On August 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the second quarter ended June 30, 2023 (Press release, 2seventy bio, AUG 14, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" rel="nofollow">View Source [SID1234634371]).

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"We launched 2seventy in late 2021 with the stated mission of delivering more time for people living with cancer through the transformative power of cell therapy," said Nick Leschly, chief kairos officer. Since the creation of 2seventy, our mission has always been dual-pronged: to deliver on the commercial potential of Abecma and to leverage our translational engine to develop an innovative cell therapy pipeline. Over the course of this year, we continue to make progress against this goal. We have successfully delivered Abecma to an extensive and growing number of patients in need of new treatment options. While the competitive intensity has increased and will have an impact on revenue in the 2nd half of 2023, we believe in the long-term commercial potential of this important therapy, particularly as we move toward earlier lines. On the development side, in June, we paused our PLAT-08 study in AML due to a Grade 5 safety event and this has since been followed by a clinical hold by FDA. We’ve collaborated with Seattle Children’s to conduct a root-cause analysis and developed amendments to the protocol. Seattle Children’s will review these amendments with FDA with the goal of resuming the study as soon as possible."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

Second quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $115 million. Based on BMS reporting an expected decline in Abecma sales in the third quarter, the Company believes Abecma will achieve the lower 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 bio reported collaborative arrangement revenue of $24.5 million and $47.5 million for the three months and six months ended June 30, 2023, respectively.
2seventy bio believes Abecma has potential peak U.S. revenues of $2 to 3 billion.
The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of $307 million. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.
"With the revenue from our Abecma collaboration and careful expense management, we significantly reduced our net loss to $42.1 million in the second quarter from $77.4 million for the same period last year," said Chip Baird, chief financial officer. "We are committed to advancing toward breakeven operations for the business while prudently investing in innovation."

ABECMA CLINICAL, REGULATORY, AND MANUFACTURING UPDATE

2seventy bio, in collaboration with BMS, continues to build on established manufacturing capacity of Abecma with an additional ramp-up planned for later this year.
The collaboration remains on track for introduction of suspension-based lentiviral vector (sLVV) in 1st half 2024.
Manufacturing performance metrics remain strong, with greater than 90% in spec rates and an average turnaround time of ~29 days.
The planned maintenance shutdown of the S12 drug product manufacturing plant was successfully completed in June and the facility is fully operational.
In addition to increasing manufacturing capacity, commercial efforts are underway to expand the U.S. treatment center footprint.
We continue to anticipate the December 16 PDUFA goal date for potential label expansion based on the KarMMa-3 data.
The Company, with BMS, is planning to initiate the KarMMa-9 study in patients with newly diagnosed multiple myeloma later this year.
UPDATE ON PLAT-08 CLINICAL STUDY OF SC-DARIC-33 IN ACUTE MYELOID LEUKEMIA (AML)

In June, the Company announced that because of a fatal (Grade 5) serious adverse event (SAE) in a patient enrolled in the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in AML, the study met protocol-defined pausing rules, pending review of the event by the appropriate regulatory and monitoring boards. On Friday, August 11, 2023, the U.S. Food and Drug Administration (FDA) formally placed the study on clinical hold via email communication. Since the study pause in June, 2seventy bio and Seattle Children’s have been conducting an internal investigation and root cause analysis of the SAE. This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study. 2seventy bio and Seattle Children’s will continue to work with FDA to provide the root cause analysis and proposed changes for the clinical study. Based on upcoming discussions with FDA, 2seventy bio and Seattle Children’s plan to amend the study accordingly and resume this study as soon as possible.

RECENT DATA HIGHLIGHTS

Abecma Data at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper): The Company presented four abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and six abstracts at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress. The presentations highlighted clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma, reinforcing Abecma’s strong clinical profile. Additional data on patient-reported outcomes from the KarMMa-3 trial were also presented. Results showed that patients with triple-class exposed RRMM treated with Abecma demonstrated statistically significant and clinically meaningful improvements in health-related quality of life, including key multiple myeloma symptoms and overall functions compared to standard regimens.
New Preclinical and Clinical Data at ASGCT (Free ASGCT Whitepaper): 2seventy bio presented five abstracts, including one late-breaking oral presentation, at this year’s American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting.
UPCOMING ANTICIPATED PIPELINE MILESTONES

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.
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 SECOND QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $36.0 million for the three months ended June 30, 2023, compared to $13.5 million for the three months ended June 30, 2022. Total revenues were $77.7 million for the six months ended June 30, 2023, compared to $21.9 million for the six months ended June 30, 2022.
Research and development expenses were $60.0 million for the three months ended June 30, 2023, compared to $64.6 million for the three months ended June 30, 2022. Research and development expenses were $128.2 million for the six months ended June 30, 2023, compared to $130.4 million for the six months ended June 30, 2022.
Selling, general and administrative expenses were $19.5 million for the three months ended June 30, 2023, compared to $17.3 million for the three months ended June 30, 2022. Selling, general and administrative expenses were $40.2 million for the six months ended June 30, 2023, compared to $41.1 million for the six months ended June 30, 2022.
Net loss was $42.1 million for the three months ended June 30, 2023, compared to $77.4 million for the three months ended June 30, 2022. Net loss was $89.1 million for the six months ended June 30, 2023, compared to $163.1 million for the six months ended June 30, 2022.
Conference Call Information

2seventy bio will host a conference call and live webcast today, August 14, at 8:00 a.m. ET to discuss 2Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BIa4096e5acd24407e8d1e2a5e32ba2e14. 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.