\n\u201cWe are off to a strong start in 2023, with a sharp focus on timely execution across our commercial business, clinical programs, and research pipeline,\u201d said Nick Leschly, chief kairos officer, 2seventy bio. \u201cAbecma <\/i>revenue remains on a strong growth trajectory as we continue to successfully execute with BMS on manufacturing scale-ups to deliver Abecma<\/i> to myeloma patients. The successful steps taken to date to increase vector and drug product manufacturing support the achievement of the upper end of our U.S. revenue guidance range. With the recent FDA acceptance of our Abecma <\/i>sBLA based on our KarMMa-3 study, we look forward to the opportunity to offer this transformational product to patients in earlier lines of treatment and, if approved, will enable us to serve thousands of additional patients in the U.S. We have made significant progress across our pipeline, and we plan to share initial clinical data from our SC-DARIC33 program for acute myeloid leukemia at the ASGCT Annual Meeting. We also look forward to providing a more in-depth look into both Abecma<\/i> and our pipeline programs, including promising pre-clinical data in our in-vivo<\/i> gene editing hemophilia A program, at our upcoming R&D Deep Dive. We believe 2023 will be a transformative year for 2seventy as we continue in our mission to deliver more time for patients living with cancer.\u201d<\/p>\n
SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS<\/b><\/p>\n Abecma<\/i> Manufacturing Progress<\/b><\/p>\n Abecma<\/i> Clinical and Regulatory Highlights<\/b><\/p>\n NOVO NORDISK COLLABORATION<\/b><\/p>\n ASGCT ABSTRACTS ACCEPTED<\/b><\/p>\n UPCOMING ANTICIPATED PIPELINE MILESTONES<\/b><\/p>\n SELECT FIRST QUARTER FINANCIAL RESULTS<\/b><\/p>\n RESEARCH & DEVELOPMENT (R&D) DEEP DIVE Conference Call Information About 2seventy bio \nWith a deep understanding of the human body\u2019s immune response to tumor cells and how to translate cell therapies into practice, we\u2019re 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 \u201cthink\u201d smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our \u201cwhy\u201d and keeping our people and culture top of mind every day.<\/p>\n \nFor more information, visit www.2seventybio.com<\/a>.<\/p>\n \nFollow 2seventy bio on social media: Twitter<\/a> and LinkedIn<\/a>.<\/p>\n \n2seventy bio is a trademark of 2seventy bio, Inc.<\/p>\n Cautionary Note Regarding Forward-Looking Statements 2seventy bio, Inc.<\/b><\/p>\n<\/td>\n<\/tr>\n Condensed Consolidated and Combined Statements of Operations and Comprehensive Loss<\/b><\/p>\n<\/td>\n<\/tr>\n (unaudited)<\/b><\/p>\n<\/td>\n<\/tr>\n (in thousands)<\/b><\/p>\n<\/td>\n<\/tr>\n For the three months ended 2023<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n<\/tr>\n \n$<\/p>\n<\/td>\n \n10,826<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n4,055<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n29,372<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n3,487<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n1,423<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n887<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n41,621<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n8,429<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n68,246<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n65,879<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n3,654<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n3,366<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n20,720<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n23,861<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n–<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n5,352<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n641<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n511<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n73<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n48<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n93,334<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n99,017<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n(51,713<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(90,588<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n2,049<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n115<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n2,643<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n4,762<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n(47,021<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(85,711<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n–<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n–<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \n$<\/p>\n<\/td>\n \n(47,021<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(85,711<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \n$<\/p>\n<\/td>\n \n(1.08<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(3.20<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \n\u00a0<\/p>\n<\/td>\n \n43,468<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n26,751<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n\n
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<\/b>2seventy bio will host a virtual R&D Deep Dive on Friday, May 19, from 10:00 a.m. \u2013 11:30 a.m. ET to highlight the Company\u2019s R&D pipeline, including updates following the 2023 ASGCT Annual Meeting, as well as an Abecma <\/i>commercial update and additional details from the hemophilia A program. Registration and access to the live webcast may be found by visiting the \u201cEvents and Presentations\u201d page in the Investors and Media section of the Company\u2019s website at https:\/\/ir.2seventybio.com\/<\/a>. A replay will be archived on the 2seventy bio website for 30 days following the event.<\/p>\n
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<\/b>2seventy bio will host a conference call and live webcast today, May 3, at 4:30 p.m. ET to discuss 1Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https:\/\/register.vevent.com\/register\/BI458c3098c2a64310b49e967327a906e7<\/a>. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: https:\/\/edge.media-server.com\/mmc\/p\/8migsv6v<\/a>. A replay of the webcast may be accessed from the \u201cNews and Events\u201d page in the Investors and Media section of the Company\u2019s website at https:\/\/ir.2seventybio.com\/<\/a> and will be available for 30 days following the event.<\/p>\n
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<\/span><\/b>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 \u2013 270 miles per hour \u2013 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.<\/p>\n
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<\/b>This release contains \u201cforward-looking statements\u201d 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 plans<\/i>to 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; statements about the strategic plans for 2seventy bio and potential corporate development opportunities including collaboration arrangements; statements regarding the Company\u2019s 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 \u201cRisk Factors\u201d in our annual report on Form 10-K for the year ended December 31, 2022, 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.<\/i><\/p>\n\n
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March 31,<\/b><\/p>\n<\/td>\n<\/tr>\n\n \n \u00a0<\/td>\n \n \n \n \n Revenue:<\/td>\n \u00a0<\/td>\n \n \n <\/tr>\n \n Service revenue<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Collaborative arrangement revenue<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Royalty and other revenue<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Total revenues<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Operating expenses:<\/td>\n \u00a0<\/td>\n \n \n <\/tr>\n \n Research and development<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Cost of manufacturing for commercial collaboration<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Selling, general and administrative<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Share of collaboration loss<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Cost of royalty and other revenue<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Change in fair value of contingent consideration<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Total operating expenses<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Loss from operations<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Interest income, net<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Other income, net<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Loss before income taxes<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Income tax (expense) benefit<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Net loss<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Net loss per share – basic and diluted<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n \n Weighted-average number of common shares used in computing net loss per share – basic and diluted<\/td>\n \u00a0<\/td>\n \n \n \n \n \n \n \n
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