Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | OVID | ||
Entity Registrant Name | Ovid Therapeutics Inc. | ||
Entity Central Index Key | 1,636,651 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 38,647,892 | ||
Entity Public Float | $ 90.4 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 36,489,618 | $ 87,125,600 |
Short-term investments | 5,011,034 | |
Prepaid and other current assets | 2,767,495 | 1,462,448 |
Total current assets | 44,268,147 | 88,588,048 |
Long-term prepaid expenses | 2,797,561 | 604,646 |
Security deposit | 122,155 | 88,940 |
Property and equipment, net | 69,867 | 51,775 |
Other assets | 391,872 | 124,194 |
Total assets | 47,649,602 | 89,457,603 |
Current liabilities: | ||
Accounts payable | 3,755,595 | 2,025,766 |
Accrued expenses | 5,088,862 | 3,995,334 |
Total current liabilities | 8,844,457 | 6,021,100 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued and outstanding at December 31, 2018 and 2017 | ||
Common stock, $0.001 par value; 125,000,000 shares authorized at December 31, 2018 and 2017, 24,654,114 and 24,606,256 shares issued and outstanding at December 31, 2018 and 2017, respectively | 24,654 | 24,606 |
Additional paid-in-capital | 191,477,598 | 184,127,565 |
Accumulated other comprehensive loss | (1,829) | |
Accumulated deficit | (152,695,278) | (100,715,668) |
Total stockholders' equity | 38,805,145 | 83,436,503 |
Total liabilities and stockholders' equity | $ 47,649,602 | $ 89,457,603 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 24,654,114 | 24,606,256 |
Common stock, shares outstanding | 24,654,114 | 24,606,256 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating expenses: | ||
Research and development | $ 33,790,031 | $ 49,972,102 |
General and administrative | 19,141,652 | 15,035,461 |
Total operating expenses | 52,931,683 | 65,007,563 |
Loss from operations | (52,931,683) | (65,007,563) |
Interest income | 952,073 | 201,509 |
Net loss | (51,979,610) | (64,806,054) |
Net loss attributable to common stockholders | $ (51,979,610) | $ (64,806,054) |
Net loss per share attributable to common stockholders, basic and diluted | $ (2.11) | $ (3.35) |
Weighted-average common shares outstanding basic and diluted | 24,631,011 | 19,344,355 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (51,979,610) | $ (64,806,054) |
Other comprehensive loss: | ||
Unrealized loss on available-for-sale securities | (1,829) | |
Comprehensive loss | $ (51,981,439) | $ (64,806,054) |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Series A Preferred Stock [Member] | Series B Preferred Stock [Member] | Series B-1 Preferred Stock [Member] |
Balance at Dec. 31, 2016 | $ 49,294,475 | $ 9,839 | $ 85,186,269 | $ (35,909,614) | $ 2,382 | $ 5,599 | ||
Balance, Shares at Dec. 31, 2016 | 9,838,590 | 2,382,069 | 5,599,282 | |||||
Issuance of Preferred Stock | 25,861,228 | 25,859,446 | $ 1,782 | |||||
Issuance of Preferred Stock, Shares | 1,781,996 | |||||||
Proceeds from Initial Public Offering, net of underwriting costs and commissions | 69,750,000 | $ 5,000 | 69,745,000 | |||||
Proceeds from Initial Public Offering, net of underwriting costs and commissions, Shares | 5,000,000 | |||||||
Deferred offering costs reclassified to additional paid-in capital | (3,087,481) | (3,087,481) | ||||||
Conversion of preferred stock into common stock | (464) | $ 9,763 | (464) | $ (2,382) | $ (5,599) | $ (1,782) | ||
Conversion of preferred stock into common stock, Shares | 9,763,346 | (2,382,069) | (5,599,282) | (1,781,996) | ||||
Issuance of common stock from exercise of stock options | $ 27,043 | $ 4 | 27,039 | |||||
Issuance of common stock from exercise of stock options , Shares | 4,320 | 4,320 | ||||||
Stock-based compensation expense | $ 6,397,756 | 6,397,756 | ||||||
Net loss | (64,806,054) | (64,806,054) | ||||||
Balance at Dec. 31, 2017 | 83,436,503 | $ 24,606 | 184,127,565 | (100,715,668) | ||||
Balance, Shares at Dec. 31, 2017 | 24,606,256 | |||||||
Issuance of common stock from exercise of stock options | $ 111,378 | $ 16 | 111,362 | |||||
Issuance of common stock from exercise of stock options , Shares | 15,744 | 15,744 | ||||||
Issuance of common stock from employee stock purchase plan | $ 174,762 | $ 32 | 174,730 | |||||
Issuance of common stock from employee stock purchase plan, Shares | 32,114 | |||||||
Stock-based compensation expense | 7,063,941 | 7,063,941 | ||||||
Other comprehensive loss | (1,829) | $ (1,829) | ||||||
Net loss | (51,979,610) | (51,979,610) | ||||||
Balance at Dec. 31, 2018 | $ 38,805,145 | $ 24,654 | $ 191,477,598 | $ (1,829) | $ (152,695,278) | |||
Balance, Shares at Dec. 31, 2018 | 24,654,114 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (51,979,610) | $ (64,806,054) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Non-cash research and development expense | 25,861,228 | |
Stock-based compensation expense | 7,063,941 | 6,397,756 |
Depreciation and amortization | 141,733 | 80,310 |
Loss on disposal of intangible assets | 4,610 | |
Change in accrued interest and accretion of discount on short-term investments | (1,240) | |
Change in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,305,047) | (793,258) |
Deferred transaction costs | 229,000 | |
Security deposit | (33,215) | (36,590) |
Long-term prepaid expenses | (2,192,915) | (604,646) |
Accounts payable | 1,649,735 | 1,076,349 |
Accrued expenses | 1,093,528 | 1,118,627 |
Due from/ to related parties | 7,369 | |
Net cash used in operating activities | (45,558,480) | (31,469,909) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (50,011,623) | |
Proceeds from maturities of short-term investments | 45,000,000 | |
Purchase of property and equipment | (33,871) | (38,907) |
Software development and other assets | (318,148) | (8,480) |
Net cash used in investing activities | (5,363,642) | (47,387) |
Cash flows from financing activities: | ||
Proceeds from initial public offering, net of offering expenses | 69,750,000 | |
Payments for transaction costs | (3,073,808) | |
Proceeds from employee stock purchase plan | 174,762 | |
Proceeds from exercise of options | 111,378 | 27,043 |
Net cash provided by financing activities | 286,140 | 66,703,235 |
Net increase (decrease) in cash and cash equivalents | (50,635,982) | 35,185,939 |
Cash and cash equivalents, at beginning of period | 87,125,600 | 51,939,661 |
Cash and cash equivalents, at end of period | $ 36,489,618 | $ 87,125,600 |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Operations | Ovid Therapeutics Inc. (the “Company”) was incorporated under the laws of the state of Delaware on April 1, 2014 and maintains its principal executive office in New York, New York. The Company commenced operations on April 1, 2014 (date of inception). The Company is a biopharmaceutical company focused exclusively on developing impactful medicines for patients and families living with rare neurological disorders. Since its inception, the Company has devoted substantially all of its efforts to business development, research and development, recruiting management and technical staff, and raising capital, and has financed its operations through issuance of convertible preferred stock (“Preferred Stock”), common stock and other equity instruments. The Company has not generated any revenue. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund operations. On February 22, 2019, the Company completed an offering and sold 12,500,000 shares of its common stock and 2,500 shares of Series A Convertible Preferred Stock at an offering price of $2.00 and $2,000, respectively, for gross proceeds of $30.0 million and $28.2 million of estimated net proceeds, after deducting underwriting discounts and commission and other and other On May 10, 2017, the Company completed its initial public offering (“IPO”) of 5,000,000 shares of the Company's common stock at a public offering price of $15.00 per share. The gross proceeds from the IPO were $75.0 million and the net proceeds were $66.7 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. At the time of the IPO the Series A Preferred Stock, the Series B Preferred Stock, and the Series B-1 Preferred Stock were automatically converted into common stock (see Note 6). The Company has not generated any revenue since inception. As a result, the Company has suffered recurring losses and requires significant cash resources to continue to execute its business plans. The Company has an accumulated deficit of $152.7 million as of December 31, 2018 and cash outflows from operating activities of $45.6 million for the year ended December 31, 2018. Historically, the Company’s major sources of cash have comprised of proceeds from various public and private offerings of our capital stock and interest income. As of December 31, 2018, the Company had approximately $41.5 million in cash, cash equivalents and short-term investments and in February 2019, the Company completed the February Offering, described in Note 12, generating an estimated $31.0 million in net proceeds. The actual amount of cash that the Company will need to operate is subject to many factors. Management’s plans to mitigate any expected shortfall of capital, to support future operations, include raising additional funds. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company or whether the Company will become profitable and generate positive operating cash flow. The Company has incurred operating losses since inception and had an accumulated deficit of $152.7 million as of December 31, 2018. The Company expects to continue to incur net losses for at least the next several years and is highly dependent on its ability to find additional sources of funding in the form of debt or equity financing to fund its operations. Management believes that the Company’s existing cash, cash equivalents and short-term investments |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (A) Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of Ovid Therapeutics Inc. and its wholly-owned subsidiary, Ovid Therapeutics Hong Kong Limited. All intercompany transactions and balances have been eliminated in consolidation. (B) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. (C) Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its drug candidates, ability to obtain regulatory approval of its drug candidates, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition and untested manufacturing capabilities (D) Deferred Transaction Costs Deferred transaction costs, primarily consisted of direct incremental legal, accounting, and other fees related to the Company’s offering of its capital stock are capitalized as incurred. The deferred transaction costs are offset against proceeds upon the consummation of an offering. (E) Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the year ended December 31, 2018 the Company had other comprehensive loss comprised of the loss on debt securities. (F) Collaboration Arrangement License and Collaboration Agreement with Takeda Pharmaceutical Company Limited The Company accounts for the license and collaboration agreement with Takeda Pharmaceutical Company Limited (“Takeda”) in accordance with Accounting Standard Codification (“ASC”) 808 – “Collaborative Arrangements.” As Ovid and Takeda are sharing 50/50 in the drug development and throughout the life of this compound, the Company records 50% of the development costs in research and development. When Ovid incurs the majority of the costs and Takeda transfers a payment to Ovid to equalize the costs, Ovid records the participation by Takeda as a reduction of its research and development expenses, as the parties under the collaboration are sharing in the costs and the payment represents reimbursement of costs by Takeda. When Takeda incurs the majority of the costs and Ovid transfers a payment to Takeda (to equalize the costs), Ovid records the participation in Takeda’s expenses as research and development costs in its statement of operations, as Ovid and Takeda are sharing in the research and development activities and this participation represents Ovid’s share of the research and development costs in the specific period. (G) Cash and Cash Equivalents The Company’s cash and cash equivalents consist of cash held in checking accounts and money market funds. The Company considers all highly liquid investments with an original maturity date of three months or less to be cash and cash equivalents. Accounts held at U.S. financial institutions are insured by the FDIC up to $250,000. Cash balances could exceed insured amounts at any given time. (H) Short-term Investments Short-term investments consist of debt securities with maturities greater than from the date of purchase. The Company all of its investments as available-for-sale securities. Debt securities are recorded at fair value with unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Realized gains and losses, amortization and accretion of premiums and discounts are included within net loss. (I) Property and Equipment Property and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. Repairs and maintenance costs are expensed. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. (J) Research and Development Expenses The Company expenses the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when the cost is incurred, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development. (K) Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, which establishes accounting for stock-based awards granted to employees for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company estimates the fair value of all awards granted using the Black-Scholes valuation model. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield, stock price and exercise price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of stock-based compensation expense. The Company elected an accounting policy to record forfeitures as they occur. The Company recognizes employee stock-based compensation expense based on the fair value of the award on the date of the grant. The compensation expense is recognized over the vesting period under the straight-line method. The Company accounts for options awards granted to nonemployee consultants and directors under ASC 505 Equity. The fair value of the option issued or committed to be issued is used to measure the transaction, as this is more reliable than the fair value of the services received. The fair value is measured at the value of the Company’s common stock at the earlier of the date that the commitment for performance by the counterparty has been reached or the counterparty’s performance is complete. Awards granted to nonemployees are remeasured to fair value at each period end date until vested and expensed on a straight-line basis over the vesting period. (L) Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company’s Level 1 assets consisted of money market funds and short-term investments totaling $40.5 million and $86.6 million as of December 31, 2018 and 2017, respectively. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. The Company had no Level 2 assets or liabilities as of December 31, 2018 and 2017. • Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company had no Level 3 assets or liabilities as of December 31, 2018 and 2017. The carrying amounts reported in the balance sheets for cash and cash equivalents, other current assets, accounts payable, and accrued expenses approximate their fair value based on the short-term maturity of these instruments. (M) Income Taxes The Company accounts for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as for net operating loss carryforwards and research and development credit. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The impact of a change in the tax laws is recorded in the period in which the law is enacted. (N) Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, stock options have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: For the Year Ended December 31, 2018 2017 Stock options to purchase common stock 4,714,383 4,298,802 (O) Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. (P) Retirement Plan The Company maintains a 401(k)-retirement plan for its employees that is intended to qualify under Sections 401(a) and 501(a) of the U.S. Internal Revenue Code of 1986, as amended (“Code”), in 2016. The Company provides all active employees with a 100% matching contribution equal to 3% of an employee’s eligible compensation deferred and 50% matching contributions on employee contributions that are between 3% and 5% of an employee’s eligible compensation deferred. These safe harbor contributions vest immediately. For the years ended December 31, 2018 and 2017 the Company contributed $210,034 and $163,942, respectively. (Q) Recent Accounting Pronouncements Recent accounting standards which have been adopted In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting. This new standard clarifies when to account for a change to the terms or conditions of share-based payment award as a modification. Under the new guidance, modification accounting is required unless the fair value, the vesting conditions, and the classification of the award remain the same as the original award. ASU 2017-09 is effective for public companies for fiscal years beginning on or after December 15, 2017. The adoption of this standard did not have a material impact on the Company’s financial statements. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires, among others, that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. ASU 2017-01 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The new standard clarifies certain aspects of the statement of cash flows, including the classification of debt prepayment or debt extinguishment costs, settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees and beneficial interests in securitization transactions. The new standard also clarifies that an entity should determine each separately identifiable source or use within the cash receipts and cash payments on the basis of the nature of the underlying cash flows. In situations in which cash receipts and payments have aspects of more than one class of cash flows and cannot be separated by source or use, the appropriate classification should depend on the activity that is likely to be the predominant source or use of cash flows for the item. ASU 2016-15 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The adoption of this standard did not have a material impact on the Company’s statement of cash flows upon adoption. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This new standard was issued to increase transparency and comparability among entities by recognizing for all leases lease assets and lease liabilities on the balance sheet and disclosing key information about lease arrangements. effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company does not expect ASU 2016-02 to have a material impact on its financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. This new standard amends certain aspects of accounting and disclosure requirements for financial instruments, including the requirement that equity investments (other than equity method investees) with readily determinable fair values are to be measured at fair value with any changes in fair value recognized in a company's results of operations. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minus impairment adjusted for changes in observable prices. The standard also includes certain amendments for the accounting for a financial liability that is measured at fair value in accordance with the fair value option and prescribes that a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination with other deferred tax assets. The ASU makes targeted changes to the presentation requirements for financial instruments under current GAAP. All entities are required to disclose financial assets and financial liabilities separately, grouped by measurement category and form of financial asset. ASU No. 2016-01 is effective for the Company as of January 1, 2018. As the Company does not have equity investments, financial liabilities measured at fair value in accordance with the fair value option or deferred tax assets, the recognition and measurement guidance of this new standard is not applicable to the Company. However, since the Company does have financial asset investments, it has adopted the presentation and disclosure requirements of this standard. New accounting standards which have not yet been adopted On November 5, 2018, the FASB issued ASU 2018-18, which amends ASC 808 to clarify when transactions between participants in a collaborative arrangement under ASC 808 are within the scope of the FASB’s new revenue standard, ASU 2014-09 (codified in ASC 606). The amendments require the application of ASC 606 existing guidance to determine the units of account that are distinct in a collaborative arrangement for purposes of identifying transactions with customers. If a unit of account within the collaborative arrangement is distinct and is with a customer, an entity shall apply the guidance in Topic 606 to that unit of account. In a transaction between collaborative participants, an entity is precluded by ASU 2018-18 from presenting a transaction together with “revenue from contracts with customers” unless the unit of account is within the scope of ASC 606 and the entity applies the guidance in ASC 606 to such unit of account. The amended guidance is effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The Company has a collaboration agreement with Takeda. However, the Company does not expect these amendments to have an impact on its financial statements, as Takeda does not meet the definition of a customer and the Company does not currently apply any of ASC 606 guidance in analogy to the collaboration. On August 29, 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other - Internal-Use Software (Subtopic 350-40) - which amends ASC 350-40 to address a customer’s accounting for implementation costs incurred in a cloud computing arrangement (“CCA”) that is a service contract. ASU No. 2018-15 aligns the accounting for costs incurred to implement a CCA that is a service arrangement with the guidance on capitalizing costs associated with developing or obtaining internal-use software. Specifically, the ASU amends ASC 350 to include in its scope implementation costs of a CCA that is a service contract and clarifies that a customer should apply ASC 350-40 to determine which implementation costs should be capitalized in a CCA that is considered a service contract. According to the standard the balance sheet line item for the presentation of capitalized implementation costs should be the same as that for the prepayment of fees related to the hosting arrangement and the manner in which an entity classifies the cash flows related to capitalized implementation costs should be the same as that in which it classifies the cash flows for the fees related to the hosting arrangement. ASU 2018-15 is effective for the Company for fiscal years beginning after December 15, 2019, including interim periods therein. Entities are permitted to apply either a retrospective or prospective transition approach to adopt the guidance. When prospective transition is chosen, entities must apply the transition requirements to any eligible costs incurred after adoption. The Company is in the process of assessing the impact of this standard on its financial statements. On August 28, 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement. This standard changes the fair value measurement disclosure requirements of ASC 820. The new standard eliminated certain disclosures, added new disclosures with regard to unrealized gains or losses included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements, as well as modified certain disclosure. ASU 2018-13 is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted. The ASU requires application of the prospective method of transition for the aforementioned new disclosure requirements and for modified disclosure with regard to measurement uncertainty while all other amendments made by the ASU must be applied retrospectively to all periods presented. The Company is in the process of assessing the impact of this standard on its financial statements. On June 20, 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This new standard simplifies the accounting for share-based payments granted to nonemployees for goods and services. The standard supersedes ASC 505-50 and expands the scope of ASC 718 to include all share-based payment arrangements related to the acquisition of goods and services from both nonemployees and employees. As such, among others, the measurement date for nonemployee awards would generally be the grant date same as the measurement date for employee equity awards and for performance-based awards, an entity is required to recognize any cost on the basis of the probable outcome of the performance conditions using the grant-date fair value of the award. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Due to the immaterial volume of nonemployee equity-based awards as well as the immaterial fair value of such awards the Company does not expect ASU 2018-07 to have a material impact on its financial statements. On March 30, 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization and Purchased Callable Debt Securities. This new standard requires premiums on callable debt securities, that have explicit, non-contingent call features that are callable at fixed prices on preset dates, to be amortized to the earliest call date. The amortization period for callable debt securities purchased at a discount will not be impacted. Under current GAAP, premiums on callable debt securities are generally amortized over the contractual life of the security. The guidance is applicable to the Company beginning on January 1, 2019. The Company will be impacted if it will have on January 1, 2019 callable debt purchased with a premium. However, based on the Company’s current investment strategy where it purchases debt securities with maturity dates of less than a year, it does not expect to have significant premiums for callable debt. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This new standard requires the measurement and recognition of expected credit losses for financial assets held at amortized cost, including loans and trade and other receivables. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss methodology, which will result in more timely recognition of credit losses. The standard also amends the impairment model for available-for-sale debt securities and requires entities to determine whether all or a portion of the unrealized loss on an available-for-sale debt security is a credit loss. Under the new guidance, an entity will recognize an allowance for credit losses on available-for-sale debt securities as a contra-account to the amortized cost basis rather than as a direct reduction of the amortized cost basis of the investment, as is currently required. ASU 2016-13 is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2019. The Company does not expect this standard to have a material impact on its financial statements due to the immaterial level of its unrealized losses on available-for-sale securities and its immaterial level of loans and receivables |
Cash Equivalents and Short-Term
Cash Equivalents and Short-Term Investments | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Cash Equivalents and Short-Term Investments | N OTE 3 – CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS All short-term investments are classified as available-for-sale. The following tables summarize the fair value of cash, cash equivalents, and short-term investments, as well as gross unrealized holding gains and losses as of December 31, 2018 and December 31, 2017: December 31, 2018 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 927,354 $ - $ - $ 927,354 Money market funds (a) 35,562,264 - - 35,562,264 Total cash and cash equivalents $ 36,489,618 $ - $ - $ 36,489,618 U.S. treasury notes (a) $ 5,012,863 $ - $ (1,829 ) $ 5,011,034 Total short-term investments $ 5,012,863 $ - $ (1,829 ) $ 5,011,034 (a) As of December 31, 2018, the Company's Level 1 assets consisted of money market funds and U.S. treasury notes totaling $40.5 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. December 31, 2017 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 526,648 $ - $ - $ 526,648 Money market funds (a) 86,598,952 - - 86,598,952 Total cash and cash equivalents $ 87,125,600 $ - $ - $ 87,125,600 (a) As of December 31, 2017, the Company's Level 1 assets consisted of money market funds totaling $86.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2017. As of December 31, 2018 and December 31, 2017, the aggregate fair value of securities that were in an unrealized loss position for less than 12 months was $5.0 million and zero, respectively. The Company did not hold any securities in an unrealized loss position for more than 12 months as of December 31, 2018. There were no realized gains or losses on available-for-sale securities during the years ended December 31, 2018 and 2017. |
Property and Equipment and Inta
Property and Equipment and Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment and Intangible Assets | NOTE 4 – PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS Property and equipment is summarized as follows: December 31, December 31, 2018 2017 Furniture and equipment $ 156,031 $ 102,690 Less accumulated depreciation (86,164 ) (50,915 ) Total property, plant and equipment, net $ 69,867 $ 51,775 Depreciation expense was $35,249 and $26,917 for the years ended December 31, 2018 and 2017 respectively. Intangible assets, net of accumulated amortization, were $391,872 and $124,194 as of December 31, 2018 and December 31, 2017, respectively, and are included in other assets. Amortization expense was $106,484 and $53,393 for the years ended December 31, 2018 and 2017, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | NOTE 5 – ACCRUED EXPENSES Accrued expenses consist of the following: December 31, December 31, 2018 2017 Clinical trials accrual $ 1,352,133 $ 753,018 Collaboration agreement accrual - 754,841 Payroll and bonus accrual 2,779,021 1,919,120 Professional fees accrual 772,785 321,852 Other 184,923 246,503 Total $ 5,088,862 $ 3,995,334 |
Stockholders' Equity and Prefer
Stockholders' Equity and Preferred Stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity and Preferred Stock | NOTE 6 – STOCKHOLDERS’ EQUITY AND PREFERRED STOCK The Company’s capital structure consists of common stock and Preferred Stock. The holders of common stock are entitled to one vote for each share held. The holders of common stock have no preemptive or other subscription rights, and there are no redemption or sinking fund provisions with respect to such shares. The common stock is subordinate to all series of Preferred Stock with respect to dividend rights and rights upon liquidation, winding up and dissolution of the Company. The holders of common stock are entitled to liquidation proceeds after all liquidation preferences for the Preferred Stock are satisfied. On May 10, 2017, the Company filed an amended and restated certificate of incorporation with the Secretary of the State of Delaware, which was approved by the Company’s Board of Directors and stockholders on April 12, 2017 and April 24, 2017, respectively, and which went effective immediately after the closing of the Company’s IPO on May 10, 2017. Pursuant to the amended and restated certificate of incorporation, the Company is authorized to issue 125,000,000 shares 2,382,069 As of December 31, 2018, no shares of preferred stock were issued or outstanding. Dividends No dividends on the common stock shall be declared and paid unless dividends on the Preferred Stock have been declared and paid. Through December 31, 2018, the Company has not declared any dividends. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | NOTE 7 – STOCK-BASED COMPENSATION On August 29, 2014, the Company’s Board of Directors adopted and approved the 2014 Equity Incentive Plan (the “2014 Plan”), which authorized the Company to grant shares of common stock in the form of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock and restricted stock units. The types of stock-based awards, including share purchase rights amount, terms, and exercisability provisions of grants are determined by the Company’s Board of Directors. The purpose of the 2014 Plan is to provide the Company with the flexibility to issue stock-based awards as part of an overall compensation package to attract and retain qualified personnel. The Company's Board of Directors adopted and the Company's stockholders approved the 2017 equity incentive plan (“2017 Plan”), which became effective immediately prior to the execution of the underwriting agreement related to the IPO on May 4, 2017. The initial reserve of shares of common stock that may be issued under the 2017 Plan was 3,052,059 shares. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance-based stock awards, and other forms of stock-based awards. Additionally, the 2017 Plan provides for the grant of performance cash awards. The Company's employees, officers, directors and consultants and advisors are eligible to receive awards under the 2017 Plan. Upon the adoption of the 2017 Plan, no further awards will be granted under the 2014 Plan. Pursuant to the terms of the 2017 Plan, on each January 1st, the plan limit shall be increased by the lesser of (x) 5% of the number of shares of common stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. Accordingly, on January 1, 2018, an additional 1,230,312 shares were reserved for issuance under the 2017 Plan. As of December 31, 2018, there were 3,657,972 shares of the Company’s common stock reserved for issuance under the 2017 Plan. The Company's Board of Directors adopted and the Company's stockholders approved the 2017 employee stock purchase plan (the “2017 ESPP”), which became effective immediately prior to the execution of the underwriting agreement related to the IPO on May 4, 2017. The initial reserve of shares of common stock that may be issued under the 2017 ESPP was 279,069 shares. On September 20, 2017, the Company’s Compensation Committee approved an offering period under the 2017 ESPP, which began on October 20, 2017. The ESPP allows employees to purchase common stock of the Company at a 15% discount to the market price on designated purchase dates. During the years ended December 31, 2018 and 2017, 32,114 and zero shares were purchased under the ESPP and the Company recorded expense of $106,004 and $12,095, respectively. The number of shares of common stock reserved for issuance under the 2017 ESPP will automatically increase on January 1 of each year, beginning on January 1, 2018 and continuing through and including January 1, 2027, by the lesser of (i) 1% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, (ii) 550,000 shares or (iii) such lesser number of shares determined by our Board. On January 1, 2018, an additional 246,062 shares were reserved for issuance under the 2017 ESPP. As of December 31, 2018, there were 493,017 shares of the Company’s common stock reserved for issuance under the 2017 ESPP. Unless specified otherwise in an individual option agreement, stock options granted under the 2014 Plan and 2017 Plan generally have a ten-year term and a four-year graded vesting period. The vesting requirement is conditioned upon the grantee’s continued service with the Company during the vesting period. Once vested, all awards are exercisable from the date of grant until they expire. The option grants are non-transferable. Vested options generally remain exercisable for 90 days subsequent to the termination of the option holder’s service with the Company. In the event of option holder’s death or disability while employed by or providing service to the Company, the exercisable period extends to twelve months. Performance-based option awards generally have similar vesting terms, with vesting commencing on the date the performance condition is achieved and expire in accordance to the specific terms of the agreement. At December 31, 2018, there were no performance-based options outstanding and unvested. The Company recognizes stock-based compensation expense based on the grant date fair value of the award over the vesting period when the performance condition becomes probable of being achieved. The fair value of options granted during the years ended December 31, 2018 and 2017 was estimated using the Black-Scholes option valuation model. The inputs for the Black-Scholes option valuation model require management’s significant assumptions and are detailed in the table below. Prior to the IPO, the common stock price was determined by the Board of Directors. In the absence of market data for the Company’s common stock, the Board of Directors considered various factors in estimating the fair value of the common stock at the time of each option grant which included but was not limited to the common stock valuation performed by a third party independent valuation firm, the Company’s performance and future economic outlook, the potential financing available to the Company, and the valuation of common stock of similar companies in the industry. The risk-free interest rates were based on the rate for U.S. Treasury securities at the date of grant with maturity dates approximately equal to the expected life at the grant date. The expected life was based on the simplified method in accordance with the Staff Accounting Bulletin No. 107 All assumptions used to calculate the grant date fair value of nonemployee options are generally consistent with the assumptions used for options granted to employees. In the event the Company terminates any of its consulting agreements, the unvested options underlying the agreements would also be cancelled. Unvested nonemployee options are marked-to-market at each reporting period until vested. The Company granted zero and 27,906 stock options to nonemployee consultants for services rendered during the years ended December 31, 2018, and 2017, respectively. There were 10,175 and 37,066 unvested nonemployee options outstanding as of December 31, 2018 and 2017, respectively. Total expense recognized related to the nonemployee stock options for the years ended December 31, 2018 and 2017 was $136,639 and $416,457 respectively. Total unrecognized compensation expenses related to the nonemployee stock options was $5,933 as of December 31, 2018. During the years ended December 31, 2018 and 2017, the Company recognized zero and $162,700 in expenses for non-employee performance-based option awards. The Company granted 1,440,578 and 1,510,436 stock options to employees during the years ended December 31, 2018 and 2017, respectively. There were 2,366,277 and 2,528,063 unvested employee options outstanding as of December 31, 2018 and 2017, respectively. Total expense recognized related to the employee stock options for the years ended December 31, 2018 and 2017 was $6,821,298 and $5,969,204, respectively. Total unrecognized compensation expense related to employee stock options was $11,802,475 as of December 31, 2018. During the years ended December 31, 2018 and 2017, the Company recognized zero and $830,997 in expenses for employee performance-based option awards. The Company’s stock-based compensation expense was recognized in operating expense as follows: For the Year Ended December 31, 2018 2017 Research and development $ 3,134,395 $ 2,417,727 General and administrative 3,929,546 3,980,029 Total $ 7,063,941 $ 6,397,756 The fair value of employee options granted during the years ended December 31, 2018 and 2017, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 84.40 % 80.39 % Expected term in years 6.01 6.08 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.62 % 2.06 % Fair value of option on grant date $ 5.93 $ 6.30 The fair value of nonemployee options granted and remeasured during the years ended December 31, 2018 and 2017, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 79.40 % 81.44 % Expected term in years 3.23 4.39 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.46 % 2.08 % Fair value of option on grant date $ 0.62 $ 6.80 The following table summarizes the number of options outstanding and the weighted average exercise price: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price Life in Years Value Options Outstanding at December 31, 2016 2,987,729 $ 7.46 8.82 $ 837,036 Vested and exercisable at December 31, 2016 683,070 $ 7.71 8.47 $ 253,969 Granted 1,538,342 9.03 9.19 Exercised (4,320 ) 6.26 Forfeited (222,949 ) 6.61 Options Outstanding December 31, 2017 4,298,802 $ 8.07 8.32 $ 8,174,686 Vested and exercisable at December 31, 2017 1,733,673 $ 7.65 7.92 $ 3,865,036 Granted 1,440,578 8.23 9.26 Exercised (15,744 ) 7.07 Forfeited (1,009,253 ) 8.16 Options Outstanding December 31, 2018 4,714,383 $ 8.10 7.89 $ 153,485 Vested and exercisable at December 31, 2018 2,337,931 $ 7.88 7.20 $ 153,485 At December 31, 2018 there was approximately $11,808,408 of unamortized share–based compensation expense, which is expected to be recognized over a remaining average vesting period of 2.17 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 8 – INCOME TAXES At December 31, 2018, the Company has available approximately $ 106,501,000 54,033,000 The Company may be subject to the NOL utilization provisions of Section 382 of the Code. The effect of an ownership change would be the imposition of an annual limitation on the use of NOL carryforwards attributable to periods before the change. The amount of the annual limitation depends upon the value of the Company immediately before the change, changes to the Company’s capital during a specified period prior to the change, and the federal published interest rate. The Company has not completed a Section 382 analysis to determine if a change in ownership has occurred. Until an analysis is completed, there can be no assurance that the existing net operating loss carry-forwards or credits are not subject to significant limitation. The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies related to the tax benefit. For the years ended December 31, 2018 and 2017, the Company had no unrecognized tax benefits or related interest and penalties accrued. The Company has not yet conducted a study of research and development credit carryforwards. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed, and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheet or statement of operations if an adjustment were required. The Company would recognize both accrued interest and penalties related to unrecognized benefits in income tax expense. The Company’s uncertain tax positions are related to years that remain subject to examination by relevant tax authorities. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2018 2017 Deferred tax assets/liabilities: Net operating loss carryovers $ 37,195,164 $ 20,880,120 Research and development tax credits 1,737,870 714,087 Share-based compensation 5,333,006 3,392,111 Accrued compensation 869,446 633,745 Depreciation (19,949 ) (10,778 ) Charitable contributions 88,353 53,038 Intangible assets 8,828,914 9,622,535 Total gross deferred tax assets/liabilities 54,032,804 35,284,858 Valuation allowance (54,032,804 ) (35,284,858 ) Net deferred tax assets (liabilities) $ - $ - A reconciliation of the statutory U.S. Federal rate to the company’s effective tax rate is as follows: December 31, 2018 2017 Federal income tax benefit at statutory rate (21.00 ) (34.00 ) State income tax, net of federal benefit (13.62 ) (11.77 ) Permanent items 0.61 0.89 Change in valuation allowance 36.02 29.18 Research and development tax credits (1.97 ) (0.56 ) Deferred re-measurement - 16.31 Other (0.04 ) (0.05 ) Effective income tax (benefit) expense rate 0 % 0 % |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 9 – License Agreements On March 26, 2015, the Company entered into an exclusive agreement with H. Lundbeck A/S (“Lundbeck”) for a worldwide perpetual licensing right related the research, development and commercialization of OV101. Pursuant to the Lundbeck license agreement, the Company agreed to make milestone payments totaling up to $181 million upon the achievement of certain development, regulatory and sales milestones. The first payment of $10 million is due upon the successful completion of the first Phase 3 trial for a product in which OV101 is an active ingredient. In addition, the agreement calls for the Company to pay royalties for an initial term based on a low double-digit percentage of sales and provides for the reduction of royalties in certain limited circumstances. As of December 31, 2018, none of these contingent payments were considered probable. In December 2016, the Company entered into a license agreement with Northwestern University, or Northwestern, pursuant to which Northwestern granted us an exclusive, worldwide license to patent rights in certain inventions, or the Northwestern Patent Rights, which relate to a specific compound and related methods of use for such compound, along with certain Know-How related to the practice of the inventions claimed in the Northwestern Patents. Under the Northwestern agreement, the Company was granted exclusive rights to research, develop, manufacture and commercialize products utilizing the Northwestern Patent Rights for all uses. The Company has agreed that it will not use the Northwestern Patent Rights to develop any products for the treatment of cancer, but Northwestern may not grant rights in the technology to others for use in cancer. The Company also has an option, exercisable during the term of the agreement to an exclusive license under certain intellectual property rights covering novel compounds with the same or similar mechanism of action as the primary compound that is the subject of the license agreement. Northwestern has retained the right, on behalf of itself and other non-profit institutions, to use the Northwestern Patent Rights and practice the inventions claimed therein for educational and research purposes and to publish information about the inventions covered by the Northwestern Patent Rights. Upon entry into the Northwestern agreement, the Company paid an upfront non-creditable one-time license issuance fee of $75,000, and is required to pay an annual license maintenance fee of $20,000, which will be creditable against any royalties payable to Northwestern following first commercial sale of licensed products under the agreement. The Company is responsible for all ongoing costs of filing, prosecuting and maintaining the Northwestern Patents, but also has the right to control such activities using its own patent counsel. In consideration for the rights granted to the Company under the Northwestern agreement, the Company is required to pay to Northwestern up to an aggregate of $5.3 million upon the achievement of certain development and regulatory milestones for the first product covered by the Northwestern Patents, and, upon commercialization of any such products, will be required to pay to Northwestern a tiered royalty on net sales of such products by the Company, its affiliates or sublicensees, at percentages in the low to mid single-digits, subject to standard reductions and offsets. The Company’s royalty obligations continue on a product-by-product and country-by-country basis until the later of the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country and 10 years following the first commercial sale of such product in such country. If the Company sublicenses a Northwestern Patent Right, it will be obligated to pay to Northwestern a specified percentage of sublicense revenue received by the Company, ranging from the high single digits to the low-teens. The Northwestern agreement requires that the Company use commercially reasonable efforts to develop and commercialize at least one product that is covered by the Northwestern Patent Rights. Unless earlier terminated, the Northwestern agreement will remain in force until the expiration of the Company’s payment obligations thereunder. The Company has the right to terminate the agreement for any reason upon prior written notice or for an uncured material breach by Northwestern. Northwestern may terminate the agreement for the Company’s uncured material breach or insolvency. As of December 31, 2018, none of these contingent payments were considered probable. Contingencies Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred. The Company is not currently involved in any legal matters arising in the normal course of business. Under the terms of their respective employment agreements, each of our named executive officers is eligible to receive severance payments and benefits upon a termination without “cause” or due to “permanent disability,” or upon “resignation for good reason,” contingent upon the named executive officer’s delivery to the Company of a satisfactory release of claims, and subject to the named executive officer’s compliance with non-competition and non-solicitation restrictive covenants for two years following the termination date. On December 15, 2016, the Company and Northwestern University (“Northwestern”) entered into a license agreement (the “License Agreement”), pursuant to which Northwestern granted the Company an exclusive license to certain patent rights and know-how, including a patent application covering a specified composition of matter (the “Patent Application”). Northwestern previously entered into a license agreement with Catalyst Pharmaceuticals, Inc. (“Catalyst”), dated August 27, 2009, pursuant to which Northwestern granted Catalyst rights under certain intellectual property rights covering a different composition of matter (the “Catalyst License”). In addition, the Company is a party to a confidential disclosure agreement with Catalyst, dated September 16, 2016 (the “CDA”). On June 25, 2018, Catalyst sent a letter to Northwestern and the Company alleging, among other things, that Northwestern breached the Catalyst License by licensing the Patent Application to the Company. Catalyst’s letter also asserted that the Company had breached our obligations under the CDA by allegedly failing to disclose that the Company had a license to the Patent Application, and that a further breach would occur if the Company makes any use of information obtained under the CDA in connection with its development program arising from the rights granted under the License Agreement. Catalyst has asserted that the combined conduct of Northwestern and the Company gives rise to various claims, including breach of contract, fraud, and tortious interference. The Company believes that Catalyst’s claims are without merit and responded by letter dated June 28, 2018, which denies any and all liability to Catalyst, and further denies that Catalyst has been damaged in any way. In July 2017, a notice of opposition and petition for cancellation was filed at the Trademark Trial and Appeal Board of the USPTO by Ovid Technologies, Inc. (“OTI”) relating to certain current and pending trademarks. OTI also instituted proceedings with the Canadian Trademark Office and European Union Intellectual Property Office opposing applications in both jurisdictions. On October 9, 2018, the Company entered into a settlement agreement with OTI in resolution of this matter. The Company will amend certain of our trademark registrations and applications and, upon acceptance of such amendments, OTI will withdraw all opposition and cancellation actions (with prejudice where possible). The parties have agreed to work in good faith to agree on alternative language if the proposed amendments are not accepted. |
Collaboration Agreement
Collaboration Agreement | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Agreement | NOTE 10 – COLLABORATION AGREEMENT Takeda Collaboration On January 6, 2017, the Company entered into a license and collaboration agreement with Takeda, pursuant to which Takeda granted the Company an exclusive license to commercialize the compound TAK-935, which the Company now refers to as OV935, in certain territories, and a co-exclusive worldwide license, together with Takeda, to develop OV935. In consideration of certain license rights granted to the Company pursuant to the Takeda collaboration, the Company issued 1,781,996 shares of its Series B-1 Preferred Stock (Note 6), pursuant to a Series B-1 preferred stock purchase agreement entered into on January 6, 2017, at an ascribed price per share of $14.513 on January 6, 2017 for an aggregate fair value of $25,861,228, which was recorded as research and development expense at the date of the transaction. The 1,781,996 shares of Series B-1 Preferred Stock held by Takeda automatically converted into 1,781,996 shares of the Company’s common stock upon the completion of its IPO. Under the Takeda collaboration, the Company is obligated to pay Takeda future payments if and when certain milestones are achieved. Upon the first patient enrollment in the first Phase 3 trial for the first of the initial indications the Company and Takeda are focusing on in the Takeda collaboration, the Company is obligated to issue to Takeda the number of unregistered shares of the Company’s common stock equal to the lesser of (a) 8% of the Company outstanding capital stock on the issuance date or (b) $50.0 million divided by the applicable share price, unless certain events occur. In the event such payment would cause Takeda to own over 19.99% of our outstanding capital stock or other events occur, such payment must be paid in cash As of December 31, 2018, none of these contingent payments were considered probable. representing costs reimbursed to the Company from Takeda The Takeda collaboration will expire upon the cessation of commercialization of the products by both the Company and Takeda. Either party may terminate the Takeda collaboration because of the other party’s uncured material breach or insolvency, for safety reasons, or, after completion of the first proof of mechanism clinical trial, for convenience. Takeda may terminate the Takeda collaboration for the Company’s (or the Company’s sublicensee’s) challenge to the patents licensed under the Takeda collaboration. If the collaboration is terminated by Takeda for material breach by the Company, bankruptcy or patent challenge or by the Company for convenience or safety reasons, the Company’s rights to the products will cease, the Company will transition all activities related to the products to Takeda, and the Company will grant Takeda an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by the Company to commercialize OV935 and products containing OV935 for the treatment of certain rare neurological disorders. If the collaboration is terminated by the Company for Takeda’s material breach or bankruptcy or by Takeda for convenience or safety reasons, Takeda’s rights to the products will cease, Takeda will transition all activities related to the products to us, and Takeda will grant us an exclusive, royalty-bearing license under certain patents and other intellectual property controlled by Takeda to commercialize OV935 and products containing OV935 for the treatment of certain rare neurological disorders. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | NOTE 11 – SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) The following tables contain selected quarterly financial information from 2018 and 2017. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total operating expenses $ 13,430 $ 13,210 $ 13,176 $ 13,116 Total other income (expense), net 247 275 214 216 Net loss $ (13,183 ) $ (12,935 ) $ (12,962 ) $ (12,900 ) Net loss applicable to common stockholders $ (13,183 ) $ (12,935 ) $ (12,962 ) $ (12,900 ) Net loss per share applicable to common stockholders - basic and diluted $ (0.54 ) $ (0.53 ) $ (0.53 ) $ (0.52 ) Three Months Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2017 2017 2017 2017 Total operating expenses $ 34,262 $ 10,288 $ 9,409 $ 11,048 Total other income (expense), net 23 40 51 88 Net loss $ (34,239 ) $ (10,248 ) $ (9,358 ) $ (10,960 ) Net loss applicable to common stockholders $ (34,239 ) $ (10,248 ) $ (9,358 ) $ (10,960 ) Net loss per share applicable to common stockholders - basic and diluted $ (3.48 ) $ (0.57 ) $ (0.38 ) $ (0.45 ) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 12 – SUBSEQUENT EVENTS Equity Awards From January 1, 2019 t hrough the date of the filing of this Form 10-K, the Company has granted option awards for an aggregate of 864,963 shares to employees with a weighted average exercise price of $2.18. Public Stock Offering On February 22, 2019, the Company completed an offering, the February Offering, and sold 12,500,000 shares of its common stock and 2,500 shares of Series A Convertible Preferred Stock at an offering price of $2.00 and $2,000, respectively, for gross proceeds of $30.0 million and $28.2 million of estimated net proceeds after deducting underwriting discounts and commission and other and other |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | (A) Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of Ovid Therapeutics Inc. and its wholly-owned subsidiary, Ovid Therapeutics Hong Kong Limited. All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates | (B) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. |
Risks and Uncertainties | (C) Risks and Uncertainties The Company is subject to risks common to companies in the development stage including, but not limited to, dependency on the clinical and commercial success of its drug candidates, ability to obtain regulatory approval of its drug candidates, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and consumers, and significant competition and untested manufacturing capabilities |
Deferred Transaction Costs | (D) Deferred Transaction Costs Deferred transaction costs, primarily consisted of direct incremental legal, accounting, and other fees related to the Company’s offering of its capital stock are capitalized as incurred. The deferred transaction costs are offset against proceeds upon the consummation of an offering. |
Comprehensive Loss | (E) Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the year ended December 31, 2018 the Company had other comprehensive loss comprised of the loss on debt securities. |
Collaboration Arrangement | (F) Collaboration Arrangement License and Collaboration Agreement with Takeda Pharmaceutical Company Limited The Company accounts for the license and collaboration agreement with Takeda Pharmaceutical Company Limited (“Takeda”) in accordance with Accounting Standard Codification (“ASC”) 808 – “Collaborative Arrangements.” As Ovid and Takeda are sharing 50/50 in the drug development and throughout the life of this compound, the Company records 50% of the development costs in research and development. When Ovid incurs the majority of the costs and Takeda transfers a payment to Ovid to equalize the costs, Ovid records the participation by Takeda as a reduction of its research and development expenses, as the parties under the collaboration are sharing in the costs and the payment represents reimbursement of costs by Takeda. When Takeda incurs the majority of the costs and Ovid transfers a payment to Takeda (to equalize the costs), Ovid records the participation in Takeda’s expenses as research and development costs in its statement of operations, as Ovid and Takeda are sharing in the research and development activities and this participation represents Ovid’s share of the research and development costs in the specific period. |
Cash and Cash Equivalents | (G) Cash and Cash Equivalents The Company’s cash and cash equivalents consist of cash held in checking accounts and money market funds. The Company considers all highly liquid investments with an original maturity date of three months or less to be cash and cash equivalents. Accounts held at U.S. financial institutions are insured by the FDIC up to $250,000. Cash balances could exceed insured amounts at any given time. |
Short-term Investments | (H) Short-term Investments Short-term investments consist of debt securities with maturities greater than from the date of purchase. The Company all of its investments as available-for-sale securities. Debt securities are recorded at fair value with unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Realized gains and losses, amortization and accretion of premiums and discounts are included within net loss. |
Property and Equipment | (I) Property and Equipment Property and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. Repairs and maintenance costs are expensed. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. |
Research and Development Expenses | (J) Research and Development Expenses The Company expenses the cost of research and development as incurred. Research and development expenses comprise costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when the cost is incurred, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development. |
Stock-Based Compensation | (K) Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, which establishes accounting for stock-based awards granted to employees for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company estimates the fair value of all awards granted using the Black-Scholes valuation model. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield, stock price and exercise price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of stock-based compensation expense. The Company elected an accounting policy to record forfeitures as they occur. The Company recognizes employee stock-based compensation expense based on the fair value of the award on the date of the grant. The compensation expense is recognized over the vesting period under the straight-line method. The Company accounts for options awards granted to nonemployee consultants and directors under ASC 505 Equity. The fair value of the option issued or committed to be issued is used to measure the transaction, as this is more reliable than the fair value of the services received. The fair value is measured at the value of the Company’s common stock at the earlier of the date that the commitment for performance by the counterparty has been reached or the counterparty’s performance is complete. Awards granted to nonemployees are remeasured to fair value at each period end date until vested and expensed on a straight-line basis over the vesting period. |
Fair Value of Financial Instruments | (L) Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company’s Level 1 assets consisted of money market funds and short-term investments totaling $40.5 million and $86.6 million as of December 31, 2018 and 2017, respectively. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. The Company had no Level 2 assets or liabilities as of December 31, 2018 and 2017. • Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company had no Level 3 assets or liabilities as of December 31, 2018 and 2017. The carrying amounts reported in the balance sheets for cash and cash equivalents, other current assets, accounts payable, and accrued expenses approximate their fair value based on the short-term maturity of these instruments. |
Income Taxes | (M) Income Taxes The Company accounts for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as for net operating loss carryforwards and research and development credit. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The impact of a change in the tax laws is recorded in the period in which the law is enacted. |
Net Loss Per Common Share | (N) Net Loss Per Common Share Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. For all periods presented, stock options have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted-average shares outstanding used to calculate both basic and diluted loss per common share are the same. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: For the Year Ended December 31, 2018 2017 Stock options to purchase common stock 4,714,383 4,298,802 |
Segment Data | (O) Segment Data The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. |
Retirement Plan | (P) Retirement Plan The Company maintains a 401(k)-retirement plan for its employees that is intended to qualify under Sections 401(a) and 501(a) of the U.S. Internal Revenue Code of 1986, as amended (“Code”), in 2016. The Company provides all active employees with a 100% matching contribution equal to 3% of an employee’s eligible compensation deferred and 50% matching contributions on employee contributions that are between 3% and 5% of an employee’s eligible compensation deferred. These safe harbor contributions vest immediately. For the years ended December 31, 2018 and 2017 the Company contributed $210,034 and $163,942, respectively. |
Recent Accounting Pronouncements | (Q) Recent Accounting Pronouncements Recent accounting standards which have been adopted In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting. This new standard clarifies when to account for a change to the terms or conditions of share-based payment award as a modification. Under the new guidance, modification accounting is required unless the fair value, the vesting conditions, and the classification of the award remain the same as the original award. ASU 2017-09 is effective for public companies for fiscal years beginning on or after December 15, 2017. The adoption of this standard did not have a material impact on the Company’s financial statements. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires, among others, that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. ASU 2017-01 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s financial statements. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. The new standard clarifies certain aspects of the statement of cash flows, including the classification of debt prepayment or debt extinguishment costs, settlement of zero-coupon debt instruments or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees and beneficial interests in securitization transactions. The new standard also clarifies that an entity should determine each separately identifiable source or use within the cash receipts and cash payments on the basis of the nature of the underlying cash flows. In situations in which cash receipts and payments have aspects of more than one class of cash flows and cannot be separated by source or use, the appropriate classification should depend on the activity that is likely to be the predominant source or use of cash flows for the item. ASU 2016-15 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The adoption of this standard did not have a material impact on the Company’s statement of cash flows upon adoption. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This new standard was issued to increase transparency and comparability among entities by recognizing for all leases lease assets and lease liabilities on the balance sheet and disclosing key information about lease arrangements. effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company does not expect ASU 2016-02 to have a material impact on its financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. This new standard amends certain aspects of accounting and disclosure requirements for financial instruments, including the requirement that equity investments (other than equity method investees) with readily determinable fair values are to be measured at fair value with any changes in fair value recognized in a company's results of operations. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minus impairment adjusted for changes in observable prices. The standard also includes certain amendments for the accounting for a financial liability that is measured at fair value in accordance with the fair value option and prescribes that a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination with other deferred tax assets. The ASU makes targeted changes to the presentation requirements for financial instruments under current GAAP. All entities are required to disclose financial assets and financial liabilities separately, grouped by measurement category and form of financial asset. ASU No. 2016-01 is effective for the Company as of January 1, 2018. As the Company does not have equity investments, financial liabilities measured at fair value in accordance with the fair value option or deferred tax assets, the recognition and measurement guidance of this new standard is not applicable to the Company. However, since the Company does have financial asset investments, it has adopted the presentation and disclosure requirements of this standard. New accounting standards which have not yet been adopted On November 5, 2018, the FASB issued ASU 2018-18, which amends ASC 808 to clarify when transactions between participants in a collaborative arrangement under ASC 808 are within the scope of the FASB’s new revenue standard, ASU 2014-09 (codified in ASC 606). The amendments require the application of ASC 606 existing guidance to determine the units of account that are distinct in a collaborative arrangement for purposes of identifying transactions with customers. If a unit of account within the collaborative arrangement is distinct and is with a customer, an entity shall apply the guidance in Topic 606 to that unit of account. In a transaction between collaborative participants, an entity is precluded by ASU 2018-18 from presenting a transaction together with “revenue from contracts with customers” unless the unit of account is within the scope of ASC 606 and the entity applies the guidance in ASC 606 to such unit of account. The amended guidance is effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The Company has a collaboration agreement with Takeda. However, the Company does not expect these amendments to have an impact on its financial statements, as Takeda does not meet the definition of a customer and the Company does not currently apply any of ASC 606 guidance in analogy to the collaboration. On August 29, 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other - Internal-Use Software (Subtopic 350-40) - which amends ASC 350-40 to address a customer’s accounting for implementation costs incurred in a cloud computing arrangement (“CCA”) that is a service contract. ASU No. 2018-15 aligns the accounting for costs incurred to implement a CCA that is a service arrangement with the guidance on capitalizing costs associated with developing or obtaining internal-use software. Specifically, the ASU amends ASC 350 to include in its scope implementation costs of a CCA that is a service contract and clarifies that a customer should apply ASC 350-40 to determine which implementation costs should be capitalized in a CCA that is considered a service contract. According to the standard the balance sheet line item for the presentation of capitalized implementation costs should be the same as that for the prepayment of fees related to the hosting arrangement and the manner in which an entity classifies the cash flows related to capitalized implementation costs should be the same as that in which it classifies the cash flows for the fees related to the hosting arrangement. ASU 2018-15 is effective for the Company for fiscal years beginning after December 15, 2019, including interim periods therein. Entities are permitted to apply either a retrospective or prospective transition approach to adopt the guidance. When prospective transition is chosen, entities must apply the transition requirements to any eligible costs incurred after adoption. The Company is in the process of assessing the impact of this standard on its financial statements. On August 28, 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement. This standard changes the fair value measurement disclosure requirements of ASC 820. The new standard eliminated certain disclosures, added new disclosures with regard to unrealized gains or losses included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements, as well as modified certain disclosure. ASU 2018-13 is effective for all entities for fiscal years beginning after December 15, 2019, including interim periods therein. Early adoption is permitted. The ASU requires application of the prospective method of transition for the aforementioned new disclosure requirements and for modified disclosure with regard to measurement uncertainty while all other amendments made by the ASU must be applied retrospectively to all periods presented. The Company is in the process of assessing the impact of this standard on its financial statements. On June 20, 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. This new standard simplifies the accounting for share-based payments granted to nonemployees for goods and services. The standard supersedes ASC 505-50 and expands the scope of ASC 718 to include all share-based payment arrangements related to the acquisition of goods and services from both nonemployees and employees. As such, among others, the measurement date for nonemployee awards would generally be the grant date same as the measurement date for employee equity awards and for performance-based awards, an entity is required to recognize any cost on the basis of the probable outcome of the performance conditions using the grant-date fair value of the award. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Due to the immaterial volume of nonemployee equity-based awards as well as the immaterial fair value of such awards the Company does not expect ASU 2018-07 to have a material impact on its financial statements. On March 30, 2017, the FASB issued ASU 2017-08, Receivables – Nonrefundable Fees and Other Costs (Subtopic 310-20): Premium Amortization and Purchased Callable Debt Securities. This new standard requires premiums on callable debt securities, that have explicit, non-contingent call features that are callable at fixed prices on preset dates, to be amortized to the earliest call date. The amortization period for callable debt securities purchased at a discount will not be impacted. Under current GAAP, premiums on callable debt securities are generally amortized over the contractual life of the security. The guidance is applicable to the Company beginning on January 1, 2019. The Company will be impacted if it will have on January 1, 2019 callable debt purchased with a premium. However, based on the Company’s current investment strategy where it purchases debt securities with maturity dates of less than a year, it does not expect to have significant premiums for callable debt. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This new standard requires the measurement and recognition of expected credit losses for financial assets held at amortized cost, including loans and trade and other receivables. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss methodology, which will result in more timely recognition of credit losses. The standard also amends the impairment model for available-for-sale debt securities and requires entities to determine whether all or a portion of the unrealized loss on an available-for-sale debt security is a credit loss. Under the new guidance, an entity will recognize an allowance for credit losses on available-for-sale debt securities as a contra-account to the amortized cost basis rather than as a direct reduction of the amortized cost basis of the investment, as is currently required. ASU 2016-13 is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2019. The Company does not expect this standard to have a material impact on its financial statements due to the immaterial level of its unrealized losses on available-for-sale securities and its immaterial level of loans and receivables |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: For the Year Ended December 31, 2018 2017 Stock options to purchase common stock 4,714,383 4,298,802 |
Cash Equivalents and Short-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Fair Value of Cash Equivalents, Short-Term Investments and Gross Unrealized Holding Gains and Losses | The following tables summarize the fair value of cash, cash equivalents, and short-term investments, as well as gross unrealized holding gains and losses as of December 31, 2018 and December 31, 2017: December 31, 2018 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 927,354 $ - $ - $ 927,354 Money market funds (a) 35,562,264 - - 35,562,264 Total cash and cash equivalents $ 36,489,618 $ - $ - $ 36,489,618 U.S. treasury notes (a) $ 5,012,863 $ - $ (1,829 ) $ 5,011,034 Total short-term investments $ 5,012,863 $ - $ (1,829 ) $ 5,011,034 (a) As of December 31, 2018, the Company's Level 1 assets consisted of money market funds and U.S. treasury notes totaling $40.5 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. December 31, 2017 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 526,648 $ - $ - $ 526,648 Money market funds (a) 86,598,952 - - 86,598,952 Total cash and cash equivalents $ 87,125,600 $ - $ - $ 87,125,600 (a) As of December 31, 2017, the Company's Level 1 assets consisted of money market funds totaling $86.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2017. |
Property and Equipment and In_2
Property and Equipment and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment is summarized as follows: December 31, December 31, 2018 2017 Furniture and equipment $ 156,031 $ 102,690 Less accumulated depreciation (86,164 ) (50,915 ) Total property, plant and equipment, net $ 69,867 $ 51,775 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: December 31, December 31, 2018 2017 Clinical trials accrual $ 1,352,133 $ 753,018 Collaboration agreement accrual - 754,841 Payroll and bonus accrual 2,779,021 1,919,120 Professional fees accrual 772,785 321,852 Other 184,923 246,503 Total $ 5,088,862 $ 3,995,334 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Recognized Stock-Based Compensation Expense | The Company’s stock-based compensation expense was recognized in operating expense as follows: For the Year Ended December 31, 2018 2017 Research and development $ 3,134,395 $ 2,417,727 General and administrative 3,929,546 3,980,029 Total $ 7,063,941 $ 6,397,756 |
Summary of Options Outstanding and Weighted Average Exercise Price | The following table summarizes the number of options outstanding and the weighted average exercise price: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price Life in Years Value Options Outstanding at December 31, 2016 2,987,729 $ 7.46 8.82 $ 837,036 Vested and exercisable at December 31, 2016 683,070 $ 7.71 8.47 $ 253,969 Granted 1,538,342 9.03 9.19 Exercised (4,320 ) 6.26 Forfeited (222,949 ) 6.61 Options Outstanding December 31, 2017 4,298,802 $ 8.07 8.32 $ 8,174,686 Vested and exercisable at December 31, 2017 1,733,673 $ 7.65 7.92 $ 3,865,036 Granted 1,440,578 8.23 9.26 Exercised (15,744 ) 7.07 Forfeited (1,009,253 ) 8.16 Options Outstanding December 31, 2018 4,714,383 $ 8.10 7.89 $ 153,485 Vested and exercisable at December 31, 2018 2,337,931 $ 7.88 7.20 $ 153,485 |
Employee Stock Option [Member] | |
Summary of Assumptions Used to Compute Fair Value of Employee Option Granted | The fair value of employee options granted during the years ended December 31, 2018 and 2017, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 84.40 % 80.39 % Expected term in years 6.01 6.08 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.62 % 2.06 % Fair value of option on grant date $ 5.93 $ 6.30 |
Nonemployee Stock Options [Member] | |
Summary of Assumptions Used to Compute Fair Value of Employee Option Granted | The fair value of nonemployee options granted and remeasured during the years ended December 31, 2018 and 2017, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2018 2017 Weighted Average Weighted Average Volatility 79.40 % 81.44 % Expected term in years 3.23 4.39 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.46 % 2.08 % Fair value of option on grant date $ 0.62 $ 6.80 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2018 2017 Deferred tax assets/liabilities: Net operating loss carryovers $ 37,195,164 $ 20,880,120 Research and development tax credits 1,737,870 714,087 Share-based compensation 5,333,006 3,392,111 Accrued compensation 869,446 633,745 Depreciation (19,949 ) (10,778 ) Charitable contributions 88,353 53,038 Intangible assets 8,828,914 9,622,535 Total gross deferred tax assets/liabilities 54,032,804 35,284,858 Valuation allowance (54,032,804 ) (35,284,858 ) Net deferred tax assets (liabilities) $ - $ - |
Reconciliation of Statutory U.S. Federal Rate to Effective Tax Rate | A reconciliation of the statutory U.S. Federal rate to the company’s effective tax rate is as follows: December 31, 2018 2017 Federal income tax benefit at statutory rate (21.00 ) (34.00 ) State income tax, net of federal benefit (13.62 ) (11.77 ) Permanent items 0.61 0.89 Change in valuation allowance 36.02 29.18 Research and development tax credits (1.97 ) (0.56 ) Deferred re-measurement - 16.31 Other (0.04 ) (0.05 ) Effective income tax (benefit) expense rate 0 % 0 % |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Selected Quarterly Financial Information | The following tables contain selected quarterly financial information from 2018 and 2017. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period. Three Months Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Total operating expenses $ 13,430 $ 13,210 $ 13,176 $ 13,116 Total other income (expense), net 247 275 214 216 Net loss $ (13,183 ) $ (12,935 ) $ (12,962 ) $ (12,900 ) Net loss applicable to common stockholders $ (13,183 ) $ (12,935 ) $ (12,962 ) $ (12,900 ) Net loss per share applicable to common stockholders - basic and diluted $ (0.54 ) $ (0.53 ) $ (0.53 ) $ (0.52 ) Three Months Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2017 2017 2017 2017 Total operating expenses $ 34,262 $ 10,288 $ 9,409 $ 11,048 Total other income (expense), net 23 40 51 88 Net loss $ (34,239 ) $ (10,248 ) $ (9,358 ) $ (10,960 ) Net loss applicable to common stockholders $ (34,239 ) $ (10,248 ) $ (9,358 ) $ (10,960 ) Net loss per share applicable to common stockholders - basic and diluted $ (3.48 ) $ (0.57 ) $ (0.38 ) $ (0.45 ) |
Nature of Operations - Addition
Nature of Operations - Additional Information (Detail) - USD ($) | Feb. 27, 2019 | Feb. 22, 2019 | May 10, 2017 | Feb. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of common stock shares from exercise of stock options | 15,744 | 4,320 | ||||
Estimated net proceeds from stock option exercised | $ 111,378 | $ 27,043 | ||||
Net proceeds from issuance of stock | 69,750,000 | |||||
Accumulated deficit | 152,695,278 | 100,715,668 | ||||
Cash outflows from operating activities | (45,558,480) | $ (31,469,909) | ||||
Cash, cash equivalents and short-term investments | $ 41,500,000 | |||||
IPO [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 5,000,000 | |||||
Subsequent Event [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Gross proceeds from issuance of stock | $ 30,000,000 | |||||
Estimated net proceeds from issuance of stock | $ 28,200,000 | $ 31,000,000 | ||||
Subsequent Event [Member] | Underwriter [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Granted time period to use option of additional shares to purchase | 30 days | 30 days | ||||
Gross proceeds from stock option exercised | $ 3,000,000 | |||||
Estimated net proceeds from stock option exercised | $ 2,800,000 | |||||
Common Stock [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of common stock shares from exercise of stock options | 15,744 | 4,320 | ||||
Common Stock [Member] | IPO [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 5,000,000 | |||||
Stock issued, price per share | $ 15 | |||||
Gross proceeds from issuance of stock | $ 75,000,000 | |||||
Net proceeds from issuance of stock | $ 66,700,000 | |||||
Common Stock [Member] | Subsequent Event [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 12,500,000 | |||||
Stock issued, price per share | $ 2 | |||||
Common Stock [Member] | Subsequent Event [Member] | Underwriter [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Stock issued, price per share | $ 2 | |||||
Issuance of common stock shares from exercise of stock options | 1,493,778 | |||||
Series A Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 2,500 | |||||
Stock issued, price per share | $ 2,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Summary of Significant Accounting Policy [Line Items] | ||
Ownership pattern | Ovid and Takeda are sharing 50/50 in the drug development and throughout the life of this compound | |
Percentage of net expenses of development costs recorded in research and development | 50.00% | |
Property and equipment, estimated useful lives | Property and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. | |
Property and equipment, useful lives | 3 years | |
Defined contribution plan name | 401(k)-retirement plan | |
Company contributions to 401(k) retirement plan | $ 210,034 | $ 163,942 |
Scenario One [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Percentage of company matching contribution to 401(k) retirement plan | 100.00% | |
Company matching contributions to employee's eligible compensation deferred | 3.00% | |
Scenario Two [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Percentage of company matching contribution to 401(k) retirement plan | 50.00% | |
Fair Value Level 1 [Member] | Money Market Funds and Short-term Investments [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Fair value assets | $ 40,500,000 | 86,600,000 |
Fair Value Level 2 [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Fair value assets | 0 | 0 |
Fair value liabilities | 0 | 0 |
Fair Value Level 3 [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Fair value assets | 0 | 0 |
Fair value liabilities | 0 | $ 0 |
Maximum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
FDIC insured amount | $ 250,000 | |
Maximum [Member] | Scenario Two [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Company matching contributions to employee's eligible compensation deferred | 5.00% | |
Minimum [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Short term investments, maturity period | 3 months | |
Minimum [Member] | Scenario Two [Member] | ||
Summary of Significant Accounting Policy [Line Items] | ||
Company matching contributions to employee's eligible compensation deferred | 3.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Shares Outstanding (Detail) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock options to purchase common stock [Member] | ||
Dilutive Securities Included and Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive Securities Excluded from computations of Diluted Weighted Average shares outstanding | 4,714,383 | 4,298,802 |
Cash Equivalents and Short-Te_3
Cash Equivalents and Short-Term Investments - Summary of Fair Value of Cash Equivalents, Short-Term Investments and Gross Unrealized Holding Gains and Losses (Detail) - USD ($) | Dec. 31, 2018 | Dec. 30, 2017 | |||
Schedule Of Available For Sale Securities [Line Items] | |||||
Total cash and cash equivalents, Amortized cost | $ 36,489,618 | $ 87,125,600 | |||
Total cash and cash equivalents, Fair value | 36,489,618 | 87,125,600 | |||
Total short-term investments, Amortized cost | 5,012,863 | ||||
Total short-term investments, Gross unrealized holding losses | (1,829) | ||||
Total short-term investments, Fair value | 5,011,034 | ||||
U.S. Treasury Notes [Member] | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Total short-term investments, Amortized cost | [1] | 5,012,863 | |||
Total short-term investments, Gross unrealized holding losses | [1] | (1,829) | |||
Total short-term investments, Fair value | [1] | 5,011,034 | |||
Cash [Member] | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Total cash and cash equivalents, Amortized cost | 927,354 | 526,648 | |||
Total cash and cash equivalents, Fair value | 927,354 | 526,648 | |||
Money Market Funds [Member] | |||||
Schedule Of Available For Sale Securities [Line Items] | |||||
Total cash and cash equivalents, Amortized cost | 35,562,264 | [1] | 86,598,952 | [2] | |
Total cash and cash equivalents, Fair value | $ 35,562,264 | [1] | $ 86,598,952 | [2] | |
[1] | As of December 31, 2018, the Company's Level 1 assets consisted of money market funds and U.S. treasury notes totaling $40.5 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. | ||||
[2] | As of December 31, 2017, the Company's Level 1 assets consisted of money market funds totaling $86.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2017. |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Summary of Fair Value of Cash Equivalents, Short-Term Investments and Gross Unrealized Holding Gains and Losses (Parenthetical) (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value Level 1 [Member] | Money Market Funds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | $ 86,600,000 | |
Fair Value Level 1 [Member] | Money Market Funds US Treasury Notes [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | $ 40,500,000 | |
Fair Value Level 2 [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | 0 | 0 |
Fair value liabilities | 0 | 0 |
Fair Value Level 3 [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | 0 | 0 |
Fair value liabilities | $ 0 | $ 0 |
Cash Equivalents and Short-Te_5
Cash Equivalents and Short-Term Investments - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2018USD ($)Investment | Dec. 31, 2017USD ($) | |
Investments Debt And Equity Securities [Abstract] | ||
Aggregate fair value of securities that were in an unrealized loss position for less than 12 months | $ 5,000,000 | $ 0 |
Number of securities in an unrealized loss position for more than 12 months | Investment | 0 | |
Gains or losses on available-for-sale securities | $ 0 | $ 0 |
Property and Equipment and In_3
Property and Equipment and Intangible Assets - Summary of Property and Equipment (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Less accumulated depreciation | $ (86,164) | $ (50,915) |
Total property, plant and equipment, net | 69,867 | 51,775 |
Furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment | $ 156,031 | $ 102,690 |
Property and Equipment and In_4
Property and Equipment and Intangible Assets - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 35,249 | $ 26,917 |
Intangible assets, net of accumulated amortization | 391,872 | 124,194 |
Amortization expense | $ 106,484 | $ 53,393 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Clinical trials accrual | $ 1,352,133 | $ 753,018 |
Collaboration agreement accrual | 754,841 | |
Payroll and bonus accrual | 2,779,021 | 1,919,120 |
Professional fees accrual | 772,785 | 321,852 |
Other | 184,923 | 246,503 |
Total | $ 5,088,862 | $ 3,995,334 |
Stockholders' Equity and Pref_2
Stockholders' Equity and Preferred Stock - Additional Information (Detail) - USD ($) | May 10, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | |||
Common stock voting rights | One vote for each share held | ||
Common stock, shares authorized | 125,000,000 | 125,000,000 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, shares outstanding | 0 | 0 | |
Preferred stock, shares issued | 0 | 0 | |
Dividends declaration and payment terms | No dividends on the common stock shall be declared and paid unless dividends on the Preferred Stock have been declared and paid. | ||
Dividends declared | $ 0 | ||
Series A Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Conversion of convertible preferred stock into common stock | (2,382,069) | ||
Series B Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Conversion of convertible preferred stock into common stock | (5,599,282) | ||
Series B-1 Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Number of shares issued | 1,781,996 | ||
Conversion of convertible preferred stock into common stock | (1,781,996) | ||
IPO [Member] | |||
Class of Stock [Line Items] | |||
Common stock, shares authorized | 125,000,000 | ||
Preferred stock, shares authorized | 10,000,000 | ||
Number of shares issued | 5,000,000 | ||
IPO [Member] | Series A Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Preferred stock, shares outstanding | 2,382,069 | ||
IPO [Member] | Series B Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Preferred stock, shares outstanding | 5,599,282 | ||
IPO [Member] | Series B-1 Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,781,996 | ||
Common Stock [Member] | |||
Class of Stock [Line Items] | |||
Conversion of convertible preferred stock into common stock | 9,763,346 | ||
Common Stock [Member] | IPO [Member] | |||
Class of Stock [Line Items] | |||
Number of shares issued | 5,000,000 | ||
Conversion of convertible preferred stock into common stock | 9,763,346 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jan. 01, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Stock-Based Compensation [Line Items] | |||
Share based compensation expense | $ 7,063,941 | $ 6,397,756 | |
Stock options, granted | 1,440,578 | 1,538,342 | |
Unrecognized compensation expenses | $ 11,808,408 | ||
Unrecognized compensation not yet recognized, period for recognition | 2 years 2 months 1 day | ||
Performance-based Option Awards [Member] | |||
Stock-Based Compensation [Line Items] | |||
Share based compensation expense | $ 0 | $ 830,997 | |
Unvested stock options, outstanding | 0 | ||
Nonemployee Stock Options [Member] | |||
Stock-Based Compensation [Line Items] | |||
Share based compensation expense | $ 136,639 | $ 416,457 | |
Unvested stock options, outstanding | 10,175 | 37,066 | |
Stock options, granted | 0 | 27,906 | |
Unrecognized compensation expenses | $ 5,933 | ||
Non-employee Performance Based Option Awards [Member] | |||
Stock-Based Compensation [Line Items] | |||
Share based compensation expense | 0 | $ 162,700 | |
Employee Stock Option [Member] | |||
Stock-Based Compensation [Line Items] | |||
Share based compensation expense | $ 6,821,298 | $ 5,969,204 | |
Unvested stock options, outstanding | 2,366,277 | 2,528,063 | |
Stock options, granted | 1,440,578 | 1,510,436 | |
Unrecognized compensation expenses | $ 11,802,475 | ||
2017 Equity Incentive Plan [Member] | |||
Stock-Based Compensation [Line Items] | |||
Common stock, reserved for future issuance | 3,052,059 | ||
Increase of equity incentive plan/ employee stock purchase plan limit description | Pursuant to the terms of the 2017 Plan, on each January 1st, the plan limit shall be increased by the lesser of (x) 5% of the number of shares of common stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. | ||
Percentage of number of shares of common stock outstanding | 5.00% | ||
Number of additional shares reserved for issuance under the plan | 1,230,312 | ||
Number of company's common stock reserved for issuance under the plan | 3,657,972 | ||
Share based compensation, term of plan | 10 years | ||
Share based compensation, graded vesting period | 4 years | ||
Share based compensation, exercisable | 90 days | ||
2017 ESPP [Member] | |||
Stock-Based Compensation [Line Items] | |||
Common stock, reserved for future issuance | 279,069 | ||
Increase of equity incentive plan/ employee stock purchase plan limit description | The number of shares of common stock reserved for issuance under the 2017 ESPP will automatically increase on January 1 of each year, beginning on January 1, 2018 and continuing through and including January 1, 2027, by the lesser of (i) 1% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, (ii) 550,000 shares or (iii) such lesser number of shares determined by our Board. | ||
Percentage of number of shares of common stock outstanding | 1.00% | ||
Number of additional shares reserved for issuance under the plan | 246,062 | ||
Number of company's common stock reserved for issuance under the plan | 493,017 | ||
Offering period description | On September 20, 2017, the Company’s Compensation Committee approved an offering period under the 2017 ESPP, which began on October 20, 2017. | ||
Share based compensation, percentage of discount from market price on purchase date | 15.00% | ||
Share based compensation, number of shares purchased | 32,114 | 0 | |
Share based compensation expense | $ 106,004 | $ 12,095 | |
Increase in number of shares each year under the plan | 550,000 | ||
2014 Equity Incentive Plan [Member] | |||
Stock-Based Compensation [Line Items] | |||
Share based compensation, term of plan | 10 years | ||
Share based compensation, graded vesting period | 4 years | ||
Share based compensation, exercisable | 90 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 7,063,941 | $ 6,397,756 |
Research and Development [Member] | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | 3,134,395 | 2,417,727 |
General and Administrative Expenses [Member] | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 3,929,546 | $ 3,980,029 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Assumptions Used to Compute Fair Value of Employee Option Granted (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Stock Option [Member] | ||
Stock-Based Compensation [Line Items] | ||
Weighted Average, Volatility | 84.40% | 80.39% |
Weighted Average, Expected term in years | 6 years 3 days | 6 years 29 days |
Weighted Average, Dividend rate | 0.00% | 0.00% |
Weighted Average, Risk-free interest rate | 2.62% | 2.06% |
Weighted Average, Fair value of option on grant date | $ 5.93 | $ 6.30 |
Nonemployee Stock Options [Member] | ||
Stock-Based Compensation [Line Items] | ||
Weighted Average, Volatility | 79.40% | 81.44% |
Weighted Average, Expected term in years | 3 years 2 months 23 days | 4 years 4 months 20 days |
Weighted Average, Dividend rate | 0.00% | 0.00% |
Weighted Average, Risk-free interest rate | 2.46% | 2.08% |
Weighted Average, Fair value of option on grant date | $ 0.62 | $ 6.80 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Options Outstanding and Weighted Average Exercise Price (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Shares, Options Outstanding, Beginning balance | 4,298,802 | 2,987,729 | |
Number of Shares, Vested and exercisable, Beginning balance | 1,733,673 | 683,070 | |
Number of Shares, Granted | 1,440,578 | 1,538,342 | |
Number of Shares, Exercised | (15,744) | (4,320) | |
Number of Shares, Forfeited | (1,009,253) | (222,949) | |
Number of Shares, Options Outstanding, Ending balance | 4,714,383 | 4,298,802 | 2,987,729 |
Number of Shares, Vested and exercisable, Ending balance | 2,337,931 | 1,733,673 | 683,070 |
Weighted Average Exercise Price, Options Outstanding | $ 8.07 | $ 7.46 | |
Weighted Average Exercise Price, Vested and exercisable | 7.65 | 7.71 | |
Weighted Average Exercise Price, Granted | 8.23 | 9.03 | |
Weighted Average Exercise Price, Exercised | 7.07 | 6.26 | |
Weighted Average Exercise Price, Forfeited | 8.16 | 6.61 | |
Weighted Average Exercise Price, Options Outstanding | 8.10 | 8.07 | $ 7.46 |
Weighted Average Exercise Price, Vested and exercisable | $ 7.88 | $ 7.65 | $ 7.71 |
Weighted Average Remaining Contractual Life, Options Outstanding | 7 years 10 months 20 days | 8 years 3 months 25 days | 8 years 9 months 25 days |
Weighted Average Remaining Contractual Life, Vested and exercisable | 7 years 2 months 12 days | 7 years 11 months 1 day | 8 years 5 months 19 days |
Weighted Average Remaining Contractual Life, Granted | 9 years 3 months 3 days | 9 years 2 months 8 days | |
Aggregate Intrinsic Value, Options Outstanding | $ 153,485 | $ 8,174,686 | $ 837,036 |
Aggregate Intrinsic Value, Vested and exercisable | $ 153,485 | $ 3,865,036 | $ 253,969 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards expiration year | 2,035 | |
Provision for income taxes | $ 0 | |
Increase in valuation allowance | 18,748,000 | $ 18,971,000 |
Valuation allowance | 54,032,804 | 35,284,858 |
Unrecognized tax benefits or related interest and penalties accrued | 0 | 0 |
Uncertain tax position | 0 | $ 0 |
New York State Division of Taxation and Finance Member [Member] | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 105,984,000 | |
Federal [Member] | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 106,501,000 | |
State [Member] | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 112,636,000 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets/liabilities: | ||
Net operating loss carryovers | $ 37,195,164 | $ 20,880,120 |
Research and development tax credits | 1,737,870 | 714,087 |
Share-based compensation | 5,333,006 | 3,392,111 |
Accrued compensation | 869,446 | 633,745 |
Depreciation | (19,949) | (10,778) |
Charitable contributions | 88,353 | 53,038 |
Intangible assets | 8,828,914 | 9,622,535 |
Total gross deferred tax assets/liabilities | 54,032,804 | 35,284,858 |
Valuation allowance | $ (54,032,804) | $ (35,284,858) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate to Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rate | (21.00%) | (34.00%) |
State income tax, net of federal benefit | (13.62%) | (11.77%) |
Permanent items | 0.61% | 0.89% |
Change in valuation allowance | 36.02% | 29.18% |
Research and development tax credits | (1.97%) | (0.56%) |
Deferred re-measurement | 16.31% | |
Other | (0.04%) | (0.05%) |
Effective income tax (benefit) expense rate | 0.00% | 0.00% |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Detail) - License Agreement [Member] | Mar. 26, 2015USD ($)Trial | Dec. 31, 2016USD ($)Product | Dec. 31, 2018 |
Lundbeck [Member] | |||
Loss Contingencies [Line Items] | |||
License agreement entered date | Mar. 26, 2015 | ||
First payment due upon completion of first phase | $ 10,000,000 | ||
Number of trial | Trial | 3 | ||
Lundbeck [Member] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
License agreement milestone payments | $ 181,000,000 | ||
Northwestern University [Member] | |||
Loss Contingencies [Line Items] | |||
License agreement entered Period | 2016-12 | ||
Upfront non-creditable one-time license issuance fee payment | $ 75,000 | ||
Annual license maintenance fee payable | $ 20,000 | ||
License agreement, description of rights and obligation | In consideration for the rights granted to the Company under the Northwestern agreement, the Company is required to pay to Northwestern up to an aggregate of $5.3 million upon the achievement of certain development and regulatory milestones for the first product covered by the Northwestern Patents, and, upon commercialization of any such products, will be required to pay to Northwestern a tiered royalty on net sales of such products by the Company, its affiliates or sublicensees, at percentages in the low to mid single-digits, subject to standard reductions and offsets. The Company’s royalty obligations continue on a product-by-product and country-by-country basis until the later of the expiration of the last-to-expire valid claim in a licensed patent covering the applicable product in such country and 10 years following the first commercial sale of such product in such country. If the Company sublicenses a Northwestern Patent Right, it will be obligated to pay to Northwestern a specified percentage of sublicense revenue received by the Company, ranging from the high single digits to the low-teens. | ||
Minimum number of product covered under license agreement | Product | 1 | ||
Northwestern University [Member] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
Consideration payable for rights grant | $ 5,300,000 |
Collaboration Agreement - Addit
Collaboration Agreement - Additional Information (Detail) - USD ($) | May 10, 2017 | Jan. 06, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Preferred stock, shares issued | 0 | 0 | ||
Preferred stock, price per share | $ 0.001 | $ 0.001 | ||
Fair value of Series B-1 Preferred Stock | $ 25,861,228 | |||
Research and development | $ 33,790,031 | 49,972,102 | ||
Series B-1 Preferred Stock [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Fair value of Series B-1 Preferred Stock | $ 1,782 | |||
Conversion of convertible preferred stock into common stock | (1,781,996) | |||
Common Stock [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Conversion of convertible preferred stock into common stock | 9,763,346 | |||
IPO [Member] | Common Stock [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Conversion of convertible preferred stock into common stock | 9,763,346 | |||
Takeda Pharmaceutical Company Limited [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Percentage of outstanding capital stock on the issuance date | 8.00% | |||
Value fixed on collaboration for share obligation terms | $ 50,000,000 | |||
Threshold percentage of outstanding capital stock to make cash payment | 19.99% | |||
Global commercial and regulatory milestone payments | $ 35,000,000 | |||
Takeda Pharmaceutical Company Limited [Member] | Collaborative Arrangement, Co-promotion [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 4,321,951 | |||
Research and development expense reimbursement received | $ 1,280,525 | |||
Takeda Pharmaceutical Company Limited [Member] | Series B-1 Preferred Stock [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Preferred stock, shares issued | 1,781,996 | |||
Preferred stock, price per share | $ 14.513 | |||
Fair value of Series B-1 Preferred Stock | $ 25,861,228 | |||
Takeda Pharmaceutical Company Limited [Member] | IPO [Member] | Common Stock [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Conversion of convertible preferred stock into common stock | 1,781,996 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Schedule of Selected Quarterly Financial Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Data [Abstract] | ||||||||||
Total operating expenses | $ 13,116,000 | $ 13,176,000 | $ 13,210,000 | $ 13,430,000 | $ 11,048,000 | $ 9,409,000 | $ 10,288,000 | $ 34,262,000 | $ 52,931,683 | $ 65,007,563 |
Total other income (expense), net | 216,000 | 214,000 | 275,000 | 247,000 | 88,000 | 51,000 | 40,000 | 23,000 | 952,073 | 201,509 |
Net loss | (12,900,000) | (12,962,000) | (12,935,000) | (13,183,000) | (10,960,000) | (9,358,000) | (10,248,000) | (34,239,000) | (51,979,610) | (64,806,054) |
Net loss applicable to common stockholders | $ (12,900,000) | $ (12,962,000) | $ (12,935,000) | $ (13,183,000) | $ (10,960,000) | $ (9,358,000) | $ (10,248,000) | $ (34,239,000) | $ (51,979,610) | $ (64,806,054) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.52) | $ (0.53) | $ (0.53) | $ (0.54) | $ (0.45) | $ (0.38) | $ (0.57) | $ (3.48) | $ (2.11) | $ (3.35) |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Feb. 27, 2019 | Feb. 22, 2019 | Feb. 28, 2019 | Mar. 07, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||||
Granted option awards | 1,440,578 | 1,538,342 | ||||
Weighted average exercise price | $ 8.23 | $ 9.03 | ||||
Issuance of common stock shares from exercise of stock options | 15,744 | 4,320 | ||||
Net proceeds from stock option exercised | $ 111,378 | $ 27,043 | ||||
Common Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock shares from exercise of stock options | 15,744 | 4,320 | ||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Granted option awards | 864,963 | |||||
Weighted average exercise price | $ 2.18 | |||||
Gross proceeds from issuance of stock | $ 30,000,000 | |||||
Estimated net proceeds from issuance of stock | $ 28,200,000 | $ 31,000,000 | ||||
Maximum allowable owning percentage of outstanding common stock by associates or affiliates. | 9.99% | |||||
Payment of share issuance expenses by persons owning 10% or more of common stock | $ 0 | |||||
Subsequent Event [Member] | Underwriter [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Gross proceeds from stock option exercised | $ 3,000,000 | |||||
Net proceeds from stock option exercised | $ 2,800,000 | |||||
Granted time period to use option of additional shares to purchase | 30 days | 30 days | ||||
Additional shares of common stock that can be purchased under the option | 1,750,000 | |||||
Subsequent Event [Member] | Common Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 12,500,000 | |||||
Stock issued, price per share | $ 2 | |||||
Subsequent Event [Member] | Common Stock [Member] | Underwriter [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock shares from exercise of stock options | 1,493,778 | |||||
Stock issued, price per share | $ 2 | |||||
Subsequent Event [Member] | Series A Convertible Preferred Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of Preferred Stock, Shares | 2,500 | |||||
Stock issued, price per share | $ 2,000 | |||||
Number of shares issued for each share of convertible preferred stock that is converted | 1,000 |