Bluebird Bio, Inc. (BLUE) 10-K Annual Report February 2015

company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2014.

“Over the last year, bluebird bio’s efforts advanced the field of gene therapy, driving us closer to our goal of transforming the lives of patients with severe genetic and rare diseases,” said Nick Leschly, chief bluebird. “In 2014, we presented groundbreaking clinical data in treating beta-thalassemia and were the first in the field to use gene therapy to treat a patient with sickle cell disease. We also acquired gene editing capabilities, strengthened our team and added a substantial amount of cash to our balance sheet, positioning us well to advance to our next stage of development. In 2015, our priorities include completing patient enrollment and obtaining more data from our ongoing clinical programs, defining the regulatory pathways to bring our product candidates to patients and continuing to advance our pipeline of promising immunotherapy and gene therapy programs.”

Recent bluebird Highlights

Presented data from beta-thalassemia program at the American Society of Hematology (ASH) annual meeting. In December 2014, bluebird bio presented data from its Northstar and HGB-205 studies demonstrating that the first four beta-thalassemia major patients treated with LentiGlobin^® were transfusion free. The Northstar Study is an ongoing, open-label, single-dose, international, multi-center Phase 1/2 study designed to evaluate the safety and efficacy of LentiGlobin for the treatment of subjects with beta-thalassemia major. The HGB-205 study is an ongoing, open-label, single-center Phase 1/2 study designed to evaluate the safety and efficacy of LentiGlobin in the treatment of subjects with beta-thalassemia major and severe sickle cell disease. The data presented at ASH build upon data presented in June 2014 from the HGB-205 study at the European Hematology Association (EHA) annual meeting.

Advanced sickle cell disease program. In October 2014, as part of the HGB-205 study, bluebird bio became the first company to treat a sickle cell disease patient with gene therapy. The company also initiated the HGB-206 study, an open-label, multi-center, U.S.-based Phase 1 study designed to evaluate the safety and efficacy of LentiGlobin for the treatment of subjects with severe sickle cell disease.

Received Breakthrough Therapy designation for LentiGlobin. In January 2015, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to LentiGlobin for the treatment of transfusion-dependent patients with beta-thalassemia major. The Breakthrough Therapy designation is supported by data from the ongoing Phase 1/2 Northstar and HGB-205 studies of LentiGlobin.

·	Advanced enrollment in CCALD trial. bluebird bio continued to enroll patients in its Starbeam Study, a Phase 2/3 study designed to evaluate the safety and efficacy of Lenti-D™ in the treatment of subjects with childhood cerebral adrenoleukodystrophy (CCALD).

·	Strengthened balance sheet. In 2014, bluebird bio raised approximately $353 million in net proceeds to fund operations, including an equity financing in December 2014 that raised approximately $243 million and an equity financing in July 2014 that raised approximately $110 million.

The following information was filed by Bluebird Bio, Inc. (BLUE) on Wednesday, February 25, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Bluebird Bio, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: BLUE
CIK: 1293971
Form Type: 10-K Annual Report
Accession Number: 0001564590-15-000948
Submitted to the SEC: Wed Feb 25 2015 4:15:55 PM EST
Accepted by the SEC: Wed Feb 25 2015
Period: Wednesday, December 31, 2014
Industry: Biological Products No Disgnostic Substances