Core Insights - MediciNova, Inc. announced an update on the ongoing Phase 2/3 clinical trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) at the 2024 Annual NEALS Meeting [1] - The trial's Principal Investigator, Dr. Björn Oskarsson, presented details on study design, objectives, and enrollment updates as of October 18, 2024 [1] - MN-166 (ibudilast) is a small molecule compound targeting neurodegenerative diseases and is in late-stage development for ALS, progressive MS, and DCM [2][3] Company Overview - MediciNova is a clinical-stage biopharmaceutical company with a focus on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [3] - The company has 11 programs in clinical development, with MN-166 (ibudilast) being the lead asset currently in Phase 3 trials for ALS and DCM [3] - MN-001 (tipelukast), another compound in development, is undergoing Phase 2 trials for idiopathic pulmonary fibrosis and non-alcoholic fatty liver disease [3]

Core Points - MediciNova, Inc. has received a $22 million grant from the NIH to conduct an Expanded Access Protocol for MN-166 (ibudilast) in ALS patients [1][2][3] - The EAP will allow ALS patients not eligible for the COMBAT-ALS trial to access MN-166 and will evaluate neurofilament light as a biomarker for neuron damage [2][3] - MN-166 is in late-stage clinical development for various neurodegenerative diseases and has received Orphan Drug Designation and Fast Track Designation from the FDA [4][5][6] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory, fibrotic, and neurodegenerative diseases [6] - The company has a pipeline of 11 clinical programs, with MN-166 being its lead asset currently in Phase 3 trials for ALS and DCM [6] - MediciNova has a strong track record of securing government grants for clinical trials [6]

Core Insights - MediciNova, Inc. announced that an abstract regarding the clinical trial of MN-166 (ibudilast) for ALS has been selected for a poster presentation at the 35th International Symposium on ALS/MND in December 2024 [1] - 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 [2] - MediciNova has a broad late-stage pipeline with 11 clinical programs, focusing on inflammatory, fibrotic, and neurodegenerative diseases, with MN-166 being the lead asset [3] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [3] - The company has two main compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles [3] - MN-166 is currently in Phase 3 trials for ALS and degenerative cervical myelopathy, and is Phase 3-ready for progressive multiple sclerosis [3]

Core Insights - MediciNova, Inc. announced the acceptance of an abstract for the presentation of the COMBAT-ALS Phase 2b/3 study of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) at the 2024 Annual NEALS Meeting [1] - The presentation will be conducted by Dr. Björn Oskarsson, the lead Principal Investigator, on October 23, 2024 [2] - MN-166 (ibudilast) is a small molecule compound targeting neurodegenerative diseases and is in late-stage clinical development for ALS, progressive MS, and DCM, among others [2][3] Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company with a focus on developing novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [3] - The company has a pipeline of 11 clinical programs, with MN-166 (ibudilast) being the lead asset currently in Phase 3 trials for ALS and DCM [3] - MN-001 (tipelukast), another compound in development, has been evaluated in Phase 2 trials for idiopathic pulmonary fibrosis and is ongoing for metabolic-associated fatty liver disease [3]

Core Viewpoint - MediciNova, Inc. has received a Notice of Allowance for a patent covering MN-166 (ibudilast) for treating post-COVID conditions, which may provide therapeutic options for a range of symptoms experienced by patients recovering from COVID-19 [1][2]. Group 1: Patent and Drug Development - The patent allows for various administration methods of MN-166, including oral, intravenous, subcutaneous, intramuscular, and inhalation, with a wide range of dosing frequencies and treatment periods [2]. - The patent is expected to expire no earlier than November 2042, providing a long exclusivity period for the company [2]. - MN-166 is currently in late-stage clinical development for neurodegenerative diseases and is also being evaluated for Long COVID and other conditions [4][5]. Group 2: Clinical Trials and Collaborations - MediciNova is collaborating with the University Health Network in Canada for a Phase 2/3 clinical trial focused on Long COVID, indicating a commitment to addressing post-COVID health challenges [3]. - The company plans to apply for a New Drug Application contingent on positive outcomes from ongoing studies, demonstrating a proactive approach to drug development [3]. Group 3: Company Overview - MediciNova is a clinical-stage biopharmaceutical company with a pipeline of therapies targeting inflammatory, fibrotic, and neurodegenerative diseases, with 11 programs currently in clinical development [5]. - The lead asset, MN-166, is in Phase 3 trials for ALS and DCM, and is Phase 3-ready for progressive MS, showcasing the company's focus on serious health conditions [5].

Financial Performance - Total operating expenses for the three months ended June 30, 2024, were $3,046,496, a decrease of 7.7% compared to $3,300,030 for the same period in 2023[8]. - The net loss for the three months ended June 30, 2024, was $2,628,200, compared to a net loss of $2,871,820 for the same period in 2023, representing a reduction of 8.5%[8]. - Basic and diluted net loss per common share for the three months ended June 30, 2024, was $0.05, an improvement from $0.06 for the same period in 2023[8]. - Comprehensive loss for the three months ended June 30, 2024, was $2,632,745, compared to $2,876,033 for the same period in 2023, indicating a decrease of 8.5%[8]. - Net loss for the six months ended June 30, 2024, was $5,382,718, compared to a net loss of $5,789,324 for the same period in 2023, representing a decrease of approximately 7.0%[13]. Operating Expenses - Research, development, and patents expenses for the six months ended June 30, 2024, totaled $3,427,918, compared to $3,212,411 for the same period in 2023, reflecting an increase of 6.7%[8]. - General and administrative expenses for the six months ended June 30, 2024, were $2,754,571, down from $3,050,862 in the same period of 2023, a decrease of 9.7%[8]. - Non-cash stock-based compensation for the six months ended June 30, 2024, was $422,885, down from $728,973 in the same period of 2023, a decrease of about 42.0%[13]. - Stock-based compensation expense for the six months ended June 30, 2024, totaled $422,885, a decrease of 42% from $728,973 in the same period of 2023[47]. Cash and Cash Equivalents - Cash and cash equivalents at the end of the period were $44,337,824, down from $52,876,271 at the end of June 2023, indicating a decrease of about 16.2%[13]. - The company reported a net cash used in operating activities of $6,679,178 for the six months ended June 30, 2024, compared to $5,560,429 for the same period in 2023, an increase of approximately 20.1%[13]. Equity and Stockholder Information - The total stockholders' equity as of June 30, 2024, was $57,405,154, down from $70,242,035 as of June 30, 2023[9]. - The Company granted 1,100,000 stock options under the 2023 Plan, with a weighted average exercise price of $1.51[46]. - As of June 30, 2024, there were 1,502,923 shares available for future grants under the 2023 Equity Incentive Plan[43]. - The estimated fair value of stock options granted during the six months ended June 30, 2024, was $0.99 per option, compared to $1.60 per option in the same period of 2023[49]. Lease Liabilities - As of June 30, 2024, total operating lease liabilities amounted to $492,530, a decrease from $626,586 as of December 31, 2023, reflecting a reduction of approximately 21.4%[36]. - The Company’s current operating lease liabilities decreased from $215,926 as of December 31, 2023, to $190,047 as of June 30, 2024, reflecting a reduction of approximately 12%[36]. - Cash paid for operating lease liabilities for the six months ended June 30, 2024, was $128,833, compared to $127,391 for the same period in 2023, indicating a slight increase of 1.1%[36]. - The right-of-use asset obtained in exchange for operating lease liability was $42,281 for the six months ended June 30, 2024, compared to $139,001 in the same period of 2023, showing a decrease of about 69.6%[13]. - The weighted-average remaining lease term as of June 30, 2024, was 2.47 years, down from 2.81 years as of June 30, 2023[36]. - The total minimum lease payments for the remaining six months of 2024 are projected to be $109,879[36]. Strategic Focus - The company is focusing on developing MN-166 and MN-001 for various serious diseases, including progressive multiple sclerosis and nonalcoholic fatty liver disease, indicating a strategic emphasis on unmet medical needs[15]. - The company operates in a single segment focused on the acquisition and development of small molecule therapeutics for serious diseases[19]. Accounting and Compliance - The company is currently evaluating the potential impact of new accounting standards on its consolidated financial statements and related disclosures[28]. Investment and Financing - The company had no proceeds from the disposal of investments in the current period, contrasting with $39,929,015 in the previous year, indicating a significant change in investment strategy[13]. - The Company has an at-the-market issuance sales agreement allowing for the sale of common stock up to an aggregate offering price of $75.0 million[50]. - No shares of common stock were sold under the ATM Agreement in the six months ended June 30, 2024 and 2023[51]. Diluted Earnings Per Share - The basic net loss per share is computed using the weighted average number of common shares outstanding during the period[51]. - Diluted net loss per share includes potentially dilutive securities, with 8,431,644 shares excluded for the three and six months ended June 30, 2024 due to anti-dilutive effects[51]. - For the same period in 2023, 8,286,416 shares were excluded from the diluted net loss per share calculation due to anti-dilutive effects[51].

Company to rededicate efforts toward updating stakeholders on corporate vision, strategy, and ongoing activities MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development, two of which are the ...

Core Viewpoint - MediciNova, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering MN-166 (ibudilast) aimed at preventing metastasis in various cancers, which is a significant advancement for the company and its intellectual property portfolio [1][3]. Patent Details - The patent, once issued, is expected to expire no earlier than July 2042 and covers the use of MN-166 in combination with various therapies such as chemotherapy, immunotherapy, and radiotherapy [2]. - The claims specifically address the prevention, amelioration, or minimization of metastasis in cancers including pancreatic, lung, breast, colorectal, melanoma, and ovarian cancers, with provisions for oral administration and varying doses and treatment periods [2]. Product Information - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for neurodegenerative diseases and other conditions [4]. - The compound is in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is also being evaluated for Long COVID and substance use disorder [5]. Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company with a diverse late-stage pipeline focused on inflammatory, fibrotic, and neurodegenerative diseases, with 11 programs in clinical development [5]. - The company has a strong track record of securing investigator-sponsored clinical trials funded through government grants, enhancing its research capabilities and potential for future growth [5].

LA JOLLA, Calif., June 03, 2024 (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 MediciNova's collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudila ...

MediciNova's Dr. Huicheng Qi presented "MN-002, THE METABOLITE OF MN-001 (TIPELUKAST) PROMOTES MACROPHAGE CHOLESTEROL EFFLUX (Abstract # 856)", demonstrating positive data regarding cholesterol efflux capacity by MN-001 (Tipelukast) and MN-002. This is a collaborative effort between MediciNova and Professor Masatsune Ogura at Department of Clinical Laboratory Technology, Juntendo University and Professor Takashi Miida at Department of Clinical Laboratory Medicine, Juntendo University. Objectives of this stu ...