Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
| Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
| Preferred stock, shares 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 dollars per share) | $ 0.001 | $ 0.001 |
| Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
| Common stock shares issued (in shares) | 71,109,514 | 71,009,866 |
| Common stock, shares outstanding (in shares) | 71,109,514 | 71,009,866 |
Condensed Consolidated Statements of Comprehensive (Loss) Income (unaudited) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
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| Statement of Comprehensive Income [Abstract] | ||||
| Net (loss) income | $ (4,684) | $ 8,521 | $ (14,919) | $ (3,174) |
| Other comprehensive (loss) income: | ||||
| Cumulative translation adjustment | (11) | 0 | (31) | 0 |
| Unrealized (loss) gain on marketable securities | (1) | 7 | (3) | (13) |
| Comprehensive (loss) income | $ (4,696) | $ 8,528 | $ (14,953) | $ (3,187) |
NATURE OF OPERATIONS |
6 Months Ended |
|---|---|
Jun. 30, 2025 | |
| 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 and maintains its principal executive office in New York, New York. The Company is a biopharmaceutical company that is dedicated to developing small molecule medicines for brain conditions with significant unmet need. Liquidity and Going Concern 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, common stock, other equity instruments, the sale and/or licensing of certain assets and the licensing of certain intellectual property. 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. The Company is also subject to other challenges and risks specific to its 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; the challenges of protecting and enhancing intellectual property rights; complying with applicable regulatory requirements; obtaining regulatory approval of any of the Company’s potential product candidates, among others. The Company’s major sources of cash have been licensing revenue, proceeds from various public and private offerings of its capital stock, option exercises and interest income. As of June 30, 2025, the Company had $38.3 million in cash, cash equivalents and marketable securities. Since its founding, the Company has generated its revenue primarily from the Company’s royalty, license and termination agreement (“RLT Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”). For most periods, the Company has incurred recurring losses, has experienced negative operating cash flows and has required significant cash resources to execute its business plans, which the Company expects will continue for the foreseeable future. The Company has an accumulated deficit of $319.2 million as of June 30, 2025, working capital of $33.2 million and net cash used in operating activities of $15.1 million for the six months ended June 30, 2025. The Company recorded net losses of $4.7 million and $14.9 million, respectively, during the three and six month periods ended June 30, 2025, and expects to incur losses in subsequent periods for at least the next several years. The Company 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 June 30, 2025 will not be sufficient to fund its current operating plans through the next 12 months from the date these condensed consolidated financial statements were available to be issued. The Company is currently evaluating strategic alternatives, including additional financings or other options such as partnerships or collaborations, strategic alliances, licensing agreements or a combination of any such transactions, which may require the Company to relinquish rights to certain drug candidates that the Company might otherwise seek to develop or commercialize independently. Adequate additional capital to fund the operations of the Company may not be available on acceptable terms or at all. The failure to raise capital will have a negative impact on the Company’s financial condition and ability to pursue its business strategy. If unsuccessful in raising additional capital, the Company may need to reduce operating expenses or will be required to delay, reduce the scope of, or eliminate additional research and development programs. These condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. The condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities and reported expenses that may be necessary if the Company were unable to continue as a going concern. Nasdaq Compliance On February 10, 2025, the Company received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC notifying the Company that the average closing bid price of the Company’s shares of common stock was below the closing bid price of $1.00 per share during the last 31 consecutive trading days. The Company had an initial period of 180 calendar days, or until August 11, 2025, to regain compliance with the minimum bid price requirement. On August 12, 2025, the Company received approval from the Listing Qualifications Department of Nasdaq to transfer the listing of the Company’s common stock from the Nasdaq Global Select Market to the Nasdaq Capital Market (the “Approval”). In connection with the Approval, the Company was granted an additional 180-day grace period, or until February 9, 2026, to regain compliance with the minimum bid price requirement. To regain compliance with the minimum bid price requirement and qualify for continued listing on the Nasdaq Capital Market, the minimum bid price per share of the Company’s common stock must be at least $1.00 for at least 10 consecutive business days during the additional 180-day grace period. If the Company does not regain compliance during this additional grace period, its common stock would be subject to delisting by Nasdaq. On July 9, 2025, the Company’s stockholders approved a series of alternate amendments to the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect, at the option of the Company’s Board of Directors, a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-10 to 1-for-40, inclusive, with such ratio to be determined by the Company’s Board of Directors in its sole discretion.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
6 Months Ended |
|---|---|
Jun. 30, 2025 | |
| Accounting Policies [Abstract] | |
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (A) Unaudited Interim Condensed Consolidated Financial Statements The interim condensed consolidated balance sheet at June 30, 2025 and the condensed consolidated statements of operations, comprehensive loss, cash flows, and stockholders’ equity for the three and six months ended June 30, 2025 and 2024 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by GAAP are condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and six months ended June 30, 2025 and 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period. The balance sheet as of December 31, 2024 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K. (B) Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP and include the accounts of Ovid Therapeutics Inc. and its wholly owned subsidiaries, Ovid Therapeutics Australia Pty Ltd. and Ovid Therapeutics Hong Kong Ltd. All intercompany transactions and balances have been eliminated in consolidation. (C) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ materially from those estimates. (D) 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 condensed consolidated balance sheets. The Company classifies its marketable securities with original maturities of less than three months as cash equivalents on its condensed 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) income 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 whose use is otherwise limited by contractual provisions. Amounts are reported as noncurrent unless restrictions are expected to be released in the next 12 months. (F) Long-Term Equity Investments Long-term equity investments consist of equity investments in the preferred shares of Gensaic, Inc., formerly M13 Therapeutics, Inc. (“Gensaic”), and Graviton Bioscience Corporation (“Graviton”), both privately held corporations. The preferred shares are not considered in-substance common stock, and the investments are accounted for at cost, with adjustments for observable changes in prices or impairments, and are classified within long-term equity investments on the condensed consolidated balance sheets with adjustments recognized in other income (expense), net on the condensed consolidated statements of operations. The Company has determined that these equity investments do not have a readily determinable fair value and elected the measurement alternative. Therefore, the carrying amount of the equity investments 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 investments are impaired. The assessment includes a review of recent operating results and trends, recent sales/acquisitions of the investees’ securities, and other publicly available data. If an investment is determined to be impaired, the Company will then write it down to its estimated fair value. As of June 30, 2025 and December 31, 2024, the equity investment in Gensaic had a carrying value of $5.1 million. As of June 30, 2025 and December 31, 2024, the equity investment in Graviton had a carrying value of $15.8 million. The initial investment in Graviton was $10.0 million, and cumulative measurement adjustments based on observable price increases totaling $5.8 million have been recognized, recorded in other income (expense), net within the statement of operations. Long-term equity investments also consist of an equity investment in the common shares of Marinus Pharmaceuticals, Inc. (“Marinus”) that were received as noncash 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 condensed consolidated balance sheets and other income (expense), net on the Company’s condensed consolidated statements of operations. As of December 31, 2024, the equity investment in Marinus had a carrying value of $0.1 million. In February 2025, Immedica, S.A. (“Immedica”) closed a cash purchase of Marinus, resulting in the sale of the Company’s equity position in Marinus to Immedica for $70,000. (G) Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: •Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company’s Level 1 assets consisted of investments in a U.S. treasury money market fund of $20.7 million as of June 30, 2025, and U.S. treasury money market fund and equity securities totaling $25.8 million as of December 31, 2024. •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 $9.9 million as of June 30, 2025 and $26.8 million as of December 31, 2024. •Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. There were no Level 3 assets or liabilities as of June 30, 2025 or December 31, 2024. The carrying amounts reported in the balance sheets for cash and cash equivalents, other current assets, accounts payable and accrued expenses approximate their fair values based on the short-term maturity of these instruments. (H) Leases The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with FASB Accounting Standards Codification (“ASC”) 842. Operating leases are included in right-of-use (“ROU”) assets, current liabilities, and long-term lease liability in the Company's condensed 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. (I) Property and Equipment Property and equipment are stated at cost and depreciated over their estimated useful lives of three years using the straight-line method. 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. (J) 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. 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. (K) Royalty Monetization Liability The Company accounted for its sale to Ligand Pharmaceuticals Incorporated (“Ligand”) of a 13% share of royalties and milestones owed to the Company related to the potential approval and commercialization of soticlestat (“Ligand Agreement”) in accordance with ASC 470, Debt, classifying the proceeds received from the sale to Ligand as debt as the Company determined that it had significant continuing involvement in the generation of the cash flows to Ligand. The Company further elected to account for the debt at fair value with changes in the fair value of the debt classified as other income (expense) in the consolidated statements of operations. In June 2024, Takeda issued a press release indicating the soticlestat trials missed their primary endpoints and noted that while Takeda would discuss the program with FDA, Takeda fully impaired the asset representing soticlestat. In 2024, the Company recorded a gain of $30.0 million due to reducing the fair value of the Ligand Agreement debt to zero as a result of the improbability that the program would be further developed into a commercial product by Takeda or another party. In January 2025, Takeda announced the discontinuation of the program. (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 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 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 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 aggregates employee and nonemployee awards for certain disclosures since nonemployee awards are not material. (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 The rights and preferences of the non-voting Series A convertible preferred stock (“Series A Preferred Stock”) are negligible relative to common stock, therefore the Series A Preferred Stock is treated as in-substance common stock on an as-converted basis when allocating net (loss) income to actual and in-substance shares of common stock. The Company applies the two-class method to allocate earnings between common stock, Series A Preferred Stock as well as other securities deemed in-substance common stock and participating securities, if any. Net (loss) income per share of Series A Preferred Stock is determined by dividing net (loss) income attributable to Series A preferred stockholders on an as-converted basis by the basic and diluted weighted-average shares of Series A Preferred Stock outstanding during the period. Net (loss) income per share of common stock is determined by dividing net income attributable to common stockholders by the basic and diluted weighted-average shares of common stock outstanding during the period. 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 and restricted stock units using the treasury-stock method and the potential impact of any preferred stock using the if-converted method. Net (loss) income per diluted share attributable to common stockholders omits the inclusion of stock options, common stock issuable upon conversion of Series A Preferred Stock, and unvested restricted stock units as these securities would be anti-dilutive. (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 (the “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 three months ended June 30, 2025 and 2024, the Company contributed $47,000 and $88,000, respectively. For the six months ended June 30, 2025 and 2024, the Company contributed $121,000 and $200,000, respectively. (P) Revenue Recognition Under ASC 606, Revenue from Contracts with Customers, 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) it satisfies the performance obligations. 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 the Company transfers 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 until the performance obligations are satisfied. (Q) Segment Reporting Under Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): “Improvements to Reportable Segment Disclosures” (“ASU 2023-07”), the Company discloses significant segment expenses regularly provided to the chief operating decision maker (“CODM”) and discloses the title and position of the CODM. (R) 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. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, (“ASU 2023-09”), which is effective for annual periods beginning after December 15, 2024. ASU 2023-09 intends to enhance the transparency as well as usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its related disclosures. In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires the disaggregation of certain expense captions into specified categories in disclosures within the notes to the consolidated financial statements to provide enhanced transparency into the expense captions presented on the face of the statements of income and comprehensive income. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, with early adoption permitted, and may be applied either prospectively or retrospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its related disclosures. The Company adopts new pronouncements relating to GAAP applicable to the Company as they are issued, and based upon the effective dates included in the pronouncements. 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 consolidated financial statements.
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CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES |
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| 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 June 30, 2025 and December 31, 2024:
The Company did not hold any securities that were in an unrealized loss position for more than 12 months as of June 30, 2025 and December 31, 2024. There were no material realized gains or losses on available-for-sale securities during the three and six months ended June 30, 2025 and 2024.
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PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS |
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| PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS | PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS Property and equipment is summarized as follows:
Depreciation expense was $61,000 and $103,000 for the three months ended June 30, 2025 and 2024, respectively. Depreciation expense was $148,000 and $204,000 for the six months ended June 30, 2025 and 2024, respectively. Intangible assets, net of accumulated amortization, were $0 and $219,000 as of June 30, 2025 and December 31, 2024, respectively, and are included in other noncurrent assets on the condensed consolidated balance sheets. Amortization expense was $38,000 and $45,000 for the three months ended June 30, 2025 and 2024, respectively. Amortization expense was $92,000 and $80,000 for the six months ended June 30, 2025 and 2024, respectively.
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LEASES |
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| Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| LEASES | LEASES In 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, New York. 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. The Company issued an irrevocable 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 condensed consolidated balance sheets. The Hudson Commons lease has a remaining lease term of approximately seven 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 was calculated using an incremental borrowing rate of 7.02%. Lease expense is included in general and administrative and research and development expenses in the condensed consolidated statements of operations. ROU asset and lease liabilities related to the Company’s operating lease are as follows:
The components of operating lease cost for the three and six months ended June 30, 2025 were as follows:
Future minimum commitments under the non-cancelable operating lease are as follows:
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ACCRUED EXPENSES |
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| Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consist of the following:
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STOCKHOLDERS’ EQUITY |
6 Months Ended |
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Jun. 30, 2025 | |
| Equity [Abstract] | |
| STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY 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 shares of preferred stock as Series A Preferred Stock, of which 1,250 are issued and outstanding as of June 30, 2025. 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. 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. There were 1,250 shares of Series A Preferred Stock outstanding as of June 30, 2025 and December 31, 2024. 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. Holders of Series A Preferred Stock are entitled to receive dividends paid to holders of common stock at an equal rate, in the same form, and in the same manner on an as-if-converted basis. Dividends Through June 30, 2025, the Company has not declared any dividends. No dividends on the common stock shall be declared and paid unless dividends on the preferred stock have been declared and paid.
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STOCK-BASED COMPENSATION |
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| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION 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 issuable 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. Following the adoption of the 2017 Plan, no further awards will be granted under the Company’s prior 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 at its discretion. On January 1, 2025, no additional shares were reserved for issuance under the 2017 Plan. As of June 30, 2025, there were 3,626,702 shares of the Company’s common stock reserved and available for issuance under the 2017 Plan. The Company’s Board of Directors adopted, and the Company’s stockholders approved, the 2017 Employee Stock Purchase Plan (“2017 ESPP”), which became effective on May 4, 2017. The initial reserve of shares of common stock issuable 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 semi-annual purchase dates. During the three months ended June 30, 2025 and 2024, no shares were purchased under the 2017 ESPP, and the Company recorded expense of $3,000 and $18,000, respectively. During the six months ended June 30, 2025 and 2024, employees purchased 34,509 and 31,561 shares under the 2017 ESPP, respectively, and the Company recorded expense of $25,000 and $33,000, respectively. The number of shares of common stock reserved for issuance under the 2017 ESPP automatically increases on January 1 of each year, beginning on January 1, 2018 and continuing through and including January 1, 2027, by the lesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 550,000 shares or (iii) such lesser number of shares determined by the Board of Directors. The Board of Directors acted prior to each of January 1, 2025 and January 1, 2024 to provide that there be no increase in the number of shares reserved for issuance under the 2017 ESPP on either such date. As of June 30, 2025, there were 248,487 shares of the Company’s common stock reserved and available for issuance under the 2017 ESPP. The Company’s Board of Directors adopted, and the Company’s stockholders approved, the 2014 Equity Incentive Plan (“2014 Plan”), which authorized the Company to grant shares of common stock in the form of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock and restricted stock units. The 2014 Plan was terminated as to future awards in May 2017, although it continues to govern the terms of options that remain outstanding under the 2014 Plan. No additional stock awards will be granted under the 2014 Plan, and all outstanding stock awards granted under the 2014 Plan that are repurchased, forfeited, expire or are cancelled will become available for grant under the 2017 Plan in accordance with its terms. As of June 30, 2025, options to purchase 956,622 shares of common stock were outstanding under the 2014 Plan. Unless specified otherwise in an individual option agreement, stock options granted under the 2014 Plan and the 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 under the 2017 Plan and 30 days under the 2014 Plan 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 18 months or 12 months, respectively, under the 2017 Plan and six months under the 2014 Plan. The fair value of options granted during the three and six months ended June 30, 2025 and 2024 was estimated using the Black-Scholes option valuation model. The inputs for the Black-Scholes option valuation model require assumptions that are detailed in the table below. The risk-free interest rates are 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 is based on the simplified method in accordance with the SEC Staff Accounting Bulletin No. Topic 14D. The Company granted 305,000 and 80,000 stock options during the three months ended June 30, 2025 and 2024, respectively, and 3,675,900 and 2,752,150 during the six months ended June 30, 2025 and 2024, respectively. There were 8,271,531 and 6,076,514 unvested options outstanding as of June 30, 2025 and 2024, respectively. Total expense recognized related to the stock options for the three months ended June 30, 2025 and 2024 was $1.2 million and $1.6 million, respectively. Total expense recognized related to the stock options for the six months ended June 30, 2025 and 2024 was $2.5 million and $3.5 million, respectively. During the three and six months ended June 30, 2025 and 2024, the Company had no outstanding performance-based option awards and did not record any related expense in those periods. The Company did not grant any restricted stock units during the three months ended June 30, 2025 and 2024. The Company granted 249,201 and 348,575 restricted stock units during the six months ended June 30, 2025 and 2024, respectively. At June 30, 2025, there were 367,337 restricted stock units outstanding. The Company’s stock-based compensation expense was recognized in operating expenses as follows:
The fair value of options granted during the three and six months ended June 30, 2025 and 2024 was estimated utilizing the following assumptions:
The following table summarizes the number of options outstanding and the weighted average exercise price:
At June 30, 2025, there was $11.2 million of unrecognized stock–based compensation expense related to stock option grants, which is expected to be recognized over a remaining average vesting period of 2.42 years.
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INCOME TAXES |
6 Months Ended |
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Jun. 30, 2025 | |
| Income Tax Disclosure [Abstract] | |
| INCOME TAXES | INCOME TAXES The Company’s interim income tax provision consists of U.S. federal and state income taxes based on the estimated annual effective tax rate that the Company expects for the full year together with the tax effect of discrete items. Each quarter the Company updates its estimate of the annual effective tax rate and records cumulative adjustments as necessary. As of June 30, 2025, the Company was in a pre-tax loss position and is anticipated to remain so throughout the year. For the three and six months ended June 30, 2025 and 2024, the Company did not record any tax benefit or expense. In assessing the realizability of deferred tax assets, management evaluates whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income in those periods in which temporary differences become deductible and/or net operating losses can be utilized. Management assesses all positive and negative evidence when determining the amount of the net deferred tax assets that are more likely than not to be realized. This evidence includes, but is not limited to, prior earnings history, scheduled reversal of taxable temporary differences, tax planning strategies and projected future taxable income. Significant weight is given to positive and negative evidence that is objectively verifiable. Based on these factors, including cumulative losses in recent years, the Company continues to maintain a full valuation allowance against its net deferred tax assets as of June 30, 2025. On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA includes significant changes, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to certain aspects of the international tax framework and the restoration of favorable tax treatment for certain business expense provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company is currently assessing its impact on its consolidated financial statements.
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COMMITMENTS AND CONTINGENCIES |
6 Months Ended |
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Jun. 30, 2025 | |
| 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 (“Northwestern Agreement”) with Northwestern University (“Northwestern”), pursuant to which Northwestern granted the Company an exclusive, worldwide license to patent rights of certain inventions (“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 In December 2021, the Company entered into an exclusive license agreement with AstraZeneca AB (“AstraZeneca”), 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. 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 an equity agreement and a collaboration and option agreement with Gensaic (“Gensaic Collaboration Agreement”). Under the terms of the equity agreement, the Company invested a total of $5.1 million in exchange for convertible preferred stock in Gensaic. The Company also retained rights to invest in future equity financing rounds. Dr. Jeremy Levin, the Company’s Chairman and Chief Executive Officer (“CEO”), is currently the Chairman of Gensaic’s board of directors. The Gensaic Collaboration Agreement involves the research and development of Gensaic’s proprietary platform for certain rare central nervous system (“CNS”) disorder targets. Under the Gensaic Collaboration Agreement, Gensaic granted the Company an option to obtain an exclusive license with respect to certain identified lead phage-derived particle (“PDP”) products, which is 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 its 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. In May 2023, the Company identified a lead PDP candidate for further research and provided $3.5 million to Gensaic to support the approved research plan and budget. The amount is expensed as the research and development occurs with the remaining amount included in prepaid expenses and other current assets in the condensed consolidated balance sheets. As of June 30, 2025 and December 31, 2024, $1.0 million remained in prepaid expenses and other current assets. No expense was recognized in the three months ended June 30, 2025 and $0.6 million was recognized for the same period in 2024. 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. As of June 30, 2025, none of these contingent payments were considered probable. The Company may terminate the Gensaic Collaboration Agreement by providing written notice to Gensaic 90 days in advance of the termination date. Non-Operating Loss During the quarter ended September 30, 2024, the Company was the victim of a criminal scheme involving a business email compromise at one of its development collaborators, which led to a fraudulent transfer totaling $1.8 million to a third-party impersonating one of the Company’s development collaborators. The matter was reported to the U.S. Secret Service and Federal Bureau of Investigation and a loss was recorded in other income (expense) in the condensed consolidated statement of operations. In January 2025, the Company fully recovered the $1.8 million and recorded a gain in other income (expense) in the condensed consolidated statement of operations. 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 that are material to the Company. Under the terms of their respective employment agreements, certain of our executive officers are eligible to receive severance payments and benefits upon a termination without “cause” or due to “permanent disability,” or upon “resignation for good reason,” contingent upon the executive officer’s delivery to the Company of a satisfactory release of claims, and subject to the executive officer’s compliance with non-competition and non-solicitation restrictive covenants.
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COLLABORATION AND LICENSE AGREEMENTS |
6 Months Ended |
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Jun. 30, 2025 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| COLLABORATION AND LICENSE AGREEMENTS | COLLABORATION AND LICENSE AGREEMENTS Takeda Collaboration In January 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, 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 no longer has any financial obligation to Takeda under the original collaboration agreement, including milestone payments or any future development and commercialization costs. In March 2021, upon the closing of the RLT Agreement, the Company received an upfront payment of $196.0 million and, if soticlestat was successfully developed, the Company would be eligible to receive up to $660.0 million in milestone payments and royalties on product sales. In October 2023, the Company sold a 13% stake in the royalty, regulatory and commercial milestone payments that the Company is eligible to receive under the RLT Agreement to Ligand for $30.0 million. The Company retained 87% of its interest in soticlestat’s potential royalties and milestones. During the three and six months ended June 30, 2025 and 2024, no revenue or expense was recognized pursuant to the RLT Agreement. In June 2024, Takeda issued a press release indicating the soticlestat trials missed their primary endpoints and noted that while Takeda would discuss the program with FDA, Takeda had fully impaired the asset representing soticlestat. In January 2025, Takeda announced the discontinuation of the program. As of June 30, 2025, the Company has no debt or other obligations to Ligand. Healx License and Option Agreement In February 2022, the Company entered an exclusive license option agreement (“Healx License and Option Agreement”) with Healx, Ltd. (“Healx”). Under the terms of the Healx License and Option Agreement, Healx secured a one-year option to investigate gaboxadol (“OV101”) as part of a potential combination therapy for Fragile X syndrome in a Phase 1B/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. In February 2023, the Company granted an extension of the option period for up to four months for Healx to continue to investigate gaboxadol. Royalties on net sales, if any, 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 it has 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 the Company is continuing to exploit gaboxadol. Further, if the Company exercises the Ovid Opt-In Right to co-develop and co-commercialize the program, it will owe an equal share of any net profits to a third party with which it previously established a licensing agreement. If the Company does not exercise the Ovid Opt-In Right, it will owe the third party an equal share of all milestone and royalty payments received. In June 2023, the Company entered into an amendment to the Healx License and Option Agreement whereby revisions were made to terms regarding the timing of the option exercise fee payable by Healx to the Company, the clinical and regulatory milestone payment structure, and the royalty payment structure. Additionally, the parties agreed that following the exercise of the option, Healx would assume direct responsibility for patent maintenance and prosecution and that the Company would transfer to Healx all supply obligations with respect to the active pharmaceutical ingredient and finished gaboxadol products and any related licensed technology and know-how in the Company’s possession that is relevant to the manufacture of such licensed products. No revenue was recognized relating to the Healx License and Option Agreement during the three and six month periods ended June 30, 2025 and 2024. Marinus Pharmaceuticals Out-License Agreement In March 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 consists 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 in March 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 had unrealized losses on the Marinus common stock of $1.2 million for the six months ended June 30, 2024, which were recorded as unrealized gains (losses) on equity securities and were reflected in other income (expense), net in the condensed consolidated statements of operations. In February 2025, Immedica closed a cash purchase of Marinus, resulting in the sale of the Company's equity position in Marinus for $70,000. In June 2025, the Company entered into an amendment to the Marinus License Agreement with Immedica wherein the parties agreed to replace ongoing royalty payment obligations and add additional licensing for a one-time payment of $7.0 million, which was remitted to the Company pursuant to the agreement within 10 days of execution. $6.3 million of the $7.0 million is related to the royalties and existing licenses which the Company recognized as revenue in the three month period ended June 30, 2025. The remaining $0.7 million is related to additional licensure to be granted within six months of the effective date of the amendment which the Company recorded as deferred revenue until the additional licenses are transferred or granted. Graviton License Agreement and Equity Purchase In April 2023, the Company entered into a collaboration and license agreement with Graviton (“Graviton Agreement”), whereby it secured from Graviton an exclusive license to develop and commercialize Graviton’s library of ROCK2 inhibitors including their lead program GV101 (OV888) in rare CNS disorders (excluding amyotrophic lateral sclerosis) worldwide (excluding China, Hong Kong, Macau and Taiwan). Under the Graviton Agreement, the Company and Graviton plan to investigate GV101 (OV888) in cerebral cavernous malformations as well as Graviton’s library of ROCK2 inhibitors in other rare CNS disorders. The Company will be responsible for all development and commercialization costs of the products. Should the Company receive regulatory approval and commercialize any of Graviton’s ROCK2 inhibitors, it will pay Graviton tiered royalties on net sales ranging from the mid- to high-teens. As part of the Graviton Agreement, the Company also purchased shares of Graviton’s preferred stock for $10.0 million. The Company recorded the purchase of the preferred stock as a long-term equity investment on its condensed consolidated balance sheets. In December 2023 and March 2024, the Company recognized unrealized gains on the investment due to an observable change in price, and recorded the gain in other income (expense), net in the condensed consolidated statements of operations. The program related to the Graviton Agreement is currently paused. In May 2025, the Company and Graviton reviewed disputed amounts invoiced pursuant to the Graviton Agreement pertaining to activity in the second half of 2024. A settlement was agreed upon and payment of approximately $0.36 million less than the originally invoiced amount was made by the Company. As of June 30, 2025, all amounts due to Graviton have been paid in full and prior Graviton-related accruals reduced to zero.
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RELATED PARTY TRANSACTIONS |
6 Months Ended |
|---|---|
Jun. 30, 2025 | |
| Related Party Transactions [Abstract] | |
| RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONS In March 2021, the Company entered into the RLT Agreement with Takeda. For a description of the RLT Agreement, see Note 11 – Collaboration and License Agreements.
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NET (LOSS) INCOME PER SHARE |
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| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NET (LOSS) INCOME PER SHARE | NET (LOSS) INCOME PER SHARE 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 in-substance common stock (see Note 2). The Series A Preferred Stock was excluded from the calculation of net (loss) income per share and presented as anti-dilutive in prior reporting periods, but is deemed in-substance common stock and is now reflected as a class of common stock for purposes of calculating net (loss) income per share for the three and six month periods ended June 30, 2025 and 2024. The impact of the change to previously reported net (loss) income per share is not material. Basic net (loss) income per common share is calculated based upon the allocation of net (loss) income to the weighted-average number of common shares outstanding during the period. For any period in which the Company records net income, diluted net income per share is calculated in the same manner as basic net (loss) income per share, except that diluted net income per common share includes outstanding common stock, common shares underlying outstanding options, and unvested restricted stock units in the number of shares used to allocate net income to share classes and in the denominator in calculating diluted net income per common share. Diluted net income per share also considers the potential impact of preferred stock using the if-converted method. Diluted net (loss) income per common share is equivalent to the basic net (loss) income per common share due to the exclusion of outstanding stock options and unvested restricted stock units because the inclusion of these securities would result in an anti-dilutive effect on per common share amounts. The following table summarizes the calculation of basic and diluted net (loss) income per share:
The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive:
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SEGMENT REPORTING |
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| Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT REPORTING | SEGMENT REPORTING The Company has determined that it operates as one segment focused on developing small molecule medicines for brain conditions with significant unmet need. The Company’s precommercial drug development candidates have similar economic and other characteristics, including all being in the small molecule therapeutic class which shares target markets, development pathways, and regulatory environments. The CODM is the Chairman and CEO, who reviews profit and loss information on a consolidated basis to assess performance and make operating and planning decisions, including resource allocations among programs. The determination of the single segment is consistent with the information provided to the CODM. As the Company’s operations are comprised of a single reporting segment, the segment assets are reflected on the accompanying condensed consolidated balance sheet as “total assets.” Segment asset information is not used by the CODM to make operating and planning decisions or allocate resources. The following tables summarize the Company’s segment information as presented to the CODM and as required in ASU 2023-07 for the periods indicated:
The program expense for OV888 (GV101) is negative for the three and six month periods ended June 30, 2025 because the Company recognized a contra-expense upon settlement of the amounts due to its collaboration partner and on reversal of an immaterial accrual estimate on final determination of amounts owed. Other research and development expenses include general office expenses allocated to research and development, including costs related to rent, depreciation of leasehold improvements and nonclinical contract labor. Other income/expense includes a gain on recovery of a fraudulent funds transfer, unrealized net gain on equity investments and interest/accretion income on securities. Other significant segment information includes:
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Insider Trading Arrangements |
3 Months Ended |
|---|---|
Jun. 30, 2025 | |
| Trading Arrangements, by Individual | |
| Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Rule 10b5-1 Arrangement Terminated | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
6 Months Ended |
|---|---|
Jun. 30, 2025 | |
| Accounting Policies [Abstract] | |
| Unaudited Interim Condensed Consolidated Financial Statements | Unaudited Interim Condensed Consolidated Financial Statements The interim condensed consolidated balance sheet at June 30, 2025 and the condensed consolidated statements of operations, comprehensive loss, cash flows, and stockholders’ equity for the three and six months ended June 30, 2025 and 2024 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP and follow the requirements of the SEC for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by GAAP are condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and six months ended June 30, 2025 and 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period. The balance sheet as of December 31, 2024 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K.
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| Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP and include the accounts of Ovid Therapeutics Inc. and its wholly owned subsidiaries, Ovid Therapeutics Australia Pty Ltd. and Ovid Therapeutics Hong Kong Ltd. All intercompany transactions and balances have been eliminated in consolidation.
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| Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ materially from those estimates.
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| Marketable Securities | 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 condensed consolidated balance sheets. The Company classifies its marketable securities with original maturities of less than three months as cash equivalents on its condensed 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) income in stockholders’ equity.
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| Restricted Cash | Restricted Cash The Company classifies as restricted cash all cash pledged as collateral to secure long-term obligations and all cash whose use is otherwise limited by contractual provisions. Amounts are reported as noncurrent unless restrictions are expected to be released in the next 12 months.
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| Long-Term Equity Investments | Long-Term Equity Investments Long-term equity investments consist of equity investments in the preferred shares of Gensaic, Inc., formerly M13 Therapeutics, Inc. (“Gensaic”), and Graviton Bioscience Corporation (“Graviton”), both privately held corporations. The preferred shares are not considered in-substance common stock, and the investments are accounted for at cost, with adjustments for observable changes in prices or impairments, and are classified within long-term equity investments on the condensed consolidated balance sheets with adjustments recognized in other income (expense), net on the condensed consolidated statements of operations. The Company has determined that these equity investments do not have a readily determinable fair value and elected the measurement alternative. Therefore, the carrying amount of the equity investments 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 investments are impaired. The assessment includes a review of recent operating results and trends, recent sales/acquisitions of the investees’ securities, and other publicly available data. If an investment is determined to be impaired, the Company will then write it down to its estimated fair value. As of June 30, 2025 and December 31, 2024, the equity investment in Gensaic had a carrying value of $5.1 million. As of June 30, 2025 and December 31, 2024, the equity investment in Graviton had a carrying value of $15.8 million. The initial investment in Graviton was $10.0 million, and cumulative measurement adjustments based on observable price increases totaling $5.8 million have been recognized, recorded in other income (expense), net within the statement of operations. Long-term equity investments also consist of an equity investment in the common shares of Marinus Pharmaceuticals, Inc. (“Marinus”) that were received as noncash 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 condensed consolidated balance sheets and other income (expense), net on the Company’s condensed consolidated statements of operations. As of December 31, 2024, the equity investment in Marinus had a carrying value of $0.1 million. In February 2025, Immedica, S.A. (“Immedica”) closed a cash purchase of Marinus, resulting in the sale of the Company’s equity position in Marinus to Immedica for $70,000.
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| Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial Accounting Standards Board (“FASB”) guidance specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: •Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. The Company’s Level 1 assets consisted of investments in a U.S. treasury money market fund of $20.7 million as of June 30, 2025, and U.S. treasury money market fund and equity securities totaling $25.8 million as of December 31, 2024. •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 $9.9 million as of June 30, 2025 and $26.8 million as of December 31, 2024. •Level 3—Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. There were no Level 3 assets or liabilities as of June 30, 2025 or December 31, 2024. The carrying amounts reported in the balance sheets for cash and cash equivalents, other current assets, accounts payable and accrued expenses approximate their fair values based on the short-term maturity of these instruments.
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| Leases | Leases The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with FASB Accounting Standards Codification (“ASC”) 842. Operating leases are included in right-of-use (“ROU”) assets, current liabilities, and long-term lease liability in the Company's condensed 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.
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| Property and Equipment | 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.
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| Research and Development Expenses | 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. 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.
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| Royalty Monetization Liability | Royalty Monetization Liability The Company accounted for its sale to Ligand Pharmaceuticals Incorporated (“Ligand”) of a 13% share of royalties and milestones owed to the Company related to the potential approval and commercialization of soticlestat (“Ligand Agreement”) in accordance with ASC 470, Debt, classifying the proceeds received from the sale to Ligand as debt as the Company determined that it had significant continuing involvement in the generation of the cash flows to Ligand. The Company further elected to account for the debt at fair value with changes in the fair value of the debt classified as other income (expense) in the consolidated statements of operations. In June 2024, Takeda issued a press release indicating the soticlestat trials missed their primary endpoints and noted that while Takeda would discuss the program with FDA, Takeda fully impaired the asset representing soticlestat. In 2024, the Company recorded a gain of $30.0 million due to reducing the fair value of the Ligand Agreement debt to zero as a result of the improbability that the program would be further developed into a commercial product by Takeda or another party. In January 2025, Takeda announced the discontinuation of the program.
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| Stock-Based Compensation | 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 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 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 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 aggregates employee and nonemployee awards for certain disclosures since nonemployee awards are not material.
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| Income Taxes | 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.
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| Net (Loss) Income per Share | Net (Loss) Income per Share The rights and preferences of the non-voting Series A convertible preferred stock (“Series A Preferred Stock”) are negligible relative to common stock, therefore the Series A Preferred Stock is treated as in-substance common stock on an as-converted basis when allocating net (loss) income to actual and in-substance shares of common stock. The Company applies the two-class method to allocate earnings between common stock, Series A Preferred Stock as well as other securities deemed in-substance common stock and participating securities, if any. Net (loss) income per share of Series A Preferred Stock is determined by dividing net (loss) income attributable to Series A preferred stockholders on an as-converted basis by the basic and diluted weighted-average shares of Series A Preferred Stock outstanding during the period. Net (loss) income per share of common stock is determined by dividing net income attributable to common stockholders by the basic and diluted weighted-average shares of common stock outstanding during the period. 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 and restricted stock units using the treasury-stock method and the potential impact of any preferred stock using the if-converted method. Net (loss) income per diluted share attributable to common stockholders omits the inclusion of stock options, common stock issuable upon conversion of Series A Preferred Stock, and unvested restricted stock units as these securities would be anti-dilutive.
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| Retirement Plan | 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 (the “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 three months ended June 30, 2025 and 2024, the Company contributed $47,000 and $88,000, respectively. For the six months ended June 30, 2025 and 2024, the Company contributed $121,000 and $200,000, respectively.
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| Revenue Recognition | Revenue Recognition Under ASC 606, Revenue from Contracts with Customers, 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) it satisfies the performance obligations. 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 the Company transfers 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 until the performance obligations are satisfied.
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| Segment Reporting | Segment Reporting Under Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): “Improvements to Reportable Segment Disclosures” (“ASU 2023-07”), the Company discloses significant segment expenses regularly provided to the chief operating decision maker (“CODM”) and discloses the title and position of the CODM.
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| 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. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, (“ASU 2023-09”), which is effective for annual periods beginning after December 15, 2024. ASU 2023-09 intends to enhance the transparency as well as usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its related disclosures. In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires the disaggregation of certain expense captions into specified categories in disclosures within the notes to the consolidated financial statements to provide enhanced transparency into the expense captions presented on the face of the statements of income and comprehensive income. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, with early adoption permitted, and may be applied either prospectively or retrospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its related disclosures. The Company adopts new pronouncements relating to GAAP applicable to the Company as they are issued, and based upon the effective dates included in the pronouncements. 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 consolidated financial statements.
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CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES (Tables) |
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Jun. 30, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Debt Securities, Available-for-Sale | 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 June 30, 2025 and December 31, 2024:
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| 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 June 30, 2025 and December 31, 2024:
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PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS (Tables) |
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Jun. 30, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Property and Equipment | Property and equipment is summarized as follows:
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LEASES (Tables) |
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Jun. 30, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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:
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| Schedule of Operating Lease Cost | The components of operating lease cost for the three and six months ended June 30, 2025 were as follows:
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| Schedule of Future Minimum Commitments | Future minimum commitments under the non-cancelable operating lease are as follows:
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ACCRUED EXPENSES (Tables) |
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Jun. 30, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Accrued Expenses | Accrued expenses consist of the following:
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STOCK-BASED COMPENSATION (Tables) |
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| 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:
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| Schedule of Allocation of Stock-based Compensation Expense by Plan |
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| Schedule of Assumptions Used to Compute Fair Value of Employee Option Granted | The fair value of options granted during the three and six months ended June 30, 2025 and 2024 was estimated utilizing the following assumptions:
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| Schedule of Options Outstanding and Weighted Average Exercise Price | The following table summarizes the number of options outstanding and the weighted average exercise price:
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NET (LOSS) INCOME PER SHARE (Tables) |
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| Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Basic and Diluted Earnings Loss Per Share | The following table summarizes the calculation of basic and diluted net (loss) income per share:
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| 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:
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SEGMENT REPORTING (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Direct Expenses With Respect to Program Segments | The following tables summarize the Company’s segment information as presented to the CODM and as required in ASU 2023-07 for the periods indicated:
The program expense for OV888 (GV101) is negative for the three and six month periods ended June 30, 2025 because the Company recognized a contra-expense upon settlement of the amounts due to its collaboration partner and on reversal of an immaterial accrual estimate on final determination of amounts owed. Other research and development expenses include general office expenses allocated to research and development, including costs related to rent, depreciation of leasehold improvements and nonclinical contract labor. Other income/expense includes a gain on recovery of a fraudulent funds transfer, unrealized net gain on equity investments and interest/accretion income on securities. Other significant segment information includes:
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NATURE OF OPERATIONS (Details) $ in Thousands |
3 Months Ended | 6 Months Ended | ||||||
|---|---|---|---|---|---|---|---|---|
Jul. 09, 2025 |
Jun. 30, 2025
USD ($)
|
Mar. 31, 2025
USD ($)
|
Jun. 30, 2024
USD ($)
|
Mar. 31, 2024
USD ($)
|
Jun. 30, 2025
USD ($)
|
Jun. 30, 2024
USD ($)
|
Dec. 31, 2024
USD ($)
|
|
| Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
| Cash, cash equivalents, and marketable securities | $ 38,347 | $ 38,347 | $ 53,075 | |||||
| Total revenue | 6,272 | $ 169 | 6,402 | $ 317 | ||||
| Accumulated deficit | 319,218 | 319,218 | $ 304,299 | |||||
| Working capital | 33,200 | 33,200 | ||||||
| Cash outflows from operating activities | (15,054) | (30,941) | ||||||
| Net (loss) income | $ (4,684) | $ (10,235) | $ 8,521 | $ (11,694) | $ (14,919) | $ (3,174) | ||
| Minimum | Subsequent Event | ||||||||
| Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
| Reverse stock split | 0.10 | |||||||
| Maximum | Subsequent Event | ||||||||
| Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
| Reverse stock split | 0.025 | |||||||
CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES - Additional Information (Details) |
3 Months Ended | 6 Months Ended | |||
|---|---|---|---|---|---|
|
Jun. 30, 2025
USD ($)
Investment
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2025
USD ($)
Investment
|
Jun. 30, 2024
USD ($)
|
Dec. 31, 2024
Investment
|
|
| Cash and Cash Equivalents [Abstract] | |||||
| Number of securities in an unrealized loss position for more than 12 months | Investment | 0 | 0 | 0 | ||
| Gains or losses on available-for-sale securities | $ | $ 0 | $ 0 | $ 0 | $ 0 | |
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Jun. 30, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Property, Plant and Equipment [Line Items] | ||
| Less accumulated depreciation | $ (1,555) | $ (1,407) |
| Property and equipment, net | 285 | 433 |
| Furniture and equipment | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | 1,534 | 1,534 |
| Leasehold improvements | ||
| Property, Plant and Equipment [Line Items] | ||
| Property and equipment, gross | $ 306 | $ 306 |
PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS - Additional Information (Details) - USD ($) |
3 Months Ended | 6 Months Ended | |||
|---|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
Dec. 31, 2024 |
|
| Property, Plant and Equipment [Abstract] | |||||
| Depreciation expense | $ 61,000 | $ 103,000 | $ 148,000 | $ 204,000 | |
| Intangible assets, net of accumulated amortization | 0 | 0 | $ 219,000 | ||
| Amortization expense | $ 38,000 | $ 45,000 | $ 92,000 | $ 80,000 | |
LEASES - Additional Information (Details) ft² in Thousands, $ in Thousands |
Mar. 10, 2022
ft²
|
Jun. 30, 2025
USD ($)
|
Dec. 31, 2024
USD ($)
|
|---|---|---|---|
| Short-Term Debt [Line Items] | |||
| Operating lease, term of contract | 10 years | ||
| Land subject to ground leases (sqft) | ft² | 19 | ||
| Rent lease | $ 2,300 | ||
| Rent payments commencement following this period | 10 months | ||
| Restricted cash | $ 1,931 | $ 1,931 | |
| Remaining lease terms | 7 years | ||
| Renewal option term | 5 years | ||
| Lease incremental borrowing rate | 7.02% | ||
| Letter of Credit | |||
| Short-Term Debt [Line Items] | |||
| Restricted cash | $ 1,900 |
LEASES - Schedule of ROU Asset and Lease Liabilities Related to the Company Operating Lease (Details) - USD ($) $ in Thousands |
Jun. 30, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Leases [Abstract] | ||
| ROU asset, net | $ 12,215 | $ 12,797 |
| Current lease liability | 1,384 | 1,336 |
| Long-term lease liability | $ 12,715 | $ 13,419 |
LEASES - Schedule of Components of Operating Lease Cost (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended |
|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2025 |
|
| Leases [Abstract] | ||
| Operating lease cost | $ 542 | $ 1,084 |
| Variable lease cost | 0 | 0 |
| Short-term lease cost | $ 0 | $ 0 |
LEASES - Schedule of Future Minimum Commitments Under the Non-Cancelable Operating Lease (Details) $ in Thousands |
Jun. 30, 2025
USD ($)
|
|---|---|
| Leases [Abstract] | |
| 2025 | $ 1,158 |
| 2026 | 2,316 |
| 2027 | 2,316 |
| 2028 | 2,469 |
| 2029 | 2,469 |
| Thereafter | 7,408 |
| Lessee, Operating Lease, Liability, to be Paid, Total | $ 18,136 |
ACCRUED EXPENSES - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands |
Jun. 30, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Payables and Accruals [Abstract] | ||
| Payroll and bonus accrual | $ 1,838 | $ 2,959 |
| Research and development accrual | 485 | 2,779 |
| Professional fees accrual | 265 | 168 |
| Other | 284 | 88 |
| Total | $ 2,872 | $ 5,994 |
STOCK-BASED COMPENSATION - Schedule of Recognized Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
|
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | $ 1,219 | $ 1,740 | $ 2,503 | $ 3,708 |
| Research and development | ||||
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | 376 | 537 | 777 | 1,066 |
| General and administrative | ||||
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | $ 843 | $ 1,203 | $ 1,726 | $ 2,642 |
STOCK-BASED COMPENSATION - Schedule of Allocation of Stock-Based Compensation Expense by Plan (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
|
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | $ 1,219 | $ 1,740 | $ 2,503 | $ 3,708 |
| Stock options and restricted stock units | ||||
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | 1,216 | 1,722 | 2,478 | 3,675 |
| Employee Stock Purchase Plan | ||||
| Stock-Based Compensation [Line Items] | ||||
| Stock-based compensation expense | $ 3 | $ 18 | $ 25 | $ 33 |
STOCK-BASED COMPENSATION - Summary of Assumptions Used to Compute Fair Value of Options Granted (Details) - Employee Stock Option - Employee Option - $ / shares |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
|
| Stock-Based Compensation [Line Items] | ||||
| Volatility | 96.60% | 79.52% | 96.76% | 79.84% |
| Expected term in years | 6 years 1 month 9 days | 6 years 29 days | 6 years 3 days | 6 years 18 days |
| Dividend rate | 0.00% | 0.00% | 0.00% | 0.00% |
| Risk-free interest rate | 3.96% | 4.64% | 4.35% | 4.33% |
| Fair value of option on grant date (in dollars per share) | $ 0.24 | $ 2.19 | $ 0.44 | $ 2.61 |
INCOME TAXES (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
|
| Income Tax Disclosure [Abstract] | ||||
| (Benefit) provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 |
SEGMENT REPORTING - Schedule of Components of Other (Income) Expense (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|---|
Jan. 31, 2025 |
Jun. 30, 2025 |
Jun. 30, 2024 |
Jun. 30, 2025 |
Jun. 30, 2024 |
|
| Segment Reporting [Abstract] | |||||
| Stock-based compensation expense | $ 1,219 | $ 1,740 | $ 2,503 | $ 3,708 | |
| Interest/accretion income on securities | 384 | 991 | 875 | 2,318 | |
| Severance expense | 0 | 3,412 | 435 | 3,412 | |
| Gain on recovery of fraudulent funds transfer | $ 1,800 | 0 | 0 | 1,800 | 0 |
| Change in valuation of royalty monetization liability | 0 | 29,028 | 0 | 29,028 | |
| Unrealized net gain on equity investments | 0 | 970 | 0 | 3,427 | |
| Depreciation and amortization | $ 99 | $ 148 | $ 240 | $ 284 | |