On December 1, 2021 2seventy bio, Inc. (Nasdaq: TSVT), an emerging immuno-oncology company, reported financial results and recent highlights for the third quarter ended September 30, 2021 (Press release, 2seventy bio, DEC 1, 2021, View Source [SID1234596339]).

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"We launched 2seventy bio a few short weeks ago and I’m highly encouraged by the way our team has taken this challenge head on," said Nick Leschly, chief kairos officer. "Our urgency to bring transformative cell therapies forward is driven by the ultimate goal, which is to provide more time to patients and their families devastated by cancer. We have hit the ground running, with the first IND acceptance for our program in AML, and another anticipated in the bNHL program by the end of the year. Exciting times are ahead, and we are fired up for 2022 as ABECMA continues to deliver for MM patients and our product engine drives more disruptive next-gen cell therapies forward in both liquid and solid tumors."

RECENT HIGHLIGHTS

COMPANY LAUNCH – On November 4, 2021, 2seventy bio launched as an independent, publicly traded company with a robust cell therapy pipeline across a range of hematologic and solid tumors including the SC-DARIC33 and bbT369 candidates that are planned, subject to IND acceptance, to enter the clinic by the first half of 2022. 2seventy bio’s portfolio also includes a development and 50/50 U.S. commercialization partnership with Bristol Myers Squibb (BMS) for ABECMA, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy, in relapsed or refractory multiple myeloma.
SC-DARIC33 IND – Today, 2seventy bio is announcing that the FDA has accepted the IND for SC-DARIC33, an investigational, pharmacologically controlled CD33-targeted autologous T cell product, developed in collaboration with Seattle Children’s Therapeutics for the potential treatment of acute myeloid leukemia (AML). PLAT-08, the Phase 1 study of SC-DARIC33 in relapsed/refractory pediatric AML, led by Seattle Children’s Therapeutics, is now open and enrolling patients (NCT: 05105152). This study is a first-in-human investigation of the DARIC T cell platform.
ASH PRESENTATIONS – On November 4, 2021, 2seventy bio announced that it will present data from its portfolio of oncology cell therapies at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. These presentations include new pre-clinical data on SC-DARIC33, and in partnership with BMS, updated results from the ongoing Phase 1 CRB-402 study of the BCMA-targeted CAR T cell therapy bb21217 in patients with relapsed and refractory multiple myeloma (RRMM). In addition, a range of analyses will be presented from the pivotal KarMMa trial of ide-cel, in partnership with BMS.
UPCOMING ANTICIPATED MILESTONES

Acceptance of investigational new drug (IND) application for bbT369 in bNHL by the end of 2021.
Presentation of new preclinical data from the SC-DARIC33 program at the 63rd ASH (Free ASH Whitepaper) Annual Meeting in December 2021.
Presentation of clinical data from the ongoing CRB-402 study of bb21217 at the 63rd ASH (Free ASH Whitepaper) Annual Meeting in December 2021.
SELECT THIRD QUARTER AND YEAR-TO-DATE 2021 FINANCIAL RESULTS

The results for the period ended September 30, 2021, have been prepared on a carve-out basis and are derived from bluebird bio, Inc.’s consolidated financial statements and accounting records. Upon separation on November 4, 2021, bluebird bio made a contribution to 2seventy bio of approximately $441.5 million in cash and cash equivalents, which is expected to be sufficient to fund current planned operations for at least the next twelve months.
Revenues: Total revenues were $19.3 million for the three months ended September 30, 2021 compared to $18.4 million for the three months ended September 30, 2020. Total revenues were $38.5 million for the nine months ended September 30, 2021 compared to $238.2 million for the nine months ended September 30, 2020. The increase for the three-month period was primarily driven by revenue recognized under our collaboration arrangement with BMS. The decrease in the nine-month period was primarily driven by revenue recorded in connection with the May 2020 BMS contract modification in the second quarter of 2020.
ABECMA Revenue: BMS reported total U.S. revenues of $67 million for ABECMA (idecabtagene vicleucel; ide-cel) in the third quarter of 2021. 2seventy bio reported net collaboration revenue of $12.3 million for the third quarter of 2021, which includes our share of revenue and costs associated with the commercialization of ABECMA in the U.S.
R&D Expenses: Research and development expenses were $61.1 million for the three months ended September 30, 2021 compared to $72.3 million for the three months ended September 30, 2020. Research and development expenses were $202.4 million for the nine months ended September 30, 2021 compared to $227.6 million for the nine months ended September 30, 2020. The decrease for the three-month period was primarily driven by decreased R&D costs under our collaboration with BMS and decreased manufacturing expenses. The decrease for the nine-month period was primarily driven by decreased manufacturing expenses.
SG&A Expenses: Selling, general and administrative expenses were $23.0 million for the three months ended September 30, 2021 compared to $22.1 million for the three months ended September 30, 2020. Selling, general and administrative expenses were $69.0 million for the nine months ended September 30, 2021 and September 30, 2020. The increase for the three-month period was primarily driven by an increase in employee compensation, benefit, and other headcount related expenses.
Net Loss: Net loss was $60.0 million for the three months ended September 30, 2021 compared to $72.1 million for the three months ended September 30, 2020. Net loss was $231.2 million for the nine months ended September 30, 2021 compared to $43.3 million for the nine months ended September 30, 2020.