Core Insights - MediciNova, Inc. has provided an update on its Phase 2b/3 clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS), known as the COMBAT-ALS study, with results presented at the 36th International Symposium on ALS/MND [1][2] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a late-stage pipeline including MN-166 (ibudilast) and MN-001 (tipelukast) [4][6] Clinical Trial Update - The COMBAT-ALS trial has successfully randomized a total of 234 participants, completing enrollment in September 2025 [5] - The baseline characteristics of participants include a mean age of 60.6 years, with 36.8% female and 63.2% male, and a racial distribution predominantly Caucasian (90.2%) [5] - The mean ALSFRS-R score at screening was 40.6, indicating the severity of the disease among participants [5] Drug Development and Designation - MN-166 (ibudilast) has received Orphan Drug Designation and Fast Track Designation from the FDA, as well as Orphan Designation from the European Commission for ALS treatment [3][2] - The drug is also in late-stage development for other neurodegenerative diseases and conditions, including progressive multiple sclerosis and glioblastoma [3][4] Future Expectations - Top-line data from the COMBAT-ALS study is anticipated by the end of 2026, with the company expressing hope that MN-166 will provide a significant therapeutic advance for ALS patients [2]

Strengthening MN-001’s Scientific Foundation and Clinical OutlookLA JOLLA, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Dear Fellow Shareholders, Following the recent publication in the Journal of Atherosclerosis and Thrombosis, I would like to provide additional perspective on why this research represents a significant milestone for MediciNova and our MN-001 program. The study, conducted in collaboration with a leading Japanese academic research team, revealed a novel mechanism by MN-002, the primary metabol ...

Core Insights - MediciNova, Inc. has appointed Dr. Christopher D. Breder as Clinical and Regulatory Advisor to enhance its drug development programs and lead the Scientific Advisory Board [1][4] - Dr. Breder brings over two decades of experience, including significant roles at the FDA and contributions to the approval of therapies for neurological conditions [2][3] - The company is focused on developing innovative therapies for neurodegenerative diseases, with a strong pipeline including MN-166 and MN-001 [5] Company Overview - MediciNova is a clinical-stage biopharmaceutical company with a late-stage pipeline targeting inflammatory, fibrotic, and neurodegenerative diseases [5] - The lead asset, MN-166 (ibudilast), is 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) [5] - MN-001 (tipelukast) is currently in a Phase 2 trial for treating hypertriglyceridemia in type 2 diabetic patients [5] Leadership and Strategy - Dr. Breder's expertise in clinical trial design and regulatory strategy positions him to effectively guide MediciNova in advancing its pipeline [3] - The company aims to combine rigorous science with patient-centered design to accelerate meaningful outcomes in neurodegenerative disease therapies [4]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $123,319, compared to $0 for the same period in 2024, indicating a significant increase[17]. - The net loss for the nine months ended September 30, 2025, was $9,195,678, compared to a net loss of $8,234,897 for the same period in 2024, representing an increase in loss of about 11.7%[17]. - The segment and consolidated net loss for the nine months ended September 30, 2025, was $(9,195,678), compared to $(8,234,897) for the same period in 2024[30]. - Revenues for the three months ended September 30, 2025, were $0.1 million, an increase from $0.0 million in 2024, attributed to the agreement with Mayo[79]. - Revenues for the nine months ended September 30, 2025, were $0.3 million, an increase from $0.0 million in 2024, attributed to the Mayo agreement[84]. Operating Expenses - Operating expenses for the nine months ended September 30, 2025, totaled $10,448,518, up from $9,491,617 in 2024, reflecting a year-over-year increase of approximately 10.1%[17]. - Total operating expenses for the three months ended September 30, 2025, were $3,504,317, an increase from $3,309,128 in 2024, resulting in an operating loss of $(3,380,998) for 2025[30]. - General and administrative expenses increased to $1.8 million for the three months ended September 30, 2025, from $1.4 million in 2024, primarily due to upfront costs associated with the SEPA[82]. - General and administrative expenses increased to $4.6 million in 2025 from $4.2 million in 2024, primarily due to SEPA fees and professional expenses[87]. Cash and Assets - Cash and cash equivalents decreased to $32,562,612 as of September 30, 2025, down from $40,359,738 at the end of 2024, a decline of approximately 19.3%[16]. - Total assets decreased to $47,578,388 as of September 30, 2025, from $55,875,926 at December 31, 2024, a reduction of about 15%[16]. - The Company had $32.6 million in cash and cash equivalents as of September 30, 2025, which is expected to meet funding requirements for at least the next 12 months[27]. - As of September 30, 2025, available cash and cash equivalents were $32.6 million, with working capital of $29.6 million, sufficient to fund operations at least through November 2026[90]. Equity and Stock Options - The company’s total stockholders' equity decreased to $43,964,756 as of September 30, 2025, from $52,503,551 at December 31, 2024, a decline of about 16.3%[16]. - The accumulated deficit as of September 30, 2025, was $435.9 million, with expectations of substantial net losses continuing for several years[69]. - As of September 30, 2025, there are 2,032,173 shares available for future grants under the 2023 Equity Incentive Plan[51]. - The Company granted 1,380,500 stock options under the 2023 Plan, with an exercise price of $2.00[55]. - The Company has a total of 970,000 shares underlying performance options subject to vesting based on corporate objectives for 2025[52]. Research and Development - Research, development, and patents expenses for the nine months ended September 30, 2025, were $5,611,429, compared to $5,287,318 in 2024, reflecting an increase of approximately 6.1%[17]. - Research and development costs for the three months ended September 30, 2025, totaled $1,523,489, compared to $1,643,659 in 2024, while total research and development costs for the nine months ended September 30, 2025, were $5,355,670, up from $4,911,359 in 2024[30][33]. - Research, development, and patents expenses for the three months ended September 30, 2025, were $1.6 million, a decrease of $0.3 million from $1.9 million in 2024[81]. - Research, development, and patents expenses rose to $5.6 million in 2025 from $5.3 million in 2024, driven by increased expenses for MN-166 and clinical trials[86]. Future Outlook - The Company expects to continue incurring losses and will require additional capital to advance its clinical trial programs[27]. - The Company has incurred net losses since inception and has negative operating cash flows[27]. - The Company entered into a Standby Equity Purchase Agreement (SEPA) allowing it to sell up to $30.0 million of common stock over 36 months[61]. - The company does not expect any material changes in risk factors affecting its business from those previously disclosed[106].

Core Insights - MediciNova, Inc. has been awarded the "Contract Research and Development Innovation Award" at the Fifth Annual BioTech Breakthrough Awards for its innovative work on MN-166 (ibudilast) [1][2][3] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [4] - The company has a late-stage pipeline that includes 11 clinical programs, with MN-166 being the lead asset currently in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) [4] - MN-166 is also being evaluated in Phase 2 trials for Long COVID and substance dependence, while MN-001 (tipelukast) is in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and non-alcoholic fatty liver disease (NAFLD) [4] Product Development - MN-166 is designed to inhibit neuroinflammation and promote neuroprotection, targeting several neurological diseases with limited treatment options, including ALS [2][3] - The ongoing Phase 2/3 COMBAT-ALS trial of MN-166 reflects the company's commitment to addressing unmet medical needs in ALS [3] Industry Recognition - The BioTech Breakthrough Awards program recognizes innovative companies and technologies in the life sciences and biotechnology sectors, highlighting excellence in biopharma, therapeutics, genomics, diagnostics, and research tools [3]

Core Insights - MediciNova, Inc. has completed patient enrollment for its Phase 2 clinical trial, MN-001-NATG-202, which is evaluating MN-001 (Tipelukast) for treating hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD) associated with Type 2 diabetes (T2DM) [1][2] Group 1: Clinical Trial Details - The MN-001-NATG-202 study is a multi-center, randomized, double-blind, placebo-controlled trial with a 1:1 randomization to receive either 500 mg/day of MN-001 or placebo for 24 weeks [2] - Co-primary endpoints include changes in liver fat content measured by controlled attenuation parameter (CAP) score and fasting serum triglycerides at Week 24 [2] - Top-line data from the trial is expected by summer 2026 [2] Group 2: About MN-001 - MN-001 (Tipelukast) is a novel, orally bioavailable small molecule that exhibits anti-inflammatory and anti-fibrotic activity through multiple mechanisms, including leukotriene receptor antagonism and inhibition of phosphodiesterase [3] - The compound has shown potential in down-regulating genes that promote fibrosis and inflammation, as well as inhibiting triglyceride synthesis in hepatocytes [3] Group 3: Disease Context - Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance, which contributes to dyslipidemia, including hypertriglyceridemia and hypercholesterolemia, increasing the risk of cardiovascular complications and liver-related conditions like NAFLD [4] - NAFLD is frequently associated with T2DM and dyslipidemia, highlighting the importance of addressing lipid abnormalities in these patients [4] Group 4: Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company with a late-stage pipeline focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [5] - The company has 11 programs in clinical development, with its lead asset, MN-166 (Ibudilast), currently in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) [5]

Core Insights - A study published in the Journal of Atherosclerosis and Thrombosis indicates that tipelukast (MN-001) and its metabolite MN-002 positively influence cholesterol metabolism in patients [1][2] Company Overview - MediciNova, Inc. is a biopharmaceutical company listed on NASDAQ (MNOV) and the Tokyo Stock Exchange (Code Number: 4875) [1] - The company is focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a pipeline that includes 11 clinical programs [5] Research Findings - The study titled "Enhancement of ABCA1 and ABCG1 Expression and Cholesterol Efflux by a Metabolite of Tipelukast" shows that MN-002 significantly enhances cholesterol efflux in macrophages by upregulating transport proteins ABCA1 and ABCG1 [2] - These findings suggest a new mechanism of action for potential therapeutic strategies against atherosclerosis and other metabolic disorders [2][3] Clinical Development - Previous clinical studies indicated that MN-001 improved serum lipid profiles in patients with Non-alcoholic fatty liver disease (NAFLD) and hypertriglyceridemia, especially in those with type 2 diabetes [4] - MediciNova is conducting a randomized, placebo-controlled, double-blind Phase 2 study in patients with hypertriglyceridemia, Type 2 diabetes, and NAFLD, with enrollment nearing completion [4]

Core Viewpoint - MediciNova, Inc. is actively engaging with investors by presenting a corporate overview at the LD Micro Main Event XIX Investor Conference, highlighting its ongoing clinical developments and future prospects [1][2]. 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 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 has been evaluated in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF) and is currently undergoing a second Phase 2 trial for non-alcoholic fatty liver disease (NAFLD) [3]. Conference Details - The presentation at the LD Micro Main Event XIX is scheduled for October 20, 2025, at 1:30 PM Pacific Time [2]. - A live webcast of the presentation will be available on the investor relations section of the MediciNova website, with a replay accessible for 90 days post-event [2]. - Drs. Iwaki and Crean will be available for one-on-one meetings throughout the conference, providing opportunities for direct engagement with investors [2].

Core Insights - MediciNova, Inc. has successfully completed patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, for MN-166 (ibudilast) targeting Amyotrophic Lateral Sclerosis (ALS) with 234 patients randomized across two treatment arms [1][2][3] Company Overview - MediciNova, Inc. 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 [7] - The lead asset, MN-166 (ibudilast), is in late-stage clinical development for ALS and other neurodegenerative conditions, and has received Orphan Drug Designation and Fast Track Designation from the FDA [4][7] Clinical Trial Details - The COMBAT-ALS study is a randomized, double-blind, placebo-controlled trial assessing the efficacy, safety, and tolerability of MN-166 over a 12-month treatment period, followed by a 6-month open-label treatment period [2][3] - The primary endpoint is the Combined Assessment of Function and Survival (CAFS), with secondary endpoints including ALSFRS-R score progression and quality of life assessments, with top-line data expected by the end of 2026 [3] Drug Mechanism and Previous Results - MN-166 (ibudilast) is designed to modulate neuroinflammation and oxidative stress pathways, and has shown promising results in preclinical models and earlier Phase 1/2 studies, indicating a favorable safety profile [2][4] - The compound also targets multiple conditions, including progressive multiple sclerosis and glioblastoma, showcasing its broad therapeutic potential [6][7]

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]