Financial Performance - As of September 30, 2024, the accumulated deficit was approximately $391.1 million, down from $396.8 million as of December 31, 2023[64]. - For the nine months ended September 30, 2024, research and development expenses increased to $9.9 million from $8.0 million for the same period in 2023, an increase of approximately 23.8%[85]. - General and administrative expenses decreased to $7.4 million for the nine months ended September 30, 2024, from $8.0 million in 2023, a decrease of approximately 7.5%[86]. - The company recorded other income of $26.6 million for the three months ended September 30, 2024, compared to zero for the same period in 2023, an increase of $26.6 million[84]. - Investment income for the three months ended September 30, 2024, was $314 thousand, down from $349 thousand in 2023, a decrease of approximately 10%[81]. - Non-cash interest expense for the sale of future royalties was zero for the three months ended September 30, 2024, down from $2.1 million in 2023, a decrease of 100%[82]. - Net cash used in operating activities was approximately $14.4 million for the nine months ended September 30, 2024, compared to $8.8 million for the same period in 2023[104][105]. - Net cash provided by financing activities was approximately $19.6 million during the nine months ended September 30, 2023, primarily from the Private Placement[106]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates to date[70]. - The company has not generated any revenue from product sales to date, relying on collaborative revenue from the sale of royalty interests in seltorexant[99]. - The company sold its royalty interest in seltorexant for an upfront payment of $60 million, with potential future milestone payments of up to $95 million[98]. - The company has not generated significant revenue from product sales and does not expect to do so until regulatory approval is obtained[99]. Cash Position and Financing - The company had approximately $26.6 million in cash, cash equivalents, and restricted cash as of September 30, 2024, sufficient to meet operating commitments for the next 12 months[90]. - The company received aggregate gross proceeds of $20.0 million from a Private Placement, incurring approximately $0.4 million in offering expenses[94]. - As of September 30, 2024, an aggregate of $22.6 million was eligible for sale under the At-the-Market Equity Offering Program[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholder interests[101]. Development and Regulatory Matters - The FDA issued a Complete Response Letter for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[63]. - The company anticipates increased expenses related to ongoing development activities and commercialization efforts for product candidates[99]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures[109].

Core Viewpoint - Minerva Neurosciences, Inc. reported its second quarter 2024 financial results and business updates, highlighting ongoing challenges with the FDA regarding its New Drug Application for roluperidone and increased research and development expenses [1][2]. Financial Performance - Research and Development (R&D) expenses for Q2 2024 were $3.9 million, up from $1.9 million in Q2 2023, primarily due to higher subcontractor fees related to drug substance validation [3]. - General and Administrative (G&A) expenses for Q2 2024 were $2.4 million, slightly down from $2.6 million in Q2 2023, attributed to lower compensation expenses [4]. - Non-cash interest expense for the sale of future royalties was $2.3 million for Q2 2024, compared to $2.0 million in Q2 2023, reflecting increased amortization of non-cash interest [5]. - The net loss for Q2 2024 was $8.2 million, or a net loss per share of $1.09, compared to a net loss of $6.2 million, or $1.12 per share in Q2 2023 [6]. Cash Position - As of June 30, 2024, the company had approximately $31.0 million in cash, cash equivalents, and restricted cash, down from $41.0 million at the end of 2023 [7]. Assets and Liabilities - Total assets as of June 30, 2024, were $46.3 million, a decrease from $56.9 million at the end of 2023 [11]. - Total liabilities increased to $90.8 million as of June 30, 2024, compared to $85.4 million at the end of 2023, with a notable rise in liabilities related to the sale of future royalties [12].

Financial Performance - The company reported an accumulated deficit of approximately $413.6 million as of June 30, 2024, compared to $396.8 million as of December 31, 2023[56]. - The net cash used in operating activities for the six months ended June 30, 2024, was approximately $10.0 million, primarily due to a net loss of $16.8 million[83]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates[73]. Revenue Generation - The company has not generated any revenue from product sales to date and has no products approved for commercial sale[61]. - The company has not generated any revenue from product sales to date and does not expect significant revenue until regulatory approval and commercialization of product candidates[78]. - The company has not generated revenue from product sales and relies on collaborative revenue from the sale of royalty interests[78]. Expenses - Research and development expenses increased to $8.0 million for the six months ended June 30, 2024, from $4.5 million for the same period in 2023, representing an increase of approximately 77.8%[70]. - General and administrative expenses decreased to $4.9 million for the six months ended June 30, 2024, down from $5.3 million in the same period in 2023, a decrease of approximately 7.5%[71]. - Non-cash interest expense for the sale of future royalties increased to $4.6 million for the six months ended June 30, 2024, from $4.0 million in the same period in 2023, an increase of approximately 15%[72]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials[78]. Cash Position - As of June 30, 2024, the company had approximately $31.0 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[73]. - The company’s existing cash and equivalents are expected to meet cash commitments for at least the next 12 months[79]. - As of June 30, 2024, an aggregate of $22.6 million was eligible for sale under the Sales Agreement[76]. Financing Activities - The net cash provided by financing activities was approximately $19.7 million during the six months ended June 30, 2023, primarily from a Private Placement[84]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[79]. Clinical Development - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[55]. - The company completed a Phase 1b clinical trial evaluating the co-administration of roluperidone and olanzapine, enrolling 17 subjects, with 13 completing the study[60]. Company Classification - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures[87].

Minerva Neurosciences (NERV) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.The ...

BURLINGTON, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Appli ...

Financial Performance - The company reported an accumulated deficit of $405.4 million as of March 31, 2024, compared to $396.8 million as of December 31, 2023[70]. - For the three months ended March 31, 2024, the company recorded a net loss of $8.6 million, an increase from a net loss of $7.0 million for the same period in 2023[70]. - The company has not generated any revenue from the sales or licensing of its product candidates, and it anticipates continuing to incur net losses for the foreseeable future[70]. - Net cash used in operating activities for Q1 2024 was approximately $6.1 million, compared to $0.1 million in Q1 2023, primarily due to a net loss of $8.6 million[102][103]. - The company reported a net loss of $8.6 million for the three months ended March 31, 2024, which was higher than the net loss of $7.0 million for the same period in 2023[102][103]. - There were no cash flows from investing or financing activities during the three months ended March 31, 2024 and 2023, resulting in a net decrease in cash of $6.1 million for Q1 2024[101][104][105]. Expenses - Research and development expenses increased to $4.2 million for the three months ended March 31, 2024, up from $2.7 million in the same period in 2023, primarily due to costs associated with the FDA's review of the NDA and the MIN-101C18 study[83]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2024, down from $2.7 million in the same period in 2023, mainly due to lower professional service fees[84]. Cash Position - As of March 31, 2024, the company had approximately $34.9 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[89]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, but additional funding may dilute existing stockholder interests[99]. - Existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months[99]. Regulatory and Clinical Developments - The FDA issued a Complete Response Letter on February 26, 2024, citing clinical deficiencies in the NDA for roluperidone, requiring additional studies to support its safety and effectiveness[71]. - The company completed a Phase 1b clinical trial in Q1 2024, enrolling 17 patients to evaluate the safety and pharmacokinetics of roluperidone co-administered with olanzapine[74]. Funding Activities - The company raised $20.0 million in gross proceeds from a private placement of common stock and warrants on June 30, 2023[92]. - The company sold its royalty interest in seltorexant to Royalty Pharma for an upfront payment of $60 million, with potential future milestone payments of up to $95 million[96]. Accounting and Reporting - The company identified critical accounting policies related to research and development costs and the liability for the sale of future royalties as significant for its financial status[106]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue thresholds are met[108].

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].