Brainstorm Cell Therapeutics Inc.

Brainstorm is incorporated in Delaware and has its principal executive offices in New York, with additional operations in Israel and Massachusetts. Its R&D center is in Petach Tikva, Israel, and it leases a GMP manufacturing center in Tel Aviv to produce NurOwn® for clinical use and potential shipment into the EU and Israel. The company stated that all of its late-stage ALS and PMS clinical trial sites are in the United States, making the U.S. the center of its clinical development activity. Its patent portfolio spans the United States, Europe, Israel, Australia, and other global markets, which is important because the company’s value depends heavily on cross-border IP protection and future commercialization rights.

Brainstorm faces the classic risks of a development-stage biotech company: clinical failure, regulatory delays, and uncertainty around whether its cell therapy will demonstrate sufficient efficacy and safety for approval. The company also depends on continued access to capital, and its recent delisting from Nasdaq to OTCQB highlights financing and liquidity pressure that can limit investor access and raise the cost of capital. Manufacturing risk is material because autologous cell therapies require tightly controlled CMC processes, and any failure in production consistency, shelf life, or distribution could disrupt trials or future commercialization. In addition, the company’s reliance on intellectual property, third-party licensing rights, and a small workforce concentrated in the U.S. and Israel creates operational and geopolitical exposure, while broader biotech sector risks include reimbursement uncertainty, competition from alternative ALS approaches, and adverse market conditions that can affect funding availability.