Financial Performance - The company incurred a net loss of $30.0 million for the fiscal year ended December 31, 2023, compared to a loss of $32.1 million in 2022, with an accumulated deficit of approximately $396.8 million as of the end of 2023[158]. - The company expects to continue incurring significant losses as it advances research and development for roluperidone and other product candidates, with future losses potentially increasing[159]. - As of December 31, 2023, the company had cash, cash equivalents, and restricted cash totaling $41.0 million, which is expected to meet cash commitments for at least the next 12 months[161]. - The company will require additional capital to finance operations and product development, with potential challenges in raising funds due to global economic conditions[162]. - The company has approximately $126.2 million in federal net operating losses (NOLs) as of December 31, 2023, with some NOLs beginning to expire in 2036 if not utilized[168]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date, indicating a high level of financial risk[158]. Regulatory Approval and Clinical Trials - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024, for the review of the NDA for roluperidone, following a previous refusal to file[157]. - The FDA filed the NDA for roluperidone on April 27, 2023, with a PDUFA goal date of February 26, 2024[174]. - The FDA identified potential review issues including the efficacy and safety of roluperidone in patients requiring antipsychotic treatment[174]. - The Phase 3 trial of roluperidone failed to meet its primary endpoint, despite the Phase 2b trial achieving statistical significance[178]. - Regulatory authorities may require additional studies or data, which could increase costs and delay the approval process[174]. - The company has no experience in advancing product candidates beyond Phase 3, which complicates the assessment of its commercialization capabilities[186]. - Enrollment challenges in clinical trials may arise due to the mental health conditions of subjects, impacting timely completion[187]. - The results of clinical trials conducted outside the U.S. may not be accepted by the FDA, potentially necessitating additional trials[179]. - The company may face significant setbacks in clinical trials due to safety or efficacy concerns, which are common in the pharmaceutical industry[178]. - Regulatory approval processes may be impacted by government funding issues or global health concerns, affecting review times[184]. - The company has previously discontinued development of MIN-117 for MDD after failing to achieve its primary endpoint in a Phase 2b trial[188]. - The company is prioritizing the development of its most advanced product candidate, roluperidone, while suspending further development of MIN-301[191]. - Regulatory approval for product candidates may be delayed or granted for narrower indications than expected, impacting commercialization timelines[192]. - Approved products will be subject to ongoing regulatory obligations, which may result in significant expenses and limit commercialization capabilities[194]. - Changes in drug indications, labeling, or safety issues may require additional regulatory submissions, potentially delaying market entry[195]. - The regulatory pathway for MIN-301 has not yet been determined, and the company plans to discuss the appropriate regulatory requirements with the FDA[208]. - The European Commission's proposal to revise pharmaceutical legislation may decrease data and market exclusivity for product candidates in the EU[206]. - Compliance with the new EU Clinical Trials Regulation may impact development plans and timelines[205]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with major pharmaceutical companies and biotechnology firms posing significant challenges due to their greater resources[212]. - Competitors may achieve regulatory approval faster or develop more effective products, which could hinder the company's market position[213]. - The company currently has a limited marketing and sales organization, which may impede its ability to effectively commercialize approved products[218]. - If the company commercializes its product candidates, it may face unfavorable pricing regulations and reimbursement practices that could adversely affect revenue[225]. - Coverage and adequate reimbursement from third-party payors are critical for product acceptance, and any limitations could materially harm the company's business[229]. - The company anticipates that pricing negotiations in international markets may delay product launches and impact revenue generation[226]. - The introduction of cost-containment measures in the EU could lead to price reductions and affect the company's ability to recoup investments in product development[228]. - The U.S. federal government may impose mandatory additional rebates and discounts on drug manufacturers if commercial prices increase faster than the Consumer Price Index-Urban, potentially impacting the ability to raise commercial prices[232]. - Coverage and reimbursement for drug products in the U.S. can vary significantly among third-party payors, leading to a time-consuming and costly coverage determination process[233]. - There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect the commercialization of product candidates[235]. - The Inflation Reduction Act of 2022 allows HHS to negotiate prices for certain drugs under Medicare, which could significantly impact the pharmaceutical industry[237]. - The EU's Regulation No 2021/2282 on Health Technology Assessment, effective January 2025, aims to enhance cooperation among EU Member States in assessing health technologies, potentially affecting pricing and reimbursement[244]. - The legislative landscape in the U.S. and EU continues to evolve, with potential future measures that may impose more rigorous coverage criteria and lower reimbursement rates[241]. - The UK’s withdrawal from the EU may lead to additional regulatory challenges and costs for drug manufacturers, particularly regarding batch testing and release requirements[249]. - Currency fluctuations, especially with the Euro, could significantly impact the costs of conducting clinical trials in Europe[246]. - The company may face increased operational risks due to geopolitical instability and public health issues, which could adversely affect business prospects[247]. - The company may need to compile additional data for cost-effectiveness assessments in some EU Member States to obtain reimbursement for its products[243]. Legal and Compliance Risks - The company faces significant risks related to product liability claims, which could result in substantial liabilities and limit the commercialization of its product candidates[263]. - The company does not currently carry product liability insurance, which may hinder its ability to commercialize products if claims arise[264]. - The company actively evaluates strategic transactions and may pursue acquisitions or joint ventures, but lacks substantial experience in integrating acquired businesses[260]. - The potential divergence of UK legislation from EU regulations post-Brexit could materially impact the company's regulatory regime and development plans[252]. - The company may incur significant additional expenses due to delays in obtaining regulatory approvals, which could adversely affect its ability to generate revenue[253]. - The company is highly dependent on key personnel, and the loss of such individuals could harm its business and financial condition[254]. - The company must manage its growth effectively to maintain relationships with strategic partners and ensure successful commercialization of its product candidates[258]. - The company faces challenges in maintaining effective internal controls over financial reporting, which could affect investor confidence and stock value[267]. - The company is exposed to risks of employee misconduct, including non-compliance with FDA regulations, which could lead to significant penalties and reputational harm[272]. - Misconduct could result in civil, criminal, and administrative penalties, including possible exclusion from federal healthcare programs, which would adversely affect the company's operations[273]. - The company must comply with various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which could impact its sales and marketing activities[275]. - Non-compliance with healthcare laws may lead to penalties, reputational harm, and diminished profits, affecting future earnings and operational restructuring[274]. - The company is subject to the Foreign Corrupt Practices Act, which imposes strict accounting and compliance requirements for international operations[279]. - Data privacy and security obligations are stringent, with potential regulatory investigations and penalties for non-compliance, impacting business operations[280]. - The company faces significant fines under the California Consumer Privacy Act, which can reach up to $7,500 per intentional violation, complicating compliance efforts[282]. - The European Union's GDPR imposes fines of up to €20 million or 4% of annual global revenue for violations, increasing legal risks and compliance costs[285]. - Compliance with the Swiss Federal Act on Data Protection may lead to increased costs and risks of noncompliance penalties[286]. - The company may face significant adverse consequences if unable to lawfully transfer personal data from the EEA or UK, including increased regulatory exposure and potential fines[288]. - Compliance with data privacy and security obligations requires significant resources and may necessitate changes to information technologies and data processing practices[290]. Cybersecurity and Operational Risks - The company is subject to U.S. and foreign export controls, sanctions, and anti-corruption laws, which could impair its ability to compete in markets[294]. - Cyberattacks and malicious activities pose a threat to the confidentiality and integrity of sensitive information, with ransomware attacks becoming increasingly prevalent[298]. - The company relies on third-party service providers for critical business systems, which may expose it to cybersecurity risks and vulnerabilities[299]. - Security incidents could disrupt the company's ability to provide services and may lead to significant financial and reputational harm[302]. - The company must conduct clinical trials in compliance with Good Clinical Practices (GCP), and failure to do so could delay regulatory approvals[304]. - Regulatory authorities enforce GCP compliance through inspections, and any non-compliance could result in the need for additional clinical trials[304]. - The company may face substantial civil and criminal penalties for violations of data privacy and security laws, impacting its operations and reputation[295]. - The company’s contracts may not sufficiently limit liability related to data privacy and security obligations, and insurance coverage may be inadequate[303]. - The company relies on third-party contract research organizations (CROs) for clinical programs, which may lead to delays and impact clinical development timelines[305]. - If CROs fail to meet contractual obligations, it could result in extended or terminated clinical trials, increased costs, and delayed revenue generation[306]. - The company does not have its own manufacturing facilities and depends on third-party manufacturers, increasing the risk of insufficient product quantities or quality issues[307]. - Regulatory compliance and quality assurance are critical, as any noncompliance by third-party manufacturers could lead to significant operational disruptions[309]. - The company faces risks related to the potential noncompliance of suppliers with regulatory requirements, which could result in delays and market disruptions[310]. Intellectual Property and Market Position - The company has a license agreement with Mitsubishi Tanabe Pharma Corporation for its lead product candidate, roluperidone, which is crucial for its operations[318]. - Future milestone payments from Royalty Pharma, totaling up to $95 million, depend on the successful development and commercialization of seltorexant by Janssen Pharmaceutica NV[319]. - The company may not successfully establish new collaborations, which could adversely affect its ability to develop and commercialize future product candidates[321]. - The patent prosecution process is expensive and time-consuming, and failure to secure patents could limit the company's competitive position[322]. - The uncertainty surrounding patent rights in the biotechnology sector poses risks to the company's ability to protect its technology and products[324]. - The expiration of patents related to proprietary products may lead to increased competition and reduced ability to recover development costs, with some patents expected to expire as early as 2028[325]. - The company has in-licensed or acquired intellectual property necessary for product development, and failure to comply with obligations could result in loss of these rights[328]. - Legal proceedings to protect intellectual property may be costly and time-consuming, with the risk of competitors infringing on patents[329]. - The company may need to license additional patents from third parties, and failure to obtain these licenses could materially harm the business[330]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its product candidates[335]. - The company faces uncertainties regarding patent protection in foreign jurisdictions, which may allow competitors to develop similar products[338]. - Compliance with procedural requirements is crucial for maintaining patent rights, as non-compliance could lead to loss of patent protection[341]. - The company may be subject to claims regarding the wrongful use of trade secrets, which could result in costly litigation and loss of valuable rights[343]. - The confidentiality of trade secrets is critical, as breaches could harm the company's competitive position[344]. Stock and Capital Structure - The market price of the company's common stock may be volatile, affecting the ability to raise capital and enter strategic partnerships[346]. - As of December 31, 2023, executive officers, directors, and holders of 5% or more of the capital stock beneficially own approximately 49.2% of the voting stock, with 19.3% held by Federated Hermes, Inc. and 18.2% held by BI[348]. - The company anticipates significant additional capital will be needed in the future to fund planned operations, including completing clinical trials for product candidates[351]. - The management is authorized to grant stock options and other equity-based awards of up to 2,078,917 shares, which may lead to additional dilution for stockholders[352]. - The company incurs significant additional legal, accounting, and compliance costs as a public company, which may divert management's time and attention[353]. - The company is classified as a "smaller reporting company," allowing it to comply with reduced reporting requirements, potentially making its securities less attractive to investors[355]. - Future sales of common stock by existing stockholders could significantly impact the market price of the company's common stock[349]. - The company may issue additional equity or debt securities in the future, which could result in further dilution for existing stockholders[351]. - The concentration of stock ownership may delay or deter a change of control and affect the market price and liquidity of the common stock[348]. - The company faces risks related to market conditions, including economic downturns and regulatory changes, which may negatively affect stock prices[347]. - The management has broad discretion over the use of proceeds from public offerings and may not apply them in ways that enhance stockholder value[350].

Financial Position - As of September 30, 2023, Minerva Neurosciences, Inc. 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[23]. - The Company had cash, cash equivalents, and restricted cash of $47.0 million, which is expected to be sufficient to meet operating commitments for the next 12 months[24]. - The Company has incurred recurring operating losses and negative cash flows from operations since inception, indicating ongoing financial challenges[23]. - The Company will need to raise additional capital to continue funding operations and later stage clinical development programs[25]. - As of September 30, 2023, accrued expenses and other liabilities totaled approximately $1.95 million, with significant increases in research and development costs and accrued bonuses compared to December 31, 2022[40]. Regulatory and Development Updates - The FDA confirmed that the NDA for roluperidone was assigned a standard review classification with a Prescription Drug User Fee Act goal date of February 26, 2024[21]. - Minerva has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously co-developed seltorexant, from which it is entitled to collect mid-single digit royalties on future sales[22]. - The Company has no commercially approved products and faces significant risks related to regulatory approvals and competition[34]. - The Company has two ongoing Phase 3 studies for seltorexant, with a third study discontinued in 2022, impacting future royalty revenues[46]. Stock and Compensation - The reverse stock split on June 17, 2022, reduced the number of outstanding shares from 42,721,566 to 5,340,193[30]. - The weighted average shares of common stock outstanding increased to 7,568,981 in Q3 2023 from 5,340,193 in Q3 2022[43]. - The Company received gross proceeds of $20 million from a private placement of common stock and warrants on June 30, 2023, with net proceeds of $19.6 million after offering expenses[50]. - The Royalty Obligation related to the sale of future royalties amounted to $79,826,671 as of September 30, 2023, including a non-cash interest expense of $19,826,671[47]. - The effective annual interest rate for the Royalty Obligation was estimated at approximately 10.7% as of September 30, 2023, up from 10.5% at the time of execution[46]. - The Company has 735,929 stock options outstanding as of September 30, 2023, with a weighted average exercise price of $14.19 and an intrinsic value of $1,037,000[56]. - The weighted average grant-date fair value of stock options outstanding on September 30, 2023, was $9.88 per share, with total unrecognized compensation costs of approximately $1.6 million[57]. - The Company has not issued any shares under its at-the-market equity offering program during the nine months ended September 30, 2023, with $22.6 million still eligible for sale[53]. - The Company has 228,213 PRSUs vested, 20,218 cancelled, and 228,209 outstanding as of September 30, 2023[62]. - 50% of the shares of common stock underlying the Company's PRSUs vested following FDA acceptance of the NDA for roluperidone, resulting in the recognition of approximately $0.2 million in non-cash compensation expense for the period ending September 30, 2023[62]. - For the three months ended September 30, 2023, total stock-based compensation expense was $371,943, a decrease from $1,036,874 in the same period of 2022[63]. - For the nine months ended September 30, 2023, total stock-based compensation expense was $1,357,317, compared to $3,161,135 for the same period in 2022[63]. Lease and Legal Matters - The Company entered into a month-to-month office lease agreement with a monthly payment of $8,290, commencing February 1, 2023[65]. - The Company has not recognized the lease agreement on the balance sheet as the term is 12 months or less[65]. - The Company is not aware of any legal claims or litigation that would materially affect its financial position or results of operations[64]. Research and Development Expenses - The Company’s research and development expenses for the three months ended September 30, 2023, were $185,075, down from $518,920 in the same period of 2022[63].

Financial Position - As of June 30, 2023, the company had an accumulated deficit of approximately $380.0 million and net cash used in operating activities was approximately $4.0 million during the six months ended June 30, 2023[28]. - The company had cash, cash equivalents, and restricted cash of $51.9 million as of June 30, 2023, which is expected to be sufficient to meet operating commitments for the next 12 months[29]. - The company needs to raise additional capital to continue funding operations and potential later-stage clinical development programs[30]. - As of June 30, 2023, accrued expenses and other current liabilities totaled approximately $1.6 million, with significant increases in accrued bonuses and professional fees compared to December 31, 2022[46]. - The company has no commercially approved products and is subject to significant risks and uncertainties related to clinical testing and regulatory approvals[39]. Stock and Securities - The company’s common stock regained compliance with Nasdaq Listing Rule 5550(b)(2) on June 16, 2023, maintaining a minimum market value of listed securities of $35 million or greater[31]. - The Company issued pre-funded warrants for an aggregate of 575,575 shares of common stock at a purchase price of $9.99 per share, with an exercise price of $0.01 per share[48]. - The Company received gross proceeds of $20.0 million from a private placement of common stock and warrants on June 30, 2023, with net proceeds amounting to $19.7 million after offering expenses[56]. - The Company has not issued or sold any shares under the at-the-market equity offering program during the six months ended June 30, 2023, with $22.6 million still eligible for sale[59]. - The Company has agreed to file a registration statement covering the resale of securities from the private placement within 45 days of closing[57]. Financial Performance - The net loss for the three months ended June 30, 2023, was $6,192,036, compared to a net loss of $8,717,714 for the same period in 2022, representing a 29% improvement[49]. - The basic and diluted net loss per share for the three months ended June 30, 2023, was $(1.12), compared to $(1.63) for the same period in 2022, indicating a 31% reduction in loss per share[49]. - Total stock-based compensation expense for the three months ended June 30, 2023, was $608,915, a decrease of 43.2% compared to $1,071,605 for the same period in 2022[69]. - Research and development expenses for the three months ended June 30, 2023, were $297,756, down 42.2% from $514,806 in the same period of 2022[69]. - General and administrative expenses for the three months ended June 30, 2023, were $311,159, a decrease of 44.2% compared to $556,799 for the same period in 2022[69]. Clinical Development - The company received a refusal to file letter from the FDA for its NDA for roluperidone in October 2022, but the NDA was filed again on April 27, 2023, with a Prescription Drug User Fee Act goal date of February 26, 2024[26]. - The company has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously sold rights to royalties from seltorexant for $60 million upfront and up to $95 million in potential future milestone payments[27]. - The Company has two ongoing Phase 3 studies for seltorexant, while a third study was discontinued in 2022[52]. Compensation and Stock Options - The Company has 700,929 common stock options outstanding as of June 30, 2023, with a weighted average exercise price of $15.69 and an intrinsic value of $2,022,000[62]. - The Company has 118,666 stock options available for future grant as of June 30, 2023[62]. - As of June 30, 2023, the total unrecognized compensation costs related to non-vested stock options were approximately $0.5 million, expected to be recognized over a weighted-average period of 0.5 year[67]. - The Company recognized approximately $0.2 million in non-cash compensation expense for the period ending June 30, 2023, due to the vesting of 50% of the PRSUs following FDA acceptance of the NDA for roluperidone[68]. - As of June 30, 2023, 228,213 PRSUs have vested, with 20,218 cancelled and 228,209 remaining outstanding[68]. Lease and Legal Matters - The Company entered into a month-to-month office lease agreement on February 1, 2023, with a monthly payment of $8,290 for approximately 491 rentable square feet[71]. - The Company is not aware of any legal claims or litigation that would materially affect its financial position or results of operations[70].

Financial Performance - As of March 31, 2023, Minerva Neurosciences had an accumulated deficit of approximately $373.8 million and net cash used in operating activities was approximately $0.1 million for the three months ended March 31, 2023[26]. - For the three months ended March 31, 2023, the net loss was $6,970,412, resulting in a basic and diluted loss per share of $1.31, compared to a net loss of $9,764,429 and a loss per share of $1.83 for the same period in 2022[45]. - The company has incurred recurring operating losses and negative cash flows from operations since inception, financing operations through various means including equity financings and collaboration agreements[26]. - Total stock-based compensation expense for the three months ended March 31, 2023, was $376,459, a decrease from $1,052,656 in the same period of 2022[60]. Cash and Liquidity - The company had cash, cash equivalents, and restricted cash totaling $36.1 million, which is expected to be sufficient to meet operating commitments for the next 12 months[27]. - The company will need to raise additional capital to fund operations and later-stage clinical development programs, with no assurance that such financing will be available on acceptable terms[28]. - As of March 31, 2023, accrued expenses and other liabilities totaled $1,540,663, a significant increase from $407,909 as of December 31, 2022[44]. - As of March 31, 2023, the total liability related to the sale of future royalties amounted to $75.7 million, which includes $15.7 million in non-cash interest expense[49]. - The effective annual interest rate for the Royalty Obligation was estimated to be approximately 10.7% as of March 31, 2023[48]. Agreements and Collaborations - The company has exclusive rights to develop and commercialize MIN-301 for Parkinson's disease and previously co-developed seltorexant with Janssen, opting out of the agreement in 2020[25]. - The Company entered into an agreement with Royalty Pharma for an upfront payment of $60 million and potential milestone payments of up to $95 million related to seltorexant[47]. - The company sold its rights to potential royalties from seltorexant to Royalty Pharma in January 2021, entitling it to collect royalties in the mid-single digits on future sales[25]. Regulatory and Compliance - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024, for the New Drug Application (NDA) of roluperidone, following a formal dispute resolution request[24]. - The company received a deficiency letter from Nasdaq regarding its Market Value of Listed Securities (MVLS), which was below the required $35 million, and has until May 30, 2023, to regain compliance[29]. Stock and Compensation - No shares of the Company's common stock were issued or sold under the At-the-Market Equity Offering Program during the three months ended March 31, 2023, with $22.6 million eligible for sale[50]. - The Company granted 476,640 performance-based restricted stock units (PRSUs) through an Exchange Program, with 50% vesting upon FDA acceptance of a new drug application for roluperidone[53]. - As of March 31, 2023, the total unrecognized compensation costs related to non-vested stock options were approximately $1.5 million, expected to be recognized over 2.6 years[56]. - On April 28, 2023, 50% of the shares underlying the PRSUs granted on August 6, 2021 vested following FDA acceptance of a new drug application for roluperidone[63]. Operations - The Company is currently conducting two Phase 3 studies with seltorexant, while a third study was discontinued in 2022[48]. - The Company has a month-to-month office lease agreement with a monthly payment of $8,290, commencing February 1, 2023[62].

Financial Performance - The company reported an accumulated deficit of $366.8 million as of December 31, 2022, compared to $334.7 million in 2021, indicating a net loss of $32.1 million for 2022, down from $49.9 million in 2021 [370]. - The net loss for the year ended December 31, 2022, was $32.1 million, compared to a net loss of $49.9 million in 2021, indicating an improvement of approximately 35.9% [392]. - The company has not generated any revenue from product sales to date and anticipates continued net losses as it develops its product candidates [399]. Research and Development - Research and development expenses for roluperidone were $12.6 million in 2022, a decrease from $14.4 million in 2021, reflecting the company's strategic focus on this lead drug candidate [385]. - Research and development expenses were $14.6 million in 2022, down from $32.0 million in 2021, reflecting a decrease of $17.4 million [393]. - Research and development costs are expensed as incurred, including licensing fees and salaries related to R&D functions [418]. - Payments under research contracts may depend on successful patient enrollment and completion of clinical trial milestones, leading to potential variability in expense recognition [418]. - The company capitalizes incomplete research projects acquired through business combinations as indefinite-lived intangible assets, subject to impairment testing [420]. Regulatory and Development Updates - The NDA for roluperidone was submitted in August 2022 but was met with a refusal to file letter from the FDA in October 2022, which remains in effect [369]. - The company anticipates ongoing discussions with the FDA regarding the status of the roluperidone NDA and development program [372]. - The company deferred the development of MIN-301 due to limited resources, resulting in a non-cash impairment charge of $15.2 million in 2021 [382]. Cash and Capital Management - As of December 31, 2022, the company had approximately $36.2 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months [399]. - The company plans to raise additional capital or seek product collaborations to support the development and commercialization of its product candidates [385]. Royalties and Agreements - The company sold its rights to potential royalties from seltorexant to Royalty Pharma for $60 million, with additional milestone payments of up to $95 million contingent on the completion of Phase 3 trials [379]. - The company entered into an agreement with Royalty Pharma for an upfront payment of $60 million for its royalty interest in seltorexant, with potential additional milestone payments of up to $95 million [403]. - The company recognized $1.9 million and $7.4 million in non-cash interest expense related to the royalty agreement for the three and twelve months ended December 31, 2022, respectively [380]. - Non-cash interest expense for the sale of future royalties rose to $7.4 million in 2022 from $6.3 million in 2021, an increase of $1.1 million [397]. - As of December 31, 2022, the company recorded a liability related to the sale of future royalties amounting to $60 million, with potential additional milestone payments of up to $95 million [427]. Impairment and Goodwill - The company recognized a non-cash charge of $15.2 million for the impairment of the MIN-301 intangible asset as of December 31, 2021, due to a strategic decision to focus on the lead drug candidate, roluperidone [422]. - The company has not recognized any impairment of goodwill for the years ended December 31, 2022, and 2021, with $14.9 million of goodwill associated with a reporting unit having zero or negative carrying value [424]. - The company tests its indefinite-lived intangibles, including IPR&D assets, for impairment annually, with no impairments recognized for the years ended December 31, 2022, and 2021 [421]. Tax and Interest - Deferred tax assets are evaluated for realization based on a more-likely-than-not criterion, with no interest or penalties related to income taxes for the years ended December 31, 2022, or 2021 [426]. - The effective annual interest rate estimated by the company as of December 31, 2022, was approximately 10.7%, with a 20% increase in clinical success probability potentially increasing non-cash interest expense by $37.7 million [428]. Stock and Shareholder Information - A reverse stock split of 1-for-8 was executed on June 17, 2022, reducing the number of outstanding shares from 42,721,566 to 5,340,193 [412].

Financial Data and Key Metrics Changes - Cash, cash equivalents, and restricted cash as of September 30, 2022, were approximately $40.3 million, down from $60.9 million as of December 31, 2021, indicating a decrease of about 33.5% [18] - Net loss for the third quarter of 2022 was $6.9 million, or a net loss per share of $1.29, compared to a net loss of $9.2 million, or a net loss per share of $1.72 for the same period in 2021, showing an improvement in loss [27] - For the nine months ended September 30, 2022, net loss was $25.4 million, or a net loss per share of $4.75, compared to a net loss of $28.6 million, or a net loss per share of $5.36 for the same period in 2021, also indicating a reduction in loss [27] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for the three months ended September 30, 2022, were $2.4 million, down from $4.5 million in the same period of 2021, a decrease of approximately 46.7% [20] - For the nine months ended September 30, 2022, R&D expenses were $11.5 million, down from $13.3 million in the same period of 2021, a decrease of approximately 13.5% [21] - General and administrative (G&A) expenses for the three months ended September 30, 2022, were $2.8 million, down from $3 million in the same period of 2021, a decrease of approximately 6.7% [23] - For the nine months ended September 30, 2022, G&A expenses were $8.7 million, down from $10.7 million in the same period of 2021, a decrease of approximately 18.7% [24] Company Strategy and Development Direction - The company submitted its NDA for roluperidone to treat negative symptoms in schizophrenia to the FDA, highlighting a significant unmet medical need as there are no approved drugs in the U.S. for this condition [9][12] - The company is focused on roluperidone as a monotherapy for a specific sub-population of schizophrenia patients who do not require continuous treatment with antipsychotics for positive symptoms [15] - The company plans to discuss the FDA's refusal to file letter in a Type A meeting, which is expected to clarify the path forward for the NDA submission [11][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Type A meeting with the FDA, which is expected to provide clarity on the NDA submission and the issues raised in the refusal to file letter [30][34] - The company is also working on an early-stage pipeline, although the primary focus remains on roluperidone as it is a late-stage asset and a key value driver [57] Other Important Information - The company filed a shelf registration statement on Form S-3 to register up to $200 million in new shares of common stock, indicating potential future capital raising efforts [18] - As of September 30, 2022, an aggregate of $22.6 million was eligible for sale under the effective registration statement [19] Q&A Session Summary Question: Can the company infer whether the FDA is comfortable with any of the issues previously outlined? - Management indicated that discussions with the FDA have been ongoing and that the upcoming Type A meeting will help clarify the situation [30] Question: What dynamics would need to play out before considering another study for roluperidone? - Management stated that clarity from the Type A meeting will determine the next steps, including whether another study is necessary [33] Question: Did the FDA provide specific reasons for the refusal to file letter? - Management confirmed that the FDA provided reasons, which will be discussed in the Type A meeting [43] Question: Is the company working on other assets in the pipeline? - Management confirmed that while the focus is on roluperidone, there is an early-stage pipeline that is being developed, albeit at a slower pace [57]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdictio ...

PART I [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2022 financial statements report a net loss of $18.5 million, a $8.4 million stockholders' deficit, and a 1-for-8 reverse stock split - On June 17, 2022, the company effected a **1-for-8 reverse stock split** of its common stock, with all share and per-share amounts retroactively adjusted[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk) - In January 2021, the company sold its royalty interest in seltorexant for a **$60 million upfront payment**, with the liability growing to **$69.9 million** by June 30, 2022, due to accrued non-cash interest[46](index=46&type=chunk)[48](index=48&type=chunk) Condensed Consolidated Balance Sheets (Unaudited) | Metric | June 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $49,753,998 | $60,755,080 | | Total assets | $64,959,298 | $77,121,918 | | Liability related to the sale of future royalties | $69,932,614 | $66,327,321 | | Total liabilities | $73,341,542 | $69,146,275 | | Total stockholders' (deficit) equity | $(8,382,244) | $7,975,643 | Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2022 ($) | Three Months Ended June 30, 2021 ($) | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,131,978 | $5,520,928 | $9,091,841 | $8,779,635 | | General and administrative | $2,833,211 | $3,442,365 | $5,862,606 | $7,691,179 | | Net loss | $(8,717,714) | $(10,589,163) | $(18,482,143) | $(19,393,896) | | Net loss per share, basic and diluted | $(1.63) | $(1.98) | $(3.46) | $(3.63) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Metric | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,001,077) | $(11,142,185) | | Net cash provided by financing activities | $(5) | $60,000,000 | | Net (decrease) increase in cash | $(11,001,082) | $48,857,815 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses roluperidone NDA preparation, Q2 2022 operating expense decreases, and the sufficiency of $49.9 million cash for the next 12 months - The company is preparing for a potential **NDA submission for roluperidone in Q3 2022**, despite FDA concerns regarding Phase 2b study applicability and post hoc analyses for the Phase 3 study[73](index=73&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk) - As of June 30, 2022, the company had approximately **$49.9 million** in cash, cash equivalents, and restricted cash, believed sufficient for **at least the next 12 months**[97](index=97&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2022, was **$11.0 million**, primarily due to a net loss of **$18.5 million**, offset by non-cash expenses[105](index=105&type=chunk) Operating Expense Comparison (Q2 2022 vs Q2 2021) | Expense Category | Q2 2022 ($ millions) | Q2 2021 ($ millions) | Change ($ millions) | | :--- | :--- | :--- | :--- | | Research & Development | $4.1 million | $5.5 million | -$1.4 million | | General & Administrative | $2.8 million | $3.4 million | -$0.6 million | [Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports this section is not applicable - Not applicable[115](index=115&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective**[117](index=117&type=chunk) - There were **no material changes** in internal control over financial reporting during the quarter[118](index=118&type=chunk) PART II — Other Information [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any legal proceedings expected to have a material adverse effect on its business - As of the report date, the company is **not party to any claim or litigation** that is expected to have a **material adverse effect** on its business[120](index=120&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include significant accumulated losses, need for additional capital, potential Nasdaq delisting due to equity deficiency, and regained bid price compliance - The company has a history of **significant losses**, with an **accumulated deficit of $353.2 million** as of June 30, 2022, and expects to continue incurring losses[123](index=123&type=chunk)[124](index=124&type=chunk) - The company will require **additional capital** to finance operations, with existing cash of **$49.9 million** deemed sufficient for **at least the next 12 months**, though future financing is not guaranteed[126](index=126&type=chunk)[127](index=127&type=chunk) - On March 8, 2022, the company received a **deficiency letter from Nasdaq** for not meeting the **$10 million stockholders' equity requirement**, but was granted an **extension until September 5, 2022**, to regain compliance[156](index=156&type=chunk) - The company **regained compliance** with Nasdaq's **$1.00 minimum bid price requirement** on July 6, 2022, following a **1-for-8 reverse stock split** implemented in June 2022[155](index=155&type=chunk) - The company is subject to **evolving U.S. and foreign data privacy and security laws**, and non-compliance could lead to **significant penalties, litigation, and reputational harm**[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[159](index=159&type=chunk) [Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports this section is not applicable - Not applicable[160](index=160&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports this section is not applicable - Not applicable[161](index=161&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) The company reports this section is not applicable - Not applicable[162](index=162&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including the Certificate of Amendment for the reverse stock split and Sarbanes-Oxley certifications - Lists exhibits filed with the report, including the **Certificate of Amendment** to the Amended and Restated Certificate of Incorporation effective June 17, 2022, and **Sarbanes-Oxley certifications**[164](index=164&type=chunk)

Financial Performance - The company reported an accumulated deficit of approximately $344.5 million as of March 31, 2022, and anticipates continued net losses for the foreseeable future [89]. - The company has incurred significant operating losses every year since inception and expects to continue incurring negative cash flow from operating activities [68]. - Net cash used in operating activities was approximately $5.8 million for the three months ended March 31, 2022, compared to $5.2 million for the same period in 2021, primarily due to net losses of $9.8 million and $8.8 million respectively [96][97][98]. Cash and Liquidity - As of March 31, 2022, the company had approximately $55.0 million in cash, cash equivalents, and restricted cash, which is expected to meet cash commitments for at least the next 12 months [89]. - The existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months [94]. - Net cash provided by financing activities was $60 million during the three months ended March 31, 2021, resulting from the sale of future royalties, while there was no cash provided from financing activities in the same period of 2022 [100]. Expenses - Research and development expenses increased to $5.0 million for Q1 2022, up from $3.3 million in Q1 2021, representing a 51.5% increase primarily due to higher consulting fees related to NDA support activities [84]. - General and administrative expenses decreased to $3.0 million for Q1 2022, down from $4.2 million in Q1 2021, a reduction of approximately 28.6% due to lower staffing and legal costs [85]. - Non-cash interest expense for the sale of future royalties increased to $1.8 million in Q1 2022 from $1.3 million in Q1 2021, reflecting a 38.5% increase due to a higher effective interest rate [88]. - Stock-based compensation expense was $1.1 million for the three months ended March 31, 2022, compared to $1.5 million for the same period in 2021 [97][98]. Future Outlook - The company is preparing for a potential NDA submission for roluperidone during Q3 2022, contingent on FDA feedback [77]. - The company anticipates needing to raise additional capital or seek product collaborations to complete the development and commercialization of its product candidates [80]. - Future capital requirements will depend on various factors, including the size and timing of clinical trials and strategic partnering activities [94]. - The uncertainty in capital markets due to the COVID-19 pandemic may negatively impact the availability and cost of capital for the company [94]. Operational Activities - The company has completed the Open-label extension of the Phase 3 study for roluperidone, focusing on negative symptoms of schizophrenia [70]. - The company has not generated any revenue from product sales and relies on collaborative revenue from the sale of royalty interests in seltorexant, which was sold to Royalty Pharma for an upfront payment of $60 million [92]. - The company reported a decrease in accounts payable of $0.3 million during the three months ended March 31, 2022, which contributed to the net cash used in operating activities [97]. Accounting Policies - The company has identified critical accounting policies related to research and development costs and the liability related to the sale of future royalties as significant for its financial status [101]. - There were no cash flows from investing activities for both the three months ended March 31, 2022, and 2021 [99].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 26-0784194 (State or other jurisdic ...