#United States #New York #NurOwn #BrainStorm Cell #Peter J. Pitts

Strategic Leadership Shift at BrainStorm Cell Therapeutics

On July 28, 2026, BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) announced a significant change in its leadership structure, appointing Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer. This strategic move comes at a critical time as the company prepares to advance its lead investigational therapy, NurOwn®, into an important Phase 3b trial, guided by a groundbreaking Special Protocol Assessment (SPA) from the FDA.

Peter J. Pitts, who is also a co-founder of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner, brings extensive expertise in regulatory affairs and corporate strategy to his new role. His immediate responsibilities will include overseeing the daily operations of BrainStorm, managing corporate partnerships, engaging with investors, and steering clinical-regulatory pathways aligned with the company's goals. This appointment is particularly significant considering that the SPA granted for NurOwn® marks the first of its kind for an ALS therapeutic candidate.

"Securing a leader of Peter's global caliber and deep FDA experience to manage our daily operations transforms our strategic position," mentioned Chaim Lebovits, President and CEO of BrainStorm. This highlights the company's vision to enhance its operational capabilities as it approaches complex discussions with corporate partners and institutional investors. As the organization navigates through high-stakes negotiations, having someone with Pitts' insights and backgrounds is considered invaluable.

Peter J. Pitts expressed his enthusiasm regarding this new venture, stating, "BrainStorm is advancing a validated, significantly de-risked clinical asset with a clear regulatory blueprint. I am fully committed because the science behind NurOwn is compelling, and the patient need in ALS is urgent." His deep connection to FDA workings will play a vital role in ensuring the regulatory success of the NurOwn® trials.

Transitioning from the position of Board Chairman, Professor Jacob Frenkel, who had been a guiding force since joining the advisory board in 2007, will now serve as Senior Advisor. Frenkel's decision to initiate this leadership transition was motivated by the need for a more hands-on executive as the company moves into the execution phase of its clinical trials.

Professor Frenkel reflected on his two-decade journey with BrainStorm, saying, "Having steered BrainStorm for two decades since its early advisory days to the launch preparation of this important late-stage trial, I am pleased to pass the torch of board leadership to Mr. Pitts. His willingness to step into an active executive role provides the ideal catalyst for my transition."

In his new role, Pitts is expected to galvanize the company's focus on commercial strategies while also enriching its alliances with researchers, policymakers, and stakeholders in the healthcare sector. His strategic foresight is deemed essential for driving innovations that have the potential to alter the course of treatment for ALS.

BrainStorm Cell Therapeutics is recognized as a pioneering developer of autologous adult stem cell therapies catering to serious neurodegenerative disorders. Its proprietary NurOwn® platform utilizes mesenchymal stem cells to produce neurotrophic factor-secreting cells aimed at regulating neuroinflammation and fostering neuroprotection. Currently, NurOwn® has achieved Orphan Drug designation from both the U.S. Food and Drug Administration and the European Medicines Agency, thus affirming its promise in treating ALS.

The upcoming Phase 3b trial represents a pivotal point in the clinical development of NurOwn®, encompassing the hopes of many patients and families touched by ALS. As BrainStorm operates under the affirmative auspices of the SPA agreement, all eyes will be on Pitts as he leads the way toward potential breakthroughs that could change lives.

For further information regarding this leading-edge research and updates on trials, visit BrainStorm Cell Therapeutics.