Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 10, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38085 | ||
Entity Registrant Name | Ovid Therapeutics Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-5270895 | ||
Entity Address, Address Line One | 441 Ninth Avenue | ||
Entity Address, Address Line Two | 14th Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10001 | ||
City Area Code | 646 | ||
Local Phone Number | 661-7661 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | OVID | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 124.9 | ||
Entity Common Stock, Shares Outstanding | 70,491,510 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2023 Annual Meeting of Stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001636651 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 185 |
Auditor Name | KPMG LLP |
Auditor Location | New York, New York |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 44,867,846 | $ 187,797,532 |
Marketable securities | 84,133,565 | 0 |
Prepaid expenses and other current assets | 2,379,280 | 2,681,597 |
Total current assets | 131,380,691 | 190,479,129 |
Long-term equity investments | 5,622,547 | 1,631,992 |
Restricted cash | 1,930,753 | 1,930,753 |
Right-of-use asset, net | 14,922,669 | 0 |
Property and equipment, net | 1,147,963 | 242,757 |
Other assets | 261,191 | 260,126 |
Total assets | 155,265,814 | 194,544,757 |
Current liabilities: | ||
Accounts payable | 1,952,910 | 7,127,046 |
Accrued expenses | 4,504,669 | 7,671,275 |
Current portion, lease liability | 533,946 | 0 |
Total current liabilities | 6,991,525 | 14,798,321 |
Long-term liabilities: | ||
Lease liability | 16,001,725 | 0 |
Total liabilities | 22,993,250 | 14,798,321 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; Series A convertible preferred stock, 10,000 shares designated, 1,250 shares issued and outstanding at December 31, 2022 and 2021 | 1 | 1 |
Common stock, $0.001 par value; 125,000,000 shares authorized; 70,466,885 and 70,364,912 shares issued and outstanding at December 31, 2022 and 2021, respectively | 70,467 | 70,359 |
Additional paid-in-capital | 357,770,825 | 351,033,589 |
Accumulated other comprehensive loss | (42,187) | 0 |
Accumulated deficit | (225,526,542) | (171,357,513) |
Total stockholders' equity | 132,272,564 | 179,746,436 |
Total liabilities and stockholders' equity | $ 155,265,814 | $ 194,544,757 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, share designated (in shares) | 10,000 | 10,000 |
Preferred stock, shares issued (in shares) | 1,250 | 1,250 |
Preferred stock, shares outstanding (in shares) | 1,250 | 1,250 |
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares issued (in shares) | 70,466,885 | 70,364,912 |
Common stock, shares outstanding (in shares) | 70,466,885 | 70,364,912 |
Accumulated other comprehensive loss | $ (42,187) | $ 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Total revenue | $ 1,502,748 | $ 208,382,779 |
Operating expenses: | ||
Research and development | 24,618,399 | 46,939,583 |
General and administrative | 32,432,510 | 37,234,104 |
Total operating expenses | 57,050,909 | 84,173,687 |
(Loss) income from operations | (55,548,161) | 124,209,092 |
Other income (expense), net | 1,379,132 | (45,690) |
(Loss) income before provision for income taxes | (54,169,029) | 124,163,402 |
Provision for income taxes | 0 | 1,328,818 |
Net (loss) income | $ (54,169,029) | $ 122,834,584 |
Net (loss) income per share, basic (in USD per share) | $ (0.77) | $ 1.78 |
Net (loss) income per share, diluted (in USD per share) | $ (0.77) | $ 1.76 |
Weighted-average common shares outstanding, basic (in shares) | 70,424,819 | 67,479,403 |
Weighted-average common shares outstanding, diluted (in shares) | 70,424,819 | 68,067,992 |
License and other revenue | ||
Revenue: | ||
Total revenue | $ 1,502,748 | $ 12,382,779 |
License revenue - related party | ||
Revenue: | ||
Total revenue | $ 0 | $ 196,000,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net (loss) income | $ (54,169,029) | $ 122,834,584 |
Other comprehensive loss: | ||
Unrealized loss on marketable securities | (42,187) | 0 |
Comprehensive (loss) income | $ (54,211,216) | $ 122,834,584 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Convertible Preferred Stock Preferred Stock |
Beginning balance (in shares) at Dec. 31, 2020 | 3,250 | |||||
Beginning balance at Dec. 31, 2020 | $ 43,631,656 | $ 65,743 | $ 337,758,007 | $ 0 | $ (294,192,097) | $ 3 |
Beginning balance (in shares) at Dec. 31, 2020 | 65,743,170 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock in asset purchase, shares (in shares) | 2,272,727 | |||||
Issuance of common stock in asset acquisition | 7,300,000 | $ 2,273 | 7,297,727 | |||
Issuance of common stock from exercise of stock options and employee stock purchase plan (in shares) | 349,015 | |||||
Issuance of common stock from exercise of stock options and employee stock purchase plan | 925,739 | $ 343 | 925,396 | |||
Conversion of series A convertible preferred stock to common stock, shares (in shares) | 2,000,000 | (2,000) | ||||
Conversion of series A convertible preferred stock to common stock | 0 | $ 2,000 | (1,998) | $ (2) | ||
Stock-based compensation expense | 5,054,457 | 5,054,457 | ||||
Net (loss) income | $ 122,834,584 | 122,834,584 | ||||
Ending balance (in shares) at Dec. 31, 2021 | 1,250 | 1,250 | ||||
Ending balance at Dec. 31, 2021 | $ 179,746,436 | $ 70,359 | 351,033,589 | 0 | (171,357,513) | $ 1 |
Ending balance (in shares) at Dec. 31, 2021 | 70,364,912 | 70,364,912 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock from exercise of stock options and employee stock purchase plan (in shares) | 101,973 | |||||
Issuance of common stock from exercise of stock options and employee stock purchase plan | $ 180,658 | $ 108 | 180,550 | |||
Stock-based compensation expense | 6,556,686 | 6,556,686 | ||||
Other comprehensive loss | (42,187) | (42,187) | ||||
Net (loss) income | $ (54,169,029) | (54,169,029) | ||||
Ending balance (in shares) at Dec. 31, 2022 | 1,250 | 1,250 | ||||
Ending balance at Dec. 31, 2022 | $ 132,272,564 | $ 70,467 | $ 357,770,825 | $ (42,187) | $ (225,526,542) | $ 1 |
Ending balance (in shares) at Dec. 31, 2022 | 70,466,885 | 70,466,885 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net (loss) income | $ (54,169,029) | $ 122,834,584 |
Adjustments to reconcile net (loss) income to cash used in operating activities: | ||
Non-cash research and development expense | 0 | 7,300,000 |
Non-cash consideration received in licensing agreement transaction | (945,366) | 0 |
Unrealized loss on equity investment | 454,811 | 0 |
Interest income and accretion of discount on marketable securities | (1,211,311) | 0 |
Stock-based compensation expense | 6,556,686 | 5,054,457 |
Depreciation and amortization expense | 512,505 | 237,079 |
Amortization of right-of-use asset | 869,100 | 0 |
Accretion of lease liability | 936,927 | 0 |
Change in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 109,292 | 40,503 |
Accounts payable | (5,174,136) | 1,702,497 |
Accrued expenses | (3,166,606) | (4,361,410) |
Deferred revenue | 0 | (12,382,779) |
Related party payable | 0 | (2,432,192) |
Related party receivable | 0 | 141,763 |
Long-term prepaid expenses | 0 | 477,171 |
Net cash (used in) provided by operating activities | (55,227,127) | 118,611,673 |
Cash flows from investing activities: | ||
Purchase of marketable securities | (172,964,441) | 0 |
Sales/maturities of marketable securities | 90,000,000 | 0 |
Purchase of long-term equity investments | (2,500,000) | (1,631,992) |
Issuance of short-term note receivable | (1,000,000) | 0 |
Purchase of property and equipment | (1,224,379) | (184,008) |
Software development and other assets | (194,397) | (5,400) |
Net cash used in investing activities | (87,883,217) | (1,821,400) |
Cash flows from financing activities: | ||
ATM and other offering costs | 0 | (21,314) |
Proceeds from exercise of options and employee stock purchase plan | 180,658 | 925,396 |
Net cash provided by financing activities | 180,658 | 904,082 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (142,929,686) | 117,694,355 |
Cash, cash equivalents and restricted cash, at beginning of period | 189,728,285 | 72,033,930 |
Cash, cash equivalents and restricted cash, at end of period | 46,798,599 | 189,728,285 |
Non-cash investing and financing activities: | ||
Right-of-use asset in exchange for lease liability | 15,791,769 | 0 |
Conversion of short-term note receivable to long-term equity investment | $ 1,000,000 | $ 0 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS Ovid Therapeutics Inc. (the “Company”) was incorporated under the laws of the state of Delaware and commenced operations on April 1, 2014 (date of inception) and maintains its principal executive office in New York, New York. The Company is a biopharmaceutical company currently focused on developing impactful medicines for patients and families living with epilepsies and seizure-related 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 the 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 the ability to secure additional capital to fund operations. Historically, the Company’s major sources of cash have been licensing revenue, proceeds from various public and private offerings of its capital stock, and interest income. As of December 31, 2022, the Company had approximately $129.0 million in cash, cash equivalents and marketable securities. Since inception, the Company has generated $222.5 million in revenue which is primarily comprised of $25.0 million received pursuant to the Company’s license and collaboration agreement (the “Angelini License Agreement”) with Angelini Pharma Rare Diseases AG (“Angelini”) and a one-time, upfront payment of $196.0 million received pursuant to the Company’s royalty, license and termination agreement ("RLT Agreement") with Takeda Pharmaceutical Company Limited (“Takeda”). Historically, the Company has incurred recurring losses, has experienced recurring negative operating cash flows and required significant cash resources to execute its business plans. The Company has an accumulated deficit of $225.5 million as of December 31, 2022, working capital of $124.4 million and had cash used in operating activities of $55.2 million for the year ended December 31, 2022. The Company recorded a net loss of $54.2 million during the fiscal year ended December 31, 2022, expects to incur losses in subsequent periods 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, licensing agreements or a combination of any such transactions. Management believes that the Company’s existing cash, cash equivalents and marketable securities as of December 31, 2022 will be sufficient to fund its current operating plans through at least 12 months from the date of filing of the Company’s Annual Report on Form 10-K. 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. The Company 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. The Company is subject to other challenges and risks specific to the Company's business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: delays or problems in the supply of the Company's product candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing the Company's intellectual property rights; complying with applicable regulatory requirements; and obtaining regulatory approval of any of the Company's product candidates. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (A) Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP") and include the accounts of Ovid Therapeutics Inc. and its wholly-owned subsidiary, Ovid Therapeutics Hong Kong Limited. All intercompany transactions and balances have been eliminated in consolidation. (B) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. (C) Comprehensive (Loss) Income Comprehensive (loss) income includes net (loss) income as well as unrealized gains and losses on available-for-sale securities. (D) Marketable Securities Marketable securities consist of investments in U.S. treasury instruments which are considered available-for-sale securities. The Company classifies its marketable securities with maturities of less than one year from the balance sheet date as current assets on its consolidated balance sheets. Unrealized gains and losses on these securities that are determined to be temporary are reported as a separate component of accumulated other comprehensive loss in stockholders' equity. (E) Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash for which use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. (F) Long-term Equity Investments Long-term equity investments consist of an equity investment in the preferred shares of Gensaic, Inc., formerly M13 Therapeutics, Inc. ("Gensaic"), a privately held corporation. The preferred shares are not considered in-substance common stock, and the investment is accounted for at cost, with adjustments for observable changes in prices or impairments, and is classified within long-term equity investments on our consolidated balance sheets with adjustments recognized in other income (expense), net on our consolidated statements of operations. The Company has determined that the equity investment does not have a readily determinable fair value and elected the measurement alternative. Therefore, the equity investment’s carrying amount will be adjusted to fair value at the time of the next observable price change for the identical or similar investment of the same issuer or when an impairment is recognized. Each reporting period, the Company performs a qualitative assessment to evaluate whether the investment is impaired. The assessment includes a review of recent operating results and trends, recent sales/acquisitions of the investee's securities, and other publicly available data. If the investment is impaired, the Company writes it down to its estimated fair value. As of December 31, 2022 and 2021, the equity investment had a carrying value of $5.1 million and $1.6 million, respectively. Long-term equity investments also consist of an equity investment in the common shares of Marinus Pharmaceuticals, Inc. ("Marinus") that was received as non-cash consideration via the terms of a licensing agreement executed between the two companies effective March 2022. The equity shares are marked-to-market at each reporting date with changes in the fair value being reflected in the carrying value of the investment on the Company's consolidated balance sheets and other income (expense), net on the Company's consolidated statements of operations. As of December 31, 2022, the equity investment in Marinus had a carrying value of approximately $0.5 million. No impairments were recognized in the years ending December 31, 2022 and 2021. (G) Note Receivable On March 17, 2022, the Company issued a convertible promissory note with a principal amount of $1.0 million to Gensaic. The note included features that permitted the Company to acquire additional equity or to settle the note in cash. In August 2022, the Company executed an agreement with Gensaic which resulted in the conversion of the note into additional equity and was recorded as a long-term equity investment in the consolidated balance sheets. The Company received interest on the convertible promissory note at the rate of 1.5% per annum through the date of conversion. (H) Fair Value of Financial Instruments Financial Accounting Standards Board guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company's Level 1 assets consisted of investments in a U.S. treasury money market fund and equity securities totaling approximately $42.5 million as of December 31, 2022. The Company’s Level 1 assets consisted of money market funds and short-term investments totaling $181.4 million as of December 31, 2021. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. The Company's Level 2 assets consisted of U.S. treasury bills totaling approximately $84.1 million as of December 31, 2022. The Company had no Level 2 assets or liabilities as of December 31, 2021. • Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when the fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company had no Level 3 assets or liabilities as of December 31, 2022 or 2021. The carrying amounts reported in the consolidated balance sheets for cash, cash equivalents and marketable securities, other current assets, accounts payable, and accrued expenses approximate their fair values based on the short-term maturity of these instruments. (I) Leases The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Lease Accounting. Operating leases are included in right-of-use ("ROU") assets, current portion, lease liability and long-term lease liability in the Company's consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines the portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period. (J) Property and Equipment Property and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. Repair and maintenance costs are expensed. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. (K) Research and Development Expenses The Company expenses the cost of research and development as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and preclinical materials as well as contracted services, license fees, and other external costs. Research and development expenses also include the cost of licensing agreements acquired from third-parties, such as the acquisition of OV350 from AstraZeneca AB. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received in accordance with ASC 730, Research and Development. (L) Stock-based Compensation The Company accounts for its stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, which establishes accounting for stock-based awards granted to employees for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company estimates the fair value of all awards granted using the Black-Scholes valuation model. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield, stock price and exercise price. Many of the assumptions require significant judgment and any changes could have an impact in the determination of stock-based compensation expense. The Company elected an accounting policy to record forfeitures as they occur. The Company recognizes employee stock-based compensation expense based on the fair value of the award on the date of the grant. The compensation expense is recognized over the vesting period under the straight-line method. The Company accounts for option awards granted to nonemployee consultants and directors in accordance with ASC 718. The fair value of the option issued or committed to be issued is used to measure the transaction, as this is more reliable than the fair value of the services received. The fair value is measured at the value of the Company’s common stock award at the earlier of the date that the commitment for performance by the counterparty has been reached or the counterparty’s performance is complete. (M) Income Taxes The Company accounts for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as for net operating loss carryforwards and research and development credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The impact of a change in the tax laws is recorded in the period in which the law is enacted. (N) Net (Loss) Income per Share Net (loss) income per common share is determined by dividing net (loss) income attributable to common stockholders by the basic and diluted weighted-average common shares outstanding during the period. The Company applies the two-class method to allocate earnings between common stock and participating securities. Net (loss) income per diluted share attributable to common stockholders adjusts the basic earnings per share attributable to common stockholders and the weighted-average number of shares of common stock outstanding for the potential dilutive impact of stock options using the treasury-stock method and the potential impact of preferred stock using the if-converted method. (O) Retirement Plan The Company maintains a 401(k)-retirement plan for its employees that is intended to qualify under Sections 401(a) and 501(a) of the U.S. Internal Revenue Code of 1986, as amended (“Code”). The Company provides all active employees with a 100% matching contribution equal to 3% of an employee’s eligible deferred compensation and a 50% matching contribution on employee contributions that are between 3% and 5% of an employee’s eligible deferred compensation. These safe harbor contributions vest immediately. For the years ended December 31, 2022 and 2021 the Company contributed $339,405 and $438,043, respectively. (P) Revenue Recognition Under ASC 606, Revenue Recognition, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. In applying ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the promises and performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligations are satisfied. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services transferred to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined using expected cost and comparable transactions. Revenue for performance obligations recognized over time is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure. Non-refundable upfront fees allocated to licenses that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of upfront license fees if the performance obligations are not satisfied. (Q) Recent Accounting Pronouncements The Company has reviewed recently issued accounting standards and plans to adopt those that are applicable. The Company does not expect the adoption of those standards to have a material impact on its financial position, results of operations, or cash flows. The Company adopts new pronouncements relating to GAAP applicable to the Company as they are issued, which may be in advance of their effective date. Management does not believe that any recently issued, but not yet effective accounting standards, if currently adopted, would have a material effect on the accompanying financial statements. (R) Reclassifications Certain prior period amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. |
CASH, CASH EQUIVALENTS AND MARK
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES | CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES The following tables summarize the fair value of cash, cash equivalents and marketable securities as well as gross unrealized holding gains and losses as of December 31, 2022 and 2021: December 31, 2022 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 2,853,042 $ — $ — $ 2,853,042 Money market funds 42,014,804 — — 42,014,804 Marketable securities 84,175,752 — (42,187) 84,133,565 Total cash, cash equivalents and marketable securities $ 129,043,599 — $ (42,187) $ 129,001,411 December 31, 2021 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 6,425,889 $ — $ — $ 6,425,889 Money market funds 181,371,643 — — 181,371,643 Marketable securities — — — — Total cash, cash equivalents and marketable securities $ 187,797,532 $ — $ — $ 187,797,532 The Company did not hold any securities that were in an unrealized loss position for more than 12 months as of December 31, 2022 and 2021. There were no material realized gains or losses on available-for-sale securities during the years ended December 31, 2022 and 2021. |
PROPERTY AND EQUIPMENT AND INTA
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS | PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETSProperty and equipment is summarized as follows: December 31, December 31, Furniture and equipment $ 1,423,032 $ 504,965 Leasehold improvements 306,312 — Less accumulated depreciation (581,381) (262,208) Total property and equipment, net $ 1,147,963 $ 242,757 Depreciation expense was $319,173 and $76,871 for the years ended December 31, 2022 and 2021 respectively. Intangible assets, net of accumulated amortization, were $222,100 and $164,092 as of December 31, 2022 and 2021, respectively, and are included in other assets. Amortization expense was $193,333 and $160,208 for the years ended December 31, 2022 and 2021, respectively. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASES | LEASES During September 2021, the Company entered into a 10-year lease agreement for its corporate headquarters with a term commencing March 10, 2022, for approximately 19,000 square feet of office space at Hudson Commons in New York, NY. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $2.3 million per year. Rent payments commenced 10 months following the commencement date of the lease, or January 10, 2023, and continue for 10 years following the rent commencement date. Rent also includes two months of free rent in the sixth and seventh months following the rent commencement date. The Company issued a letter of credit in the amount of $1.9 million in association with the execution of the lease agreement; the letter of credit is characterized as restricted cash on the Company's consolidated balance sheets. The Hudson Commons lease has a remaining lease term of 10 years and includes a single renewal option for an additional five years. The Company did not include the renewal option in the lease term when calculating the lease liability as the Company is not reasonably certain that it will exercise the renewal option. The present value of the lease payments is calculated using an incremental borrowing rate of 7.02%. Lease expense is included in general and administrative and research and development expenses in the consolidated statements of operations. ROU asset and lease liabilities related to the Company's operating lease are as follows: December 31, Right-of-use asset $ 14,922,669 Current lease liability 533,946 Long-term lease liability $ 16,001,725 The components of operating lease cost for the year ended December 31, 2022 were as follows: December 31, Operating lease cost $ 1,806,028 Variable lease cost — Short-term lease cost — Future minimum commitments under the non-cancelable operating lease are as follows: 2023 $ 1,672,886 2024 2,316,303 2025 2,316,303 2026 2,316,303 2027 2,316,303 Thereafter 12,347,235 $ 23,285,333 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consist of the following: December 31, December 31, Payroll and bonus accrual $ 3,233,802 $ 3,764,666 Research and development accrual 395,247 1,795,190 Professional fees accrual 682,664 1,564,955 Other 192,956 546,464 Total $ 4,504,669 $ 7,671,275 |
STOCKHOLDERS_ EQUITY AND PREFER
STOCKHOLDERS’ EQUITY AND PREFERRED STOCK | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY AND PREFERRED STOCK | 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, as amended, the Company is authorized to issue up to 125,000,000 shares of common stock and 10,000,000 shares of Preferred Stock. The Company has designated 10,000 of the 10,000,000 authorized shares of Preferred Stock as non-voting Series A Convertible Preferred Stock (“Series A 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. Subject to preferences that may apply to any outstanding series of Preferred Stock, holders of the common stock are entitled to receive ratably any dividends declared on a non-cumulative basis. Shares of Series A Preferred Stock will be entitled to receive dividends at a rate equal to (on an as-if-converted-to-common stock basis), and in the same form and manner as, dividends actually paid on shares of common stock. The common stock is subordinate to all series of Preferred Stock with respect to 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 November 2020, the Company entered into a sales agreement (the “2020 ATM agreement”) with Cowen and Company, LLC ("Cowen") under which the Company may offer and sell in “at the market offerings,” from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million through Cowen acting as sales agent. As of December 31, 2022, the Company has not sold any shares of its common stock under the 2020 ATM agreement. There were 1,250 shares of Series A Preferred Stock outstanding as of December 31, 2022 and 2021. Each share of Series A Preferred Stock is convertible into 1,000 shares of common stock at any time at the holder’s option. However, the holder will be prohibited, subject to certain exceptions, from converting shares of Series A Preferred Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than, at the written election of the holder, either 9.99% or 14.99% of the total number of shares of common stock then issued and outstanding, which percentage may be changed at the holder’s election to any other number less than or equal to 19.99% upon 61 days’ notice to the Company; provided, however, that effective 61 days after delivery of such notice, such beneficial ownership limitations shall not be applicable to any holder that beneficially owns either 10.0% or 15.0%, as applicable based on the holder’s initial written election noted above, of the total number of shares of common stock issued and outstanding immediately prior to delivery of such notice. In the event of a liquidation, dissolution, or winding up of the Company, holders of Series A Preferred Stock will receive a payment equal to $0.001 per share of Series A Preferred Stock before any proceeds are distributed to the holders of common stock. In March 2021, certain of the Company's stockholders elected to convert an aggregate of 2,000 shares of Series A Preferred Stock owned by such holders into an aggregate of 2,000,000 shares of the Company's common stock. Dividends No dividends on the common stock shall be declared and paid unless dividends on the Preferred Stock have been declared and paid. Through December 31, 2022, the Company has not declared any dividends. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION The Company’s Board of Directors adopted and approved the 2014 Equity Incentive Plan (the “2014 Plan”), which authorized the Company to grant shares of common stock in the form of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock and restricted stock units. The types of stock-based awards, including share purchase rights amount, terms, and provisions for exercising grants were determined by the Company’s Board of Directors. The Company's Board of Directors adopted, and the Company's stockholders approved, the 2017 equity incentive plan (“2017 Plan”), which became effective 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, 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, 2021, an additional 3,287,158 shares were reserved for issuance under the 2017 Plan. As of December 31, 2021, there were 4,397,067 shares of the Company’s common stock reserved for issuance under the 2017 Plan. On January 1, 2022, an additional 1,000,000 shares were reserved for issuance under the 2017 Plan. As of December 31, 2022, there were 3,187,069 shares of the Company’s common stock reserved for issuance under the 2017 Plan. On January 1, 2023, an additional 3,523,344 shares were reserved for issuance under the 2017 Plan. The Company's Board of Directors adopted, and the Company's stockholders approved the 2017 employee stock purchase plan (the “2017 ESPP”), which became effective on May 4, 2017. The initial reserve of shares of common stock that may be issued under the 2017 ESPP was 279,069 shares. The 2017 ESPP allows employees to purchase common stock of the Company at a 15% discount to the market price on designated purchase dates. During the years ended December 31, 2022 and 2021, 76,455 and 60,490 shares were purchased under the 2017 ESPP and the Company recorded expense of $85,319 and $83,787, respectively. The number of shares of common stock reserved for issuance under the 2017 ESPP will automatically increase on January 1 of each year, beginning on January 1, 2018 and continuing through and including January 1, 2027, by the lesser of (i) 1% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, (ii) 550,000 shares or (iii) such lesser number of shares determined by our Board. The Board acted prior to January 1, 2023 to provide that there be no increase in the number of shares reserved for issuance under the 2017 ESPP. As of December 31, 2022 and 2021, there were 416,607 and 493,062 shares of the Company’s common stock reserved for issuance under the 2017 ESPP. Unless specified otherwise in an individual option agreement, stock options granted under the 2014 Plan and 2017 Plan generally have a ten-year term and a four-year graded vesting period. The vesting requirement is generally conditioned upon the grantee’s continued service with the Company during the vesting period. Once vested, all options granted 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 the 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 vesting terms, with vesting occurring on the date the performance condition is achieved and expire in accordance with the specific terms of the agreement. At December 31, 2022 and 2021, there were 100,000 and 150,000 performance-based options outstanding and unvested, respectively, that include options to vest upon the achievement of certain research and development milestones. The fair value of options granted during the years ended December 31, 2022 and 2021 was estimated using the Black-Scholes option valuation model. The inputs for the Black-Scholes option valuation model require significant assumptions made by management 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 is 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. The Company granted zero and 170,000 stock options to nonemployee consultants for services rendered during the years ended December 31, 2022 and 2021, respectively. There were 127,459 and 181,250 unvested nonemployee options outstanding as of December 31, 2022 and 2021, respectively. Total expense recognized related to the nonemployee stock options for the years ended December 31, 2022 and 2021 was $575,995 and $584,092, respectively. Total unrecognized compensation expenses related to the nonemployee stock options was $626,977 and $67,471 as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021, there were no expenses for nonemployee performance-based option awards recognized. The Company granted 4,575,641 and 1,875,913 stock options to employees during the years ended December 31, 2022 and 2021, respectively. There were 6,090,889 and 4,407,308 unvested employee options outstanding as of December 31, 2022 and 2021, respectively. Total expense recognized related to the employee stock options for the years ended December 31, 2022 and 2021 was $5.9 million and $4.4 million, respectively. Total unrecognized compensation expense related to employee stock options was $11.5 million and $10.3 million as of December 31, 2022 and 2021, respectively. During the years ended December 31, 2022 and 2021, the Company recognized $118,075 and zero in expenses for employee performance-based option awards. The Company’s stock-based compensation expense was recognized in operating expenses as follows: For the Year Ended December 31, 2022 2021 Research and development $ 1,770,599 $ 1,679,183 General and administrative 4,786,087 3,375,274 Total $ 6,556,686 $ 5,054,457 For the Year Ended December 31, 2022 2021 Stock options $ 6,471,367 $ 4,970,670 Employee Stock Purchase Plan 85,319 83,787 Total $ 6,556,686 $ 5,054,457 The fair value of employee options granted during the years ended December 31, 2022 and 2021, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2022 2021 Weighted Weighted Volatility 87.16 % 84.38 % Expected term in years 6.07 6.03 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.21 % 0.90 % Fair value of option on grant date $ 2.12 $ 2.50 The fair value of nonemployee options granted and remeasured during the years ended December 31, 2022 and 2021, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2022 2021 Weighted Weighted Volatility 0.00 % 80.43 % Expected term in years 0 6.23 Dividend rate 0.00 % 0.00 % Risk-free interest rate 0.00 % 1.03 % Fair value of option on grant date $ — $ 2.49 The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Weighted Weighted Aggregate Options outstanding December 31, 2020 10,403,420 $ 5.26 7.59 $ 652,438 Vested and exercisable at December 31, 2020 5,395,658 $ 6.45 6.13 $ 445,599 Granted 2,045,913 3.53 9.47 Exercised (288,525) 2.36 Forfeited or expired (1,384,050) 4.08 Options outstanding December 31, 2021 10,776,758 $ 4.97 6.07 $ 2,389,890 Vested and exercisable at December 31, 2021 6,188,200 $ 5.98 4.63 $ 1,531,907 Granted 4,575,641 2.89 9.26 Exercised (25,518) 1.91 Forfeited or expired (2,365,643) 5.56 Options outstanding December 31, 2022 12,961,238 $ 4.13 7.42 $ 62,158 Vested and exercisable at December 31, 2022 6,742,890 $ 5.05 6.20 $ 61,214 At December 31, 2022, there was $12.1 million of unamortized share–based compensation expense, which is expected to be recognized over a remaining average vesting period of 2.26 years. At December 31, 2021, there was $10.4 million of unamortized share–based compensation expense, which is expected to be recognized over a remaining average vesting period of 2.61 years. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES At December 31, 2022, the Company has available $153.5 million and $177.1 million of unused net operating loss ("NOL") carryforwards for federal and state tax purposes, respectively, that may be applied against future taxable income. The Company also has $163.9 million of unused NOL carryforwards for New York City purposes. The NOL carryforwards will begin to expire in the year 2035 if not utilized prior to that date. Under Section 382 and Section 383 of the Internal Revenue Code of 1986, if a corporation undergoes an ownership change, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. On each of August 10, 2015 and February 22, 2019 the Company experienced an ownership change. The Company anticipates a significant portion of its pre-change NOLs to be limited, but has not yet completed a formal Section 382 analysis. The Company maintains a full valuation allowance against its net deferred tax assets. The valuation allowance increased by $10.4 million and decreased by $26.5 million during the years 2022 and 2021, respectively. The increase in valuation allowance in 2022 is primarily due to increases in NOL carryforwards and capitalized research and experimentation costs. The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets and liabilities were as follows: December 31, 2022 2021 Deferred tax assets/liabilities: Net operating loss carryforwards $ 55,472,573 $ 49,086,998 Intangible assets 6,332,176 7,121,484 Capitalized research and development costs 4,246,071 — Stock-based compensation 4,384,751 4,663,578 Lease liability 3,544,624 — Research and development tax credits 3,046,253 2,422,331 Accrued compensation — (28,243) Charitable contributions — 87,672 Depreciation (241,096) (51,920) Right-of-use asset (3,198,857) — Other 97,494 — Total gross deferred tax assets/liabilities 73,683,989 63,301,900 Valuation allowance (73,683,989) (63,301,900) Net deferred tax assets (liabilities) $ — $ — A reconciliation of the statutory U.S. Federal rate to the Company’s effective tax rate is as follows: December 31, 2022 2021 Federal income tax benefit at statutory rate 21.00 21.00 State income tax, net of federal benefit (0.27) 1.05 Permanent items (1.26) 0.53 Change in valuation allowance (18.50) (21.39) Research and development tax credits 1.28 (1.05) Other (2.25) 0.93 Effective income tax expense rate 0.00 % 1.07 % The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies related to the tax benefit. For the years ended December 31, 2022 and 2021, the Company had no unrecognized tax benefits or related interest and penalties accrued. The Company would recognize both accrued interest and penalties related to unrecognized benefits in provision for income taxes. The Company’s uncertain tax positions yet to be determined would be related to years that remain subject to examination by relevant tax authorities. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES License Agreements Northwestern University License Agreement 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 of certain invention ("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 Patent Rights. The Company is developing OV329 under this agreement. 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 Patent Rights, 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 Patent Rights, 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. AstraZeneca AB License Agreement On December 30, 2021, the Company entered into an exclusive license agreement with AstraZeneca AB, for a library of early-stage small molecules targeting the KCC2 transporter, including lead candidate OV350. Upon execution of the agreement, the Company was obligated to pay an upfront cash payment of $5.0 million and issued shares of the Company's common stock in an amount that equaled $7.3 million based on the volume-weighted average price of shares of the Company's common stock for the 30 business days immediately preceding the execution date of the transaction. Since the intangibles acquired in the AstraZeneca license agreement do not have an alternative future use, all costs incurred were treated as research and development expense. The Company recorded a total of $12.3 million as research and development expense related to this agreement during December 2021. Pursuant to the AstraZeneca license agreement, the Company agreed to potential milestone payments of up to $203.0 million upon the achievement of certain developmental, regulatory and sales milestones. The first payment of $3.0 million is due upon the successful completion of the first Phase 2 clinical study of a licensed product following a positive biomarker readout in a Phase 1 clinical study. Gensaic Collaboration and Option Agreement In August 2022, the Company entered into a collaboration and option agreement (the "Collaboration Agreement") with Gensaic. The Collaboration Agreement involves the research and development of phage-derived particle ("PDP") products on Gensaic's proprietary platform for certain central nervous system rare disorder targets. Under the Collaboration Agreement, Gensaic grants the Company an exclusive option to obtain an exclusive license with respect to certain identified lead PDP products, which are exercisable at any time prior to the expiration of the option period. Once a product is identified by the Company that demonstrates sufficient efficacy, the Company may exercise its option with respect to the specific research program for that PDP product. The Company shall reimburse Gensaic for Gensaic's research costs related to the specific research plan for PDP products identified. The research plan and budget shall be mutually agreed upon by the parties and shall not exceed $3.0 million in any research year. The Company will record these reimbursement payments as research and development costs in the period the research costs are incurred. If a product is ultimately commercialized under this agreement, the Company shall make tiered royalty payments to Gensaic in the mid-single to low double-digit range based on the net sales of all licensed PDP products during the royalty term. The Company is also responsible for potential tiered milestone payments of up to $452.0 million based upon the achievement of certain sales milestone events and developmental milestone approvals for three or more products. Gensaic also has the option to become a collaborative partner in the development and commercialization of PDP products in exchange for a fee based on a percentage of the costs incurred by the Company through the date Gensaic exercises its option. The Company would no longer be required to pay Gensaic royalty or milestone payments if Gensaic elects to exercise its option. The Company may terminate this agreement by providing written notice to Gensaic 90 days in advance of the termination date. As of December 31, 2022, none of these contingent payments were considered probable. Contingencies Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred. The Company is not currently involved in any legal matters arising in the normal course of business. Under the terms of their respective employment agreements, each of the Company's named executive officers is eligible to receive severance payments and benefits upon a termination without “cause” or due to “permanent disability,” or upon “resignation for good reason,” contingent upon the named executive officer’s delivery to the Company of a satisfactory release of claims, and subject to the named executive officer’s compliance with non-competition and non-solicitation restrictive covenants for two years following the termination date. |
COLLABORATION AGREEMENTS
COLLABORATION AGREEMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION AGREEMENTS | COLLABORATION AGREEMENTS Angelini Collaboration On July 9, 2020, the Company entered into the Angelini License Agreement, pursuant to which the Company granted to Angelini exclusive rights to develop and commercialize OV101, a selective agonist of the GABAA receptor, for the treatment of Angelman syndrome in the European Economic Area as well as Switzerland, the United Kingdom, Russia and Turkey (the “European Territory”). On March 29, 2021, the Company received a notice of termination of the Angelini License Agreement. Subsequently, Angelini and the Company mutually agreed to waive the six-month termination notice provisions and the Angelini License Agreement terminated effective March 31, 2021. The Company has been released from its performance obligations and will not be entitled to any future milestone payments under the Angelini License Agreement. The Company evaluated the Angelini License Agreement to determine whether it was a collaborative arrangement for purposes of ASC 808, Collaborative Arrangements. The Company concluded that because Angelini was not the ultimate decision maker or the legal owner of the license, Angelini was not considered an active participant and therefore the Angelini License Agreement was outside of the scope of ASC 808. The Company concluded that Angelini was a customer with regard to the combined license and research and development activities and as such the Angelini License Agreement should be evaluated under ASC 606. The Company identified the following material promises under the Angelini License Agreement: (1) licensing of intellectual property with respect to OV101; (2) completion of certain ongoing trials; (3) transfer of a specified amount of compound and related information; (4) potential for funding 35% of the cost for Angelini future trials limited to $7.0 million; and (5) completion of the manufacturing process technology transfer. The Company determined that the $7.0 million represented a potential payment to a customer and was deferred. The transfer of compound and the related information was considered a contingent milestone payment that would be recognized upon acceptance of the milestone by Angelini. The Company further determined that the license and the completion of ongoing trials were distinct from each other, as each had value without the other. As such, for purposes of ASC 606, the Company determined that these two material promises, represented distinct performance obligations. Pursuant to the Angelini License Agreement and during the year ended December 31, 2020, Angelini made an upfront payment to the Company of $20.0 million. Upon the transfer of the specified amount of compound and related information and acceptance by Angelini, Angelini paid the Company an additional $5.0 million. This performance obligation was determined to be variable consideration which was constrained and not considered part of the upfront transaction price allocation. The Company determined the transaction price was equal to the upfront fee of $20.0 million. The transaction price was allocated based on the standalone selling price of the license and the ongoing trials. During the year ended December 31, 2022, no revenue was recognized pursuant to the Angelini License Agreement. During the year ended December 31, 2021, and effective upon the termination of the Angelini License Agreement, the Company recognized $12.4 million of revenue consisting of $5.4 million of license revenue related to ongoing trials and the $7.0 million related to the potential 35% funding of the cost for Angelini future trials. Takeda Collaboration On January 6, 2017, the Company entered into a license and collaboration agreement with Takeda under which the Company licensed from Takeda certain exclusive rights to develop and commercialize soticlestat in certain territories. In March 2021, the Company entered into the RLT Agreement with Takeda, pursuant to which Takeda secured rights to the Company’s 50% global share in soticlestat, and the Company granted to Takeda an exclusive worldwide license under the Company’s relevant intellectual property rights to develop and commercialize the investigational medicine soticlestat for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome. Under the RLT Agreement, all rights in soticlestat are owned by Takeda or exclusively licensed to Takeda by the Company. Takeda assumed all responsibility for, and costs of, both development and commercialization of soticlestat, and the Company will no longer have any financial obligation to Takeda under the original collaboration agreement, including milestone payments or any future development and commercialization costs. On March 29, 2021 upon the closing of the RLT Agreement, the Company received an upfront payment of $196.0 million and, if soticlestat is successfully developed, will be eligible to receive up to an additional $660.0 million upon Takeda achieving developmental, regulatory and sales milestones. In addition, the Company will be entitled to receive tiered royalties beginning in the low double-digits, and up to 20% on sales of soticlestat if regulatory approval is achieved. Royalties will be payable on a country-by-country and product-by-product basis for any indications that soticlestat is approved for and sold during the period beginning on the date of the first commercial sale of such product in such country and ending on the later to occur of the expiration of patent rights covering the product in such country and a specified anniversary of such first commercial sale. The Company identified the following material promises under the RLT Agreement: (1) no later than the second business day prior to the closing of the RLT Agreement (the “Closing Date”), the Company and Takeda were required to agree on an estimate of the development expenses that accrued, or would accrue, under the original collaboration agreement as of March 31, 2021; (2) on the Closing Date, the Company was required to (i) provide and transfer to Takeda the materials, information and data relating to the soticlestat program, including clinical trial data and results, as further set forth in the RLT Agreement, (ii) assign to Takeda certain agreements applicable to the soticlestat program, and (iii) assign to Takeda all of its right, title and interest in, to and under all intellectual property rights developed or created pursuant to the original collaboration agreement and owned jointly by the Company and Takeda as of the Closing Date; (3) within 45 days after March 31, 2021, the Company and Takeda were required to provide a written report to the finance officer designated by the other party setting forth a final total of the development expenses that accrued as of March 31, 2021 and, within 10 business days after receipt of such report, the finance officers shall agree on whether a net settlement payment is due from Takeda to the Company or from the Company to Takeda; and (4) within 75 days after the Closing Date, to the extent not provided on the Closing Date, Ovid shall provide to Takeda (i) any materials, information and data relating to the soticlestat program, including clinical trial data and results, as further set forth in the RLT Agreement, (ii) other documents (including all expired agreements and related data developed thereunder) to the extent relating to the soticlestat program that are necessary for the exploitation, development, commercialization and manufacture of soticlestat, as further set forth in the RLT Agreement and (iii) any tangible embodiments of the intellectual property rights controlled by Ovid that are reasonably necessary for, used in or held for use in Takeda’s exploitation of the soticlestat program. The Company determined the transaction price was equal to the upfront fee of $196.0 million and was associated with all four performance obligations identified above. It is noted that the incremental effort associated with performance obligations three and four is negligible and not material in the context of the RLT Agreement since all of the information was related to the collaboration period for which the Company already had the information readily available. Therefore, since they were not material in the context of the RLT Agreement, the full upfront fee was allocated to the two performance obligations satisfied at closing. During the year ended December 31, 2022, no expense was recognized pursuant to the RLT Agreement. During the year ended December 31, 2021, the Company recognized a credit in research and development expenses of $2.5 million and recognized $0.1 million in general and administrative expenses representing costs which were reimbursed to the Company from Takeda. Healx License and Option Agreement On February 1, 2022, the Company entered into the Healx License and Option Agreement. Under the terms of the Healx License and Option Agreement, Healx, Ltd. has secured a one-year option to investigate gaboxadol "(OV101") as part of a potential combination therapy for Fragile X syndrome in a Phase 2A clinical trial, as well as a treatment for other indications, for an upfront payment of $0.5 million, and fees to support prosecution and maintenance of the Company's relevant intellectual property rights. At the end of the one-year option period, Healx had the option to secure rights to an exclusive license under the Company's relevant intellectual property rights, in exchange for an additional payment of $2.0 million, development and commercial milestone payments, and low to mid-tier double digit royalties. This option period was extended for an additional three months as of February 1, 2023. If applicable, royalties are payable on a country-by-country and product-by-product basis during the period beginning on the date of the first commercial sale of such product in such country and ending on the later to occur of the expiration of patent rights covering the product in such country and a specified anniversary of such first commercial sale. Healx will assume all responsibility for, and costs of, both development and commercialization of gaboxadol following the exercise of the option. The Company will retain the option to co-develop and co-commercialize the program with Healx ("Ovid Opt-In Right"), at the end of a positive readout of clinical Phase 2B and would share net profits and losses in lieu of the milestones and royalty payments. If the Ovid-Opt-In Right were exercised, the Company would be required to pay Healx 50% of development costs. The Company does not plan to conduct further trials of gaboxadol. The term of the Healx License and Option Agreement will continue until the later of (a) the expiration of all relevant royalty terms, or in the event that Healx does not exercise its option during the option period defined in the Healx License and Option Agreement ("Option Period"), the expiration of such period, or (b) in the event that Healx does exercise its option during the Option Period, and the Company does not exercise the Ovid Opt-In Right during the period of time we have to opt-in ("Opt-In Period") or the opt-in terms are otherwise terminated, upon the expiration of all payment obligations, or (c) in the event that Healx does exercise the Option during the Option Period, and the Company does exercise the Ovid Opt-In Right during the Opt-In Period, such time as neither Healx nor Ovid is continuing to exploit the gaboxadol. During the year ended December 31, 2022, the Company recorded revenue of $0.5 million associated with the Healx License and Option Agreement. Marinus Pharmaceuticals Out-License Agreement On March 1, 2022, the Company entered into an exclusive patent license agreement with Marinus ("Marinus License Agreement"). Under the Marinus License Agreement, the Company granted Marinus an exclusive, non-transferable (except as expressly provided therein), royalty-bearing right and license under certain Ovid patents relating to ganaxolone to develop, make, have made, commercialize, promote, distribute, sell, offer for sale and import licensed products in the territory (which consist of the United States, the European Economic Area, United Kingdom and Switzerland) for the treatment of CDKL5 deficiency disorders. Following the date of regulatory approval by the FDA of the first licensed product in the territory which was received on March 18, 2022, Marinus issued, at the Company's option, 123,255 shares of Marinus common stock, par value $0.001 per share, as payment. The Marinus License Agreement also provides for payment of royalties from Marinus to the Company in single digits on net sales of each such licensed product sold. The Company recorded revenue and an associated investment in equity securities of approximately $0.9 million related to the patent license agreement on March 18, 2022, based on the price of Marinus common stock on March 1, 2022. The Company had unrealized losses on the Marinus common stock of $0.5 million for the year ended December 31, 2022, which were recorded as an unrealized loss on equity securities and reflected in other income (expenses), net in the consolidated statements of operations. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 12 – RELATED PARTY TRANSACTIONSIn March 2021, the Company entered into the RLT Agreement with Takeda. For a description of the RLT Agreement, see Note 11. |
NET (LOSS) INCOME PER SHARE
NET (LOSS) INCOME PER SHARE | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
NET (LOSS) INCOME PER SHARE | NET (LOSS) INCOME PER SHAREBasic net (loss) income per share is calculated based upon the weighted-average number of common shares outstanding during the period, excluding outstanding stock options that have not yet vested. Diluted net income per share is calculated based upon the weighted-average number of common shares outstanding during the period plus the dilutive impact of weighted-average common equivalent shares outstanding during the period resulting from the assumed exercise of outstanding stock options determined under the treasury stock method and the assumed conversion of preferred stock into common shares determined using the if-converted method. Diluted net loss per share is equivalent to the basic net loss per share due to the exclusion of outstanding stock options and convertible preferred stock because the inclusion of these securities would result in an anti-dilutive effect on per share amounts. The basic and diluted net (loss) income per common share is presented in conformity with the two-class method required for participating securities and multiple classes of shares. The Company considers its preferred stock to be participating securities. For any period in which the Company records net income, undistributed earnings allocated to the participating securities are subtracted from net income in determining net income attributable to common stockholders. The undistributed earnings have been allocated based on the participation rights of preferred stock and common shares as if the earnings for the year have been distributed. For periods in which the Company recognizes a net loss, undistributed losses are allocated only to common shares as the participating securities do not contractually participate in the Company’s losses. Basic net (loss) income per share is computed by dividing the net (loss) income attributable to common stockholders by the weighted-average number of common shares outstanding during the period. The following tables summarizes the calculation of basic and diluted net (loss) income per share: For the Year Ended December 31, 2022 2021 Net (loss) income $ (54,169,029) $ 122,834,584 Net income attributable to participating securities — (2,997,344) Net (loss) income attributable to common stockholders $ (54,169,029) $ 119,837,240 For the Year Ended December 31, 2022 2021 Net (loss) income attributable to common stockholders $ (54,169,029) $ 119,837,240 Weighted average common shares outstanding used in computing net (loss) income per share - basic 70,424,819 67,479,403 Weighted average common shares outstanding used in computing net (loss) income per share - diluted 70,424,819 68,067,992 Net (loss) income per share, basic $ (0.77) $ 1.78 Net (loss) income per share, diluted $ (0.77) $ 1.76 The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: For the Year Ended For the Year Ended December 31, 2022 2021 Stock options to purchase common stock 12,961,238 10,776,758 Common stock issuable upon conversion of Series A convertible preferred stock 1,250,000 1,250,000 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and ConsolidationThe accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP") and include the accounts of Ovid Therapeutics Inc. and its wholly-owned subsidiary, Ovid Therapeutics Hong Kong Limited. All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates | Use of EstimatesThe preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. |
Comprehensive Income (Loss) | Comprehensive (Loss) IncomeComprehensive (loss) income includes net (loss) income as well as unrealized gains and losses on available-for-sale securities. |
Marketable Securities | Marketable SecuritiesMarketable securities consist of investments in U.S. treasury instruments which are considered available-for-sale securities. The Company classifies its marketable securities with maturities of less than one year from the balance sheet date as current assets on its consolidated balance sheets. Unrealized gains and losses on these securities that are determined to be temporary are reported as a separate component of accumulated other comprehensive loss in stockholders' equity. |
Restricted Cash | Restricted CashThe Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash for which use is otherwise limited by contractual provisions. Amounts are reported as non-current unless restrictions are expected to be released in the next 12 months. |
Long-term Equity Investment | Long-term Equity Investments Long-term equity investments consist of an equity investment in the preferred shares of Gensaic, Inc., formerly M13 Therapeutics, Inc. ("Gensaic"), a privately held corporation. The preferred shares are not considered in-substance common stock, and the investment is accounted for at cost, with adjustments for observable changes in prices or impairments, and is classified within long-term equity investments on our consolidated balance sheets with adjustments recognized in other income (expense), net on our consolidated statements of operations. The Company has determined that the equity investment does not have a readily determinable fair value and elected the measurement alternative. Therefore, the equity investment’s carrying amount will be adjusted to fair value at the time of the next observable price change for the identical or similar investment of the same issuer or when an impairment is recognized. Each reporting period, the Company performs a qualitative assessment to evaluate whether the investment is impaired. The assessment includes a review of recent operating results and trends, recent sales/acquisitions of the investee's securities, and other publicly available data. If the investment is impaired, the Company writes it down to its estimated fair value. As of December 31, 2022 and 2021, the equity investment had a carrying value of $5.1 million and $1.6 million, respectively. Long-term equity investments also consist of an equity investment in the common shares of Marinus Pharmaceuticals, Inc. ("Marinus") that was received as non-cash consideration via the terms of a licensing agreement executed between the two companies effective March 2022. The equity shares are marked-to-market at each reporting date with changes in the fair value being reflected in the carrying value of the investment on the Company's consolidated balance sheets and other income (expense), net on the Company's consolidated statements of operations. As of December 31, 2022, the equity investment in Marinus had a carrying value of approximately $0.5 million. No impairments were recognized in the years ending December 31, 2022 and 2021. |
Note Receivable | Note ReceivableOn March 17, 2022, the Company issued a convertible promissory note with a principal amount of $1.0 million to Gensaic. The note included features that permitted the Company to acquire additional equity or to settle the note in cash. In August 2022, the Company executed an agreement with Gensaic which resulted in the conversion of the note into additional equity and was recorded as a long-term equity investment in the consolidated balance sheets. The Company received interest on the convertible promissory note at the rate of 1.5% per annum through the date of conversion. |
Fair Value of Financial Instruments | Fair Value of Financial InstrumentsFinancial Accounting Standards Board guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: • Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company's Level 1 assets consisted of investments in a U.S. treasury money market fund and equity securities totaling approximately $42.5 million as of December 31, 2022. The Company’s Level 1 assets consisted of money market funds and short-term investments totaling $181.4 million as of December 31, 2021. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. The Company's Level 2 assets consisted of U.S. treasury bills totaling approximately $84.1 million as of December 31, 2022. The Company had no Level 2 assets or liabilities as of December 31, 2021. • Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when the fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. The Company had no Level 3 assets or liabilities as of December 31, 2022 or 2021. The carrying amounts reported in the consolidated balance sheets for cash, cash equivalents and marketable securities, other current assets, accounts payable, and accrued expenses approximate their fair values based on the short-term maturity of these instruments. |
Leases | LeasesThe Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Lease Accounting. Operating leases are included in right-of-use ("ROU") assets, current portion, lease liability and long-term lease liability in the Company's consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines the portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period. |
Property and Equipment | Property and EquipmentProperty and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. Repair and maintenance costs are expensed. The Company reviews the recoverability of all long-lived assets, including the related useful life, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. |
Research and Development Expenses | Research and Development ExpensesThe Company expenses the cost of research and development as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and preclinical materials as well as contracted services, license fees, and other external costs. Research and development expenses also include the cost of licensing agreements acquired from third-parties, such as the acquisition of OV350 from AstraZeneca AB. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received in accordance with ASC 730, Research and Development. |
Stock-based Compensation | Stock-based CompensationThe Company accounts for its stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, which establishes accounting for stock-based awards granted to employees for services and requires companies to expense the estimated fair value of these awards over the requisite service period. The Company estimates the fair value of all awards granted using the Black-Scholes valuation model. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield, stock price and exercise price. Many of the assumptions require significant judgment and any changes could have an impact in the determination of stock-based compensation expense. The Company elected an accounting policy to record forfeitures as they occur. The Company recognizes employee stock-based compensation expense based on the fair value of the award on the date of the grant. The compensation expense is recognized over the vesting period under the straight-line method. The Company accounts for option awards granted to nonemployee consultants and directors in accordance with ASC 718. The fair value of the option issued or committed to be issued is used to measure the transaction, as this is more reliable than the fair value of the services received. The fair value is measured at the value of the Company’s common stock award at the earlier of the date that the commitment for performance by the counterparty has been reached or the counterparty’s performance is complete. |
Income Taxes | Income TaxesThe Company accounts for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as for net operating loss carryforwards and research and development credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The impact of a change in the tax laws is recorded in the period in which the law is enacted. |
Net (Loss) Income Per Share | Net (Loss) Income per Share Net (loss) income per common share is determined by dividing net (loss) income attributable to common stockholders by the basic and diluted weighted-average common shares outstanding during the period. The Company applies the two-class method to allocate earnings between common stock and participating securities. Net (loss) income per diluted share attributable to common stockholders adjusts the basic earnings per share attributable to common stockholders and the weighted-average number of shares of common stock outstanding for the potential dilutive impact of stock options using the treasury-stock method and the potential impact of preferred stock using the if-converted method. |
Retirement Plan | Retirement PlanThe Company maintains a 401(k)-retirement plan for its employees that is intended to qualify under Sections 401(a) and 501(a) of the U.S. Internal Revenue Code of 1986, as amended (“Code”). The Company provides all active employees with a 100% matching contribution equal to 3% of an employee’s eligible deferred compensation and a 50% matching contribution on employee contributions that are between 3% and 5% of an employee’s eligible deferred compensation. These safe harbor contributions vest immediately. For the years ended December 31, 2022 and 2021 the Company contributed $339,405 and $438,043, respectively. |
Revenue Recognition | Revenue Recognition Under ASC 606, Revenue Recognition, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. In applying ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the promises and performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligations are satisfied. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services transferred to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined using expected cost and comparable transactions. Revenue for performance obligations recognized over time is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure. Non-refundable upfront fees allocated to licenses that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of upfront license fees if the performance obligations are not satisfied. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company has reviewed recently issued accounting standards and plans to adopt those that are applicable. The Company does not expect the adoption of those standards to have a material impact on its financial position, results of operations, or cash flows. The Company adopts new pronouncements relating to GAAP applicable to the Company as they are issued, which may be in advance of their effective date. Management does not believe that any recently issued, but not yet effective accounting standards, if currently adopted, would have a material effect on the accompanying financial statements. |
Reclassifications | ReclassificationsCertain prior period amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. |
CASH, CASH EQUIVALENTS AND MA_2
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Debt Securities | The following tables summarize the fair value of cash, cash equivalents and marketable securities as well as gross unrealized holding gains and losses as of December 31, 2022 and 2021: December 31, 2022 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 2,853,042 $ — $ — $ 2,853,042 Money market funds 42,014,804 — — 42,014,804 Marketable securities 84,175,752 — (42,187) 84,133,565 Total cash, cash equivalents and marketable securities $ 129,043,599 — $ (42,187) $ 129,001,411 December 31, 2021 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 6,425,889 $ — $ — $ 6,425,889 Money market funds 181,371,643 — — 181,371,643 Marketable securities — — — — Total cash, cash equivalents and marketable securities $ 187,797,532 $ — $ — $ 187,797,532 |
Schedule of Cash and Cash Equivalents | The following tables summarize the fair value of cash, cash equivalents and marketable securities as well as gross unrealized holding gains and losses as of December 31, 2022 and 2021: December 31, 2022 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 2,853,042 $ — $ — $ 2,853,042 Money market funds 42,014,804 — — 42,014,804 Marketable securities 84,175,752 — (42,187) 84,133,565 Total cash, cash equivalents and marketable securities $ 129,043,599 — $ (42,187) $ 129,001,411 December 31, 2021 Amortized cost Gross unrealized holding gains Gross unrealized holding losses Fair value Cash $ 6,425,889 $ — $ — $ 6,425,889 Money market funds 181,371,643 — — 181,371,643 Marketable securities — — — — Total cash, cash equivalents and marketable securities $ 187,797,532 $ — $ — $ 187,797,532 |
PROPERTY AND EQUIPMENT AND IN_2
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment is summarized as follows: December 31, December 31, Furniture and equipment $ 1,423,032 $ 504,965 Leasehold improvements 306,312 — Less accumulated depreciation (581,381) (262,208) Total property and equipment, net $ 1,147,963 $ 242,757 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of ROU Asset and Lease Liabilities Related to Operating Lease | ROU asset and lease liabilities related to the Company's operating lease are as follows: December 31, Right-of-use asset $ 14,922,669 Current lease liability 533,946 Long-term lease liability $ 16,001,725 |
Schedule of Operating Lease Cost | The components of operating lease cost for the year ended December 31, 2022 were as follows: December 31, Operating lease cost $ 1,806,028 Variable lease cost — Short-term lease cost — |
Schedule of Future Minimum Commitments | Future minimum commitments under the non-cancelable operating lease are as follows: 2023 $ 1,672,886 2024 2,316,303 2025 2,316,303 2026 2,316,303 2027 2,316,303 Thereafter 12,347,235 $ 23,285,333 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: December 31, December 31, Payroll and bonus accrual $ 3,233,802 $ 3,764,666 Research and development accrual 395,247 1,795,190 Professional fees accrual 682,664 1,564,955 Other 192,956 546,464 Total $ 4,504,669 $ 7,671,275 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Recognized Stock-Based Compensation Expense | The Company’s stock-based compensation expense was recognized in operating expenses as follows: For the Year Ended December 31, 2022 2021 Research and development $ 1,770,599 $ 1,679,183 General and administrative 4,786,087 3,375,274 Total $ 6,556,686 $ 5,054,457 |
Schedule of Allocation of Stock-based Compensation Expense by Plan | For the Year Ended December 31, 2022 2021 Stock options $ 6,471,367 $ 4,970,670 Employee Stock Purchase Plan 85,319 83,787 Total $ 6,556,686 $ 5,054,457 |
Schedule of Assumptions Used to Compute Fair Value of Employee Option Granted | The fair value of employee options granted during the years ended December 31, 2022 and 2021, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2022 2021 Weighted Weighted Volatility 87.16 % 84.38 % Expected term in years 6.07 6.03 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.21 % 0.90 % Fair value of option on grant date $ 2.12 $ 2.50 The fair value of nonemployee options granted and remeasured during the years ended December 31, 2022 and 2021, respectively, was estimated by utilizing the following assumptions: For the Year Ended December 31, 2022 2021 Weighted Weighted Volatility 0.00 % 80.43 % Expected term in years 0 6.23 Dividend rate 0.00 % 0.00 % Risk-free interest rate 0.00 % 1.03 % Fair value of option on grant date $ — $ 2.49 |
Schedule of Options Outstanding and Weighted Average Exercise Price | The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Weighted Weighted Aggregate Options outstanding December 31, 2020 10,403,420 $ 5.26 7.59 $ 652,438 Vested and exercisable at December 31, 2020 5,395,658 $ 6.45 6.13 $ 445,599 Granted 2,045,913 3.53 9.47 Exercised (288,525) 2.36 Forfeited or expired (1,384,050) 4.08 Options outstanding December 31, 2021 10,776,758 $ 4.97 6.07 $ 2,389,890 Vested and exercisable at December 31, 2021 6,188,200 $ 5.98 4.63 $ 1,531,907 Granted 4,575,641 2.89 9.26 Exercised (25,518) 1.91 Forfeited or expired (2,365,643) 5.56 Options outstanding December 31, 2022 12,961,238 $ 4.13 7.42 $ 62,158 Vested and exercisable at December 31, 2022 6,742,890 $ 5.05 6.20 $ 61,214 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets and liabilities were as follows: December 31, 2022 2021 Deferred tax assets/liabilities: Net operating loss carryforwards $ 55,472,573 $ 49,086,998 Intangible assets 6,332,176 7,121,484 Capitalized research and development costs 4,246,071 — Stock-based compensation 4,384,751 4,663,578 Lease liability 3,544,624 — Research and development tax credits 3,046,253 2,422,331 Accrued compensation — (28,243) Charitable contributions — 87,672 Depreciation (241,096) (51,920) Right-of-use asset (3,198,857) — Other 97,494 — Total gross deferred tax assets/liabilities 73,683,989 63,301,900 Valuation allowance (73,683,989) (63,301,900) Net deferred tax assets (liabilities) $ — $ — |
Schedule of Reconciliation of Statutory U.S. Federal Rate to Effective Tax Rate | A reconciliation of the statutory U.S. Federal rate to the Company’s effective tax rate is as follows: December 31, 2022 2021 Federal income tax benefit at statutory rate 21.00 21.00 State income tax, net of federal benefit (0.27) 1.05 Permanent items (1.26) 0.53 Change in valuation allowance (18.50) (21.39) Research and development tax credits 1.28 (1.05) Other (2.25) 0.93 Effective income tax expense rate 0.00 % 1.07 % |
NET (LOSS) INCOME PER SHARE (Ta
NET (LOSS) INCOME PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings (Loss) Per Share | The following tables summarizes the calculation of basic and diluted net (loss) income per share: For the Year Ended December 31, 2022 2021 Net (loss) income $ (54,169,029) $ 122,834,584 Net income attributable to participating securities — (2,997,344) Net (loss) income attributable to common stockholders $ (54,169,029) $ 119,837,240 For the Year Ended December 31, 2022 2021 Net (loss) income attributable to common stockholders $ (54,169,029) $ 119,837,240 Weighted average common shares outstanding used in computing net (loss) income per share - basic 70,424,819 67,479,403 Weighted average common shares outstanding used in computing net (loss) income per share - diluted 70,424,819 68,067,992 Net (loss) income per share, basic $ (0.77) $ 1.78 Net (loss) income per share, diluted $ (0.77) $ 1.76 |
Schedule of Computations of Diluted Weighted-Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: For the Year Ended For the Year Ended December 31, 2022 2021 Stock options to purchase common stock 12,961,238 10,776,758 Common stock issuable upon conversion of Series A convertible preferred stock 1,250,000 1,250,000 |
NATURE OF OPERATIONS - Addition
NATURE OF OPERATIONS - Additional Information (Details) - USD ($) | 12 Months Ended | 105 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Cash, cash equivalents, and marketable securities | $ 129,001,411 | $ 187,797,532 | $ 129,001,411 |
Revenue recognized | 1,502,748 | 208,382,779 | 222,500,000 |
Accumulated deficit | (225,526,542) | (171,357,513) | (225,526,542) |
Working capital | 124,400,000 | 124,400,000 | |
Cash outflows from operating activities | (55,227,127) | 118,611,673 | |
Net (loss) income | $ (54,169,029) | $ 122,834,584 | |
Angelini License Agreement | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Revenue recognized | 25,000,000 | ||
Takeda License and Termination Agreement | |||
Organization Consolidation And Presentation Of Financial Statements [Line Items] | |||
Revenue recognized | $ 196,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Mar. 17, 2022 | |
Summary of Significant Accounting Policy [Line Items] | |||
Equity method investments | $ 5,100,000 | $ 1,600,000 | |
Impairment recognized | 0 | 0 | |
Long-term equity investments | 5,622,547 | 1,631,992 | |
Debt securities, available-for-sale | $ 84,133,565 | 0 | |
Estimated useful life (in years) | 3 years | ||
Defined contribution plan name | 401(k)-retirement plan | ||
Contribution amount to retirement plan | $ 339,405 | 438,043 | |
Pension Plan, Matching Scenario One | |||
Summary of Significant Accounting Policy [Line Items] | |||
Percentage of matching contribution from employer | 100% | ||
Percentage of eligible employees' contribution | 3% | ||
Pension Plan, Matching Scenario Two | |||
Summary of Significant Accounting Policy [Line Items] | |||
Percentage of matching contribution from employer | 50% | ||
Fair Value, Level 3 | |||
Summary of Significant Accounting Policy [Line Items] | |||
Fair value assets | $ 0 | 0 | |
Fair value liabilities | 0 | 0 | |
Money Market Funds and Short-term Investments | Fair Value, Level 1 | |||
Summary of Significant Accounting Policy [Line Items] | |||
Fair value assets | 42,500,000 | $ 181,400,000 | |
Promissory Notes | |||
Summary of Significant Accounting Policy [Line Items] | |||
Long-term equity investments | $ 1,000,000 | ||
Interest rate, stated percentage | 1.50% | ||
Marinus Therapeutics Inc | |||
Summary of Significant Accounting Policy [Line Items] | |||
Equity method investments | $ 500,000 | ||
Minimum | Pension Plan, Matching Scenario Two | |||
Summary of Significant Accounting Policy [Line Items] | |||
Percentage of eligible employees' contribution | 3% | ||
Maximum | Pension Plan, Matching Scenario Two | |||
Summary of Significant Accounting Policy [Line Items] | |||
Percentage of eligible employees' contribution | 5% |
CASH, CASH EQUIVALENTS AND MA_3
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES - Schedule of Cash, Cash Equivalents And Marketable Securities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable securities, amortized cost | $ 84,175,752 | $ 0 |
Gross unrealized holding gains | 0 | 0 |
Gross unrealized holding losses | (42,187) | 0 |
Marketable securities, fair value | 84,133,565 | 0 |
Amortized cost | 129,043,599 | 187,797,532 |
Fair value | 129,001,411 | 187,797,532 |
Cash | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash and cash equivalents, amortized cost | 2,853,042 | 6,425,889 |
Cash and cash equivalents, fair value | 2,853,042 | 6,425,889 |
Money market funds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash and cash equivalents, amortized cost | 42,014,804 | 181,371,643 |
Cash and cash equivalents, fair value | $ 42,014,804 | $ 181,371,643 |
CASH, CASH EQUIVALENTS AND MA_4
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Investment | Dec. 31, 2021 USD ($) Investment | |
Cash and Cash Equivalents [Abstract] | ||
Number of securities in an unrealized loss position for more than 12 months | Investment | 0 | 0 |
Gains or losses on available-for-sale securities | $ | $ 0 | $ 0 |
PROPERTY AND EQUIPMENT AND IN_3
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS - Schedule of Property and Equipment (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Less accumulated depreciation | $ (581,381) | $ (262,208) |
Total property and equipment, net | 1,147,963 | 242,757 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,423,032 | 504,965 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 306,312 | $ 0 |
PROPERTY AND EQUIPMENT AND IN_4
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 319,173 | $ 76,871 |
Intangible assets, net of accumulated amortization | 222,100 | 164,092 |
Amortization expense | $ 193,333 | $ 160,208 |
LEASES - Additional Information
LEASES - Additional Information (Details) ft² in Thousands | 12 Months Ended | ||
Mar. 10, 2022 ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Operating lease, term of contract (in years) | 10 years | ||
Land subject to ground leases (sqft) | ft² | 19 | ||
Lease rent | $ 2,300,000 | ||
Commencement of rent payments (in months) | 10 months | ||
Free rent period (in months) | 2 months | ||
Restricted cash | $ 1,930,753 | $ 1,930,753 | |
Remaining lease term (in years) | 10 years | ||
Renewal option term (in years) | 5 years | ||
Lease incremental borrowing rate (as percent) | 7.02% | ||
Letter of Credit | |||
Lessee, Lease, Description [Line Items] | |||
Restricted cash | $ 1,900,000 |
LEASES - Schedule of ROU Asset
LEASES - Schedule of ROU Asset and Lease Liabilities Related to Operating Lease (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Right-of-use asset, net | $ 14,922,669 | $ 0 |
Current portion, lease liability | 533,946 | 0 |
Lease liability | $ 16,001,725 | $ 0 |
LEASES - Schedule of Operating
LEASES - Schedule of Operating Lease Cost (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 1,806,028 |
Variable lease cost | 0 |
Short-term lease cost | $ 0 |
LEASES - Schedule of Future Min
LEASES - Schedule of Future Minimum Commitments (Details) | Dec. 31, 2022 USD ($) |
Leases [Abstract] | |
2023 | $ 1,672,886 |
2024 | 2,316,303 |
2025 | 2,316,303 |
2026 | 2,316,303 |
2027 | 2,316,303 |
Thereafter | 12,347,235 |
Total operating lease | $ 23,285,333 |
ACCRUED EXPENSES - Schedule of
ACCRUED EXPENSES - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Payroll and bonus accrual | $ 3,233,802 | $ 3,764,666 |
Research and development accrual | 395,247 | 1,795,190 |
Professional fees accrual | 682,664 | 1,564,955 |
Other | 192,956 | 546,464 |
Accrued expenses | $ 4,504,669 | $ 7,671,275 |
STOCKHOLDERS_ EQUITY AND PREF_2
STOCKHOLDERS’ EQUITY AND PREFERRED STOCK (Details) | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 shares | Dec. 31, 2022 USD ($) vote $ / shares shares | Dec. 31, 2021 shares | Nov. 30, 2020 USD ($) | |
Class Of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||
Preferred stock, share designated (in shares) | 10,000 | 10,000 | ||
Number of votes per share | vote | 1 | |||
Preferred stock, shares outstanding (in shares) | 1,250 | 1,250 | ||
Dividends declared | $ | $ 0 | |||
Common Stock | ||||
Class Of Stock [Line Items] | ||||
Conversion of series A convertible preferred stock to common stock, shares (in shares) | 2,000,000 | 2,000,000 | ||
ATM Agreement | Cowen And Company, LLC | Common Stock | ||||
Class Of Stock [Line Items] | ||||
Number of common stock shares issued (in shares) | 0 | |||
Maximum | ATM Agreement | Cowen And Company, LLC | ||||
Class Of Stock [Line Items] | ||||
Net proceeds from offering, value | $ | $ 75,000,000 | |||
Series A Convertible Preferred Stock | ||||
Class Of Stock [Line Items] | ||||
Preferred stock, share designated (in shares) | 10,000 | |||
Number of common stock shares issued (in shares) | 2,000 | |||
Preferred stock, shares outstanding (in shares) | 1,250 | 1,250 | ||
Number of shares issued for each share of convertible preferred stock that is converted | 1,000 | |||
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% | |||
Allowable voting right percentage of outstanding common stock holders | 19.99% | |||
Allowable voting right percentage of outstanding common stock holders upon notice of days | 61 days | |||
Preferred stock, liquidation preference per share (in USD per share) | $ / shares | $ 0.001 | |||
Series A Convertible Preferred Stock | Maximum | ||||
Class Of Stock [Line Items] | ||||
Beneficial ownership limitations, percentage of issued and outstanding common stock | 15% | |||
Series A Convertible Preferred Stock | Minimum | ||||
Class Of Stock [Line Items] | ||||
Beneficial ownership limitations, percentage of issued and outstanding common stock | 10% |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
Jan. 01, 2023 | Jan. 01, 2022 | Jan. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 6,556,686 | $ 5,054,457 | |||
Granted option awards (in shares) | 4,575,641 | 2,045,913 | |||
Unrecognized compensation expenses | $ 12,100,000 | $ 10,400,000 | |||
Remaining average vesting period (in years) | 2 years 3 months 3 days | 2 years 7 months 9 days | |||
Performance-based Option Awards | |||||
Stock-Based Compensation [Line Items] | |||||
Performance based options outstanding (in shares) | 100,000 | 150,000 | |||
Performance-based Option Awards | Nonemployee Option | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 0 | $ 0 | |||
Performance-based Option Awards | Employee Option | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | 118,075 | 0 | |||
Stock options to purchase common stock | Nonemployee Option | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 575,995 | $ 584,092 | |||
Granted option awards (in shares) | 0 | 170,000 | |||
Unvested stock options, outstanding (in shares) | 127,459 | 181,250 | |||
Unrecognized compensation expenses | $ 626,977 | $ 67,471 | |||
Stock options to purchase common stock | Employee Option | |||||
Stock-Based Compensation [Line Items] | |||||
Share based compensation expense | $ 5,900,000 | $ 4,400,000 | |||
Granted option awards (in shares) | 4,575,641 | 1,875,913 | |||
Unvested stock options, outstanding (in shares) | 6,090,889 | 4,407,308 | |||
Unrecognized compensation expenses | $ 11,500,000 | $ 10,300,000 | |||
2017 Equity Incentive Plan | |||||
Stock-Based Compensation [Line Items] | |||||
Number of common stock initially reserved for future issuance (in shares) | 3,052,059 | ||||
Percentage increase, outstanding stock maximum | 5% | ||||
Number of additional shares reserved for issuance under the plan (in shares) | 1,000,000 | 3,287,158 | 3,187,069 | 4,397,067 | |
Stock option granted, Term (in years) | 10 years | ||||
Stock options, vesting period (in years) | 4 years | ||||
Vested options, exercisable period (in days) | 90 days | ||||
2017 Equity Incentive Plan | Subsequent Event | |||||
Stock-Based Compensation [Line Items] | |||||
Number of additional shares reserved for issuance under the plan (in shares) | 3,523,344 | ||||
2017 ESPP | |||||
Stock-Based Compensation [Line Items] | |||||
Number of common stock initially reserved for future issuance (in shares) | 416,607 | 493,062 | |||
Number of additional shares reserved for issuance under the plan (in shares) | 0 | ||||
Common stock, reserved for future issuance | 279,069 | ||||
Percentage of discount from market price on purchase date | 15% | ||||
Share based compensation, number of shares purchased | 76,455 | 60,490 | |||
Share based compensation expense | $ 85,319 | $ 83,787 | |||
Percentage increase, outstanding stock maximum | 1% | ||||
Number of additional shares authorized (in shares) | 550,000 |
STOCK-BASED COMPENSATION - Sche
STOCK-BASED COMPENSATION - Schedule of Recognized Stock-Based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 6,556,686 | $ 5,054,457 |
Research and development | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | 1,770,599 | 1,679,183 |
General and administrative | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 4,786,087 | $ 3,375,274 |
STOCK-BASED COMPENSATION - Sc_2
STOCK-BASED COMPENSATION - Schedule of Allocation of Stock-Based Compensation Expense by Plan (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 6,556,686 | $ 5,054,457 |
Stock options | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | 6,471,367 | 4,970,670 |
Employee Stock Purchase Plan | ||
Stock-Based Compensation [Line Items] | ||
Stock-based compensation expense, Total | $ 85,319 | $ 83,787 |
STOCK-BASED COMPENSATION - Sc_3
STOCK-BASED COMPENSATION - Schedule of Assumptions Used to Compute Fair Value of Employee Option Granted (Details) - Stock options to purchase common stock - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Option | ||
Stock-Based Compensation [Line Items] | ||
Volatility | 87.16% | 84.38% |
Expected term in years | 6 years 25 days | 6 years 10 days |
Dividend rate | 0% | 0% |
Risk-free interest rate | 2.21% | 0.90% |
Fair value of option on grant date | $ 2.12 | $ 2.50 |
Nonemployee Option | ||
Stock-Based Compensation [Line Items] | ||
Volatility | 0% | 80.43% |
Expected term in years | 0 years | 6 years 2 months 23 days |
Dividend rate | 0% | 0% |
Risk-free interest rate | 0% | 1.03% |
Fair value of option on grant date | $ 0 | $ 2.49 |
STOCK-BASED COMPENSATION - Sc_4
STOCK-BASED COMPENSATION - Schedule of Options Outstanding and Weighted Average Exercise Price (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares | |||
Options outstanding, beginning balance (in shares) | 10,776,758 | 10,403,420 | |
Vested and exercisable, beginning balance (in shares) | 6,188,200 | 5,395,658 | |
Granted (in shares) | 4,575,641 | 2,045,913 | |
Exercised (in shares) | (25,518) | (288,525) | |
Forfeited, (in shares) | (2,365,643) | (1,384,050) | |
Options outstanding, ending balance (in shares) | 12,961,238 | 10,776,758 | 10,403,420 |
Vested and exercisable, ending balance (in shares) | 6,742,890 | 6,188,200 | 5,395,658 |
Weighted Average Exercise Price | |||
Options outstanding, beginning balance (in USD per share) | $ 4.97 | $ 5.26 | |
Vested and exercisable, beginning balance (in USD per share) | 5.98 | 6.45 | |
Granted (in USD per share) | 2.89 | 3.53 | |
Exercised (in USD per share) | 1.91 | 2.36 | |
Forfeited (in USD per share) | 5.56 | 4.08 | |
Options outstanding, ending balance (in USD per share) | 4.13 | 4.97 | $ 5.26 |
Vested and exercisable, ending balance (in USD per share) | $ 5.05 | $ 5.98 | $ 6.45 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Additional Disclosures [Abstract] | |||
Weighted Average Remaining Contractual Life, Options outstanding (in years) | 7 years 5 months 1 day | 6 years 25 days | 7 years 7 months 2 days |
Weighted Average Remaining Contractual Life, Vested and exercisable (in years) | 6 years 2 months 12 days | 4 years 7 months 17 days | 6 years 1 month 17 days |
Weighted Average Remaining Contractual Life, Granted (in years) | 9 years 3 months 3 days | 9 years 5 months 19 days | |
Aggregate Intrinsic Value, Options outstanding | $ 62,158 | $ 2,389,890 | $ 652,438 |
Aggregate Intrinsic Value, Vested and exercisable | $ 61,214 | $ 1,531,907 | $ 445,599 |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Increase (decrease) in valuation allowance | $ 10,400,000 | $ (26,500,000) |
Unrecognized tax benefits or related interest and penalties accrued | 0 | $ 0 |
New York State Division of Taxation and Finance | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 163,900,000 | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 153,500,000 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 177,100,000 |
INCOME TAXES - Schedule of Defe
INCOME TAXES - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets/liabilities: | ||
Net operating loss carryforwards | $ 55,472,573 | $ 49,086,998 |
Intangible assets | 6,332,176 | 7,121,484 |
Capitalized research and development costs | 4,246,071 | 0 |
Stock-based compensation | 4,384,751 | 4,663,578 |
Lease liability | 3,544,624 | 0 |
Research and development tax credits | 3,046,253 | 2,422,331 |
Accrued compensation | 0 | (28,243) |
Charitable contributions | 0 | 87,672 |
Depreciation | (241,096) | (51,920) |
Right-of-use asset | (3,198,857) | 0 |
Other | 97,494 | 0 |
Total gross deferred tax assets/liabilities | 73,683,989 | 63,301,900 |
Valuation allowance | (73,683,989) | (63,301,900) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
INCOME TAXES - Schedule of Reco
INCOME TAXES - Schedule of Reconciliation of Statutory U.S. Federal Rate to Effective Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax benefit at statutory rate | 21% | 21% |
State income tax, net of federal benefit | (0.27%) | 1.05% |
Permanent items | (1.26%) | 0.53% |
Change in valuation allowance | (18.50%) | (21.39%) |
Research and development tax credits | 1.28% | (1.05%) |
Other | (2.25%) | 0.93% |
Effective income tax expense rate | 0% | 1.07% |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | 1 Months Ended | 12 Months Ended | ||||
Dec. 30, 2021 USD ($) shares | Aug. 31, 2022 USD ($) | Dec. 31, 2016 USD ($) product | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2017 USD ($) | |
Loss Contingencies [Line Items] | ||||||
License agreement milestone payments (up to) | $ 203,000,000 | |||||
Common stock, shares issued (in shares) | shares | 70,466,885 | 70,364,912 | ||||
Research and development | $ 24,618,399 | $ 46,939,583 | ||||
Research plan and budget, expected costs | $ 3,000,000 | |||||
Maximum | License Agreement | ||||||
Loss Contingencies [Line Items] | ||||||
License agreement milestone payments (up to) | $ 452,000,000 | |||||
Lundbeck | ||||||
Loss Contingencies [Line Items] | ||||||
First payment due upon completion of first phase | 3,000,000 | |||||
Northwestern University | License Agreement | ||||||
Loss Contingencies [Line Items] | ||||||
Upfront non-creditable one-time license issuance fee payment | $ 75,000 | |||||
Annual license maintenance fee payable | $ 20,000 | |||||
Minimum number of product covered under license agreement | product | 1 | |||||
Northwestern University | Maximum | License Agreement | ||||||
Loss Contingencies [Line Items] | ||||||
Consideration payable for rights grant (up to) | $ 5,300,000 | |||||
AstraZeneca | ||||||
Loss Contingencies [Line Items] | ||||||
Upfront cash payment | $ 5,000,000 | |||||
Common stock, shares issued (in shares) | shares | 7,300,000 | |||||
Research and development | $ 12,300,000 |
COLLABORATION AGREEMENTS (Detai
COLLABORATION AGREEMENTS (Details) - USD ($) | 12 Months Ended | 105 Months Ended | |||||
Mar. 01, 2022 | Feb. 01, 2022 | Mar. 29, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 1,502,748 | $ 208,382,779 | $ 222,500,000 | ||||
Common stock, shares issued (in shares) | 70,466,885 | 70,364,912 | 70,466,885 | ||||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Unrealized loss on equity securities | $ 500,000 | ||||||
Collaborative Arrangement, Co-promotion | Takeda Pharmaceutical Company Limited | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Agreement ownership share | 50% | 50% | |||||
Collaborative Arrangement, Co-promotion | Takeda Pharmaceutical Company Limited | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Up-front fee | $ 196,000,000 | ||||||
Upfront payment under royalty and termination agreement | $ 196,000,000 | ||||||
Aggregate milestone payments | $ 660,000,000 | ||||||
Related party transaction expenses recognized | 0 | ||||||
Research and development expense reimbursement received | $ 2,500,000 | ||||||
General and administrative expense reimbursement received | $ 100,000 | ||||||
Collaborative Arrangement, Co-promotion | Takeda Pharmaceutical Company Limited | Maximum | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Additional payment on sales percentage | 20% | ||||||
Healx License and Option Agreement . | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 500,000 | ||||||
Up front payment | $ 500,000 | ||||||
Development and commercial milestone payments | $ 2,000,000 | ||||||
Percentage of development costs | 50% | ||||||
Marinus License Agreement | Marinus Pharmaceuticals, Inc. | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Common stock, shares issued (in shares) | 123,255 | ||||||
Common stock, par value (in USD per share) | $ 0.001 | ||||||
Patent License Agreement | Marinus Pharmaceuticals, Inc. | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 900,000 | ||||||
Angelini | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Potential funding cost percent | 35% | 35% | |||||
Future cost of agreement | $ 7,000,000 | ||||||
Deferred upfront payment costs | 7,000,000 | ||||||
Revenue recognized | 0 | $ 12,400,000 | |||||
License revenue | 5,400,000 | ||||||
Amount for potential future trials | $ 7,000,000 | ||||||
Angelini | License Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Upfront payment under license agreement | $ 20,000,000 | ||||||
Additional up front fee amount | 5,000,000 | ||||||
Up-front fee | $ 20,000,000 |
NET (LOSS) INCOME PER SHARE - S
NET (LOSS) INCOME PER SHARE - Schedule of Basic and Diluted Earnings (Loss) Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net (loss) income | $ (54,169,029) | $ 122,834,584 |
Net income attributable to participating securities | 0 | (2,997,344) |
Net (loss) income attributable to common stockholders | (54,169,029) | 119,837,240 |
Net (loss) income attributable to common stockholders, basic | $ (54,169,029) | $ 119,837,240 |
Weighted average common shares outstanding used in computing net (loss) income per share - basic (in shares) | 70,424,819 | 67,479,403 |
Weighted average common shares outstanding used in computing net (loss) income per share - diluted (in shares) | 70,424,819 | 68,067,992 |
Net (loss) income per share, basic (in USD per share) | $ (0.77) | $ 1.78 |
Net (loss) income per share, diluted (in USD per share) | $ (0.77) | $ 1.76 |
NET (LOSS) INCOME PER SHARE -_2
NET (LOSS) INCOME PER SHARE - Schedule of Computations of Diluted Weighted-Average Shares Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options to purchase common stock | ||
Dilutive Securities Included and Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computations of diluted weighted-average shares outstanding (in shares) | 12,961,238 | 10,776,758 |
Common stock issuable upon conversion of Series A convertible preferred stock | ||
Dilutive Securities Included and Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computations of diluted weighted-average shares outstanding (in shares) | 1,250,000 | 1,250,000 |