Appointment follows 12-month interim tenure of scientific, regulatory and commercial achievements for Phase 3 trial preparation in ALS

PALO ALTO, Calif., Nov. 13, 2026 /PRNewswire-PRWeb/ -- Neuvivo Inc., a late-stage biopharmaceutical company specializing in immunological treatments for neurodegenerative diseases, today announces it has appointed Mike McGrath MD, PhD. as permanent CEO.

The permanent appointment results from what Neuvivo has been able to achieve in Mike's 12-month tenure as interim CEO of Neuvivo, following his appointment by the Neuvivo Board of Directors in October 2025.

During his interim tenure, Neuvivo completed a retrospective analysis of two Phase 2 studies that transformed the company's development strategy. The analysis identified a subgroup of patients defined by slow disease progression and representing approximately 40% of people with ALS. In this subgroup, NP001 was associated with meaningful benefits in vital capacity, ALSFRS-R (a widely accepted clinical endpoint in ALS) and survival. The findings, published in Biomedicines (Goyal et al., 2025) and presented at the 36th International Symposium on ALS/MND, gave Neuvivo a clearly defined patient population and a path to a pivotal trial. Neuvivo then held a Type C meeting with the U.S. Food and Drug Administration (FDA), whose feedback supports a pivotal Phase 3 trial of NP001 in slow-progressing ALS.

As CEO, Mike's immediate forthcoming priorities are to complete the financing required for the Phase 3 trial, complete the identification of a CRO capable of running a Phase 3 trial for slow progressing ALS as an orphan indication. Mike will also lead the effort to participate in an application for grant funding awarded from The National Institute of Neurological Disorders and Stroke (NINDS) using the Accelerating Access to Critical Therapies for ALS Act to study NP001 in additional ALS patients.

Mike was selected as interim CEO from Chief Scientific Officer because of his 40-year research in the role of macrophages, the cornerstone of the innate immune system, in the pathogenesis of AIDS and ultimately ALS. He has also had 20 years of involvement in the development of Neuvivo's lead candidate NP001, and has worked in ALS for over 20 years. This has enabled Mike to build relationships with, and then center himself in the ALS KOL community. Mike now advises one of the largest ALS patient advocacy groups, the ALS Network.

NP001 itself is the product of 30 years of preclinical and clinical development directed by Mike who is emeritus Professor of Medicine at The University of California, San Francisco (UCSF). Mike initially worked on the role played by macrophages in dementia during his time at San Francisco General Hospital, beginning in 1985. As an immunologist at the center of the AIDS epidemic, Mike noted that AIDS dementia symptoms reversed when the HIV viral load decreased and macrophages activation resolved. This was one of the first suggestions that dementia or CNS degenerative diseases could potentially be reversible. ALS-like symptoms that were identified in AIDS patients also resolved with an anti-viral therapy.

"ALS remains a terrible and incurable disease for patients, despite dozens of therapeutic clinical attempts over the last 20 years. Neuvivo believes an immunological approach, as well as research that identifies subdivision of ALS patients, might provide an immune targeted therapeutic option for these patients," said Mike McGrath, CEO, Neuvivo. "I am looking forward to utilizing my skillset to drive Neuvivo to deliver its lead candidate through the clinic and to commercialization of this therapy. Beyond ALS, we believe this immunological approach could be applied to a range of other neurodegenerative diseases. The potential for Neuvivo to help patients from a range of different neurodegenerative conditions is considerable."

"For more than 25 years, Mike has been a pioneer in understanding the role of the immune system in neurodegenerative disease, long before the field caught up with him," said John Curnutte, MD, PhD, member of the Board of Directors, Neuvivo. "He has led Neuvivo to the threshold of a pivotal Phase 3 trial of NP001, a novel approach designed to restore balance to the innate immune system in ALS. His scientific vision, deep ties to the ALS community, and proven ability to secure financing and grant support make him exactly the right leader for Neuvivo as permanent CEO. This is a defining moment for the company and for the people living with ALS who urgently need new options."

About Neuvivo

Neuvivo is a privately held, late clinical-stage biopharmaceutical company specializing in immunotherapies for the treatment of rare neurodegenerative diseases. Neuvivo's lead candidate NP001 is a small molecule investigational therapy designed to restore equilibrium between pro- and anti-inflammatory processes within a dysfunctional innate immune system. NP001's lead indication is amyotrophic lateral sclerosis (ALS), a disease of urgent unmet need with few approved treatment options. For ALS, NP001 has completed pre-Phase 3 activity supported by data from two Phase 2 studies. The therapy also has potential to target a range of other neurological conditions. NP001 has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration (FDA). Founded in 2020, Neuvivo is headquartered in Palo Alto, California. For more information, please visit www.neuvivo.com.

Media Contact

Neil Hunter, Hunter PR, 44 7821 255568, neil@hunterpr.biz

Jacob Zarling,Operations Manager, Neuvivo, 1 6504406766, info@neuvivo.com, www.neuvivo.com

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SOURCE Neuvivo Inc.