Bluebird bio Inc. recently received approval for Lyfgenia, a gene therapy for sickle cell disease, marking a significant milestone as it represents the company's third U.S. drug approval since its split in November 2021.

The treatment process for Lyfgenia is intricate, requiring the collection and modification of patients' blood stem cells, followed by a hematopoietic stem cell transplant.

As of November 2024, Bluebird reported 57 patient starts for Lyfgenia, including 17 specifically for this therapy, but has revised its initial projection for patient starts in 2024 down to approximately 85 from a previous estimate of 85-105.

Despite the approval, the rollout of Lyfgenia has been sluggish, and the company faces the risk of running out of cash by the first quarter of 2025, which underscores the urgent need for additional funding.

In light of its financial challenges, Bluebird is in a critical period as it seeks to raise cash within the next few months to sustain its operations.

To conserve cash, Bluebird has implemented significant cost-cutting measures, including laying off 25% of its workforce and executing a 1-for-20 reverse stock split.

In March 2024, the company secured a $175 million term loan from Hercules Capital and is actively exploring further financing options to extend its runway.

Analysts indicate that Bluebird could achieve cash flow break-even in the second half of 2025 if it successfully scales to 40 drug deliveries per quarter.

The company is also facing stiff competition from Vertex Pharmaceuticals and CRISPR Therapeutics, which has launched a competing CRISPR-based treatment called Casgevy, priced lower than Lyfgenia.

Looking ahead, Bluebird plans to present its 2025 strategy at the upcoming J.P. Morgan Healthcare Conference in January 2025, as the gene therapy market continues to evolve.