Brainstorm Cell Therapeutics (BCLI) Q2 2024 earnings summary

Executive summary

• Achieved FDA alignment on Special Protocol Assessment (SPA) and Chemistry, Manufacturing, and Controls (CMC) for the planned Phase 3b NurOwn trial in ALS, with trial initiation targeted for late 2024 or early 2025.

• Selected a leading CRO and established a network of over 12 ALS clinical centers to ensure broad patient access.

• Leadership team strengthened with the promotion of Dr. Bob Dagher to EVP and CMO and the appointment of Dr. Hartoun Hartounian as EVP and COO.

• The company is actively pursuing non-dilutive funding, including a grant application for up to $15 million, and is focused on maximizing shareholder value while maintaining Nasdaq listing compliance.

• Brainstorm continues to face significant financial and regulatory challenges, including ongoing litigation and Nasdaq listing compliance issues.

Financial highlights

• Cash, cash equivalents, and restricted cash were $3.65 million as of June 30, 2024, up from $0.75 million a year earlier.

• Net loss for Q2 2024 was $2.5 million, improved from $5.3 million in Q2 2023; net loss per share was $0.04 versus $0.13.

• Research and development expenses for Q2 2024 were $0.9 million, down from $2.8 million in Q2 2023.

• General and administrative expenses for Q2 2024 were $2 million, compared to $2.7 million in Q2 2023.

• Operating expenses for Q2 2024 were $2.98 million, a decrease from $5.45 million in Q2 2023.

Outlook and guidance

• Key near-term milestones include securing trial site agreements, obtaining additional non-dilutive funding, and enrolling the first patient in the Phase 3b trial.

• Manufacturing processes for the Phase 3b trial are well-advanced and on track to meet production timelines.

• The company expects to continue generating losses from clinical development and regulatory activities, resulting in negative cash flow from operations.

• Additional capital will be required to fund the planned Phase 3b ALS trial and future commercialization efforts; management is considering further equity and debt financing.

• If unable to raise sufficient capital, the company may not be able to continue as a going concern.