Hit by several delays for its gene therapy programs, Bluebird bio Inc (NASDAQ:BLUE) ended 2021 with a cash and equivalents balance of approximately $442 million. The full-year 2022 cash burn is expected to be less than $400 million. 

The company's expectation of generating operating losses and negative operating cash flows and the need for additional funding to support its planned operations raise substantial doubt regarding its ability to continue as a going concern.

Bluebird is exploring multiple financing opportunities, including plans to sell priority review vouchers. The company would be eligible to receive upon potential approval of beti-cel and eli-cel in 2022 while focusing on further cost efficiencies.

Also See: FDA Pushes Review Period For Bluebird bio's Neurodegenerative Disease, Thalassemia Gene Therapies.

Q4 sales reached $1.61 million, missing the consensus of $5.08 million. It posted an EPS loss of $(1.83), better the consensus of $1.88.

In December, the FDA placed a partial clinical hold on the lovotibeglogene autotemcel gene therapy program for sickle cell disease (SCD) patients under 18.

Following the review of the questions from the FDA and an assessment of the timeline for manufacturing drug product lots and collecting analytical comparability data in the HGB-210 study, Bluebird bio reaffirmed plans to submit the BLA for lovo-cel in Q1 2023.

Price Action: BLUE shares are down 11% at $4.45 during the market session on the last check Monday.