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 patients, with advanced preparations and FDA Special Protocol Assessment secured.

• Strong collaboration with FDA, securing alignment on Chemistry, Manufacturing, and Controls.

• Strategic partnerships established for clinical trial execution and manufacturing, including IQVIA and Pluri Inc.

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

• Team dedication highlighted by salary reductions and periods of unpaid work to advance the trial.

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.

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

Outlook and guidance

• Preparations underway to initiate Phase 3b trial and begin patient enrollment in 2025, targeting ~200 participants.

• Anticipates needing $20-30 million annually to complete the trial, with funding to be raised incrementally as milestones are achieved.

• Actively pursuing multiple funding avenues, including licensing non-core assets and non-dilutive grants.

• Confident that achieving key milestones will improve market valuation and facilitate further funding.