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CAMBRIDGE, Mass.--(BUSINESS WIRE)--2seventy bio, Inc. (Nasdaq: TSVT), today announced a restructuring of its business operations and research and development model to significantly reduce costs while supporting the execution of a prioritized plan for the long-term growth of the company.
马萨诸塞州剑桥-(BUSINESS WIRE)-2seventy bio,Inc。(纳斯达克股票代码:TSVT)今天宣布重组其业务运营和研发模式,以大幅降低成本,同时支持执行优先计划公司的长期成长。
“2seventy’s mission remains the same: to unleash the power of the T-cell and develop un-incremental treatments for people living with cancer,” said Nick Leschly, chief kairos officer. “However, the macro environment for oncology cell therapy companies and the near-term headwinds we have seen in our own business have led us to examine how we pursue our mission.
凯洛斯首席官尼克·莱斯利(Nick Leschly)说:“2事件的使命保持不变:释放T细胞的力量,为癌症患者开发联合国渐进式治疗方案。“然而,肿瘤细胞治疗公司的宏观环境和我们在自己的业务中看到的近期头风使我们研究了我们如何追求我们的使命。
Today we are taking hard but necessary steps to streamline our team and optimize our R&D approach and cost structure. In this process, we have focused on how to move efficiently and more cost effectively to develop innovative therapies for patients and create value for shareholders. Unfortunately, we will be saying goodbye to many highly talented and committed members of our team.
今天,我们正在努力但必要的步骤来简化我们的团队并优化我们的研发方法和成本结构。在这个过程中,我们专注于如何高效和更具成本效益地为患者开发创新疗法并为股东创造价值。不幸的是,我们将祝贺我们团队中许多极具才能和忠诚的成员。
I want to thank each of them for their amazing dedication to 2seventy and our mission to help those in need, doing everything we can to deliver more TIME.”.
我要感谢他们每个人对2事件的惊人奉献,以及我们帮助有需要的人的使命,尽我们所能提供更多时间“。
“The difficult but necessary changes we are making to our workforce, our programs and our cost structure reflect our commitment to advancing our pipeline and achieving value creating milestones with existing cash,” said Chip Baird, chief operating officer. “Our U.S. Abecma collaboration provides a source of revenue to offset investment in our pipeline programs, and while we continue to be optimistic about Abecma’s future, particularly given the potential third-line label expansion at the end of the year, we are planning conservatively.
首席运营官Chip Baird说:“我们对劳动力,计划和成本结构所做的艰难但必要的改变反映了我们致力于推进我们的管道并利用现有现金实现创造价值的里程碑。“我们的美国Abecma合作提供了一个收入来源来抵消我们管道计划的投资,虽然我们对Abecma的未来仍然持乐观态度,特别是考虑到年底潜在的三线标签扩张,我们正在保守规划。
We expect today’s changes will preserve runway into at least 2026, and we will continue to focus on careful expense management and thoughtful capital allocation while staying true to our mission of driving programs forward for patients in need. I echo Nick’s gratitude to the members of our team who will be departing 2seventy and look forward to continuing to uphold 2seventy’s unwavering focus on patients as we move into a new chapter.”.
我们预计今天的变化将使跑道保持至少2026年,我们将继续关注谨慎的费用管理和深思熟虑的资本分配,同时坚持我们为有需要的患者推进驾驶计划的使命。我感谢尼克对我们团队的成员们的感谢,他们将离开2Sevent,并期待在我们进入新章节时继续坚持2Sevent对患者的坚定关注。
Business Updates, Restructure Actions and Financial Impacts
业务更新,重组行动和财务影响
Elimination of 176 roles, representing approximately 40% of our workforce
取消176个角色,约占我们劳动力的40%
Expected annualized cost savings of at least $65 million, or approximately $130 million in the 2024-2025 period; additional savings possible as we continue rigorous efforts to right-size facilities and related external spend by 2025 to better reflect our current needs.
预计2024-2025年期间每年至少节省6500万美元或约1.3亿美元;随着我们在2025年继续努力调整设施规模和相关外部支出以更好地反映我们目前的需求,我们可以节省更多资金。
One-time restructuring costs of approximately $9 million, primarily incurred in the third quarter of 2023.
一次性重组成本约为900万美元,主要发生在2023年第三季度。
Implemented a capital-efficient translational development paradigm blending internal manufacturing (270-MPH), our expanded JW Therapeutics collaboration as well as select academic centers to efficiently explore our innovative cell therapies in the clinic
实施了融合内部制造(270-MPH)的资本高效转化发展范式,我们扩大了JW Therapeutics合作,并选择了学术中心,以有效探索我们在临床上的创新细胞疗法
Current balance of cash, cash equivalents, and marketable securities expected to support operations into 2026
目前的现金,现金等价物和可销售证券余额预计将支持到2026年的运营
Abecma and Pipeline Portfolio Updates
Abecma和管道组合更新
Abecma “Return to Growth:”
Abecma“回归增长:
Revenue and impact to 2seventy: Based on an anticipated decline in Abecma sales in the third quarter, we believe full-year 2023 U.S. revenue for Abecma could be lower than the $470-$570 million range previously projected. 2seventy continues to expect Abecma to remain profitable this year and contribute significantly toward our cash runway into at least 2026 and remains confident in Abecma’s long-term commercial potential..
收入和对2事件的影响:根据预计第三季度Abecma销售额下降,我们认为Abecma全年2023年美国收入可能低于此前预计的4.7亿至5.7亿美元范围。2事件继续期望Abecma今年保持盈利,并至少在2026年为我们的现金跑道做出重大贡献,并对Abecma的长期商业潜力保持信心。。
Upcoming Milestones: The December 16, 2023 PDUFA date for potential label expansion based on the KarMMa-3 data in adult patients with triple-class exposed relapsed or refractory multiple myeloma and the planned initiation of the KarMMa-9 study in patients with newly diagnosed multiple myeloma with sub-optimal response post-ASCT later this year provide both short- and medium-term grounds for continued optimism in the commercial potential of Abecma..
即将到来的里程碑:12月16日,2023年PDUFA基于成人三级暴露复发或难治性多发性骨髓瘤患者的KarMMa-3数据进行潜在标签扩展的日期,以及计划在新诊断的多发性骨髓瘤患者中开始KarMMa-9研究,ASCT后反应欠佳今年晚些时候为商业持续乐观提供了短期和中期的理由Abecma的潜力。。
Updates on bbT369 and SC-DARIC-33 Programs
bbT369和SC-DARIC-33程序的更新
Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) (wholly-owned)
bbT369在复发和/或难治性B细胞非霍奇金淋巴瘤(B-NHL)(国有)患者中的I期CRC-403研究
Clinical Data Update: Today, 2seventy is disclosing that the safety profile, CAR expansion kinetics, including the potential role of the CBL-B gene edit, and the clinical efficacy data, including complete responses in some patients observed to date is supportive of the Company’s decision to continue the Phase I study..
临床数据更新:今天,2事件披露了安全性,CAR扩展动力学,包括CBL-B基因编辑的潜在作用,以及临床疗效数据,包括迄今为止观察到的一些患者的完全反应,支持该公司的决定继续进行I期研究。。
Future Development: While interest and enrollment at clinical study sites has been strong and initial data are encouraging, the Phase I dose escalation study of bbT369 has progressed slower than anticipated, due in part to the FDA mandated safety stagger and the often-aggressive nature of relapsed and/or refractory B-NHL, which can result in patients becoming ineligible for treatment.
未来发展:虽然临床研究地点的兴趣和入学率很高,初步数据令人鼓舞,但bbT369的I期剂量递增研究进展缓慢于预期,部分原因是FDA规定的安全错失和经常具有攻击性复发和/或难治性B-NHL,这可能导致患者不符合治疗条件。
Despite these challenges, the study is actively enrolling at the third dose level. Given the anticipated pace of accrual and treatment, the Company expects to present the first data from the bbT369 study at a medical meeting in 2024..
尽管存在这些挑战,但该研究正在积极参与第三剂量水平。鉴于预期的应计和治疗速度,公司预计将在2024年的医疗会议上提交bbT369研究的第一批数据。。
Consistent with the rest of the pipeline, the Company has markedly streamlined the cost structure for this program, gating further investment beyond Phase I on the achievement of transformational efficacy.
与其余部分一致,该公司显着简化了该计划的成本结构,为实现转型效率提供了超越第一阶段的进一步投资。
PLAT-08 clinical study of SC-DARIC-33 in acute myeloid leukemia (AML) and next generation AML program (wholly-owned)
SC-DARIC-33在急性髓性白血病(AML)和下一代AML计划(国有)中的PLAT-08临床研究
The Company is working with the FDA to enable restart of the Phase 1 study, which is currently on clinical hold. 2seventy plans to limit financial commitment to the current Phase I trial.
该公司正在与FDA合作,重新启动目前处于临床暂停状态的1期研究。2最终计划限制对当前I期试验的财务承诺。
The Company will provide the next update on the PLAT-08 study upon completion of the Phase I dose escalation.
在完成I期剂量递增后,公司将提供PLAT-08研究的下一次更新。
Partnered pipeline continues to develop and expand – two new programs approaching the clinic at year end
合作的管道继续发展和扩大——年底有两个新的项目接近诊所
MUC-16 program in ovarian cancer (Regeneron partnership)
MUC-16卵巢癌计划(Regeneron合作伙伴关系)
IND submission is on track and anticipated by the end of 2023
IND提交正在进行中,预计到2023年底
MAGE-A4 T cell receptor (TCR) program in solid tumors (led by JW Therapeutics)
实体瘤中的MAGE-A4 T细胞受体(TCR)程序(由JW Therapeutics领导)
Led by JW Therapeutics, initiation of an investigator-initiated study in China is ahead of schedule and anticipated by end of 2023.
在JW Therapeutics的领导下,在中国开展的一项由研究者发起的研究提前完成,预计到2023年底。
JW Therapeutics Partnership Expansion
JW Therapeutics Partnership扩展
As announced in a separate press release today, 2seventy bio and JW Therapeutics are planning to expand their collaboration to include an additional solid tumor program and the first-in-human assessment of 2seventy’s proprietary autoimmune-directed CAR T cell product.
正如今天在另一份新闻稿中所宣布的那样,2seventy bio和JW Therapeutics计划扩大合作范围,包括额外的实体肿瘤计划和2seventy专有的自身免疫定向CAR T细胞产品的首次人体评估。
Leadership Transitions
领导转变
Nick Leschly has informed the Company’s Board of Directors that he intends to step down as CEO upon the Board’s identification of his successor. The Company expects that Mr. Leschly will be appointed Chairman of the Board upon this transition. The Board has retained an executive recruitment firm to assist with the search for Mr.
尼克·莱什利(Nick Leschly)告知该公司的董事会,他打算在董事会确定其继任者后辞职为首席执行官。该公司预计Leschly先生将在此次转型后被任命为董事会主席。董事会保留了一家高管招聘公司,协助寻找先生。
Leschly’s successor as CEO..
Leschly担任首席执行官的继任者。。
“After nearly 14 years as CEO of bluebird and 2seventy I feel beyond grateful and humbled to have had the opportunity to help bring four cell therapies to patients and do our part to advance the field,' said Nick Leschly, chief kairos officer. 'I very much look forward to continuing to work closely with the board and leadership team to advance 2seventy’s mission for patients.'.
凯洛斯首席官尼克·莱斯利(Nick Leschly)说:“作为蓝鸟(bluebird)首席执行官和2seventy的首席执行官近14年后,我感到非常感激,谦卑有机会帮助为患者带来四种细胞疗法,并为推进该领域做出贡献。”我非常期待继续与董事会和领导团队密切合作,推进2seventy对患者的使命。
Additionally, Chip Baird, formerly Chief Financial Officer, is now Chief Operating Officer expanding his responsibilities to include finance, corporate development, investor relations and corporate communications as well as portfolio and program/alliance management.
此外,前首席财务官Chip Baird现在是首席运营官,扩大其职责,包括财务,公司发展,投资者关系和公司沟通以及投资组合和计划/联盟管理。
Conference Call Information
电话会议信息
2seventy bio will host a conference call and live webcast today, September 12, at 8:00 a.m. ET to discuss today’s announcement. To join the live conference call, please register at: https://register.vevent.com/register/BIc10c340a7f244db5a5fc17394a8f3552. Upon registering, each participant will be provided with call details and access codes.
2seventy bio将于9月12日上午8:00召开电话会议和现场网络广播,讨论今天的公告。要加入现场电话会议,请注册:https://register.vevent.com/register/BIc10c340a7f244db5a5fc17394a8f3552.注册后,将为每个参与者提供呼叫详细信息和访问代码。
The live webcast may be accessed by visiting the event link at: https://edge.media-server.com/mmc/p/rd7agmkn. A replay of the webcast may be accessed from the “News and Events” page in the Investors and Media section of the Company’s website at https://ir.2seventybio.com/ and will be available for 30 days following the event..
可以通过访问以下活动链接访问实时网络广播:https://edge.media-server.com/mmc/p/rd7agmkn.可以从公司网站的投资者和媒体部分的“新闻和事件”页面访问网络广播的回放https://ir.2seventybio.com/并将在活动结束后30天内提供。。
About 2seventy bio
关于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..
我们的名字2seventy bio反映了我们为什么要做我们的事-时间。癌症已经过时了,我们的目标是以最大的速度将人类思想转化为行动-每小时270英里-为我们服务的人提供更多的时间。我们正在建立领先的免疫肿瘤细胞治疗公司,专注于发现和开发真正破坏癌症治疗领域的新疗法。。
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.
通过深入了解人体对肿瘤细胞的免疫反应以及如何将细胞疗法转化为实践,我们正在应用这些知识来提供专注于广泛血液系统恶性肿瘤的下一代细胞疗法,包括第一个FDA批准的CAR T细胞治疗多发性骨髓瘤,以及实体瘤。
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..
我们的研究和开发专注于提供旨在“思考”比疾病更聪明,更快的疗法。重要的是,我们仍然专注于通过保持真实和真实的“为什么”来实现这些目标,并每天将我们的人民和文化置于首位。。
For more information, visit www.2seventybio.com.
有关更多信息,请访问www.2seventybio.com。
Follow 2seventy bio on social media: X (Twitter) and LinkedIn.
在社交媒体上遵循2seventy bio:X(Twitter)和LinkedIn。
2seventy bio is a trademark of 2seventy bio, Inc.
2seventy bio是2seventy bio,Inc。的商标。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性陈述的警示
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) timelines and expectations with respect to regulatory approval and related filings for our product candidates; statements regarding expected ABECMA U.S.
本版本包含适用法律法规范围内的“前瞻性声明”。这些声明包括但不限于:关于我们的计划,策略,时间表和对我们产品候选人的开发,制造或销售的期望的声明,包括我们产品候选人和ABECMA(ide cel)时间表正在进行和计划进行的临床试验的结果和预期时间,以及我们产品候选人的监管批准和相关文件的期望;关于预期ABECMA美国的声明。
revenue; statements regarding expected benefits from our strategic collaborations; 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; the implementation, timing and results of our strategic restructuring efforts; the estimated charges and costs expected to be incurred in connection with such restructuring efforts and the projected cost savings resulting from such restructuring efforts; the anticipated resignation of our CEO and the Company’s expectation regarding his appointment as Chairman; 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.
收入;关于我们战略合作预期收益的声明;关于我们预计披露我们正在进行的临床试验数据的时间的声明;关于我们的产品候选人的功效和感知治疗益处的陈述以及潜在的适应症;关于2seventy bio战略计划和潜在企业发展机会(包括合作安排)的声明;我们战略重组工作的实施,时机和结果;预计与此类重组工作相关的预计费用和成本以及此类重组工作所产生的预计成本节约;我们首席执行官的预期辞职以及公司对其任命主席的期望;关于公司财务状况,费用,运营结果,对资本使用的期望,现金跑道和其他未来财务结果的陈述;以及关于我们执行战略优先事项的能力的声明。
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, uncertain.
本新闻稿中的任何前瞻性声明均基于管理层当前的期望和信念,并存在许多不确定的风险。