\n\u201cIn our first full year of operations, 2seventy made tremendous strides across all aspects of our business: from advancing early-stage research, building out manufacturing capabilities, initiating clinical studies, and delivering to patients in the commercial setting with Abecma<\/i>,\u201d said Nick Leschly, chief kairos officer. \u201cBolstered by strong growth in the fourth quarter, we delivered Abecma <\/i>to hundreds of patients with multiple myeloma in the U.S. and expect continued strong growth in 2023. With our partners at BMS, we continue to develop this product into earlier lines of multiple myeloma treatment on the back of positive data from the KarMMa-3 study and the planned KarMMa-9 study and continue to grow our manufacturing capabilities to support a potential peak sales opportunity of $2-3 billion in the U.S. With our recent financing and the growth of Abecma, <\/i>we are in a strong position to continue to prudently advance our clinical and preclinical pipeline, driving towards delivering proof-of-concept data this year for our bbT369 and SC-DARIC33 programs and advancement of MUC and MAGE solid tumor programs to IND by the end of the year. I couldn\u2019t be more optimistic for what lies ahead in 2023 and the position we are in today, and that is thanks to the hard work of our employees, the patients and physicians who participate in our studies, and our shareholders who share in our mission to deliver more time to patients with cancer.\u201d\n<\/p>\n
Abecma<\/i> Commercial Summary
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<\/b>Our partner, Bristol Myers Squibb (BMS), reported total U.S. Abecma <\/i>(idecabtagene vicleucel; ide-cel) fourth quarter revenues of $94 million, which represents 25% growth over the prior quarter, and 40% growth over the fourth quarter of 2021, and full year revenues of $297 million, which is in line with our stated 2022 U.S. Abecma<\/i> revenue guidance of $250-300 million, in each case such revenue is shared equally with BMS. Assuming continued strong demand for Abecma<\/i> and achievement of planned increases in manufacturing capacity throughout the year, we anticipate topline 2023 U.S. revenues of $470-570 million.\n<\/p>\n
\nAssuming continued increases in manufacturing capacity and growth in the addressable patient population based on an anticipated approval in 3L+ multiple myeloma, we expect Abecma<\/i> to generate $200-300 million in operating income for 2seventy bio in the 2024-25 period.\n<\/p>\n
\nWe reported Abecma<\/i>-related collaborative arrangement revenue of $8.7 million for the fourth quarter of 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the year.\n<\/p>\n
Financial Guidance
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<\/b>At the end of February 2023, 2seventy bio raised approximately $117 million in net proceeds through a public equity offering. Based on our current operating plans, which includes these net proceeds and the ongoing commercialization of Abecma,<\/i> we believe our current cash position will be sufficient to fund operations into 2026.\n<\/p>\n
\n\u201cThe financial outlook for 2seventy continues to strengthen, and the recent equity financing puts us in a privileged position, with cash runway now into 2026,\u201d said Chip Baird, chief financial officer. \u201cWe expect the cash flow from the Abecma<\/i> collaboration to grow significantly over the 2023-25 time period, which will continue to reduce our annual net cash spend and our need for future capital infusions. Our pipeline programs have the potential to deliver meaningful benefit for cancer patients and we will balance an entrepreneurial mindset with a disciplined approach to capital allocation.\u201d\n<\/p>\n
RECENT HIGHLIGHTS
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<\/b>KARMMA-3 DATA IN NEJM – <\/b>On February 10, 2023, 2seventy announced the publication of our KarMMa-3 data in the New England Journal of Medicine. <\/i>The positive results of this pivotal Phase 3 showed at median follow up of 18.6 months, treatment with Abecma <\/i>(n=254)demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001). This represents a 51% reduction in risk of disease progression or death with Abecma. <\/i>Based on results from KarMMa-3, Abecma <\/i>is the first and only chimeric antigen receptor (CAR) T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. 2seventy and BMS anticipate submitting an sBLA to the FDA in the first quarter of 2023 to seek approval in the third line setting.\n<\/p>\n
REGENERON COLLABORATION AMENDMENT<\/b> \u2013 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\u2019s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron\u2019s 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.\n<\/p>\n
BOARD APPOINTMENT \u2013 <\/b>Earlier this month, 2seventy bio announced the appointment of Wei Lin, M.D. to the company\u2019s Board of Directors.\n<\/p>\n
UPCOMING ANTICIPATED MILESTONES PIPELINE<\/b><\/p>\n FINANCIAL GUIDANCE<\/b><\/p>\n SELECT FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS<\/b><\/p>\n 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.\n<\/p>\n \nFor more information, visit www.2seventybio.com<\/a>.\n<\/p>\n \nFollow 2seventy bio on social media: Twitter<\/a> and LinkedIn<\/a>.\n<\/p>\n \n2seventy bio is a trademark of 2seventy bio, Inc.\n<\/p>\n Cautionary Note Regarding Forward-Looking Statements 2seventy bio, Inc.<\/b><\/p>\n Condensed Consolidated and Combined Statements of Operations and Comprehensive Loss<\/b><\/p>\n (unaudited)<\/b><\/p>\n (in thousands)<\/b><\/p>\n<\/td>\n<\/tr>\n For the three months ended December 31,<\/b><\/p>\n<\/td>\n For the twelve months ended December 31,<\/b><\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2021<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2022<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n 2021<\/b><\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n$\n<\/p>\n<\/td>\n \n41,126\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n3,836\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n55,489\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n$\n<\/p>\n<\/td>\n \n21,381\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n13,933\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n11,394\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n32,358\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n26,921\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n \n\u00a0\n<\/p>\n<\/td>\n \n1,118\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n803\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n3,649\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n \n6,220\n<\/p>\n<\/td>\n 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\n23,499\n<\/p>\n<\/td>\n \n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
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<\/b>ABECMA<\/b><\/p>\n\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.\n<\/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, 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\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, 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.<\/i><\/p>\n\n
\n \n \n \n \n \u00a0<\/td>\n \u00a0<\/td>\n<\/tr>\n \n \n \n \u00a0<\/td>\n \n \n \n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Revenue:<\/td>\n \n \u00a0<\/td>\n \n \u00a0<\/td>\n \n \u00a0<\/td>\n <\/tr>\n \n Service revenue<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Collaborative arrangement revenue<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Royalty and other revenue<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Total revenues<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Operating expenses:<\/td>\n \n \u00a0<\/td>\n \n \u00a0<\/td>\n \n \u00a0<\/td>\n <\/tr>\n \n Research and development<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Cost of manufacturing for commercial collaboration<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Selling, general and administrative<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Share of collaboration loss<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Cost of royalty and other revenue<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Change in fair value of contingent consideration<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Total operating expenses<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Loss from operations<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Interest income, net<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Other (loss) income, net<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Loss before income taxes<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Income tax (expense) benefit<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Net loss<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Net loss per share – basic and diluted<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \n Weighted-average number of common shares used in computing net loss per share – basic and diluted<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n \u00a0<\/td>\n \n \n \n
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