Brainstorm Cell Therapeutics Reports $11.6 Million Net Loss for 2024, Focuses on NurOwn® ALS Trial

Brainstorm Cell Therapeutics Inc. reported a net loss of $11.6 million for the year ended December 31, 2024, compared to a net loss of $17.2 million in 2023. The company generated no revenue during either period. The decrease in net loss was primarily due to a reduction in research and development expenses, which fell from $10.7 million in 2023 to $4.7 million in 2024, and a decrease in general and administrative expenses, declining from $10.7 million to $7.0 million. The decrease in research and development expenses resulted from lower costs associated with Phase 3 clinical trials, materials and cleanroom facilities, payroll, and stock-based compensation.

Significant developments during 2024 included the submission of a Special Protocol Assessment (SPA) request to the FDA for a planned Phase 3b clinical trial of NurOwn® for the treatment of ALS in February, followed by the FDA's approval of the SPA in April. In June, the company announced alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of the Phase 3b trial. The company also announced a memorandum of understanding with Pluri Inc. in November 2024 to manufacture NurOwn® for the Phase 3b trial. Organizational changes included the promotion of Dr. Ibrahim Dagher to Executive Vice President and Chief Medical Officer and the appointment of Dr. Hartoun Hartounian as Executive Vice President and Chief Operating Officer.

The company's 2024 financial statements reflect a cash balance of $371,000 as of December 31, 2024. Net cash used in operating activities for the year was $9.1 million, while net cash provided by financing activities was $7.97 million, primarily from sales of common stock under the ATM program and private placements. The company employed 29 people as of year-end. The company's NurOwn® technology platform is based on autologous bone marrow-derived mesenchymal stem cells, and the company is pursuing regulatory approval for NurOwn® in ALS, as well as advancing its clinical development in progressive multiple sclerosis and Alzheimer's disease.

The company's intellectual property portfolio includes approximately 30 granted patents and pending applications. In December 2024, the company received a Notice of Allowance from the USPTO for a patent application covering its proprietary exosome technology. The company also presented new biomarker data suggesting that ALS patients may benefit from longer-term treatment with NurOwn® at the 3rd Annual ALS Drug Development Summit in May 2024. The company's Biologics License Application (BLA) for NurOwn® for the treatment of ALS was withdrawn in November 2023 without prejudice.

The company's outlook is focused on initiating and completing the Phase 3b trial for NurOwn® in ALS, and subsequent commercialization efforts if approved. The company anticipates incurring substantial operating losses for the foreseeable future and will require substantial additional funding to pursue its business objectives and continue operations. The company is exploring various funding options, including additional public and private offerings of its common stock and warrants. The company acknowledges the risks associated with its business, including the inherent risks in developing novel therapies, the uncertainties of regulatory approval, and the challenges of commercialization.