[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section identifies forward-looking statements, outlines factors causing actual results to differ, and notes the company's non-obligation to update them [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section identifies forward-looking statements, outlines factors causing actual results to differ, and notes the company's non-obligation to update them - Forward-looking statements are identified by terms such as 'aim,' 'anticipate,' 'believe,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'project,' 'should,' 'will,' 'would,' and similar expressions[9](index=9&type=chunk) - Key factors that may cause actual results to differ materially include the ability to acquire or in-license novel compounds, successful development and therapeutic potential of drug candidates, regulatory approval, timing of clinical trials, market size, funding, intellectual property disputes, and the impact of geopolitical tensions and economic conditions[10](index=10&type=chunk) - The company assumes no obligation to update or revise these forward-looking statements, even if new information becomes available[11](index=11&type=chunk) [PART I. Financial Information](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Ovid Therapeutics Inc.'s unaudited condensed consolidated financial statements and detailed notes on accounting policies [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets provide a snapshot of the company's financial position as of June 30, 2025, and December 31, 2024, showing a decrease in total assets and stockholders' equity, primarily driven by a reduction in marketable securities and an increase in accumulated deficit Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $28,415 | $26,301 | | Marketable securities | $9,932 | $26,774 | | Total current assets | $42,089 | $55,940 | | Total assets | $77,428 | $92,167 | | Total current liabilities | $8,924 | $10,522 | | Total liabilities | $21,639 | $23,941 | | Total stockholders' equity | $55,789 | $68,226 | | Accumulated deficit | $(319,218) | $(304,299) | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Revenue significantly increased for the three and six months ended June 30, 2025, driven by a licensing agreement, resulting in a net loss for 2025 Condensed Consolidated Statements of Operations (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total revenue | $6,272 | $169 | $6,402 | $317 | | Research and development | $6,465 | $12,582 | $13,123 | $22,984 | | General and administrative | $4,880 | $8,104 | $10,902 | $15,267 | | Total operating expenses | $11,345 | $20,686 | $24,025 | $38,251 | | Loss from operations | $(5,073) | $(20,517) | $(17,623) | $(37,934) | | Other income (expense), net | $389 | $29,038 | $2,704 | $34,760 | | Net (loss) income | $(4,684) | $8,521 | $(14,919) | $(3,174) | | Net (loss) income per share of common stock, basic | $(0.06) | $0.12 | $(0.21) | $(0.04) | [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The condensed consolidated statements of comprehensive loss show a comprehensive loss for the three and six months ended June 30, 2025, primarily driven by the net loss, with minor impacts from cumulative translation adjustments and unrealized losses on marketable securities Condensed Consolidated Statements of Comprehensive (Loss) Income (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net (loss) income | $(4,684) | $8,521 | $(14,919) | $(3,174) | | Cumulative translation adjustment | $(11) | — | $(31) | — | | Unrealized (loss) gain on marketable securities | $(1) | $7 | $(3) | $(13) | | Comprehensive (loss) income | $(4,696) | $8,528 | $(14,953) | $(3,187) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) The condensed consolidated statements of stockholders' equity detail changes in equity components, showing a decrease in total stockholders' equity from December 31, 2024, to June 30, 2025, primarily due to net losses and other comprehensive losses, partially offset by stock-based compensation expense Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Item | Balance, Dec 31, 2024 | Balance, June 30, 2025 | | :----------------------------------- | :-------------------- | :--------------------- | | Common Stock (shares) | 71,009,866 | 71,109,514 | | Common Stock (amount) | $71 | $71 | | Additional Paid-In Capital | $372,489 | $375,005 | | Accumulated Other Comprehensive Loss | $(35) | $(69) | | Accumulated Deficit | $(304,299) | $(319,218) | | Total Stockholders' Equity | $68,226 | $55,789 | - Issuance of common stock from exercise of stock options and purchases from employee stock purchase plan contributed **$13 thousand** to additional paid-in capital for the six months ended June 30, 2025[22](index=22&type=chunk) - Stock-based compensation expense totaled **$2,503 thousand** for the six months ended June 30, 2025[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The condensed consolidated statements of cash flows indicate a net increase in cash, cash equivalents, and restricted cash for the six months ended June 30, 2025, primarily driven by cash provided by investing activities, which offset significant cash used in operating activities Condensed Consolidated Statements of Cash Flows (in thousands) | Item | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(15,054) | $(30,941) | | Net cash provided by investing activities | $17,155 | $33,010 | | Net cash provided by financing activities | $13 | $584 | | Net increase in cash, cash equivalents and restricted cash | $2,114 | $2,653 | | Cash, cash equivalents and restricted cash, at end of period | $30,346 | $31,625 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes explain the company's financial statements, covering operations, accounting policies, assets, liabilities, equity, and agreements [NOTE 1 – Nature of Operations](index=11&type=section&id=NOTE%201%20%E2%80%93%20Nature%20of%20Operations) Ovid Therapeutics Inc. is a biopharmaceutical company focused on developing small molecule medicines for brain conditions. The company has historically incurred losses and negative operating cash flows, raising substantial doubt about its ability to continue as a going concern, necessitating additional funding or strategic alternatives - Ovid Therapeutics Inc. is a biopharmaceutical company developing small molecule medicines for brain conditions with significant unmet need[26](index=26&type=chunk) - The company has an accumulated deficit of **$319.2 million** as of June 30, 2025, and has incurred recurring losses and negative operating cash flows[29](index=29&type=chunk) - Management believes existing cash, cash equivalents, and marketable securities (**$38.3 million** as of June 30, 2025) will not be sufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) [NOTE 2 – Summary of Significant Accounting Policies](index=12&type=section&id=NOTE%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note details the accounting principles for financial statements, covering interim nature, consolidation, estimates, and policies for various financial items - The interim condensed consolidated financial statements are unaudited and prepared in accordance with GAAP and SEC interim reporting requirements, with certain notes condensed or omitted[35](index=35&type=chunk) - Marketable securities, primarily U.S. treasury instruments, are classified as available-for-sale, with unrealized gains/losses reported in accumulated other comprehensive (loss) income[38](index=38&type=chunk) - The company expenses research and development costs as incurred, including clinical trial costs, manufacturing, contracted services, and license fees[47](index=47&type=chunk) - The company accounts for stock-based compensation using the Black-Scholes valuation model and recognizes expense over the vesting period[49](index=49&type=chunk) - Revenue is recognized when the customer obtains control of promised goods or services, reflecting the consideration expected, with upfront license fees deferred until performance obligations are satisfied[56](index=56&type=chunk)[59](index=59&type=chunk) [NOTE 3 – Cash, Cash Equivalents and Marketable Securities](index=16&type=section&id=NOTE%203%20%E2%80%93%20Cash,%20Cash%20Equivalents%20and%20Marketable%20Securities) This note provides a detailed breakdown of the company's cash, cash equivalents, and marketable securities, categorized by fair value hierarchy levels, showing a decrease in total holdings from December 31, 2024, to June 30, 2025 Fair Value of Cash, Cash Equivalents and Marketable Securities (in thousands) | Item | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :--------------------------- | :--------------------------- | | Cash | $7,679 | $522 | | Cash equivalents | $20,736 | $25,779 | | Marketable securities | $9,932 | $26,774 | | Total | $38,347 | $53,075 | - The company's Level 1 assets (unadjusted quoted prices in active markets) primarily consisted of investments in a U.S. treasury money market fund, totaling **$20.7 million** as of June 30, 2025[43](index=43&type=chunk) - Level 2 assets (observable inputs other than Level 1 quoted prices) consisted of U.S. treasury bills, totaling **$9.9 million** as of June 30, 2025[43](index=43&type=chunk) [NOTE 4 – Property and Equipment and Intangible Assets](index=17&type=section&id=NOTE%204%20%E2%80%93%20Property%20and%20Equipment%20and%20Intangible%20Assets) This note details the company's property and equipment, net, and intangible assets, net, showing a decrease in both categories from December 31, 2024, to June 30, 2025, due to accumulated depreciation and amortization Property and Equipment, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Furniture and equipment | $1,534 | $1,534 | | Leasehold improvements | $306 | $306 | | Less accumulated depreciation | $(1,555) | $(1,407) | | Total property and equipment, net | $285 | $433 | - Intangible assets, net, decreased from **$219 thousand** as of December 31, 2024, to **$0** as of June 30, 2025[68](index=68&type=chunk) - Depreciation expense was **$61 thousand** for the three months ended June 30, 2025, and **$148 thousand** for the six months ended June 30, 2025[67](index=67&type=chunk) [NOTE 5 – Leases](index=17&type=section&id=NOTE%205%20%E2%80%93%20Leases) This note outlines the company's operating lease for its corporate headquarters, detailing the ROU asset and lease liabilities, remaining lease term, and future minimum commitments. The lease has a 10-year term commencing March 2022, with an annual base rent of $2.3 million - The company has a 10-year operating lease for its corporate headquarters, with a remaining term of approximately **seven years** and an annual base rent of **$2.3 million**[69](index=69&type=chunk)[70](index=70&type=chunk) ROU Asset and Lease Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | ROU asset, net | $12,215 | $12,797 | | Current lease liability | $1,384 | $1,336 | | Long-term lease liability | $12,715 | $13,419 | Future Minimum Commitments Under Non-Cancelable Operating Lease (in thousands) | Year | Amount | | :----------------------------------- | :----- | | 2025 | $1,158 | | 2026 | $2,316 | | 2027 | $2,316 | | 2028 | $2,469 | | 2029 | $2,469 | | Thereafter | $7,408 | | Total | $18,136 | [NOTE 6 – Accrued Expenses](index=18&type=section&id=NOTE%206%20%E2%80%93%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, showing a significant decrease from December 31, 2024, to June 30, 2025, primarily driven by reductions in payroll and bonus accruals and research and development accruals Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | 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 | [NOTE 7 – Stockholders' Equity](index=18&type=section&id=NOTE%207%20%E2%80%93%20Stockholders'%20Equity) This note details the company's capital structure, including common and Series A Preferred Stock, authorized shares, voting rights, and conversion features - The company is authorized to issue up to **125,000,000 shares** of common stock and **10,000,000 shares** of preferred stock[74](index=74&type=chunk) - As of June 30, 2025, **71,109,514 shares** of common stock and **1,250 shares** of Series A Preferred Stock were issued and outstanding[16](index=16&type=chunk)[74](index=74&type=chunk)[76](index=76&type=chunk) - Each share of Series A Preferred Stock is convertible into **1,000 shares** of common stock, subject to beneficial ownership limitations[76](index=76&type=chunk) - No dividends have been declared through June 30, 2025[77](index=77&type=chunk) [NOTE 8 – Stock-Based Compensation](index=19&type=section&id=NOTE%208%20%E2%80%93%20Stock-Based%20Compensation) This note details the company's stock-based compensation plans, including options, RSUs, associated expenses, and valuation assumptions - The 2017 Equity Incentive Plan had **3,626,702 shares** reserved and available for issuance as of June 30, 2025[78](index=78&type=chunk) - Total stock-based compensation expense was **$1.2 million** for the three months ended June 30, 2025, and **$2.5 million** for the six months ended June 30, 2025[83](index=83&type=chunk) Stock-Based Compensation Expense by Operating Expense (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $376 | $537 | $777 | $1,066 | | General and administrative | $843 | $1,203 | $1,726 | $2,642 | | Total | $1,219 | $1,740 | $2,503 | $3,708 | - As of June 30, 2025, there was **$11.2 million** of unrecognized stock-based compensation expense, expected to be recognized over an average vesting period of **2.42 years**[84](index=84&type=chunk) [NOTE 9 – Income Taxes](index=20&type=section&id=NOTE%209%20%E2%80%93%20Income%20Taxes) This note explains income tax accounting, noting no tax benefit due to pre-tax losses and a full valuation allowance, and mentions the OBBBA's potential impact - The company did not record any tax benefit or expense for the three and six months ended June 30, 2025 and 2024, due to being in a pre-tax loss position[86](index=86&type=chunk) - A full valuation allowance is maintained against net deferred tax assets as of June 30, 2025, due to cumulative losses in recent years[87](index=87&type=chunk) - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, and the company is currently assessing its impact on its consolidated financial statements[88](index=88&type=chunk) [NOTE 10 – Commitments and Contingencies](index=21&type=section&id=NOTE%2010%20%E2%80%93%20Commitments%20and%20Contingencies) This note details license agreements, outlining payments and obligations, and covers a recovered fraudulent transfer and general contingencies - Under the Northwestern Agreement, the company is developing OV329 and is obligated to pay up to **$5.3 million** in development and regulatory milestones, plus tiered royalties on net sales[89](index=89&type=chunk)[91](index=91&type=chunk) - The AstraZeneca license agreement for the KCC2 transporter library includes potential milestone payments of up to **$203.0 million**[94](index=94&type=chunk)[95](index=95&type=chunk) - The Gensaic Collaboration Agreement involves an equity investment of **$5.1 million** and potential tiered royalty payments (mid-single to low double-digit range) and milestone payments (up to **$452.0 million**) for PDP products[96](index=96&type=chunk)[98](index=98&type=chunk) - A **$1.8 million** fraudulent transfer due to a business email compromise in Q3 2024 was fully recovered in January 2025, resulting in a gain[100](index=100&type=chunk)[101](index=101&type=chunk) [NOTE 11 – Collaboration and License Agreements](index=23&type=section&id=NOTE%2011%20%E2%80%93%20Collaboration%20and%20License%20Agreements) This note updates key collaboration and license agreements, including Takeda, Healx, Marinus, and Graviton, detailing program statuses and amendments - Takeda discontinued the soticlestat program in January 2025, following missed primary endpoints in Phase 3 trials in June 2024. The company has no debt or obligations to Ligand related to the royalty monetization[108](index=108&type=chunk) - The Healx License and Option Agreement for gaboxadol was amended in June 2023, revising option exercise fees, milestone payments, and royalty structures, with Healx assuming development and commercialization responsibilities[109](index=109&type=chunk)[112](index=112&type=chunk) - The Marinus License Agreement was amended in June 2025, replacing ongoing royalty obligations with a one-time payment of **$7.0 million**, of which **$6.3 million** was recognized as revenue[116](index=116&type=chunk) - The Graviton License Agreement for ROCK2 inhibitors (GV101/OV888) is currently paused, and all amounts due to Graviton have been paid in full as of June 30, 2025[117](index=117&type=chunk)[118](index=118&type=chunk) [NOTE 12 – Related Party Transactions](index=25&type=section&id=NOTE%2012%20%E2%80%93%20Related%20Party%20Transactions) This note refers to the Takeda Collaboration as a related party transaction, further detailed in Note 11 - The Takeda Collaboration, described in Note 11, is considered a related party transaction[119](index=119&type=chunk) [NOTE 13 – Net (Loss) Income Per Share](index=25&type=section&id=NOTE%2013%20%E2%80%93%20Net%20(Loss)%20Income%20Per%20Share) This note explains basic and diluted net (loss) income per share calculation using the two-class method and lists excluded dilutive securities - The Series A Preferred Stock is treated as in-substance common stock for net (loss) income per share calculation using the two-class method[120](index=120&type=chunk) Net (Loss) Income Per Share (in thousands, except share and per share data) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net (loss) income per share, basic (Common Stock) | $(0.06) | $0.12 | $(0.21) | $(0.04) | | Net (loss) income per share, diluted (Common Stock) | $(0.06) | $0.12 | $(0.21) | $(0.04) | | Weighted average common stock shares outstanding, basic | 71,109,514 | 70,916,471 | 71,077,747 | 70,816,585 | - Potentially dilutive securities, including stock options (**18.8 million**) and common stock issuable upon conversion of Series A Preferred Stock (**1.25 million**), were excluded from diluted EPS calculations for the six months ended June 30, 2025, as they were anti-dilutive[123](index=123&type=chunk) [NOTE 14 – Segment Reporting](index=26&type=section&id=NOTE%2014%20%E2%80%93%20Segment%20Reporting) The company operates as a single segment focused on developing small molecule medicines for brain conditions, with the Chairman and CEO as CODM - The company operates as one segment, focused on developing small molecule medicines for brain conditions, with the Chairman and CEO as the CODM[124](index=124&type=chunk) Segment Information (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $6,272 | $169 | $6,402 | $317 | | Total research and development expenses | $6,465 | $12,582 | $13,123 | $22,984 | | Total general and administrative expenses | $4,880 | $8,104 | $10,902 | $15,267 | | Operating loss | $(5,073) | $(20,517) | $(17,623) | $(37,934) | | Net (loss) income | $(4,684) | $8,521 | $(14,919) | $(3,174) | - The negative program expense for OV888 (GV101) in 2025 is due to a contra-expense recognized upon settlement with a collaboration partner and reversal of an accrual estimate[125](index=125&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, covering biopharmaceutical focus, pipeline, risks, revenue, expenses, liquidity, and accounting policies [Overview](index=28&type=section&id=Overview) Ovid Therapeutics Inc. is a biopharmaceutical company focused on developing small molecule medicines for brain conditions, with a pipeline of three novel mechanisms of action targeting seizures. The company has incurred significant operating losses since inception and expects this trend to continue as it advances its drug candidates through development - Ovid Therapeutics is a biopharmaceutical company focused on developing small molecule medicines for brain conditions, with a pipeline of three novel mechanisms of action (MoAs) targeting seizures[128](index=128&type=chunk) - The company has generated **$6.4 million** in royalty and licensing revenue for the six months ended June 30, 2025, compared to **$0.3 million** for the same period in 2024[130](index=130&type=chunk) - As of June 30, 2025, the company had **$38.3 million** in cash, cash equivalents, and marketable securities, and an accumulated deficit of **$319.2 million**[130](index=130&type=chunk) - The company expects to incur significant expenses and operating losses for at least the next several years as it advances drug candidates through preclinical and clinical development[131](index=131&type=chunk) [Significant Risks and Uncertainties](index=29&type=section&id=Significant%20Risks%20and%20Uncertainties) This section highlights risks from global economic slowdown, inflation, geopolitical tensions, and challenges in pharmaceutical development and regulatory approval - The company faces risks from global economic slowdown, inflation, interest rate fluctuations, and geopolitical tensions (e.g., China-Taiwan, Ukraine, Israel wars) which may adversely affect its business and financial performance[133](index=133&type=chunk) - Other specific risks include challenges in identifying, acquiring, or in-licensing product candidates, obtaining regulatory approval, pharmaceutical product development uncertainty, protecting intellectual property, and complying with regulatory requirements[134](index=134&type=chunk) [Going Concern](index=29&type=section&id=Going%20Concern) Insufficient capital raises substantial doubt about the company's going concern ability, prompting evaluation of strategic alternatives like financing or partnerships - As of June 30, 2025, the company had **$38.3 million** in cash, cash equivalents, and marketable securities, which is not sufficient to fund projected operating expenses for at least 12 months[135](index=135&type=chunk) - The accumulated deficit was **$319.2 million** as of June 30, 2025, and the company expects to continue incurring operating losses[135](index=135&type=chunk) - Strategic alternatives being evaluated include additional financing, partnerships, collaborations, or licensing agreements, which may involve relinquishing rights to certain drug candidates or reducing R&D programs[135](index=135&type=chunk)[136](index=136&type=chunk) [Financial Operations Overview](index=31&type=section&id=Financial%20Operations%20Overview) This section outlines financial operations, including revenue from licensing, R&D and G&A expenses, and other income/expense items - Revenue is primarily generated from licensing and collaboration agreements, with no commercial drug sales to date[137](index=137&type=chunk) - Research and development expenses are expensed as incurred and are expected to increase as drug candidates advance through preclinical and clinical trials[138](index=138&type=chunk)[139](index=139&type=chunk) - General and administrative expenses consist mainly of employee-related costs, public company operating costs, and professional fees[143](index=143&type=chunk) - Other income (expense), net, includes interest income, unrealized gains/losses on long-term equity investments, and gains from fraudulent funds transfer recovery[144](index=144&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section compares financial performance for Q2 and H1 2025 versus 2024, focusing on revenue, R&D, G&A, and other income/expense [Comparison of the Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Q2 2025 saw increased revenue from a licensing amendment and decreased operating expenses due to restructuring, resulting in a net loss Results of Operations (in thousands) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change $ | | :----------------------------------- | :--------------------------- | :--------------------------- | :------- | | License and other revenue | $6,272 | $169 | $6,103 | | Research and development | $6,465 | $12,582 | $(6,117) | | General and administrative | $4,880 | $8,104 | $(3,224) | | Total operating expenses | $11,345 | $20,686 | $(9,341) | | Net (loss) income | $(4,684) | $8,521 | $(13,205) | - Revenue increased by **$6.1 million**, primarily from the Marinus License Agreement amendment[146](index=146&type=chunk) - Research and development expenses decreased by **$6.1 million**, mainly due to the pause of the OV888 (GV101) program and reduced headcount from organizational restructuring[147](index=147&type=chunk) - General and administrative expenses decreased by **$3.2 million**, driven by organizational restructuring and cost reductions[148](index=148&type=chunk) - Other income (expense), net, decreased by **$28.6 million**, primarily due to a **$29.0 million** gain from royalty monetization liability adjustment in the prior year[149](index=149&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) H1 2025 revenue increased from a licensing amendment, operating expenses decreased due to program pause and restructuring, resulting in a net loss Results of Operations (in thousands) | Item | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change $ | | :----------------------------------- | :--------------------------- | :--------------------------- | :------- | | License and other revenue | $6,402 | $317 | $6,085 | | Research and development | $13,123 | $22,984 | $(9,861) | | General and administrative | $10,902 | $15,267 | $(4,365) | | Total operating expenses | $24,025 | $38,251 | $(14,226) | | Net loss | $(14,919) | $(3,174) | $(11,745) | - Revenue increased by **$6.1 million**, primarily from the Marinus License Agreement amendment[151](index=151&type=chunk) - Research and development expenses decreased by **$9.9 million**, mainly due to the pause of the OV888 (GV101) program and reduced headcount from organizational restructuring[152](index=152&type=chunk) - General and administrative expenses decreased by **$4.4 million**, due to organizational restructuring, reduced headcount, and cost reduction strategies[153](index=153&type=chunk) - Other income (expense), net, decreased by **$32.1 million**, primarily due to a **$29.0 million** gain from royalty monetization liability adjustment in the prior year[154](index=154&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is constrained, raising going concern doubts; significant future R&D funding requires additional capital, potentially leading to dilution or relinquished rights - As of June 30, 2025, total cash, cash equivalents, and marketable securities were **$38.3 million**, insufficient to fund operations for the next 12 months[155](index=155&type=chunk) - The company had an accumulated deficit of **$319.2 million** and working capital of **$33.2 million** as of June 30, 2025[156](index=156&type=chunk) - Future capital uses include compensation, R&D services, clinical costs, legal, regulatory, and general overhead expenses[157](index=157&type=chunk) - The company may need to raise additional capital through equity offerings, debt financings, or collaborations, which could result in dilution or relinquishing valuable rights[159](index=159&type=chunk)[161](index=161&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) The company's cash flows for the six months ended June 30, 2025, show significant cash used in operating activities, largely offset by cash provided by investing activities, resulting in a net increase in cash, cash equivalents, and restricted cash Summary of Cash Flows (in thousands) | Item | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(15,054) | $(30,941) | | Net cash provided by investing activities | $17,155 | $33,010 | | Net cash provided by financing activities | $13 | $584 | | Net increase in cash, cash equivalents and restricted cash | $2,114 | $2,653 | - Net cash used in operating activities was **$15.1 million** for the six months ended June 30, 2025, primarily due to net loss and a reduction in accounts payable and accrued expenses, partially offset by stock-based compensation[166](index=166&type=chunk) - Net cash provided by investing activities was **$17.2 million** for the six months ended June 30, 2025, mainly from the maturity of marketable securities[167](index=167&type=chunk) [Smaller Reporting Company Status and a Non-Accelerated Filer](index=36&type=section&id=Smaller%20Reporting%20Company%20Status%20and%20a%20Non-Accelerated%20Filer) As a smaller reporting company and non-accelerated filer, the company benefits from scaled-back disclosure obligations in SEC filings - The company is a smaller reporting company, allowing for scaled-back disclosures, such as reduced executive compensation information and two years of audited financial statements[169](index=169&type=chunk)[170](index=170&type=chunk) - As a non-accelerated filer, the company is exempt from auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act[171](index=171&type=chunk) [Critical Accounting Policies and Estimates](index=37&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes to critical accounting policies and estimates occurred during the three and six months ended June 30, 2025 - No material changes to critical accounting policies and estimates occurred during the three and six months ended June 30, 2025[173](index=173&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity, but short-term, low-risk investments mitigate material impact from rate changes - The company's primary market risk is interest rate sensitivity, with **$38.3 million** in cash, cash equivalents, and marketable securities as of June 30, 2025[174](index=174&type=chunk) - An immediate **100 basis point** change in interest rates would not materially affect the fair market value of its cash equivalents and marketable securities due to their short-term maturities and low-risk profile[174](index=174&type=chunk) - The company intends to maintain its portfolio in institutional money market funds comprised of U.S. treasury and U.S. treasury-backed repurchase agreements, as well as treasury notes and high-quality short-term corporate bonds[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they were effective. No material changes in internal control over financial reporting occurred during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[176](index=176&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[178](index=178&type=chunk) [PART II. Other Information](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently involved in any material legal proceedings[180](index=180&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details comprehensive risks impacting the company's business, financial condition, and growth, covering development, regulatory, IP, and operational aspects [Summary of Select Risks Associated with Our Business](index=38&type=section&id=Summary%20of%20Select%20Risks%20Associated%20with%20Our%20Business) Key risks include going concern doubts, need for capital, expected losses, macroeconomic impacts, capital raising limitations, and early-stage drug development challenges - There is substantial doubt about the company's ability to continue as a going concern, requiring additional capital that may not be available[182](index=182&type=chunk) - The company expects to incur substantial operating losses for the foreseeable future and may never achieve profitability[182](index=182&type=chunk) - Macroeconomic conditions, including economic downturns, inflation, interest rates, and geopolitical events, could adversely affect the business[182](index=182&type=chunk) - The company is early in its drug development efforts, and failure to successfully develop, receive regulatory approval for, and commercialize drug candidates would harm the business[182](index=182&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=40&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section details the company's precarious financial position, emphasizing going concern doubts, expected losses, and macroeconomic impacts on financing - The company's existing cash, cash equivalents, and marketable securities (**$38.3 million** as of June 30, 2025) are insufficient to fund operations for the next 12 months, raising substantial doubt about its going concern ability[185](index=185&type=chunk) - The company expects to continue incurring substantial operating losses and may never achieve profitability, with an accumulated deficit of **$319.2 million** as of June 30, 2025[190](index=190&type=chunk) - Macroeconomic factors, including inflation, high interest rates, trade disputes, and geopolitical tensions, could adversely affect the company's business, increase operating costs, and limit access to capital[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - The company's ability to raise capital using a Form S-3 registration statement is limited to **one-third of its public float** (currently less than **$75.0 million**), potentially increasing the cost and difficulty of future financings[201](index=201&type=chunk) [Risks Related to the Development and Commercialization of Our Drug Candidates](index=43&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Our%20Drug%20Candidates) This section outlines risks in drug development and commercialization, including early-stage challenges, clinical trial unpredictability, side effects, market acceptance, and competition - The company is early in its drug development efforts and has no approved drugs for commercial sale, making its ability to generate revenue dependent on successful development, regulatory approval, and commercialization of current and future candidates[205](index=205&type=chunk)[206](index=206&type=chunk) - Preclinical and early clinical trial results are not necessarily predictive of future outcomes; for example, soticlestat failed to meet primary endpoints in Phase 3 trials after promising early results[214](index=214&type=chunk) - Drug candidates may cause undesirable side effects, leading to delays or prevention of regulatory approval, limited commercial potential, or significant negative consequences post-approval[230](index=230&type=chunk)[232](index=232&type=chunk) - Market acceptance of approved drug candidates is uncertain and depends on factors like efficacy, safety, cost, and marketing efforts, especially given the small and difficult-to-assess patient populations for rare neurological disorders[234](index=234&type=chunk)[236](index=236&type=chunk)[241](index=241&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies with greater resources and experience, which could limit its ability to develop or commercialize drug candidates[237](index=237&type=chunk)[238](index=238&type=chunk)[239](index=239&type=chunk) [Risks Related to Licensing and Collaboration Arrangements](index=51&type=section&id=Risks%20Related%20to%20Licensing%20and%20Collaboration%20Arrangements) This section details risks from licensing and collaborations, including loss of control, increased capital needs, dilution, and uncertain outcomes - Collaborations may require the company to relinquish important rights and control over drug candidate development and commercialization, and partners may not commit adequate resources or may terminate agreements[250](index=250&type=chunk)[252](index=252&type=chunk)[257](index=257&type=chunk) - Future acquisitions or strategic partnerships could increase capital requirements, dilute stockholders, incur debt or contingent liabilities, and divert management attention[253](index=253&type=chunk) - The company's business strategy relies on acquiring or in-licensing compounds, but there is no assurance that suitable strategic collaborations will materialize or be successful[256](index=256&type=chunk) - The discontinuation of the soticlestat program by Takeda exemplifies the risk that collaborations may not result in successful development and commercialization[257](index=257&type=chunk) [Risks Related to Regulatory Compliance](index=53&type=section&id=Risks%20Related%20to%20Regulatory%20Compliance) This section addresses regulatory compliance risks, including fraud laws, privacy, non-compliance penalties, and the impact of healthcare reforms on drug pricing and orphan designations - The company's relationships with healthcare professionals and third-party payors are subject to federal and state healthcare fraud and abuse laws, false claims laws, and privacy laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act)[258](index=258&type=chunk) - Non-compliance with these laws could lead to significant civil, criminal, and administrative penalties, damages, fines, and exclusion from government healthcare programs[260](index=260&type=chunk) - Market acceptance and sales of approved drugs depend on adequate coverage and reimbursement from third-party payors, which are influenced by cost containment efforts and legislative reforms like the PPACA and IRA[262](index=262&type=chunk)[264](index=264&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk)[271](index=271&type=chunk) - Failure to obtain or maintain orphan drug designations or exclusivity could limit the profitability of drug candidates, as exclusivity can be lost under certain conditions[274](index=274&type=chunk)[276](index=276&type=chunk) - Even with regulatory approval, drug candidates remain subject to ongoing oversight, including manufacturing, labeling, promotion, and post-market requirements, with non-compliance leading to potential restrictions or withdrawal of approval[277](index=277&type=chunk)[279](index=279&type=chunk) [Risks Related to Our Intellectual Property](index=58&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section highlights IP protection uncertainties, covering patent validity, infringement claims, trade secret risks, and impacts of changing patent laws - The company relies on patents, trade secrets, and confidentiality agreements to protect its intellectual property, but obtaining and maintaining broad patent protection is expensive, time-consuming, and uncertain[284](index=284&type=chunk) - Third parties may challenge the validity, enforceability, or scope of the company's patents, or allege infringement of their own intellectual property rights, leading to costly litigation and potential loss of commercialization rights[285](index=285&type=chunk)[295](index=295&type=chunk)[297](index=297&type=chunk) - Changes in U.S. or foreign patent laws, or their interpretation, could diminish the value of patents and weaken the company's ability to obtain or enforce patent protection[289](index=289&type=chunk)[303](index=303&type=chunk) - Reliance on third parties requires sharing trade secrets, increasing the risk of misappropriation or unauthorized disclosure, which could harm the business[305](index=305&type=chunk) [Risks Related to Our Dependence on Third Parties](index=63&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section outlines risks from reliance on third parties for manufacturing and clinical trials, including delays, quality issues, and regulatory non-compliance - The company relies entirely on third parties for drug manufacturing, formulation, storage, distribution, and testing, introducing risks such as inability to meet specifications, manufacturing capacity issues, and non-compliance with cGMP[307](index=307&type=chunk)[309](index=309&type=chunk) - Reliance on Contract Research Organizations (CROs) for preclinical studies and clinical trials means limited influence over their performance, and non-compliance with GLPs/GCPs could lead to unreliable data and delays in regulatory approval[310](index=310&type=chunk)[311](index=311&type=chunk)[313](index=313&type=chunk) - Termination of relationships with CROs or manufacturers could result in substantial costs, management time, and delays in clinical development timelines[316](index=316&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=64&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) This section addresses operational risks, including management dependence, talent retention, growth management, employee misconduct, and cybersecurity and data privacy threats - The company is highly dependent on its senior management team, including the CEO, and the loss of key personnel or inability to attract and retain qualified staff could harm the business[317](index=317&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk) - Expanding the organization poses challenges in identifying, hiring, integrating, and retaining new personnel, potentially diverting management attention and leading to operational inefficiencies[322](index=322&type=chunk) - The company is exposed to risks of employee misconduct, including non-compliance with regulatory standards and fraud, which could lead to significant fines, sanctions, and reputational harm[324](index=324&type=chunk) - Increasing dependence on IT systems and sensitive data makes the company vulnerable to cyberattacks, security incidents, and data breaches, which could disrupt operations, lead to regulatory actions, and harm reputation[325](index=325&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk) - The company is subject to stringent and evolving data privacy and security laws (e.g., HIPAA, CCPA, GDPR), and non-compliance or perceived failure to comply could result in investigations, litigation, fines, and business disruptions[338](index=338&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk)[348](index=348&type=chunk) [Risks Related to Being a Public Company](index=69&type=section&id=Risks%20Related%20to%20Being%20a%20Public%20Company) This section addresses public company risks, including reduced investor appeal from smaller reporting status and challenges in maintaining effective internal controls - As a 'smaller reporting company,' the company's reduced disclosure requirements may make its common stock less attractive to investors, potentially leading to a less active trading market and increased stock price volatility[352](index=352&type=chunk)[354](index=354&type=chunk) - The company previously identified and remediated material weaknesses in internal control over financial reporting related to fund transfers and vendor information updates, and failure to maintain effective controls in the future could adversely affect investor confidence and stock value[355](index=355&type=chunk)[357](index=357&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk) [Risks Related to the Ownership of Our Common Stock and Other General Matters](index=71&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Our%20Common%20Stock%20and%20Other%20General%20Matters) This section discusses common stock ownership risks, including Nasdaq delisting, price volatility, dilution, ownership concentration, and anti-takeover provisions - The company received notice of non-compliance with Nasdaq's minimum bid price requirement (**$1.00 per share**) and was granted an extension until **February 9, 2026**, to regain compliance, with a potential reverse stock split as a measure[360](index=360&type=chunk)[361](index=361&type=chunk) - Failure to maintain Nasdaq listing requirements could reduce liquidity, lower the stock price, and negatively impact the ability to raise equity financing and provide employee incentives[362](index=362&type=chunk) - The market price of the common stock has been and is likely to remain volatile, influenced by clinical trial results, regulatory developments, competition, and general market conditions[363](index=363&type=chunk) - Stockholders will be diluted by the conversion of **1,250,000 shares** of Series A Preferred Stock and the exercise of **18,752,703 outstanding stock options**[366](index=366&type=chunk) - Concentration of ownership (approximately **41.6%** by executive officers, directors, and principal stockholders) and anti-takeover provisions in organizational documents could prevent new investors from influencing significant corporate decisions or make an acquisition more difficult[367](index=367&type=chunk)[373](index=373&type=chunk)[374](index=374&type=chunk)[378](index=378&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities, no use of proceeds to report, and no purchases of equity securities by the issuer or affiliated purchasers during the period - No unregistered sales of equity securities occurred during the period[380](index=380&type=chunk) - No purchases of equity securities by the issuer or affiliated purchasers were made[381](index=381&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) This section reports that no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025 - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[382](index=382&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, stock certificates, certifications of principal officers, and XBRL-related documents - Exhibits include the Amended and Restated Certificate of Incorporation, Bylaws, stock certificates, and certifications of principal executive and financial officers[386](index=386&type=chunk) - XBRL Instance Document, Taxonomy Extension Schema, and Cover Page are also furnished as exhibits[386](index=386&type=chunk) [Signatures](index=76&type=section&id=SIGNATURES) [Signatures](index=76&type=section&id=Signatures) This section contains the duly authorized signatures of the company's Chief Executive Officer and Chief Business and Financial Officer, certifying the submission of the Quarterly Report on Form 10-Q - The report is signed by Jeremy M. Levin, Chief Executive Officer, and Jeffrey Rona, Chief Business and Financial Officer, on August 13, 2025[390](index=390&type=chunk)

Core Insights - Ovid Therapeutics Inc. reported business updates and financial results for Q2 2025, highlighting advancements in its drug pipeline and financial performance [1][19]. Pipeline and Business Updates - The company is advancing its pipeline with key readouts expected soon, including Phase 1 data for OV329, a potential treatment for conditions driven by excess neuronal excitation [2][3]. - OV329 is designed to be a safer GABA-aminotransferase inhibitor, aiming to replace vigabatrin, which has serious safety concerns [4][5]. - The Phase 1 study for OV329 is on track for topline results in late Q3 2025, with plans for a Phase 2a trial in adults with treatment-resistant focal onset seizures [9][16]. - Ovid is also progressing its KCC2 direct activator programs, with OV350's safety data expected in Q4 2025 and OV4071's first-in-human studies anticipated in early 2026 [10][11][12]. Financial Performance - As of June 30, 2025, Ovid had cash, cash equivalents, and marketable securities totaling $38.3 million, expected to support operations into early H2 2026 [7][22]. - Revenue from royalty agreements increased to $6.3 million in Q2 2025, compared to $169,000 in the same period of 2024 [22]. - Research and development expenses decreased to $6.5 million in Q2 2025 from $12.6 million in Q2 2024, reflecting organizational restructuring [22]. - The company reported a net loss of $4.7 million for Q2 2025, compared to a net income of $8.5 million in Q2 2024 [22]. Strategic Developments - Ovid entered a $7.0 million agreement with Immedica Pharma AB to monetize ganaxolone royalties, strengthening its balance sheet and extending its operational runway [14][15]. - The company plans to explore strategic options to accelerate development and offset costs, including partnerships and monetizing intellectual property [17][18].

Company Overview - Ovid Therapeutics Inc. is a biopharmaceutical company based in New York, focused on developing small molecule medicines for brain conditions with significant unmet needs [2] - The company is advancing a pipeline of novel, targeted small molecule candidates that address neuronal hyperexcitability associated with various neurological and neuropsychiatric disorders [2] Product Pipeline - Ovid is developing OV329, a next-generation GABA-aminotransferase inhibitor, aimed at treating treatment-resistant seizures and other undisclosed indications [2] - The company is also working on OV350, OV4071, and additional compounds that activate the KCC2 transporter for multiple central nervous system disorders [2] Upcoming Events - Company management will participate in the BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025 [1]

Core Viewpoint - Ovid Therapeutics has entered into a definitive agreement with Immedica Pharma for the sale of future royalties related to ganaxolone sales outside of China, providing Ovid with a non-dilutive capital infusion of $7 million to support its ongoing operations [1][2]. Group 1: Transaction Details - Immedica will pay $7 million in cash to acquire 100% of the royalty rights held by Ovid, enhancing Immedica's focus on ganaxolone by gaining control of additional intellectual property rights [1]. - The transaction includes royalties associated with a previous agreement Ovid had with Marinus Pharmaceuticals regarding ganaxolone for CDKL5 deficiency disorder [4]. - Ovid recorded approximately $566,000 in ganaxolone royalty revenues in 2024, indicating the current revenue scale from this asset [2]. Group 2: Company Backgrounds - Ovid Therapeutics is a biopharmaceutical company focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline of novel candidates targeting neurological disorders [7]. - Immedica is a pharmaceutical company dedicated to the commercialization of medicines for rare diseases, with a global distribution network serving patients in over 50 countries [6].

OV329 Program & Clinical Development - OV329 is a next-generation GABA-aminotransferase inhibitor being developed for neuronal hyperexcitability and seizures[27] - Phase 1 topline results for OV329, including biomarker data, are expected in Q3 2025[20, 16] - A Phase 2a trial in patients with focal-onset seizures is planned to start in Q1 2026, with topline results expected in Q1 2027[20] - Phase 1 trial includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, with a total of 64 participants (48 receiving active treatment)[90] Biomarker Strategy - The OV329 Phase 1 trial incorporates a comprehensive biomarker strategy using magnetic resonance spectroscopy (MRS), transcranial magnetic stimulation (TMS), and electroencephalogram (EEG) to assess target engagement and pharmacodynamic effects[43, 45] - MRS will measure GABA concentrations in the medial parietal lobe to validate target engagement[45] - TMS will assess cortical excitability and brain circuit function, with metrics like cortical silent period (CSP) and paired-pulse long-interval intracortical inhibition (LICI)[45] - EEG will measure brain waves linked to inhibitory (GABAergic) activity, focusing on high and low frequencies[45] - Targeted directional changes in TMS biomarkers are anticipated, with increases in CSP and LICI, consistent with the effects of therapeutic vigabatrin[74] Market Opportunity - The company estimates a >$1 billion market opportunity for OV329 in drug-resistant epilepsy (DRE), targeting 65,000 adults with focal onset seizures and a price of $16,000 per year[38] - There is a substantial opportunity within the developmental epileptic encephalopathies (DEE) segment, with a potential market of ~20,000 patients and an average price of $60,000 per year, representing a >$1 billion market[116] Safety & Tolerability - In the Phase 1 trial, no treatment-related adverse events (AEs) or serious adverse events (SAEs) were observed in 30 treated participants, with headache being the most common AE[95, 94] - Comprehensive ocular safety metrics in Phase 1 showed no vision or ocular findings associated with OV329 treatment[96] - Preclinical studies show OV329 does not accumulate in the retina, unlike vigabatrin, suggesting a differentiated safety profile[107, 109]

Summary of Ovid Therapeutics (OVID) Update / Briefing June 12, 2025 Company Overview - **Company**: Ovid Therapeutics (OVID) - **Focus**: Development of epilepsy treatments, specifically targeting uncontrolled neuronal hyperexcitability through innovative drug mechanisms Key Industry Insights - **Industry Context**: The epilepsy drug development landscape is characterized by a lack of novel mechanisms, with only two new mechanisms introduced in the last fifteen years despite the existence of over 30 anti-seizure medications [17][18] - **Market Opportunity**: Approximately 30-40% of individuals with drug-resistant epilepsy continue to experience seizures, indicating a significant unmet need for effective treatments [18][25] Core Program: OV329 - **Drug Profile**: OV329 is a next-generation GABA aminotransferase inhibitor designed to enhance GABA levels in the brain, aiming for improved safety and efficacy compared to existing treatments [19][21] - **Mechanism of Action**: OV329 works by inhibiting the enzyme that breaks down GABA, thereby increasing its availability in synaptic regions, which is crucial for controlling seizures [22][24] - **Clinical Development**: A Phase 1 readout is expected by the end of Q3 2025, with a Phase 2a study planned for early 2027 [60][66] Biomarker Strategy - **Biomarker Utilization**: The company employs a comprehensive biomarker strategy using MR spectroscopy, transcranial magnetic stimulation (TMS), and electroencephalography (EEG) to assess drug efficacy and safety [28][30][32] - **Expected Outcomes**: The biomarkers are anticipated to demonstrate target engagement, pharmacodynamic effects, and safety profiles, providing confidence in the drug's potential [63][64][66] Safety and Efficacy - **Safety Profile**: Initial Phase 1 results indicate no serious adverse events, with mild headaches being the most common side effect. Comprehensive ophthalmologic assessments show no visual changes, suggesting a favorable safety profile [65][66] - **Efficacy Expectations**: The drug is expected to show significant increases in GABA concentration and improvements in inhibitory measures, which are critical for its anti-seizure effects [63][64] Competitive Landscape - **Differentiation Strategy**: Ovid aims to differentiate OV329 through its unique mechanism of action and improved safety profile, addressing the needs of patients who are often on polypharmacy regimens [77] Additional Insights - **Patient-Centric Approach**: The company emphasizes its commitment to developing effective treatments for patients with drug-resistant epilepsy, highlighting the personal stories of affected families to underscore the urgency of their mission [70][72] - **Future Directions**: Ovid plans to leverage the data from ongoing studies to inform future clinical trials and regulatory submissions, aiming to establish OV329 as a leading treatment option in the epilepsy market [74][75] This summary encapsulates the critical points discussed during the Ovid Therapeutics update, focusing on the company's strategic direction, the innovative approach of OV329, and the broader implications for the epilepsy treatment landscape.

Core Insights - Ovid Therapeutics Inc. is hosting an event on June 12, 2025, to discuss the application of biomarkers in epilepsy and the pharmacodynamic activity of its OV329 program [1][2] - The event will feature Dr. Alexander Rotenberg, a leading expert in neurology, who will discuss the emerging use of biomarkers in anti-seizure medicine development [1][3] Company Overview - Ovid Therapeutics is focused on developing small molecule medicines for brain conditions with significant unmet needs, including treatment-resistant epilepsy [5] - The company is advancing a pipeline that includes OV329, a next-generation GABA-aminotransferase inhibitor designed to provide a novel approach for patients with treatment-resistant seizures [3][5] Clinical Development - OV329 is currently completing a Phase 1 study that evaluates its effects on pharmacodynamic biomarkers, safety, tolerability, and pharmacokinetics [3] - The program is expected to have a topline readout in Q3 2025, indicating progress in its clinical development [2]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for Q1 2025 show a net loss of **$10.2 million**, an improvement from Q1 2024, with total assets decreasing to **$81.7 million** due to reduced cash and marketable securities [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$81.7 million** from **$92.2 million** at year-end 2024, driven by a decline in cash and marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $21,136 | $26,301 | | Marketable securities | $21,860 | $26,774 | | Total current assets | $45,921 | $55,940 | | Total assets | $81,654 | $92,167 | | **Liabilities & Equity** | | | | Total current liabilities | $9,307 | $10,522 | | Total liabilities | $22,377 | $23,941 | | Accumulated deficit | $(314,533) | $(304,299) | | Total stockholders' equity | $59,276 | $68,226 | | Total liabilities and stockholders' equity | $81,654 | $92,167 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the net loss improved to **$10.2 million** from **$11.7 million** in Q1 2024, primarily due to reduced R&D and G&A expenses Statement of Operations Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $130 | $148 | | Research and development | $6,659 | $10,397 | | General and administrative | $6,021 | $7,168 | | Total operating expenses | $12,680 | $17,565 | | Loss from operations | $(12,550) | $(17,417) | | Other income (expense), net | $2,315 | $5,723 | | **Net loss** | **$(10,235)** | **$(11,694)** | | Net loss per common share | $(0.14) | $(0.17) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used **$10.3 million** in cash in Q1 2025, a reduction from Q1 2024, resulting in a **$5.2 million** decrease in total cash and equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,280) | $(16,686) | | Net cash provided by investing activities | $5,102 | $20,188 | | Net cash provided by financing activities | $13 | $228 | | **Net (decrease) increase in cash** | **$(5,165)** | **$3,731** | | Cash, cash equivalents and restricted cash, at end of period | $23,067 | $32,703 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, accounting policies, and significant events, including **$43.0 million** in cash, soticlestat program discontinuation, and a **$1.8 million** fraudulent transfer recovery - Management believes that the Company's existing cash, cash equivalents and marketable securities of **$43.0 million** as of March 31, 2025, will be sufficient to fund its current operating plans for at least the next 12 months[33](index=33&type=chunk)[34](index=34&type=chunk) - In January 2025, Takeda announced the discontinuation of the soticlestat program, eliminating continuing debt or obligations to Ligand Pharmaceuticals related to the prior royalty sale[52](index=52&type=chunk)[115](index=115&type=chunk) - In January 2025, the Company fully recovered **$1.8 million** from a fraudulent transfer that occurred in 2024 and recorded it as a gain in other income[108](index=108&type=chunk) - The company operates as a single segment focused on developing medicines for brain conditions, with the Chairman and CEO as the Chief Operating Decision Maker (CODM)[130](index=130&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, attributing reduced net loss to lower operating expenses from restructuring and program pauses, confirming **$43.0 million** cash sufficiency for 12 months [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Total operating expenses decreased by **$4.9 million** in Q1 2025, driven by **$3.7 million** lower R&D and **$1.1 million** lower G&A expenses due to restructuring and program pauses Change in Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change $ | | :--- | :--- | :--- | :--- | | Research and development | $6,659 | $10,397 | $(3,738) | | General and administrative | $6,021 | $7,168 | $(1,147) | | **Total operating expenses** | **$12,680** | **$17,565** | **$(4,885)** | - The **$3.7 million** decrease in R&D expenses was primarily due to the pause of the OV888 (GV101) program and reduced headcount from the Q2 2024 organizational restructuring[153](index=153&type=chunk) - The decrease in G&A expenses was primarily due to the organizational restructuring executed in Q2 2024, which reduced payroll and other costs[154](index=154&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$43.0 million** in cash and equivalents, deemed sufficient for 12 months, while facing an accumulated deficit and capital raising limitations - As of March 31, 2025, the company had **$43.0 million** in cash, cash equivalents and marketable securities, which is believed to be sufficient to fund operations for at least 12 months[156](index=156&type=chunk) - The company has an at-the-market (ATM) offering program for up to **$75.0 million**, but its ability to sell shares is currently limited to one-third of its public float in any 12-month period because its public float is less than **$75.0 million**[165](index=165&type=chunk)[166](index=166&type=chunk) - Future funding requirements include potential milestone payments up to an aggregate of **$279.3 million** under license agreements with AstraZeneca and Northwestern, which are contingent and not recorded on the balance sheet[160](index=160&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity, though short-term investments mitigate material impact from rate changes - The company's primary market risk is interest rate sensitivity, but due to the short-term maturities of its investments, a **100 basis point** change in interest rates is not expected to have a material effect on their fair market value[177](index=177&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[179](index=179&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[181](index=181&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[183](index=183&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks including the need for additional capital, high drug development failure rates, competition, intellectual property challenges, and Nasdaq listing compliance issues - The company will require additional capital, which may not be available, and failure to obtain it will force delays, limits, or termination of drug development[187](index=187&type=chunk) - All drug candidates are in early clinical or preclinical development, with a high risk of failure, and success depends on successful development, regulatory approval, and commercialization[185](index=185&type=chunk)[207](index=207&type=chunk) - On February 10, 2025, the company received a notice from Nasdaq for non-compliance with the minimum **$1.00** bid price requirement and has until August 11, 2025, to regain compliance[359](index=359&type=chunk) - The company's ability to raise capital via its Form S-3 registration statement is limited to one-third of its public float (currently under **$75.0 million**) in any 12-month period[203](index=203&type=chunk) - A material weakness in internal control over financial reporting related to a fraudulent transfer was identified in Q3 2024 and remediated as of December 31, 2024[353](index=353&type=chunk)[355](index=355&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=71&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025[381](index=381&type=chunk) [Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and officer certifications

Core Insights - Ovid Therapeutics Inc. reported strong progress in its clinical pipeline, with a focus on developing small molecule medicines for brain conditions, particularly treatment-resistant seizures and other neurological disorders [2][3][16] Clinical Pipeline - The lead program, OV329, is a next-generation GABA aminotransferase inhibitor aimed at treating drug-resistant epilepsies, with topline results expected in Q3 2025 [4][8] - OV350, the first direct activator of the potassium chloride cotransporter 2 (KCC2), has been initiated in a Phase 1 trial, with safety and tolerability results anticipated by year-end 2025 [9][10] - The company is also developing OV4071, an oral KCC2 direct activator, expected to enter clinical development by the end of 2026 [11][12] Financial Performance - As of March 31, 2025, Ovid had cash, cash equivalents, and marketable securities totaling $43.0 million, which is projected to support operations into the second half of 2026 [6][15] - Revenues from royalty agreements for Q1 2025 were $130,000, a decrease from $148,000 in Q1 2024 [15][19] - Research and development expenses decreased to $6.7 million in Q1 2025 from $10.4 million in the same period in 2024, reflecting organizational restructuring [15][18] Business Strategy - Ovid plans to explore partnerships and co-development opportunities to accelerate development and offset costs, while maintaining fiscal discipline to achieve key clinical milestones [14][12] - Anticipated milestones include results for OV329's pharmacodynamic biomarker and safety data in Q3 2025, and the initiation of a Phase 2a study for OV329 in Q1 2026 [13][12]

Company Overview - Ovid Therapeutics (OVID) is expected to report a quarterly loss of $0.14 per share, reflecting a year-over-year change of +17.7% [3] - Revenues are anticipated to be $0.07 million, down 53.3% from the same quarter last year [3] Earnings Expectations - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a stable outlook from covering analysts [4] - The Most Accurate Estimate for Ovid is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -1.45%, suggesting a bearish sentiment among analysts [10] Historical Performance - In the last reported quarter, Ovid was expected to post a loss of $0.16 per share but actually reported a loss of $0.13, achieving a surprise of +18.75% [12] - Over the past four quarters, Ovid has beaten consensus EPS estimates three times [13] Comparative Industry Analysis - ImmunityBio (IBRX), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.12 for the same quarter, indicating a year-over-year change of +40% [17] - ImmunityBio's revenues are projected to be $15.69 million, up 39125% from the previous year [17] - The consensus EPS estimate for ImmunityBio has been revised 1.5% lower over the last 30 days, resulting in an Earnings ESP of -2.85% [18]