Ovid Therapeutics (OVID) - 2023 Q1 - Quarterly Report

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This section identifies forward-looking statements, warns of material differences in actual results due to risks, and disclaims any obligation to update - The report contains forward-looking statements, identifiable by terms such as "aim," "anticipate," "believe," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "project," "should," "target," "will," "would."[9] - Actual results may differ materially from current expectations due to factors outlined in Part II, Item 1A, "Risk Factors."[10] - The company assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.[10] PART I. FINANCIAL INFORMATION PART I. FINANCIAL INFORMATION This part presents unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and controls for Q1 2023 Item 1. Financial Statements (Unaudited) Item 1. Financial Statements (Unaudited) This item presents Ovid Therapeutics Inc.'s unaudited condensed consolidated financial statements, including balance sheets, operations, comprehensive loss, equity, and cash flows for Q1 2023 Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $63,051,928 | $44,867,846 | | Marketable securities | $54,668,093 | $84,133,565 | | Prepaid expenses and other current assets | $1,799,343 | $2,379,280 | | Total current assets | $119,519,364 | $131,380,691 | | Total assets | $143,367,004 | $155,265,814 | | Accounts payable | $1,831,490 | $1,952,910 | | Accrued expenses | $4,085,369 | $4,504,669 | | Current portion, lease liability | $804,139 | $533,946 | | Total current liabilities | $6,720,998 | $6,991,525 | | Total liabilities | $22,419,322 | $22,993,250 | | Total stockholders' equity | $120,947,682 | $132,272,564 | | Accumulated deficit | $(238,882,751) | $(225,526,542) | - Total assets decreased by $11.9 million from $155.3 million at December 31, 2022, to $143.4 million at March 31, 2023, primarily due to a decrease in marketable securities.[17] Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | License and other revenue | $66,160 | $1,445,366 | | Total revenue | $66,160 | $1,445,366 | | Research and development | $6,614,717 | $7,832,269 | | General and administrative | $8,343,748 | $9,880,203 | | Total operating expenses | $14,958,465 | $17,712,472 | | Loss from operations | $(14,892,305) | $(16,267,106) | | Other income (expense), net | $1,536,095 | $209,050 | | Net loss | $(13,356,209) | $(16,108,056) | | Net loss per share, basic | $(0.19) | $(0.23) | | Net loss per share, diluted | $(0.19) | $(0.23) | - Net loss improved to $(13.4) million for the three months ended March 31, 2023, from $(16.1) million in the prior-year period.[19] - Total revenue decreased significantly from $1.4 million in Q1 2022 to $66,160 in Q1 2023.[19] Condensed Consolidated Statements of Comprehensive Loss Condensed Consolidated Statements of Comprehensive Loss | Metric | For The Three Months Ended March 31, 2023 | For The Three Months Ended March 31, 2022 | | :-------------------------------- | :---------------------------------------- | :---------------------------------------- | | Net loss | $(13,356,209) | $(16,108,056) | | Unrealized gain on marketable securities | $47,817 | — | | Comprehensive loss | $(13,308,392) | $(16,108,056) | - Comprehensive loss improved to $(13.3) million for the three months ended March 31, 2023, from $(16.1) million in the prior-year period, partly due to an unrealized gain on marketable securities.[21] Condensed Consolidated Statements of Stockholders' Equity Condensed Consolidated Statements of Stockholders' Equity | Item | Balance, Dec 31, 2022 | Issuance of Common Stock | Stock-based Compensation Expense | Other Comprehensive Income | Net Loss | Balance, Mar 31, 2023 | | :-------------------------------- | :-------------------- | :----------------------- | :----------------------------- | :------------------------- | :------------- | :-------------------- | | Preferred Stock Amount | $1 | $0 | $0 | $0 | $0 | $1 | | Common Stock Amount | $70,467 | $25 | $0 | $0 | $0 | $70,492 | | Additional Paid-In Capital | $357,770,825 | $66,968 | $1,916,518 | $0 | $0 | $359,754,310 | | Accumulated Other Comprehensive Loss | $(42,187) | $0 | $0 | $47,817 | $0 | $5,630 | | Accumulated Deficit | $(225,526,542) | $0 | $0 | $0 | $(13,356,209) | $(238,882,751) | | Total Stockholders' Equity | $132,272,564 | $66,993 | $1,916,518 | $47,817 | $(13,356,209) | $120,947,682 | - Total stockholders' equity decreased by $11.3 million to $120.9 million as of March 31, 2023, primarily due to the net loss.[23] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | For The Three Months Ended March 31, 2023 | For The Three Months Ended March 31, 2022 | | :-------------------------------- | :---------------------------------------- | :---------------------------------------- | | Net cash used in operating activities | $(12,112,260) | $(20,086,419) | | Net cash provided by (used in) investing activities | $30,228,849 | $(1,076,165) | | Net cash provided by financing activities | $66,993 | $33,079 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $18,183,582 | $(21,129,505) | | Cash, cash equivalents and restricted cash, at end of period | $64,982,181 | $168,598,780 | - Net cash increased by $18.2 million in Q1 2023, a significant improvement from a $21.1 million decrease in Q1 2022, driven by investing activities.[25] - Net cash provided by investing activities was $30.2 million in Q1 2023, primarily from sales/maturities of marketable securities.[25] Notes to Unaudited Condensed Consolidated Financial Statements Notes to Unaudited Condensed Consolidated Financial Statements These notes detail financial position, operations, cash flows, accounting policies, asset/liability breakdowns, equity changes, and collaboration agreements NOTE 1 – NATURE OF OPERATIONS NOTE 1 – NATURE OF OPERATIONS - Ovid Therapeutics Inc. is a biopharmaceutical company focused on developing medicines for epilepsies and seizure-related disorders.[27] - The company had an accumulated deficit of $238.9 million as of March 31, 2023, and incurred a net loss of $13.4 million for the three months ended March 31, 2023.[29][30] - As of March 31, 2023, the company had approximately $117.7 million in cash, cash equivalents, and marketable securities, which management believes will fund current operating plans through at least the next 12 months.[29][30] NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (A) Unaudited Interim Condensed Consolidated Financial Statements (A) Unaudited Interim Condensed Consolidated Financial Statements - Interim financial statements are unaudited, prepared in accordance with GAAP and SEC requirements, and include normal recurring adjustments.[33][34] (B) Basis of Presentation and Consolidation (B) Basis of Presentation and Consolidation - The condensed consolidated financial statements include Ovid Therapeutics Inc. and its wholly owned subsidiary, Ovid Therapeutics Hong Kong Limited, with all intercompany transactions eliminated.[35] (C) Use of Estimates (C) Use of Estimates - Preparation of financial statements requires management to make estimates and assumptions that affect reported amounts of assets, liabilities, income, and expenses.[36] (D) Marketable Securities (D) Marketable Securities - Marketable securities consist of U.S. treasury instruments, classified as available-for-sale, with unrealized gains and losses reported in accumulated other comprehensive loss.[37] (E) Restricted Cash (E) Restricted Cash - Restricted cash includes all cash pledged as collateral for long-term obligations or limited by contractual provisions, reported as non-current unless restrictions are released within 12 months.[38] (F) Long-Term Equity Investments (F) Long-Term Equity Investments - Long-term equity investments include Gensaic, Inc. preferred shares (accounted for at cost, $5.1 million carrying value) and Marinus Pharmaceuticals, Inc. common shares (marked-to-market, $0.9 million carrying value as of March 31, 2023).[39][40] (G) Fair Value of Financial Instruments (G) Fair Value of Financial Instruments - The company uses a three-level fair value hierarchy: Level 1 for quoted prices in active markets ($61.6 million as of March 31, 2023) and Level 2 for observable inputs other than quoted prices ($54.7 million as of March 31, 2023).[41][42] (H) Leases (H) Leases - Operating leases are recognized as right-of-use (ROU) assets and lease liabilities on the balance sheet, based on the present value of lease payments.[43] (I) Property and Equipment (I) Property and Equipment - Property and equipment are stated at cost and depreciated over three years using the straight-line method; recoverability is reviewed when circumstances indicate carrying amount might not be recoverable.[44] (J) Research and Development Expenses (J) Research and Development Expenses - Research and development expenses, including clinical trial costs, manufacturing, contracted services, and license fees, are expensed as incurred.[45] (K) Stock-based Compensation (K) Stock-based Compensation - Stock-based compensation is accounted for under ASC 718, expensing the estimated fair value of awards over the requisite service period using the Black-Scholes valuation model.[46][47] (L) Income Taxes (L) Income Taxes - Income taxes are accounted for under the asset and liability method, recognizing deferred tax assets and liabilities for future tax consequences, with valuation allowances provided if realization is not probable.[49] (M) Net Loss per Share (M) Net Loss per Share - Net loss per common share is determined by dividing net loss attributable to common stockholders by the basic and diluted weighted-average common shares outstanding, applying the two-class method for participating securities.[50][51] (N) Revenue Recognition (N) Revenue Recognition - Revenue is recognized under ASC 606 when a customer obtains control of promised goods or services, reflecting the expected consideration, after identifying contracts, performance obligations, transaction price, and allocation.[52][53] (O) Recent Accounting Pronouncements (O) Recent Accounting Pronouncements - The company has reviewed recently issued accounting standards and does not expect their adoption to have a material impact on its financial position, results of operations, or cash flows.[56][57] NOTE 3 – CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES NOTE 3 – CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES | Category | March 31, 2023 (Fair Value) | December 31, 2022 (Fair Value) | | :-------------------------------- | :-------------------------- | :--------------------------- | | Cash | $2,346,359 | $2,853,042 | | Money market funds | $60,705,569 | $42,014,804 | | Marketable securities | $54,668,093 | $84,133,565 | | Total | $117,720,021 | $129,001,411 | - Total cash, cash equivalents, and marketable securities decreased by $11.3 million to $117.7 million as of March 31, 2023, primarily due to a reduction in marketable securities.[58] - Gross unrealized holding gains on marketable securities were $5,630 as of March 31, 2023, compared to gross unrealized holding losses of $42,187 as of December 31, 2022.[58] NOTE 4 – PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS NOTE 4 – PROPERTY AND EQUIPMENT AND INTANGIBLE ASSETS | Category | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Furniture and equipment | $1,436,592 | $1,423,032 | | Leasehold improvements | $306,312 | $306,312 | | Less accumulated depreciation | $(689,841) | $(581,381) | | Total property and equipment, net | $1,053,063 | $1,147,963 | - Net property and equipment decreased to $1.05 million as of March 31, 2023, from $1.15 million at December 31, 2022, due to depreciation expense of $108,460.[60] - Intangible assets, net, decreased to $185,910 as of March 31, 2023, from $222,100 at December 31, 2022, with amortization expense of $36,190.[61] NOTE 5 – LEASES NOTE 5 – LEASES - The company has a 10-year operating lease for its corporate headquarters, with annual base rent of $2.3 million, commencing January 10, 2023.[62][63] | Item | Amount | | :-------------------- | :------------- | | Right-of-use asset | $14,669,362 | | Current lease liability | $804,139 | | Long-term lease liability | $15,698,324 | | Year | Future Minimum Commitments | | :--- | :------------------------- | | 2023 | $1,351,177 | | 2024 | $2,316,303 | | 2025 | $2,316,303 | | 2026 | $2,316,303 | | 2027 | $2,316,303 | | Thereafter | $12,347,235 | | Total | $22,963,624 | NOTE 6 – ACCRUED EXPENSES NOTE 6 – ACCRUED EXPENSES | Category | March 31, 2023 | December 31, 2022 | | :-------------------------- | :------------- | :---------------- | | Payroll and bonus accrual | $1,895,602 | $3,233,802 | | Research and development accrual | $1,343,672 | $395,247 | | Professional fees accrual | $675,234 | $682,664 | | Other | $170,861 | $192,956 | | Total | $4,085,369 | $4,504,669 | - Accrued expenses decreased by $0.4 million to $4.1 million as of March 31, 2023, primarily due to a reduction in payroll and bonus accruals.[66] NOTE 7 – STOCKHOLDERS' EQUITY NOTE 7 – STOCKHOLDERS' EQUITY - As of March 31, 2023, there were 70,491,510 common shares outstanding and 1,250 shares of Series A Convertible Preferred Stock, convertible into 1,000 common shares each.[17][69] - The company has an 'at the market' (ATM) agreement for up to $75.0 million in common stock sales, with no shares sold as of March 31, 2023.[70] - No dividends have been declared through March 31, 2023.[71] NOTE 8 – STOCK-BASED COMPENSATION NOTE 8 – STOCK-BASED COMPENSATION - Total stock-based compensation expense for the three months ended March 31, 2023, was $1,916,518, up from $1,324,812 in the prior-year period.[82][83] | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Stock options | $1,901,364 | $1,303,793 | | Employee Stock Purchase Plan | $15,154 | $21,019 | | Total | $1,916,518 | $1,324,812 | - As of March 31, 2023, there was approximately $14.7 million of unrecognized stock-based compensation expense, expected to be recognized over a remaining average vesting period of 2.57 years.[83] NOTE 9 – INCOME TAXES NOTE 9 – INCOME TAXES - No tax benefit or expense was recorded for the three months ended March 31, 2023, as the company was in a pre-tax loss position.[85] - The company maintains a full valuation allowance against its net deferred tax assets due to cumulative losses, indicating that realization is not more likely than not.[87] NOTE 10 – COMMITMENTS AND CONTINGENCIES NOTE 10 – COMMITMENTS AND CONTINGENCIES License Agreements License Agreements Northwestern University License Agreement Northwestern University License Agreement - Ovid licensed exclusive worldwide rights for OV329 from Northwestern University in December 2016, with an upfront fee of $75,000 and an annual maintenance fee of $20,000.[88][90] - The agreement includes potential milestone payments up to $5.3 million and tiered royalties in the low to mid-single digits on net sales.[90] AstraZeneca AB License Agreement AstraZeneca AB License Agreement - Ovid entered an exclusive license agreement with AstraZeneca in December 2021 for KCC2 transporter small molecules, including OV350.[93] - The upfront payment included $5.0 million cash and $7.3 million in common stock, totaling $12.3 million expensed as R&D.[93] - Potential milestone payments could reach up to $203.0 million, with the first $3.0 million due upon successful completion of the first Phase 2 clinical study.[94] Gensaic Collaboration and Option Agreement Gensaic Collaboration and Option Agreement - Ovid entered a collaboration and option agreement with Gensaic in August 2022 for R&D of phage-derived particle (PDP) products targeting CNS rare disorders.[95] - Ovid will reimburse Gensaic for research costs, not exceeding $3.0 million in any research year.[97] - The agreement includes potential tiered royalty payments (mid-single to low double-digits) and milestone payments up to $452.0 million for three or more products.[98] Contingencies Contingencies - The company is not currently involved in any material legal matters.[100] - Certain executive officers are eligible for severance payments and benefits upon specific termination events, contingent on a release of claims and compliance with restrictive covenants.[101] NOTE 11 – COLLABORATION AND LICENSE AGREEMENTS NOTE 11 – COLLABORATION AND LICENSE AGREEMENTS Takeda Collaboration Takeda Collaboration - In March 2021, Ovid entered the RLT Agreement with Takeda, transferring all rights in soticlestat to Takeda.[103][104] - Ovid received an upfront payment of $196.0 million and is eligible for up to an additional $660.0 million in developmental, regulatory, and sales milestones.[104] - Ovid will receive tiered royalties beginning in the low double-digits, and up to 20% on sales of soticlestat if regulatory approval is achieved.[104] Healx License and Option Agreement Healx License and Option Agreement - Ovid granted Healx an exclusive option to investigate gaboxadol (OV101) for Fragile X syndrome, receiving an upfront payment of $0.5 million in Q1 2022.[109][111] - Healx has an option to secure an exclusive license for an additional $2.0 million, development/commercial milestone payments, and low to mid-tier double-digit royalties.[109] - Ovid retains an option to co-develop and co-commercialize, sharing net profits and losses in lieu of milestones and royalties.[110] Marinus Pharmaceuticals Out-License Agreement Marinus Pharmaceuticals Out-License Agreement - Ovid granted Marinus an exclusive license for ganaxolone patents for CDKL5 deficiency disorders in March 2022.[112] - Marinus issued 123,255 shares of its common stock as payment, valued at approximately $0.9 million, recorded as revenue and an equity investment.[113] - Ovid recognized unrealized gains on the Marinus common stock investment of $0.4 million for the three months ended March 31, 2023.[113] NOTE 12 – RELATED PARTY TRANSACTIONS NOTE 12 – RELATED PARTY TRANSACTIONS - The RLT Agreement with Takeda, detailed in Note 11, is considered a related party transaction.[114] NOTE 13 – NET LOSS PER SHARE NOTE 13 – NET LOSS PER SHARE | Metric | For the Three Months Ended March 31, 2023 | For the Three Months Ended March 31, 2022 | | :-------------------------------- | :---------------------------------------- | :---------------------------------------- | | Net loss attributable to common stockholders | $(13,356,209) | $(16,108,056) | | Weighted average common shares outstanding used in computing net loss per share - basic | 70,490,704 | 70,345,828 | | Weighted average common shares outstanding used in computing net loss per share - diluted | 70,490,704 | 70,345,828 | | Net loss per share, basic | $(0.19) | $(0.23) | | Net loss per share, diluted | $(0.19) | $(0.23) | - Basic and diluted net loss per common share was $(0.19) for Q1 2023, an improvement from $(0.23) in Q1 2022.[119] - Potentially dilutive securities were excluded from diluted EPS calculation as their inclusion would be anti-dilutive due to the net loss.[119] NOTE 14 – SUBSEQUENT EVENT NOTE 14 – SUBSEQUENT EVENT - On April 30, 2023, Ovid licensed Graviton's ROCK2 inhibitors, including GV101, for rare CNS disorders worldwide (excluding China, Hong Kong, Macau, and Taiwan).[120] - Ovid will be responsible for all development and commercialization costs and will pay tiered royalties (mid to high teens) on net sales.[120] - As part of the collaboration, Ovid purchased $10 million of Graviton's Series A Preferred Stock.[120] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section discusses Ovid Therapeutics Inc.'s financial condition, operational results, risks, liquidity, capital resources, and critical accounting policies for Q1 2023 Overview Overview - Ovid Therapeutics is a biopharmaceutical company focused on developing medicines for epilepsies and seizure-related disorders with a differentiated pipeline of three novel mechanisms of action.[123] - The company had an accumulated deficit of $238.9 million as of March 31, 2023, and expects to incur significant expenses and operating losses for the foreseeable future.[124][125] - Takeda anticipates regulatory filing for soticlestat's pivotal Phase 3 trials in Lennox-Gastaut and Dravet syndromes in Takeda's 2024 fiscal year.[126] Significant Risks and Uncertainties Significant Risks and Uncertainties - Global economic slowdown, high inflation rates, and geopolitical events (e.g., Russia-Ukraine war) may materially affect the business, financial condition, and growth prospects.[128] - Inflationary factors may increase operating costs (labor, R&D) and rising interest rates could make obtaining traditional financing more difficult.[128] - Industry-specific risks include challenges in identifying/acquiring product candidates, obtaining regulatory approval, clinical success uncertainty, and protecting intellectual property.[129] Financial Operations Overview Financial Operations Overview Revenue Revenue - Revenue has been generated from various licensing and collaboration agreements, with no revenue from commercial drug sales to date.[130] - The company does not expect to generate further revenue until regulatory approval and commercialization of drug candidates, or through future R&D payments, license fees, and milestone payments.[130][131] Research and Development Expenses Research and Development Expenses - R&D expenses are expensed as incurred and include employee-related costs, consultant fees, CRO/CMO expenses, preclinical/development activities, and license/milestone payments.[132] - R&D expenses are expected to increase significantly as current and future drug candidates advance through preclinical studies and clinical trials.[133] - The duration, costs, and timing of clinical trial programs are uncertain and depend on factors such as the number of trials, per patient costs, patient enrollment, and regulatory requirements.[133][136] General and Administrative Expenses General and Administrative Expenses - General and administrative expenses primarily consist of employee-related expenses (salaries, benefits, stock-based compensation) for executive, finance, legal, business development, and support functions.[135] - Other G&A expenses include costs associated with operating as a public company, travel, conferences, and professional fees for auditing, tax, and legal services.[135] Other Income (Expense), net Other Income (Expense), net - Other income (expense), net, primarily consists of unrealized gains (losses) on long-term equity investments and interest income and accretion of discount on marketable securities.[137] Reclassifications Reclassifications - Certain prior period amounts have been reclassified for consistency with the current period presentation, with no effect on reported results of operations.[138] Results of Operations Results of Operations Revenue Revenue | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------- | :-------------------------------- | :-------------------------------- | | License and other revenue | $66,160 | $1,445,366 | - Royalty revenue decreased significantly to $66,160 for Q1 2023, compared to $1.4 million in Q1 2022.[140] Research and Development Expenses Research and Development Expenses | Category | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Preclinical and development expenses | $2,983 | $2,120 | | Payroll and payroll-related expenses | $2,854 | $4,936 | | Other expenses | $778 | $776 | | Total research and development | $6,615 | $7,832 | - Total R&D expenses decreased by $1.2 million to $6.6 million in Q1 2023, primarily due to a $2.0 million reduction in payroll and related expenses following a 2022 organizational restructuring.[141] - The decrease was partially offset by an $0.86 million increase in preclinical and development expenses related to the OV329 Phase 1 clinical trial.[141] General and Administrative Expenses General and Administrative Expenses | Category | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Payroll and payroll-related expenses | $4,746 | $4,768 | | Legal and professional fees | $1,880 | $3,092 | | General office expenses | $1,717 | $2,020 | | Total general and administrative | $8,344 | $9,880 | - General and administrative expenses decreased by $1.5 million to $8.3 million in Q1 2023, mainly due to lower legal and consulting fees and general office expenses.[142] Provision for Income Taxes Provision for Income Taxes - No tax benefit or expense was recorded for the three months ended March 31, 2023 or 2022.[143] Other Income (Expense), net Other Income (Expense), net - Other income (expense), net, for Q1 2023 included unrealized gains/losses on long-term equity investments and interest earned on marketable securities, showing a significant increase compared to Q1 2022.[144] Liquidity and Capital Resources Liquidity and Capital Resources Overview Overview - As of March 31, 2023, total cash, cash equivalents, and marketable securities were $117.7 million, down from $129.0 million at December 31, 2022.[145] - The company had an accumulated deficit of $238.9 million and a net loss of $13.4 million for Q1 2023, but believes current resources are sufficient for at least the next 12 months.[146] Future Funding Requirements Future Funding Requirements - The company anticipates substantial future capital requirements for drug development, regulatory approval, and commercialization.[147] - Contingent milestone payment obligations under license agreements (AstraZeneca, Northwestern) could aggregate up to $279.3 million, but are not reasonably estimable for timing/probability.[148] - Future funding will rely on equity offerings, debt financings, and collaborations, with no committed external source of liquidity and potential for dilution or restrictive covenants.[149] At-the-Market Offering Program At-the-Market Offering Program - The company has an 'at-the-market' (ATM) offering program for up to $75.0 million of common stock.[150] - As of March 31, 2023, the full $75.0 million under the ATM program remained available, with no shares sold.[150] Cash Flows Cash Flows Net Cash Used In Operating Activities Net Cash Used In Operating Activities | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(12,112) | $(20,086) | - Net cash used in operating activities decreased to $12.1 million in Q1 2023 from $20.1 million in Q1 2022, driven by a lower net loss and $1.9 million in stock-based compensation expense.[152][153] Net Cash Provided By (Used In) Investing Activities Net Cash Provided By (Used In) Investing Activities | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash provided by (used in) investing activities | $30,229 | $(1,076) | - Net cash provided by investing activities was $30.2 million in Q1 2023, primarily from $40.0 million in sales/maturities of marketable securities.[25][154] Net Cash Provided By Financing Activities Net Cash Provided By Financing Activities | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash provided by financing activities | $67 | $33 | - Net cash provided by financing activities was $66,993 in Q1 2023, resulting from proceeds from stock option exercises and employee stock purchase plan purchases.[155] Smaller Reporting Company Status Smaller Reporting Company Status - Ovid Therapeutics Inc. qualifies as a 'smaller reporting company,' allowing scaled-back disclosure requirements in SEC filings.[156][157] - Scaled disclosures include reduced executive compensation information and providing two years of audited financial statements.[157] Critical Accounting Policies and Estimates Critical Accounting Policies and Estimates - The company's financial statements rely on management's estimates and assumptions, particularly for accrued expenses and stock-based compensation.[157] - No material changes to critical accounting policies were reported for the three months ended March 31, 2023.[158] Item 3. Quantitative and Qualitative Disclosures About Market Risk Item 3. Quantitative and Qualitative Disclosures About Market Risk Ovid Therapeutics Inc.'s primary market risk is interest rate sensitivity on its $117.7 million cash and marketable securities, with minimal fair value impact from rate changes - The primary market risk exposure is interest rate sensitivity, with $117.7 million in cash, cash equivalents, and marketable securities as of March 31, 2023.[159] - Due to the short-term maturities and low-risk profile of investments (U.S. Treasury, money market funds), a 100 basis point change in interest rates would not materially affect fair value.[159] Item 4. Controls and Procedures Item 4. Controls and Procedures As of March 31, 2023, Ovid Therapeutics Inc.'s disclosure controls were effective, with no material changes in internal control over financial reporting - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of March 31, 2023.[162] - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2023.[163] PART II. OTHER INFORMATION PART II. OTHER INFORMATION This part covers legal proceedings, comprehensive risk factors related to business, financial position, drug development, licensing, regulatory compliance, intellectual property, and exhibits Item 1. Legal Proceedings Item 1. Legal Proceedings Ovid Therapeutics Inc. is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings.[166] Item 1A. Risk Factors Item 1A. Risk Factors This section details significant risks to Ovid Therapeutics Inc.'s business, financial condition, and growth, including financial, development, licensing, regulatory, intellectual property, third-party, operational, and public company risks Summary of Selected Risks Associated with Our Business Summary of Selected Risks Associated with Our Business - The company has incurred significant operating losses and expects to continue doing so, requiring additional capital that may not be available.[168] - All current drug candidates are in preclinical development, and future success depends on successful clinical development, regulatory approval, and commercialization.[168] - Key risks include reliance on Takeda for soticlestat payments, regulatory compliance (e.g., healthcare fraud laws), obtaining adequate reimbursement, and protecting intellectual property.[168] Risks Related to Our Financial Position and Need for Additional Capital Risks Related to Our Financial Position and Need for Additional Capital - The company has an accumulated deficit of $238.9 million and expects to incur substantial operating losses for the foreseeable future, requiring additional capital.[170][178][179] - Failure to obtain necessary capital could force delays, limits, or termination of drug development efforts.[178][182] - The ability to use net operating loss (NOL) carryforwards (e.g., $130.9 million federal) to offset future taxable income may be limited by Section 382 of the Internal Revenue Code and other tax law changes.[183][185][186] Risks Related to the Development and Commercialization of Our Drug Candidates Risks Related to the Development and Commercialization of Our Drug Candidates - All current drug candidates are in preclinical development, and success depends on timely completion of preclinical/clinical development and regulatory approvals.[187][188][190] - Clinical trials are expensive, time-consuming, and have uncertain outcomes; delays or failures in demonstrating safety and efficacy could harm the business.[205][206] - Drug candidates may cause undesirable side effects, leading to delayed approval, limited commercial potential, or significant negative consequences post-approval.[218][220] - The company faces substantial competition from major pharmaceutical and biotechnology companies with greater resources and experience.[223][224] Risks Related to Licensing and Collaboration Arrangements Risks Related to Licensing and Collaboration Arrangements - Ovid is dependent on Takeda's successful development and commercialization of soticlestat for up to $660.0 million in milestones and tiered royalties; failure would materially harm the business.[237][238][239] - In-licensing or acquiring drug candidates involves diligence, development, and payment obligations, and potential disputes over intellectual property rights.[240][241] - Future collaborations may require relinquishing important rights and control over drug candidate development and commercialization.[242] Risks Related to Regulatory Compliance Risks Related to Regulatory Compliance - Relationships with customers, physicians, 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).[249][250] - Non-compliance with these laws could result in significant civil, criminal, and administrative penalties, fines, and exclusion from government healthcare programs.[253] - Market acceptance and sales depend on adequate coverage and reimbursement from third-party payors, which are influenced by cost containment and healthcare reforms like the PPACA and Inflation Reduction Act.[255][256][262] Risks Related to Our Intellectual Property Risks Related to Our Intellectual Property - The company's success depends on obtaining and maintaining patent protection for drug candidates, which is expensive, time-consuming, and uncertain.[272] - Patent applications may fail to issue, or issued patents may be challenged, narrowed, or invalidated, potentially depriving the company of necessary rights or meaningful exclusivity.[273][275] - Changes in U.S. or foreign patent laws or their interpretation could diminish the value of patents and impair the ability to protect drug candidates.[276][290] - Reliance on third parties requires sharing trade secrets, increasing the risk of discovery, misappropriation, or unauthorized disclosure by competitors.[292][293] Risks Related to Our Dependence on Third Parties Risks Related to Our Dependence on Third Parties - The company relies entirely on third-party manufacturers for clinical and commercial drug supplies, facing risks like quality issues, manufacturing delays, and cGMP non-compliance.[295][297] - Dependence on CROs and clinical trial sites for preclinical studies and clinical trials means limited influence over their performance.[298] - Failure by CROs to comply with GLPs/GCPs or meet deadlines could lead to clinical trial delays, increased costs, and jeopardize regulatory approval.[300][301] Risks Related to Our Business Operations, Employee Matters and Managing Growth Risks Related to Our Business Operations, Employee Matters and Managing Growth - The company is highly dependent on its senior management team, including Dr. Jeremy Levin, and faces risks if it cannot retain or recruit qualified personnel.[304][305] - Expected organizational expansion may lead to difficulties in managing growth, diverting management attention and potentially causing operational inefficiencies.[308] - Risks include employee misconduct, non-compliance with regulatory standards, and insider trading, which could result in significant fines, sanctions, and reputational harm.[309] - Dependence on IT systems and a hybrid work environment increase vulnerability to data security incidents and cyberattacks, posing financial, legal, and reputational risks.[310][312] Risks Related to Being a Public Company Risks Related to Being a Public Company - As a 'smaller reporting company,' Ovid uses scaled-back disclosures, which may make its common stock less attractive to investors and increase price volatility.[317][318] - Having ceased to be an 'emerging growth company' as of December 31, 2022, the company now faces increased compliance costs and demands, including Section 404(b) attestation requirements.[320][321] - Failure to maintain effective internal control over financial reporting could adversely affect investor confidence and the value of common stock.[322][323] Risks Related to the Ownership of Our Common Stock and Other General Matters Risks Related to the Ownership of Our Common Stock and Other General Matters - The market price of common stock is volatile, influenced by clinical trial results, regulatory developments, competition, and economic conditions, potentially leading to substantial losses.[324][325] - Future equity or debt sales may dilute stockholders and impose business restrictions; the company has an ATM program for up to $75.0 million.[329][330] - Concentration of ownership (approx. 49% by insiders and principal stockholders) and anti-takeover provisions could limit stockholder influence and deter acquisitions.[332][334][338][342] - The company does not anticipate paying cash dividends, making capital appreciation the sole source of gain for the foreseeable future.[337] Item 6. Exhibits Item 6. Exhibits This section lists Form 10-Q exhibits, including corporate documents, stock certificates, investor agreements, executive certifications, and Inline XBRL files - Exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), stock certificates, investor rights agreements, and certifications from principal executive and financial officers.[347] - The filing includes Inline XBRL instance and taxonomy extension documents for interactive data.[347] SIGNATURES SIGNATURES The report was signed on May 5, 2023, by the CEO and CBFO, affirming compliance with Securities Exchange Act of 1934 requirements - The report was signed on May 5, 2023, by Jeremy M. Levin (CEO) and Jeffrey Rona (CBFO), confirming compliance with Securities Exchange Act of 1934 requirements.[351]