On March 16, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2022 (Press release, 2seventy bio, MAR 16, 2023, View Source [SID1234628885]).

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"In our first full year of operations, 2seventy made tremendous strides across all aspects of our business: from advancing early-stage research, building out manufacturing capabilities, initiating clinical studies, and delivering to patients in the commercial setting with Abecma," said Nick Leschly, chief kairos officer. "Bolstered by strong growth in the fourth quarter, we delivered Abecma to hundreds of patients with multiple myeloma in the U.S. and expect continued strong growth in 2023. With our partners at BMS, we continue to develop this product into earlier lines of multiple myeloma treatment on the back of positive data from the KarMMa-3 study and the planned KarMMa-9 study and continue to grow our manufacturing capabilities to support a potential peak sales opportunity of $2-3 billion in the U.S. With our recent financing and the growth of Abecma, we are in a strong position to continue to prudently advance our clinical and preclinical pipeline, driving towards delivering proof-of-concept data this year for our bbT369 and SC-DARIC33 programs and advancement of MUC and MAGE solid tumor programs to IND by the end of the year. I couldn’t be more optimistic for what lies ahead in 2023 and the position we are in today, and that is thanks to the hard work of our employees, the patients and physicians who participate in our studies, and our shareholders who share in our mission to deliver more time to patients with cancer."

Abecma Commercial Summary
Our partner, Bristol Myers Squibb (BMS), reported total U.S. Abecma (idecabtagene vicleucel; ide-cel) fourth quarter revenues of $94 million, which represents 25% growth over the prior quarter, and 40% growth over the fourth quarter of 2021, and full year revenues of $297 million, which is in line with our stated 2022 U.S. Abecma revenue guidance of $250-300 million, in each case such revenue is shared equally with BMS. Assuming continued strong demand for Abecma and achievement of planned increases in manufacturing capacity throughout the year, we anticipate topline 2023 U.S. revenues of $470-570 million.

Assuming continued increases in manufacturing capacity and growth in the addressable patient population based on an anticipated approval in 3L+ multiple myeloma, we expect Abecma to generate $200-300 million in operating income for 2seventy bio in the 2024-25 period.

We reported Abecma-related collaborative arrangement revenue of $8.7 million for the fourth quarter of 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the year.

Financial Guidance
At the end of February 2023, 2seventy bio raised approximately $117 million in net proceeds through a public equity offering. Based on our current operating plans, which includes these net proceeds and the ongoing commercialization of Abecma, we believe our current cash position will be sufficient to fund operations into 2026.

"The financial outlook for 2seventy continues to strengthen, and the recent equity financing puts us in a privileged position, with cash runway now into 2026," said Chip Baird, chief financial officer. "We expect the cash flow from the Abecma collaboration to grow significantly over the 2023-25 time period, which will continue to reduce our annual net cash spend and our need for future capital infusions. Our pipeline programs have the potential to deliver meaningful benefit for cancer patients and we will balance an entrepreneurial mindset with a disciplined approach to capital allocation."

RECENT HIGHLIGHTS
KARMMA-3 DATA IN NEJM – On February 10, 2023, 2seventy announced the publication of our KarMMa-3 data in the New England Journal of Medicine. The positive results of this pivotal Phase 3 showed at median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001). This represents a 51% reduction in risk of disease progression or death with Abecma. Based on results from KarMMa-3, Abecma is the first and only chimeric antigen receptor (CAR) T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and refractory multiple myeloma in a randomized, controlled Phase 3 trial. 2seventy and BMS anticipate submitting an sBLA to the FDA in the first quarter of 2023 to seek approval in the third line setting.

REGENERON COLLABORATION AMENDMENT – In January, 2seventy bio announced an expanded translational collaboration with Regeneron to facilitate the acceleration of novel cell therapy-based combinations for solid tumors. The collaboration will leverage 2seventy bio’s unique cell therapy engineering and early-stage development capabilities, including the newly built in-house clinical cell therapy manufacturing facility, with Regeneron’s differentiated antibodies and bispecifics. To support this expanded clinical development plan Regeneron made an approximately $20 million equity investment in 2seventy bio at a 50% premium and has committed to another approximately $20 million in near-term pre-clinical and clinical milestones. The parties will continue sharing costs for these activities in a manner largely consistent with the existing agreement, with Regeneron covering 75% of certain preclinical costs necessary to study combinations and 100% of the costs for the arms of the clinical studies that include Regeneron agents through regulatory approval. For other programs, cost-sharing will follow the existing 50/50 cost sharing agreement.

BOARD APPOINTMENT – Earlier this month, 2seventy bio announced the appointment of Wei Lin, M.D. to the company’s Board of Directors.

UPCOMING ANTICIPATED MILESTONES
ABECMA

Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma by end of 2023
Potential FDA approval of sBLA in 3L+ multiple myeloma by the end of 2023
PIPELINE

Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023
Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia by the end of 2023
Submission of an IND for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron by end of 2023
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors by end of 2023
FINANCIAL GUIDANCE

Topline U.S. Abecma revenue of $470-570 million in 2023
Net cash spend of $180-220 million in 2023
Cash runway into 2026
SELECT FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Our partner, BMS, reported total U.S. revenues of $94 million and $297 million for Abecma for the three and twelve months ended December 31, 2022, respectively. 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 $8.7 million for the three months ended December 31, 2022 and collaborative arrangement revenue net of share of collaboration loss of $3.1 million for the twelve months ended December 31, 2022.
Total 2seventy bio revenues were $56.2 million for the three months ended December 31, 2022 compared to $16.0 million for the three months ended December 31, 2021. Total revenues were $91.5 million for the twelve months ended December 31, 2022 compared to $54.5 million for the twelve months ended December 31, 2021. The increase for both the three and twelve-month periods was primarily due to an increase in service revenue in the fourth quarter of 2022, driven by the release of deferred revenue relating to bb21217, the development of which was discontinued in 2022.
Research and development expenses were $60.1 million for the three months ended December 31, 2022 compared to $57.2 million for the three months ended December 31, 2021. This increase was primarily driven by increased costs for manufacturing activities of suspension lentiviral vector for ide-cel and MAGE-A4 development, partially offset by a decrease in costs related to our share of research and development expenses under our collaboration with BMS. Research and development expenses were $248.7 million for the twelve months ended December 31, 2022, compared to $252.6 million for the twelve months ended December 31, 2021. This decrease was primarily driven by a decrease in costs related to our share of research and development expenses under our collaboration with BMS, partially offset by increases in costs for manufacturing activities of suspension lentiviral vector.
Selling, general and administrative expenses were $18.7 million for the three months ended December 31, 2022, compared to $24.5 million for the three months ended December 31, 2021. Selling, general and administrative expenses were $79.5 million for the twelve months ended December 31, 2022, compared to $93.5 million for the twelve months ended December 31, 2021. The decrease for both the three and twelve-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 due to a lower allocation of these costs to selling, general and administrative expense based on headcount and facility square footage.
Net loss was $23.1 million for the three months ended December 31, 2022, compared to $61.0 million for the three months December 31, 2021. Net loss was $254.2 million for the twelve months ended December 31, 2022, compared to $292.2 million for the twelve months ended December 31, 2021.
2seventy bio ended 2022 with cash, cash equivalents and marketable securities of $267.7 million.