- Company to focus exclusively on
commercialization and development of Abecma, in partnership with
Bristol Myers Squibb - - Company to sell R&D pipeline to
Regeneron to launch Regeneron Cell Medicines business led by
2seventy bio’s Chief Scientific Officer, Philip Gregory - Chip
Baird named incoming Chief Executive Officer; Nick Leschly named
incoming Chairman of Board of Directors - - Expected annual cost
savings of approximately $150 million in 2024 and $200 million in
2025; cash runway extended beyond 2027 - - Conference call to be
held today at 8:00 a.m. ET -
2seventy bio, Inc. (Nasdaq: TSVT), announced today that it is
transforming the Company to focus exclusively on the
commercialization and development of Abecma (idecabtagene
vicleucel), its BCMA-targeted CAR T therapy for multiple myeloma.
The actions announced today follow an extensive evaluation of the
Company’s business and strategic alternatives by its Board of
Directors. As a result of this strategic re-alignment, the Company
expects annual savings of approximately $150 million in 2024 and
approximately $200 million in 2025, inclusive of one-time
restructuring costs of approximately $8 million. The Company
expects to have extended cash runway beyond 2027.
In connection with the Company’s strategic re-alignment, and as
announced in a separate press release today by Regeneron
Pharmaceuticals, Inc., the Company has entered into an asset
purchase agreement (“APA”) with Regeneron to sell the Company’s
oncology and autoimmune research and development programs, clinical
manufacturing capabilities, and related platform technologies.
“Together with the Board, we have completed a thorough
assessment of our business and strategic options. Based on this
process, 2seventy has decided to focus our mission on the growth
and success of Abecma,” said Nick Leschly, outgoing chief kairos
officer and incoming board chair. “As part of this decision, we
will divest our research and development programs, with the
majority of our stellar R&D team transitioning to Regeneron.
While the decision to reshape 2seventy was driven by a series of
challenging realities, it has resulted in an outcome that we
believe is right for patients, employees, and our shareholders. The
Board is confident that the actions announced today will maximize
value for shareholders and best position our assets to deliver for
patients. We believe deeply in the potential of our innovative
science and are pleased that it is going to Regeneron, who are
building a visionary cell-based medicines center based on the
people and science from 2seventy. I also have a great deal of
confidence in Chip and the team at the new, streamlined 2seventy,
and that under their leadership and in partnership with BMS, Abecma
will return to growth commercially and deliver value for
shareholders.”
“Moving forward, 2seventy will be sharply focused on Abecma,
with a streamlined team and a dramatically different cost structure
and financial profile,” said Chip Baird, incoming chief executive
officer. “We believe this approach will give 2seventy the financial
runway to continue to work closely with our partners at BMS to
support a potential third-line launch of Abecma later this year and
a return to growth for the commercial business. In addition to the
approximately 160 members of the team transitioning to Regeneron,
we have made the hard decision to reduce the remaining workforce to
better align with the reshaped focus of the Company and reduce
expenses overall. I want to thank the incredible members of the
2seventy bio team: those whose tremendous contributions will allow
our important research and development work to continue at
Regeneron, those who will be staying on to help realize the full
value of Abecma, and those who will be departing the
organization.”
2seventy bio’s Focused Strategy on Abecma
2seventy bio will focus exclusively on the development and
commercialization of Abecma, which offers significant clinical
benefits and long-term potential in the treatment of patients with
multiple myeloma. The Company’s go-forward organization will
include approximately 65 employees, primarily in quality and
supporting functions.
2seventy bio, in partnership with Bristol Myers Squibb (BMS), is
taking actions to return Abecma to commercial growth in 2024. The
Company expects a final PDUFA action following the planned
Oncologic Drugs Advisory Committee (ODAC) meeting on the
supplemental Biologics License Application (sBLA) for Abecma based
on the KarMMA-3 clinical study, which, if approved, would expand
the label into the larger third line setting. 2seventy bio and BMS
are expanding its Abecma site footprint to enable more patients to
access the treatment. This includes educating physicians on
treatment sequencing and the emerging data supporting the use of
BCMA-directed CAR Ts before other BCMA-targeted therapies, and
competitively differentiating Abecma’s real-world safety, efficacy
and product reliability and predictability profile. The Company
will continue to support the quality control of the lentiviral
vector (LVV) manufacturing for Abecma and support the transition to
suspension LVV which will deliver additional efficiencies and cost
savings.
Management Team and Board of Directors
Upon closing of the transaction with Regeneron, Chip Baird,
chief operating officer, will become chief executive officer of
2seventy bio. The newly formed 2seventy bio leadership team will
also include Vicki Eatwell, currently senior vice president of
finance, who will become chief financial officer and Jessica Snow,
senior vice president, quality and head of operations.
Additionally at closing, 2seventy bio’s Board of Directors will
be comprised of Nick Leschly, chairman; Denice Torres, lead
independent director, a former Johnson & Johnson executive with
deep experience on public and private company Boards; Chip Baird,
incoming chief executive officer of 2seventy bio; Sarah Glickman,
chief financial officer of Criteo; Wei Lin, M.D., CMO of Erasca;
Dan Lynch, Google Ventures; and Marcela Maus, Mass General Cancer
Center. After 13 years of service on the bluebird bio and 2seventy
bio Board of Directors, Dan Lynch will step down from the Board in
June and will continue in an advisory role for 2seventy bio.
Regeneron Asset Purchase Agreement
Under the terms of the APA, Regeneron intends to purchase
2seventy bio’s research and development pipeline, including its
bbT369 program in b-NHL, SC-DARIC33 in AML, MUC16 in ovarian
cancer, MAGE-A4, autoimmune, and several unnamed targets. Upon
closing of the transaction, Regeneron will assume 100% of the
ongoing program, infrastructure and personnel costs related to
these programs. In consideration, 2seventy bio will receive an
upfront payment of $5 million, a milestone payment for the first
major market approval of the first approved product and royalties
on revenues generated by the products. In addition, Regeneron has
agreed to sublease a portion of the office, lab and manufacturing
space in Cambridge, Mass. and sublease the entire facility in
Seattle, Wash. The asset purchase is expected to close in the first
half of 2024 subject to certain closing conditions including
SEC-filings required by 2seventy bio and landlord consent of the
sublease agreements.
As part of this agreement, approximately 160 2seventy bio
employees will transition to Regeneron, including chief scientific
officer, Philip Gregory and chief medical officer, Steve
Bernstein.
Conference Call Information
2seventy bio will host a conference call and live webcast today,
January 30, 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/BIe0fdf7cfb0b34b4cabf30021f343eb38.
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/vb89h9jm. 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 financial
position and cash runway; statements about the expected cash
savings resulting from the strategic re-alignment and announced
restructuring of our business operations and sale of our oncology
research and development programs; 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 regulatory approval of
ABECMA (ide-cel) in additional indications and in earlier line
settings, if at all; statements about our plans, strategies,
timelines and expectations with respect to regulatory approval and
related filings for our product candidates; statements regarding
our plans to continue to advance our manufacturing strategy to
expand capacity and increase manufacturing efficiency for ABECMA
across the supply chain and our plans to increase the number of
ABECMA treating sites; statements regarding expected benefits from
our strategic collaboration; statements about the efficacy and
perceived therapeutic benefits of our product candidates and the
potential indications; 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 plans with respect to the 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 and our
quarterly report on Form 10-Q for the quarter ended September 30,
2023, 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/20240129369390/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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