Minerva Neurosciences (NERV) 10-Q 7 Nov 23 2023 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 02, 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	Q3
Document Period End Date	Sep. 30, 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		6,993,406

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current assets
Cash and cash equivalents	$ 46,903,960	$ 36,093,606
Restricted cash	100,000	100,000
Refundable regulatory fee		3,117,218
Prepaid expenses and other current assets	1,221,220	848,117
Total current assets	48,225,180	40,158,941
Equipment, net	12,245	16,326
Capitalized software, net	23,412	42,567
Goodwill	14,869,399	14,869,399
Total assets	63,130,236	55,087,233
Current liabilities
Accounts payable	1,395,070	969,667
Accrued expenses and other current liabilities	1,954,590	407,909
Total current liabilities	3,349,660	1,377,576
Liability related to the sale of future royalties	79,826,671	73,733,876
Total liabilities	83,176,331	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 September 30, 2023 and December 31, 2022, respectively
Common stock; $0.0001 par value; 125,000,000 shares authorized; 6,993,406 and 5,340,193 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively	699	534
Additional paid-in capital	367,746,175	346,785,322
Accumulated deficit	(387,792,969)	(366,810,075)
Total stockholders' (deficit) equity	(20,046,095)	(20,024,219)
Total liabilities and stockholders' (deficit) equity	$ 63,130,236	$ 55,087,233

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares	Sep. 30, 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

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Expenses
Research and development	$ 3,443,537	$ 2,367,364	$ 7,984,566	$ 11,459,205
General and administrative	2,635,583	2,839,784	7,963,067	8,702,390
Total expenses	6,079,120	5,207,148	15,947,633	20,161,595
Loss from operations	(6,079,120)	(5,207,148)	(15,947,633)	(20,161,595)
Foreign exchange (losses) gains	(5,096)	2,063	(20,988)	(135)
Investment income	348,681	180,091	1,078,522	259,886
Non-cash interest expense for the sale of future royalties	(2,084,911)	(1,875,482)	(6,092,795)	(5,480,775)
Net loss	$ (7,820,446)	$ (6,900,476)	$ (20,982,894)	$ (25,382,619)
Net loss per share, basic	$ (1.03)	$ (1.29)	$ (3.41)	$ (4.75)
Net loss per share, diluted	$ (1.03)	$ (1.29)	$ (3.41)	$ (4.75)
Weighted average shares outstanding, basic	7,568,981	5,340,193	6,148,276	5,340,195
Weighted average shares outstanding, diluted	7,568,981	5,340,193	6,148,276	5,340,195

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, 2021	7,975,643	$ 534	342,676,508	(334,701,399)
Balance (in shares) at Dec. 31, 2021		5,340,196
Net loss	(25,382,619)
Balance at Sep. 30, 2022	(14,245,846)	$ 534	345,837,638	(360,084,018)
Balance (in shares) at Sep. 30, 2022		5,340,193
Balance at Mar. 31, 2022	(736,130)	$ 534	343,729,164	(344,465,828)
Balance (in shares) at Mar. 31, 2022		5,340,196
Stock-based compensation	1,071,605		1,071,605
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	(8,717,714)			(8,717,714)
Balance at Jun. 30, 2022	(8,382,244)	$ 534	344,800,764	(353,183,542)
Balance (in shares) at Jun. 30, 2022		5,340,193
Stock-based compensation	1,036,874		1,036,874
Net loss	(6,900,476)			(6,900,476)
Balance at Sep. 30, 2022	(14,245,846)	$ 534	345,837,638	(360,084,018)
Balance (in shares) at Sep. 30, 2022		5,340,193
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
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
Net loss	$ (20,982,894)
Balance at Sep. 30, 2023	$ (20,046,095)	$ 699	367,746,175	(387,792,969)
Balance (in shares) at Sep. 30, 2023	6,993,406	6,993,406
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
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	(309,602)		(309,602)
Vesting of performance-based restricted stock units		$ 23	(23)
Vesting of performance-based restricted stock units (in shares)		228,213
Stock-based compensation	608,915		608,915
Net loss	(6,192,036)			(6,192,036)
Balance at Jun. 30, 2023	(12,510,901)	$ 699	367,460,923	(379,972,523)
Balance (in shares) at Jun. 30, 2023		6,993,406
Costs related to issuance of common stock and warrants	(86,691)		(86,691)
Stock-based compensation	371,943		371,943
Net loss	(7,820,446)			(7,820,446)
Balance at Sep. 30, 2023	$ (20,046,095)	$ 699	$ 367,746,175	$ (387,792,969)
Balance (in shares) at Sep. 30, 2023	6,993,406	6,993,406

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited)	9 Months Ended		32 Months Ended
	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)
Cash flows from operating activities:
Net loss	$ (20,982,894)	$ (25,382,619)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	4,081
Amortization of capitalized software	19,155	2,128
Stock-based compensation expense	1,357,317	3,161,135
Non-cash interest expense associated with the sale of future royalties	6,092,795	5,480,775	$ 19,826,671
Changes in operating assets and liabilities
Refundable regulatory fee	3,117,218	(3,117,218)
Prepaid expenses and other current assets	(373,103)	(57,173)
Accounts payable	425,403	(1,320,327)
Accrued expenses and other current liabilities	1,546,681	698,232
Net cash used in operating activities	(8,793,347)	(20,535,067)
Cash flows from investing activities:
Net cash provided by investing activities	0	0
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 financing activities	19,603,701	(5)
Net increase (decrease) in cash, cash equivalents and restricted cash	10,810,354	(20,535,072)
Cash, cash equivalents and restricted cash
Beginning of period	36,193,606	60,855,080
End of period	47,003,960	40,320,008	47,003,960
Reconciliation of the Condensed Consolidated Statements of Cash Flows to the Condensed Consolidated Balance Sheets
Cash and cash equivalents	46,903,960	40,220,008	46,903,960
Restricted cash	100,000	100,000	100,000
Total cash, cash equivalents and restricted cash	$ 47,003,960	$ 40,320,008	$ 47,003,960

Nature of Operations and Liquid

Nature of Operations and Liquidity	9 Months Ended
	Sep. 30, 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 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 2. 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 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 September 30, 2023, the Company had an accumulated deficit of approximately $ 387.8 million and net cash used in operating activities was approximately $ 8.8 million during the nine months ended September 30, 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 September 30, 2023, the Company had cash, cash equivalents, and restricted cash of $ 47.0 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	9 Months Ended
	Sep. 30, 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 September 30, 2023, the results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. The results of operations for the three and nine months ended September 30, 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 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 September 30, 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	9 Months Ended
	Sep. 30, 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: September 30, 2023 December 31, 2022 Research and development costs and other accrued expenses $ 656,341 $ 279,434 Accrued bonus 1,089,783 14,832 Professional fees 128,225 113,643 Vacation pay 80,241 — Accrued expenses and other current liabilities $ 1,954,590 $ 407,909

Net Loss Per Share of Common St

Net Loss Per Share of Common Stock	9 Months Ended
	Sep. 30, 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 September 30, 2023. The following table sets forth the computation of basic and diluted loss per share for common stockholders: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Net loss $ ( 7,820,446 ) $ ( 6,900,476 ) $ ( 20,982,894 ) $ ( 25,382,619 ) Weighted average shares of common stock outstanding 7,568,981 5,340,193 6,148,276 5,340,195 Net loss per share of common stock – basic and diluted $ ( 1.03 ) $ ( 1.29 ) $ ( 3.41 ) $ ( 4.75 ) The following securities outstanding at September 30, 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Common stock options 735,929 467,429 735,929 467,429 Performance-based restricted stock units (“PRSUs”) 228,209 456,422 228,209 456,422 Common stock warrants 5,099 5,099 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 September 30, 2023 , 228,213 PRSUs have vested, 20,218 have been cancelled and 228,209 remain outstanding.

Sale of Future Royalties

Sale of Future Royalties	9 Months Ended
	Sep. 30, 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 September 30, 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 September 30, 2023: September 30, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 19,826,671 Liability related to the sale of future royalties $ 79,826,671

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 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, and, therefore, will be reflected on the condensed consolidated financial statements for the three and nine months ended September 30, 2023. The Company incurred approximately $ 0.4 million in offering expenses as of September 30, 2023, which have been included as a component of additional paid-in capital, resulting in net proceeds of $ 19.6 million as of September 30, 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 nine months ended September 30, 2023 , no shares of the Company’s common stock were issued or sold under the Sales Agreement. As of September 30, 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 September 30, 2023 .

Stock Award Plan and Stock-Base

Stock Award Plan and Stock-Based Compensation	9 Months Ended
	Sep. 30, 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 nine months ended September 30, 2023 is as follows: Shares Weighted- Weighted- Total Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted 62,500 $ 7.30 Exercised — $ — Forfeited ( 27,500 ) $ 36.60 Outstanding September 30, 2023 735,929 $ 14.19 8.1 $ 1,037 Exercisable September 30, 2023 301,197 $ 27.33 6.7 $ 85 Available for future grant 783,666 The weighted average grant-date fair value of stock options outstanding on September 30, 2023 was $ 9.88 per share. Total unrecognized compensation costs related to non-vested stock options at September 30, 2023 were approximately $ 1.6 million and are expected to be recognized within future operating results over a weighted-average period of 2.1 years. The total intrinsic value of the options exercised during the nine months ended September 30, 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 nine months ended September 30, 2023 and 2022, the Company utilized the following assumptions: Nine Months Ended September 30, 2023 September 30, 2022 Expected term (years) 5.50 5.50 - 6.25 Risk free interest rate 4.68 % 1.96 % - 3.25 % Volatility 119 % 76 % - 97 % Dividend yield 0 % 0 % Weighted average grant date fair value per share of common stock $ 6.26 $ 4.78 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. The total unrecognized compensation cost related to non-vested stock options at September 30, 2023 was approximately $ 0.2 million and is expected to be recognized within future operating results over a weighted-average period of 0.3 year. 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 September 30, 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 September 30, 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: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 185,075 $ 518,920 $ 667,558 $ 1,534,899 General and administrative 186,868 517,954 689,759 1,626,236 Total $ 371,943 $ 1,036,874 $ 1,357,317 $ 3,161,135

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 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.

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 September 30, 2023, the results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. The results of operations for the three and nine months ended September 30, 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 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 September 30, 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)	9 Months Ended
	Sep. 30, 2023
Payables and Accruals [Abstract]
Schedule of Accrued Expenses and Other Liabilities	Accrued expenses and other liabilities consist of the following: September 30, 2023 December 31, 2022 Research and development costs and other accrued expenses $ 656,341 $ 279,434 Accrued bonus 1,089,783 14,832 Professional fees 128,225 113,643 Vacation pay 80,241 — Accrued expenses and other current liabilities $ 1,954,590 $ 407,909

Net Loss Per Share of Common _2

Net Loss Per Share of Common Stock (Tables)	9 Months Ended
	Sep. 30, 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Net loss $ ( 7,820,446 ) $ ( 6,900,476 ) $ ( 20,982,894 ) $ ( 25,382,619 ) Weighted average shares of common stock outstanding 7,568,981 5,340,193 6,148,276 5,340,195 Net loss per share of common stock – basic and diluted $ ( 1.03 ) $ ( 1.29 ) $ ( 3.41 ) $ ( 4.75 )
Securities Excluded from Calculation of Weighted Average Shares Outstanding as their Effect is Antidilutive	The following securities outstanding at September 30, 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Common stock options 735,929 467,429 735,929 467,429 Performance-based restricted stock units (“PRSUs”) 228,209 456,422 228,209 456,422 Common stock warrants 5,099 5,099 5,099 5,099

Sale of Future Royalties (Table

Sale of Future Royalties (Tables)	9 Months Ended
	Sep. 30, 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 September 30, 2023: September 30, 2023 Upfront payment from the sale of future royalties $ 60,000,000 Non-cash interest expense associated with the sale of future royalties 19,826,671 Liability related to the sale of future royalties $ 79,826,671

Stock Award Plan and Stock-Ba_2

Stock Award Plan and Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 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 nine months ended September 30, 2023 is as follows: Shares Weighted- Weighted- Total Outstanding January 1, 2023 700,929 $ 15.69 8.6 $ — Granted 62,500 $ 7.30 Exercised — $ — Forfeited ( 27,500 ) $ 36.60 Outstanding September 30, 2023 735,929 $ 14.19 8.1 $ 1,037 Exercisable September 30, 2023 301,197 $ 27.33 6.7 $ 85 Available for future grant 783,666
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 nine months ended September 30, 2023 and 2022, the Company utilized the following assumptions: Nine Months Ended September 30, 2023 September 30, 2022 Expected term (years) 5.50 5.50 - 6.25 Risk free interest rate 4.68 % 1.96 % - 3.25 % Volatility 119 % 76 % - 97 % Dividend yield 0 % 0 % Weighted average grant date fair value per share of common stock $ 6.26 $ 4.78
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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 185,075 $ 518,920 $ 667,558 $ 1,534,899 General and administrative 186,868 517,954 689,759 1,626,236 Total $ 371,943 $ 1,036,874 $ 1,357,317 $ 3,161,135

NATURE OF OPERATIONS AND LIQU_2

NATURE OF OPERATIONS AND LIQUIDITY - Additional Information (Details) - USD ($)		1 Months Ended	9 Months Ended
	Jan. 19, 2021	Jan. 31, 2021	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Nature Of Operations And Liquidity [Line Items]
Accumulated deficit			$ 387,792,969		$ 366,810,075
Net cash used in operating activities			8,793,347	$ 20,535,067
Cash, cash equivalents, restricted cash and marketable securities			$ 47,000,000
Seltorexant | Royalty Pharma
Nature Of Operations And Liquidity [Line Items]
Up front payment	$ 60,000,000	$ 60,000,000
Maximum | Seltorexant | Royalty Pharma
Nature Of Operations And Liquidity [Line Items]
Potential future milestone payments		$ 95,000,000

SIGNIFICANT ACCOUNTING POLICI_3

SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($)				9 Months Ended
	Aug. 12, 2022	Jun. 17, 2022	Jun. 16, 2022	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 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 ($)	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Research and development costs and other accrued expenses	$ 656,341	$ 279,434
Accrued bonus	1,089,783	14,832
Professional fees	128,225	113,643
Vacation pay	80,241
Accrued expenses and other current liabilities	$ 1,954,590	$ 407,909

NET LOSS PER SHARE OF COMMON _3

NET LOSS PER SHARE OF COMMON STOCK - Additional Information (Details) - $ / shares		1 Months Ended		9 Months Ended
	Apr. 28, 2023	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 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 ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022
Earnings Per Share [Abstract]
Net loss	$ (7,820,446)	$ (6,192,036)	$ (6,970,412)	$ (6,900,476)	$ (8,717,714)	$ (9,764,429)	$ (20,982,894)	$ (25,382,619)
Weighted average shares of common stock outstanding - basic	7,568,981			5,340,193			6,148,276	5,340,195
Weighted average shares of common stock outstanding - diluted	7,568,981			5,340,193			6,148,276	5,340,195
Net loss per share, basic	$ (1.03)			$ (1.29)			$ (3.41)	$ (4.75)
Net loss per share, diluted	$ (1.03)			$ (1.29)			$ (3.41)	$ (4.75)

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	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 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	735,929	467,429	735,929	467,429
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	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	5,099	5,099

Sale of Future Royalties - Addi

Sale of Future Royalties - Additional Information (Details) - USD ($)		1 Months Ended
	Jan. 19, 2021	Jan. 31, 2021	Sep. 30, 2023
Sale Of Future Royalties [Line Items]
Liability related to the sale of future royalties	$ 60,000,000		$ 79,826,671
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	$ 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 ($)	9 Months Ended		32 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 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	$ 6,092,795	$ 5,480,775	19,826,671
Liability related to the sale of future royalties	$ 79,826,671		$ 79,826,671	$ 60,000,000

STOCKHOLDERS' EQUITY - Private

STOCKHOLDERS' EQUITY - Private Placement of Common Stock and Warrants - Additional Information (Details) - USD ($)				1 Months Ended	9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Jun. 27, 2023	Jun. 30, 2023	Sep. 30, 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) - USD ($)	3 Months Ended	9 Months Ended
	Jun. 30, 2023	Sep. 30, 2023
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 ($)		3 Months Ended		9 Months Ended
	Apr. 28, 2023	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Aug. 06, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Common stock, shares issued		6,993,406		6,993,406		5,340,193
Fair value of common stock on grant date (in dollars per share)				$ 9.88
Total intrinsic value of the stock options exercised				$ 0	$ 0
Dividend yield (as a percent)				0%
Non-cash compensation expense		$ 371,943	$ 1,036,874	$ 1,357,317	$ 3,161,135
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)				$ 6.26	$ 4.78
Total unrecognized compensation costs		1,600,000		$ 1,600,000
Weighted-average period over which unrecognized compensation costs is expected to be recognized				2 years 1 month 6 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		$ 200,000		$ 200,000
Weighted-average period over which unrecognized compensation costs is expected to be recognized				3 months 18 days
PRSU'S vested		228,213		228,213
PRSU'S outstanding		228,209		228,209
PRSU'S cancelled				20,218
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	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Shares Issuable Pursuant to Stock Options
Outstanding at the beginning of period (in shares)	700,929
Granted (in shares)	62,500
Forfeited (in shares)	(27,500)
Outstanding at the end of the period (in shares)	735,929	700,929
Exercisable at the end of the period (in shares)	301,197
Available for future grant (in shares)	783,666
Weighted-Average Exercise Price
Outstanding at the beginning of period (in dollars per share)	$ 15.69
Granted (in dollars per share)	7.3
Forfeited (in dollars per share)	36.6
Outstanding at the end of the period (in dollars per share)	14.19	$ 15.69
Exercisable at the end of the period (in dollars per share)	$ 27.33
Weighted-Average Remaining Contractual Term Outstanding (Years)	8 years 1 month 6 days	8 years 7 months 6 days
Weighted-Average Remaining Contractual Term Exercisable (Years)	6 years 8 months 12 days
Total Intrinsic Value Outstanding at the end of period	$ 1,037
Total Intrinsic Value Exercisable	$ 85

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	9 Months Ended
	Sep. 30, 2023	Sep. 30, 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	$ 9.88
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (years)	5 years 6 months
Risk free interest rate	4.68%
Volatility	119%
Dividend yield	0%	0%
Weighted average grant date fair value per share of common stock	$ 6.26	$ 4.78
Employee Stock Option | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (years)		6 years 3 months
Risk free interest rate		3.25%
Volatility		97%
Employee Stock Option | Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (years)		5 years 6 months
Risk free interest rate		1.96%
Volatility		76%

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		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense	$ 371,943	$ 1,036,874	$ 1,357,317	$ 3,161,135
Research and Development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense	185,075	518,920	667,558	1,534,899
General and Administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock based compensation expense	$ 186,868	$ 517,954	$ 689,759	$ 1,626,236

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