability is reasonably assured. The Company is a development stage company and has had no revenues from product sales to date. When the Company enters into an arrangement that meets the definition of a collaboration under ASC 808, Collaborative Arrangements , the Company recognizes revenue as research and development is performed and its respective share of the expenses are incurred. The Company assesses whether the arrangement contains multiple elements or deliverables, which may include (1) licenses to the Company's technology, (2) research and development activities performed for the collaboration partner, and (3) participation on joint steering committees. Payments may include non-refundable, upfront payments, milestone payments upon achieving significant development events, and royalties on future sales. Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price, and (iii) best estimate of selling price. The best estimate of selling price reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. The consideration allocated to each unit of accounting is then recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Supply or service transactions may involve the charge of a nonrefundable initial fee with subsequent periodic payments for future products or services. The up-front fees, even if nonrefundable, are recognized as revenue as the products and/or services are delivered and performed over the term of the arrangement. |
Liability Related To The Sale Of Future Royalties | Liability related to the sale of future royalties The Company treats the sale of future royalties to Royalty Pharma as a debt financing, as the Company has significant continuing involvement in facilitating the transfer of royalties to Royalty Pharma and Royalty Pharma has recourse against the Company relating to the payments due from Janssen. As a result, the Company recorded the upfront payment of $ 60 million from this transaction as a liability related to the sale of future royalties, and up to an additional $ 95 million in potential milestone payments will also be recorded as a liability related to the sale of future royalties and amortized as interest expense over the estimated remaining life of the agreement. Under the terms of the agreement, all payments from Royalty Pharma to the Company, including the initial upfront payment of $ 60 million as well as amortized interest expense and potential milestone payments, are not repayable to Royalty Pharma in the event that Janssen discontinues the clinical development of seltorexant or ceases to pursue its commercialization at a future date for any reason. The liability related to sale of future royalties and the related interest expense is based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources. To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related non-cash interest expense. For further discussion of the sale of future royalties, please refer to Note 5, Sale of Future Royalties. |
Segment Information | Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief decision maker, who is the Chief Executive Officer, reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company views its operations and manages its business as one operating segment. |
Comprehensive Loss | Comprehensive loss The Company had no items of comprehensive loss other than its net loss for each period presented. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Fair Value of Cash Equivalents and Marketable Securities Measured on Recurring Basis and Determined by Valuation Techniques | The following tables present information about the Company’s cash equivalents and marketable securities as of December 31, 2023 and 2022, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2023 Total Level 1 Level 2 Level 3 Cash equivalents $ 27,351,596 $ 27,351,596 $ — $ — Total fair value $ 27,351,596 $ 27,351,596 $ — $ — December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents $ 34,557,146 $ 34,557,146 $ — $ — Total fair value $ 34,557,146 $ 34,557,146 $ — $ — |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: Year Ended December 31, 2023 2022 Research and development costs and other accrued expenses $ 777,680 $ 279,434 Accrued bonus 590,769 14,832 Professional fees 166,648 113,643 Accrued expenses and other current liabilities $ 1,535,097 $ 407,909 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Loss Per Share | The following table sets forth the computation of basic and diluted loss per share for common stockholders: Year Ended December 31, 2023 2022 Net loss $ ( 30,005,353 ) $ ( 32,108,676 ) Weighted average shares of common stock outstanding 6,506,372 5,340,194 Net loss per share of common stock – basic and diluted $ ( 4.61 ) $ ( 6.01 ) |
Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive | The following securities outstanding at December 31, 2023 and 2022 have been excluded from the calculation of weighted average shares outstanding as their effect on the calculation of loss per share is antidilutive: Year Ended December 31, 2023 2022 Common stock options 1,157,229 700,929 Performance-based restricted stock units 228,209 456,422 Common stock warrants 5,099 5,099 |
Sale of Future Royalties (Table
Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Sale Of Future Royalties [Abstract] | |
Summary of Activity of the Royalty Obligation | The following table shows the activity of the Royalty Obligation since the transaction inception through December 31, 2023: December 31, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 22,016,823 Liability related to the sale of future royalties $ 82,016,823 |
Stock Award Plan and Stock-Ba_2
Stock Award Plan and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity for Employees and Non-Employees | Stock option activity for employees and non-employees for the year ended December 31, 2023 is as follows: Shares Weighted- Weighted- Total Intrinsic Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted 483,800 $ 6.52 Exercised — $ — Cancelled/Forfeited ( 27,500 ) $ 36.60 Outstanding December 31, 2023 1,157,229 $ 11.36 8.5 $ 745 Exercisable December 31, 2023 389,767 $ 22.17 7.0 $ 213 Available for future grant 362,366 |
Summary of Assumptions Used in Black Scholes Model to Estimate Fair Value of Stock Options | The Company uses the Black-Scholes model to estimate the fair value of stock options granted. For stock options granted during the years ended December 31, 2023 and 2022, the Company utilized the following assumptions: Year Ended December 31, 2023 2022 Expected term (years) 5.50 - 6.25 5.50 - 6.25 Risk free interest rate 4.68 % - 4.74 % 1.96 % - 3.62 % Volatility 115 % - 119 % 75 % - 97 % Dividend yield 0 % 0 % Weighted average grant date fair value per share of common stock $ 5.67 $ 3.48 |
Schedule of Stock-Based Compensation Expense Included in the Company's Consolidated Statements of Operations | The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Year Ended December 31, 2023 2022 Research and development $ 909,845 $ 2,007,681 General and administrative 1,058,536 2,101,138 Total $ 1,968,381 $ 4,108,819 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Federal, Foreign and State Income Taxes | The provision for federal, foreign and state income taxes for the years ended December 31, 2023 and 2022 are as follows: Year Ended December 31, 2023 2022 Current income tax provision (benefit) Federal $ — $ — Foreign — — State — — Deferred income tax provision (benefit) Federal — — Foreign — — State — — Total income tax provision (benefit) $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | Net deferred tax assets (liabilities) as of December 31, 2023 and 2022 consist of the following: Year Ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 34,490,808 $ 26,695,408 Research and development tax credits 145,115 145,115 Capitalized research and development costs 27,901,874 29,527,069 Stock-based compensation 8,911,005 10,038,836 Deferred start-up and license costs 3,011,692 3,559,272 Sale of royalties 22,406,996 20,144,095 Total deferred tax assets 96,867,490 90,109,795 Deferred tax asset valuation allowance ( 96,867,059 ) ( 90,108,904 ) Net deferred tax assets 431 891 Deferred tax liabilities: Depreciation ( 431 ) ( 891 ) Total deferred tax liabilities ( 431 ) ( 891 ) Total $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation between the Company’s effective tax rate and the federal statutory rate for the years ended December 31, 2023 and 2022 are as follows: Year Ended December 31, 2023 2022 Federal statutory rate 21.00 % 21.00 % Permanent differences ( 0.57 %) ( 0.08 %) State income taxes, net of federal benefit 0.00 % 0.00 % Valuation allowance ( 20.44 %) ( 20.92 %) Effective tax rate ( 0.00 %) 0.00 % |
NATURE OF OPERATIONS AND LIQU_2
NATURE OF OPERATIONS AND LIQUIDITY - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jan. 19, 2021 | Jan. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Nature Of Operations And Liquidity [Line Items] | ||||
Accumulated deficit | $ 396,815,428 | $ 366,810,075 | ||
Net cash used in operating activities | 14,784,732 | $ 24,645,143 | ||
Cash, cash equivalents, restricted cash and marketable securities | 41,000,000 | |||
Seltorexant | Royalty Pharma | ||||
Nature Of Operations And Liquidity [Line Items] | ||||
Up front payment | $ 60,000,000 | $ 60,000,000 | $ 60,000,000 | |
Maximum | Seltorexant | Royalty Pharma | ||||
Nature Of Operations And Liquidity [Line Items] | ||||
Potential future milestone payments | $ 95,000,000 | |||
Common Stock | ||||
Nature Of Operations And Liquidity [Line Items] | ||||
Common stock issued and sold | 1,425,000 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) | 1 Months Ended | 12 Months Ended | 35 Months Ended | ||||||
Aug. 12, 2022 USD ($) | Jun. 17, 2022 shares | Jun. 16, 2022 shares | Jan. 19, 2021 USD ($) | Jan. 31, 2021 USD ($) | Dec. 31, 2023 USD ($) Segment shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2023 USD ($) shares | |
Significant Accounting Policies [Line Items] | |||||||||
Restricted cash balances as collateral for corporate credit cards | $ 100,000 | $ 100,000 | $ 100,000 | ||||||
Interest or penalties related to income taxes | $ 0 | 0 | |||||||
Equipment estimated useful life | 3 years | 3 years | |||||||
Impairment of long-lived assets | $ 0 | 0 | |||||||
Impairment of goodwill | 0 | $ 0 | |||||||
Revenues from product sales to date | 0 | ||||||||
Upfront Payment Paid | 60,000,000 | $ 60,000,000 | |||||||
Additional potential milestone payments | $ 95,000,000 | $ 95,000,000 | |||||||
Number of operating segments | Segment | 1 | ||||||||
Number of shares of common stock authorized | shares | 125,000,000 | 125,000,000 | 125,000,000 | 125,000,000 | |||||
Outstanding shares of common stock reverse stock splits | shares | 5,340,193 | 42,721,566 | |||||||
Reverse stock split | The Company’s common stock began trading on The Nasdaq Global Market on a split-adjusted basis when the market opened on June 21, 2022. Effective September 12, 2022, the Company transferred the listing of its common stock from The Nasdaq Global Market to The Nasdaq Capital Market. | ||||||||
User fees paid, related to roluperidone | $ 3,117,218 | ||||||||
Goodwill | $ 14,869,399 | $ 14,869,399 | $ 14,869,399 | ||||||
Single Reporting Unit | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Impairment of long-lived assets | 0 | ||||||||
Goodwill | $ 14,900,000 | $ 14,900,000 | |||||||
Development-stage Proprietary Compounds | MIN-301 | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Impairment of in-process research and development | $ 15,200,000 | ||||||||
Impairment Of Intangible Asset Indefinite Lived Excluding Goodwill Statement Of Income Or Comprehensive Income Extensible Enumeration Not Disclosed Flag | true | ||||||||
Seltorexant | Royalty Pharma | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Upfront Payment | $ 60,000,000 | $ 60,000,000 | $ 60,000,000 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Cash Equivalents and Marketable Securities Measured on Recurring Basis and Determined by Valuation Techniques (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 27,351,596 | $ 34,557,146 |
Cash and Cash Equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 27,351,596 | 34,557,146 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 27,351,596 | 34,557,146 |
Level 1 | Cash and Cash Equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 27,351,596 | $ 34,557,146 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES - Accrued Expenses and Other Liabilities (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development costs and other accrued expenses | $ 777,680 | $ 279,434 |
Accrued bonus | 590,769 | 14,832 |
Professional fees | 166,648 | 113,643 |
Accrued expenses and other current liabilities | $ 1,535,097 | $ 407,909 |
NET LOSS PER SHARE OF COMMON _3
NET LOSS PER SHARE OF COMMON STOCK - Additional Information (Details) - $ / shares | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Apr. 28, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | |
Performance-based Restricted Stock Units | ||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Vesting percentage | 50% | |||
PRSU'S vested | 228,213 | 228,213 | ||
PRSU'S cancelled | 20,218 | |||
PRSU'S outstanding | 228,209 | 228,209 | ||
Private Placement | ||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Shares of common stock to purchase by warrant | 575,575 | 575,575 | 575,575 | |
Common stock exercise price per share | $ 9.99 | |||
Exercise price of pre-funded warrants | $ 0.01 | |||
Pre-funded warrants issuable nominal consideration per share | $ 0.01 |
NET LOSS PER SHARE OF COMMON _4
NET LOSS PER SHARE OF COMMON STOCK - Computation of Basic and Diluted Loss Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (30,005,353) | $ (32,108,676) |
Weighted average shares of common stock outstanding - basic | 6,506,372 | 5,340,194 |
Weighted average shares of common stock outstanding - diluted | 6,506,372 | 5,340,194 |
Net loss per share, basic | $ (4.61) | $ (6.01) |
Net loss per share, diluted | $ (4.61) | $ (6.01) |
NET LOSS PER SHARE OF COMMON _5
NET LOSS PER SHARE OF COMMON STOCK - Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Common Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 1,157,229 | 700,929 |
Performance-based restricted stock units ("PRSUs") | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 228,209 | 456,422 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 5,099 | 5,099 |
Sale of Future Royalties - Addi
Sale of Future Royalties - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jan. 19, 2021 | Jan. 31, 2021 | Dec. 31, 2023 | |
Sale Of Future Royalties [Line Items] | |||
Liability related to the sale of future royalties | $ 60,000,000 | $ 82,016,823 | |
Annual interest rate on interest expense | 10.50% | 10.97% | |
Seltorexant | Royalty Pharma | |||
Sale Of Future Royalties [Line Items] | |||
Upfront payment for royalty interest sold | $ 60,000,000 | $ 60,000,000 | $ 60,000,000 |
Additional milestone payments | $ 95,000,000 |
Sale of Future Royalties - Summ
Sale of Future Royalties - Summary of Activity of the Royalty Obligation (Details) - USD ($) | 12 Months Ended | 35 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Jan. 19, 2021 | |
Sale Of Future Royalties [Abstract] | ||||
Upfront payment from the sale of future royalties | $ 60,000,000 | $ 60,000,000 | ||
Non-cash interest expense associated with the sale of future royalties | 8,282,947 | $ 7,406,555 | 22,016,823 | |
Liability related to the sale of future royalties | $ 82,016,823 | $ 82,016,823 | $ 60,000,000 |
STOCKHOLDERS' EQUITY - Private
STOCKHOLDERS' EQUITY - Private Placement of Common Stock and Warrants - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2023 | Jun. 30, 2023 | Jun. 27, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | |
Class of Warrant or Right [Line Items] | |||||
Offering expenses | $ 396,293 | ||||
Net proceeds from issuance of private placement | $ 19,999,994 | ||||
Private Placement | |||||
Class of Warrant or Right [Line Items] | |||||
Shares of common stock to purchase by warrant | 575,575 | 575,575 | 575,575 | 575,575 | |
Common stock exercise price per share | $ 9.99 | $ 9.99 | |||
Exercise price of pre-funded warrants | $ 0.01 | ||||
Private Placement | Investors | Securities Purchase Agreement | |||||
Class of Warrant or Right [Line Items] | |||||
Sale of stock issue date | Jun. 27, 2023 | ||||
Common stock issued and sold | 1,425,000 | ||||
Purchase price per share | $ 10 | ||||
Shares of common stock to purchase by warrant | 575,575 | ||||
Common stock exercise price per share | $ 9.99 | ||||
Pre-funded warrants exercise price exercisable time description | The price per pre-funded warrant represents the price of $10.00 per Share sold in the Private Placement, minus the $0.01 per share exercise price of each such pre-funded warrant. The pre-funded warrants are exercisable at any time after their original issuance and will not expire until exercised in full. | ||||
Exercise price of pre-funded warrants | $ 0.01 | ||||
Notice period to change beneficial ownership limitation | 61 days | ||||
Maximum beneficial ownership limitation | 19.99% | ||||
Gross proceeds from issuance of private placement | $ 20,000,000 | ||||
Offering expenses | $ 400,000 | ||||
Net proceeds from issuance of private placement | $ 19,600,000 | ||||
Maximum percentage of common stock affiliates collectively hold | 10% |
STOCKHOLDERS' EQUITY - At-the-M
STOCKHOLDERS' EQUITY - At-the-Market Equity Offering Program - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) shares | |
Class Of Warrant Or Right [Line Items] | |
Sales of common stock, value | $ | $ 19,999,994 |
Sales Agreement | |
Class Of Warrant Or Right [Line Items] | |
Sale of stock issue date | Sep. 30, 2022 |
Eligible for sale of equity | 22,600,000 |
Common Stock | |
Class Of Warrant Or Right [Line Items] | |
Sales of common stock, value | $ | $ 142 |
Common stock issued and sold | 1,425,000 |
Common Stock | Sales Agreement | |
Class Of Warrant Or Right [Line Items] | |
Common stock issued and sold | 0 |
STOCKHOLDERS' EQUITY - Term Loa
STOCKHOLDERS' EQUITY - Term Loan Warrants - Additional Information (Details) | Jan. 15, 2016 USD ($) Tranche $ / shares shares |
Warrant | |
Class Of Warrant Or Right [Line Items] | |
Expiration anniversary date of issuance | 10 years |
Term Loan | Term A Loans | |
Class Of Warrant Or Right [Line Items] | |
Shares of common stock to purchase by warrant | shares | 5,099 |
Common stock exercise price per share | $ / shares | $ 44.13 |
Loan and Security Agreement | Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Aggregate principal amount | $ | $ 15,000,000 |
Number of tranches | Tranche | 2 |
STOCK AWARD PLAN AND STOCK-BA_3
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Apr. 28, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Aug. 06, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock, shares issued | 6,993,406 | 5,340,193 | ||
Fair value of common stock on grant date (in dollars per share) | $ 8.31 | |||
Total intrinsic value of the stock options exercised | $ 0 | $ 0 | ||
Dividend yield (as a percent) | 0% | |||
Non-cash compensation expense | $ 1,968,381 | $ 4,108,819 | ||
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Fair value of common stock on grant date (in dollars per share) | $ 5.67 | $ 3.48 | ||
Total unrecognized compensation costs | $ 3,600,000 | |||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 2 years 10 months 24 days | |||
Dividend yield (as a percent) | 0% | 0% | ||
Performance-based Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting percentage | 50% | |||
Vesting period of PRSUs after acceptance | 5 years | |||
Total unrecognized compensation costs | $ 0 | |||
PRSU'S outstanding | 228,209 | |||
PRSU'S cancelled | 20,218 | |||
PRSU'S vested | 228,213 | |||
Non-cash compensation expense | $ 200,000 | |||
Incremental Non-cash Compensation Cost | 50% | |||
Option Exchange Program [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock, shares issued | 953,980 | |||
Common stock exchanged for PRSUs | 476,640 |
STOCK AWARD PLAN AND STOCK-BA_4
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Stock Option Activity for Employees and Non-Employees (Details) - Employees and Non-Employees Stock Option - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Shares Issuable Pursuant to Stock Options | ||
Outstanding at the beginning of period (in shares) | 700,929 | |
Granted (in shares) | 483,800 | |
Cancelled/Forfeited (in shares) | (27,500) | |
Outstanding at the end of the period (in shares) | 1,157,229 | 700,929 |
Exercisable at the end of the period (in shares) | 389,767 | |
Available for future grant (in shares) | 362,366 | |
Weighted-Average Exercise Price | ||
Outstanding at the beginning of period (in dollars per share) | $ 15.69 | |
Granted (in dollars per share) | 6.52 | |
Cancelled/forfeited(in dollars per share) | 36.6 | |
Outstanding at the end of the period (in dollars per share) | 11.36 | $ 15.69 |
Exercisable at the end of the period (in dollars per share) | $ 22.17 | |
Weighted-Average Remaining Contractual Term Outstanding (Years) | 8 years 6 months | 8 years 7 months 6 days |
Weighted-Average Remaining Contractual Term Exercisable (Years) | 7 years | |
Total Intrinsic Value Outstanding at the end of period | $ 745 | |
Total Intrinsic Value Exercisable | $ 213 |
STOCK AWARD PLAN AND STOCK-BA_5
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Summary of Assumptions Used in Black Scholes Model to Estimate Fair Value of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0% | |
Weighted average grant date fair value per share of common stock | $ 8.31 | |
Employee Stock Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0% | 0% |
Weighted average grant date fair value per share of common stock | $ 5.67 | $ 3.48 |
Employee Stock Option | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Risk free interest rate | 4.68% | 1.96% |
Volatility | 115% | 75% |
Employee Stock Option | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 3 months | 6 years 3 months |
Risk free interest rate | 4.74% | 3.62% |
Volatility | 119% | 97% |
STOCK AWARD PLAN AND STOCK-BA_6
STOCK AWARD PLAN AND STOCK-BASED COMPENSATION - Schedule of Stock-Based Compensation Expense Included in the Company's Consolidated Statements of Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 1,968,381 | $ 4,108,819 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | 909,845 | 2,007,681 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 1,058,536 | $ 2,101,138 |
INCOME TAXES - Net Deferred Tax
INCOME TAXES - Net Deferred Tax Assets (Liabilities) (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 34,490,808 | $ 26,695,408 |
Research and development tax credits | 145,115 | 145,115 |
Capitalized research and development costs | 27,901,874 | 29,527,069 |
Stock-based compensation | 8,911,005 | 10,038,836 |
Deferred start-up and license costs | 3,011,692 | 3,559,272 |
Sale of royalties | 22,406,996 | 20,144,095 |
Total deferred tax assets | 96,867,490 | 90,109,795 |
Deferred tax asset valuation allowance | (96,867,059) | (90,108,904) |
Net deferred tax assets | 431 | 891 |
Deferred tax liabilities: | ||
Depreciation | (431) | (891) |
Total deferred tax liabilities | $ (431) | $ (891) |
INCOME TAXES - Schedule of Effe
INCOME TAXES - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21% | 21% |
Permanent differences | (0.57%) | (0.08%) |
State income taxes, net of federal benefit | 0% | 0% |
Valuation allowance | (20.44%) | (20.92%) |
Effective tax rate | 0% | 0% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | |||
Increase (decrease) in valuation allowance on net deferred tax assets | $ 6,800,000 | $ 8,800,000 | |
Unrecognized tax benefits, liability | 0 | $ 0 | 0 |
Interest and penalties recognized | 0 | 0 | |
Interest and penalties accrued | 0 | 0 | $ 0 |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses | 126,200,000 | $ 126,200,000 | |
Operating losses, year begin to expire | 2036 | ||
Federal | Unlimited Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses | 104,800,000 | $ 104,800,000 | |
Federal | Federal research and development | |||
Operating Loss Carryforwards [Line Items] | |||
Federal research and development credits | 100,000 | $ 100,000 | |
Federal research and development credits expiration year | 2027 | ||
New jersey | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses | 7,700,000 | $ 7,700,000 | |
Operating losses, year begin to expire | 2029 | ||
Massachusetts | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating losses | $ 116,300,000 | $ 116,300,000 | |
Operating losses, year begin to expire | 2037 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - Regus | 1 Months Ended | |
Oct. 11, 2022 ft² | Jan. 31, 2024 USD ($) | |
Loss Contingencies [Line Items] | ||
Lease rentable square feet | ft² | 491 | |
Lease description | In January 2024, the Company renewed the month-to-month lease agreement commencing on February 1, 2024, with a monthly payment of $8,697. The Company has elected to not recognize the lease agreement on the balance sheet as the term of the agreement is 12 months or less. | |
Subsequent Event | ||
Loss Contingencies [Line Items] | ||
Lease commencement date | Feb. 01, 2024 | |
Monthly rental rate | $ | $ 8,697 |