2seventy bio Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Progress

REGENERON COLLABORATION AMENDMENT – In January, 2seventy bio announced an expanded translational collaboration with Regeneron to facilitate the acceleration of novel cell therapy-based combinations for solid tumors. The collaboration will leverage 2seventy bio’s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron’s differentiated antibodies and bispecifics. To support this expanded clinical development plan Regeneron made an approximately $20 million equity investment in 2seventy bio at a 50% premium and has committed to another approximately $20 million in near-term pre-clinical and clinical milestones. The parties will continue sharing costs for these activities in a manner largely consistent with the existing agreement, with Regeneron covering 75% of certain preclinical costs necessary to study combinations and 100% of the costs for the arms of the clinical studies that include Regeneron agents through regulatory approval. For other programs, cost-sharing will follow the existing 50/50 cost sharing agreement.

BOARD APPOINTMENT – Earlier this month, 2seventy bio announced the appointment of Wei Lin, M.D. to the company’s Board of Directors.

UPCOMING ANTICIPATED MILESTONES

ABECMA

• Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma by end of 2023
• Potential FDA approval of sBLA in 3L+ multiple myeloma by the end of 2023

PIPELINE

• Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023
• Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia by the end of 2023
• Submission of an IND for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron by end of 2023
• Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors by end of 2023

FINANCIAL GUIDANCE

• Topline U.S. Abecma revenue of $470-570 million in 2023
• Net cash spend of $180-220 million in 2023
• Cash runway into 2026

SELECT FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

• Our partner, BMS, reported total U.S. revenues of $94 million and $297 million for Abecma for the three and twelve months ended December 31, 2022, respectively. 2seventy bio and BMS share equally in all profits and losses related to development, manufacture, and commercialization of Abecma in the U.S. We reported collaborative arrangement revenue of $8.7 million for the three months ended December 31, 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the twelve months ended December 31, 2022.
• Total 2seventy bio revenues were $56.2 million for the three months ended December 31, 2022 compared to $16.0 million for the three months ended December 31, 2021. Total revenues were $91.5 million for the twelve months ended December 31, 2022 compared to $54.5 million for the twelve months ended December 31, 2021. The increase for both the three and twelve-month periods was primarily due to an increase in service revenue in the fourth quarter of 2022, driven by the release of deferred revenue relating to bb21217, the development of which was discontinued in 2022.
• Research and development expenses were $60.1 million for the three months ended December 31, 2022 compared to $57.2 million for the three months ended December 31, 2021. This increase was primarily driven by increased costs for manufacturing activities of suspension lentiviral vector for ide-cel and MAGE-A4 development, partially offset by a decrease in costs related to our share of research and development expenses under our collaboration with BMS. Research and development expenses were $248.7 million for the twelve months ended December 31, 2022, compared to $252.6 million for the twelve months ended December 31, 2021. This decrease was primarily driven by a decrease in costs related to our share of research and development expenses under our collaboration with BMS, partially offset by increases in costs for manufacturing activities of suspension lentiviral vector.
• Selling, general and administrative expenses were $18.7 million for the three months ended December 31, 2022, compared to $24.5 million for the three months ended December 31, 2021. Selling, general and administrative expenses were $79.5 million for the twelve months ended December 31, 2022, compared to $93.5 million for the twelve months ended December 31, 2021. The decrease for both the three and twelve-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy bio’s operating model and a decrease in IT and other facility-related costs due to a lower allocation of these costs to selling, general and administrative expense based on headcount and facility square footage.
• Net loss was $23.1 million for the three months ended December 31, 2022, compared to $61.0 million for the three months December 31, 2021. Net loss was $254.2 million for the twelve months ended December 31, 2022, compared to $292.2 million for the twelve months ended December 31, 2021.
• 2seventy bio ended 2022 with cash, cash equivalents and marketable securities of $267.7 million.

About 2seventy bio

Our name, 2seventy bio, reflects why we do what we do – TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering and developing new therapies that truly disrupt the cancer treatment landscape.

With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver next generation cellular therapies that focus on a broad range of hematologic malignancies, including the first FDA-approved CAR T cell therapy for multiple myeloma, as well as solid tumors. Our research and development is focused on delivering therapies that are designed with the goal to “think” smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day.

For more information, visit www.2seventybio.com.

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2seventy bio is a trademark of 2seventy bio, Inc.

Cautionary Note Regarding Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements about our plans, strategies, timelines and expectations with respect to the development, manufacture or sale of our product candidates, including the results and expected timing of ongoing and planned clinical trials for our product candidates and for ABECMA (ide-cel) in additional indications and in earlier line settings; statements about our plans, strategies, timelines and expectations with respect to regulatory approval and related filings for our product candidates; statements regarding our plansto continue to advance our manufacturing strategy to expand capacity for ABECMA across the supply chain; statements regarding expected benefits from our strategic collaboration; statements regarding our projected timing for disclosing data from our ongoing clinical trials; statements about the efficacy and perceived therapeutic benefits of our product candidates and the potential indications, market opportunities and demand therefor; statements about the strategic plans for 2seventy bio and potential corporate development opportunities including collaboration arrangements; statements regarding the company’s financial condition, expenses, results of operations, expectations regarding use of capital, cash runway and other future financial results; and statements about our ability to execute our strategic priorities. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, our limited independent operating history and the risk that our accounting and other management systems may not be prepared to meet the financial reporting and other requirements of operating as an independent public company; the risk that dedicated financial and/or strategic funding sources may not be available on favorable terms or at all; the risk that the separation may adversely impact our ability to attract or retain key personnel; the risk that our BLAs and INDs will not be accepted for filing by the FDA on the timeline that we expect, or at all; the risk that our plans with respect to the preclinical and clinical development and regulatory approval of our product candidates may not be successfully achieved on the planned timeline, or at all; the risk that ABECMA will not be as commercially successful as we may anticipate; and the risk that we are unable to manage our operating expenses or cash use for operations. 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 annual report on Form 10-K for the year ended December 31, 2021, as supplemented and/or modified by our most recent Quarterly Report on Form 10-Q and any other filings that we have made or will make with the Securities and Exchange Commission in the future. All information in this press release is as of the date of the release, and 2seventy bio undertakes no duty to update this information unless required by law.

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Investors:

Elizabeth Pingpank, 860-463-0469

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Media:

Morgan Adams, 774-313-9852

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KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Oncology Health General Health Research Science Pharmaceutical Biotechnology

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