RARE Daily

Gene Therapy Focused Bluebird Bio Restructures to Extend Cash Runway

April 5, 2022

Gene therapy focused biotech Bluebird Bio said it is initiating a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years.

The gene therapy focused biotech joins a growing list of companies that are paring staff and programs to stay afloat as biotech continues to be hammered on Wall Street. Just last week, Taysha Gene Therapies said it was restructuring, laying off 35 percent of its workforce and focusing most of its activities on advancing just two of its 30 program pipeline of CNS gene therapies.

Bluebird says it intends to sharpen its focus on near-term catalysts, including anticipated U.S. Food and Drug Administration approvals for its gene therapies for beta-thalassemia and cerebral adrenoleukodystrophy in 2022, and the potential submission of a biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease planned in the first quarter of 2023. The company expects to maintain targeted research efforts focused on in vivo lentiviral vector (LVV) gene therapy and will deprioritize direct investments in reduced toxicity conditioning and cryopreserved apheresis.

The initiative is expected to reduce the company’s cash burn in 2022 to less than $340 million, with a 35 to 40 percent reduction in operating costs anticipated by year-end 2022, which is expected to be reflected in bluebird’s operating budget for 2023. As part of the changes, bluebird plans to reduce its workforce by approximately 30 percent. The restructuring is expected to extend the company’s cash runway into the first half of 2023.

“Today, we are taking decisive action to extend our cash runway, and put Bluebird in a stronger position to execute on our strategic priorities and ultimately bring potentially curative gene therapies to patients and their families,” said Andrew Obenshain, CEO of Bluebird Bio. “The decision to reduce our workforce in support of a more focused set of priorities was not taken lightly, and we are grateful to every Bluebird who has helped to progress the field of gene therapy and championed our mission.”

Cost savings and the extended cash runway generated through the restructuring are intended to bring Bluebird through crucial upcoming milestones while the company continues to evaluate additional financing options, including public or private equity financings and monetizing any priority review vouchers that may be issued upon approval of beti-cel or eli-cel.

If approved, beti-cel for beta-thalassemia and eli-cel for cerebral adrenoleukodystrophy will be the first ex-vivo LVV gene therapies available in the United States. The FDA has set PDUFA goal dates of August 19, 2022 for beti-cel and September 16, 2022 for eli-cel. The therapies are expected to be reviewed in consecutive FDA advisory committee meetings tentatively scheduled for June 9 and 10, 2022.

Author: Rare Daily Staff

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