SEC Filings

Form 10-K
OVID THERAPEUTICS INC. filed this Form 10-K on 03/07/2019
Document Outline
Entire Document (5341.9 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 4 - PART I
Page 5 - Our Focus: Rare Neurological Disorders
Page 6 - Scientifically Driven
Page 7 - Our Pipeline
Page 8 - OV101 and Tonic Inhibition
Page 9 - The Role of GABA in Phasic and Tonic Inhibition
Page 10 - Figure 3: Phasic inhibition is rapid and short-lived. Tonic inhibition is more persistent.
Page 11 - Figure 4. How OV101 is designed to address tonic inhibition by restoring activity of the extrasynapt
Page 12 - Angelman Syndrome
Page 13 - Preclinical Data in Angelman Syndrome.
Page 14 - Fragile X Syndrome
Page 15 - FMR1
Page 16 - FMR1
Page 17 - Safety and Tolerability
Page 18 - The STARS Trial
Page 19 - Efficacy Endpoint Data
Page 20 - ELARA
Page 21 - Dravet Syndrome
Page 22 - The Role of Cholesterol Metabolism in Epileptic Encephalopathies
Page 23 - OV935 Preclinical Data
Page 24 - PTZ Kindling Model
Page 25 - Figure 16: OV935 increased survival in APP/PS1 transgenic mouse model.
Page 26 - Figure 18: Dose-dependent reduction in plasma 24HC by OV935 in a Phase 1 multiple ascending-dose tri
Page 27 - Primary Endpoint: Safety and Tolerability Results
Page 28 - ENDYMION
Page 29 - License and Collaboration Agreement with Takeda
Page 30 - Northwestern License
Page 31 - Sales and Marketing
Page 32 - Intellectual Property
Page 33 - Government Regulation
Page 34 - Clinical Trials
Page 35 - Orphan Drug Act
Page 36 - Post-Approval Requirements
Page 37 - Coverage and Reimbursement
Page 38 - to
Page 39 - Item 1A. Risk Factors
Page 40 - We will require additional capital to finance our operations, which may not be available on acceptab
Page 41 - Raising additional capital or acquiring or licensing assets by issuing equity or debt securities may
Page 42 - Our ability to use our net operating loss carryforwards and certain other tax attributes may be limi
Page 43 - Because the results of preclinical studies or earlier clinical trials are not necessarily predictive
Page 44 - Angelman syndrome has no FDA-approved treatments, and the clinical endpoints to obtain approval are
Page 45 - We may need to conduct additional clinical or non-clinical studies in order to enroll children young
Page 46 - If we are not successful in discovering, developing and commercializing additional drug candidates,
Page 47 - Clinical trials are very expensive, time-consuming and difficult to design and implement.
Page 48 - We may be required to relinquish important rights to and control over the development and commercial
Page 49 - If the market opportunities for our drug candidates are smaller than we believe they are, even assum
Page 50 - Even if we obtain regulatory approval for our current or future drug candidates, they will remain su
Page 51 - If we are unable to establish sales and marketing capabilities, or enter into agreements with third
Page 52 - Product liability lawsuits against us could cause us to incur substantial liabilities and could limi
Page 53 - Coverage and adequate reimbursement may not be available for our current or any future drug candidat
Page 54 - Healthcare legislative reform measures may have a negative impact on our business and results of ope
Page 55 - Risks Related to Our Intellectual Property
Page 56 - We may be unable to prevent third parties from selling, making, promoting, manufacturing, or distrib
Page 57 - Patent terms may be inadequate to protect our competitive position on our drug candidates for an ade
Page 58 - We may be subject to claims asserting that our employees, consultants or advisors have wrongfully us
Page 59 - Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the
Page 60 - We intend to rely on third parties to conduct, supervise and monitor our preclinical studies and cli
Page 61 - Risks Related to Our Business Operations, Employee Matters and Managing Growth
Page 62 - Our employees, principal investigators, consultants and commercial partners may engage in misconduct
Page 63 - There is no public market for our Series A preferred stock.
Page 64 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 65 - We will continue to incur increased costs as a result of operating as a public company, and our mana
Page 66 - We may be subject to securities litigation, which is expensive and could divert management attention
Page 67 - Some provisions of our charter documents and Delaware law may have anti-takeover effects that could
Page 68 - Item 3. Legal Proceedings
Page 69 - PART II
Page 70 - Use of Proceeds
Page 71 - Balance Sheet Data:
Page 72 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 73 - Recent Events
Page 74 - General and Administrative Expenses
Page 75 - Results of Operations
Page 76 - Income Taxes
Page 77 - Net Cash in Investing Activities
Page 78 - Accrued Clinical Expenses
Page 79 - Item 7A
Page 80 - PART III
Page 81 - PART IV
Page 82 - N/A
Page 83 - Item 16. Form 10-K Summary
Page 84 - SIGNATURES
Page 85 - OVID THERAPEUTICS INC.
Page 86 - Report of Independent Registered Public Accounting Firm
Page 87 - PART I FINANCIAL INFORMATION
Page 88 - OVID THERAPEUTICS INC.
Page 89 - OVID THERAPEUTICS INC.
Page 90 - OVID THERAPEUTICS INC.
Page 91 - OVID THERAPEUTICS INC.
Page 92 - OVID THERAPEUTICS, INC.
Page 93 - License and Collaboration Agreement with Takeda Pharmaceutical Company Limited
Page 94 - N/A
Page 95 - Recent accounting standards which have been adopted
Page 96 - New accounting standards which have not yet been adopted
Page 97 - OTE 3 CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
Page 98 - NOTE 4 PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS
Page 99 - NOTE 7 STOCK-BASED COMPENSATION
Page 100 - N/A
Page 101 - NOTE 8 INCOME TAXES
Page 102 - NOTE 9 COMMITMENTS AND CONTINGENCIES
Page 103 - Contingencies
Page 104 - NOTE 10 COLLABORATION AGREEMENT
Page 105 - NOTE 11 SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
Subdocument 2 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - N/A
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