Revenue and Financial Performance - The company reported no revenue from product candidates as none have been approved for commercialization[113]. - Collaborative revenue recognized in 2020 was approximately $41.2 million, previously included under deferred revenue[114]. - The company has not generated any revenue from product sales to date, only collaborative revenue from opting out of the license agreement with Janssen and a one-time sale of royalty interests for $60 million[132]. Expenses - Research and development expenses decreased to $3.3 million for Q1 2021 from $8.1 million in Q1 2020, a reduction of approximately 59%[122]. - General and administrative expenses remained stable at $4.2 million for both Q1 2021 and Q1 2020[123]. - The company anticipates an increase in expenses related to ongoing development activities, particularly for research and clinical trials[132]. Cash and Financing - Cash, cash equivalents, and restricted cash totaled approximately $80.2 million as of March 31, 2021[127]. - Net cash used in operating activities for Q1 2021 was approximately $5.2 million, primarily due to a net loss of $8.8 million[136]. - Net cash provided by financing activities in Q1 2021 was $60 million, resulting from the sale of future royalties[139]. - The company recorded an upfront payment of $60 million from the sale of future royalties as a liability to be amortized to interest expense over the life of the arrangement[142]. - The company expects its cash, cash equivalents, and restricted cash to be sufficient to meet cash commitments for at least the next 12 months[133]. - Net cash provided by investing activities was zero in Q1 2021, compared to $17.0 million in Q1 2020 due to the maturity and redemption of marketable securities[138]. Clinical Trials and Product Development - The Phase 3 trial of roluperidone did not meet its primary or key secondary endpoints in the intent-to-treat population[110]. - The mean improvement in negative symptoms for the 64 mg dose of roluperidone was 7.5 points during the 40-week open-label extension[105]. - The overall relapse rate during the open-label extension was 11.7%[107]. - The company expects to incur significant commercialization expenses for product sales, marketing, manufacturing, and distribution, contingent upon obtaining regulatory approval for its product candidates[133]. Financial Position - The company had an accumulated deficit of approximately $293.6 million as of March 31, 2021[127]. - The company has no off-balance sheet arrangements as defined under SEC rules[140]. - The company treats the sale of future royalties as a debt financing due to significant continuing involvement in facilitating the transfer of royalties[142].

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2020 Earnings Conference Call March 8, 2021 8:30 AM ET Company Participants William Boni - VP, IR and Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Jason Butler - JMP Jeet Mukherjee - Jefferies Joel Beatty - Citi Myles Minter - William Blair Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) Delaware 26-0784194 (State or other jurisdic ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2020 Results Earnings Conference Call November 2, 2020 8:30 AM ET Company Participants William Boni - VP, IR & Corporate Communications Remy Luthringer - Executive Chairman and Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Joel Beatty - Citi Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Jeet Mukherjee - Jefferies Operator Welcome to the Minerva Neuroscie ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-36517 (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (617) 600-7373 (Former Name, Former Address ...

Financial Data and Key Metrics Changes - As of June 30, 2020, the company reported cash, cash equivalents, restricted cash, and marketable securities of approximately $35.3 million, which is expected to meet capital requirements into early 2022 [11] - Research and development (R&D) expenses decreased to $5.8 million in Q2 2020 from $8.3 million in Q2 2019, and for the first six months of 2020, R&D expenses were $13.8 million compared to $19.9 million in the same period of 2019 [12][13] - General and administrative (G&A) expenses increased to $5.9 million in Q2 2020 from $4.6 million in Q2 2019, with six-month G&A expenses rising to $10.1 million from $9.3 million year-over-year [14] - The company reported a net income of $29.5 million for Q2 2020, compared to a net loss of $12.5 million in Q2 2019, and a net income of $17.4 million for the first six months of 2020 compared to a net loss of $28.3 million in the same period of 2019 [14] Business Line Data and Key Metrics Changes - The company opted out of the co-development agreement with Janssen for seltorexant, resulting in the recognition of $41.2 million in collaborative revenue during Q2 2020, which included a $30 million payment made by Janssen in 2017 [15] Company Strategy and Development Direction - The company remains focused on the development of roluperidone, which aims to be the first drug approved to treat negative symptoms in schizophrenia, addressing a significant unmet medical need [5][10] - The decision to opt out of the seltorexant program allows the company to retain full financial interest in future revenues while aligning resources towards the approval of roluperidone [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of roluperidone based on Phase 3 trial data, highlighting its innovative mechanism of action and safety profile [10] - The company plans to request a meeting with the FDA to discuss the data package and the path forward for roluperidone's development [8][22] Other Important Information - The Phase 3 trial of roluperidone included over 500 patients and showed statistically significant improvements in negative symptoms and functional outcomes, particularly with the 64 mg dose [7][8] - The company is preparing for a potential additional Phase 3 study based on FDA feedback, which may involve a simpler design with one dose and no extension [31][36] Q&A Session Summary Question: Why did the company opt out of the seltorexant program? - The decision was based on a return on investment analysis, determining that opting out would provide a better return for shareholders compared to the investment required for the Phase 3 program [19] Question: When will the company share additional details of the Phase 3 publication for roluperidone? - The company plans to submit a request for an FDA meeting soon, and the most important metrics for investors will be related to functional improvements and the impact of avolition [20][22] Question: What are the plans for an additional Phase 3 study for roluperidone? - If an additional study is needed, it would likely involve one dose without an extension, focusing on the best primary endpoint for measuring negative symptoms [31][36] Question: How does the company view the potential for development in the broader insomnia market for seltorexant? - The company believes that insomnia is already covered in the trials run by Janssen for major depressive disorder, as insomnia is a significant driver of depression [38] Question: What are the company's partnering priorities for roluperidone? - The company remains open to discussions with pharmaceutical companies and will provide updates post-FDA meeting [42]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission File No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdiction of Incorporation or Organization) 1601 Trapelo Road, Suite 286 Waltham, MA 02451 (Address of Principal Executive Offices) (Zip Code) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the qua ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q1 2020 Earnings Conference Call May 4, 2020 8:30 AM ET Company Participants William Boni - Vice President of Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Rick Russell - President Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Jason Butler - JMP Securities Joel Beatty - Citi Biren Amin - Jefferies Myles Minter - William Blair Douglas ...

PART I — Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the three months ended **March 31, 2020**, show a net loss of **$12.2 million**, a decrease in total assets to **$68.8 million**, and continued operation with a significant accumulated deficit of **$298.9 million** and negative cash flows from operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of **March 31, 2020**, the company reported total assets of **$68.8 million**, a decrease from **$77.5 million** at December 31, 2019, primarily due to a reduction in marketable securities, while total liabilities slightly increased to **$50.2 million** and total stockholders' equity decreased to **$18.6 million** from **$27.8 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2020 ($M) | December 31, 2019 ($M) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 30.0 | 21.4 | | Marketable securities | 7.5 | 24.4 | | Total current assets | 38.5 | 47.1 | | Total assets | 68.8 | 77.5 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | 7.1 | 6.6 | | Total liabilities | 50.2 | 49.7 | | Accumulated deficit | (298.9) | (286.7) | | Total stockholders' equity | 18.6 | 27.8 | | Total liabilities and stockholders' equity | 68.8 | 77.5 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended **March 31, 2020**, the company reported a net loss of **$12.2 million**, or **($0.31)** per share, an improvement from the net loss of **$15.8 million**, or **($0.41)** per share, in the same period of 2019, primarily due to lower research and development expenses Condensed Consolidated Statement of Operations (Unaudited) | Metric | Three Months Ended March 31, 2020 ($M) | Three Months Ended March 31, 2019 ($M) | | :--- | :--- | :--- | | Research and development | 8.1 | 11.6 | | General and administrative | 4.2 | 4.7 | | Total expenses | 12.3 | 16.3 | | Loss from operations | (12.3) | (16.3) | | Net loss | (12.2) | (15.8) | | Net loss per share, basic and diluted | (0.31) | (0.41) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first quarter of **2020**, net cash used in operating activities was **$9.2 million**, net cash provided by investing activities was **$17.0 million** from marketable securities maturities, and net cash provided by financing activities was **$0.8 million** from stock option exercises, resulting in a net increase in cash of **$8.6 million** and an end-of-period balance of **$30.1 million** Cash Flow Summary (Unaudited) | Activity | Three Months Ended March 31, 2020 ($M) | Three Months Ended March 31, 2019 ($M) | | :--- | :--- | :--- | | Net cash used in operating activities | (9.2) | (9.6) | | Net cash provided by (used in) investing activities | 17.0 | (10.6) | | Net cash provided by financing activities | 0.8 | 0.5 | | Net increase (decrease) in cash | 8.6 | (19.6) | | Cash, cash equivalents and restricted cash, end of period | 30.1 | 30.7 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's operations, liquidity, accounting policies, and key agreements, highlighting its clinical-stage biopharmaceutical nature, an accumulated deficit of **$298.9 million**, sufficient cash for the next **12 months**, and a significant unaccrued **$6.5 million** contingency with Janssen regarding seltorexant cost-sharing obligations - The company is a clinical-stage biopharmaceutical company focused on **CNS diseases**, with lead candidates roluperidone, seltorexant (co-developed with Janssen), and **MIN-301**[24](index=24&type=chunk) - As of **March 31, 2020**, the company had an accumulated deficit of approximately **$298.9 million** and believes its existing cash of **$37.6 million** is sufficient to fund operations for at least the next **12 months**[26](index=26&type=chunk)[27](index=27&type=chunk) - The company is in a dispute with its partner Janssen regarding the achievement of "**Decision Point 4**" for the seltorexant program, with Janssen having invoiced Minerva for **$6.5 million** for its 40% share of **Phase 3** development costs through **March 31, 2020**, which Minerva has not accrued due to the disagreement[73](index=73&type=chunk)[84](index=84&type=chunk) - In 2019, the company determined that the **MIN-117** In-process Research and Development (IPR&D) asset was fully impaired, resulting in a **$19.0 million** expense included in R&D[41](index=41&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical program status, financial results, and liquidity, noting the fully enrolled **Phase 3** roluperidone trial with **Q2 2020** top-line results expected, discontinued **MIN-117** development, positive **Phase 2b** seltorexant results but a cost-sharing dispute with Janssen, decreased R&D expenses to **$8.1 million** in **Q1 2020**, and sufficient cash for the next **12 months** while acknowledging future capital needs [Clinical Updates](index=19&type=section&id=Clinical%20Updates) The pivotal **Phase 3** trial for roluperidone in schizophrenia is fully enrolled with **515 patients**, with **12-week** top-line results expected in **Q2 2020**, while **MIN-117** development for **MDD** has been discontinued after a failed **Phase 2b** trial, and seltorexant has shown positive **Phase 2b** results but faces a cost-sharing disagreement with Janssen regarding **Phase 3** obligations - The pivotal **Phase 3** trial of roluperidone (**MIN-101C07**) has completed enrollment with **515 patients**, and top-line results from the **12-week** double-blind portion are anticipated in the second quarter of **2020**[96](index=96&type=chunk)[97](index=97&type=chunk) - Following the failure of the **Phase 2b** trial of **MIN-117** to meet its primary and key secondary endpoints, the company has no plans for further clinical development of **MIN-117** in **Major Depressive Disorder (MDD)**[106](index=106&type=chunk)[108](index=108&type=chunk) - The company disagrees with its partner Janssen that "**Decision Point 4**" has been reached for the seltorexant program, which would trigger cost-sharing obligations, and Janssen has invoiced the company for **$6.5 million** for **Phase 3** costs through **March 31, 2020**[123](index=123&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) For the three months ended **March 31, 2020**, R&D expenses decreased by **$3.5 million** to **$8.1 million** compared to the same period in 2019, primarily due to lower development costs for the roluperidone and **MIN-117** trials, while general and administrative expenses also decreased by **$0.5 million** to **$4.2 million** mainly from lower non-cash stock-based compensation and professional fees Comparison of Operating Expenses (Q1 2020 vs Q1 2019) | Expense Category | Q1 2020 ($M) | Q1 2019 ($M) | Change ($M) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | 8.1 | 11.6 | (3.5) | Lower development expenses for **Phase 3** roluperidone and **Phase 2b MIN-117** trials | | General & Administrative | 4.2 | 4.7 | (0.5) | Decrease in non-cash stock-based compensation and professional fees | [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) As of **March 31, 2020**, the company had **$37.6 million** in cash, cash equivalents, restricted cash, and marketable securities, which management believes is sufficient for at least the next **12 months**, but acknowledges the need for additional capital to fully fund development programs, especially given a potential significant payment to Janssen - The company had approximately **$37.6 million** in cash, cash equivalents, restricted cash, and marketable securities as of **March 31, 2020**[140](index=140&type=chunk) - Management asserts that existing cash is sufficient to meet commitments for at least the next **12 months**, but acknowledges the need to raise additional capital for future operations and later-stage clinical development[140](index=140&type=chunk)[146](index=146&type=chunk) - A significant financial uncertainty is the dispute with Janssen; if the company is required to make a significant payment, it may need to incur debt or raise equity, which may not be available on acceptable terms[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable for the reporting period - The company states that this section is not applicable[158](index=158&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the **CEO and CFO**, evaluated the effectiveness of the company's disclosure controls and procedures as of **March 31, 2020**, concluding they were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - The **CEO and CFO** concluded that the company's disclosure controls and procedures were effective as of **March 31, 2020**[160](index=160&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[161](index=161&type=chunk) PART II — Other Information [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business - As of the report date, the company is not involved in any legal proceedings expected to have a material adverse effect on the business[163](index=163&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company highlights significant risks, including its history of substantial losses, the expectation of continued losses, the need for additional capital to finance operations, and a new material risk factor concerning the **COVID-19** pandemic, which could adversely affect business operations, delay clinical trials, and negatively impact capital markets, potentially limiting the ability to raise funds - The company has a history of significant losses, with a net loss of **$12.2 million** for **Q1 2020** and an accumulated deficit of **$298.9 million** as of **March 31, 2020**, and expects to incur significant losses for the foreseeable future[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - The company will require additional capital to finance its operations and complete the development of its product candidates, and future financing may not be available on acceptable terms, if at all[168](index=168&type=chunk)[170](index=170&type=chunk) - The **COVID-19** pandemic poses significant risks, including potential disruption to business operations, delays in clinical trials due to patient retention and site access issues, and negative impacts on global financial markets, which could hinder the ability to raise capital[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered securities or repurchase any of its equity securities during the three months ended **March 31, 2020** - No unregistered securities were sold during the three months ended **March 31, 2020**[175](index=175&type=chunk) - No securities were repurchased by the issuer during the three months ended **March 31, 2020**[176](index=176&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the quarterly report, including the company's certificate of incorporation, bylaws, and certifications from the **CEO and CFO** pursuant to the **Sarbanes-Oxley** Act - The report includes required exhibits such as corporate governance documents and **Sarbanes-Oxley** certifications from the **CEO and CFO**[182](index=182&type=chunk)

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2019 Earnings Conference Call March 9, 2020 8:30 AM ET Company Participants William Boni - Vice President of Investor Relations & Corporate Communications Remy Luthringer - Executive Chairman & Chief Executive Officer Geoff Race - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Jason Butler - JMP Securities Douglas Tsao - H.C. Wainwright Shawn Egan - Citi Biren Amin - Jefferies Myles Minter - William Blair ...