2seventy bio Q1 2024 Financial Results and Recent Progress

2seventy bio, Inc. has reported its financial results and recent highlights for the first quarter ending March 31, 2024. In this period, the company completed a strategic realignment to focus exclusively on Abecma, a treatment for multiple myeloma, aiming to drive commercial growth and financial sustainability.

The U.S. FDA recently approved Abecma for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, based on the KarMMa-3 trial results. This approval broadens the patient base eligible for Abecma, which had first-quarter revenues of $52 million in the U.S., as reported by Bristol Myers Squibb (BMS). The commercialization efforts, in partnership with BMS, are expected to return to growth in the latter half of 2024, despite competitive dynamics.

Additionally, the FDA approved the use of a suspension lentiviral vector (sLVV) for manufacturing Abecma, anticipated to support increased demand. Both 2seventy bio and BMS share equally in the profits and losses related to Abecma’s development, manufacturing, and commercialization in the U.S. The company reported a collaborative arrangement loss of $1.2 million for the quarter.

Financially, 2seventy bio recorded total revenues of $12.4 million for the first quarter, a decline from $41.6 million in the same period of 2023. Research and development expenses were $43.9 million, down from $68.2 million. Selling, general, and administrative expenses also decreased to $12.7 million from $20.7 million. Restructuring expenses were $4.2 million, with no such expenses in the first quarter of 2023. The net loss for the quarter was $52.7 million, compared to $47 million in the previous year.

The company ended the quarter with $181.4 million in cash, cash equivalents, and marketable securities, providing a cash runway beyond 2027.

Abecma, targeted at B-cell maturation antigen (BCMA), is a genetically modified autologous T cell immunotherapy for treating adult patients with triple-class exposed relapsed or refractory multiple myeloma. The therapy involves significant safety warnings, including risks of Cytokine Release Syndrome (CRS), neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), prolonged cytopenia, and secondary hematological malignancies. CRS, a potentially life-threatening condition, occurred in 89% of patients treated in clinical trials. Neurologic toxicities were reported in 40% of patients, with severe cases in some instances.

2seventy bio and BMS continue to address these safety concerns and manage the risks associated with Abecma through comprehensive monitoring and supportive care measures. The therapy is available only under a Risk Evaluation and Mitigation Strategy (REMS) program due to its associated risks.

The company remains focused on commercializing Abecma exclusively, following its strategic divestiture of other research and development areas to Regeneron. This move is expected to streamline operations and reduce costs, enhancing 2seventy bio’s ability to concentrate on the growth and development of Abecma.

In summary, 2seventy bio has strategically repositioned itself to focus on Abecma, aiming for commercial growth and long-term financial stability. The recent FDA approval is set to expand the therapy’s market, despite the competitive landscape, and the company is well-positioned financially to sustain its operations and growth initiatives.