2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress
Abecma (idecabtagene vicleucel) generated
2seventy bio provides update on PLAT-08 study in AML with partner Seattle Children’s
Ended quarter with
Conference call today at 8:00 AM ET
“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
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Second quarter Abecma
U.S. revenues, as reported by Bristol Myers Squibb (BMS), were . Based on BMS reporting an expected decline in Abecma sales in the third quarter, the Company believes Abecma will achieve the lower end of$115 million 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 and$24.5 million for the three months and six months ended June 30, 2023, respectively.$47.5 million -
2seventy bio believes Abecma has potential peak
U.S. revenues of to 3 billion.$2 -
The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of
. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.$307 million
“With the revenue from our Abecma collaboration and careful expense management, we significantly reduced our net loss to
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.
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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.
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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
RECENT DATA HIGHLIGHTS
- Abecma Data at ASCO and EHA: The Company presented four abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting and six abstracts at the European Hematology Association (EHA) 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: 2seventy bio presented five abstracts, including one late-breaking oral presentation, at this year’s American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.
UPCOMING ANTICIPATED PIPELINE MILESTONES
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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.
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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
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Total 2seventy bio revenues were
for the three months ended June 30, 2023, compared to$36.0 million for the three months ended June 30, 2022. Total revenues were$13.5 million for the six months ended June 30, 2023, compared to$77.7 million for the six months ended June 30, 2022.$21.9 million -
Research and development expenses were
for the three months ended June 30, 2023, compared to$60.0 million for the three months ended June 30, 2022. Research and development expenses were$64.6 million for the six months ended June 30, 2023, compared to$128.2 million for the six months ended June 30, 2022.$130.4 million -
Selling, general and administrative expenses were
for the three months ended June 30, 2023, compared to$19.5 million for the three months ended June 30, 2022. Selling, general and administrative expenses were$17.3 million for the six months ended June 30, 2023, compared to$40.2 million for the six months ended June 30, 2022.$41.1 million -
Net loss was
for the three months ended June 30, 2023, compared to$42.1 million for the three months ended June 30, 2022. Net loss was$77.4 million for the six months ended June 30, 2023, compared to$89.1 million for the six months ended June 30, 2022.$163.1 million
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: https://edge.media-server.com/mmc/p/ovopwzwn. 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 https://ir.2seventybio.com/ and will be available for 30 days following the event.
About 2seventy bio
Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering and developing new therapies that truly disrupt the cancer treatment landscape.
With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver next generation cellular therapies that focus on a broad range of hematologic malignancies, including the first FDA-approved CAR T cell therapy for multiple myeloma, as well as solid tumors. Our research and development is focused on delivering therapies that are designed with the goal to “think” smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day.
For more information, visit www.2seventybio.com.
Follow 2seventy bio on social media: X (Twitter) and LinkedIn.
2seventy bio is a trademark of 2seventy bio, Inc.
Cautionary Note Regarding Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements about our plans, strategies, timelines and expectations with respect to the development, manufacture or sale of our product candidates, including the results and expected timing of ongoing and planned clinical trials for our product candidates and for ABECMA (ide-cel) in additional indications and in earlier line settings; statements about our plans, strategies, timelines and expectations with respect to regulatory approval and related filings for our product candidates; statements regarding expected ABECMA
2seventy bio, Inc. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
|||||||||||||||
(unaudited) |
|||||||||||||||
(in thousands, except per share data) |
|||||||||||||||
For the three months ended
|
|
For the six months ended
|
|||||||||||||
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenue: | |||||||||||||||
Service revenue | $ |
5,022 |
|
$ |
5,666 |
|
$ |
15,848 |
|
$ |
9,721 |
|
|||
Collaborative arrangement revenue |
|
29,034 |
|
|
7,035 |
|
|
58,406 |
|
|
10,522 |
|
|||
Royalty and other revenue |
|
1,992 |
|
|
781 |
|
|
3,415 |
|
|
1,668 |
|
|||
Total revenues |
|
36,048 |
|
|
13,482 |
|
|
77,669 |
|
|
21,911 |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
59,980 |
|
|
64,557 |
|
|
128,226 |
|
|
130,436 |
|
|||
Cost of manufacturing for commercial collaboration |
|
3,610 |
|
|
3,882 |
|
|
7,264 |
|
|
7,248 |
|
|||
Selling, general and administrative |
|
19,489 |
|
|
17,278 |
|
|
40,209 |
|
|
41,139 |
|
|||
Share of collaboration loss |
|
- |
|
|
4,290 |
|
|
- |
|
|
9,642 |
|
|||
Cost of royalty and other revenue |
|
907 |
|
|
364 |
|
|
1,548 |
|
|
875 |
|
|||
Change in fair value of contingent consideration |
|
53 |
|
|
83 |
|
|
126 |
|
|
131 |
|
|||
Total operating expenses |
|
84,039 |
|
|
90,454 |
|
|
177,373 |
|
|
189,471 |
|
|||
Loss from operations |
|
(47,991 |
) |
|
(76,972 |
) |
|
(99,704 |
) |
|
(167,560 |
) |
|||
Interest income, net |
|
3,090 |
|
|
213 |
|
|
5,139 |
|
|
328 |
|
|||
Other income (expense), net |
|
2,812 |
|
|
(661 |
) |
|
5,455 |
|
|
4,101 |
|
|||
Loss before income taxes |
|
(42,089 |
) |
|
(77,420 |
) |
|
(89,110 |
) |
|
(163,131 |
) |
|||
Income tax (expense) benefit |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Net loss | $ |
(42,089 |
) |
$ |
(77,420 |
) |
$ |
(89,110 |
) |
$ |
(163,131 |
) |
|||
Net loss per share - basic and diluted | $ |
(0.83 |
) |
$ |
(2.02 |
) |
$ |
(1.89 |
) |
$ |
(5.00 |
) |
|||
Weighted-average number of common shares used in computing net loss per share - basic and diluted |
|
50,966 |
|
|
38,381 |
|
|
47,238 |
|
|
32,598 |
|
2seventy bio, Inc. |
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Condensed Consolidated Balance Sheet Data |
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(unaudited) |
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(in thousands) |
|||||
As of June 30, 2023 |
As of December 31, 2022 |
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Cash, cash equivalents and marketable securities | $ |
306,546 |
$ |
267,684 |
|
Total assets |
|
705,713 |
|
656,665 |
|
Total liabilities |
|
338,218 |
|
346,199 |
|
Total stockholders' equity |
|
367,495 |
|
310,466 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814766402/en/
Investors & Media:
Jenn Snyder, 617-448-0281
Jenn.snyder@2seventybio.com
Morgan
morgan.adams@2seventybio.com
Source: 2seventy bio, Inc.