Brainstorm Cell Therapeutics (BCLI) Q4 2024 earnings summary

Executive summary

• 2024 focused on foundational work for the critical Phase 3b trial of NurOwn, targeting ALS, with trial design aligned with FDA and leading ALS experts.

• Special Protocol Assessment secured with FDA, de-risking regulatory pathway and aligning on Chemistry, Manufacturing, and Controls.

• Partnerships established with IQVIA for trial execution and Pluri Inc. for GMP-compliant manufacturing; plans for a new U.S.-based manufacturing center.

• Regained Nasdaq compliance and strengthened IP portfolio with new exosome technology patent.

• Team and leadership have taken salary reductions or worked without compensation to prioritize trial progress amid financial constraints.

Financial highlights

• Research and development expenditures for 2024 were $4.7 million, down from $10.7 million in 2023.

• General and administrative expenses for 2024 were $7 million, compared to $10.7 million in 2023.

• Net loss for 2024 was $11.6 million ($2.31 per share), improved from $17.2 million ($6 per share) in 2023.

• Cash equivalents and restricted cash at year-end 2024 were $0.44 million, down from $1.5 million at year-end 2023.

• Warrant inducement agreement expected to raise $1.64 million in gross proceeds, closing around April 1, 2025.

Outlook and guidance

• Phase 3b trial preparations advancing, with patient enrollment expected after IND module submissions and clinical trial agreements are finalized.

• Phase 3b trial of NurOwn in ALS to enroll ~200 participants, with regulatory and CMC alignment achieved with FDA.

• Anticipated annual funding need for the trial is $20-30 million; raising all funds upfront is not practical given current market conditions.

• Expectation that achieving milestones (IND submission, FDA clearance, CTA signings, first patient enrollment) will improve market valuation and facilitate further funding.

• Actively pursuing licensing of non-core assets, non-dilutive grants, and strategic partnerships for additional capital.