MediciNova(MNOV) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Presents MediciNova's unaudited condensed consolidated financial statements and management's discussion for the quarter ended March 31, 2025 ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) Details MediciNova's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, cash flows, and accompanying notes for Q1 2025 Condensed Consolidated Balance Sheets Provides a snapshot of MediciNova's financial position, detailing assets, liabilities, and equity as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights | Metric | March 31, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $36,571,466 | $40,359,738 | | Total current assets | $37,679,307 | $41,074,279 | | Total assets | $52,431,150 | $55,875,926 | | Total current liabilities | $2,133,684 | $2,959,123 | | Total liabilities | $2,500,674 | $3,372,375 | | Total stockholders' equity | $49,930,476 | $52,503,551 | | Accumulated deficit | $(429,615,362) | $(426,751,242) | Condensed Consolidated Statements of Operations and Comprehensive Loss Outlines MediciNova's financial performance, including operating expenses, interest income, and net loss for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Research, development and patents | $1,839,802 | $1,781,869 | | General and administrative | $1,362,708 | $1,354,124 | | Total operating expenses | $3,202,510 | $3,135,993 | | Operating loss | $(3,202,510) | $(3,135,993) | | Interest income | $336,111 | $397,510 | | Net loss | $(2,864,120) | $(2,754,518) | | Basic and diluted net loss per common share | $(0.06) | $(0.06) | | Comprehensive loss | $(2,859,018) | $(2,763,410) | Condensed Consolidated Statements of Stockholders' Equity Details changes in MediciNova's stockholders' equity, including share-based compensation, net loss, and foreign currency adjustments for Q1 2025 and Q1 2024 Changes in Stockholders' Equity | Metric | Balance at Dec 31, 2024 ($) | Share-based Compensation ($) | Net Loss ($) | Foreign Currency Translation Adjustments ($) | Balance at Mar 31, 2025 ($) | | :-------------------------- | :---------------------- | :----------------------- | :------- | :------------------------------------- | :---------------------- | | Total stockholders' equity | $52,503,551 | $285,943 | $(2,864,120) | $5,102 | $49,930,476 | | Metric | Balance at Dec 31, 2023 ($) | Share-based Compensation ($) | Net Loss ($) | Foreign Currency Translation Adjustments ($) | Balance at Mar 31, 2024 ($) | | :-------------------------- | :---------------------- | :----------------------- | :------- | :------------------------------------- | :---------------------- | | Total stockholders' equity | $62,378,424 | $215,430 | $(2,754,518) | $(8,892) | $59,830,444 | Condensed Consolidated Statements of Cash Flows Presents MediciNova's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Cash Flows | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss | $(2,864,120) | $(2,754,518) | | Non-cash stock-based compensation | $285,943 | $215,430 | | Net cash used in operating activities | $(3,783,661) | $(3,868,248) | | Net change in cash and cash equivalents | $(3,788,272) | $(3,860,643) | | Cash and cash equivalents, end of period | $36,571,466 | $47,138,799 | Notes to Condensed Consolidated Financial Statements Provides detailed explanations and disclosures for MediciNova's condensed consolidated financial statements, covering accounting policies and financial items 1. Interim Financial Information Describes MediciNova's business, operating segment, accounting policies for R&D, and evaluation of new FASB ASUs - MediciNova is a biopharmaceutical company focused on developing novel therapeutics for serious diseases with unmet medical needs, primarily in the U.S. market. Its main product candidates are MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic and metabolic disorders[25] - The company operates as a single operating segment focused on the acquisition and development of small molecule therapeutics[29] - Research and development costs, including patent-related expenses, are expensed in the period incurred[32][33] - The company is evaluating the potential impact of recently issued FASB ASUs 2023-09 (Income Taxes) and 2024-03 (Expense Disaggregation Disclosures), which will enhance income tax and expense disclosures in future periods[37][38] 2. Revenue Recognition Explains MediciNova's revenue recognition policies, primarily for research and development services, based on performance obligation satisfaction - Revenues historically consist mainly of research and development services, recognized upon the satisfaction of performance obligations, either at a point in time or over time[39] 3. Fair Value Measurements Details MediciNova's fair value measurement hierarchy and the valuation of mutual funds as of March 31, 2025, and December 31, 2024 - Fair value measurements are categorized into a three-tier hierarchy (Level 1, 2, 3) based on the observability of inputs[40][41] Fair Value of Mutual Funds | | March 31, 2025 ($) | December 31, 2024 ($) | Valuation Inputs | | :---------- | :------------- | :---------------- | :--------------- | | Mutual funds | $21,728,258 | $21,501,081 | Level 1 | 4. Commitments and Contingencies Outlines MediciNova's operating lease liabilities, potential milestone payments, and confirms no material legal proceedings - The company has operating leases for real estate in the United States and Japan, including a new Tokyo office lease effective June 2024[43] Operating Lease Liabilities | Metric | March 31, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :---------------- | | Current operating lease liabilities | $189,860 | $193,769 | | Non-current operating lease liabilities | $165,198 | $211,460 | | Total operating lease liabilities | $355,058 | $405,229 | | Weighted-average remaining lease term | 1.76 years | 1.98 years | | Weighted-average discount rate | 9.6% | 9.6% | - Future potential milestone payments under license agreements for MN-166 (ibudilast) and MN-001 (tipelukast) are $10 million, and for all other products, they total $16.5 million as of March 31, 2025[46] - The company is not aware of any material legal proceedings or claims that would adversely affect its business[47] 5. Stock-based Compensation Discusses MediciNova's equity incentive plan, performance options, stock-based compensation expense, and unamortized compensation cost - The 2023 Equity Incentive Plan is the successor to the 2013 Plan, with 2,025,173 shares remaining available for future grants as of March 31, 2025[49][50] - As of March 31, 2025, 1,030,000 shares underlying performance options were subject to vesting based on the achievement of corporate objectives and employee performance for 2025[51] Stock-based Compensation Expense | Expense Category | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research, development and patents | $124,191 | $81,669 | | General and administrative | $161,752 | $133,761 | | Total stock-based compensation expense | $285,943 | $215,430 | - As of March 31, 2025, there was $1.0 million of unamortized compensation cost related to unvested stock option awards, expected to be recognized over a remaining weighted-average vesting period of 0.79 years[56] 6. Stockholders' Equity Addresses MediciNova's At-The-Market (ATM) issuance sales agreement and the absence of sales under it during the reporting period - The company has an At-The-Market (ATM) issuance sales agreement for up to $75.0 million in common stock sales, but no shares were sold under this agreement in the three months ended March 31, 2025, or 2024[58][59] 7. Net Loss Per Share Presents MediciNova's basic and diluted net loss per common share and the exclusion of anti-dilutive stock options Net Loss Per Common Share | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Basic and diluted net loss per common share | $(0.06) | $(0.06) | | Shares used to compute basic and diluted net loss per common share | 49,046,246 shares | 49,046,246 shares | - Potentially dilutive outstanding stock options totaling 7,909,394 shares (Q1 2025) and 8,578,644 shares (Q1 2024) were excluded from diluted net loss per common share calculation due to their anti-dilutive effect[61] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Management's analysis of MediciNova's financial performance, liquidity, and capital resources for the three months ended March 31, 2025 Overview Introduces MediciNova's biopharmaceutical focus, product development strategy, and accumulated deficit as of March 31, 2025 - MediciNova is a biopharmaceutical company focused on developing novel therapeutics for serious diseases with unmet medical needs, primarily in the U.S. market, with key product candidates MN-166 (ibudilast) and MN-001 (tipelukast)[65] - The company's strategy involves advancing MN-166 and MN-001 through investigator-sponsored trials, grants, and company-funded trials, while also seeking strategic partnerships[67] - MediciNova has an accumulated deficit of $429.6 million as of March 31, 2025, and expects to incur substantial net losses for the next several years[66] Research, Development and Patents Expenses Analyzes MediciNova's research, development, and patent expenses, noting stability with shifts in MN-001 and personnel costs Research, Development and Patents Expenses (in thousands) | Expense Category | Three months ended March 31, 2025 (in thousands $) | Three months ended March 31, 2024 (in thousands $) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | External development expense: MN-166 | $1,084 | $1,064 | | External development expense: MN-001 | $219 | $94 | | R&D personnel expense | $388 | $431 | | Patent expenses | $100 | $140 | | Total research, development and patent expense | $1,840 | $1,782 | - Research, development and patents expenses remained relatively stable quarter-over-quarter, with an increase in MN-001 related expenses and stock option expense offset by decreased payroll costs from a reduction in headcount[76] General and Administrative Expenses Discusses MediciNova's general and administrative expenses, noting their stability and potential for future increases with business expansion General and Administrative Expenses | Expense Category | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | General and administrative | $1,362,708 | $1,354,124 | - General and administrative expenses may increase in future periods if the company expands its infrastructure due to product development success, capital raising, or increased business development activities[71] Critical Accounting Estimates Highlights the role of management estimates in financial statements and confirms no material changes to critical accounting policies - The preparation of consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and expenses[72] - There have been no material changes to the critical accounting policies discussed in the Annual Report on Form 10-K during the three months ended March 31, 2025[73] IPR&D and Goodwill Explains MediciNova's accounting for indefinite-lived IPR&D and goodwill, including impairment testing and potential future charges - In-process research and development (IPR&D) and goodwill are indefinite-lived intangible assets that are not amortized but are tested annually for impairment[74] - A qualitative impairment assessment as of December 31, 2024, indicated no impairment for goodwill and indefinite-lived intangible assets[75] - A sustained decline in stock price or other material changes in assumptions could result in a material goodwill and/or intangible asset impairment charge in future periods[75] Results of Operations Compares MediciNova's financial results for the three months ended March 31, 2025, and 2024, focusing on key expense categories and interest income Comparison of the three months ended March 31, 2025 and 2024 Compares MediciNova's research, development, patent, general, and administrative expenses, and interest income for Q1 2025 versus Q1 2024 - Research, development and patents expenses were $1.8 million for both the three months ended March 31, 2025 and 2024, remaining relatively stable[76] - General and administrative expenses were $1.4 million for both the three months ended March 31, 2025 and 2024, also remaining relatively stable[77] Interest Income Comparison | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | Change ($) | | :------------- | :-------------------------------- | :-------------------------------- | :----- | | Interest income | $336,111 | $397,510 | $(61,399) | - The decrease in interest income was primarily driven by a decrease in the company's cash balance generating interest[78] Liquidity and Capital Resources Assesses MediciNova's cash position, working capital, and funding outlook, noting net cash used in operating activities and ATM agreement status Net Cash Used in Operating Activities | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | Change ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Net cash used in operating activities | $(3,783,661) | $(3,868,248) | $84,587 (decrease in usage) | Liquidity Position (as of March 31, 2025) | Metric | Amount ($) | | :------------------------ | :----------- | | Cash and cash equivalents | $36.6 million | | Working capital | $35.5 million | - The company believes it has sufficient working capital to fund operations at least through May 2026, but cannot provide assurance that these resources will be sufficient to conduct all planned research and development programs[80] - No shares of common stock were sold under the $75.0 million At-The-Market (ATM) issuance sales agreement in the three months ended March 31, 2025, or 2024[81][82] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK States that MediciNova has no applicable disclosures regarding quantitative and qualitative market risk for the reporting period - The company has no applicable disclosures for quantitative and qualitative market risk[83] ITEM 4. CONTROLS AND PROCEDURES Details the evaluation of MediciNova's disclosure controls and procedures, confirming their effectiveness and reporting no material changes in internal control Evaluation of Disclosure Controls and Procedures Concludes that MediciNova's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025 - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025[86] Changes in Internal Control over Financial Reporting Reports no material changes in MediciNova's internal control over financial reporting during the most recent fiscal quarter - There has been no change in the company's internal control over financial reporting during the most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting[87] PART II. OTHER INFORMATION Presents additional information beyond financial statements, including legal proceedings, risk factors, and other disclosures ITEM 1. LEGAL PROCEEDINGS Confirms MediciNova is not involved in any material legal proceedings as of March 31, 2025 - The company is not involved in any material legal proceedings as of March 31, 2025[90] ITEM 1A. RISK FACTORS Refers to previously disclosed risk factors in the Annual Report on Form 10-K, noting no material changes for the current quarter - Readers should carefully consider the risk factors discussed in Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2024[91] - No material changes from the previously disclosed risk factors in the Annual Report on Form 10-K were identified during the quarter ended March 31, 2025[91] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS Reports no unregistered sales of equity securities or use of proceeds for the period - None to report[92] ITEM 3. DEFAULTS UPON SENIOR SECURITIES Reports no defaults upon senior securities for the period - None to report[92] ITEM 4. MINE SAFETY DISCLOSURES States that this item is not applicable to MediciNova's operations - Not applicable[92] ITEM 5. OTHER INFORMATION Reports no adoption or termination of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by officers or directors - No officers or directors informed the company of the adoption or termination of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended March 31, 2025[92] ITEM 6. EXHIBITS Lists the exhibits filed with the Form 10-Q, including certifications from principal executive and financial officers, and Inline XBRL documents - The report includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2) and Inline XBRL documents (Exhibits 101.INS, 101.SCH, 104)[94] SIGNATURES Provides the official signatures of MediciNova's President, CEO, and CFO, certifying the report - The report is signed by Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer, and Jason Kruger, Chief Financial Officer, on behalf of MediciNova, Inc[99]