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 ...

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, 2019 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 ...

Financial Data and Key Metrics Changes - As of September 30, 2019, the company reported cash, cash equivalents, restricted cash, and marketable securities of approximately $60 million, which is expected to meet cash commitments for at least the next 12 months [26] - Research and development expenses for Q3 2019 were $9.7 million, compared to $8.4 million in Q3 2018, while for the nine months ended September 30, 2019, expenses were $29.6 million compared to $25.9 million for the same period in 2018 [26] - General and administrative expenses for Q3 2019 were $4.6 million, up from $4.1 million in Q3 2018, and for the nine months ended September 30, 2019, they were $13.9 million compared to $12.2 million in the same period in 2018 [27] - The company reported a net loss of $14 million for Q3 2019, compared to a net loss of $12 million in Q3 2018, and for the nine months ended September 30, 2019, the net loss was $42.3 million compared to $37 million for the same period in 2018 [28] Business Line Data and Key Metrics Changes - The company has completed and read out top-line results from four trials with seltorexant in major depressive disorder (MDD) and insomnia [9] - Enrollment in the Phase 2b trial with MIN-117 in MDD has been concluded, with top-line results expected in Q4 2019 [9][18] - Patient enrollment in the pivotal Phase III trial with roluperidone has resumed, with expectations to complete enrollment of 501 patients by year-end [10][11] Market Data and Key Metrics Changes - Seltorexant has shown meaningful and consistent improvement in mood and sleep symptoms across trials, with the 20 mg dose demonstrating the most robust effects [20][21] - The company is currently discussing next steps in the seltorexant program with Janssen, indicating ongoing collaboration in the market [23] Company Strategy and Development Direction - The company aims to maintain the quality of patient screening and selection in clinical trials, prioritizing integrity over speed in recruitment [11] - There is a focus on advancing roluperidone, seltorexant, and MIN-117 through clinical testing, with an emphasis on differentiating these products from currently approved treatments [23] - The company is preparing for the filing of a new drug application for roluperidone, with a commercial supply agreement already in place [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their clinical-stage products to address significant unmet medical needs, particularly in treating negative symptoms of schizophrenia [14][23] - The company is optimistic about the upcoming results from clinical trials and the potential for regulatory pathways for their product candidates [65] Other Important Information - The company has completed drug-drug interaction studies for roluperidone, showing minimal interaction with cytochrome P450 enzymes, which is favorable for its use as a monotherapy or in combination [33] - A new patent application related to MIN-117 for neuropathic pain has been filed, indicating exploration of additional therapeutic areas [34] Q&A Session Summary Question: Clarification on site expansion for roluperidone Phase III - Management clarified that they are not adding new sites to counter recruitment delays, emphasizing the importance of maintaining study integrity [31] Question: Results from drug-drug interaction studies for roluperidone - Management confirmed that the studies showed minimal interaction with key cytochrome enzymes, supporting the drug's use in various treatment settings [33] Question: Timeline for seltorexant and Janssen collaboration - Management indicated that they are working closely with Janssen to finalize plans based on feedback from an upcoming end of Phase II meeting with the FDA [39] Question: Safety data requirements for roluperidone filing - Management stated that they can start filing based on the 12-week double-blind phase results, with the 12-month safety data potentially added in a rolling basis [40] Question: Proportion of US to EU patients in roluperidone trials - Management confirmed that they aim for approximately 30% of patients from the US, but this is not mandatory, and they are monitoring safety and efficacy across regions [55] Question: Powering assumptions for MIN-117 trial - Management confirmed a clinically meaningful threshold of a 2.5 point difference over placebo for the MADRS scale, with good recruitment in the US [56] Question: Interest in advancing MIN-117 into Phase III - Management indicated that they will evaluate options based on the results of the ongoing trials before making decisions on partnerships or independent advancement [60]

[PART I — Financial Information](index=4&type=section&id=PART%20I%20%E2%80%94%20Financial%20Information) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2019, show a decrease in total assets to $110.8 million from $139.1 million at year-end 2018, primarily due to a reduction in cash and marketable securities, with a net loss of $42.3 million for the nine months [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2019, total assets decreased to $110.8 million from $139.1 million, mainly due to a reduction in cash and marketable securities, while total liabilities increased to $55.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,906 | $50,235 | | Marketable securities | $22,027 | $37,762 | | Total current assets | $61,409 | $90,018 | | Total assets | $110,813 | $139,136 | | **Liabilities & Equity** | | | | Total current liabilities | $9,896 | $3,609 | | Total liabilities | $55,286 | $48,871 | | Accumulated deficit | ($256,818) | ($214,553) | | Total stockholders' equity | $55,527 | $90,265 | | Total liabilities and stockholders' equity | $110,813 | $139,136 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported increased operating expenses and a wider net loss for both the three and nine months ended September 30, 2019, compared to the same periods in 2018, with net loss per share increasing to $1.08 for the nine months Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $9,674 | $8,369 | $29,600 | $25,881 | | General and administrative | $4,607 | $4,055 | $13,897 | $12,221 | | Loss from operations | ($14,282) | ($12,424) | ($43,498) | ($38,102) | | Net loss | ($13,962) | ($12,021) | ($42,266) | ($36,968) | | Net loss per share | ($0.36) | ($0.31) | ($1.08) | ($0.95) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2019, net cash used in operating activities was $29.3 million, offset by $16.4 million provided by investing activities, resulting in a net decrease in cash of $12.3 million Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,251) | ($32,142) | | Net cash provided by investing activities | $16,397 | $96,917 | | Net cash provided by (used in) financing activities | $525 | ($3,510) | | **Net (decrease) increase in cash** | **($12,329)** | **$61,265** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's operations as a clinical-stage biopharmaceutical firm focused on CNS diseases, its liquidity position of $60.0 million, and significant accounting policies including the Janssen co-development agreement and stock-based compensation - The company is a clinical-stage biopharmaceutical company focused on developing treatments for central nervous system (CNS) diseases, with key product candidates including roluperidone, seltorexant, MIN-117, and MIN-301[22](index=22&type=chunk) - As of September 30, 2019, the company had cash, cash equivalents, and marketable securities of **$60.0 million**, which management believes is sufficient to fund operations for at least the next 12 months, though additional capital will be required for later-stage clinical programs[25](index=25&type=chunk)[26](index=26&type=chunk) - An amendment to the co-development agreement with Janssen resulted in an upfront payment of **$30 million** and forgiveness of **$11.2 million** in collaborative expenses, recorded as deferred revenue[76](index=76&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Research and development | $652 | $2,006 | | General and administrative | $1,569 | $4,997 | | **Total** | **$2,221** | **$7,003** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing CNS disease treatments, provides updates on clinical programs including delays for roluperidone and positive results for seltorexant, and notes increased R&D and G&A expenses, ending the quarter with $60.0 million in cash [Clinical Updates](index=21&type=section&id=Clinical%20Updates) The company provided significant updates across its product pipeline, including a cyber-attack delaying roluperidone Phase 3 results to H1 2020, completed enrollment for MIN-117 Phase 2b with Q4 2019 results expected, and positive Phase 2b results for seltorexant in MDD and insomnia - A cyber-attack on an external contractor disrupted patient recruitment for the roluperidone Phase 3 trial, delaying expected top-line results from the 12-week portion to the first half of 2020[102](index=102&type=chunk) - Enrollment was completed in the MIN-117 Phase 2b trial for Major Depressive Disorder (MDD), with top-line results expected in the fourth quarter of 2019[115](index=115&type=chunk) - Seltorexant (MIN-202) showed positive top-line results in a Phase 2b trial for MDD, with the **20 mg dose demonstrating a statistically significant improvement in MADRS score** compared to placebo[119](index=119&type=chunk) - In a Phase 2b trial for insomnia, seltorexant demonstrated highly statistically significant (p ≤ 0.001) improvement in Latency to Persistent Sleep (LPS), the primary endpoint[131](index=131&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Comparing the three and nine months ended September 30, 2019, to the same periods in 2018, the company saw an increase in operating expenses, driven by higher R&D costs for clinical trials and increased G&A expenses from professional fees and stock-based compensation Comparison of Operating Expenses (in millions) | Expense Category | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $9.7 | $8.4 | $29.6 | $25.9 | | General & Administrative | $4.6 | $4.1 | $13.9 | $12.2 | - The increase in R&D expenses was primarily driven by higher development costs for the Phase 3 trial of roluperidone and the Phase 2b trial of MIN-117[144](index=144&type=chunk)[149](index=149&type=chunk) - The increase in G&A expenses was mainly due to higher professional fees for pre-commercial activities and increased non-cash stock-based compensation[145](index=145&type=chunk)[150](index=150&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2019, the company had approximately $60.0 million in cash and equivalents, deemed sufficient for the next 12 months, but acknowledges the need for additional capital to fund future operations and later-stage clinical trials given its history of net losses and an accumulated deficit of $256.8 million - The company had approximately **$60.0 million** in cash, cash equivalents, marketable securities, and restricted cash as of September 30, 2019[154](index=154&type=chunk) - Management asserts that existing cash is sufficient to fund operations for at least the next 12 months, but acknowledges the need to raise additional capital to complete the development and commercialization of its product candidates[154](index=154&type=chunk)[160](index=160&type=chunk) Cash Flow Summary for Nine Months Ended Sep 30 (in millions) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Operating activities | ($29.2) | ($32.1) | | Investing activities | $16.4 | $96.9 | | Financing activities | $0.5 | ($3.5) | | **Net (decrease) increase in cash** | **($12.3)** | **$61.3** | [Quantitative and Qualitative Disclosures about Market Risk](index=30&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[173](index=173&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2019, 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 September 30, 2019[175](index=175&type=chunk) - No changes were made to the internal control over financial reporting during the third quarter of 2019 that have materially affected, or are reasonably likely to materially affect, these controls[176](index=176&type=chunk) [PART II — Other Information](index=31&type=section&id=PART%20II%20%E2%80%94%20Other%20Information) [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any legal proceedings that it believes would have a material adverse effect on its business - As of the filing date, the company is not involved in any material legal proceedings[178](index=178&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company highlights key risks, including its history of significant losses, which are expected to continue as it advances its clinical programs, the need for additional capital, and vulnerability to system failures and cyber-attacks - The company has a history of significant losses, with a net loss of **$42.3 million** for the nine months ended September 30, 2019, and an accumulated deficit of **$256.8 million**[181](index=181&type=chunk) - The company will require substantial additional capital to fund its operations and clinical development, and failure to secure this funding could force it to delay, scale back, or discontinue programs[183](index=183&type=chunk)[185](index=185&type=chunk) - The company's operations are vulnerable to system failures and cyber-attacks, as demonstrated by a recent incident at an external contractor that disrupted patient recruitment for the roluperidone Phase 3 trial[186](index=186&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the three months ended September 30, 2019, the company did not sell any unregistered securities or repurchase any of its equity securities - There were no unregistered sales of equity securities during the third quarter of 2019[187](index=187&type=chunk) - The company did not repurchase any of its equity securities during the third quarter of 2019[188](index=188&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) On November 1, 2019, the Board of Directors amended and restated the company's bylaws, establishing the Court of Chancery of the State of Delaware as the exclusive forum for certain legal actions - The company's bylaws were amended and restated effective November 1, 2019[191](index=191&type=chunk) - The updated bylaws designate the Court of Chancery of the State of Delaware as the exclusive forum for specific types of stockholder litigation[191](index=191&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Bylaws, a Commercial Supply Agreement with Catalent, and certifications from the CEO and CFO - Key exhibits filed include the Amended and Restated Bylaws (Exhibit 3.2) and a Commercial Supply Agreement with Catalent Germany Schorndorf GmbH (Exhibit 10.1)[195](index=195&type=chunk)

Financial Data and Key Metrics Changes - As of June 30, 2019, cash, cash equivalents, restricted cash, and marketable securities were approximately $69.4 million, sufficient to meet cash commitments for at least the next 12 months [38] - Research and Development (R&D) expenses were $8.3 million in Q2 2019, down from $9.1 million in Q2 2018, reflecting decreased nonclinical and clinical pharmacology expenses [39] - General and Administrative (G&A) expenses increased to $4.6 million in Q2 2019 from $3.9 million in Q2 2018, primarily due to increased non-cash stock-based compensation and salary costs [40] - Net loss for Q2 2019 was $12.5 million, unchanged from Q2 2018, while the net loss for the first six months of 2019 was $28.3 million compared to $24.9 million for the same period in 2018 [42] Business Line Data and Key Metrics Changes - The company reported positive top-line results in two Phase 2b trials with seltorexant for major depressive disorder (MDD) and insomnia, indicating significant improvements in symptoms [10][11] - The Phase 3 trial with roluperidone is ongoing, focusing on patients with schizophrenia and negative symptoms, with approximately 500 patients expected to be enrolled [28] Market Data and Key Metrics Changes - The recent studies indicate that seltorexant shows efficacy in both adjunctive and monotherapy treatment of MDD, with significant improvements noted in patients with insomnia [20][26] - The insomnia study demonstrated statistically significant improvements in sleep latency in elderly patients, suggesting a favorable profile for seltorexant in this demographic [24][25] Company Strategy and Development Direction - The company aims to address unmet medical needs in neuropsychiatric disorders, with a focus on developing seltorexant and roluperidone as key therapeutic options [13][35] - Preparations for a New Drug Application (NDA) for roluperidone are underway, pending positive Phase 3 results, with a focus on ensuring adherence to trial parameters [32][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of seltorexant to treat multiple patient groups in MDD and insomnia [35] - The company is optimistic about the second half of 2019, anticipating important results from late-stage clinical trials [35][89] Other Important Information - The company is co-developing seltorexant with Janssen Pharmaceutica NV, which is noted as the only late-stage specific orexin-2 antagonist in development [14] - The safety and tolerability profile of seltorexant is comparable to that of placebo, indicating a favorable risk-benefit ratio [27] Q&A Session Summary Question: Impact of Phase 2 results on seltorexant program - Management indicated that the Phase 2 results will help fine-tune the development plan but will not change the basic strategy for Phase 3 studies [46][48] Question: Breakdown of patients in the Phase 3 roluperidone program - Management confirmed efforts to achieve approximately 30% of patients from the U.S., with current enrollment aligning well with this target [50] Question: Timeline for NDA filing if Phase 3 results are successful - Management stated that preparations for the NDA are on track, with a focus on obtaining 12 months of safety data post-Phase 3 results [54][55] Question: Key takeaways from the MDD1009 study for seltorexant - The study confirmed the drug's direct effect on mood and reassured management about the drug's innovative mechanism of action [60][62] Question: Treatment effect differences with the 20 mg dose before week-5 - Management noted that differentiation between placebo and treatment was observed after two weeks, consistent with previous studies [81] Question: Evaluation of both 20 mg and 40 mg doses in the ongoing trial - The ongoing trial is a flexible dose study allowing for both 20 mg and 40 mg doses to be evaluated [85]