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 June 30, 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 No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdiction of In ...

Clinical Programs - Roluperidone (MIN-101) is in Phase 3 development for negative symptoms in schizophrenia, with top-line results expected in Q4 2019 [3, 6, 65] The Phase 3 study design replicates the successful Phase 2b trial [6] The study involves 501 patients randomized 1:1:1 to 32 mg and 64 mg doses of MIN-101 versus placebo [15] - Seltorexant (MIN-202) Phase 2b trial (aMDD2001) showed a statistically significant improvement in MADRS total score at the 20 mg dose compared to placebo (p=0083) [3, 36, 40] A key secondary outcome showed an even greater difference from placebo for the seltorexant 20 mg arm in patients with clinically significant insomnia (ISI ≥ 15) with LS mean difference versus placebo of 49 on the MADRS total score and a 2-sided p-value of 0050 [36] Two further Phase 2b trials with TLR are expected in the near future [44] - MIN-117 is in an ongoing Phase 2b study for major depressive disorder and anxiety, with top-line results anticipated in Q4 2019 [3, 65] The study involves 324 patients [62] Financial Status - The company had a cash balance of $793 million as of March 31, 2019, providing a cash runway to early 2021 [65] Market Opportunity - Negative symptoms are identified as the leading unmet need in schizophrenia by treating physicians [32] - MDD affects 173 million adults in the US (71% of the population over age 18 and over) [47]

Financial Data and Key Metrics Changes - Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2019, were approximately $79.3 million, sufficient to meet cash commitments for at least the next 12 months [29] - Research and development expenses increased to $11.6 million in Q1 2019 from $8.4 million in Q1 2018, primarily due to higher development expenses for clinical trials [30] - General and administrative expenses rose to $4.7 million in Q1 2019 from $4.3 million in Q1 2018, attributed to increased non-cash stock-based compensation and salary costs [31] - Net loss for Q1 2019 was $15.8 million, or a loss per share of $0.41, compared to a net loss of $12.4 million, or a loss per share of $0.32, in Q1 2018 [31] Business Line Data and Key Metrics Changes - The company has five late-stage clinical efficacy trials ongoing with three product candidates, including a Phase 3 trial for roluperidone and Phase 2b trials for MIN-117 and seltorexant [10][11] - Enrollment for the Phase 3 trial of roluperidone is expected to complete in the second half of 2019, with top-line results anticipated in Q4 2019 [13] - The Phase 2b trial for MIN-117 is expected to complete enrollment of approximately 324 patients in Q3 2019, with top-line results also expected in Q4 2019 [17] Market Data and Key Metrics Changes - Increased competition for recruitment of schizophrenia patients has been noted, impacting enrollment timelines [13][37] - The company is actively engaging in commercial preparation activities for roluperidone, including filing a trade name application and finalizing supply agreements [25][26] Company Strategy and Development Direction - The company aims to address unmet medical needs in psychiatric disorders, focusing on innovative treatments for schizophrenia and major depressive disorders [10][19] - Preparatory work for regulatory filing and commercialization of roluperidone is ongoing, including clinical pharmacology studies and manufacturing registration batches [15] - The company is committed to maintaining high standards in clinical trial conduct and patient selection to ensure the success of its trials [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of their product candidates to meet significant unmet needs in the market [10][19] - The company anticipates that the completion of its NDA preparation will not be impacted by recent enrollment delays, maintaining timelines for potential product launches in 2021 or 2022 [58][59] Other Important Information - The company has engaged a senior commercial leader and third-party vendor partners to finalize launch plans for roluperidone [26] - The company is conducting payor research to define the value proposition and access strategy for its products [26] Q&A Session Summary Question: Timeline delays for roluperidone Phase 3 screening failures - Management indicated that recent screening failures are random and reflect strict eligibility criteria, with no direct correlation to new site openings [35][36] Question: Decision-making process and timing with J&J regarding seltorexant trials - Management confirmed that data from the trials will be available in Q2 2019, with no clinical linked milestones affecting the decision-making process [43][44] Question: Secondary endpoints for seltorexant depression study - Management highlighted the importance of secondary endpoints related to insomnia complaints and the unique mechanism of action of the drug [50][52] Question: Changes in expenses over the year - Management noted that while trial costs are significant, they expect to keep expenses under control moving forward [55][57] Question: Impact of enrollment delays on roluperidone launch timing - Management reassured that the launch timeline remains unaffected, with preparations proceeding smoothly [58][59]

[PART I — Financial Information](index=4&type=section&id=PART%20I%20%E2%80%94%20Financial%20Information) This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis for Minerva Neurosciences, Inc. [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited):) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, with detailed notes. [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20March%2031%2C%202019%20and%20December%2031%2C%202018) This table provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific dates. **Condensed Consolidated Balance Sheets (Selected Items, in millions):** | Item | March 31, 2019 | December 31, 2018 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $30.6 | $50.2 | | Marketable securities | $48.6 | $37.8 | | Total current assets | $80.3 | $90.0 | | Total assets | $129.8 | $139.1 | | Total current liabilities | $6.9 | $3.6 | | Total liabilities | $52.4 | $48.9 | | Total stockholders' equity | $77.4 | $90.3 | - Total current assets decreased from **$90.0 million** at December 31, 2018, to **$80.3 million** at March 31, 2019, primarily due to a decrease in cash and cash equivalents[13](index=13&type=chunk) - Total liabilities increased from **$48.9 million** at December 31, 2018, to **$52.4 million** at March 31, 2019, driven by increases in accounts payable and accrued expenses[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) This table outlines the company's financial performance over specific periods, focusing on expenses and net loss. **Condensed Consolidated Statements of Operations (Selected Items, in millions, except per share data):** | Item | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $11.6 | $8.4 | | General and administrative | $4.7 | $4.3 | | Total expenses | $16.3 | $12.7 | | Net loss | $(15.8) | $(12.4) | | Net loss per share, basic and diluted | $(0.41) | $(0.32) | | Weighted average shares outstanding | 38,968,110 | 38,749,343 | - Net loss increased to **$15.8 million** for the three months ended March 31, 2019, from **$12.4 million** in the prior year period, primarily due to higher research and development expenses[15](index=15&type=chunk) - Research and development expenses increased by approximately **$3.2 million** year-over-year, reflecting increased clinical trial activities[15](index=15&type=chunk) [Condensed Consolidated Statement of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Stockholders'%20Equity%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) This table details changes in the company's equity, including total equity, accumulated deficit, and additional paid-in capital. **Condensed Consolidated Statement of Stockholders' Equity (Selected Items, in millions, except share data):** | Item | March 31, 2019 | March 31, 2018 | | :-------------------------- | :------------- | :------------- | | Total Stockholders' Equity | $77.4 | $121.3 | | Accumulated Deficit | $(230.4) | $(176.8) | | Additional Paid-In Capital | $307.8 | $298.1 | | Common Stock Shares Outstanding | 39,025,471 | 38,749,343 | - Total stockholders' equity decreased from **$90.3 million** at January 1, 2019, to **$77.4 million** at March 31, 2019, primarily due to the net loss incurred during the period[18](index=18&type=chunk) - Accumulated deficit increased by **$15.8 million** to **$230.4 million** as of March 31, 2019, reflecting the net loss for the quarter[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) This table summarizes the cash inflows and outflows from operating, investing, and financing activities for the reported periods. **Condensed Consolidated Statements of Cash Flows (Selected Items, in millions):** | Cash Flow Activity | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(9.6) | $(10.9) | | Net cash (used in) provided by investing activities | $(10.5) | $31.3 | | Net cash provided (used in) by financing activities | $0.5 | $(1.3) | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(19.6) | $19.1 | | Cash, cash equivalents and restricted cash, End of period | $30.7 | $45.2 | - Net cash used in operating activities decreased to **$9.6 million** in Q1 2019 from **$10.9 million** in Q1 2018, despite a higher net loss, due to favorable changes in operating assets and liabilities[21](index=21&type=chunk) - Investing activities shifted from providing **$31.3 million** in Q1 2018 to using **$10.5 million** in Q1 2019, primarily due to increased purchases of marketable securities[21](index=21&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements. [NOTE 1 — Nature of Operations and Liquidity](index=8&type=section&id=NOTE%201%20%E2%80%94%20NATURE%20OF%20OPERATIONS%20AND%20LIQUIDITY) Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates for central nervous system diseases. - Minerva Neurosciences is a clinical-stage biopharmaceutical company developing four proprietary compounds for CNS diseases: roluperidone (schizophrenia), seltorexant (insomnia/MDD), MIN-117 (MDD), and MIN-301 (Parkinson's disease)[22](index=22&type=chunk) - The company has an accumulated deficit of approximately **$230.4 million** as of March 31, 2019, and incurred **$9.6 million** in net cash used in operating activities for the three months ended March 31, 2019[24](index=24&type=chunk) - As of March 31, 2019, the company had **$79.3 million** in cash, cash equivalents, marketable securities, and restricted cash, which is believed to be sufficient for at least the next 12 months, but additional capital will be needed for later-stage clinical development[25](index=25&type=chunk)[26](index=26&type=chunk) [NOTE 2 — Significant Accounting Policies](index=9&type=section&id=NOTE%202%20%E2%80%94%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the significant accounting policies used in preparing the condensed consolidated financial statements, including revenue recognition and lease accounting. - The company adopted ASC Topic 842, Leases, effective January 1, 2019, using a modified retrospective approach, resulting in the recognition of operating lease liabilities and right-of-use assets of approximately **$0.4 million** each on the balance sheet[44](index=44&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk) - Research and development costs, including licensing fees and fees paid to consultants and CROs, are expensed as incurred[35](index=35&type=chunk) - The company has no commercially approved products and has not generated revenue from product sales to date, applying ASC 606 for revenue recognition, deferring unearned revenue[51](index=51&type=chunk)[53](index=53&type=chunk) [NOTE 3 — Accrued Expenses and Other Liabilities](index=14&type=section&id=NOTE%203%20%E2%80%94%20ACCRUED%20EXPENSES%20AND%20OTHER%20LIABILITIES) This note provides a breakdown of accrued expenses and other liabilities, showing a significant increase in research and development costs and accrued bonus. **Accrued Expenses and Other Liabilities (in millions):** | Item | March 31, 2019 | December 31, 2018 | | :-------------------------------- | :------------- | :---------------- | | Research and development costs and other accrued expenses | $2.6 | $1.4 | | Accrued bonus | $0.5 | — | | Professional fees | $0.4 | $0.5 | | Vacation pay | $0.3 | — | | **Total** | **$3.7** | **$1.8** | - Total accrued expenses and other current liabilities increased by over **$1.9 million** from December 31, 2018, to March 31, 2019, primarily due to increases in research and development costs and accrued bonus[65](index=65&type=chunk) [NOTE 4 — Net Loss Per Share of Common Stock](index=14&type=section&id=NOTE%204%20%E2%80%94%20NET%20LOSS%20PER%20SHARE%20OF%20COMMON%20STOCK) This note details the computation of basic and diluted net loss per share, indicating that diluted loss per share is the same as basic loss per share. **Net Loss Per Share of Common Stock (in millions, except per share and share data):** | Item | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(15.8) | $(12.4) | | Weighted average shares outstanding | 38,968,110 | 38,749,343 | | Net loss per share – basic and diluted | $(0.41) | $(0.32) | - The net loss per share increased from **$(0.32)** in Q1 2018 to **$(0.41)** in Q1 2019[66](index=66&type=chunk) - Potentially dilutive securities, including common stock options, restricted stock units, and common stock warrants, were excluded from diluted EPS calculation as their effect was anti-dilutive due to the net loss[67](index=67&type=chunk) [NOTE 5 — Debt](index=15&type=section&id=NOTE%205%20%E2%80%94%20DEBT) This note describes the company's Loan and Security Agreement, with all Term A Loans fully repaid in August 2018, resulting in zero outstanding borrowings. - The company's Term A Loans, totaling **$10 million**, matured and were fully repaid on August 1, 2018[69](index=69&type=chunk)[70](index=70&type=chunk) - Interest expense decreased from **$0.1 million** in Q1 2018 to zero in Q1 2019 due to the repayment of the Term A loans[71](index=71&type=chunk) [NOTE 6 — Co-Development and License Agreement](index=15&type=section&id=NOTE%206%20%E2%80%94%20CO-DEVELOPMENT%20AND%20LICENSE%20AGREEMENT) This note details the co-development and license agreement with Janssen Pharmaceutica NV for seltorexant, including an amendment that provided a $30 million upfront payment. - Minerva has a co-development and license agreement with Janssen for seltorexant, granting Minerva exclusive commercialization rights in the Minerva Territory (EU, Switzerland, Liechtenstein, Iceland, Norway)[23](index=23&type=chunk)[72](index=72&type=chunk) - An August 2017 amendment resulted in a **$30 million** upfront payment from Janssen, waiver of **$11.2 million** in previously accrued collaborative expenses, and future milestone payments of up to **$40 million** for Phase 3 insomnia trials[75](index=75&type=chunk)[78](index=78&type=chunk) - Under the amendment, Minerva assumed strategic control of seltorexant's clinical development for insomnia and has no further financial obligations until after 'Decision Point 4'[76](index=76&type=chunk) [NOTE 7 — Stockholders' Equity](index=16&type=section&id=NOTE%207%20%E2%80%94%20STOCKHOLDERS'%20EQUITY) This note describes the warrants issued to lenders in connection with the Loan Agreement, allowing for the purchase of common stock. - In connection with the Loan Agreement, Minerva issued warrants to lenders to purchase **40,790 shares** of common stock at an exercise price of **$5.516** per share[80](index=80&type=chunk) - The fair value of these warrants was estimated at **$0.2 million** using a Black-Scholes model and was included as a discount to the Term A Loans and a component of additional paid-in capital[80](index=80&type=chunk) [NOTE 8 — Stock Award Plan and Stock-Based Compensation](index=17&type=section&id=NOTE%208%20%E2%80%94%20STOCK%20AWARD%20PLAN%20AND%20STOCK-BASED%20COMPENSATION) This note details the company's 2013 Equity Incentive Plan, including stock option and restricted stock unit (RSU) activity and related compensation expense. **Stock Option Activity (Q1 2019):** | Item | Shares Issuable Pursuant to Stock Options | Weighted Average Exercise Price | | :-------------------------- | :-------------------------------------- | :------------------------------ | | Outstanding January 1, 2019 | 8,498,047 | $6.99 | | Exercised | (87,500) | $6.00 | | Forfeited | (31,875) | $6.51 | | Outstanding March 31, 2019 | 8,378,672 | $7.00 | | Exercisable March 31, 2019 | 4,078,271 | $6.46 | **Stock-Based Compensation Expense (in millions):** | Category | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $0.7 | $0.5 | | General and administrative | $1.8 | $1.6 | | **Total** | **$2.5** | **$2.1** | - Total unrecognized compensation costs related to non-vested stock options at March 31, 2019, was approximately **$21.2 million**, expected to be recognized over a weighted-average period of 3.0 years[81](index=81&type=chunk) [NOTE 9 — Commitments and Contingencies](index=18&type=section&id=NOTE%209%20%E2%80%94%20COMMITMENTS%20AND%20CONTINGENCIES) The company is not currently aware of any legal proceedings or claims that would have a material adverse effect on its financial position or results of operations. - The company is not currently involved in any legal proceedings or claims that are expected to have a material adverse effect on its financial position or results of operations[87](index=87&type=chunk) [NOTE 10 — Leases](index=19&type=section&id=NOTE%2010%20%E2%80%94%20LEASES) This note details the company's operating sublease for its corporate headquarters, which commenced in November 2017 and expires in July 2021. - The company's primary lease commitment is an office sublease expiring July 31, 2021, with monthly rental rates escalating from **$14,808** to **$16,288**[89](index=89&type=chunk) **Future Operating Sublease Payments (as of March 31, 2019, in millions):** | Year | Waltham | | :--- | :------ | | 2019 (remaining) | $0.14 | | 2020 | $0.19 | | 2021 | $0.11 | | **Total Sublease payments** | **$0.45** | | Less: imputed interest | $(0.05) | | **Total operating Sublease liabilities** | **$0.40** | [NOTE 11 — Related Party Transactions](index=19&type=section&id=NOTE%2011%20%E2%80%94%20RELATED%20PARTY%20TRANSACTIONS) This note discloses a services agreement with V-Watch SA for approximately $105 thousand, where Minerva's CEO is the chairman of V-Watch's board. - Minerva entered into a **$105,000** services agreement with V-Watch SA for the use of its SomnoArt device in clinical trials[92](index=92&type=chunk) - This is considered a related party transaction as Minerva's CEO is the chairman of V-Watch's board, and a Minerva stockholder (Index Ventures) holds over **10%** of V-Watch's capital stock[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its status as a clinical-stage biopharmaceutical company. [Overview](index=20&type=section&id=Overview) Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing product candidates for central nervous system (CNS) diseases. - Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing product candidates for central nervous system (CNS) diseases, with four proprietary compounds in its portfolio[95](index=95&type=chunk)[96](index=96&type=chunk) - The company has not received regulatory approvals for any product candidates and has not generated revenue from sales or licenses, expecting to incur net losses and negative cash flow for the foreseeable future[97](index=97&type=chunk) [Clinical Updates](index=20&type=section&id=Clinical%20Updates) This section provides updates on the clinical development progress of the company's key product candidates. [Roluperidone (MIN-101)](index=20&type=section&id=Roluperidone%20(MIN-101)) The Phase 3 clinical trial for roluperidone (MIN-101) for negative symptoms in schizophrenia is ongoing, with top-line results expected in Q4 2019. - Enrollment for the pivotal Phase 3 clinical trial of roluperidone for negative symptoms in schizophrenia is expected to complete in the second half of 2019, with top-line results available in Q4 2019[98](index=98&type=chunk)[100](index=100&type=chunk) - Pre-clinical studies showed roluperidone significantly increased Brain-Derived Neurotrophic Factor (BDNF) and Glial Cell-Derived Neurotrophic Factor (GDNF) release, suggesting potential for disease modification and improved neuroplasticity[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - The Journal of Clinical Psychiatry published results demonstrating cognitive improvements in schizophrenia patients treated with roluperidone, correlating with improvements in negative symptoms[107](index=107&type=chunk) [MIN-117](index=21&type=section&id=MIN-117) A Phase 2b trial for MIN-117 in Major Depressive Disorder (MDD) with anxious distress is ongoing, with top-line results expected in Q4 2019. - A Phase 2b trial for MIN-117 in MDD with anxious distress is recruiting approximately **324 patients** in the U.S. and Europe, with enrollment expected to complete in Q3 2019 and top-line results in Q4 2019[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - A U.S. patent application has been filed for MIN-117 to treat pain, based on pre-clinical rat models showing significant reduction in nociceptive and chemotherapy-induced neuropathic pain[111](index=111&type=chunk)[112](index=112&type=chunk) [Seltorexant (MIN-202)](index=22&type=section&id=Seltorexant%20(MIN-202)) Enrollment is complete for two Phase 2b trials of seltorexant in MDD and one in insomnia disorder, with top-line results expected in Q2 and Q3 2019. - Enrollment is complete for the Phase 2b 2001 Trial (MDD adjunctive therapy) and 2005 Trial (insomnia disorder), with top-line results expected in Q2 2019[113](index=113&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - Enrollment is also complete for the Phase 2b 2002 Trial (seltorexant vs. quetiapine in MDD), with top-line results expected in Q3 2019[114](index=114&type=chunk)[117](index=117&type=chunk) [MIN-301](index=22&type=section&id=MIN-301) Pre-clinical studies of MIN-301 in non-human primates showed improvements in Parkinson's disease models, supporting its advancement towards clinical trials. - Results from a non-human primate study showed that treatment with an analog of MIN-301 improved symptoms in a Parkinson's disease model[120](index=120&type=chunk) - These findings support advancing MIN-301 into clinical trials for Parkinson's disease, with a Phase 1 study expected to commence after an IND or IMPD filing[120](index=120&type=chunk) [Financial Overview](index=24&type=section&id=Financial%20Overview) This section provides an overview of the company's revenue, expenses, and other financial components. [Revenue](index=24&type=section&id=Revenue) The company has not generated any revenue from product sales or licenses to date, but has deferred revenue from the Janssen co-development agreement. - Minerva has not recognized any revenue from product sales or licenses as none of its product candidates have been approved for commercialization[121](index=121&type=chunk) - Deferred Revenue from the Amendment to the Co-Development and License Agreement with Janssen will be recognized in future periods, subject to certain future events[121](index=121&type=chunk) [Research and Development Expenses](index=24&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses are expensed as incurred and are expected to be the largest category of operating expenses, increasing with ongoing trials. - Research and development expenses include fees for consultants, CROs, clinical trials, licensing, materials, regulatory compliance, and R&D employee compensation, all expensed as incurred[122](index=122&type=chunk) - R&D expenses are expected to increase as the company continues planned pre-clinical and clinical trials and hires additional R&D staff[123](index=123&type=chunk) [General and Administrative Expenses](index=24&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses cover executive, finance, legal, auditing, and tax functions, and are expected to increase due to public company operations. - General and administrative expenses primarily consist of costs for executive, finance, legal, auditing, and tax functions, including salaries, bonuses, facility costs, professional fees, and non-cash stock-based compensation[125](index=125&type=chunk) - These expenses are expected to increase due to operating as a publicly-traded company, compliance costs, investor relations, and infrastructure enhancements to support business growth[126](index=126&type=chunk) [Foreign Exchange (Losses) Gains](index=24&type=section&id=Foreign%20Exchange%20(Losses)%20Gains) Foreign exchange losses or gains arise from clinical trial expenses denominated in Euros, reflecting changes in currency rates. - Foreign exchange losses/gains result from clinical trial expenses denominated in Euros, reflecting currency rate fluctuations between the date an expense is recorded and the payment date[127](index=127&type=chunk) - The company expects to continue incurring Euro-denominated expenses as certain planned clinical trials are conducted in Europe[127](index=127&type=chunk) [Investment Income](index=24&type=section&id=Investment%20Income) Investment income is generated from the company's cash equivalents and marketable securities. - Investment income is derived from earnings on the company's cash equivalents and marketable securities[128](index=128&type=chunk) [Interest Expense](index=24&type=section&id=Interest%20Expense) Interest expense relates to the company's outstanding loan with Oxford Finance LLC and Silicon Valley Bank. - Interest expense is associated with the company's loan agreement with Oxford Finance LLC and Silicon Valley Bank[128](index=128&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, comparing key financial metrics between the reported periods. [Comparison of Three Months Ended March 31, 2019 versus March 31, 2018](index=24&type=section&id=Comparison%20of%20Three%20Months%20Ended%20March%2031%2C%202019%20versus%20March%2031%2C%202018) This section compares the financial performance for the three months ended March 31, 2019, against the same period in 2018, detailing changes in key expense categories. - Research and development expenses increased by **$3.2 million** to **$11.6 million** in Q1 2019 (from **$8.4 million** in Q1 2018), primarily due to higher development expenses for roluperidone Phase 3 and MIN-117 Phase 2b clinical trials[129](index=129&type=chunk) - General and administrative expenses increased by **$0.4 million** to **$4.7 million** in Q1 2019 (from **$4.3 million** in Q1 2018), mainly due to increased non-cash stock-based compensation and salary costs[130](index=130&type=chunk) - Investment income increased by **$0.1 million** to **$0.5 million** in Q1 2019 (from **$0.4 million** in Q1 2018), while interest expense decreased by **$0.1 million** to zero due to the repayment of Term A loans[132](index=132&type=chunk)[133](index=133&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations, including sources and uses of funds. [Sources of Liquidity](index=25&type=section&id=Sources%20of%20Liquidity) The company has incurred significant losses and negative cash flows, with existing cash resources expected to be sufficient for the next 12 months, but future funding is uncertain. - As of March 31, 2019, the company had an accumulated deficit of approximately **$230.4 million** and **$79.3 million** in cash, cash equivalents, marketable securities, and restricted cash[134](index=134&type=chunk) - Existing cash resources are believed to be sufficient for at least the next 12 months, but future expenditures are subject to variability based on clinical trial design, timing, and funding availability[134](index=134&type=chunk) [Sources of Funds](index=25&type=section&id=Sources%20of%20Funds) Key funding sources include an amendment to the co-development and license agreement with Janssen, a public offering of common stock, and proceeds from warrant exercises. - The Amendment to the Co-Development and License Agreement with Janssen provided a **$30 million** upfront payment in August 2017 and includes future milestone payments of **$20 million** at the start of a Phase 3 insomnia trial and another **$20 million** at **50%** patient enrollment[135](index=135&type=chunk) - A public offering of common stock in July 2017 generated net proceeds of approximately **$41.6 million** from the sale of **5,750,000 shares** at **$7.75** per share[136](index=136&type=chunk) - The exercise of warrants in March 2017 generated gross proceeds of approximately **$9.4 million** from **1,621,073 shares** of common stock[137](index=137&type=chunk) [Uses of Funds](index=26&type=section&id=Uses%20of%20Funds) The company has not generated revenue and expects expenses to increase due to ongoing development activities, clinical trials, regulatory approvals, and public company operations. - The company has not generated revenue and expects increasing expenses from ongoing R&D, clinical trials, regulatory approvals, and public company operations, including potential commercialization costs[138](index=138&type=chunk) - Future cash needs are expected to be financed through equity offerings, debt financings, third-party funding, or collaborations, which may lead to stockholder dilution or restrictive covenants[139](index=139&type=chunk) - The company fully repaid its **$10.0 million** Term A Loan on August 1, 2018[140](index=140&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) This section summarizes the company's cash flows from operating, investing, and financing activities for the three months ended March 31, 2019 and 2018. **Net Cash Flows (in millions):** | Activity | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Operating activities | $(9.6) | $(10.9) | | Investing activities | $(10.5) | $31.3 | | Financing activities | $0.5 | $(1.3) | | **Net (decrease) increase in cash** | **$(19.6)** | **$19.1** | - Net cash used in operating activities decreased to **$9.6 million** in Q1 2019 from **$10.9 million** in Q1 2018, primarily due to changes in operating assets and liabilities offsetting the net loss[143](index=143&type=chunk)[144](index=144&type=chunk) - Net cash used in investing activities was **$10.5 million** in Q1 2019, a significant shift from **$31.3 million** provided in Q1 2018, mainly due to increased purchases of marketable securities[145](index=145&type=chunk)[146](index=146&type=chunk) - Net cash provided by financing activities was **$0.5 million** in Q1 2019 from stock option exercises, compared to **$1.3 million** used in Q1 2018 for loan repayments[147](index=147&type=chunk) [Off-Balance Sheet Arrangements](index=27&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements during the periods presented. - The company did not have any off-balance sheet arrangements as defined under SEC rules during the periods presented[148](index=148&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies and estimates remain consistent with those disclosed in its 2018 Annual Report on Form 10-K. - The critical accounting policies and estimates for Q1 2019 remain consistent with those identified in the 2018 Annual Report on Form 10-K, covering areas such as stock-based compensation, R&D costs, IPR&D, goodwill, income taxes, and impairment of long-lived assets[149](index=149&type=chunk) [Recent Accounting Pronouncements](index=27&type=section&id=Recent%20Accounting%20Pronouncements) The company has adopted several new accounting pronouncements, including ASU No. 2016-02 (Leases), with no material impact except for lease assets and liabilities. - The company adopted ASU No. 2016-02 (Leases), ASU No. 2017-08 (Receivables—Nonrefundable Fees), and ASU No. 2018-07 (Stock Compensation) effective January 1, 2019[57](index=57&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) - The adoption of ASC 842 (Leases) resulted in the recognition of **$0.4 million** in operating lease liabilities and right-of-use assets, but other pronouncements had no material impact on the consolidated financial statements[60](index=60&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) - The company is currently evaluating the impact of ASU No. 2017-04 (Intangibles — Goodwill and Other), effective for annual periods beginning after December 15, 2019[64](index=64&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period. - The company has no applicable quantitative and qualitative disclosures about market risk for the reported period[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2019, concluding they were effective. - The company's disclosure controls and procedures were evaluated as effective at a reasonable assurance level as of March 31, 2019[154](index=154&type=chunk) - There were no material changes in internal control over financial reporting during the latest fiscal quarter[155](index=155&type=chunk) [PART II — Other Information](index=28&type=section&id=PART%20II%20%E2%80%94%20Other%20Information) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits. [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings or claims that are expected to have a material adverse effect on its business. - The company is not currently party to any claim or litigation that is reasonably expected to have a material adverse effect on its business, financial condition, or results of operations[157](index=157&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company operates in a rapidly changing environment with inherent risks, including significant losses and the expectation of continued losses requiring additional capital. - The company has incurred significant losses since its inception in 2007, with a net loss of **$15.8 million** for Q1 2019 and an accumulated deficit of **$230.4 million** as of March 31, 2019[159](index=159&type=chunk)[160](index=160&type=chunk) - The company expects to continue incurring significant losses and will require additional capital to finance operations and complete product development, which may not be available on acceptable terms[161](index=161&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - Future funding requirements depend on factors such as clinical trial timing and costs, regulatory approvals, intellectual property maintenance, market acceptance, and commercialization expenses[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered equity securities or repurchase any equity securities during the three months ended March 31, 2019. - No unregistered securities were sold during the three months ended March 31, 2019[165](index=165&type=chunk) - No equity securities were repurchased during the three months ended March 31, 2019[166](index=166&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there are no defaults upon senior securities applicable to the company for the reported period. - This item is not applicable to the company for the reported period[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures applicable to the company for the reported period. - This item is not applicable to the company for the reported period[168](index=168&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information applicable to the company for the reported period. - This item is not applicable to the company for the reported period[169](index=169&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits incorporated by reference or filed as part of the report, including organizational documents and certifications. - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, an Employment Agreement, CEO and CFO certifications (Sarbanes-Oxley Act Sections 302 and 906), and XBRL related documents[171](index=171&type=chunk) [SIGNATURES](index=32&type=section&id=SIGNATURES) This section contains the official signatures certifying the accuracy and completeness of the financial report. - The report is signed by Geoffrey Race, Chief Financial Officer (Principal Financial Officer) on behalf of Minerva Neurosciences, Inc. on May 6, 2019[174](index=174&type=chunk)[175](index=175&type=chunk)

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2018 Earnings Conference Call March 12, 2019 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 Operator Welcome to the Minerva Ne ...

Part I [Business](index=3&type=section&id=Item%201.%20Business) Minerva Neurosciences is a clinical-stage biopharmaceutical company developing product candidates for Central Nervous System diseases, with a portfolio of four proprietary compounds and no current revenue - Minerva is a clinical-stage biopharmaceutical company focused on developing and commercializing product candidates for Central Nervous System (CNS) diseases[13](index=13&type=chunk) - The company has not received regulatory approval for any product candidates and has not generated any revenue from sales, expecting significant operating losses to continue[19](index=19&type=chunk) Product Candidate Portfolio | Product Candidate | Indication(s) | |---|---| | Roluperidone (MIN-101) | Negative symptoms in schizophrenia | | Seltorexant (MIN-202) | Insomnia disorder, adjunctive treatment of Major Depressive Disorder (MDD) | | MIN-117 | Major Depressive Disorder (MDD) | | MIN-301 | Parkinson's disease | [Our Pipeline of Advanced Clinical-Stage Programs](index=5&type=section&id=Our%20Pipeline%20of%20Advanced%20Clinical-Stage%20Programs) The company's pipeline includes roluperidone in Phase 3, seltorexant and MIN-117 in Phase 2b, and MIN-301 in pre-clinical development Clinical Trial Status | Program | Primary Indications | Development Phase | |---|---|---| | Roluperidone (MIN-101) | Negative symptoms in Schizophrenia | Phase 3 initiated Dec 2017 | | Seltorexant (MIN-202) | Primary Insomnia | Phase 2b initiated Dec 2017 | | Seltorexant (MIN-202) | Major Depressive Disorder (adjunctive) | Phase 2b initiated Dec 2017 | | MIN-117 | Major Depressive Disorder (monotherapy) | Phase 2b initiated Apr 2018 | | MIN-301 | Parkinson's Disease | Pre-clinical | [License Agreements](index=10&type=section&id=License%20Agreements) Minerva holds exclusive licenses for roluperidone and MIN-117 from MTPC and a co-development agreement with Janssen for seltorexant, involving milestone and royalty payments - The company has an exclusive license from MTPC for roluperidone and MIN-117, with worldwide rights excluding most of Asia, obligated to pay tiered royalties and potential commercial milestone payments up to **$47.5 million** for each compound[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) - Under the amended agreement with Janssen for seltorexant, Minerva received a **$30 million** upfront payment, with up to **$40 million** in additional milestone payments for the insomnia indication, and Janssen waived its right to royalties on insomnia sales in Minerva's territory[71](index=71&type=chunk) - The amendment with Janssen also forgave **$11.2 million** in previously accrued collaborative expenses owed by Minerva, with these funds and the **$30 million** upfront payment recorded as deferred revenue[71](index=71&type=chunk) [Competition](index=12&type=section&id=Competition) The company faces significant competition across its pipeline from established and emerging therapies in schizophrenia, MDD, insomnia, and Parkinson's disease - Roluperidone's competitors for negative symptoms in schizophrenia include Acadia's Pimavanserin, Lundbeck's Lu AF11167, and products from Roche, Takeda, and others[78](index=78&type=chunk) - MIN-117 faces competition from numerous generic antidepressants (SSRIs, SNRIs) and newer branded therapies like Lundbeck's Brintellix, Janssen's esketamine, and Allergan's rapastinel[79](index=79&type=chunk)[82](index=82&type=chunk) - Seltorexant's primary competitor in the orexin antagonist class is Merck's Belsomra®, though Minerva believes seltorexant's selectivity for the orexin 2 receptor may offer a superior profile[84](index=84&type=chunk)[85](index=85&type=chunk) [Intellectual Property](index=14&type=section&id=Intellectual%20Property) The company protects its product candidates through patents and exclusivity, with key compound patents expiring between 2020 and 2030, and formulation patents extending later Key Patent Expiration Timelines | Product Candidate | Patent Type | Earliest Expiration Year | |---|---|---| | Roluperidone | Compound (US/Foreign) | 2021 | | Roluperidone | Modified-Release Formulation | 2035 | | MIN-117 | Compound (US/Foreign) | 2020 | | MIN-117 | Low-Dose Compositions/Use | 2034 | | Seltorexant | Compound (Europe) | 2030 | | MIN-301 | Method of Use | 2028 | - Product candidates may be eligible for data and marketing exclusivity, generally **five years** in the U.S. and **ten years** in the EU for small molecules, with MIN-301 potentially receiving **twelve years** in the U.S. if approved as a biologic[103](index=103&type=chunk)[104](index=104&type=chunk) [Government Regulation and Product Approval](index=16&type=section&id=Government%20Regulation%20and%20Product%20Approval) Product approval is subject to extensive regulation by the FDA and EMA, involving rigorous clinical trials, marketing authorization procedures, and ongoing post-approval compliance - In the EU, marketing authorization requires submitting an MAA through one of four procedures, with the centralized procedure granting approval across the EEA and having a standard review time of **210 days**[110](index=110&type=chunk)[111](index=111&type=chunk) - In the U.S., the FDA approval process requires submitting an IND before clinical trials and an NDA after successful trials, a lengthy process proving safety and effectiveness through adequate and well-controlled studies[118](index=118&type=chunk)[119](index=119&type=chunk)[125](index=125&type=chunk) - Commercial success depends on obtaining coverage and adequate reimbursement from government and private payors, who are increasingly implementing cost-containment measures[146](index=146&type=chunk)[147](index=147&type=chunk) - The withdrawal of the United Kingdom from the EU (Brexit) could materially impact the future regulatory regime for product approval and commercialization in the UK[155](index=155&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including financial losses, funding needs, clinical trial failures, regulatory uncertainty, reliance on third parties, and intellectual property challenges - The company has a history of significant losses (**$50.2 million** in 2018) and an accumulated deficit of **$214.6 million** as of December 31, 2018, expecting continued losses and potential unprofitability[160](index=160&type=chunk)[161](index=161&type=chunk) - The company will require additional capital to finance operations, and failure to secure funding on acceptable terms could force delays, scale-backs, or discontinuation of development programs[163](index=163&type=chunk)[165](index=165&type=chunk) - There is a high risk that product candidates could fail in clinical trials or not receive regulatory approval due to lack of efficacy, safety issues, or disagreement with regulators on trial design[169](index=169&type=chunk)[173](index=173&type=chunk) - The company relies on third-party CROs to conduct clinical trials and third-party manufacturers for all product supply, increasing risks related to quality, compliance (cGMP), and supply chain continuity[271](index=271&type=chunk)[275](index=275&type=chunk) - Key patents for roluperidone and MIN-117 are expected to expire as soon as **2021** and **2020**, respectively, potentially leading to increased competition shortly after product launch[291](index=291&type=chunk) [Unresolved Staff Comments](index=53&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[327](index=327&type=chunk) [Properties](index=53&type=section&id=Item%202.%20Properties) The company's principal executive offices are in a leased 5,923 square foot facility in Waltham, Massachusetts, with the sublease expiring in July 2021 - The company leases approximately **5,923 square feet** of office space at 1601 Trapelo Road, Suite 286, Waltham, Massachusetts 02451[328](index=328&type=chunk) - The current sublease expires on **July 27, 2021**[328](index=328&type=chunk) [Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business - As of the filing date, the company is not party to any claim or litigation expected to have a material adverse effect on the business[329](index=329&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[330](index=330&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=54&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "NERV" since July 2014, with no equity repurchases in Q4 2018 - Common stock has traded on the Nasdaq Global Market under the symbol **"NERV"** since **July 1, 2014**[333](index=333&type=chunk) - The company did not repurchase any of its equity securities during the quarter ended **December 31, 2018**[336](index=336&type=chunk) [Selected Financial Data](index=54&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is not applicable - Not applicable[337](index=337&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of $50.2 million in 2018 due to increased R&D and G&A expenses, holding $88.1 million in cash, sufficient for 12 months, but anticipates needing more capital Results of Operations (in thousands) | | 2018 | 2017 | |---|---:|---:| | Research and development | $34,889 | $30,256 | | General and administrative | $16,841 | $10,914 | | Total expenses | $51,730 | $41,170 | | Loss from operations | $(51,730) | $(41,170) | | Net loss | $(50,171) | $(31,523) | - The increase in R&D expenses in 2018 was primarily due to higher development costs for the Phase 3 trial of roluperidone and the Phase 2b trial of MIN-117, partially offset by lower expenses for the seltorexant program[361](index=361&type=chunk) - The increase in G&A expenses was mainly due to higher non-cash stock-based compensation and increased salary costs from staffing up for pre-commercial activities[362](index=362&type=chunk) - As of December 31, 2018, the company had cash, cash equivalents, restricted cash, and marketable securities of **$88.1 million** and believes this is sufficient to fund operations for at least the next **12 months**[367](index=367&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=63&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable - Not applicable[400](index=400&type=chunk) [Financial Statements and Supplementary Data](index=64&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Consolidated financial statements show total assets of $139.1 million, liabilities of $48.9 million, and a net loss of $50.2 million for 2018, with a full valuation allowance on deferred tax assets Consolidated Balance Sheet Highlights (as of Dec 31, 2018, in millions) | | Amount | |---|---:| | Cash and cash equivalents | $50.2 | | Marketable securities | $37.8 | | In-process research and development | $34.2 | | Total Assets | $139.1 | | Deferred revenue | $41.2 | | Total Liabilities | $48.9 | | Total Stockholders' Equity | $90.3 | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2018, in millions) | | Amount | |---|---:| | Research and development expense | $34.9 | | General and administrative expense | $16.8 | | Loss from operations | $(51.7) | | Net loss | $(50.2) | | Net loss per share | $(1.29) | - The company adopted the new revenue recognition standard (ASC 606) on **January 1, 2018**, which did not have a material impact on its consolidated financial statements[460](index=460&type=chunk) - As of December 31, 2018, the company had federal net operating loss carryforwards of approximately **$53.9 million**, which begin to expire in **2027**[494](index=494&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=85&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting and financial disclosure - None[506](index=506&type=chunk) [Controls and Procedures](index=85&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2018, with no auditor attestation report due to emerging growth company status - Management concluded that disclosure controls and procedures were effective as of **December 31, 2018**[508](index=508&type=chunk) - Management concluded that internal control over financial reporting was effective as of **December 31, 2018**, based on the COSO 2013 framework[510](index=510&type=chunk) - The annual report does not include an auditor's attestation report on internal control over financial reporting, as permitted for emerging growth companies under the JOBS Act[511](index=511&type=chunk) [Other Information](index=85&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None[513](index=513&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=86&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2019 proxy statement - Information required by this item is incorporated by reference from the definitive proxy statement for the **2019 Annual Meeting of Stockholders**[515](index=515&type=chunk) [Executive Compensation](index=86&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation is incorporated by reference from the 2019 proxy statement - Information required by this item is incorporated by reference from the definitive proxy statement for the **2019 Annual Meeting of Stockholders**[516](index=516&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=86&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and equity compensation plans is incorporated by reference from the 2019 proxy statement - Information required by this item is incorporated by reference from the definitive proxy statement for the **2019 Annual Meeting of Stockholders**[517](index=517&type=chunk) [Certain Relationships and Related Person Transactions, and Director Independence](index=86&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Person%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related person transactions, and director independence is incorporated by reference from the 2019 proxy statement - Information required by this item is incorporated by reference from the definitive proxy statement for the **2019 Annual Meeting of Stockholders**[518](index=518&type=chunk) [Principal Accountant Fees and Services](index=86&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services is incorporated by reference from the 2019 proxy statement - Information required by this item is incorporated by reference from the definitive proxy statement for the **2019 Annual Meeting of Stockholders**[519](index=519&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=87&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all documents filed as part of the Form 10-K, including consolidated financial statements and various exhibits - This section lists all exhibits filed with the Form 10-K, including material contracts, governance documents, and required certifications[521](index=521&type=chunk)[523](index=523&type=chunk) [Form 10-K Summary](index=92&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not applicable[528](index=528&type=chunk)