8-K: 2seventy bio Halts Enrollment in KarMMa-9 Study, Anticipates Strong Q3 Revenue Growth for Abecma

2seventy bio discontinues enrollment in the Phase 3 KarMMa-9 study, expecting over $80 million in cost savings and a 30% revenue increase for Abecma in Q3.

Summary

• 2seventy bio, in partnership with Bristol Myers Squibb, has decided to discontinue enrollment in the Phase 3 KarMMa-9 study evaluating Abecma in newly diagnosed multiple myeloma patients with suboptimal response to autologous stem cell transplant.
• This decision is expected to save the company over $80 million in the next several years and accelerate their path to breakeven in 2025.
• The company anticipates a 30% increase in Abecma U.S. revenue in the third quarter compared to the second quarter's $54 million.
• Demand for Abecma, measured by new patients undergoing apheresis, is also expected to show double-digit growth in the third quarter compared to the second quarter of 2024.
• The discontinuation of the KarMMa-9 study is due to the improved treatment landscape for newly diagnosed multiple myeloma, which has resulted in fewer eligible patients for the study.
• 2seventy bio and BMS remain committed to the value of Abecma and its role in multiple myeloma treatment.

Sentiment

Score: 7

Explanation: The document presents a positive outlook with strong revenue growth expectations and cost savings, but also acknowledges risks and challenges associated with the treatment and the company's reliance on a partner.

Positives

• The discontinuation of the KarMMa-9 study will result in over $80 million in cost savings.
• Abecma is expected to see a 30% revenue increase in Q3, indicating strong commercial performance.
• The company is on track to reach breakeven in 2025.
• The company has a strong cash position with a runway beyond 2027.
• The company has streamlined its operations and reduced operating expenses.
• Abecma has a differentiated safety profile and competitive efficacy.
• Real-world data for Abecma is consistent with or better than the KarMMa study results.
• The company is focused on expanding the reach of Abecma to more patients.

Negatives

• The discontinuation of the KarMMa-9 study suggests a change in the company's strategy for Abecma in newly diagnosed multiple myeloma.
• The company is reliant on Bristol Myers Squibb for the development and commercialization of Abecma.
• The document highlights the risk of early deaths in the Abecma arm of the KarMMa-3 study, although this was confounded by crossover.
• The document mentions the risk of serious side effects associated with Abecma, including Cytokine Release Syndrome, neurologic toxicities, and secondary malignancies.

Risks

• The company's success is heavily dependent on the commercial success of Abecma.
• There are risks associated with the manufacturing and supply of Abecma.
• The company faces competition in the multiple myeloma treatment market.
• The company's financial performance is subject to various risks and uncertainties.
• The document mentions the risk of serious side effects associated with Abecma, including Cytokine Release Syndrome, neurologic toxicities, and secondary malignancies.
• The company is reliant on Bristol Myers Squibb for the development and commercialization of Abecma, and any issues with this partnership could impact the company's performance.

Future Outlook

The company expects to reach breakeven in 2025 and is focused on driving the continued success of Abecma. They plan to continue expanding the reach of Abecma to as many multiple myeloma patients as possible.

Management Comments

• Chip Baird, chief executive officer, stated that the decision to discontinue the KarMMa-9 study will conserve over $80 million in near-term expenditures and accelerate the path to breakeven in 2025.
• Anna Truppel-Hartmann, chief medical officer, noted that the NDMM treatment landscape has improved considerably, leading to fewer eligible patients for the KarMMa-9 study.

Industry Context

The discontinuation of the KarMMa-9 study reflects the rapidly evolving treatment landscape for multiple myeloma, with the increasing use of quadruplet therapy induction and more aggressive consolidation therapies. This decision also highlights the importance of strategic capital allocation in the biotech industry.

Comparison to Industry Standards

• The document references the KarMMa-3 study, which showed a 3x longer median progression-free survival (mPFS) and an 8x higher percentage of complete response (CR) compared to standard regimens, indicating a strong efficacy profile for Abecma.
• Real-world evidence (RWE) studies show that Abecma's efficacy is consistent with or better than the KarMMa study, despite the inclusion of sicker patients, suggesting a robust performance in diverse patient populations.
• The document mentions that Abecma has a reliable manufacturing process with 94% US commercial manufacturing success rate, which is a key factor for the success of CAR T-cell therapies.
• The document compares Abecma's results to standard regimens in the KarMMa-3 study, showing a significant improvement in progression-free survival (PFS) and overall response rate (ORR).
• The document also references other studies and data sources, such as the CIBMTR database and French centers, to demonstrate the consistency of Abecma's efficacy in different settings.

Related Party Transactions

• The document mentions a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio for Abecma in the U.S.

Stakeholder Impact

• Shareholders will benefit from the cost savings and increased revenue, as well as the accelerated path to breakeven.
• Patients will benefit from the continued availability of Abecma and the company's focus on expanding its reach.
• Employees may be impacted by the streamlined cost structure and focus on Abecma.
• The company's partnership with Bristol Myers Squibb is crucial for the continued success of Abecma.

Next Steps

• The company will continue to focus on the commercialization of Abecma.
• The company will continue to look for ways to optimize its business for growth.
• The company will continue to invest in additional studies to generate data and further optimize real world use of Abecma.

Key Dates

Keywords

Abecma, multiple myeloma, CAR T-cell therapy, KarMMa-9, Bristol Myers Squibb, revenue growth, cost savings, clinical trial, breakeven, cancer treatment