On November 7, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the third quarter ended September 30, 2022 (Press release, 2seventy bio, NOV 7, 2022, View Source [SID1234623216]).
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"In our first year of operations, 2seventy bio has made tremendous progress in our mission of delivering more time to patients with cancer," said Nick Leschly, chief kairos officer. "Abecma has exceeded our expectations and is gaining momentum with potential to become a multi-billion dollar product. We now have hundreds of patients treated in the commercial setting and importantly we continue to see consistent efficacy and safety results between our clinical trials and our real-world data. We are excited to share our plans to initiate the KarMMa-9 study in newly diagnosed patients, in partnership with BMS. In addition, we have made important progress towards establishing a highly differentiated pipeline and sustainable product engine: our DARIC-33 and bbT369 studies in AML and B-NHL, respectively, are enrolling patients and our solid tumor programs with Regeneron are fast approaching the starting line with our MUC-16 CAR program. More broadly, we have made great progress on building translational throughput capacity with our internal drug product manufacturing facility nearing completion and we expect our strategic collaboration with JW Therapeutics to accelerate solid tumor development starting with putting our MAGE-A4 program into the clinic. Taken together, we believe we are on track to establishing a unique end to end cell therapy product engine, exploring four clinical-stage assets by 2024 and continuing to expand Abecma into earlier lines. As we wrap up 2022, we look forward to presenting important Abecma data at ASH (Free ASH Whitepaper) and more broadly on our pipeline in 2023."
RECENT PIPELINE HIGHLIGHTS
STRATEGIC PARTNERSHIP WITH JW THERAPEUTICS – Last month, 2seventy bio and JW Therapeutics announced a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy therapy products in the Chinese mainland, Hong Kong (China), and Macao (China). The initial focus of the collaboration is 2seventy bio’s MAGE-A4 t cell receptor (TCR) program in solid tumors which is being developed as part of a collaboration with Regeneron. Under the terms of the agreement, 2seventy bio will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China). JW Therapeutics will be responsible for development, manufacturing, and commercialization within China. 2seventy bio is eligible to receive milestones and royalties on product revenues in China.
ADDITIONAL PROGRESS – 2seventy bio’s clinical studies of DARIC-33 in acute myeloid leukemia (AML) and bbT369 in B cell non-Hodgkin lymphoma (B-NHL) are open and enrolling. We plan to share clinical data from these programs in the future. The company continues to execute pre-investigational new drug (IND) work to support a MUC-16 IND in 2023.
Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS) reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) third quarter revenues of $75 million. Based on strong commercial demand for Abecma, we remain on track to achieve the upper end of our stated 2022 U.S. Abecma revenue guidance of $250-300 million. Given the continued strong demand for Abecma and our growing belief in its potential to play an important role in earlier lines of therapy, we plan to initiate the KarMMa-9 study in partnership with BMS in patients with newly diagnosed multiple myeloma who have a suboptimal response to transplant and we are continuing to advance our manufacturing strategy to expand capacity across the supply chain.
We reported collaborative arrangement revenue of $4.1 million for the third quarter, which includes our share of gross profit/loss less costs associated with the commercialization of Abecma in the U.S. Vector and drug product supply remains on track to meet our commercial plan for 2022 and we are continuing to invest in increasing manufacturing capacity in the future.
ABECMA HIGHLIGHTS
KARMMA-2 DATA AT ASH (Free ASH Whitepaper) – Earlier this month, 2seventy bio announced that data from two cohorts of the KarMMa-2 study of Abecma (idecabtagene vicleucel), conducted in partnership with BMS, in patients who have suboptimal response to transplant or early relapse will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Data from KarMMa-2 Cohorts 2a and 2c suggest the potential for early treatment with Abecma in patients with second-line and newly diagnosed multiple myeloma, and that promising outcomes can be achieved treating patients with suboptimal response after transplant. These results support further evaluation of Abecma in patients with newly diagnosed multiple myeloma in the KarMMa-9 study.
KARMMA-9 STUDY IN NEWLY-DIAGNOSED MULTIPLE MYELOMA – In September, 2seventy bio announced plans to initiate the KarMMa-9 study, in partnership with BMS, to evaluate Abecma in newly diagnosed multiple myeloma patients who have suboptimal response to transplant. The company intends to provide additional information about the design and timing of the study at the earliest upcoming opportunity
SELECT THIRD QUARTER 2022 FINANCIAL RESULTS
Our partner, BMS, reported total U.S. revenues of $75 million for Abecma for the three months ended September 30, 2022. 2seventy bio and BMS share equally in all profits and losses related to development, manufacture and commercialization of Abecma in the U.S. We reported collaborative arrangement revenue of $4.1 million for the three months ended September 30, 2022. For the first and second quarters of 2022, we reported a share of collaboration loss of $5.4 million and $4.3 million, respectively.
Total 2seventy bio revenues were $13.4 million for the three months ended September 30, 2022 compared to $19.3 million for the three months ended September 30, 2021. Total revenues were $35.3 million for the nine months ended September 30, 2022 compared to $38.5 million for the nine months ended September 30, 2021. The decrease for the three-month period was primarily driven by a decrease in Abecma collaborative arrangement revenue and the decrease for the nine-month period was largely attributable to a decrease in ide-cel ex-U.S. service revenue and royalty and other revenue.
Research and development expenses were $61.7 million for the three months ended September 30, 2022 compared to $61.1 million for the three months ended September 30, 2021. Research and development expenses were $199.4 million for the nine months ended September 30, 2022, compared to $202.4 million for the nine months ended September 30, 2021. The slight increase for the three-month period was primarily driven by increases in IT and other facility-related costs and collaboration research funding costs, partially offset by decreased license and milestone fees. The decrease for the nine -month period was primarily driven by decreased collaboration research funding costs due to a decrease in our share of research and development costs under our collaboration with BMS, partially offset by an increase in IT and other facility-related costs.
Selling, general and administrative expenses were $19.6 million for the three months ended September 30, 2022, compared to $23.0 million for the three months ended September 30, 2021. Selling, general and administrative expenses were $60.7 million for the nine months ended September 30, 2022, compared to $69.0 million for the nine months ended September 30, 2021. The decrease for both the three- and nine-month periods was primarily driven by decreased employee compensation expenses, reflective of efforts to streamline 2seventy bio’s operating model and a decrease in IT and other facility-related costs.
Net loss was $67.9 million for the three months ended September 30, 2022, compared to $60.0 million for the three months ended September 30, 2021. Net loss was $231.0 million for the nine months ended September 30, 2022, compared to $231.2 million for the nine months ended September 30, 2021.
2seventy bio ended the third quarter of 2022 with cash, cash equivalents and marketable securities of $324.5 million.