ADDED
The number of outstanding shares of the registrant s common stock, par value $0.001 per share, as of March 5, 2026 was 49,221,246 .
Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and prevention of acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD), and hypertriglyceridemia.
In June 2019, we announced a kick-off meeting for the Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS, referred to as the COMBAT-ALS trial.
In September 2025, we announced the completion of patient enrollment in the COMBAT-ALS Phase 2/3 clinical trial, evaluating MN-166 (ibudilast) for the treatment of ALS.
A total of 234 patients have been randomized across two treatment arms at multiple clinical sites in the United States and Canada.
In December 2025, we announced the study update and patient characteristics of the COMBAT-ALS phase 2/3 clinical trial at the 36th International Symposium of ALS/MND at San Diego, California.
While it has been in use for more than 40 years in Japan and Korea for the treatment of asthma and post-stroke dizziness, we are developing MN-166 (ibudilast) for the treatment of progressive MS, ALS, degenerative cervical myelopathy, glioblastoma, and prevention of acute respiratory distress syndrome.
The FDA has granted Fast Track designations to MN-166 (ibudilast) for two separate indications: the treatment of progressive MS and the treatment of ALS.
patents that cover the use of MN-166 (ibudilast) for the treatment of progressive MS, for the treatment of ALS, and for the treatment of glioblastoma.
In December 2025, we announced the successful completion of patient enrollment in the COMBAT-ALS Phase 2/3 11 clinical trial, evaluating MN-166 (ibudilast) for the treatment of ALS.
REMOVED
The number of outstanding shares of the registrant s common stock, par value $0.001 per share, as of February 17, 2025 was 49,046,246 .
In June 2019, we announced a kick-off meeting for the Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS.
Substance Dependence and Addiction: In November 2017, we announced a collaboration with Oregon Health Science University to initiate a biomarker study for evaluating MN-166 (ibudilast) in methamphetamine use disorder and this trial is ongoing.
Investigators at Columbia University and the New York State Psychiatric Institute (NYSPI) previously completed a Phase 1b/2a clinical trial of MN-166 (ibudilast) in opioid withdrawal that was funded by National Institute Drug Abuse (NIDA).
Investigators at Columbia University and the NYSPI also conducted a NIDA-funded, Phase 2a clinical trial to evaluate the efficacy of MN-166 (ibudilast) in the treatment of patients addicted to prescription opioids or heroin.
In March 2016, we announced that positive findings from the results of this completed study in opioid dependence were presented at the Behavior, Biology and Chemistry: Translational Research in Addiction Meeting.
Researchers at University of California, Los Angeles (UCLA) were granted approval and funding by the National Institute on Alcoholism and Alcohol Abuse (NIAAA) for a clinical trial to evaluate MN-166 (ibudilast) for the treatment of alcohol dependence.
This clinical trial has been completed and results were presented at the American College of Neuropsychopharmacology (ACNP) s 54th Annual Meeting in December 2015.
In May 2018, we announced a new NIDA-funded clinical trial of MN-166 (ibudilast) in alcohol dependence and withdrawal in collaboration with researchers at UCLA.
This clinical trial has been completed and positive findings were presented at the American Psychological Association 2020 Annual Convention which was held online in August 2020.