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– Completed enrollment in Northstar-2, Phase 3 study of LentiGlobinTM drug product in patients with transfusion-dependent β-thalassemia (TDT) and non-β0/β0 genotypes –
– Presented updated clinical results from studies in relapsed/refractory multiple myeloma, TDT and severe sickle cell disease (SCD) at American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Annual Meeting –
– Announced topline interim clinical data from Starbeam Study of Lenti-DTM drug product in cerebral adrenoleukodystrophy (CALD) –
– Appointed John O. Agwunobi, M.D. and Douglas A. Melton, Ph.D. to Board of Directors –
– Completed public offering of common stock, raising net proceeds of $436.8 million; ended quarter with $1.2 billion in cash, cash equivalents and marketable securities –
bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, today reported business highlights and financial results for the second quarter ended June 30, 2017.
“In the first half of 2017, we’ve made tremendous progress against our stated goals and continue to build momentum to the end of the year. New data from our bb2121 anti-BCMA CAR T program reinforced our confidence in this program, and we and Celgene are moving full speed ahead to continue to the next stage of development. We presented early data demonstrating the impact of manufacturing improvements for LentiGlobin, with our first patients with TDT in Northstar-2 showing significantly higher drug product VCNs than we saw in previous studies. We also announced interim data from the first 17 patients in the Starbeam study of Lenti-D that showed 88% of those patients met the primary endpoint,” said Nick Leschly, chief bluebird. “We look forward to sharing more of our progress later this year at ASH, where we will provide updated data on our TDT and multiple myeloma programs, as well as a first look at the progress made in the HGB-206 study in severe SCD with changes in the study protocol. For the rest of the year, we’re remaining laser-focused on the execution of our clinical development goals across our programs to bring our transformative therapies to patients and on preparing our organization to bring our gene therapy products to many more patients in a commercial setting.”
Second Quarter 2017 Financial Results and Financial Guidance
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D™ product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin™ product candidate, currently in four clinical studies for the treatment of transfusion-dependent β-thalassemia, and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio also has discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington and Europe.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s financial condition and results of operations, as well as the advancement of, and anticipated development and regulatory milestones and plans related to the Company’s product candidates and clinical studies. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks that the preliminary results from our clinical trials will not continue or be repeated in our ongoing clinical studies, the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, the risk of a delay in the enrollment of patients in our clinical studies, the risks that the changes we have made in the LentiGlobin drug product manufacturing process or the HGB-206 clinical study protocol will not result in improved patient outcomes, risks that the current or planned clinical studies of the LentiGlobin drug product will be insufficient to support regulatory submissions or marketing approval in the United States and European Union, the risk that our collaborations, including our collaboration with Celgene, will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.
bluebird bio, Inc.
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
Three Months Ended
Six Months Ended
|Research and development||64,311||41,760||119,339||83,671|
|General and administrative||21,197||18,363||41,481||34,318|
Change in fair value of contingent consideration
|Total operating expenses||84,538||61,527||161,283||120,406|
|Loss from operations||(67,822||)||(59,975||)||(137,735||)||(117,355||)|
|Interest (expense) income, net||(2,242||)||981||(687||)||1,932|
|Other (expense) income, net||(834||)||(76||)||(1,189||)||(66||)|
|Loss before income taxes||(70,898||)||(59,070||)||(139,611||)||(115,489||)|
|Income tax benefit||—||226||—||371|
|Net loss per share - basic and diluted:||$||(1.73||)||$||(1.59||)||$||(3.41||)||$||(3.12||)|
Weighted-average number of common shares used in computing net loss per share - basic and diluted:
bluebird bio, Inc.
Condensed Consolidated Balance Sheets Data
|Cash, cash equivalents and marketable securities||$||1,197,059||$||884,830|
|Total stockholders' equity||1,200,019||869,440|
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...