Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | Minerva Neurosciences, Inc. | |
Entity Central Index Key | 0001598646 | |
Amendment Flag | false | |
Entity Current Reporting Status | Yes | |
Document Type | 10-Q | |
Document Fiscal Period Focus | Q1 | |
Document Period End Date | Mar. 31, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Document Fiscal Year Focus | 2023 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | NERV | |
Entity Tax Identification Number | 26-0784194 | |
Entity File Number | 001-36517 | |
Entity Address, Address Line One | 1500 District Avenue | |
Entity Address, City or Town | Burlington | |
Entity Address, State or Province | MA | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Postal Zip Code | 01803 | |
City Area Code | 617 | |
Local Phone Number | 600-7373 | |
Document Transition Report | false | |
Document Quarterly Report | true | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 5,568,406 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 35,978,199 | $ 36,093,606 |
Restricted cash | 100,000 | 100,000 |
Refundable regulatory fee | 3,117,218 | |
Prepaid expenses and other current assets | 596,045 | 848,117 |
Total current assets | 36,674,244 | 40,158,941 |
Equipment, net | 14,966 | 16,326 |
Capitalized software, net | 36,182 | 42,567 |
Goodwill | 14,869,399 | 14,869,399 |
Total assets | 51,594,791 | 55,087,233 |
Current liabilities | ||
Accounts payable | 960,998 | 969,667 |
Accrued expenses and other current liabilities | 1,540,663 | 407,909 |
Total current liabilities | 2,501,661 | 1,377,576 |
Liability related to the sale of future royalties | 75,711,302 | 73,733,876 |
Total liabilities | 78,212,963 | 75,111,452 |
Commitments and contingencies (Note 8) | ||
Stockholders' (deficit) equity | ||
Preferred stock; $0.0001 par value; 100,000,000 shares authorized; none issued or outstanding as of March 31, 2023 and December 31, 2022, respectively | ||
Common stock; $0.0001 par value; 125,000,000 shares authorized; 5,340,193 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 534 | 534 |
Additional paid-in capital | 347,161,781 | 346,785,322 |
Accumulated deficit | (373,780,487) | (366,810,075) |
Total stockholders' (deficit) equity | (26,618,172) | (20,024,219) |
Total liabilities and stockholders' (deficit) equity | $ 51,594,791 | $ 55,087,233 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 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 | 5,340,193 | 5,340,193 |
Common stock, shares outstanding | 5,340,193 | 5,340,193 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Expenses | ||
Research and development | $ 2,653,553 | $ 4,959,863 |
General and administrative | 2,694,965 | 3,029,395 |
Total expenses | 5,348,518 | 7,989,258 |
Loss from operations | (5,348,518) | (7,989,258) |
Foreign exchange losses | (8,686) | (3,794) |
Investment income | 364,218 | 7,417 |
Non-cash interest expense for the sale of future royalties | (1,977,426) | (1,778,794) |
Net loss | $ (6,970,412) | $ (9,764,429) |
Net loss per share, basic | $ (1.31) | $ (1.83) |
Net loss per share, diluted | $ (1.31) | $ (1.83) |
Weighted average shares outstanding, basic | 5,340,193 | 5,340,196 |
Weighted average shares outstanding, diluted | 5,340,193 | 5,340,196 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' (Deficit) Equity (Unaudited) - 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 | 1,052,656 | 1,052,656 | ||
Net loss | (9,764,429) | (9,764,429) | ||
Balance at Mar. 31, 2022 | (736,130) | $ 534 | 343,729,164 | (344,465,828) |
Balance (in shares) at Mar. 31, 2022 | 5,340,196 | |||
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 | ||
Stock-based compensation | $ 376,459 | 376,459 | ||
Net loss | (6,970,412) | (6,970,412) | ||
Balance at Mar. 31, 2023 | $ (26,618,172) | $ 534 | $ 347,161,781 | $ (373,780,487) |
Balance (in shares) at Mar. 31, 2023 | 5,340,193 | 5,340,193 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 26 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | |
Cash flows from operating activities: | |||
Net loss | $ (6,970,412) | $ (9,764,429) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,360 | ||
Amortization of capitalized software | 6,385 | ||
Stock-based compensation expense | 376,459 | 1,052,656 | |
Non-cash interest expense associated with the sale of future royalties | 1,977,426 | 1,778,794 | $ 15,711,302 |
Changes in operating assets and liabilities | |||
Refundable regulatory fee | 3,117,218 | ||
Prepaid expenses and other current assets | 252,072 | 695,878 | |
Accounts payable | (8,669) | (267,047) | |
Accrued expenses and other current liabilities | 1,132,754 | 695,779 | |
Net cash used in operating activities | (115,407) | (5,808,369) | |
Cash flows from investing activities: | |||
Net cash provided by investing activities | 0 | ||
Cash flows from financing activities: | |||
Net cash provided by financing activities | 0 | ||
Net decrease in cash, cash equivalents and restricted cash | (115,407) | (5,808,369) | |
Cash, cash equivalents and restricted cash | |||
Beginning of period | 36,193,606 | 60,855,080 | |
End of period | 36,078,199 | 55,046,711 | 36,078,199 |
Reconciliation of the Condensed Consolidated Statements of Cash Flows to the Condensed Consolidated Balance Sheets | |||
Cash and cash equivalents | 35,978,199 | 54,946,711 | 35,978,199 |
Restricted cash | 100,000 | 100,000 | 100,000 |
Total cash, cash equivalents and restricted cash | $ 36,078,199 | $ 55,046,711 | $ 36,078,199 |
Nature of Operations and Liquid
Nature of Operations and Liquidity | 3 Months Ended |
Mar. 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 product candidates to treat patients suffering from central nervous system (“CNS”) 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. Previously in October 2022, the Company announced that it received a refusal to file letter (“RTF”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for roluperidone for the treatment of negative symptoms in schizophrenia. On April 27, 2023, the FDA filed the Company’s NDA for roluperidone. The decision to file the NDA followed the Company’s request for formal dispute resolution and appeal of the October 2022 RTF. On May 8, 2023, the Company received confirmation from the FDA that the NDA for roluperidone has been assigned a standard review classification, and that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) 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 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Clinical and Regulatory Updates—Type C Meeting (March 2, 2022)” for more information. The Company also 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 further discussion of the joint development agreement with Janssen and the sale of future royalties, please refer to Note 5, Sale of Future Royalties. Liquidity The accompanying interim condensed consolidated 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 March 31, 2023, the Company had an accumulated deficit of approximately $ 373.8 million and net cash used in operating activities was approximately $ 0.1 million during the three months ended March 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 March 31, 2023, the Company had cash, cash equivalents, and restricted cash of $ 36.1 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 in order 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. On December 1, 2022, the Company received a deficiency letter from Nasdaq notifying the Company that for the last 30 consecutive business days, its minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $ 35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). In accordance with the listing rules of Nasdaq, the Company has been provided an initial period of 180 calendar days, or until May 30, 2023, to regain compliance. If compliance is not achieved by May 30, 2023, the Company expects that Nasdaq would provide written notification that its securities are subject to delisting. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 — SIGNIFICANT ACCOUNTING POLICIES Basis of presentation The interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim reporting and the requirements of the Securities and Exchange Commission (“SEC”) in accordance with Regulation S-X, Rule 8-03. Under those rules, certain notes and financial information that are normally required for annual financial statements can be condensed or omitted. In the opinion of the Company’s management, the accompanying financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of March 31, 2023, the results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year. The consolidated balance sheet as of December 31, 2022 was derived from the audited annual financial statements. The accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2023. 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 held 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 each of March 31, 2023 and December 31, 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. Recent accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective date. The Company believes that the impact of recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the condensed consolidated financial statements or do not apply to the Company . |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 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: March 31, 2023 December 31, 2022 Research and development costs and other accrued expenses $ 996,298 $ 279,434 Accrued bonus 396,494 14,832 Professional fees 95,083 113,643 Vacation pay 52,788 — Accrued expenses and other current liabilities $ 1,540,663 $ 407,909 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 3 Months Ended |
Mar. 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. The following table sets forth the computation of basic and diluted loss per share for common stockholders: Three Months Ended March 31, 2023 2022 Net loss $ ( 6,970,412 ) $ ( 9,764,429 ) Weighted average shares of common stock outstanding 5,340,193 5,340,196 Net loss per share of common stock – basic and diluted $ ( 1.31 ) $ ( 1.83 ) The following securities outstanding at March 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: Three Months Ended March 31, 2023 2022 Common stock options 700,929 452,433 Performance-based restricted stock units 456,422 456,422 Common stock warrants 5,099 5,099 |
Sale of Future Royalties
Sale of Future Royalties | 3 Months Ended |
Mar. 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 approxim ately 10.5 %. As of March 31, 2023, the Company estimated the effective annual interest rate to be approximately 10.7 %. 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 two Phase 3 studies with seltorexant, a third Phase 3 study was discontinued during 2022. The following table shows the activity of the Royalty Obligation since the transaction inception through March 31, 2023: March 31, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 15,711,302 Liability related to the sale of future royalties $ 75,711,302 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | NOTE 6 — STOCKHOLDERS’ EQUITY 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 three months ended March 31, 2023 , no shares of the Company’s common stock were issued or sold under the Sales Agreement. As of March 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 fair value of the warrants was estimated at $ 0.2 million using a Black-Scholes model and assuming: (i) expected volatility of 100.8 %, (ii) risk free interest rate of 1.83 %, (iii) an expected life of 10 years and (iv) no dividend payments. The fair value of the warrants was included as a discount to the term loans drawn at such time and also as a component of additional paid-in capital and were amortized to interest expense over the term of the loan. Although the term loans were repaid in August 2018, all related warrants were outstanding and exercisable as of March 31, 2023 . |
Stock Award Plan and Stock-Base
Stock Award Plan and Stock-Based Compensation | 3 Months Ended |
Mar. 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. Option Exchange Program On June 11, 2021, the Company’s stockholders, upon recommendation of the board of directors of the Company, approved a one-time stock option exchange program (the “Exchange Program”) for certain employee option holders (including its named executive officers) (the “Eligible Participants”) who remained employed by the Company through the completion of the Exchange Program. The Exchange Program permitted Eligible Participants to surrender stock options issued and outstanding under the Plan granted before July 1, 2020, with a per-share exercise price of $ 35.76 or greater (the “Eligible Options”), in exchange for a grant of performance-based restricted stock units (“PRSUs”) that will settle in shares of the Company’s common stock upon vesting. 50 % of the new PRSUs vest upon the FDA acceptance of a new drug application for roluperidone, provided that such acceptance is not “over protest” and occurs within three years after the grant date, with the remaining new PRSUs vesting upon roluperidone receiving FDA marketing approval, provided that such approval occurs within five years after the grant date. On July 6, 2021, the Company filed with the SEC a Tender Offer Statement on Schedule TO disclosing the terms and conditions of the Exchange Program. The Exchange Program closed on August 3, 2021. 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 Exchange Program were cancelled and shares subject to the cancelled options again became available for issuance under the Plan. The non-cash incremental stock-based compensation cost associated with the Exchange Program was $ 0.5 million. This 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. This incremental compensation cost will be recognized when it is deemed probable that the two vesting conditions of the PRSUs will be achieved. Stock Option Awards Stock option activity for employees and non-employees for the three months ended March 31, 2023 is as follows: Shares Weighted- Weighted- Total Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted — Exercised — Forfeited — Outstanding March 31, 2023 700,929 $ 15.69 8.3 $ — Exercisable March 31, 2023 295,807 $ 30.41 7.0 $ — Available for future grant 118,666 The weighted average grant-date fair value of stock options outstanding on March 31, 2023 was $ 10.75 per share. Total unrecognized compensation costs related to non-vested stock options at March 31, 2023 were approximately $ 1.5 million and are expected to be recognized within future operating results over a weighted-average period of 2.6 years. The total intrinsic value of the options exercised during the three months ended March 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 volatilities for industry peer companies, as the Company did not have sufficient trading history for its common stock. 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 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 three months ended March 31, 2023 and 2022, the Company utilized the following assumptions: Three Months Ended March 31, 2023 2022 Expected term (years) — 6.25 Risk free interest rate — 1.96 % Volatility — 97.18 % Dividend yield — 0.00 % Weighted average grant date fair value per share of common stock — $ 4.96 Performance-Based Restricted Stock Units On August 6, 2021, the Company granted 476,640 PRSUs through the Exchange Program. The Exchange Program was treated as a Type II modification (Probable-to improbable) under ASC 718. The total PRSUs outstanding at March 31, 2023 was 456,422 . The Company will recognize the unrecognized grant-date fair value of the pre-modification stock options as well as any incremental non-cash compensation cost of the PRSUs granted in the Exchange Program, if the vesting conditions of the PRSUs are achieved or if they become probable. The Company is using the pre-modification stock options for determining the compensation cost related to the PRSUs as the vesting conditions remain uncertain for the new PRSUs. The total unrecognized compensation costs related to non-vested stock options at March 31, 2023 were approximately $ 0.7 million and are expected to be recognized within future operating results over a weighted-average period of 0.7 year. As of March 31, 2023 , no PRSUs have vested and 20,218 have been cancelled. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations: Three Months Ended March 31, 2023 2022 Research and development $ 184,727 $ 501,173 General and administrative 191,732 551,483 Total $ 376,459 $ 1,052,656 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 8 — 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. The lease is on a month-to-month basis commencing on February 1, 2023 , with a monthly payment of $ 8,290 . 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 Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 9 — SUBSEQUENT EVENTS 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 a new drug application for roluperidone. As a result, 50 % of the shares of common stock underlying the Company’s PRSUs granted on August 6, 2021 vested. The remaining PRSUs would vest upon roluperidone receiving FDA marketing approval provided that such approval occurs within five years after the August 6, 2021 grant date. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim reporting and the requirements of the Securities and Exchange Commission (“SEC”) in accordance with Regulation S-X, Rule 8-03. Under those rules, certain notes and financial information that are normally required for annual financial statements can be condensed or omitted. In the opinion of the Company’s management, the accompanying financial statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to present fairly the financial position as of March 31, 2023, the results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year. The consolidated balance sheet as of December 31, 2022 was derived from the audited annual financial statements. The accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 8, 2023. |
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 held 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. |
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 each of March 31, 2023 and December 31, 2022 . |
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. |
Recent Accounting Pronouncements | Recent accounting pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective date. The Company believes that the impact of recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the condensed consolidated financial statements or do not apply to the Company |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: March 31, 2023 December 31, 2022 Research and development costs and other accrued expenses $ 996,298 $ 279,434 Accrued bonus 396,494 14,832 Professional fees 95,083 113,643 Vacation pay 52,788 — Accrued expenses and other current liabilities $ 1,540,663 $ 407,909 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 3 Months Ended |
Mar. 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: Three Months Ended March 31, 2023 2022 Net loss $ ( 6,970,412 ) $ ( 9,764,429 ) Weighted average shares of common stock outstanding 5,340,193 5,340,196 Net loss per share of common stock – basic and diluted $ ( 1.31 ) $ ( 1.83 ) |
Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive | The following securities outstanding at March 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: Three Months Ended March 31, 2023 2022 Common stock options 700,929 452,433 Performance-based restricted stock units 456,422 456,422 Common stock warrants 5,099 5,099 |
Sale of Future Royalties (Table
Sale of Future Royalties (Tables) | 3 Months Ended |
Mar. 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 March 31, 2023: March 31, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 15,711,302 Liability related to the sale of future royalties $ 75,711,302 |
Stock Award Plan and Stock-Ba_2
Stock Award Plan and Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 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 three months ended March 31, 2023 is as follows: Shares Weighted- Weighted- Total Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted — Exercised — Forfeited — Outstanding March 31, 2023 700,929 $ 15.69 8.3 $ — Exercisable March 31, 2023 295,807 $ 30.41 7.0 $ — Available for future grant 118,666 |
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 three months ended March 31, 2023 and 2022, the Company utilized the following assumptions: Three Months Ended March 31, 2023 2022 Expected term (years) — 6.25 Risk free interest rate — 1.96 % Volatility — 97.18 % Dividend yield — 0.00 % Weighted average grant date fair value per share of common stock — $ 4.96 |
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: Three Months Ended March 31, 2023 2022 Research and development $ 184,727 $ 501,173 General and administrative 191,732 551,483 Total $ 376,459 $ 1,052,656 |
NATURE OF OPERATIONS AND LIQU_2
NATURE OF OPERATIONS AND LIQUIDITY - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Nature Of Operations And Liquidity [Line Items] | |||
Accumulated deficit | $ 373,780,487 | $ 366,810,075 | |
Net cash used in operating activities | 115,407 | $ 5,808,369 | |
Cash, cash equivalents, restricted cash and marketable securities | $ 36,100,000 | ||
Minimum market value of listed securities required for continued listing | $ 35,000,000 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($) | 3 Months Ended | |||||
Aug. 12, 2022 | Jun. 17, 2022 | Jun. 16, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | |
Reclassification [Line Items] | ||||||
Number of shares of common stock authorized | 125,000,000 | 125,000,000 | 125,000,000 | |||
Outstanding shares of common stock reverse stock splits | 5,340,193 | 42,721,566 | ||||
Restricted cash balances as collateral for corporate credit cards | $ 100,000 | $ 100,000 | $ 100,000 | |||
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 |
ACCRUED EXPENSES AND OTHER LI_3
ACCRUED EXPENSES AND OTHER LIABILITIES - Accrued Expenses and Other Liabilities (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development costs and other accrued expenses | $ 996,298 | $ 279,434 |
Accrued bonus | 396,494 | 14,832 |
Professional fees | 95,083 | 113,643 |
Vacation pay | 52,788 | |
Accrued expenses and other current liabilities | $ 1,540,663 | $ 407,909 |
NET LOSS PER SHARE OF COMMON _3
NET LOSS PER SHARE OF COMMON STOCK - Computation of Basic and Diluted Loss Per Share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (6,970,412) | $ (9,764,429) |
Weighted average shares of common stock outstanding - basic | 5,340,193 | 5,340,196 |
Weighted average shares of common stock outstanding - diluted | 5,340,193 | 5,340,196 |
Net loss per share, basic | $ (1.31) | $ (1.83) |
Net loss per share, diluted | $ (1.31) | $ (1.83) |
NET LOSS PER SHARE OF COMMON _4
NET LOSS PER SHARE OF COMMON STOCK - Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 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 | 700,929 | 452,433 |
Performance-based Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities outstanding excluded from the calculation of weighted average shares outstanding | 456,422 | 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 ($) | Jan. 19, 2021 | Mar. 31, 2023 |
Sale Of Future Royalties [Line Items] | ||
Liability related to the sale of future royalties | $ 60,000,000 | $ 75,711,302 |
Annual interest rate on interest expense | 10.50% | 10.70% |
Seltorexant | Royalty Pharma | ||
Sale Of Future Royalties [Line Items] | ||
Upfront payment for royalty interest sold | $ 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 ($) | 3 Months Ended | 26 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Jan. 19, 2021 | |
Sale Of Future Royalties [Abstract] | ||||
Upfront payment from the sale of future royalties | $ 60,000,000 | |||
Non-cash interest expense associated with the sale of future royalties | $ 1,977,426 | $ 1,778,794 | 15,711,302 | |
Liability related to the sale of future royalties | $ 75,711,302 | $ 75,711,302 | $ 60,000,000 |
STOCKHOLDERS' EQUITY - At-the-M
STOCKHOLDERS' EQUITY - At-the-Market Equity Offering Program - Additional Information (Details) - Sales Agreement | 3 Months Ended |
Mar. 31, 2023 shares | |
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] | |
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 |
Class Of Warrant Or Right [Line Items] | |
Fair value of warrants estimated | $ | $ 200,000 |
Warrant | |
Class Of Warrant Or Right [Line Items] | |
Expiration anniversary date of issuance | 10 years |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Price Volatility | |
Class Of Warrant Or Right [Line Items] | |
Alternative investment, measurement input | 100.8 |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Risk Free Interest Rate | |
Class Of Warrant Or Right [Line Items] | |
Alternative investment, measurement input | 1.83 |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Expected Term | |
Class Of Warrant Or Right [Line Items] | |
Expected life | 10 years |
Warrant | Valuation Technique, Option Pricing Model | Measurement Input, Expected Dividend Payment | |
Class Of Warrant Or Right [Line Items] | |
Expected dividend | $ / shares | $ 0 |
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 ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||||
Aug. 06, 2021 | Jun. 11, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock, shares issued | 5,340,193 | 5,340,193 | |||
Fair value of common stock on grant date (in dollars per share) | $ 10.75 | ||||
Total intrinsic value of the stock options exercised | $ 0 | $ 0 | |||
Dividend yield (as a percent) | 0% | ||||
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) | $ 4.96 | ||||
Total unrecognized compensation costs | $ 1.5 | ||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 2 years 7 months 6 days | ||||
Dividend yield (as a percent) | 0% | ||||
Performance-based Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares issued | 476,640 | ||||
Total unrecognized compensation costs | $ 0.7 | ||||
Weighted-average period over which unrecognized compensation costs is expected to be recognized | 8 months 12 days | ||||
Granted (in shares) | 476,640 | ||||
PRSU'S outstanding | 456,422 | ||||
PRSU'S cancelled | 20,218 | ||||
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 | ||||
Non-cash incremental stock-based compensation cost | $ 0.5 | ||||
Option Exchange Program [Member] | Performance-based Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Exercise price per unit | $ 35.76 | ||||
Vesting percentage | 50% | ||||
Option Exchange Program [Member] | Performance-based Restricted Stock Units | FDA [Member] | Minimum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period of PRSUs after acceptance | 3 years | ||||
Option Exchange Program [Member] | Performance-based Restricted Stock Units | FDA [Member] | Maximum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period of PRSUs after acceptance | 5 years |
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 - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Shares Issuable Pursuant to Stock Options | ||
Outstanding at the beginning of period (in shares) | 700,929 | |
Outstanding at the end of the period (in shares) | 700,929 | 700,929 |
Exercisable at the end of the period (in shares) | 295,807 | |
Available for future grant (in shares) | 118,666 | |
Weighted-Average Exercise Price | ||
Outstanding at the beginning of period (in dollars per share) | $ 15.69 | |
Outstanding at the end of the period (in dollars per share) | 15.69 | $ 15.69 |
Exercisable at the end of the period (in dollars per share) | $ 30.41 | |
Weighted-Average Remaining Contractual Term Outstanding (Years) | 8 years 3 months 18 days | 8 years 7 months 6 days |
Weighted-Average Remaining Contractual Term Exercisable (Years) | 7 years |
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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 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 | $ 10.75 | |
Employee Stock Option | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 3 months | |
Risk free interest rate | 1.96% | |
Volatility | 97.18% | |
Dividend yield | 0% | |
Weighted average grant date fair value per share of common stock | $ 4.96 |
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 ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 376,459 | $ 1,052,656 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | 184,727 | 501,173 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 191,732 | $ 551,483 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - Regus | Oct. 11, 2022 USD ($) ft² |
Loss Contingencies [Line Items] | |
Lease rentable square feet | ft² | 491 |
Lease description | The lease is on a month-to-month basis commencing on February 1, 2023, with a monthly payment of $8,290. 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. |
Lease commencement date | Feb. 01, 2023 |
Monthly rental rate | $ | $ 8,290 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - Performance-based Restricted Stock Units | Apr. 28, 2023 |
Subsequent Event [Line Items] | |
Vesting percentage | 50% |
Vesting period of PRSUs after acceptance | 5 years |