bluebird bio to Provide Update on Program Milestones and 2022 Financial Outlook at the 40th Annual J.P. Morgan Healthcare Conference
In 2022, bluebird is focused on the FDA review of two gene therapies – betibeglogene autotemcel (beti-cel), for beta-thalassemia and elivaldogene autotemcel (eli-cel), for cerebral adrenoleukodystrophy (CALD) – and is prepared to launch both beti-cel and eli-cel for patients in the
Additionally, bluebird bio expects to complete the manufacturing of commercial drug product validation lots for its third gene therapy, lovotibeglogene autotemcel (lovo-cel), for sickle cell disease in mid-2022. The Company is evaluating what impact, if any, the ongoing partial clinical hold of lovo-cel for patients under the age of 18 may have on the projected timing of the first quarter of 2023 for the submission of the BLA.
“In 2021, bluebird bio relaunched as an independent company focused on severe genetic diseases,” said
2022 Financial Outlook
The Company’s preliminary unaudited restricted cash, cash and cash equivalents and marketable securities balance was approximately
Presentation at the 2022
The bluebird bio management team will present on
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 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.
For more information, visit bluebirdbio.com or follow us on social media at @bluebirdbio, LinkedIn, Instagram and YouTube.
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 our projected financial position and performance in 2022 including expected cash burn and potential cash inflows, the timing and expectations for potential regulatory approvals of beti-cel and eli-cel and the associated commercial launches, and our expectations for manufacturing and validation activities for lovo-cel. Such forward-looking statements are based on historical performance and current expectations and projections about our future 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 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
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Investors:
Courtney O’Leary, 978-621-7347
coleary@bluebirdbio.com
or
Media:
sarah.alspach@bluebirdbio.com
Source: bluebird bio, Inc.