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  • Nov 6, 2024

  • Nov 5, 2024

      Show headlines and story abstract
    • 9:05AM ET on Tuesday Nov 05, 2024 by Dow Jones
      Companies Mentioned: BLUE

      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, such as statements regarding the transformative, long-term potential of bluebird's therapies, the results of an analysis of lovo-cel's clinical impact on patients with a history of stroke, and the durability and clinical benefit of lovo-cel and beti-cel. Such forward-looking statements are based on historical performance and current expectations and projections about bluebird's 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 bluebird's control and could cause bluebird's 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's business, particularly those identified in the risk factors discussion in bluebird bio's Annual Report on Form 10-K for the year ended December 31, 2023, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to: delays and challenges in bluebird's commercialization and manufacturing of its products; the internal and external costs required for bluebird's ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected which has caused bluebird, and may in the future cause bluebird to use cash more quickly than it expects or change or curtail some of its plans or both; substantial doubt exists regarding bluebird's ability to continue as a going concern; bluebird's expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than bluebird's assumptions; the risk that the efficacy and safety results from bluebird's prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that QTCs experience delays in their ability to enroll or treat patients; the risk that bluebird experiences delays in establishing operational readiness across its supply chain; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of bluebird's therapies; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; and the risk that bluebird's therapies will not be successfully commercialized. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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