2seventy bio Reports Fourth Quarter and Full Year 2024 Financial Results

Entered into definitive merger agreement to be acquired by Bristol Myers Squibb at a price of $5.00 per share in an all-cash transaction; expected to close in the second quarter of 2025

Abecma generated $242 million U.S. sales in 2024

79% reduction in year-over-year net cash spend reflects continued streamlining of cost structure

Ended 2024 with approximately $184 million in cash, cash equivalents, and marketable securities

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 25, 2025-- 

2seventy bio, Inc. (Nasdaq: TSVT), today reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2024.

"2024 was a pivotal year for 2seventy as we made significant changes to our business to streamline cost structure and focus solely on Abecma," said Chip Baird, chief executive officer, 2seventy bio. "This week marks four years since Abecma received FDA approval as the first anti-BCMA CAR T cell therapy approved for relapsed or refractory multiple myeloma. Together with BMS, we remain committed to expanding the reach of this important therapy. We launched 2seventy with the goal of providing more time to patients, and we believe with BMS' experience and resources, we can continue to improve outcomes for people living with multiple myeloma."

On March 10, 2seventy bio announced a definitive merger agreement to be acquired by Bristol Myers Squibb $(BMS)$. Under the terms of the agreement, BMS will commence a tender offer to acquire all outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction. 2seventy bio's Board of Directors unanimously recommends that 2seventy bio stockholders tender their shares in the tender offer.

ABECMA COMMERCIAL AND REGULATORY HIGHLIGHTS

   -- Full year Abecma$(R)$ (idecabtagene vicleucel; ide-cel) U.S. sales, as 
      reported by Bristol Myers Squibb $(BMS.UK)$, were $242 million. 
 
   -- 2seventy bio and BMS continue to focus on competitively differentiating 
      Abecma's safety and efficacy profile supported by the strength of the 
      KarMMa-3 and real-world data. 
 
   -- The Company and BMS share equally in all profits and losses related to 
      development, manufacturing, and commercialization of Abecma in the U.S. 
      2seventy bio reported share of collaboration loss of approximately $3.3 
      million related to the collaboration with BMS for the three months ended 
      December 31, 2024. 

SELECT FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

   -- Total revenues were $2.9 million for the three months ended December 31, 
      2024, compared to $10.7 million for the three months ended December 31, 
      2023. Total revenues were $37.9 million for the twelve months ended 
      December 31, 2024, compared to $100.4 million for the twelve months ended 
      December 31, 2023. 
 
   -- Research and development expenses were $8.7 million for the three months 
      ended December 31, 2024, compared to $51.2 million for the three months 
      ended December 31, 2023. Research and development expenses were $76.9 
      million for the twelve months ended December 31, 2024, compared to $230.8 
      million for the twelve months ended December 31, 2023. 
 
   -- Selling, general and administrative expenses were $8.5 million for the 
      three months ended December 31, 2024, compared to $16.2 million for the 
      three months ended December 31, 2023. Selling, general and administrative 
      expenses were $43.9 million for the twelve months ended December 31, 
      2024, compared to $69.4 million for the twelve months ended December 31, 
      2023. 
 
   -- Net loss was $19.5 million for the three months ended December 31, 2024, 
      compared to $56.8 million for the three months ended December 31, 2023. 
      Net loss was $57.2 million for the twelve months ended December 31, 2024, 
      compared to $217.6 million for the twelve months ended December 31, 2023. 
 
   -- Cash, cash equivalents, and marketable securities totaled $183.6 million 
      as of December 31, 2024. 

Merger Agreement Details and Path to Completion

The closing of the transaction with BMS is expected to occur in the second quarter of 2025 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of 2seventy bio's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, BMS will acquire all remaining shares of 2seventy bio common stock that are not tendered in the tender offer through a second-step merger at the same price in the tender offer of $5.00 per share.

Following the completion of this transaction, 2seventy bio's common stock will no longer be listed for trading on Nasdaq.

In connection with the execution of the merger agreement, certain stockholders of 2seventy bio owning approximately 5.3% of the outstanding shares of 2seventy bio's common stock have entered into tender and support agreements pursuant to which they have agreed to tender all of their owned shares in the offer.

In light of the announced transaction, 2seventy will not be hosting an earnings conference call or providing financial guidance for 2025.

ABECMA U.S. INDICATION

ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES

   -- Cytokine Release Syndrome $(CRS)$, including fatal or life-threatening 
      reactions, occurred in patients following treatment with ABECMA. Do not 
      administer ABECMA to patients with active infection or inflammatory 
      disorders. Treat severe or life-threatening CRS with tocilizumab or 
      tocilizumab and corticosteroids. 
 
   -- Neurologic Toxicities, which may be severe or life-threatening, occurred 
      following treatment with ABECMA, including concurrently with CRS, after 
      CRS resolution, or in the absence of CRS. Monitor for neurologic events 
      after treatment with ABECMA. Provide supportive care and/or 
      corticosteroids as needed. 
 
   -- Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome 
      (HLH/MAS) including fatal and life-threatening reactions, occurred in 
      patients following treatment with ABECMA. HLH/MAS can occur with CRS or 
      neurologic toxicities. 
 
   -- Prolonged Cytopenia with bleeding and infection, including fatal outcomes 
      following stem cell transplantation for hematopoietic recovery, occurred 
      following treatment with ABECMA. 
 
   -- T cell malignancies have occurred following treatment of hematologic 
      malignancies with BCMA- and CD19-directed genetically modified autologous 
      T cell immunotherapies, including ABECMA 
 
   -- ABECMA is available only through a restricted program under a Risk 
      Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. 

Warnings and Precautions:

Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.

Cytokine Release Syndrome $(CRS.UK)$: CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including >= Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of >=Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 10(6) CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 10(6) CAR-positive T cells.

The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

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