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Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly Report for the period ending Thursday, June 30, 2022

SEC Filings

BLUE Quarterly Reports

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE
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Exhibit 99.1

bluebird bio Reports First Quarter 2022 Financial Results and Highlights Operational Progress

- BLAs for beti-cel for β-thalassemia and eli-cel for cerebral adrenoleukodystrophy,
to be discussed at an FDA Advisory Committee Meeting on June 9-10, 2022 -

- Company restructuring initiated in April to reduce operating costs
by 35 to 40 percent by year-end 2022 -

- Ended quarter with $312M in restricted cash, cash and cash equivalents
and marketable securities -

CAMBRIDGE, Mass. May 9, 2022 – bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the first quarter ended March 31, 2022, and shared recent operational progress.

“For more than a decade, bluebird bio has helped chart the path for the field of gene therapy and today, we are closer than ever before to realizing our mission of bringing potentially curative gene therapies to patients and their families,” said Andrew Obenshain, chief executive officer, bluebird bio. “We have taken action to sharpen our focus and our finances, as the FDA completes its review of the beti-cel and eli-cel BLAs, and we prepare for the launch of two gene therapies in the second half of the year. In parallel, we are actively collecting the manufacturing comparability data required for lovo-cel and remain focused on submitting our BLA for sickle cell disease to the FDA in Q1 2023.”


RECENT HIGHLIGHTS

BETI-CEL AND ELI-CEL
ADVISORY COMMITTEE MEETING ON JUNE 9-10, 2022 – On April 13, the U.S Food and Drug Administration (FDA) confirmed its plans to review betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) in an FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting that will take place over two days on June 9-10, 2022. The advisory committee will discuss the efficacy and safety data supporting the benefit/risk of beti-cel and eli-cel respectively, as well as safety information relevant to both therapies. If approved, beti-cel and eli-cel would be the Company’s first FDA approved therapies as an independent severe genetic disease company. An overview of the agenda was included in the Federal Register announcement posted on April 13. The full agenda will be determined by the FDA and included in briefing materials that will be posted by the FDA closer to the date of the advisory committee meeting.

LOVO-CEL
CONTINUED PROGRESS TOWARD BLA SUBMISSION – bluebird bio has enrolled more than half of the patients in the HGB-210 study that will be needed to support manufacturing data requirements for the lovotibeglogene autotemcel (lovo-cel) biologics licensing application (BLA) and the Company is on track to submit a BLA to the FDA for sickle cell disease (SCD) in the first quarter of 2023. As previously communicated, the Company has treated all patients in HGB-206 Group C who will form the primary basis of efficacy for BLA submission, with the demonstration of analytical comparability and validation of the commercial manufacturing process as the key remaining actions prior to submission of the planned BLA. Enrollment and dosing for patients 18 and older are continuing in the HGB-210 study and the Company remains in active dialogue with the FDA about the resolution of the partial clinical hold for patients under 18.


COMPANY
RESTRUCTURING UPDATE – On April 5, 2022, bluebird bio announced a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years,


The following information was filed by Bluebird Bio, Inc. (BLUE) on Monday, May 9, 2022 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Bluebird Bio, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

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Inside Bluebird Bio, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses And Other Current Liabilities
Accrued Expenses And Other Current Liabilities (Tables)
Accrued Expenses And Other Current Liabilities - Narrative (Details)
Accrued Expenses And Other Current Liabilities - Schedule Of Accrued Expenses And Other Current Liabilities (Details)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies (Detail)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies (Policies)
Commitments And Contingencies
Commitments And Contingencies (Detail)
Description Of The Business
Description Of The Business (Detail)
Discontinued Operations
Discontinued Operations (Tables)
Discontinued Operations - Narrative (Details)
Discontinued Operations - Revenue And Expenses (Details)
Discontinued Operations - Significant Non-Cash Items And Capital Expenditures (Details)
Equity
Equity (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Narrative (Detail)
Fair Value Measurements - Recorded Amount Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Fair Value Measurements - Schedule Of Unrealized Loss On Investments (Details)
Income Taxes
Leases
Leases - Narrative (Details)
Marketable Securities
Marketable Securities (Detail)
Marketable Securities (Tables)
Net Loss Per Share
Net Loss Per Share (Detail)
Net Loss Per Share (Tables)
Property, Plant And Equipment, Net
Property, Plant And Equipment, Net (Tables)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (Detail)
Restructuring
Restructuring (Tables)
Restructuring - Accrued Liabilities Activity (Details)
Restructuring - Narrative (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Narrative (Detail)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Expense By Classification (Detail)
Stock-Based Compensation - Summary Of Restricted Stock Units (Detail)
Stock-Based Compensation - Summary Of Stock Option Activity Under Plan (Detail)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense By Award Type (Detail)
Subsequent Events
Subsequent Events (Details)
Ticker: BLUE
CIK: 1293971
Form Type: 10-Q Quarterly Report
Accession Number: 0001293971-22-000048
Submitted to the SEC: Thu Aug 04 2022 4:11:22 PM EST
Accepted by the SEC: Thu Aug 04 2022
Period: Thursday, June 30, 2022
Industry: Biological Products No Disgnostic Substances

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