SANTA CLARA, California — July 10, 2025: In March of this year, WideTrial launched an Expanded Access program (EAP) in ALS in partnership with a large academic medical center. This EAP – "Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers in ALS" (SEANOBI-ALS) -- provides MN-166 (ibudilast) to people with ALS who cannot take part in regular clinical trials. To support this program, the National Institute of Neurological Disorders and Stroke (NINDS) has awarded the EAP’s Sponsor --the academic medical center-- a grant under the ACT For ALS of 2021.

The NINDS grant allows SEANOBI-ALS to include a total 200 patients, enrolled across multiple ALS clinics in the U.S. over a 4-year period, with each participating patient receiving MN-166 for a duration of up to 6 months.

The first treatment location, Mayo Clinic Jacksonville, has enrolled 15 patients as of the end of June 2025. Two (2) additional locations, Mayo Clinic Rochester and Mayo Clinic Arizona, will begin enrolling patients in July. Five (5) more clinical sites have been invited to join and each of the five has begun the onboarding process. An additional eight (8) pre-selected clinics will be invited this summer, and each clinic that completes its onboarding steps by the end of 2025 will be granted openings for at least 5 patients. The list of clinics to be invited in 2025 includes all nine (9) U.S. sites of the COMBAT-ALS Phase 2/3 research trial for MN-166.

As expected, the demand for access to this EAP far surpasses the budgeted capacity of 200 patients. Therefore, WideTrial and the Sponsor continue to work together to get the program scope increased. This includes continuous dialog with the outside parties who determine the maximum number of patients and the duration of treatment permitted under this EAP.

Although each participating clinic makes its own enrollment decisions, WideTrial will provide participating clinics with the contact details of patients in their region who have expressed interest via the WideTrial website and who have consented to information sharing.

About EAPs: Expanded Access programs (EAPs) are a type of FDA-authorized clinical trial that prioritizes experimental treatment access for patients with serious conditions who lack other meaningful, potentially disease-modifying treatment options – particularly patients who cannot get into research trials of new medicines due to inclusion/exclusion criteria or difficulty traveling to trial sites.

About this EAP: SEANOBI-ALS was designed for swift activation of participating clinics and minimal-burden on clinical staff, in comparison to research trials. This program’s secondary objective is to generate valuable data about the kinds of patients who may benefit most from the experimental treatment.

About WideTrial: WideTrial is an emerging company with the mission of making experimental treatment options accessible to all people with serious or life-threatening diseases. The team is personally aware of the devastating toll ALS takes on patients and families and is relentlessly committed to integrating well-managed EAPs into healthcare at meaningful scale.