Abecma (idecabtagene vicleucel) generated $115
million U.S. commercial revenue in 2Q 2023, supporting lower end of
U.S. revenue guidance of $470-570 million
2seventy bio provides update on PLAT-08 study
in AML with partner Seattle Children’s
Ended quarter with $307 million cash, cash
equivalents, and marketable securities; maintaining cash runway
into 2026
Conference call today at 8:00 AM ET
2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology
cell therapy company, today reported financial results and recent
highlights for the second quarter ended June 30, 2023.
“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 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
- 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:
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 U.S. revenue and
our plans to continue to advance our manufacturing strategy to
expand capacity and increase manufacturing efficiency for ABECMA
across the supply chain; statements regarding expected benefits
from our strategic collaboration; statements regarding our
projected timing for disclosing data from our ongoing clinical
trials; statements about the Grade 5 SAE in the PLAT-08 study,
resulting trial pause and hold, our and our partner Seattle
Children’s planned discussions with the FDA regarding the hold and
root cause analysis, and the ability of our partner Seattle
Children’s to resume this study; statements about the efficacy and
perceived therapeutic benefits of our product candidates and the
potential indications; statements about the strategic plans for
2seventy bio and potential corporate development opportunities
including collaboration arrangements; statements regarding the
Company’s financial condition, expenses, results of operations,
expectations regarding use of capital, cash runway and other future
financial results; and statements about our ability to execute our
strategic priorities. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, our limited independent operating history and the risk
that our accounting and other management systems may not be
prepared to meet the financial reporting and other requirements of
operating as an independent public company; the risk that dedicated
financial and/or strategic funding sources may not be available on
favorable terms or at all; the risk that the separation may
adversely impact our ability to attract or retain key personnel;
the risk that our BLAs and INDs will not be accepted for filing by
the FDA on the timeline that we expect, or at all; the risk that
our plans with respect to the preclinical and clinical development
and regulatory approval of our product candidates may not be
successfully achieved on the planned timeline, or at all; the risk
that ABECMA will not be as commercially successful as we may
anticipate; and the risk that we are unable to manage our operating
expenses or cash use for operations. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause our actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in our annual report on Form 10-K for the year ended
December 31, 2022, as supplemented and/or modified by our most
recent Quarterly Report on Form 10-Q and any other filings that we
have made or will make with the Securities and Exchange Commission
in the future. All information in this press release is as of the
date of the release, and 2seventy bio undertakes no duty to update
this information unless required by law.
2seventy bio, Inc.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except per
share data)
For the three months ended
June 30,
For the six months ended June
30,
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.
Condensed Consolidated Balance
Sheet Data
(unaudited)
(in thousands)
As of June 30,2023 As of December 31,2022
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 Adams, 774-313-9852 morgan.adams@2seventybio.com
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