On May 3, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy Company, reported financial results and recent highlights for the first quarter ended March 31, 2023 (Press release, 2seventy bio, MAY 3, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-first-quarter-financial-results-and-0" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-first-quarter-financial-results-and-0" rel="nofollow">View Source [SID1234630898]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are off to a strong start in 2023, with a sharp focus on timely execution across our commercial business, clinical programs, and research pipeline," said Nick Leschly, chief kairos officer, 2seventy bio. "Abecma revenue remains on a strong growth trajectory as we continue to successfully execute with BMS on manufacturing scale-ups to deliver Abecma to myeloma patients. The successful steps taken to date to increase vector and drug product manufacturing support the achievement of the upper end of our U.S. revenue guidance range. With the recent FDA acceptance of our Abecma sBLA based on our KarMMa-3 study, we look forward to the opportunity to offer this transformational product to patients in earlier lines of treatment and, if approved, will enable us to serve thousands of additional patients in the U.S. We have made significant progress across our pipeline, and we plan to share initial clinical data from our SC-DARIC33 program for acute myeloid leukemia at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. We also look forward to providing a more in-depth look into both Abecma and our pipeline programs, including promising pre-clinical data in our in-vivo gene editing hemophilia A program, at our upcoming R&D Deep Dive. We believe 2023 will be a transformative year for 2seventy as we continue in our mission to deliver more time for patients living with cancer."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

First quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $118 million, representing 26% growth over the prior quarter and 111% growth over the same quarter last year. Based on strong first quarter performance, the Company believes Abecma will achieve the upper end of U.S. revenue guidance of $470-570 million.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. 2seventy reported collaborative arrangement revenue of $23.0 million for the three months ended March 31, 2023, and share of collaboration loss of $5.4 million for the three months ended March 31, 2022.
Abecma was cash-flow positive in the first quarter and the Company expects the Abecma collaboration to be cash flow positive throughout 2023 and to generate between $200 and $300 million of operating income for 2seventy bio during the 2024-2025 period, based on management’s current operating plans.
The Company believes Abecma has potential peak U.S. revenues of $2 to 3 billion.
2seventy bio successfully completed an equity financing in the first quarter, raising approximately $117 million in net proceeds.
The Company ended the first quarter of 2023 with cash, cash equivalents and marketable securities of $341.4 million. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026 and potentially beyond.
Abecma Manufacturing Progress

During the first quarter, the Food and Drug Administration (FDA) approved a second adherent vector manufacturing suite, which will further increase vector capacity.
The FDA approved the Company’s plan for establishing comparability between adherent lentiviral vector and suspension-based lentiviral vector (sLVV) manufacturing processes. BMS and 2seventy continue to accelerate the introduction of sLVV manufacturing processes and we expect commercial introduction of sLVV in the first half of 2024.
BMS recently entered into an agreement for a manufacturing facility to produce viral vectors which is in line with our dual sourcing strategy, leveraging external partners as well as internalizing vector. BMS expects the Libertyville, Illinois site to be contributing by 2025. The combination of this new facility coupled with progress toward transitioning to suspension vector supports bringing more products to patients.
A successful step-up in drug product manufacturing capacity was completed in the first quarter and additional ramp-ups are planned for later this year.
Abecma Clinical and Regulatory Highlights

The FDA has accepted BMS and 2seventy bio’s supplemental Biologics License Application (sBLA) for Abecma in adult patients with triple-class exposed relapsed or refractory multiple myeloma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023.
The sBLA was based on interim results from the KarMMa-3 study evaluating Abecma compared with standard combination regimens. The KarMMa-3 study population represents heavily pretreated triple-class exposed patients with high unmet need in their 3rd to 5th line of therapy.
In this difficult-to-treat population, Abecma delivered a 51% risk reduction and clinical benefit compared to the standard of care arm.
Data from KarMMa-3 were published in The New England Journal of Medicine in February 2023.
Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma is anticipated later this year.
NOVO NORDISK COLLABORATION

The joint 2seventy bio and Novo Nordisk collaborative research program focused on an in vivo gene editing treatment for hemophilia A achieved positive proof of concept data triggering a $15 million milestone payment to 2seventy bio from Novo Nordisk.
This program represents a natural extension of the Company’s gene editing capabilities which are also being applied to its oncology programs, including the bbT369 clinical program for non-Hodgkin lymphoma.
Proof of concept data to be disclosed during the Company’s R&D Deep Dive on May 19, 2023.
ASGCT ABSTRACTS ACCEPTED

The American Society of Gene & Cell Therapies (ASGCT) (Free ASGCT Whitepaper) released the abstract titles for its 2023 Annual Meeting which will include new data from 2seventy bio’s portfolio of preclinical and clinical programs:
Late-Breaking Oral Presentation [#3092]: First in human studies show activation of SC-DARIC33, a rapamycin-regulated anti-CD33 CAR T cell therapy, in patients with AML
Oral Presentation [#148]: Enhanced anti-AML potency of DARIC33 by iSynPro-IL-15*: an IL-15 expression module driven by a tightly regulated synthetic promoter activated by antigen receptor signaling
Poster Presentation [#585]: bbT369, a clinical-stage dual-targeted and CBLB gene edited autologous CAR T product for non-Hodgkin Lymphoma, shows edit driven enhanced activity in preclinical in vitro and in vivo models
Poster Presentation [#612]: A novel TGFb switch receptor drives robust MAGE-A4 TCR anti-tumor activity with a favorable safety profile
Poster Presentation [#608]: RESET: a novel TCR coupled antigen receptor displaying superior targeting sensitivity and pharmacologically controlled anti-tumor activity
UPCOMING ANTICIPATED PIPELINE MILESTONES

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 anticipated by the end of 2023
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron anticipated by end of 2023
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023
SELECT FIRST QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $41.6 million for the three months ended March 31, 2023, compared to $8.4 million for the three months ended March 31, 2022. The increase for the three-month period was primarily driven by an increase in collaborative arrangement revenue recognized under our collaboration with BMS, as discussed in further detail above.
Research and development expenses were $68.2 million for the three months ended March 31, 2023, compared to $65.9 million for the three months ended March 31, 2022.
Selling, general and administrative expenses were $20.7 million for the three months ended March 31, 2023, compared to $23.9 million for the three months ended March 31, 2022. The decrease for the three-month period reflects cost containment measures across overhead and business functions.
Net loss was $47.0 million for the three months ended March 31, 2023, compared to $85.7 million for the three months ended March 31, 2022.
RESEARCH & DEVELOPMENT (R&D) DEEP DIVE
2seventy bio will host a virtual R&D Deep Dive on Friday, May 19, from 10:00 a.m. – 11:30 a.m. ET to highlight the Company’s R&D pipeline, including updates following the 2023 ASGCT (Free ASGCT Whitepaper) Annual Meeting, as well as an Abecma commercial update and additional details from the hemophilia A program. Registration and access to the live webcast may be found by visiting the "Events and Presentations" page in the Investors and Media section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A replay will be archived on the 2seventy bio website for 30 days following the event.

Conference Call Information
2seventy bio will host a conference call and live webcast today, May 3, at 4:30 p.m. ET to discuss 1Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BI458c3098c2a64310b49e967327a906e7. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.