LA JOLLA, Calif., Jan. 29, 2026 (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 that as of the end of January 2026, 12 sites in the US are activated and 100 patients have been enrolled in the SEANOBI study (Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS; NCT 06743776) representing 50% of the planned 200-enrollment, ev ...

Core Insights - MediciNova, Inc. has navigated a challenging 2025 marked by global uncertainty, achieving significant milestones including the completion of patient enrollment in three clinical trials and launching a large-scale Expanded Access Program for ALS [1] Clinical Development Highlights - MN-001 (tipelukast) Phase 2 trial for hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and Type 2 diabetes (T2DM) completed enrollment in November 2025, with top-line data expected in summer 2026 [3] - The COMBAT-ALS Study Phase 2b/3 trial for ALS completed enrollment in September 2025, with top-line results anticipated by year-end 2026 [7] - The Expanded Access Program for ALS, initiated in March 2025 with a $22 million NIH grant, has 12 active U.S. sites and 87 patients enrolled as of December 15, 2025 [7] - The OXTOX Study Phase 2b trial for chemotherapy-induced peripheral neuropathy in metastatic colon cancer completed enrollment in December 2025, with results timing yet to be determined [7] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases, with a strong pipeline based on MN-166 (ibudilast) and MN-001 (tipelukast) [5] - MN-166 is currently in Phase 3 for ALS and degenerative cervical myelopathy, and is Phase 3-ready for progressive multiple sclerosis [5]

Core Insights - Several small-cap biotech and healthcare companies experienced notable gains in after-hours trading, driven by recent corporate updates and clinical milestones Company Updates - Inspira Technologies Oxy B.H.N. Ltd. (IINN) rose 5.88% to $1.08 following a recent definitive agreement for a registered direct offering of its ordinary shares and a Standby Equity Purchase Agreement with YA II PN, Ltd. [2] - Galectin Therapeutics Inc. (GALT) increased by 1.79% to close at $6.27, despite no new corporate developments reported [3] - MediciNova, Inc. (MNOV) advanced 4.83% to $1.52 after successfully completing patient enrollment in its Phase 2 OXTOX study, evaluating MN-166 for chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [4] - Marker Therapeutics, Inc. (MRKR) gained 5.56% to $1.33 without any new company-specific announcements [5] - Sharps Technology, Inc. (STSS) climbed nearly 4% to $2.09, also without fresh updates [6] - DiaMedica Therapeutics Inc. (DMAC) rose 2.89% to $8.55 after a productive pre-IND meeting with the FDA regarding its planned study of DM199 in preeclampsia [6] - Corbus Pharmaceuticals Holdings, Inc. (CRBP) edged higher by 1.36% to $8.21, following the completion of its Phase 1a study of CRB-913 and initiation of the Phase 1b CANYON-1 trial [7] - ProMIS Neurosciences, Inc. (PMN) added 0.83% to $8.49, recovering slightly after a decline earlier in the day, with the completion of enrollment of 144 patients in its PRECISE-AD Phase 1b clinical trial for Alzheimer's disease [8]

Core Insights - MediciNova, Inc. has successfully completed patient enrollment in the Phase 2 clinical trial, OXTOX study, evaluating MN-166 (ibudilast) for preventing chemotherapy-induced peripheral neuropathy in metastatic colorectal cancer patients [1][2] Group 1: Clinical Trial Details - The OXTOX study is a randomized, placebo-controlled trial with 100 patients enrolled across 11 clinical sites in Australia [1] - Participants will continue chemotherapy along with either MN-166 or placebo until disease progression or unacceptable side effects, with the study concluding when the final patient reaches six months post-chemotherapy [2] Group 2: About MN-166 (ibudilast) - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for various neurodegenerative diseases, including ALS and progressive MS [3] - The compound has Orphan Drug Designation and Fast Track Status from the US FDA for ALS, and Orphan Drug Designation from the EMA [3] Group 3: About MediciNova - MediciNova is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [4] - The company has a strong pipeline, with MN-166 in Phase 3 for ALS and DCM, and MN-001 (tipelukast) in Phase 2 for treating hypertriglyceridemia in type 2 diabetic patients [4]

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]

Core Insights - The recent study published in the Journal of Atherosclerosis and Thrombosis highlights a novel mechanism by which MN-002, the primary metabolite of MN-001, enhances cholesterol efflux in macrophages, crucial for combating atherosclerosis and cardiovascular disease [1][2] - MN-001 shows potential in addressing multiple metabolic disorders, including hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes (T2DM), due to its multi-modal activity and strong safety profile [2][3] Clinical Progress and Future Steps - Patient enrollment for the Phase 2 trial (MN-001-NATG-202) in patients with hypertriglyceridemia and NAFLD due to T2DM has been completed, with top-line results expected by summer 2026 [3] - The combination of newly published mechanistic findings and upcoming trial results will guide the advancement of MN-001 as a potential first-in-class therapy for metabolic and cardiovascular diseases [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 strong pipeline including MN-166 (ibudilast) and MN-001 (tipelukast) [4]

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]