Expected to deliver up to
Management team to host conference call today,
bluebird intends to sharpen its focus on near-term catalysts, including anticipated FDA 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
“Over more than a decade, bluebird has made remarkable advances across research, development and manufacturing of gene therapies, and has set the standard for scientific understanding in this rapidly expanding field,” said
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, betibeglogene autotemcel (beti-cel) for beta-thalassemia and elivaldogene autotemcel (eli-cel, Lenti-D™) for cerebral adrenoleukodystrophy will be the first ex-vivo LVV gene therapies available in the US. The FDA has set PDUFA goal dates of
Investor Conference Call Information
bluebird bio will host a call for analysts and investors today,
To access the live webcast of bluebird’s presentation, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird website for 90 days following the event.
About bluebird bio, Inc.
bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.
With a dedicated focus on severe genetic diseases, bluebird has industry-leading clinical and research programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.
Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the world—setting the standard for the industry. Today, bluebird continues to forge new paths, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds.
bluebird bio Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, including our statements regarding potential cost-savings from our restructuring, expected reductions of operating expenses, our expectations that the cost savings from the restructuring will extend our cash runway into the first half of 2023, and our expectations regarding the timing for a potential BLA submission for lovo-cel, and anticipated FDA approval of the BLAs for beti-cel and eli-cel. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
Courtney O’Leary, 978-621-7347
Source: bluebird bio, Inc.