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2seventy bio Inc. reports developments centered on Abecma, its FDA-approved CAR T cell therapy for multiple myeloma, and the U.S. collaboration with Bristol Myers Squibb. News commonly covers Abecma commercialization, regulatory and clinical updates, KarMMa study decisions, collaborative arrangement revenue, operating results, cash position, cost management, material agreements, capital-structure disclosures and governance matters.
2seventy bio reported first-quarter 2022 results, achieving $56 million in U.S. commercial revenue from ABECMA. The company remains on track to meet its revenue guidance of $250-$300 million for the year. The firm ended the quarter with $452.5 million in cash, projecting a runway into 2025. Key milestones include the enrollment of first patients in vital clinical studies for SC-DARIC33 and bbT369, with potential advancements in treatment for AML and B-NHL. The company reported a net loss of $85.7 million, reflecting ongoing investments in its operations.
2seventy bio (NASDAQ: TSVT) announced promising preclinical data for bbT369, a novel CAR T cell therapy targeting CD79a and CD20, showing enhanced efficacy against B cell non-Hodgkin lymphoma (B-NHL). bbT369 aims to address limitations of existing CAR T therapies by overcoming known mechanisms of treatment failure. Currently, the CRC-403 Phase 1/2 study is enrolling patients to assess its safety and efficacy, with initial results expected in 2022. This innovative approach could offer new hope for patients with relapsed or refractory B-NHL.
2seventy bio (Nasdaq: TSVT) will present at the CG Horizons in Oncology Virtual Conference on April 14, 2022, at 1:30 PM ET. The focus will be on new approaches to attacking AML. Live webcasts of the presentations will be accessible in the Investors and Media section of the company's website, with replays available for 30 days afterward. 2seventy bio aims to revolutionize cancer therapies through innovative cell treatments, emphasizing speed and efficacy in research and development.
2seventy bio (Nasdaq: TSVT) closed a $170 million private placement and reported 2021 financial results, with ABECMA generating $158 million in U.S. revenue. The company anticipates 2022 U.S. ABECMA revenues of $250-$300 million, tracking towards the high end due to strong patient demand. Cost reduction measures decreased net cash spend guidance to $190-$220 million for 2022, extending cash runway into 2025.
Positive developments include increased ABECMA manufacturing capacity planned for 2022, and key management appointments to drive growth.
2seventy bio, Inc. (NASDAQ: TSVT) has announced a private placement sale of approximately 13.9 million shares at $12.20 per share, raising around $170 million. The financing, closing on March 17, 2022, will bolster the company's cash runway through 2025, supporting its ongoing research, development, and commercialization of ABECMA. With a cash reserve of $362.2 million at the end of 2021, combined with a decrease in net cash spend to $190-$220 million, the company is positioned for critical upcoming milestones.
2seventy bio, Inc. (NASDAQ: TSVT) announced key leadership appointments, welcoming Steven Bernstein, M.D. as chief medical officer and promoting Susan Abu-Absi, Ph.D. to chief technology & manufacturing officer. Dr. Bernstein brings over 25 years of experience in oncology and translational science, while Dr. Abu-Absi has a solid background in cell and gene therapy development. The company aims to enhance its cell therapy product engine, focusing on transformative treatments for cancer patients.
2seventy bio (NASDAQ: TSVT) announced its participation in two upcoming investor conferences. The first is the SVB Leerink 10th Annual Global Healthcare Conference on February 16, 2022, at 2:20pm ET, featuring a fireside chat. The second event is the Cowen Virtual 42nd Annual Healthcare Conference on March 7, 2022, at 12:50pm ET, where the company will discuss "Novel Oncology Targets." Live webcasts will be available on 2seventy bio's website, with replays archived for 30 days.
2seventy bio provided a strong outlook for 2022, predicting $250-300M in location value="LC/us"U.S. revenue from its CAR-T product ABECMA, which has generated $150M in 2021. The company ended 2021 with approximately $360M in cash, expecting a reduced net cash spend of $220-250M in 2022. The FDA has cleared the IND for bbT369 targeting B-cell non-Hodgkin lymphoma, and a new solid tumor CAR-T program targeting MUC16 was unveiled, reflecting ongoing innovation in their pipeline.
2seventy bio has entered an option and license agreement with Novo Nordisk for developing an in vivo gene editing treatment for hemophilia A, leveraging its megaTAL™ technology. The agreement includes an upfront payment of $5 million and eligible future payments totaling $40 million. Additionally, 2seventy bio has partnered with Genevant Sciences to utilize its lipid nanoparticle technology for mRNA delivery. This collaboration is seen as a significant expansion of 2seventy bio's oncology pipeline.
2seventy bio (NASDAQ: TSVT) announced new clinical data from its oncology cell therapy portfolio at the American Society of Hematology Annual Meeting. Key highlights include updates from the Phase 1 CRB-402 study of bb21217 for multiple myeloma and analyses from the pivotal KarMMa study of ABECMA, the first CAR T cell therapy for this condition. Patients treated with ABECMA showed improved quality of life and durable responses, with 69% overall response rates and a 23.8-month median duration of response. Preclinical data for SC-DARIC33 were also presented, indicating its potential to treat pediatric AML.