Approximately 40% workforce reduction combined
with related actions expected to achieve $130+ million savings in
the 2024-2025 period; projected cash runway into at least 2026 to
support focus on long-term mission
Company to internally advance fewer pipeline
programs while expanding collaboration with JW Therapeutics to
include new solid tumor and autoimmune programs; Company to gate
at-risk investment in bbT369 (NHL) and SC-DARIC33 (AML) programs
pending further clinical data readouts
CEO Nick Leschly announces plans to step down
as CEO and transition to Chairman of Board of Directors; CEO search
process has been initiated; CFO Chip Baird promoted to Chief
Operating Officer
Conference call today at 8:00 AM ET
2seventy bio, Inc. (Nasdaq: TSVT), today announced a
restructuring of its business operations and research and
development model to significantly reduce costs while supporting
the execution of a prioritized plan for the long-term growth of the
company.
“2seventy’s mission remains the same: to unleash the power of
the T-cell and develop un-incremental treatments for people living
with cancer,” said Nick Leschly, chief kairos officer. “However,
the macro environment for oncology cell therapy companies and the
near-term headwinds we have seen in our own business have led us to
examine how we pursue our mission. Today we are taking hard but
necessary steps to streamline our team and optimize our R&D
approach and cost structure. In this process, we have focused on
how to move efficiently and more cost effectively to develop
innovative therapies for patients and create value for
shareholders. Unfortunately, we will be saying goodbye to many
highly talented and committed members of our team. I want to thank
each of them for their amazing dedication to 2seventy and our
mission to help those in need, doing everything we can to deliver
more TIME.”
“The difficult but necessary changes we are making to our
workforce, our programs and our cost structure reflect our
commitment to advancing our pipeline and achieving value creating
milestones with existing cash,” said Chip Baird, chief operating
officer. “Our U.S. Abecma collaboration provides a source of
revenue to offset investment in our pipeline programs, and while we
continue to be optimistic about Abecma’s future, particularly given
the potential third-line label expansion at the end of the year, we
are planning conservatively. We expect today’s changes will
preserve runway into at least 2026, and we will continue to focus
on careful expense management and thoughtful capital allocation
while staying true to our mission of driving programs forward for
patients in need. I echo Nick’s gratitude to the members of our
team who will be departing 2seventy and look forward to continuing
to uphold 2seventy’s unwavering focus on patients as we move into a
new chapter.”
Business Updates, Restructure Actions and Financial
Impacts
- Elimination of 176 roles, representing approximately 40% of our
workforce
- Expected annualized cost savings of at least $65 million, or
approximately $130 million in the 2024-2025 period; additional
savings possible as we continue rigorous efforts to right-size
facilities and related external spend by 2025 to better reflect our
current needs.
- One-time restructuring costs of approximately $9 million,
primarily incurred in the third quarter of 2023.
- Implemented a capital-efficient translational development
paradigm blending internal manufacturing (270-MPH), our expanded JW
Therapeutics collaboration as well as select academic centers to
efficiently explore our innovative cell therapies in the
clinic
- Current balance of cash, cash equivalents, and marketable
securities expected to support operations into 2026
Abecma and Pipeline Portfolio Updates
- Abecma “Return to Growth:”
- Revenue and impact to 2seventy: Based on an anticipated
decline in Abecma sales in the third quarter, we believe full-year
2023 U.S. revenue for Abecma could be lower than the $470-$570
million range previously projected. 2seventy continues to expect
Abecma to remain profitable this year and contribute significantly
toward our cash runway into at least 2026 and remains confident in
Abecma’s long-term commercial potential.
- Upcoming Milestones: The December 16, 2023 PDUFA date
for potential label expansion based on the KarMMa-3 data in adult
patients with triple-class exposed relapsed or refractory multiple
myeloma and the planned initiation of the KarMMa-9 study in
patients with newly diagnosed multiple myeloma with sub-optimal
response post-ASCT later this year provide both short- and
medium-term grounds for continued optimism in the commercial
potential of Abecma.
- Updates on bbT369 and SC-DARIC-33 Programs
- Phase I CRC-403 study of bbT369 in patients with
relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL)
(wholly-owned)
- Clinical Data Update: Today, 2seventy is disclosing that
the safety profile, CAR expansion kinetics, including the potential
role of the CBL-B gene edit, and the clinical efficacy data,
including complete responses in some patients observed to date is
supportive of the Company’s decision to continue the Phase I
study.
- Future Development: While interest and enrollment at
clinical study sites has been strong and initial data are
encouraging, the Phase I dose escalation study of bbT369 has
progressed slower than anticipated, due in part to the FDA mandated
safety stagger and the often-aggressive nature of relapsed and/or
refractory B-NHL, which can result in patients becoming ineligible
for treatment. Despite these challenges, the study is actively
enrolling at the third dose level. Given the anticipated pace of
accrual and treatment, the Company expects to present the first
data from the bbT369 study at a medical meeting in 2024.
- Consistent with the rest of the pipeline, the Company has
markedly streamlined the cost structure for this program, gating
further investment beyond Phase I on the achievement of
transformational efficacy.
- PLAT-08 clinical study of SC-DARIC-33 in acute myeloid
leukemia (AML) and next generation AML program (wholly-owned)
- The Company is working with the FDA to enable restart of the
Phase 1 study, which is currently on clinical hold. 2seventy plans
to limit financial commitment to the current Phase I trial.
- The Company will provide the next update on the PLAT-08 study
upon completion of the Phase I dose escalation.
- Partnered pipeline continues to develop and expand – two new
programs approaching the clinic at year end
- MUC-16 program in ovarian cancer (Regeneron partnership)
- IND submission is on track and anticipated by the end of
2023
- MAGE-A4 T cell receptor (TCR) program in solid tumors (led
by JW Therapeutics)
- Led by JW Therapeutics, initiation of an investigator-initiated
study in China is ahead of schedule and anticipated by end of
2023.
- JW Therapeutics Partnership Expansion
- As announced in a separate press release today, 2seventy bio
and JW Therapeutics are planning to expand their collaboration to
include an additional solid tumor program and the first-in-human
assessment of 2seventy’s proprietary autoimmune-directed CAR T cell
product.
Leadership Transitions Nick Leschly has informed the
Company’s Board of Directors that he intends to step down as CEO
upon the Board’s identification of his successor. The Company
expects that Mr. Leschly will be appointed Chairman of the Board
upon this transition. The Board has retained an executive
recruitment firm to assist with the search for Mr. Leschly’s
successor as CEO.
“After nearly 14 years as CEO of bluebird and 2seventy I feel
beyond grateful and humbled to have had the opportunity to help
bring four cell therapies to patients and do our part to advance
the field," said Nick Leschly, chief kairos officer. "I very much
look forward to continuing to work closely with the board and
leadership team to advance 2seventy’s mission for patients."
Additionally, Chip Baird, formerly Chief Financial Officer, is
now Chief Operating Officer expanding his responsibilities to
include finance, corporate development, investor relations and
corporate communications as well as portfolio and program/alliance
management.
Conference Call Information 2seventy bio will host a
conference call and live webcast today, September 12, at 8:00 a.m.
ET to discuss today’s announcement. To join the live conference
call, please register at:
https://register.vevent.com/register/BIc10c340a7f244db5a5fc17394a8f3552.
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/rd7agmkn. 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) timelines and expectations with
respect to regulatory approval and related filings for our product
candidates; statements regarding expected ABECMA U.S. revenue;
statements regarding expected benefits from our strategic
collaborations; statements regarding our projected timing for
disclosing data from our ongoing clinical trials; 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; the
implementation, timing and results of our strategic restructuring
efforts; the estimated charges and costs expected to be incurred in
connection with such restructuring efforts and the projected cost
savings resulting from such restructuring efforts; the anticipated
resignation of our CEO and the Company’s expectation regarding his
appointment as Chairman; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230912518500/en/
Investors: Elizabeth Pingpank Hickin, 860-463-0469
Elizabeth.pingpank@2seventybio.com
Media: Jenn Snyder, 617-448-0281
Jenn.snyder@2seventybio.com
Morgan Adams Shields, 774-313-9852
morgan.adams@2seventybio.com
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