NewcelX Adds ALS Expert to SAB, Signaling Push for Novel AstroRx Therapy

ZURICH, SWITZERLAND – November 17, 2025 – NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage biotechnology company developing cell-based and small-molecule therapies, today announced the appointment of Dr. Jeremy Shefner, a renowned neurologist specializing in Amyotrophic Lateral Sclerosis (ALS), to its Scientific Advisory Board (SAB). This strategic move is intended to strengthen the company’s ALS program, particularly the development of its AstroRx® therapy, and integrate neuromuscular expertise into NewcelX’s broader neuroscience platform.

Building an ALS Powerhouse

Dr. Shefner brings over three decades of experience in ALS research and clinical care to NewcelX. As Chief Medical Officer for Clinical Research at Barrow Neurological Institute and a leading figure in the Northeast ALS Consortium (NEALS), he is considered a key opinion leader in the field. “Dr. Shefner’s deep understanding of ALS pathophysiology, clinical trial design, and biomarker development will be invaluable as we advance AstroRx® and explore new therapeutic avenues,” stated a company spokesperson. His appointment underscores NewcelX’s commitment to assembling a world-class team of experts to tackle this devastating neurodegenerative disease. Barrow Neurological Institute, a prominent research center, has recently received significant funding to drive national ALS clinical research, and Dr. Shefner’s leadership will likely influence the trajectory of NewcelX’s program.

AstroRx®: A Novel Approach to ALS Treatment

AstroRx® represents a unique approach to ALS therapy. Unlike many current treatments focused on symptom management or slowing disease progression, AstroRx® aims to address the underlying cellular dysfunction. The therapy utilizes functional astrocytes – specialized brain cells crucial for supporting motor neurons – derived from human embryonic stem cells. In ALS, these astrocytes often become dysfunctional, contributing to motor neuron damage. AstroRx® is designed to compensate for these malfunctioning cells, potentially slowing or even halting disease progression.

NewcelX recently completed a Phase 1/2a clinical trial in Israel, demonstrating the safety and tolerability of a single dose of AstroRx®. Preliminary results indicated a statistically significant and clinically meaningful reduction in the rate of ALS progression during the first three months post-treatment. However, the observed benefits waned over time, suggesting the need for repeat dosing. The company is preparing to initiate a U.S. Phase 2a study, utilizing a repeated dosing regimen every three months, to evaluate the potential for sustained therapeutic effects. While the company’s stock has experienced significant volatility in recent months, this progress with AstroRx®, combined with Dr. Shefner’s expertise, represents a crucial step forward.

Navigating a Competitive Landscape

The ALS treatment market is characterized by a substantial unmet need and increasing innovation. While riluzole and edaravone have been the mainstay treatments for years, newer therapies like tofersen, targeting specific genetic mutations, are emerging. Several other companies are actively pursuing various approaches, including gene therapy, small molecule drugs, and cellular therapies. “The field is incredibly active, but the challenge remains to find therapies that truly modify disease progression and improve the quality of life for ALS patients,” commented an independent neurodegenerative disease expert.

NewcelX faces stiff competition, but AstroRx®’s unique mechanism of action – directly addressing astrocyte dysfunction – differentiates it from many existing and investigational therapies. The company's focus on repeat dosing in the upcoming U.S. Phase 2a study is critical, as maintaining sustained therapeutic benefits is a major hurdle in ALS treatment. The recent appointment of Dr. Shefner will provide invaluable guidance in designing and implementing this study, optimizing dosing regimens, and identifying biomarkers to monitor treatment response. The company’s financial stability remains a concern, given the substantial costs associated with clinical development, but its innovative approach and strategic partnerships could position it for success.