LA JOLLA, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), announces that Yuichi Iwaki, M.D., Ph.D., President and CEO, and David H. Crean, Ph.D., Chief Business Officer, will present a corporate overview at the LD Micro Main Event XIX Investor Conference. The conference is being held on October 19 – 22, 2025 at the Hotel Del Corona ...

~Patient Recruitment Closed~LA JOLLA, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS). A total of 234 patients have been randomized across two treatment ...

Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [3] - The company has a late-stage pipeline that includes 11 clinical programs, primarily centered around two compounds: MN-166 (ibudilast) and MN-001 (tipelukast) [3] - MN-166 (ibudilast) is currently in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is Phase 3-ready for progressive multiple sclerosis (MS) [3] Clinical Trials - An abstract regarding the Phase 2b/3 COMBAT clinical trial of MN-166 (ibudilast) in ALS patients has been selected for a poster presentation at the 36th International Symposium on ALS/MND scheduled for December 5-7, 2025 [1][2] - The presentation will cover trial updates and baseline characteristics, indicating ongoing progress in the clinical development of MN-166 [2] Product Information - MN-166 (ibudilast) is a small molecule that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, and is being developed for various neurodegenerative diseases, including ALS, progressive MS, and DCM [2] - The compound is also under investigation for other conditions such as glioblastoma, Long COVID, chemotherapy-induced peripheral neuropathy (CIPN), and substance use disorder [2]

Core Viewpoint - MediciNova, Inc. has made significant progress in its clinical trials and secured a Standby Equity Purchase Agreement to enhance its financial flexibility for ongoing research and development initiatives [2][3][4]. Group 1: Financial Developments - The company signed a Standby Equity Purchase Agreement (SEPA) for up to $30 million worth of common stock over 36 months, allowing it to sell shares at 97% of the market price [2]. - Proceeds from the SEPA will be utilized to advance R&D programs and support general corporate activities [2][4]. Group 2: Clinical Trials and Research Progress - MediciNova achieved the target enrollment for its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast), aimed at treating Amyotrophic Lateral Sclerosis (ALS) [3][4]. - The company is also conducting a large Expanded Access Program (EAP) supported by a $22 million grant from the National Institutes of Health (NIH) [3]. - Additionally, the company is nearing completion of its Phase 2 clinical trial for MN-001 (Tipelukast) targeting hypertriglyceridemia and fatty liver disease due to Type 2 diabetes [3][5]. Group 3: Company Overview - MediciNova is a clinical-stage biopharmaceutical company with a late-stage pipeline focused on inflammatory, fibrotic, and neurodegenerative diseases [5]. - The company has 11 programs in clinical development, with MN-166 being evaluated in multiple Phase 2 and Phase 3 trials for various conditions [5].

Core Viewpoint - MediciNova, Inc. is set to present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference, highlighting its clinical-stage biopharmaceutical developments and pipeline [1][3]. Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [3]. - The company has a late-stage pipeline that includes 11 clinical programs based on two main compounds: MN-166 (ibudilast) and MN-001 (tipelukast) [3]. Clinical Development - MN-166 (ibudilast) is currently in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is ready for Phase 3 for progressive multiple sclerosis (MS) [3]. - MN-166 is also being evaluated in Phase 2 trials for Long COVID and substance dependence [3]. - MN-001 (tipelukast) has been evaluated in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF), with an ongoing Phase 2 trial for non-alcoholic fatty liver disease (NAFLD) [3]. Conference Details - The presentation will be available on-demand starting at 7:00 am ET on September 5, 2025, and a live webcast can be accessed through the investor relations section of the MediciNova website [2][3]. - Drs. Iwaki and Crean will be available for one-on-one meetings throughout the conference [3].

Core Insights - MediciNova, Inc. has successfully enrolled the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial for MN-166 (ibudilast), aimed at treating Amyotrophic Lateral Sclerosis (ALS) [1][2] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a pipeline that includes 11 clinical programs [4] - The lead asset, MN-166 (ibudilast), is in late-stage clinical development for ALS and other neurodegenerative conditions, and is also being evaluated for Long COVID and substance dependence [4] Product Details - MN-166 (ibudilast) is a small molecule that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, and is being developed for various conditions including ALS, progressive multiple sclerosis, and glioblastoma [3] - The COMBAT-ALS study has enrolled participants across multiple sites in the US and Canada, indicating a broad collaborative effort [2]

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents MediciNova's unaudited condensed consolidated financial statements and management's analysis of financial condition [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS](index=5&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) Presents MediciNova's unaudited condensed consolidated financial statements, detailing balance sheets, operations, equity, cash flows, and related accounting notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Provides a snapshot of the company's assets, liabilities, and equity at specific reporting dates | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------------- | :------------------ | :---------------------- | | Cash and cash equivalents | $34,259,637 | $40,359,738 | | Total current assets | $35,123,834 | $41,074,279 | | Total assets | $49,823,875 | $55,875,926 | | Total current liabilities | $2,648,176 | $2,959,123 | | Total liabilities | $2,967,006 | $3,372,375 | | Total stockholders' equity | $46,856,869 | $52,503,551 | - Cash and cash equivalents decreased by approximately **$6.1 million** from December 31, 2024, to June 30, 2025[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's revenues, expenses, and net loss over specific reporting periods | Metric (Three months ended June 30) | 2025 (USD) | 2024 (USD) | | :---------------------------------- | :------------ | :------------ | | Revenues | $134,599 | $0 | | Operating expenses | $3,741,691 | $3,046,496 | | Operating loss | $(3,607,092) | $(3,046,496) | | Net loss | $(3,281,185) | $(2,628,200) | | Basic and diluted net loss per share| $(0.07) | $(0.05) | | Metric (Six months ended June 30) | 2025 (USD) | 2024 (USD) | | :---------------------------------- | :------------ | :------------ | | Revenues | $134,599 | $0 | | Operating expenses | $6,944,201 | $6,182,489 | | Operating loss | $(6,809,602) | $(6,182,489) | | Net loss | $(6,145,305) | $(5,382,718) | | Basic and diluted net loss per share| $(0.13) | $(0.11) | - Revenues increased to **$0.13 million** for both the three and six months ended June 30, 2025, from zero in the prior year periods, primarily due to a new agreement with Mayo Foundation for Medical Education and Research[17](index=17&type=chunk)[79](index=79&type=chunk)[84](index=84&type=chunk) - Net loss increased for both the three-month and six-month periods ended June 30, 2025, compared to 2024, driven by higher operating expenses, particularly in research, development, and patents[17](index=17&type=chunk)[81](index=81&type=chunk)[86](index=86&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Outlines changes in the company's equity due to net loss, share-based compensation, and other transactions | Metric (Six Months Ended June 30) | 2025 (USD) | 2024 (USD) | | :-------------------------------- | :------------ | :------------ | | Balance at December 31 | $52,503,551 | $62,378,424 | | Share-based compensation | $490,840 | $422,885 | | Net loss | $(6,145,305) | $(5,382,718) | | Balance at June 30 | $46,856,869 | $57,405,154 | - Total stockholders' equity decreased from **$52.5 million** at December 31, 2024, to **$46.9 million** at June 30, 2025, primarily due to the net loss incurred during the period[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Reports the cash inflows and outflows from operating, investing, and financing activities | Metric (Six months ended June 30) | 2025 (USD) | 2024 (USD) | | :-------------------------------- | :------------ | :------------ | | Net cash used in operating activities | $(6,090,067) | $(6,679,178) | | Net cash used in investing activities | $0 | $(891) | | Effect of exchange rate changes | $(10,034) | $18,451 | | Net change in cash and cash equivalents | $(6,100,101) | $(6,661,618) | | Cash and cash equivalents, end of period | $34,259,637 | $44,337,824 | - Net cash used in operating activities decreased by **$0.6 million** for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to changes in operating assets and liabilities[22](index=22&type=chunk)[89](index=89&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of accounting policies, significant transactions, and financial statement items - MediciNova, Inc. is a biopharmaceutical company focused on developing novel therapeutics for serious diseases with unmet medical needs, primarily MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic and metabolic disorders[25](index=25&type=chunk)[68](index=68&type=chunk) - The company has incurred net losses since its inception and expects to continue incurring substantial net losses as it advances its clinical trial programs[28](index=28&type=chunk)[69](index=69&type=chunk) [1. Interim Financial Information](index=10&type=section&id=1.%20Interim%20Financial%20Information) Outlines the company's business focus, financial statement basis, liquidity, and key accounting policies - MediciNova's primary development focus is on MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic and metabolic disorders[25](index=25&type=chunk)[68](index=68&type=chunk) - The company had **$34.3 million** in cash and cash equivalents as of June 30, 2025, and believes it has sufficient cash for at least the next 12 months, but expects to require additional capital for future clinical trial programs[28](index=28&type=chunk)[90](index=90&type=chunk) - The company operates in a single operating segment: the acquisition and development of small molecule therapeutics for serious diseases with unmet medical needs[30](index=30&type=chunk) [2. Revenue Recognition](index=14&type=section&id=2.%20Revenue%20Recognition) Details the company's revenue recognition policy, primarily from R&D services, including a new Mayo agreement - MediciNova recognized **$0.1 million** in revenue for the three and six months ended June 30, 2025, from an agreement with Mayo Foundation for Medical Education and Research to support clinical research services for MN-166 (ibudilast) in ALS[42](index=42&type=chunk)[79](index=79&type=chunk)[84](index=84&type=chunk) [3. Fair Value Measurements](index=14&type=section&id=3.%20Fair%20Value%20Measurements) Describes the fair value hierarchy for financial instruments, classifying mutual funds as Level 1 | Financial Instrument | June 30, 2025 (Carrying Amount USD) | June 30, 2025 (Fair Value USD) | December 31, 2024 (Carrying Amount USD) | December 31, 2024 (Fair Value USD) | Valuation Inputs | | :------------------- | :---------------------------------- | :----------------------------- | :-------------------------------------- | :------------------------------- | :--------------- | | Mutual funds | $31,972,516 | $31,972,516 | $21,501,081 | $21,501,081 | Level 1 | [4. Commitments and Contingencies](index=15&type=section&id=4.%20Commitments%20and%20Contingencies) Details lease commitments, potential milestone payments, and confirms no material legal proceedings | Lease Liability Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--------------------- | :------------------ | :---------------------- | | Current operating lease liabilities | $184,842 | $193,769 | | Non-current operating lease liabilities | $117,038 | $211,460 | | Total operating lease liabilities | $301,880 | $405,229 | | Weighted-average remaining lease term (years) | 1.57 | 1.98 | | Weighted-average discount rate | 9.6% | 9.6% | - Future potential milestone payments for MN-166 (ibudilast) and MN-001 (tipelukast) are **$10 million**, with an additional **$16.5 million** for other products, as of June 30, 2025[48](index=48&type=chunk) [5. Stock-based Compensation](index=16&type=section&id=5.%20Stock-based%20Compensation) Describes equity incentive plans, stock option activity, and recognized compensation expense | Stock Option Activity (Six months ended June 30, 2025) | Number of Option Shares | Weighted Average Exercise Price (USD) | | :----------------------------------------------------- | :---------------------- | :------------------------------------ | | Outstanding at December 31, 2024 | 7,040,894 | $5.12 | | Granted | 1,380,500 | $2.00 | | Cancelled | (512,000) | $2.84 | | Outstanding at June 30, 2025 | 7,909,394 | $4.73 | | Exercisable at June 30, 2025 | 6,678,933 | $5.22 | | Stock-based Compensation Expense (Six months ended June 30) | 2025 (USD) | 2024 (USD) | | :---------------------------------------------------------- | :---------- | :---------- | | Research, development and patents | $196,273 | $160,218 | | General and administrative | $294,567 | $262,667 | | Total stock-based compensation expense | $490,840 | $422,885 | - As of June 30, 2025, 2,025,173 shares remain available for future grants under the 2023 Plan[52](index=52&type=chunk) [6. Stockholders' Equity](index=19&type=section&id=6.%20Stockholders'%20Equity) Discusses the At-The-Market (ATM) Issuance Sales Agreement and its usage - The company has an ATM Agreement allowing it to sell common stock up to an aggregate offering price of **$75.0 million** through B. Riley FBR, Inc[60](index=60&type=chunk)[91](index=91&type=chunk) - No shares of common stock were sold under the ATM Agreement during the three and six months ended June 30, 2025, or 2024[61](index=61&type=chunk)[92](index=92&type=chunk) [7. Net Loss Per Share](index=19&type=section&id=7.%20Net%20Loss%20Per%20Share) Explains the calculation of basic and diluted net loss per share, excluding anti-dilutive options | Potentially Dilutive Stock Options Excluded | June 30, 2025 | June 30, 2024 | | :------------------------------------------ | :------------ | :------------ | | Three months ended | 7,909,394 | 8,431,644 | | Six months ended | 7,909,394 | 8,431,644 | [8. Subsequent Events](index=19&type=section&id=8.%20Subsequent%20Events) Discloses the Standby Equity Purchase Agreement (SEPA) with Yorkville for future equity sales - On July 30, 2025, MediciNova entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville, allowing the company to sell up to **$30.0 million** of its common stock over 36 months[64](index=64&type=chunk) - The SEPA includes a Nasdaq Exchange Cap, limiting the issuance to 19.99% of outstanding shares unless stockholder approval is obtained or the average price per share meets a specified threshold[64](index=64&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=17&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Provides management's perspective on MediciNova's financial condition, operational results, and strategic development goals - MediciNova's strategy focuses on advancing MN-166 (ibudilast) for multiple indications and MN-001 (tipelukast) for fibrotic and other diseases, seeking non-dilutive financings and strategic partnerships[70](index=70&type=chunk) - The company expects to increase research, development, and patent costs through the remainder of 2025 as development programs progress[71](index=71&type=chunk) [Overview](index=20&type=section&id=Overview) Introduces MediciNova's biopharmaceutical focus and accumulated deficit - MediciNova is a biopharmaceutical company focused on developing novel therapeutics for serious diseases with unmet medical needs, specifically MN-166 (ibudilast) and MN-001 (tipelukast)[68](index=68&type=chunk) - The company has an accumulated deficit of **$432.9 million** as of June 30, 2025, and anticipates substantial net losses for the next several years[69](index=69&type=chunk) [Research, Development and Patents Expenses](index=21&type=section&id=Research,%20Development%20and%20Patents%20Expenses) Details the company's expenditures on research, development, and patent activities | R&D Expense Category (Three months ended June 30) | 2025 (USD) | 2024 (USD) | | :------------------------------------------------ | :---------- | :---------- | | External development expense (MN-166) | $1,535,000 | $947,000 | | External development expense (MN-001) | $187,000 | $128,000 | | Total research, development and patent expense | $2,189,000 | $1,646,000 | | R&D Expense Category (Six months ended June 30) | 2025 (USD) | 2024 (USD) | | :------------------------------------------------ | :---------- | :---------- | | External development expense (MN-166) | $2,618,000 | $2,011,000 | | External development expense (MN-001) | $406,000 | $222,000 | | Total research, development and patent expense | $4,028,000 | $3,428,000 | - Research, development and patents expenses increased by **$0.6 million** for both the three and six months ended June 30, 2025, primarily due to increased MN-166 related expenses (MRC-001 PK study and DCM study) and MN-001 clinical trial expenses, partially offset by decreased MN-166 manufacturing costs and payroll[81](index=81&type=chunk)[86](index=86&type=chunk) [General and Administrative Expenses](index=21&type=section&id=General%20and%20Administrative%20Expenses) Reports the company's general and administrative operational costs - General and administrative expenses remained stable at **$1.4 million** for the three months and **$2.8 million** for the six months ended June 30, 2025, compared to the same periods in 2024[82](index=82&type=chunk)[87](index=87&type=chunk) [Critical Accounting Estimates](index=21&type=section&id=Critical%20Accounting%20Estimates) Confirms no material changes to critical accounting policies from the prior annual report - There have been no material changes to the critical accounting policies discussed in the Annual Report on Form 10-K for the year ended December 31, 2024[76](index=76&type=chunk) [IPR&D and Goodwill](index=23&type=section&id=IPR%26D%20and%20Goodwill) Discusses the annual impairment testing for goodwill and indefinite-lived intangible assets - Goodwill and indefinite-lived intangible assets are tested annually for impairment, with a qualitative assessment as of December 31, 2024, indicating no impairment[77](index=77&type=chunk)[78](index=78&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Compares financial performance for the three and six months ended June 30, 2025 and 2024 [Comparison of the three months ended June 30, 2025 and 2024](index=23&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030,%202025%20and%202024) Compares key financial metrics for the three-month periods, highlighting revenue and expense changes | Metric (Three months ended June 30) | 2025 (USD) | 2024 (USD) | Change (USD) | | :---------------------------------- | :------------ | :------------ | :------------ | | Revenues | $134,599 | $0 | +$134,599 | | Cost of Services | $116,349 | $0 | +$116,349 | | Research, Development and Patents | $2,188,652 | $1,646,049 | +$542,603 | | General and Administrative | $1,436,690 | $1,400,447 | +$36,243 | | Interest Income | $324,955 | $435,351 | -$(110,396) | - The increase in revenues and cost of services is attributed to the new agreement with Mayo, which began principal services in April 2025[79](index=79&type=chunk)[80](index=80&type=chunk) - Interest income decreased due to a lower cash balance generating interest[83](index=83&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030,%202025%20and%202024) Compares key financial metrics for the six-month periods, detailing revenue and expense changes | Metric (Six months ended June 30) | 2025 (USD) | 2024 (USD) | Change (USD) | | :-------------------------------- | :------------ | :------------ | :------------ | | Revenues | $134,599 | $0 | +$134,599 | | Cost of Services | $116,349 | $0 | +$116,349 | | Research, Development and Patents | $4,028,454 | $3,427,918 | +$600,536 | | General and Administrative | $2,799,398 | $2,754,571 | +$44,827 | | Interest Income | $661,066 | $832,861 | -$(171,795) | - The increase in R&D expenses for the six-month period was primarily due to MN-166 (MRC-001 PK and DCM studies) and MN-001 clinical trial expenses, partially offset by reduced MN-166 manufacturing costs and payroll[86](index=86&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, working capital, and ability to fund future operations - Net cash used in operating activities decreased to **$6.1 million** for the six months ended June 30, 2025, from **$6.7 million** in the prior year, mainly due to changes in operating assets and liabilities[89](index=89&type=chunk) - As of June 30, 2025, the company had **$34.3 million** in cash and cash equivalents and **$32.5 million** in working capital, which is believed to be sufficient to fund operations through at least August 2026[90](index=90&type=chunk) [Equity Financing](index=24&type=section&id=Equity%20Financing) Discusses the company's At-The-Market (ATM) equity sales agreement - No shares were sold under the At-The-Market (ATM) Agreement during the three and six months ended June 30, 2025, or 2024[92](index=92&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=25&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) States that there are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[93](index=93&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=25&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Confirms effective disclosure controls and procedures with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[96](index=96&type=chunk) - There have been no material changes in internal control over financial reporting during the most recent fiscal quarter[97](index=97&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) Provides additional information including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=26&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) States MediciNova is not involved in any material legal proceedings as of June 30, 2025 - MediciNova is not involved in any material legal proceedings as of June 30, 2025[100](index=100&type=chunk) [ITEM 1A. RISK FACTORS](index=26&type=section&id=ITEM%201A.%20RISK%20FACTORS) Refers to previously disclosed risk factors with no material changes reported - There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[101](index=101&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=26&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Indicates no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities and use of proceeds to report[102](index=102&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=26&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) States there were no defaults upon senior securities to report - No defaults upon senior securities to report[102](index=102&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=26&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) Indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[102](index=102&type=chunk) [ITEM 5. OTHER INFORMATION](index=26&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Reports no officer or director trading arrangement adoptions or terminations during the quarter - 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 June 30, 2025[102](index=102&type=chunk) [ITEM 6. EXHIBITS](index=27&type=section&id=ITEM%206.%20EXHIBITS) Lists exhibits filed with the Quarterly Report, including certifications and XBRL documents - The report includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act of 2002[104](index=104&type=chunk) [SIGNATURES](index=28&type=section&id=SIGNATURES) Confirms the official signing of the report by the company's principal executive and financial officers - The report is signed by Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer, and Jason Kruger, Chief Financial Officer, on August 14, 2025[109](index=109&type=chunk)

Core Viewpoint - MediciNova, Inc. has announced a Standby Equity Purchase Agreement (SEPA) allowing the company to raise up to $30 million in common stock over 36 months to support its R&D initiatives and general corporate activities [1][2][3]. Group 1: SEPA Details - The SEPA allows MediciNova to sell its common stock at a price equal to 97% of the market price, with the right to sell up to 100% of the daily trading volume during the five days prior to the transaction [2][4]. - The proceeds from the SEPA will be utilized to advance R&D programs and for general corporate purposes [2][3]. Group 2: Company Strategy and Focus - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for serious diseases with unmet medical needs, primarily targeting the U.S. market [5]. - The company is concentrating its development efforts on MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic and metabolic disorders [5].

Core Insights - MediciNova, Inc. is nearing completion of patient randomization in its Phase 2/3 COMBAT-ALS trial, with only single-digit enrollment remaining [2][3] - The company is also seeking the final two patients for its Phase 2 trial targeting dyslipidemia and fatty liver disease in type 2 diabetes patients [2][3] - The COMBAT-ALS program has generated significant interest within the ALS community, and the company is preparing for regulatory discussions with the FDA, expecting top-line data by the end of next year [3] MediciNova's Development Programs - MN-166 (ibudilast) is in late-stage clinical development for neurodegenerative diseases, including ALS, and has received Orphan Drug Designation and Fast Track Designation from the FDA [4] - MN-001 (tipelukast) is being developed for fibrotic and metabolic disorders, showing promise in down-regulating genes that promote fibrosis and inflammation [5] - The company focuses on addressing unmet medical needs in difficult-to-treat conditions through its development activities [6] Funding and Strategic Development - MediciNova's strategy includes advancing its pipeline through various funding sources, including investigator-sponsored trials, government grants, and strategic alliances [7]

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)](index=6&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20(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](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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) | $(426,751,242) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) Outlines MediciNova's financial performance, including operating expenses, interest income, and net loss for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three months ended March 31, 2025 ($) | 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) | $(2,763,410) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS'%20EQUITY) Details changes in MediciNova's stockholders' equity, including share-based compensation, net loss, and foreign currency adjustments for Q1 2025 and Q1 2024 Changes in Stockholders' Equity | Metric | Balance at Dec 31, 2024 ($) | 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) | $59,830,444 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Presents MediciNova's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Cash Flows | Metric | Three months ended March 31, 2025 ($) | 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](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for MediciNova's condensed consolidated financial statements, covering accounting policies and financial items [1. Interim Financial Information](index=10&type=section&id=1.%20Interim%20Financial%20Information) 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](index=25&type=chunk) - The company operates as a single operating segment focused on the acquisition and development of small molecule therapeutics[29](index=29&type=chunk) - Research and development costs, including patent-related expenses, are expensed in the period incurred[32](index=32&type=chunk)[33](index=33&type=chunk) - 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](index=37&type=chunk)[38](index=38&type=chunk) [2. Revenue Recognition](index=14&type=section&id=2.%20Revenue%20Recognition) 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](index=39&type=chunk) [3. Fair Value Measurements](index=14&type=section&id=3.%20Fair%20Value%20Measurements) 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](index=40&type=chunk)[41](index=41&type=chunk) Fair Value of Mutual Funds | | March 31, 2025 ($) | December 31, 2024 ($) | Valuation Inputs | | :---------- | :------------- | :---------------- | :--------------- | | Mutual funds | $21,728,258 | $21,501,081 | Level 1 | [4. Commitments and Contingencies](index=16&type=section&id=4.%20Commitments%20and%20Contingencies) Outlines MediciNova's operating lease liabilities, potential milestone payments, and confirms no material legal proceedings - The company has operating leases for real estate in the United States and Japan, including a new Tokyo office lease effective June 2024[43](index=43&type=chunk) Operating Lease Liabilities | Metric | March 31, 2025 ($) | 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 **$16.5 million** as of March 31, 2025[46](index=46&type=chunk) - The company is not aware of any material legal proceedings or claims that would adversely affect its business[47](index=47&type=chunk) [5. Stock-based Compensation](index=17&type=section&id=5.%20Stock-based%20Compensation) Discusses MediciNova's equity incentive plan, performance options, stock-based compensation expense, and unamortized compensation cost - The 2023 Equity Incentive Plan is the successor to the 2013 Plan, with **2,025,173 shares** remaining available for future grants as of March 31, 2025[49](index=49&type=chunk)[50](index=50&type=chunk) - As of March 31, 2025, **1,030,000 shares** underlying performance options were subject to vesting based on the achievement of corporate objectives and employee performance for 2025[51](index=51&type=chunk) Stock-based Compensation Expense | Expense Category | Three months ended March 31, 2025 ($) | 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](index=56&type=chunk) [6. Stockholders' Equity](index=20&type=section&id=6.%20Stockholders'%20Equity) 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 **$75.0 million** in common stock sales, but no shares were sold under this agreement in the three months ended March 31, 2025, or 2024[58](index=58&type=chunk)[59](index=59&type=chunk) [7. Net Loss Per Share](index=20&type=section&id=7.%20Net%20Loss%20Per%20Share) Presents MediciNova's basic and diluted net loss per common share and the exclusion of anti-dilutive stock options Net Loss Per Common Share | Metric | Three months ended March 31, 2025 ($) | 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](index=61&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=21&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management's analysis of MediciNova's financial performance, liquidity, and capital resources for the three months ended March 31, 2025 [Overview](index=21&type=section&id=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](index=65&type=chunk) - 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](index=67&type=chunk) - 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](index=66&type=chunk) [Research, Development and Patents Expenses](index=22&type=section&id=Research,%20Development%20and%20Patents%20Expenses) 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 | $1,782 | - Research, development and patents expenses remained relatively stable quarter-over-quarter, with an increase in MN-001 related expenses and stock option expense offset by decreased payroll costs from a reduction in headcount[76](index=76&type=chunk) [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses) Discusses MediciNova's general and administrative expenses, noting their stability and potential for future increases with business expansion General and Administrative Expenses | Expense Category | Three months ended March 31, 2025 ($) | 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](index=71&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) 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](index=72&type=chunk) - 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](index=73&type=chunk) [IPR&D and Goodwill](index=24&type=section&id=IPR%26D%20and%20Goodwill) 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](index=74&type=chunk) - A qualitative impairment assessment as of December 31, 2024, indicated no impairment for goodwill and indefinite-lived intangible assets[75](index=75&type=chunk) - 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](index=75&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) 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](index=24&type=section&id=Comparison%20of%20the%20three%20months%20ended%20March%2031,%202025%20and%202024) 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](index=76&type=chunk) - General and administrative expenses were **$1.4 million** for both the three months ended March 31, 2025 and 2024, also remaining relatively stable[77](index=77&type=chunk) Interest Income Comparison | Metric | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | Change ($) | | :------------- | :-------------------------------- | :-------------------------------- | :----- | | Interest income | $336,111 | $397,510 | $(61,399) | - The decrease in interest income was primarily driven by a decrease in the company's cash balance generating interest[78](index=78&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses MediciNova's cash position, working capital, and funding outlook, noting net cash used in operating activities and ATM agreement status Net Cash Used in Operating Activities | Metric | Three months ended March 31, 2025 ($) | 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](index=80&type=chunk) - 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](index=81&type=chunk)[82](index=82&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=26&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) 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](index=83&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=26&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) 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](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) 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](index=86&type=chunk) [Changes in Internal Control over Financial Reporting](index=26&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) 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](index=87&type=chunk) PART II. OTHER INFORMATION Presents additional information beyond financial statements, including legal proceedings, risk factors, and other disclosures [ITEM 1. LEGAL PROCEEDINGS](index=27&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) 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](index=90&type=chunk) [ITEM 1A. RISK FACTORS](index=27&type=section&id=ITEM%201A.%20RISK%20FACTORS) 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](index=91&type=chunk) - 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](index=91&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=27&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Reports no unregistered sales of equity securities or use of proceeds for the period - None to report[92](index=92&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=27&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Reports no defaults upon senior securities for the period - None to report[92](index=92&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=27&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) States that this item is not applicable to MediciNova's operations - Not applicable[92](index=92&type=chunk) [ITEM 5. OTHER INFORMATION](index=27&type=section&id=ITEM%205.%20OTHER%20INFORMATION) 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](index=92&type=chunk) [ITEM 6. EXHIBITS](index=28&type=section&id=ITEM%206.%20EXHIBITS) 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](index=94&type=chunk) 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](index=99&type=chunk)