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What changed in Minerva Neurosciences, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Minerva Neurosciences, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+199 added−231 removedSource: 10-K (2025-02-25) vs 10-K (2024-02-22)

Top changes in Minerva Neurosciences, Inc.'s 2024 10-K

199 paragraphs added · 231 removed · 152 edited across 2 sections

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

7 edited+0 added−0 removed19 unchanged
Biggest changeDepending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards, and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: • our incident response plan; • incident detection and response processes; • a disaster recovery/business continuity plan; • encryption of certain data; • network security controls; • access controls; • asset management, tracking and disposal; • systems monitoring; • employee training; • penetration testing; • cybersecurity insurance; and • outsourced cybersecurity staff.
Biggest changeDepending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards, and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: • our incident response plan; • incident detection and response processes; • a disaster recovery/business continuity plan; • encryption of certain data; • network security controls; • access controls; • asset management, tracking and disposal; • systems monitoring; • employee training; • penetration testing; • cybersecurity insurance; and • outsourced cybersecurity staff. 66 Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes.
As part of our vendor security due diligence and to manage cybersecurity risks associated with our use of certain vendors, we perform risk assessments on vendors and may include cybersecurity 66 obligations in our contracts with them.
As part of our vendor security due diligence and to manage cybersecurity risks associated with our use of certain vendors, we perform risk assessments on vendors and may include cybersecurity obligations in our contracts with them.
Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, our vendor due diligence may involve different levels of assessment designed to help identify cybersecurity risks associated with a provider and we may impose contractual obligations related to cybersecurity on the provider.
Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, our vendor due diligence involves different levels of assessment designed to help identify cybersecurity risks associated with a provider. For example, we may impose contractual obligations related to cybersecurity on the provider.
Risk Factors in this Annual Report on Form 10-K, including: • Our business and operations would suffer in the event of system failures ; and • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
Risk Factors in this Annual Report on Form 10-K, including: • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
Effective September 12, 2022, our common stock began trading on The Nasdaq Capital Market under the symbol “NERV.” Holders of Record As of the close of business on February 19, 2024, there were approximately 38 holders of record of our common stock, including Cede & Co., a nominee for The Depository Trust Company (“DTC”), which holds shares of our common stock on behalf of an indeterminate number of beneficial owners.
Effective September 12, 2022, our common stock began trading on The Nasdaq Capital Market under the symbol “NERV.” Holders of Record As of the close of business on February 20, 2025, there were approximately 35 holders of record of our common stock, including Cede & Co., a nominee for The Depository Trust Company (“DTC”), which holds shares of our common stock on behalf of an indeterminate number of beneficial owners.
The lease is on a month-to-month basis commencing on February 1, 2024, with a monthly payment of $8,697. The term of the previous lease agreements for this space was from July 15, 2022 through January 31, 2024. We believe that our existing facility is sufficient for our current needs for the foreseeable future. IT EM 3.
The lease is on a month-to-month basis commencing on February 1, 2025, with a monthly payment of $9,106. The term of the previous lease agreements for this space was from July 15, 2022 through January 31, 2025. We believe that our existing facility is sufficient for our current needs for the foreseeable future. IT EM 3.
Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. For example, the Company's information security function works with management, including our Chief Operating Officer (“COO”) to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
For example, the Company's information security function works with management, including our Chief Operating Officer (“COO”) to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

145 edited+47 added−79 removed164 unchanged
Biggest changeTo test the estimated value of the liability related to the sale of future royalties and the non-cash interest expense, our audit procedures included the following, among others: • In the prior years to test the initial recognition of the liability related to the sale of future royalties, with the assistance of our fair value specialists, we: – Evaluated the appropriateness of the methodology used to estimate the implied discount rate, evaluated the significant assumptions discussed above that are used by management to estimate the future royalties to be paid and tested the underlying data used by the Company in its analysis. – Compared the significant assumptions used by management to relevant industry forecasts and economic trends, to evaluate consistency with external market and industry data, as well as consistency with evidence obtained in other areas of the audit. • In the current year to test the subsequent recognition of the liability related to the sale of future royalties, we obtained the liability calculation and accretion schedule and: – Reviewed changes in significant estimates and assumptions used by management. – Recalculated the liability related to the sale of future royalties and associated non-cash interest expense. – Evaluated whether there were any events or underlying factors that would indicate reassessment of the accounting conclusions. /s/ DELOITTE & TOUCHE LLP Boston, Massachusetts February 22, 2024 We have served as the Company’s auditor since 2013.
Biggest changeTo test the estimated value of the liability related to the sale of future royalties and the change in estimate, our audit procedures included the following, among others: • Tested changes in significant estimates and assumptions used by management. • Recalculated the liability related to the sale of future royalties and associated other income/expense. • Corroborated third-party information used in recalculation, focusing on the probabilities and timing of payments, using public data. • Evaluated the accounting treatment of the remeasurement of the liability. /s/ Deloitte & Touche LLP Boston, Massachusetts February 25, 2025 We have served as the Company’s auditor since 2013.
General and administrative costs also include costs for maintaining a publicly listed company including increased audit and legal fees, compliance with securities laws, corporate governance and investor relations. Foreign Exchange (Losses) Gains Foreign exchange (losses) gains are comprised primarily of (losses) and gains on foreign currency transactions primarily related to research and development expenses.
General and administrative costs also include costs for maintaining a publicly listed company including increased audit and legal fees, compliance with securities laws, corporate governance and investor relations. Foreign Exchange Gains (Losses) Foreign exchange gains (losses) are comprised primarily of gains and (losses) on foreign currency transactions primarily related to research and development expenses.
We incur certain expenses, primarily in Euros, and record these expenses in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date that an expense is recorded and the payment date is recorded as a foreign currency (loss) or gain.
We incur certain expenses, primarily in Euros, and record these expenses in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date that an expense is recorded and the payment date is recorded as a foreign currency gain or (loss).
Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances.
Impairment may result from, among other things, deterioration in the performance of the acquired business, adverse market conditions, adverse changes in applicable laws or regulations and a variety of other circumstances.
As the reporting unit had a positive fair value, there was no impairment associated with this reporting unit.
As the reporting unit had a positive fair value, there was no impairment associated with this reporting unit.
Exhibit Filing Date Filed Herewith 3.1 Amended and Restated Certificate of Incorporation of the Registrant S-1/A 333-195169 3.1 June 10, 2014 3.2 Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant 8-K 001-36517 3.1 June 17, 2022 3.3 Amended and Restated Bylaws of the Registrant 10-Q 001-36517 3.2 November 4, 2019 4.1 Form of Common Stock Certificate S-1/A 333-195169 4.1 June 10, 2014 4.2 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 10-K 001-36517 4.2 March 8, 2023 10.1 Share Purchase Agreement between the Registrant, Mind-NRG SA and Various Shareholders dated as of February 11, 2014 S-1 333-195169 10.13 April 9, 2014 10.2 † Form of Indemnification Agreement between the Registrant and each of its directors and executive officers S-1/A 333-195169 10.1 June 10, 2014 10.3* License Agreement between Mitsubishi Pharma Corporation and the Registrant f/k/a Cyrenaic Pharmaceuticals, Inc., dated as of August 30, 2007 S-1/A 333-195169 10.2 June 10, 2014 10.4* Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant f/k/a Cyrenaic Pharmaceuticals, Inc., dated as of June 16, 2011 S-1/A 333-195169 10.3 June 10, 2014 10.5* Second Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of January 20, 2014 S-1/A 333-195169 10.4 June 10, 2014 10.6* License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant as successor in interest to Sonkei Pharmaceuticals, Inc., dated as of September 1, 2008 S-1/A 333-195169 10.5 June 10, 2014 10.7* Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of January 20, 2014 S-1/A 333-195169 10.6 June 10, 2014 10.8* Co-Development and License Agreement between Janssen Pharmaceutica, N.V. and the Registrant, dated as of February 13, 2014 S-1/A 333-195169 10.7 June 10, 2014 10.9 Form of Securities Purchase Agreement between certain investors referenced therein and the Registrant, dated as of March 13, 2015 8-K 001-36517 10.1 March 18, 2015 10.10 Form of Registration Rights Agreement between certain investors referenced therein and the Registrant, dated as of March 13, 2015 8-K 001-36517 10.3 March 18, 2015 10.11 Second Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of April 21, 2015 10-Q 001-36517 10.5 May 7, 2015 10.12 † Amended and Restated Non-Employee Director Compensation Plan 10-Q 001-36517 10.1 November 7, 2023 10.13 Common Stock Purchase Agreement, dated March 17, 2016, by and between David Kupfer and the Registrant 8-K 001-36517 10.1 March 18, 2016 85 Exhibit No.
Exhibit Filing Date Filed Herewith 3.1 Amended and Restated Certificate of Incorporation of the Registrant S-1/A 333-195169 3.1 June 10, 2014 3.2 Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant 8-K 001-36517 3.1 June 17, 2022 3.3 Amended and Restated Bylaws of the Registrant 10-Q 001-36517 3.2 November 4, 2019 4.1 Form of Common Stock Certificate S-1/A 333-195169 4.1 June 10, 2014 4.2 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 10-K 001-36517 4.2 March 8, 2023 10.1 Share Purchase Agreement between the Registrant, Mind-NRG SA and Various Shareholders dated as of February 11, 2014 S-1 333-195169 10.13 April 9, 2014 10.2 † Form of Indemnification Agreement between the Registrant and each of its directors and executive officers S-1/A 333-195169 10.1 June 10, 2014 10.3* License Agreement between Mitsubishi Pharma Corporation and the Registrant f/k/a Cyrenaic Pharmaceuticals, Inc., dated as of August 30, 2007 S-1/A 333-195169 10.2 June 10, 2014 10.4* Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant f/k/a Cyrenaic Pharmaceuticals, Inc., dated as of June 16, 2011 S-1/A 333-195169 10.3 June 10, 2014 10.5* Second Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of January 20, 2014 S-1/A 333-195169 10.4 June 10, 2014 10.6* License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant as successor in interest to Sonkei Pharmaceuticals, Inc., dated as of September 1, 2008 S-1/A 333-195169 10.5 June 10, 2014 10.7* Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of January 20, 2014 S-1/A 333-195169 10.6 June 10, 2014 10.8* Co-Development and License Agreement between Janssen Pharmaceutica, N.V. and the Registrant, dated as of February 13, 2014 S-1/A 333-195169 10.7 June 10, 2014 10.9 Form of Securities Purchase Agreement between certain investors referenced therein and the Registrant, dated as of March 13, 2015 8-K 001-36517 10.1 March 18, 2015 10.10 Form of Registration Rights Agreement between certain investors referenced therein and the Registrant, dated as of March 13, 2015 8-K 001-36517 10.3 March 18, 2015 10.11 Second Amendment to License Agreement between Mitsubishi Tanabe Pharma Corporation and the Registrant, dated as of April 21, 2015 10-Q 001-36517 10.5 May 7, 2015 10.12 † Amended and Restated Non-Employee Director Compensation Plan 10-Q 001-36517 10.1 November 7, 2023 10.13 Common Stock Purchase Agreement, dated March 17, 2016, by and between David Kupfer and the Registrant 8-K 001-36517 10.1 March 18, 2016 84 Exhibit No.
Liability Related to the Sale of Future Royalties Critical Audit Matter Description As described in Notes 2 and 5 to the consolidated financial statements, 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.
Liability Related to the Sale of Future Royalties - Refer to Notes 2 and 5 to the financial statements Critical Audit Matter Description As described in Notes 2 and 5 to the consolidated financial statements, 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.
As such, the data from these studies are the basis for the decision to submit the application at this stage of development as we believe they provide data to support the long-term safety and efficacy in adults in an area of high unmet medical need.
As such, the data from these studies are the basis for the decision to submit the application at 71 this stage of development as we believe they provide data to support the long-term safety and efficacy in adults in an area of high unmet medical need.
The timing of future capital requirements depends upon many factors including the size and timing of future clinical trials, the timing and scope of any strategic partnering activity and the progress of other research and development activities. Cash Flows The tables below set forth our significant sources and uses of cash for the periods.
The timing of future capital requirements depends upon many factors including the size and timing of future clinical trials, the timing and scope of any strategic partnering activity and the progress of other research and development activities. 76 Cash Flows The tables below set forth our significant sources and uses of cash for the periods.
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities 77 and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis.
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis.
The communication of critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones.
The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the 77 successful enrollment of patients and the completion of clinical trial milestones.
Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity.
Diluted income (loss) per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that shared in the earnings of the entity.
F- 16 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 .
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 .
Executive Chairman and Chief Executive Officer (Principal Executive Officer) Date: February 22, 2024 POWER O F ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS , that each person whose signature appears below constitutes and appoints Remy Luthringer, Ph.D. and Frederick Ahlholm, and each of them, his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Executive Chairman and Chief Executive Officer (Principal Executive Officer) Date: February 25, 2025 POWER O F ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS , that each person whose signature appears below constitutes and appoints Remy Luthringer, Ph.D. and Frederick Ahlholm, and each of them, his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Investment Income Investment income consists of income earned on our cash equivalents and marketable securities. Non-cash interest expense for the sale of future royalties Non-cash interest expense for the sale of future royalties consists of the non-cash interest expense associated with the Royalty Pharma agreement.
Investment Income Investment income consists of income earned on our cash equivalents and marketable securities. 73 Non-Cash Interest Expense for the Sale of Future Royalties Non-cash interest expense for the sale of future royalties consists of the non-cash interest expense associated with the Royalty Pharma agreement.
Directors, Executive Officers and Corporate Governance The information required by this Item 10 will be contained in the sections entitled “Election of Directors,” “Information Regarding the Board and Corporate Governance,” “Executive Officers” and “Delinquent Section 16(a) Reports” appearing in the definitive proxy statement we will file in connection with our 2024 Annual Meeting of Stockholders and is incorporated by reference herein.
Directors, Executive Officers and Corporate Governance The information required by this Item 10 will be contained in the sections entitled “Election of Directors,” “Information Regarding the Board and Corporate Governance,” “Executive Officers” and “Delinquent Section 16(a) Reports” appearing in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein.
Based on this assessment, our management concluded that, as of December 31, 2023, our internal control over financial reporting was effective based on those criteria. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Based on this assessment, our management concluded that, as of December 31, 2024, our internal control over financial reporting was effective based on those criteria. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this Item 12 will be contained in the sections entitled “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” appearing in the definitive proxy statement we will file in connection with our 2024 Annual Meeting of Stockholders and is incorporated by reference herein.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this Item 12 will be contained in the sections entitled “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” appearing in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein.
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. NOTE 10 — RELATED PARTY TRANSACTIONS None. NOTE 11 — SUBSEQUENT EVENTS None. F- 20 IT EM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. ITE M 9A.
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. NOTE 10 — RELATED PARTY TRANSACTIONS None. NOTE 11 — SUBSEQUENT EVENTS None. F- 19 IT EM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. ITE M 9A.
The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2023 and 2022 . Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value.
The Company believes that all long-lived assets are recoverable, and no impairment was deemed necessary at December 31, 2024 and 2023 . Goodwill The Company tests its goodwill for impairment annually, or whenever events or changes in circumstances indicate an impairment may have occurred, by comparing its reporting unit’s carrying value to its fair value.
IT EM 13. Certain Relationships and Related Person Transactions, and Director Independence The information required by this Item 13 will be contained in the sections entitled “Transactions with Related Persons Related Person Transactions Policy and Procedures” appearing in the definitive proxy statement we will file in connection with our 2024 Annual Meeting of Stockholders and is incorporated by reference herein.
IT EM 13. Certain Relationships and Related Person Transactions, and Director Independence The information required by this Item 13 will be contained in the sections entitled “Transactions with Related Persons Related Person Transactions Policy and Procedures” appearing in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein.
Form 10-K Summary Not applicable. 87 SIGNATU RES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. MINERVA NEUROSCIENCES, INC. By: /s/ Remy Luthringer, Ph.D. Remy Luthringer, Ph.D.
Form 10-K Summary Not applicable. 86 SIGNATU RES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. MINERVA NEUROSCIENCES, INC. By: /s/ Remy Luthringer, Ph.D. Remy Luthringer, Ph.D.
In transition to FASB ASC Topic 842, Leases (“ASC 842”), the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. F- 11 In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.).
In transition to FASB ASC Topic 842, Leases (“ASC 842”), the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. F- 10 In accordance with ASC 842, components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.).
F- 8 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 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.
During the twelve months ended December 31, 2023 , no shares of the Company’s common stock were issued or sold under the Sales Agreement. As of December 31, 2023 , an aggregate of $ 22.6 million was eligible for sale pursuant to the Sales Agreement under the Company’s effective registration statement on Form S-3 (File No. 333-267424).
During the twelve months ended December 31, 2024 , no shares of the Company’s common stock were issued or sold under the Sales Agreement. As of December 31, 2024 , 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).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024 , in conformity with accounting principles generally accepted in the United States of America.
F- 13 The liability related to sale of future royalties and the related interest expense is based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources.
F- 12 The liability related to sale of future royalties and the related interest expense is based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external sources.
The remaining PRSUs vest upon roluperidone receiving FDA marketing approval, provided that such approval occurs within five years after the August 6, 2021 grant date. As of December 31, 2023 , 228,213 PRSUs have vested, 20,218 have been cancelled, and 228,209 remain outstanding.
The remaining PRSUs vest upon roluperidone receiving FDA marketing approval, provided that such approval occurs within five years after the August 6, 2021 grant date. As of December 31, 2024 , 228,213 PRSUs have vested, 20,218 have been cancelled, and 228,209 remain outstanding.
IT EM 11. Executive Compensation The information required by this Item 11 will be contained in the sections entitled “Executive Compensation” and “Director Compensation” appearing in the definitive proxy statement we will file in connection with our 2024 Annual Meeting of Stockholders and is incorporated by reference herein. IT EM 12.
Executive Compensation The information required by this Item 11 will be contained in the sections entitled “Executive Compensation” and “Director Compensation” appearing in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein. IT EM 12.
The price per pre-funded warrant represents the price of $10.00 per Share to be 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 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.
In both studies, if patients were taking antipsychotic treatments, they were discontinued and a washout period of two days was implemented before beginning the assigned study treatment. Both studies capture comparative placebo-controlled data through their 12-week double-blind period.
In both studies, if patients were taking antipsychotic treatments, they were discontinued and a washout period of at minimum two days was implemented before beginning the assigned study treatment. Both studies capture comparative placebo-controlled data through their 12-week double-blind period.
PSP Total score (key secondary endpoint measuring vocational and social skills) reached statistical significance for both ITT and mITT populations (p 71 ≤ 0.022 and p ≤ 0.017, respectively). Further improvements in the NSFS and PSP Total score were also seen during the 40-week OL period.
PSP Total score (sole key secondary endpoint measuring vocational and social skills) reached statistical significance for both ITT and mITT populations (p ≤ 0.022 and p ≤ 0.017, respectively). Further improvements in the NSFS and PSP Total score were also seen during the 40-week OL period.
We have a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2023 and 2022. As of December 31, 2023, $14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value.
We have a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2024 and 2023. As of December 31, 2024, $14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value.
The Company has a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2023 and 2022. As of December 31, 2023 , $ 14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value.
The Company has a single reporting unit, which is the level that the goodwill impairment test is performed. There was no impairment of goodwill for the years ended December 31, 2024 and 2023. As of December 31, 2024 , $ 14.9 million of goodwill was associated with a reporting unit with zero or negative carrying value.
Income tax years beginning in 2019 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized.
Income tax years beginning in 2021 for federal and state purposes are generally subject to examination by taxing authorities, although net operating losses from all prior years are subject to examinations and adjustments for at least three years following the year in which the tax attributes are utilized.
The warrants were immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions, will expire on the ten-year anniversary of the date of issuance. The term loans were repaid in August 2018. All related warrants were outstanding and exercisable as of December 31, 2023 .
The warrants were immediately exercisable upon issuance, and other than in connection with certain mergers or acquisitions, will expire on the ten-year anniversary of the date of issuance. The term loans were repaid in August 2018. All related warrants were outstanding and exercisable as of December 31, 2024 .
As of December 31, 2023 , the Company had approximately $ 0.1 million of federal research and development credits that will begin to expire in 2027 , if not utilized. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates.
As of December 31, 2024 , the Company had approximately $ 0.1 million of federal research and development credits that will begin to expire in 2027 , if not utilized. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates.
The Company classifies penalties and interest expense related to income tax liabilities as an income tax expense. There were no interest and penalties recognized in the statements of operations for the years ended December 31, 2023 and 2022, or accrued on the balance sheets as of December 31, 2023 and 2022 .
The Company classifies penalties and interest expense related to income tax liabilities as an income tax expense. There were no interest and penalties recognized in the statements of operations for the years ended December 31, 2024 and 2023, or accrued on the balance sheets as of December 31, 2024 and 2023 .
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.
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. F- 8 Restricted cash Cash accounts with any type of restriction are classified as restricted.
F- 6 MINERVA NEUROSCIENCES, INC. Notes To Consolidated Financial Statements December 31, 2023 and 2022 NOTE 1 — NATURE OF OPERATIONS AND LIQUIDITY Nature of Operations Minerva Neurosciences, Inc. (“Minerva” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases.
F- 6 MINERVA NEUROSCIENCES, INC. Notes To Consolidated Financial Statements December 31, 2024 and 2023 NOTE 1 — NATURE OF OPERATIONS AND LIQUIDITY Nature of Operations Minerva Neurosciences, Inc. (“Minerva” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system (“CNS”) diseases.
Net Cash Provided by Financing Activities Net cash provided by financing activities of approximately $19.6 million during the year ended December 31, 2023 was primarily due to the net proceeds from the Private Placement closed in June 2023. Net cash provided by financing activities was zero during the year ended December 31, 2022.
Net cash provided by financing activities of approximately $19.6 million during the year ended December 31, 2023 was primarily due to the net proceeds from the Private Placement closed in June 2023.
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.
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 an additional $ 95 million in potential future milestone payments.
Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Minerva Neurosciences, Inc. and subsidiaries (the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ (deficit) equity, and cash flows, for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”).
Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Minerva Neurosciences, Inc. and subsidiaries (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, stockholders’ deficit, and cash flows, for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).
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.
In June 2023, in connection with the Private Placement (as defined and described in Note 6, Stockholders’ Deficit), 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 was $ 9.99 per share, which was paid to the Company upon issuance of the pre-funded warrants.
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 incremental cost was measured as F- 17 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.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.
As of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 Framework).
As of December 31, 2024, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 Framework).
(1) Financial Statements Report of Independent Registered Public Accounting Firm Consolidated Balance Sheets as of December 31, 2023 and 2022 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 Consolidated Statements of Stockholders’ (Deficit) Equity for the Years Ended December 31, 2023 and 2022 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 Notes to Consolidated Financial Statements (2) Schedules Schedules have been omitted as all required information has been disclosed in the financial statements and related footnotes.
(1) Financial Statements Report of Independent Registered Public Accounting Firm Consolidated Balance Sheets as of December 31, 2024 and 2023 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2024 and 2023 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 Notes to Consolidated Financial Statements (2) Schedules Schedules have been omitted as all required information has been disclosed in the financial statements and related footnotes.
To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related non-cash interest expense. For further discussion of the sale of future royalties, please refer to Note 5, Sale of Future Royalties.
To the extent the Company’s future estimates of royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than its previous estimates, the Company will recognize related non-cash interest expense or other income. For further discussion of the sale of future royalties, please refer to Note 5, Sale of Future Royalties.
F- 19 NOTE 9 — COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of the Company’s business activities.
NOTE 9 — COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of the Company’s business activities.
(3) Exhibits 84 The following exhibits are filed as part of this Annual Report on Form 10-K or are incorporated herein by reference. Exhibit No. Description of Exhibit Form File No.
(3) Exhibits 83 The following exhibits are filed as part of this Annual Report on Form 10-K or are incorporated herein by reference. Exhibit No. Description of Exhibit Form File No.
Pursuant to the Securities Purchase Agreement, we 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).
Pursuant to the securities purchase agreement, we 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 defined in the securities purchase agreement).
In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2019 to present. As of December 31, 2023 and 2022 , the Company had no liability recorded for unrecognized tax benefit.
In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2021 to present. As of December 31, 2024 and 2023 , the Company had no liability recorded for unrecognized tax benefit.
IT EM 14. Principal Accounting Fees and Services The information required by this Item 14 will be contained in the section entitled “Principal Accountant Fees and Services” appearing in the definitive proxy statement we will file in connection with our 2024 Annual Meeting of Stockholders and is incorporated by reference herein. 83 Pa rt IV IT EM 15.
IT EM 14. Principal Accounting Fees and Services The information required by this Item 14 will be contained in the section entitled “Principal Accountant Fees and Services” appearing in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein. 82 Pa rt IV IT EM 15.
Remy Luthringer 10-Q 001-36517 10.1 August 4, 2016 10.15 † Employment Agreement, dated as of August 1, 2016, by and between Mind-NRG SARL and Geoffrey Race 10-Q 001-36517 10.2 August 4, 2016 10.16 † Employment Agreement, dated as of August 1, 2016, by and between the Registrant and Frederick Ahlholm 10-Q 001-36517 10.3 August 4, 2016 10.17† Form of Restricted Stock Unit Agreement under the Amended and Restated 2013 Equity Incentive Plan of the Registrant 8-K 001-36517 10.1 December 16, 2016 10.18† Form of Option Grant Agreement under the Amended and Restated 2013 Equity Incentive Plan 10-K 001-36517 10.36 March 13, 2017 10.19 Amendment No. 1 to Co-Development and License Agreement dated June 13, 2017, by and between the Registrant and Janssen Pharmaceutica NV 8-K 001-36517 10.1 June 14, 2017 10.20* Commercial Supply Agreement by and between the Registrant and Catalent Germany Schorndorf GmbH, dated September 18, 2019 10-Q 001-36517 10.1 November 4, 2019 10.21 Open Market Sale Agreement, dated as of September 14, 2022, by and between the Registrant and Jefferies LLC S-3 333-267424 1.2 September 14, 2022 10.22 Settlement Agreement, dated as of June 24, 2020, by and between the Registrant and Janssen Pharmaceutica, N.V. 10-Q 001-36517 10.2 August 3, 2020 10.23† Amended and Restated 2013 Equity Incentive Plan 10-Q 001-36517 10.2 November 7, 2023 10.24* Royalty Purchase Agreement, dated as of January 15, 2021, by and between the Registrant and RPI 2019 Intermediate Finance Trust (redacted) 10-K 001-36517 10.48 March 8, 2021 10.25* Remy Luthringer Supplemental Retention Benefits Letter Agreement (redacted) 10-Q 001-36517 10.1 May 12, 2021 10.26 First Amendment to the Employment Agreement of Geoff Race by and between Mind-NRG SARL and Geoff Race, effective October 11, 2021 8-K 001-36517 10.1 October 12, 2021 10.27 Amended and Restated Employment Agreement by and between Minerva Neurosciences, Inc. and Frederick Ahlholm, effective October 11, 2021 8-K 001-36517 10.2 October 12, 2021 10.28 First Amendment to the Employment Agreement of Remy Luthringer by and between Mind-NRG SARL and Remy Luthringer, effective December 13, 2022 8-K 001-36517 10.1 December 13, 2022 10.29 Second Amendment to the Employment Agreement of Remy Luthringer by and between Mind-NRG SARL and Remy Luthringer, effective March 6, 2023 10-K 001-36517 10.30 March 8, 2023 10.30 Securities Purchase Agreement, dated June 27, 2023, by and among Minerva Neurosciences, Inc. and the purchasers party thereto 8-K 001-36517 10.1 June 28, 2023 21.1 List of Subsidiaries 10-K 001-36517 21.1 March 1, 2022 86 Exhibit No.
Remy Luthringer 10-Q 001-36517 10.1 August 4, 2016 10.15 † Employment Agreement, dated as of August 1, 2016, by and between Mind-NRG SARL and Geoffrey Race 10-Q 001-36517 10.2 August 4, 2016 10.16 † Employment Agreement, dated as of August 1, 2016, by and between the Registrant and Frederick Ahlholm 10-Q 001-36517 10.3 August 4, 2016 10.17† Form of Restricted Stock Unit Agreement under the Amended and Restated 2013 Equity Incentive Plan of the Registrant 8-K 001-36517 10.1 December 16, 2016 10.18† Form of Option Grant Agreement under the Amended and Restated 2013 Equity Incentive Plan 10-K 001-36517 10.36 March 13, 2017 10.19 Amendment No. 1 to Co-Development and License Agreement dated June 13, 2017, by and between the Registrant and Janssen Pharmaceutica NV 8-K 001-36517 10.1 June 14, 2017 10.20* Commercial Supply Agreement by and between the Registrant and Catalent Germany Schorndorf GmbH, dated September 18, 2019 10-Q 001-36517 10.1 November 4, 2019 10.21 Open Market Sale Agreement, dated as of September 14, 2022, by and between the Registrant and Jefferies LLC S-3 333-267424 1.2 September 14, 2022 10.22 Settlement Agreement, dated as of June 24, 2020, by and between the Registrant and Janssen Pharmaceutica, N.V. 10-Q 001-36517 10.2 August 3, 2020 10.23† Amended and Restated 2013 Equity Incentive Plan 10-Q 001-36517 10.2 November 7, 2023 10.24* Royalty Purchase Agreement, dated as of January 15, 2021, by and between the Registrant and RPI 2019 Intermediate Finance Trust (redacted) 10-K 001-36517 10.48 March 8, 2021 10.25* Remy Luthringer Supplemental Retention Benefits Letter Agreement (redacted) 10-Q 001-36517 10.1 May 12, 2021 10.26 First Amendment to the Employment Agreement of Geoff Race by and between Mind-NRG SARL and Geoff Race, effective October 11, 2021 8-K 001-36517 10.1 October 12, 2021 10.27 Amended and Restated Employment Agreement by and between Minerva Neurosciences, Inc. and Frederick Ahlholm, effective October 11, 2021 8-K 001-36517 10.2 October 12, 2021 10.28 First Amendment to the Employment Agreement of Remy Luthringer by and between Mind-NRG SARL and Remy Luthringer, effective December 13, 2022 8-K 001-36517 10.1 December 13, 2022 10.29 Second Amendment to the Employment Agreement of Remy Luthringer by and between Mind-NRG SARL and Remy Luthringer, effective March 6, 2023 10-K 001-36517 10.30 March 8, 2023 10.30 Securities Purchase Agreement, dated June 27, 2023, by and among Minerva Neurosciences, Inc. and the purchasers party thereto 8-K 001-36517 10.1 June 28, 2023 19.1 Statement of Company Policy on Insider Trading and Disclosure X 85 Exhibit No.
Management applied significant judgment in determining the appropriate accounting treatment for the transaction and accounted for the sale of future revenue to Royalty Pharma as a debt financing, as the Company continues to have significant continuing involvement in the generation of the cash flows.
Management applied significant judgment in determining the appropriate accounting treatment for the transaction and accounted for the sale of future royalties to Royalty Pharma as a debt financing, as the Company continues to have significant involvement in the generation of the cash flows.
Financial Statements and Supplementary Data Page Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 ) F- 1 Consolidated Balance Sheets as of December 31, 2023 and 2022 F- 3 Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 F- 4 Consolidated Statements of Stockholders’ (Deficit) Equity for the Years Ended December 31, 2023 and 2022 F- 5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F- 6 Notes to Consolidated Financial Statements F- 7 81 REPORT OF INDEPENDENT REGIST ERED PUBLIC ACCOUNTING FIRM To the shareholders and the Board of Directors of Minerva Neurosciences, Inc.
Financial Statements and Supplementary Data Page Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 ) F- 1 Consolidated Balance Sheets as of December 31, 2024 and 2023 F- 3 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 F- 4 Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2024 and 2023 F- 5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 F- 6 Notes to Consolidated Financial Statements F- 7 80 REPORT OF INDEPENDENT REGIST ERED PUBLIC ACCOUNTING FIRM To the shareholders and the Board of Directors of Minerva Neurosciences, Inc.
As the remaining shares underlying the pre-funded warrants are issuable for nominal consideration of $ 0.01 per share, 575,575 shares of common stock underlying the unexercised pre-funded warrants were considered outstanding for purposes of the calculation of loss per share as of December 31, 2023.
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 income (loss) per share as of December 31, 2024.
Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2023.
Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024.
We have incurred significant operating losses since inception and expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future in connection with the clinical and regulatory activities associated with advancing our product candidates. As of December 31, 2023 and 2022, we had an accumulated deficit of $396.8 million and $366.8 million, respectively.
We have incurred significant operating losses since inception and expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future in connection with the clinical and regulatory activities associated with advancing our product candidates. As of December 31, 2024 and 2023, we had an accumulated deficit of $395.4 million and $396.8 million, respectively.
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.
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, Royalty Pharma has recourse against the Company relating to payments due from Janssen and therefore, the Company is deemed to have significant continuing involvement.
Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance.
Segment information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) about which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is the Chief Executive Officer.
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.
During 2020, the Company exercised its right to opt out of the co-development and license agreement (the “Janssen 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.
Private Placement of Common Stock and Warrants On June 27, 2023, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which we 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 our 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.
Private Placement of Common Stock and Warrants On June 27, 2023, we entered into a securities purchase agreement with certain institutional accredited investors, pursuant to which we agreed to issue and sell in a private placement (i) an aggregate of 1,425,000 shares of our 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.
Leases On October 11, 2022, the Company entered into an office lease agreement with Regus to lease approximately 491 rentable square feet of office space located at 1500 District Avenue, Burlington, MA 01803. In January 2024, the Company renewed the month-to-month lease agreement commencing on February 1, 2024 , with a monthly payment of $ 8,697 .
Leases On October 11, 2022, the Company entered into an office lease agreement with Regus to lease approximately 491 rentable square feet of office space located at 1500 District Avenue, Burlington, MA 01803. In January 2025, the Company renewed the month-to-month lease agreement commencing on February 1, 2025 , with a monthly payment of $ 9,106 .
F- 1 How We Addressed the Matter in Our Audit Our testing approach included both consideration of the accounting treatment, and the recognition and valuation of the liability.
F- 1 How We Addressed the Matter in Our Audit Our audit procedures included both consideration of the accounting treatment, and the recognition and valuation of the liability.
In June 2020, we exercised our right to opt out of our agreement with Janssen for the future Phase 3 development and commercialization of seltorexant. Under the terms of the opt-out agreement, we were 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 June 2020, we exercised our right to opt out of our agreement with Janssen for the Phase 3 development of seltorexant and as a result, we were 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.
Liquidity and Capital Resources Sources of Liquidity As of December 31, 2023, we had an accumulated deficit of approximately $396.8 million. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the development and potential commercialization of our product candidates and to support our operations as a public company.
Liquidity and Capital Resources Sources of Liquidity As of December 31, 2024, we had an accumulated deficit of approximately $395.4 million. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the development and potential commercialization of our product candidates and to support our operations as a public company.
Loss per share Basic loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding for the period.
Income (loss) per share Basic income (loss) per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period.
F- 12 The following tables present information about the Company’s cash equivalents and marketable securities as of December 31, 2023 and 2022, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2023 Total Level 1 Level 2 Level 3 Cash equivalents $ 27,351,596 $ 27,351,596 $ — $ — Total fair value $ 27,351,596 $ 27,351,596 $ — $ — December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents $ 34,557,146 $ 34,557,146 $ — $ — Total fair value $ 34,557,146 $ 34,557,146 $ — $ — Cash equivalents include short-term, highly-liquid instruments, consisting of money market accounts and short-term investments with maturities from the date of purchase of 90 days or less.
F- 11 The following tables present information about the Company’s cash equivalents and marketable securities as of December 31, 2024 and 2023, measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value: December 31, 2024 Total Level 1 Level 2 Level 3 Cash equivalents $ 19,574,213 $ 19,574,213 $ — $ — Total fair value $ 19,574,213 $ 19,574,213 $ — $ — December 31, 2023 Total Level 1 Level 2 Level 3 Cash equivalents $ 27,351,596 $ 27,351,596 $ — $ — Total fair value $ 27,351,596 $ 27,351,596 $ — $ — 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.
We are developing roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson’s disease.
We are developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson’s disease.
As of December 31, 2023, the Company had cash, cash equivalents, and restricted cash of $ 41.0 million, which it believes will be sufficient to meet the Company ’ s operating commitments for the next 12 months from the date its financial statements are issued.
As of December 31, 2024, the Company had cash, cash equivalents, and restricted cash of $ 21.5 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 historic direct costs relating to each of our product candidates are summarized as follows (in thousands): Year Ended December 31, 2023 2022 Roluperidone $ 11,795 $ 12,624 MIN-117 — 17 MIN-301 — — Total $ 11,795 $ 12,641 Completion dates and costs can vary significantly by product candidate and are difficult to predict.
The historic direct costs relating to each of our product candidates are summarized as follows (in thousands): Year Ended December 31, 2024 2023 Roluperidone $ 11,448 $ 11,795 MIN-117 — — MIN-301 — — Total $ 11,448 $ 11,795 Completion dates and costs can vary significantly by product candidate and are difficult to predict.
Clinical and Regulatory Updates Roluperidone Phase 1b Clinical Trial (MIN-101C18) In October 2023, we initiated a clinical trial to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the co-administration of roluperidone and olanzapine in adult subjects with moderate to severe negative symptoms of schizophrenia.
Phase 1b Clinical Trial (MIN-101C18) In the first quarter of 2024, we completed a clinical trial initiated in October 2023 to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the co-administration of roluperidone and olanzapine in adult subjects with moderate to severe negative symptoms of schizophrenia.
On May 8, 2023, we received confirmation from the FDA that the NDA for roluperidone has been filed in accordance with the Appeal Granted letter dated April 27, 2023 and assigned a standard review classification and a PDUFA goal date of February 26, 2024.
On May 8, 2023, we received confirmation from the FDA that the NDA for roluperidone has been filed in accordance with the Appeal Granted letter dated April 27, 2023 and assigned a standard review classification and a Prescription Drug User Fee Act (“PDUFA”) goal date of February 26, 2024.
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.
Diluted income (loss) per share is computed by dividing the net income (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, but only to the extent that their inclusion is dilutive.
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”).
The Company also has exclusive rights to develop and commercialize MIN-301, a compound for the treatment of Parkinson’s disease. In addition, Minerva previously co-developed seltorexant with Janssen Pharmaceutica NV (“Janssen”) for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”).
The valuation allowance increased by approximately $ 6.8 million and $ 8.8 million during the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 , the Company had approximately $ 126.2 million of federal net operating losses that will begin to expire in 2036 , if not utilized.
The valuation allowance decreased by approximately $ 0.8 million and increased by approximately $ 6.8 million during the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 , the Company had approximately $ 156.8 million of federal net operating losses that will begin to expire in 2036 , if not utilized.
As of December 31, 2023, we 74 had approximately $41.0 million in cash, cash equivalents, and restricted cash, which we believe will be sufficient to meet our operating commitments for the next 12 months from the date our financial statements are issued.
As of December 31, 2024, we had approximately $21.5 million in cash, cash equivalents, and restricted cash, which we believe will be sufficient to meet our operating commitments for the next 12 months from the date our financial statements are issued.

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Other NERV 10-K year-over-year comparisons