-- Achievement of initial enrollment targets in Starbeam and Northstar studies --
-- Presenting HGB-205 beta-thalassemia/sickle cell disease study update at EHA --
“We are pleased with the strong start to 2015, especially the faster
than expected enrollment for our key adrenoleukodystrophy and
beta-thalassemia studies,” said
- STARBEAM ENROLLMENT -- Earlier than expected achievement of 15 patient enrollment target for the Starbeam Study of Lenti-D in childhood cerebral adrenoleukodystrophy with 18 patients enrolled.
- NORTHSTAR ENROLLMENT -- Earlier than expected achievement of 15 patient enrollment target for the Northstar Study of LentiGlobin in patients with beta-thalassemia major; expanding study to include up to three adolescent patients.
SICKLE CELL DISEASE (SCD) DATA PRESENTATION AT EHA -- Data from
the HGB-205 study of LentiGlobin to be presented at the 20th
Congressof the European Hematology Association(EHA) in Vienna, Austriafrom June 11-14, 2015, including data on the first SCD patient treated with LentiGlobin.
- LENTIVIRAL INTELLECTUAL PROPERTY (IP) ESTATE EXPANSION -- Expanded our foundational IP license agreement with Institut Pasteur to include additional patents and expanded fields of use, including for CAR T cells and TCRs.
First Quarter 2015 Financial Results and Financial Guidance
Cash Position: Cash, cash equivalents and marketable securities
March 31, 2015were $469.3 million, compared to $492.0 millionas of December 31, 2014, a decrease of $22.7 million.
Revenues: Collaboration revenue was
$6.3 millionfor the first quarters of 2015 and 2014. Collaboration revenue is primarily comprised of the amortization of deferred revenue related to the $75.0 millionupfront payment received in 2013 under our collaboration agreement with Celgene.
R&D Expenses: Research and development expenses were
$23.7 millionfor the first quarter of 2015, compared to $11.5 millionfor the same period in 2014, an increase of $12.2 million. The increase in research and development expenses was primarily attributable to increased clinical and manufacturing costs related to our two clinical stage product candidates, as well as increased spending on our CAR T and gene editing preclinical programs.
G&A Expenses: General and administrative expenses were
$7.3 millionfor the first quarter of 2015, compared to $5.5 millionfor the same period in 2014, an increase of $1.8 million. The increase in general and administrative expenses was primarily attributable to increased employee and contractor related costs to support our overall growth and increased professional services costs.
Net Loss: Net loss was
$24.8 millionfor the first quarter of 2015, compared to net loss of $10.6 millionfor the first quarter of 2014.
Financial Guidance: bluebird bio expects that its cash, cash
equivalents and marketable securities of
$469.3 millionas of March 31, 2015will be sufficient to fund its operations through 2017.
About bluebird bio, Inc.
With its lentiviral-based gene therapy and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. bluebird bio’s clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). bluebird bio also has a preclinical CAR T immuno-oncology program in collaboration with Celgene Corporation, as well as discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies.
bluebird bio has operations in Cambridge, Massachusetts, Seattle,
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, the sufficiency of its cash, cash equivalents and marketable
securities, as well as the advancement of, and anticipated milestones
related to the Company’s product candidates and clinical studies, and
anticipated milestones for 2015. 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, 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 the Company’s clinical studies, the risk that
the results of previously conducted studies involving similar product
candidates will not be repeated or observed in ongoing or future studies
involving current product candidates, the risk that our collaboration
Availability of other information about bluebird bio
Investors and others should note that we communicate with our investors
and the public using our company website (www.bluebirdbio.com),
our investor relations website (http://www.bluebirdbio.com/investor-splash.html),
including but not limited to investor presentations and FAQs,
|bluebird bio, Inc.|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(in thousands, except per share data)|
Three months ended
|Research and license fees||—||85|
|Research and development||23,719||11,463|
|General and administrative||7,336||5,540|
|Change in fair value of contingent consideration||215||—|
|Total operating expenses||31,270||17,003|
|Loss from operations||(24,926||)||(10,668||)|
|Other income, net||139||59|
|Net loss per share - basic and diluted:||$||(0.76||)||$||(0.44||)|
Weighted-average number of common shares used
in computing net loss per share - basic and diluted:
|bluebird bio, Inc.|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||469,314||$||492,003|
|Total stockholders' equity||474,499||491,257|
Source: bluebird bio, Inc.
bluebird bio, Inc.
Jim DeTore, 339-499-9355
Chief Financial Officer
Pure Communications, Inc.
Dan Budwick, 973-271-6085