CAMBRIDGE, Mass. - 2seventy bio, Inc. (NASDAQ:TSVT) and Bristol Myers Squibb (NYSE:BMY) have jointly announced the discontinuation of enrollment in the Phase 3 KarMMa-9 study. The study was evaluating the efficacy of Abecma with lenalidomide maintenance in newly diagnosed multiple myeloma (NDMM) patients with a suboptimal response to autologous stem cell transplant.
The decision is expected to save 2seventy bio over $80 million in the coming years and accelerate the company's path to breakeven in 2025. The move comes as the treatment landscape for NDMM has significantly improved, leading to fewer eligible patients for the study than initially anticipated.
Despite the halt, 2seventy bio reports a re-acceleration in Abecma's U.S. revenues, expecting a 30% increase in third-quarter revenue from the second quarter's $54 million. The demand for Abecma, as indicated by new patients undergoing apheresis, is also projected to show double-digit growth compared to the previous quarter.
Abecma, a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy, is indicated for adult patients with relapsed or refractory multiple myeloma after at least two prior lines of therapy. The therapy has a differentiated safety profile and competitive efficacy, particularly when combined with effective bridging therapies.
Chip Baird, CEO of 2seventy bio, emphasized the company's commitment to value creation for all stakeholders and the continued focus on delivering more time for patients. Anna Truppel-Hartmann, Chief Medical Officer, expressed gratitude to the patients, families, investigators, and study staff involved in the trial.
2seventy bio and Bristol Myers Squibb share equally in the profits and losses related to the development, manufacturing, and commercialization of Abecma in the U.S. The companies remain dedicated to expanding Abecma's reach to multiple myeloma patients.
This news is based on a press release statement and reflects the current expectations and projections about the financial performance and corporate strategies of 2seventy bio and Bristol Myers Squibb.
In other recent news, 2Seventy Bio reported significant developments in its Q2 2024 earnings call, with a spotlight on its ABECMA product. The company noted modest revenue growth and double-digit patient growth in apheresis for ABECMA, alongside a reduction of $28 million in operating expenses. The firm also recorded collaboration revenue of $4.4 million with Bristol-Myers Squibb (NYSE:BMY) and highlighted the FDA's approval for earlier line patient treatment, which has boosted ABECMA's performance in the US market.
In terms of future expectations, 2Seventy Bio anticipates further reductions in operating expenses into 2025 and projects a revised net cash spend range for 2024 between $40 million and $60 million. The company also expects ABECMA to return to growth in the upcoming months. However, it's important to note that the company refrained from providing specific revenue guidance for ABECMA sales and updates on the timing of pipeline assets led by Regeneron (NASDAQ:REGN).
Analysts have provided mixed feedback, with some expressing concerns over the lack of specific revenue guidance and pipeline updates. However, others have focused on the positive aspects of ABECMA's safety profile, its increased use due to FDA approval, and significant progression-free survival and efficacy benefits shown in clinical trials.
InvestingPro Insights
In light of 2seventy bio's strategic decision to discontinue the KarMMa-9 study, an analysis of the company's financial health and market performance provides additional context for investors. According to InvestingPro data, 2seventy bio, Inc. (NASDAQ:TSVT) has a market capitalization of approximately $246.68 million, demonstrating its standing in the biotech sector. Despite analysts anticipating a sales decline in the current year, 2seventy bio's liquid assets are reported to exceed its short-term obligations, which may provide some financial stability as the company navigates through its strategic shift.
The company's stock price movements have been quite volatile, with a notable strong return over the last three months of 26.86%. This could be indicative of investor confidence in the company's long-term prospects despite recent challenges. Additionally, the InvestingPro Tips highlight that the company is not expected to be profitable this year, and has been unprofitable over the last twelve months. These insights suggest a cautious approach for investors considering the company's performance trajectory.
With a P/E Ratio of -1.55 and an adjusted P/E Ratio for the last twelve months as of Q2 2024 of -1.47, the company's valuation metrics reflect its current lack of profitability. However, the company's price/book ratio stands at a relatively modest 1.05, which could appeal to value-oriented investors.
For those interested in a deeper dive into the financials and strategic outlook of 2seventy bio, InvestingPro offers additional tips for a comprehensive analysis. There are a total of 10 InvestingPro Tips available, which can be accessed for more detailed guidance on the company's financial health and market performance at https://www.investing.com/pro/TSVT.
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