Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 06, 2019 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | OVID | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Entity Registrant Name | Ovid Therapeutics Inc. | |
Entity Central Index Key | 0001636651 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 47,816,434 | |
Entity Shell Company | false | |
Entity File Number | 001-38085 | |
Entity Tax Identification Number | 46-5270895 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 1460 Broadway | |
Entity Address, Address Line Two | Suite 15044 | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 646 | |
Local Phone Number | 661-7661 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 37,907,904 | $ 36,489,618 |
Short-term investments | 5,011,034 | |
Related party receivable | 600,104 | |
Prepaid expenses and other current assets | 1,242,591 | 2,167,391 |
Total current assets | 39,150,495 | 44,268,147 |
Long-term prepaid expenses | 1,006,620 | 2,797,561 |
Security deposit | 113,550 | 122,155 |
Property and equipment, net | 72,241 | 69,867 |
Other assets | 351,271 | 391,872 |
Total assets | 40,694,177 | 47,649,602 |
Current liabilities: | ||
Accounts payable | 5,341,548 | 3,755,595 |
Accrued expenses | 4,681,695 | 5,088,862 |
Related party payable | 337,773 | |
Total current liabilities | 10,361,016 | 8,844,457 |
Related party payable - noncurrent | 286,562 | |
Total liabilities | 10,647,578 | 8,844,457 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; Series A convertible preferred stock, 10,000 and zero shares designated, 3,762 and zero shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 4 | |
Common stock, $0.001 par value; 125,000,000 shares authorized; 37,466,434 and 24,654,114 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 37,467 | 24,654 |
Additional paid-in-capital | 226,196,440 | 191,477,598 |
Accumulated other comprehensive loss | (1,829) | |
Accumulated deficit | (196,187,312) | (152,695,278) |
Total stockholders' equity | 30,046,599 | 38,805,145 |
Total liabilities and stockholders' equity | $ 40,694,177 | $ 47,649,602 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 37,466,434 | 24,654,114 |
Common stock, shares outstanding | 37,466,434 | 24,654,114 |
Series A Convertible Preferred Stock | ||
Preferred stock, share designated | 10,000 | 0 |
Preferred stock, shares issued | 3,762 | 0 |
Preferred stock, shares outstanding | 3,762 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 11,597,633 | $ 8,544,547 | $ 30,052,432 | $ 25,168,446 |
General and administrative | 5,168,103 | 4,631,228 | 14,089,106 | 14,636,941 |
Total operating expenses | 16,765,736 | 13,175,775 | 44,141,538 | 39,805,387 |
Loss from operations | (16,765,736) | (13,175,775) | (44,141,538) | (39,805,387) |
Interest income | 131,164 | 213,992 | 649,504 | 725,709 |
Net loss | (16,634,572) | (12,961,783) | (43,492,034) | (39,079,678) |
Net loss attributable to common stockholders | $ (16,634,572) | $ (12,961,783) | $ (43,492,034) | $ (39,079,678) |
Common Stock [Member] | ||||
Operating expenses: | ||||
Net loss per share, basic and diluted | $ (0.43) | $ (0.53) | $ (1.21) | $ (1.59) |
Weighted-average shares outstanding basic and diluted | 38,504,825 | 24,634,380 | 35,872,441 | 24,623,225 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (16,634,572) | $ (12,961,783) | $ (43,492,034) | $ (39,079,678) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | 11,347 | 1,829 | (4,675) | |
Comprehensive loss | $ (16,634,572) | $ (12,950,436) | $ (43,490,205) | $ (39,084,353) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Other Comprehensive Income/(Loss) [Member] | Accumulated Deficit [Member] | Convertible Preferred Stock [Member] |
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 | |||||
Stock-based compensation expense | 1,794,967 | 1,794,967 | ||||
Issuance of common stock from exercise of stock options | 12,678 | $ 2 | 12,676 | |||
Issuance of common stock from exercise of stock options, Shares | 1,751 | |||||
Issuance of common stock from ESPP purchase | 62,723 | $ 10 | 62,713 | |||
Issuance of common stock from ESPP purchase, Shares | 9,972 | |||||
Other comprehensive gain (loss) | (35,914) | $ (35,914) | ||||
Net loss | (13,182,758) | (13,182,758) | ||||
Balance at Mar. 31, 2018 | 72,088,199 | $ 24,618 | 185,997,921 | (35,914) | (113,898,426) | |
Balance, Shares at Mar. 31, 2018 | 24,617,979 | |||||
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 | |||||
Net loss | (39,079,678) | |||||
Balance at Sep. 30, 2018 | 49,971,068 | $ 24,654 | 189,746,438 | (4,675) | (139,795,349) | |
Balance, Shares at Sep. 30, 2018 | 24,654,114 | |||||
Balance at Mar. 31, 2018 | 72,088,199 | $ 24,618 | 185,997,921 | (35,914) | (113,898,426) | |
Balance, Shares at Mar. 31, 2018 | 24,617,979 | |||||
Stock-based compensation expense | 1,844,205 | 1,844,205 | ||||
Issuance of common stock from exercise of stock options | 98,701 | $ 14 | 98,687 | |||
Issuance of common stock from exercise of stock options, Shares | 13,993 | |||||
Other comprehensive gain (loss) | 19,892 | 19,892 | ||||
Net loss | (12,935,140) | (12,935,140) | ||||
Balance at Jun. 30, 2018 | 61,115,857 | $ 24,632 | 187,940,813 | (16,022) | (126,833,566) | |
Balance, Shares at Jun. 30, 2018 | 24,631,972 | |||||
Stock-based compensation expense | 1,693,609 | 1,693,609 | ||||
Issuance of common stock from ESPP purchase | 112,038 | $ 22 | 112,016 | |||
Issuance of common stock from ESPP purchase, Shares | 22,142 | |||||
Other comprehensive gain (loss) | 11,347 | 11,347 | ||||
Net loss | (12,961,783) | (12,961,783) | ||||
Balance at Sep. 30, 2018 | 49,971,068 | $ 24,654 | 189,746,438 | (4,675) | (139,795,349) | |
Balance, Shares at Sep. 30, 2018 | 24,654,114 | |||||
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 | |||||
Proceeds from February Offering, net of underwriting costs and commissions | 30,522,028 | $ 13,994 | 30,508,031 | $ 3 | ||
Proceeds from February Offering, net of underwriting costs and commissions, Shares | 13,993,778 | 2,500 | ||||
Stock-based compensation expense | 1,642,540 | 1,642,540 | ||||
Issuance of common stock from ESPP purchase | 73,104 | $ 45 | 73,059 | |||
Issuance of common stock from ESPP purchase, Shares | 45,126 | |||||
Other comprehensive gain (loss) | 3,179 | 3,179 | ||||
Net loss | (13,800,195) | (13,800,195) | ||||
Balance at Mar. 31, 2019 | 57,245,801 | $ 38,693 | 223,701,228 | 1,350 | (166,495,473) | $ 3 |
Balance, Shares at Mar. 31, 2019 | 38,693,018 | 2,500 | ||||
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 | |||||
Net loss | (43,492,034) | |||||
Balance at Sep. 30, 2019 | 30,046,599 | $ 37,467 | 226,196,440 | (196,187,312) | $ 4 | |
Balance, Shares at Sep. 30, 2019 | 37,466,434 | 3,762 | ||||
Balance at Mar. 31, 2019 | 57,245,801 | $ 38,693 | 223,701,228 | 1,350 | (166,495,473) | $ 3 |
Balance, Shares at Mar. 31, 2019 | 38,693,018 | 2,500 | ||||
Underwriting costs of Offering | (1,193) | (1,193) | ||||
Stock-based compensation expense | 1,251,908 | 1,251,908 | ||||
Other comprehensive gain (loss) | (1,350) | $ (1,350) | ||||
Net loss | (13,057,267) | (13,057,267) | ||||
Balance at Jun. 30, 2019 | 45,437,899 | $ 38,693 | 224,951,943 | (179,552,740) | $ 3 | |
Balance, Shares at Jun. 30, 2019 | 38,693,018 | 2,500 | ||||
Stock-based compensation expense | 1,184,481 | 1,184,481 | ||||
Issuance of common stock from ESPP purchase | 58,791 | $ 36 | 58,755 | |||
Issuance of common stock from ESPP purchase, Shares | 35,416 | |||||
Conversion of common stock to series A convertible preferred stock | $ (1,262) | 1,261 | $ 1 | |||
Conversion of common stock to series A convertible preferred stock, Shares | (1,262,000) | 1,262 | ||||
Net loss | (16,634,572) | (16,634,572) | ||||
Balance at Sep. 30, 2019 | $ 30,046,599 | $ 37,467 | $ 226,196,440 | $ (196,187,312) | $ 4 | |
Balance, Shares at Sep. 30, 2019 | 37,466,434 | 3,762 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (43,492,034) | $ (39,079,678) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Stock-based compensation expense | 4,078,929 | 5,332,781 |
Depreciation and amortization expense | 201,201 | 86,441 |
Change in accrued interest and accretion of discount on short-term investments | 12,863 | (23,949) |
Change in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 924,800 | (1,284,232) |
Security deposit | 8,605 | (32,965) |
Related party receivable | 600,104 | |
Long-term prepaid expenses | 1,790,941 | (3,938,957) |
Accounts payable | 1,455,155 | 2,513,619 |
Accrued expenses | (407,167) | 1,834,070 |
Related party payable | 624,335 | |
Net cash used in operating activities | (34,202,268) | (34,592,870) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (49,975,100) | |
Proceeds from maturities of short-term investments | 5,000,000 | 28,000,000 |
Purchase of property and equipment | (25,911) | (39,492) |
Software development and other assets | (6,265) | (291,096) |
Net cash provided by (used in) investing activities | 4,967,824 | (22,305,688) |
Cash flows from financing activities: | ||
Proceeds from February Offering, net of offering expenses | 30,520,835 | |
Proceeds from employee stock purchase plan | 131,895 | 174,761 |
Proceeds from exercise of options | 111,377 | |
Net cash provided by financing activities | 30,652,730 | 286,138 |
Net increase (decrease) in cash and cash equivalents | 1,418,286 | (56,612,420) |
Cash and cash equivalents, at beginning of period | 36,489,618 | 87,125,600 |
Cash and cash equivalents, at end of period | 37,907,904 | $ 30,513,180 |
Non-cash investing and financing activities: | ||
Software development and other costs in accrued expenses | 125,852 | |
Purchase of property and equipment in accounts payable | $ 4,946 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2019 | |
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 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. In October 2019, the Company sold 9,000,000 shares of its common stock and 4,000 shares of Series A Convertible Preferred Stock (“Series A Preferred Stock”) at a public offering price of $2.50 and $2,500 per share, respectively, for gross proceeds of $32.5 million and estimated net proceeds of $30.5 million after deducting underwriting discounts and commission and other In February 2019, the Company sold 13,993,778 shares of its common stock and 2,500 shares of Series A Preferred Stock at a public offering price of $2.00 and $2,000 per share, respectively, for gross proceeds of $33.0 million and net proceeds of $30.5 million after deducting underwriting discounts and commission and other The Company has not generated any revenue since inception. As a result, the Company has incurred recurring losses and requires significant cash resources to execute its business plans. The Company has an accumulated deficit of $196.2 million as of and had cash outflows from operating activities of $34.2 million for the nine months ended The Company has incurred operating losses since inception and 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 through either equity offerings, debt financings, collaborations, strategic alliances, or licensing agreements or a combination of any such transactions. Management believes that the Company’s existing cash, and cash equivalents as of September 30, 2019, combined with the proceeds from the October Offering, will be sufficient to fund its current operating plans through at least the next 12 months from the date of filing of the Company’s Quarterly Report on Form 10-Q. Adequate additional funding may not be available to the Company on acceptable terms or at all. The failure to raise capital as and when needed could have a negative impact on the Company’s financial condition and ability to pursue its business strategy. If the Company is unable to raise capital, it may be required to delay, reduce the scope of or eliminate research and development programs, or obtain funds through arrangements with collaborators or others that may require the Company to relinquish rights to certain drug candidates that the Company might otherwise seek to develop or commercialize independently. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 7, 2019. There have been no material changes to the significant accounting policies during the period ended September 30, 2019, except for items mentioned below. (A) Unaudited Interim Condensed Financial Statements The interim condensed balance sheet at September 30, 2019, the condensed statements of operations, comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018, and the condensed statements of cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP are condensed or omitted. These condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2019 and 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The balance sheet as of December 31, 2018 included herein was derived from the audited financial statements as of that date. These interim condensed financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K. (B) Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with 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. (C) 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 income and expenses during the reporting period. Actual results could differ materially from those estimates. (D) 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. • 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. • 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 carrying amounts reported in the balance sheets for cash and cash equivalents, related party receivables, other current assets, accounts payable, accrued expenses, and current related party payables approximate their fair value based on the short-term maturity of these instruments. ( E) Recent Accounting Pronouncements Recent accounting standards which have been adopted On June 20, 2018, the FASB issued Accounting Standards Update (“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 Accounting Standards Codification (“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, which is the same as the measurement date for employee equity awards and for performance-based awards, an entity is now 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. T he adoption of ASU 2018-07 on January 1, 2019 did not have a material impact on the Company’s 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 was applicable to the Company beginning on January 1, 2019. The adoption of ASU 2017-08 did not have a material impact on the Company’s financial statements. 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. This new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The adoption of ASU 2016-02 did not have a material impact on the Company’s financial statements. New accounting standards which have not yet been adopted 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 eliminates certain disclosures, adds 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 modifies 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. 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 | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Cash Equivalents and Short-Term Investments | NOTE 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 September 30, 2019 and December 31, 2018: September 30, 2019 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 141,572 $ - $ - $ 141,572 Money market funds (a) 37,766,332 - - 37,766,332 Total cash and cash equivalents $ 37,907,904 $ - $ - $ 37,907,904 (a) As of September 30, 2019, the Company's Level 1 assets consisted of money market funds totaling $37.8 million. The Company had no level 2 or level 3 assets or liabilities as of September 30, 2019. 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 $40.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. As of September 30, 2019 and December 31, 2018, the aggregate fair value of securities that were in an unrealized loss position for less than 12 months was zero $ |
Property and Equipment and Inta
Property and Equipment and Intangible Assets | 9 Months Ended |
Sep. 30, 2019 | |
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: September 30, December 31, 2019 2018 Furniture and equipment $ 186,888 $ 156,031 Less accumulated depreciation (114,647 ) (86,164 ) Total property and equipment, net $ 72,241 $ 69,867 Depreciation expense was $28,000 and $26,000 for the nine months ended September 30, 2019 and 2018, respectively. Depreciation expense was $10,000 and $7,000 for the three months ended September 30, 2019 and 2018, respectively. Intangible assets, net of accumulated amortization, were $351,000 and $392,000 as of September 30, 2019 and December 31, 2018, respectively, and are included in other assets. Amortization expense was $173,000 and $61,000 for the nine months ended September 30, 2019 and 2018, respectively. Amortization expense was $46,000 and $25,000 for the three months ended September 30, 2019 and 2018, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | NOTE 5 – ACCRUED EXPENSES Accrued expenses consist of the following: September 30, December 31, 2019 2018 Clinical trials accrual $ 1,479,223 $ 1,352,133 Payroll and bonus accrual 2,109,293 2,779,021 Professional fees accrual 856,463 772,785 Other 236,716 184,923 Total $ 4,681,695 $ 5,088,862 |
Stockholders' Equity and Prefer
Stockholders' Equity and Preferred Stock | 9 Months Ended |
Sep. 30, 2019 | |
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. Pursuant to the Company’s amended and restated certificate of incorporation, the Company is authorized to issue up to 125,000,000 shares of common stock and 10,000,000 shares of 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. In September 2019, the Company entered into an exchange agreement with entities affiliated with Biotechnology Value Fund, L.P., pursuant to which the Company exchanged an aggregate of 1,262,000 shares of the Company’s common stock, owned by the Exchanging Stockholders for an aggregate of 1,262 shares of the Company’s Series A Convertible Preferred Stock. The Exchange Shares were issued without registration under the Securities Act of 1933, as amended, in reliance on the exemption from registration contained in Section 3(a)(9) of the Securities Act. In February 2019, the Company sold 13,993,778 shares of its common stock and 2,500 shares of Series A Preferred Stock at a public offering price of $2.00 and $2,000 per share, respectively, for gross proceeds of $33.0 million and net proceeds of $30.5 million, after deducting underwriting discounts and commission and other offering expenses payable by the Company. None of these expenses consisted of payments made by the Company to directors, officers or persons owning 10% or more of the Company’s common stock or to their associates, or to the Company’s affiliates. Each share of non-voting Series A Preferred Stock is convertible into 1,000 shares of common stock, provided that conversion will be prohibited, subject to certain exceptions, if, as a result, the holder and its affiliates would beneficially own more than 9.99% or 14.99%, at the holder’s election, of the common stock then 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 September 30, 2019 , the Company has not declared any dividends. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
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 Company's Board of Directors adopted and the Company's stockholders approved the 2017 equity incentive plan (“2017 Plan”), which became effective immediately on May 4, 2017. The initial reserve of shares of common stock 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. On January 1, 2019, an additional 1,232,705 shares were reserved for issuance under the 2017 Plan. As of September 30, 2019, there were 3,726,302 shares of the Company’s common stock reserved and available 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 Company’s initial public offering 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 three months ended September 30, 2019 and 2018, 35,416 and 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 generally 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 12 months. Performance-based option awards generally have similar terms, with vesting commencing on the date the performance condition is achieved and expire in accordance with the specific terms of the agreement. At September 30, 2019, there were 665,375 performance-based options outstanding and unvested that include options to be granted upon the achievement of certain research and development milestones. The fair value of options granted during the nine months ended September 30, 2019 and 2018 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. 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 SEC Staff Accounting Bulletin No. Topic 14D. The expected volatility was estimated based on historical volatility information of peer companies that are publicly available. 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 175,000 and zero stock options to nonemployee consultants for services rendered during the nine months ended September 30, 2019 and 2018, respectively. There were 152,073, and 12,356 unvested nonemployee options outstanding as of September 30, 2019, and 2018, respectively. Total expense recognized related to the nonemployee stock options for the three months ended September 30, 2019 and 2018 was $35,000 and $40,730, respectively. Total expense recognized related to the nonemployee stock options for the nine months ended September 30, 2019 and 2018 was $17,000 and $133,000, respectively. Total unrecognized compensation expenses related to the nonemployee stock options was $339,475 as of September 30, 2019. During the nine months ended September 30, 2019 and 2018, the Company recognized no expense for nonemployee performance-based option awards. The Company granted 1,781,115 and 1,352,578 stock options to employees during the nine months ended September 30, 2019 and 2018 respectively. There were 2,615,208 and 2,493,308 unvested employee options outstanding as of September 30, 2019, and 2018, respectively. Total expense recognized related to the employee stock options for the three months ended September 30, 2019 and 2018 was $1.1 million and $1.6 million, respectively. Total expense recognized related to the employee stock options for the nine months ended September 30, 2019 and 2018 was $ 4.0 The Company’s stock-based compensation expense was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 545,742 $ 790,770 $ 1,872,617 $ 2,296,259 General and administrative 638,740 902,836 2,206,312 3,036,522 Total $ 1,184,482 $ 1,693,606 $ 4,078,929 $ 5,332,781 Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Stock options $ 1,149,617 $ 1,663,566 $ 3,979,138 $ 5,256,112 Employee Stock Purchase Plan 34,865 30,040 99,791 76,669 Total $ 1,184,482 $ 1,693,606 $ 4,078,929 $ 5,332,781 The fair value of employee options granted during the three and nine months ended September 30, 2019 and 2018 was estimated by utilizing the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average Volatility 76.55 % 89.04 % 84.38 % 84.56 % Expected term in years 6.08 5.78 6.07 6.00 Dividend rate 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 1.72 % 2.78 % 2.43 % 2.60 % Fair value of option on grant date $ 1.44 $ 4.84 $ 1.52 $ 6.06 The fair value of nonemployee options granted and remeasured during the three and the nine months ended September 30, 2019 and 2018 was estimated by utilizing the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average Volatility - 85.80 % 74.56 % 85.80 % Expected term in years - 3.48 5.30 3.48 Dividend rate - 0.00 % 0.00 % 0.00 % Risk-free interest rate - 2.77 % 2.37 % 2.77 % Fair value of option on measurement date - $ 2.92 $ 1.07 $ 2.92 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 December 31, 2018 4,714,383 $ 8.10 7.89 $ 153,485 Granted 1,956,115 2.02 9.46 Exercised - - - Forfeited or expired (791,740 ) 6.63 - Options Outstanding September 30, 2019 5,878,758 $ 6.28 7.77 $ 2,411,391 Vested and exercisable at September 30, 2019 3,111,477 $ 7.92 6.76 $ 252,705 At September 30, 2019 there was approximately $6.6 million of unamortized share–based compensation expense, which is expected to be recognized over a remaining average vesting period of 2.01 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | NOTE 8 – INCOME TAXES The Company did not record a federal or state income tax provision for the periods presented as it has incurred net losses since inception. In addition, the net deferred tax assets generated from the net operating losses have been fully reserved as the Company believes it is not more likely than not that the benefit will be realized. During the nine months ended September 30, 2018, the Company recorded a $186,000 refundable credit towards future New York City tax expense as a reduction to operating expenses. The credit is for qualified emerging technology companies focused on biotechnology located in New York City. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
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 (the “Lundbeck Agreement”). . Pursuant to the amended Lundbeck license agreement, the Company agreed to make milestone payments totaling up to $189.0 million upon the achievement of certain development, regulatory and sales milestones. As amended, the first payment of $1.0 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 called for the Company to pay royalties for an initial term based on a low double-digit percentage of sales. The Lundbeck Amendment reduced such royalties from a low-double digit percentage of sales to single-digit and a low-double digit percentage of sales. In addition, the Lundbeck Agreement, as amended, removed the right of first negotiation that was granted by the Company to Lundbeck. Finally, the Lundbeck Agreement, as amended, removed the distinction for countries in the Asian Major Markets, now the Asian Major Markets will be treated the same as the rest of the world and the Company agreed to add certain regulatory milestones in the Asian Major Markets and such additional regulatory milestones are included in the total milestone payments of $189.0 million reported above. In December 2016, the Company entered into a license agreement with Northwestern University (“Northwestern”), pursuant to which Northwestern granted the Company an exclusive, worldwide license to patent rights in certain inventions (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 September 30, 2019, 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, certain of our executive officers are 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 executive officer’s delivery to the Company of a satisfactory release of claims, and subject to the executive officer’s compliance with non-competition and non-solicitation restrictive covenants. Pursuant to the Northwestern agreement, 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 its 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. On May 20, 2019, the Company entered into a Settlement Agreement with Catalyst, pursuant to which Catalyst released the Company from any and all claims, known or unknown, arising from or related to the dispute between Catalyst and Northwestern, the License Agreement, and/or the claims that Catalyst asserted against the Company in the June 25, 2018 letter. Under the settlement the Company retains all rights and privileges previously granted to the Company under the Northwestern Licensing Agreement. |
Collaboration Agreement
Collaboration Agreement | 9 Months Ended |
Sep. 30, 2019 | |
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 with Takeda to jointly develop and commercialize the compound TAK-935, which the Company has licensed from Takeda and now refers to as OV935 (soticlestat), in certain territories. 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 (including preferred stock on an as-converted basis) on the issuance date or (b) $50.0 million divided by the applicable share price. The remaining potential global commercial and regulatory milestone payments equal approximately $35.0 million and can be satisfied in cash or unregistered shares of the Company’s common stock at its election, unless certain events occur. In the event a payment settled in shares of the Company’s common stock would cause Takeda to own over 19.99% of the Company’s outstanding capital stock or certain other events occur, such payment must be paid in cash. None of these potential milestone payments mentioned above are deemed probable at September 30, 2019. During the nine months ended September 30, 2019, the Company recognized a credit in research and development expenses of $3.6 million representing costs to be reimbursed to the Company from Takeda During the nine months ended September 30, 2018, the Company recognized a credit of $681,000 in research and development expenses representing expenses reimbursed to the Company from Takeda in respect of this collaboration agreement. During the three months ended September 30, 2019, the Company recognized a credit of $ in research and development expenses representing costs reimbursable to the Company from Takeda. During the three months ended September 30, 2018, the Company recognized a credit of $776,000 research and development expenses 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 the Company, and Takeda will grant the Company 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. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 11 – RELATED PARTY TRANSACTIONS As part of the Company’s collaboration agreement with Takeda the Company recognized a long-term liability representing long-term prepaid expenses to be reimbursed to Takeda. On March 24, 2019, the Company entered into a separation and consulting agreement with Dr. Matthew During as President and Chief Scientific Officer Pursuant to the separation and consulting agreement, Dr. During agreed to non-solicit and non-compete covenants through such time as he remains a consultant to the Company, as well as a general release of claims in connection therewith. Dr. During agreed to a three-year consulting arrangement, pursuant to which he will be paid, amongst other specific milestone and meeting related fees, $150,000 per year for his role as the Chairman of our Scientific Advisory Board and $150,000 per year for other advisory and consulting services. Further, Dr. During was granted options to acquire 100,000 shares of common stock at an exercise price of $1.76 per share, the fair market value on April 1, 2019, which options shall vest in full upon completion of a specific clinical milestone, subject to Dr. During’s continued service through such vesting date. In the event such option does not vest by December 31, 2020, the stock option will expire. Provided further, in recognition of Dr. During’s service on the Scientific Advisory Board, Dr. During was granted options to acquire 75,000 shares of common stock at an exercise price equal to $1.76 per share, the fair market value on April 1, 2019. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NOTE 12 – NET LOSS PER 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, the common shares underlying the 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. Under the terms of the Series A Preferred Stock issued in 2019, Preferred stockholders do not share in losses of the Company and have no obligation to fund losses or transfer assets. Since there is a loss, diluted EPS should be computed in the same manner as basic EPS and because no potential common shares shall be included in the computation of any diluted per-share amounts when a loss exists, the Series A Preferred Stock should be excluded from the computation of basic and diluted EPS. There was no Preferred Stock issued or outstanding in 2018. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: Nine Months Ended September 30, 2019 2018 Stock options to purchase common stock 5,878,758 5,197,915 Series A convertible preferred stock 3,762 - |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 13 – SUBSEQUENT EVENTS Public Stock Offering On October 4, 2019, the Company sold 9,000,000 shares of its common stock and 4,000 shares of Series A Convertible Preferred Stock at a public offering price of $2.50 and $2,500 per share, respectively, for gross proceeds of $32.5 million and estimated net proceeds of $30.5 million after deducting underwriting discounts and commission and other |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Unaudited Interim Condensed Financial Statements | (A) Unaudited Interim Condensed Financial Statements The interim condensed balance sheet at September 30, 2019, the condensed statements of operations, comprehensive loss and stockholders’ equity for the three and nine months ended September 30, 2019 and 2018, and the condensed statements of cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP are condensed or omitted. These condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2019 and 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The balance sheet as of December 31, 2018 included herein was derived from the audited financial statements as of that date. These interim condensed financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K. |
Basis of Presentation and Consolidation | (B) Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with 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 | (C) 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 income and expenses during the reporting period. Actual results could differ materially from those estimates. |
Fair Value of Financial Instruments | (D) 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. • 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. • 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 carrying amounts reported in the balance sheets for cash and cash equivalents, related party receivables, other current assets, accounts payable, accrued expenses, and current related party payables approximate their fair value based on the short-term maturity of these instruments. |
Recent Accounting Pronouncements | ( E) Recent Accounting Pronouncements Recent accounting standards which have been adopted On June 20, 2018, the FASB issued Accounting Standards Update (“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 Accounting Standards Codification (“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, which is the same as the measurement date for employee equity awards and for performance-based awards, an entity is now 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. T he adoption of ASU 2018-07 on January 1, 2019 did not have a material impact on the Company’s 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 was applicable to the Company beginning on January 1, 2019. The adoption of ASU 2017-08 did not have a material impact on the Company’s financial statements. 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. This new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The adoption of ASU 2016-02 did not have a material impact on the Company’s financial statements. New accounting standards which have not yet been adopted 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 eliminates certain disclosures, adds 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 modifies 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. 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-Te_2
Cash Equivalents and Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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 September 30, 2019 and December 31, 2018: September 30, 2019 Amortized Gross unrealized Gross unrealized Fair cost holding gains holding losses value Cash $ 141,572 $ - $ - $ 141,572 Money market funds (a) 37,766,332 - - 37,766,332 Total cash and cash equivalents $ 37,907,904 $ - $ - $ 37,907,904 (a) As of September 30, 2019, the Company's Level 1 assets consisted of money market funds totaling $37.8 million. The Company had no level 2 or level 3 assets or liabilities as of September 30, 2019. 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 $40.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. |
Property and Equipment and In_2
Property and Equipment and Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment is summarized as follows: September 30, December 31, 2019 2018 Furniture and equipment $ 186,888 $ 156,031 Less accumulated depreciation (114,647 ) (86,164 ) Total property and equipment, net $ 72,241 $ 69,867 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: September 30, December 31, 2019 2018 Clinical trials accrual $ 1,479,223 $ 1,352,133 Payroll and bonus accrual 2,109,293 2,779,021 Professional fees accrual 856,463 772,785 Other 236,716 184,923 Total $ 4,681,695 $ 5,088,862 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Recognized Stock-Based Compensation Expense | The Company’s stock-based compensation expense was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Research and development $ 545,742 $ 790,770 $ 1,872,617 $ 2,296,259 General and administrative 638,740 902,836 2,206,312 3,036,522 Total $ 1,184,482 $ 1,693,606 $ 4,078,929 $ 5,332,781 |
Schedule of Allocation of Stock-based Compensation Expense by Plan | Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Stock options $ 1,149,617 $ 1,663,566 $ 3,979,138 $ 5,256,112 Employee Stock Purchase Plan 34,865 30,040 99,791 76,669 Total $ 1,184,482 $ 1,693,606 $ 4,078,929 $ 5,332,781 |
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 December 31, 2018 4,714,383 $ 8.10 7.89 $ 153,485 Granted 1,956,115 2.02 9.46 Exercised - - - Forfeited or expired (791,740 ) 6.63 - Options Outstanding September 30, 2019 5,878,758 $ 6.28 7.77 $ 2,411,391 Vested and exercisable at September 30, 2019 3,111,477 $ 7.92 6.76 $ 252,705 |
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 three and nine months ended September 30, 2019 and 2018 was estimated by utilizing the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average Volatility 76.55 % 89.04 % 84.38 % 84.56 % Expected term in years 6.08 5.78 6.07 6.00 Dividend rate 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 1.72 % 2.78 % 2.43 % 2.60 % Fair value of option on grant date $ 1.44 $ 4.84 $ 1.52 $ 6.06 |
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 three and the nine months ended September 30, 2019 and 2018 was estimated by utilizing the following assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average Volatility - 85.80 % 74.56 % 85.80 % Expected term in years - 3.48 5.30 3.48 Dividend rate - 0.00 % 0.00 % 0.00 % Risk-free interest rate - 2.77 % 2.37 % 2.77 % Fair value of option on measurement date - $ 2.92 $ 1.07 $ 2.92 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [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: Nine Months Ended September 30, 2019 2018 Stock options to purchase common stock 5,878,758 5,197,915 Series A convertible preferred stock 3,762 - |
Nature of Operations - Addition
Nature of Operations - Additional Information (Detail) - USD ($) | Nov. 05, 2019 | Oct. 04, 2019 | Oct. 31, 2019 | Feb. 28, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Gross proceeds from issuance of stock | $ 33,000,000 | |||||||
Net proceeds from issuance of stock | $ 30,500,000 | |||||||
Accumulated deficit | $ 196,187,312 | $ 152,695,278 | ||||||
Cash outflows from operating activities | $ (34,202,268) | $ (34,592,870) | ||||||
Subsequent Event [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Gross proceeds from issuance of stock | $ 3,400,000 | $ 32,500,000 | $ 32,500,000 | |||||
Net proceeds from issuance of stock | $ 3,200,000 | $ 30,500,000 | $ 30,500,000 | |||||
Subsequent Event [Member] | Underwriter [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Stock issued, price per share | $ 2.50 | |||||||
Additional shares of common stock that can be purchased under the option | 1,350,000 | |||||||
Granted time period to use option of additional shares to purchase | 30 days | 30 days | ||||||
Common Stock [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Number of shares issued | 13,993,778 | 13,993,778 | ||||||
Stock issued, price per share | $ 2 | |||||||
Common Stock [Member] | Subsequent Event [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Number of shares issued | 9,000,000 | 9,000,000 | ||||||
Stock issued, price per share | $ 2.50 | $ 2.50 | ||||||
Series A Convertible Preferred Stock [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Number of shares issued | 2,500 | |||||||
Stock issued, price per share | $ 2,000 | |||||||
Series A Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Number of shares issued | 4,000 | 4,000 | ||||||
Stock issued, price per share | $ 2,500 | $ 2,500 |
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 ($) | Sep. 30, 2019 | Dec. 31, 2018 | ||
Schedule Of Available For Sale Securities [Line Items] | ||||
Total cash and cash equivalents, Amortized cost | $ 37,907,904 | $ 36,489,618 | ||
Total cash and cash equivalents, Fair value | 37,907,904 | 36,489,618 | ||
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 | 5,012,863 | |||
Total short-term investments, Gross unrealized holding losses | (1,829) | |||
Total short-term investments, Fair value | 5,011,034 | |||
Cash [Member] | ||||
Schedule Of Available For Sale Securities [Line Items] | ||||
Total cash and cash equivalents, Amortized cost | 141,572 | 927,354 | ||
Total cash and cash equivalents, Fair value | 141,572 | 927,354 | ||
Money Market Funds [Member] | ||||
Schedule Of Available For Sale Securities [Line Items] | ||||
Total cash and cash equivalents, Amortized cost | 37,766,332 | [1] | 35,562,264 | [2] |
Total cash and cash equivalents, Fair value | $ 37,766,332 | [1] | $ 35,562,264 | [2] |
[1] | (a) As of September 30, 2019, the Company's Level 1 assets consisted of money market funds totaling $37.8 million. The Company had no level 2 or level 3 assets or liabilities as of September 30, 2019. | |||
[2] | As of December 31, 2018, the Company's Level 1 assets consisted of money market funds and U.S. treasury notes totaling $40.6 million. The Company had no level 2 or level 3 assets or liabilities as of December 31, 2018. |
Cash Equivalents and Short-Te_4
Cash Equivalents and Short-Term Investments - Summary of Fair Value of Cash Equivalents, Short-Term Investments and Gross Unrealized Holding Gains and Losses (Parenthetical) (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Fair Value Level 1 [Member] | Money Market Funds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | $ 37,800,000 | |
Fair Value Level 1 [Member] | Money Market Funds US Treasury Notes [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Fair value assets | $ 40,600,000 | |
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) $ in Millions | Sep. 30, 2019USD ($)Investment | Dec. 31, 2018USD ($) |
Investments Debt And Equity Securities [Abstract] | ||
Aggregate fair value of securities that were in an unrealized loss position for less than 12 months | $ | $ 0 | $ 5 |
Number of securities in an unrealized loss position for more than 12 months | Investment | 0 |
Property and Equipment and In_3
Property and Equipment and Intangible Assets - Summary of Property and Equipment (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Less accumulated depreciation | $ (114,647) | $ (86,164) |
Total property and equipment, net | 72,241 | 69,867 |
Furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment | $ 186,888 | $ 156,031 |
Property and Equipment and In_4
Property and Equipment and Intangible Assets - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||||
Depreciation expense | $ 10,000 | $ 7,000 | $ 28,000 | $ 26,000 | |
Intangible assets, net of accumulated amortization | 351,000 | 351,000 | $ 392,000 | ||
Amortization expense | $ 46,000 | $ 25,000 | $ 173,000 | $ 61,000 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Clinical trials accrual | $ 1,479,223 | $ 1,352,133 |
Payroll and bonus accrual | 2,109,293 | 2,779,021 |
Professional fees accrual | 856,463 | 772,785 |
Other | 236,716 | 184,923 |
Total | $ 4,681,695 | $ 5,088,862 |
Stockholders' Equity and Pref_2
Stockholders' Equity and Preferred Stock - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Feb. 28, 2019 | Sep. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | |
Class Of Stock [Line Items] | |||||
Common stock, shares authorized | 125,000,000 | 125,000,000 | 125,000,000 | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||
Common stock voting rights | one vote for each share held | ||||
Payment of share issuance expenses by persons owning 10% or more of common stock | $ 0 | $ 0 | |||
Gross proceeds from issuance of stock | 33,000,000 | ||||
Net proceeds from issuance of stock | $ 30,500,000 | ||||
Maximum allowable owning percentage of outstanding common stock by associates or affiliates | 9.99% | ||||
Maximum allowable voting right percentage of outstanding common stock holders | 14.99% | ||||
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 | ||||
Convertible Preferred Stock [Member] | |||||
Class Of Stock [Line Items] | |||||
Conversion of common stock to series A convertible preferred stock, Shares | 1,262 | ||||
Number of shares issued | 2,500 | ||||
Convertible Preferred Stock [Member] | Biotechnology Value Fund, L.P [Member] | |||||
Class Of Stock [Line Items] | |||||
Conversion of common stock to series A convertible preferred stock, Shares | 1,262 | ||||
Common Stock [Member] | |||||
Class Of Stock [Line Items] | |||||
Conversion of common stock to series A convertible preferred stock, Shares | (1,262,000) | ||||
Number of shares issued | 13,993,778 | 13,993,778 | |||
Stock issued, price per share | $ 2 | ||||
Common Stock [Member] | Biotechnology Value Fund, L.P [Member] | |||||
Class Of Stock [Line Items] | |||||
Conversion of common stock to series A convertible preferred stock, Shares | 1,262,000 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Class Of Stock [Line Items] | |||||
Number of shares issued | 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 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jan. 01, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 1,184,482 | $ 1,693,606 | $ 4,078,929 | $ 5,332,781 | |
Stock options, granted | 1,956,115 | ||||
Unrecognized compensation expenses | $ 6,600,000 | $ 6,600,000 | |||
Unrecognized compensation not yet recognized, period for recognition | 2 years 3 days | ||||
Performance-based Option Awards [Member] | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 9,000 | 0 | |||
Unvested stock options, outstanding | 665,375 | 665,375 | |||
Nonemployee Stock Options [Member] | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 35,000 | $ 40,730 | $ 17,000 | $ 133,000 | |
Unvested stock options, outstanding | 152,073 | 12,356 | 152,073 | 12,356 | |
Stock options, granted | 175,000 | 0 | |||
Unrecognized compensation expenses | $ 339,475 | $ 339,475 | |||
Non-employee Performance Based Option Awards [Member] | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | 0 | $ 0 | |||
Employee Stock Option [Member] | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 1,100,000 | $ 1,600,000 | $ 4,000,000 | $ 5,100,000 | |
Unvested stock options, outstanding | 2,615,208 | 2,493,308 | 2,615,208 | 2,493,308 | |
Stock options, granted | 1,781,115 | 1,352,578 | |||
Unrecognized compensation expenses | $ 6,300,000 | $ 6,300,000 | |||
2017 Equity Incentive Plan [Member] | |||||
Stock-Based Compensation [Line Items] | |||||
Common stock, reserved for future issuance | 3,052,059 | 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 | 1,232,705 | ||||
Number of company's common stock reserved for issuance under the plan | 3,726,302 | 3,726,302 | |||
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 | 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 common 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 | 246,541 | ||||
Number of company's common stock reserved for issuance under the plan | 659,016 | 659,016 | |||
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 | 35,416 | 22,142 | 80,542 | 32,114 | |
Share based compensation expense | $ 35,000 | $ 30,000 | $ 100,000 | $ 77,000 | |
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 ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-Based Compensation [Line Items] | ||||
Stock-based compensation expense, Total | $ 1,184,482 | $ 1,693,606 | $ 4,078,929 | $ 5,332,781 |
Research and Development [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Stock-based compensation expense, Total | 545,742 | 790,770 | 1,872,617 | 2,296,259 |
General and Administrative Expenses [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Stock-based compensation expense, Total | $ 638,740 | $ 902,836 | $ 2,206,312 | $ 3,036,522 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Allocation of Stock-Based Compensation Expense by Plan (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-Based Compensation [Line Items] | ||||
Share based compensation expense | $ 1,184,482 | $ 1,693,606 | $ 4,078,929 | $ 5,332,781 |
Stock Options [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Share based compensation expense | 1,149,617 | 1,663,566 | 3,979,138 | 5,256,112 |
Employee Stock Purchase Plan [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Share based compensation expense | $ 34,865 | $ 30,040 | $ 99,791 | $ 76,669 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Assumptions Used to Compute Fair Value of Employee Option Granted (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Stock Option [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Weighted Average, Volatility | 76.55% | 89.04% | 84.38% | 84.56% |
Weighted Average, Expected term in years | 6 years 29 days | 5 years 9 months 10 days | 6 years 25 days | 6 years |
Weighted Average, Dividend rate | 0.00% | 0.00% | 0.00% | 0.00% |
Weighted Average, Risk-free interest rate | 1.72% | 2.78% | 2.43% | 2.60% |
Weighted Average, Fair value of option on grant/measurement date | $ 1.44 | $ 4.84 | $ 1.52 | $ 6.06 |
Nonemployee Stock Options [Member] | ||||
Stock-Based Compensation [Line Items] | ||||
Weighted Average, Volatility | 85.80% | 74.56% | 85.80% | |
Weighted Average, Expected term in years | 3 years 5 months 23 days | 5 years 3 months 18 days | 3 years 5 months 23 days | |
Weighted Average, Dividend rate | 0.00% | 0.00% | 0.00% | |
Weighted Average, Risk-free interest rate | 2.77% | 2.37% | 2.77% | |
Weighted Average, Fair value of option on grant/measurement date | $ 2.92 | $ 1.07 | $ 2.92 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Options Outstanding and Weighted Average Exercise Price (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Number of Shares, Options Outstanding, Beginning balance | 4,714,383 | |
Number of Shares, Granted | 1,956,115 | |
Number of Shares, Forfeited or expired | (791,740) | |
Number of Shares, Options Outstanding, Ending balance | 5,878,758 | 4,714,383 |
Number of Shares, Vested and exercisable, Ending balance | 3,111,477 | |
Weighted Average Exercise Price, Options Outstanding | $ 8.10 | |
Weighted Average Exercise Price, Granted | 2.02 | |
Weighted Average Exercise Price, Forfeited or expired | 6.63 | |
Weighted Average Exercise Price, Options Outstanding | 6.28 | $ 8.10 |
Weighted Average Exercise Price, Vested and exercisable | $ 7.92 | |
Weighted Average Remaining Contractual Life, Options Outstanding | 7 years 9 months 7 days | 7 years 10 months 20 days |
Weighted Average Remaining Contractual Life, Granted | 9 years 5 months 16 days | |
Weighted Average Remaining Contractual Life, Vested and exercisable | 6 years 9 months 3 days | |
Aggregate Intrinsic Value, Options Outstanding | $ 2,411,391 | $ 153,485 |
Aggregate Intrinsic Value, Vested and exercisable | $ 252,705 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Income Taxes Disclosure [Line Items] | ||
Federal or state income tax provision | $ 0 | |
New York State Division of Taxation and Finance Member [Member] | ||
Income Taxes Disclosure [Line Items] | ||
Refundable tax credit towards future tax expense | $ 186,000 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Detail) - License Agreement [Member] | Mar. 26, 2015USD ($)Trial | Dec. 31, 2016USD ($)Product | Sep. 30, 2019 |
Lundbeck [Member] | |||
Loss Contingencies [Line Items] | |||
License agreement entered date | Mar. 26, 2015 | ||
First payment due upon completion of first phase | $ 1,000,000 | ||
Number of trial | Trial | 3 | ||
Lundbeck [Member] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
License agreement milestone payments | $ 189,000,000 | ||
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) - Takeda Pharmaceutical Company Limited [Member] - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Jan. 06, 2017 | |
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 | ||||
Collaborative Arrangement, Co-promotion [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Research and development expense reimbursement received | $ 725,000 | $ 776,000 | $ 3,600,000 | $ 681,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | Apr. 01, 2019 | Sep. 30, 2019 |
Related Party Transaction [Line Items] | ||
Options granted to acquire shares | 1,956,115 | |
Exercise price per share | $ 2.02 | |
Separation and Consulting Agreement [Member] | Dr. During [Member] | ||
Related Party Transaction [Line Items] | ||
Consulting arrangement period | 3 years | |
Fees to be paid per year | $ 150,000 | |
Other advisory and consulting services to be paid per year | $ 150,000 | |
Common Stock [Member] | Separation and Consulting Agreement [Member] | Dr. During [Member] | 75000 Shares Vest After December, 2020 [Member] | ||
Related Party Transaction [Line Items] | ||
Options granted to acquire shares | 75,000 | |
Exercise price per share | $ 1.76 | |
Common Stock [Member] | Separation and Consulting Agreement [Member] | Dr. During [Member] | 100,000 Shares Vest Before December 31, 2020 [Member] | ||
Related Party Transaction [Line Items] | ||
Options granted to acquire shares | 100,000 | |
Exercise price per share | $ 1.76 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) | Sep. 30, 2018shares |
Earnings Per Share [Abstract] | |
Preferred stock, shares issued | 0 |
Preferred stock, shares outstanding | 0 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Shares Outstanding (Detail) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
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 | 5,878,758 | 5,197,915 |
Series A Convertible Preferred 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 | 3,762 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | Nov. 05, 2019 | Oct. 04, 2019 | Oct. 31, 2019 | Feb. 28, 2019 | Mar. 31, 2019 | Sep. 30, 2019 |
Subsequent Event [Line Items] | ||||||
Gross proceeds from issuance of stock | $ 33,000,000 | |||||
Estimated net proceeds from issuance of stock | 30,500,000 | |||||
Payment of share issuance expenses by persons owning 10% or more of common stock | $ 0 | $ 0 | ||||
Maximum allowable owning percentage of outstanding common stock by associates or affiliates | 9.99% | |||||
Maximum allowable voting right percentage of outstanding common stock holders | 14.99% | |||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Gross proceeds from issuance of stock | $ 3,400,000 | $ 32,500,000 | $ 32,500,000 | |||
Estimated net proceeds from issuance of stock | $ 3,200,000 | 30,500,000 | $ 30,500,000 | |||
Payment of share issuance expenses by persons owning 10% or more of common stock | $ 0 | |||||
Maximum allowable owning percentage of outstanding common stock by associates or affiliates | 9.99% | |||||
Maximum allowable voting right percentage of outstanding common stock holders | 14.99% | |||||
Subsequent Event [Member] | Underwriter [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Stock issued, price per share | $ 2.50 | |||||
Granted time period to use option of additional shares to purchase | 30 days | 30 days | ||||
Common Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from February Offering, net of underwriting costs and commissions, Shares | 13,993,778 | 13,993,778 | ||||
Stock issued, price per share | $ 2 | |||||
Common Stock [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from February Offering, net of underwriting costs and commissions, Shares | 9,000,000 | 9,000,000 | ||||
Stock issued, price per share | $ 2.50 | $ 2.50 | ||||
Series A Convertible Preferred Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from February Offering, net of underwriting costs and commissions, 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 | |||||
Series A Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from February Offering, net of underwriting costs and commissions, Shares | 4,000 | 4,000 | ||||
Stock issued, price per share | $ 2,500 | $ 2,500 | ||||
Number of shares issued for each share of convertible preferred stock that is converted | 1,000 |