Fulcrum Therapeutics, Inc. reported a significant turnaround in its financial performance for the nine months ended September 30, 2024, achieving a net income of $6.8 million, compared to a net loss of $72.6 million for the same period in 2023. This improvement was primarily driven by an $80 million upfront payment from a collaboration and license agreement with Sanofi for the commercialization of losmapimod outside the United States. The company’s accumulated deficit as of September 30, 2024, stood at $502.8 million.

Total revenue for the nine months ended September 30, 2024, included $80,000 from collaboration agreements, a notable increase from $1.9 million in the same period of the previous year. However, collaboration revenue for the third quarter of 2024 was $0, down from $759,000 in the same quarter of 2023. Operating expenses for the nine months decreased slightly to $82.5 million from $84.6 million in the prior year, with research and development expenses accounting for $51.7 million, down from $52.8 million.

The company’s cash and cash equivalents rose significantly to $72.6 million as of September 30, 2024, compared to $25.6 million at the end of 2023. Total current assets also increased to $267.5 million from $242.2 million over the same period. Fulcrum Therapeutics anticipates needing substantial additional funding to support ongoing product development and commercialization efforts.

In a strategic shift, the company announced a restructuring plan in September 2024, which included a workforce reduction from 80 to 51 employees, aimed at focusing on advancing pociredir for sickle cell disease and other therapeutic agents. This restructuring resulted in $2.1 million in charges related to severance and other employee-related costs.

The company has faced challenges in its clinical trials, particularly with losmapimod, which did not meet its primary endpoint in the Phase 3 REACH trial, leading to the suspension of its development. Fulcrum is currently focused on advancing pociredir, which is in a Phase 1b trial for sickle cell disease, with clinical data expected in 2025.

Overall, while Fulcrum Therapeutics has made strides in its financial performance and strategic focus, it continues to navigate significant operational challenges and uncertainties in the biotechnology landscape.