Abecma (idecabtagene vicleucel) data to be
presented at ASH 2023; multiple new analyses of KarMMa-3 and
KarMMa-2c add to growing body of data supporting the potential
safety and efficacy of Abecma in earlier lines of treatment
Abecma generated $69 million U.S. commercial
revenue in the third quarter of 2023; $302 million U.S. commercial
revenue year-to-date
Two solid tumor programs positioned to enter
clinical trials in 2024
Ended quarter with $284.3 million cash, cash
equivalents, and marketable securities
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 third quarter ended September 30, 2023.
“This quarter, 2seventy completed a significant reshaping of our
organization, enabling us to advance our pipeline in an efficient
and more cost-effective manner. We are also supporting BMS’ efforts
to return Abecma to growth through a variety of commercial and
medical affairs initiatives, including adding more treatment sites
and boots on the ground,” said Nick Leschly, chief kairos officer.
“Collectively, we believe these measures will give us the ability
to continue our mission of delivering time to patients, operate
within a more disciplined cost structure and deliver value for our
shareholders.”
SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS
- Third quarter Abecma U.S. revenues, as reported by Bristol
Myers Squibb (BMS), were $69 million. The decline in third quarter
sales was due to increased competition from other BCMA-targeted
therapies in addition to the planned manufacturing maintenance in
June. The Company anticipates that competitive dynamics will
continue to impact Abecma sales in the fourth quarter. Based on
year-to-date results and current expectations for the fourth
quarter, 2seventy bio does not expect to achieve the original
revenue guidance of $470-570 million for 2023.
- In order to restore growth in Abecma, BMS and 2seventy bio are
focused on rapidly expanding the treating site footprint,
competitively differentiating Abecma’s real-world data and safety
profile, and educating on treatment sequencing and the emerging
data supporting the use of Abecma before T cell engagers and
antibody drug conjugates, including those targeting BCMA.
- 2seventy bio and BMS share equally in all profits and losses
related to development, manufacturing, and commercialization of
Abecma in the United States. 2seventy bio reported collaborative
arrangement revenue of $0.5 million and $48.0 million for the three
months and nine months ended September 30, 2023, respectively.
- In September, the Company 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. This
restructuring is expected to achieve $130+ million savings in
2024-2025 period.
- The Company anticipates staying within the previously-guided
net cash spend range of $180-220 million for 2023.
- 2seventy bio ended the third quarter of 2023 with cash, cash
equivalents and marketable securities of $284.3 million. While the
Company has sufficient cash to fund current planned operations for
at least 12 months, we are no longer providing specific cash runway
guidance.
“While Abecma performance was impacted due to the evolving
competitive landscape, we and our partners at BMS believe in the
long-term potential of Abecma to meaningfully impact the lives of
multiple myeloma patients. We support BMS’ efforts to improve the
commercial performance for the product,” said Chip Baird, chief
operating officer. “As we gain more visibility to the commercial
trajectory for Abecma, we will continue to carefully manage our
cash to preserve our financial runway.”
SELECTED ABECMA DATA TO BE PRESENTED AT ASH
Oral Presentation: Idecabtagene Vicleucel (ide-cel) Versus
Standard Regimens in Patients (pts) with Triple-Class Exposed (TCE)
Relapsed and Refractory Multiple Myeloma (RRMM): Updated Analysis
from KarMMa-3 Presenter: Paula Rodriguez-Otero Date
& Time: Monday, December 11, 4:45pm PT
In the final progression-free survival (PFS) analysis from the
Phase 3 KarMMa-3 study in patients with RRMM who received 2-4 prior
regimens, significantly longer PFS was maintained with ide-cel
versus standard regimens. In pts who received ide-cel (n = 225) or
a standard regimen (n = 126), median PFS (95% CI) was 15.7
(12.5–18.9) vs 4.4 (3.4–5.8) months, respectively. The ide-cel
safety profile was consistent with previous reports, with no
parkinsonism or Guillain–Barré syndrome reported. Ide-cel continued
to demonstrate durable, clinically meaningful improvements in
pt-reported outcomes, including symptoms, functioning, and quality
of life (QOL) vs standard regimens. Interim overall survival (OS)
will be included in the presentation.
Poster Presentation: Efficacy and Safety of Idecabtagene
Vicleucel (ide-cel) in Patients with Clinical High-Risk Newly
Diagnosed Multiple Myeloma (MM) with an Inadequate Response to
Frontline Autologous Stem Cell Transplantation (ASCT): KarMMa-2
Cohort 2c Extended Follow-up Presenters: Madhav
Dhodapkar; Melissa Alsina Date & Time: Saturday,
December 9, 5:30 – 7:30pm PT
In updated data from the KarMMa-2 cohort 2c study, ide-cel
continued to demonstrate deep, durable responses in patients with
an inadequate response to frontline ASCT. No new safety signals
were observed with extended follow-up, and no deaths were reported.
No patients who received lenalidomide maintenance post ide-cel
experienced disease progression.
“The updated clinical data to be presented on Abecma reinforces
the potential of this therapy to play an important role in earlier
lines,” said Steve Bernstein, chief medical officer. “In the
extended follow-up from the KarMMa-3 study, we saw responses from
some patients continue to deepen. The additional data from the
KarMMa-2, cohort 2c study is supportive of our registrational
KarMMa-9 study in a similar patient population which is now open
and enrolling. We look forward to presenting these data at ASH
along with additional sub-analyses that reinforce the impact of
Abecma on patient-reported outcomes, quality of life and clinical
use.”
RECENT UPDATES
- MUC16 DATA PRESENTED AT SITC – In November, 2seventy bio
presented new pre-clinical data on its MUC16-targeted CAR T-cell
therapy in ovarian cancer, being developed as part of our expanded
collaboration with Regeneron, in a poster presentation at the 38th
Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
These preclinical data support the IND submission for MUC16, which
is on track for end of year. The Company recently completed
270-MPH, an in-house clinical drug product manufacturing site, to
more effectively support growing U.S. clinical needs. MUC16 will be
the first program to be manufactured in this facility.
- EXPANSION OF PARTNERSHIP WITH JW THERAPEUTICS – In
September, 2seventy bio and JW Therapeutics announced their
intention to expand their strategic alliance. The expansion, based
on the partnership that was established last year, builds upon the
companies’ translational and clinical cell therapy development
platform originally designed to more rapidly explore T cell-based
immunotherapy therapy products in Greater China. Specifically, the
companies intend to add up to two additional candidates from the
2seventy bio portfolio, one in solid tumor indications using T-cell
receptor (TCR) based technology and a second in autoimmune disease
using a CAR T cell approach.
UPCOMING ANTICIPATED PIPELINE MILESTONES
- Submission of an Investigational New Drug (IND) application for
MUC16 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 THIRD QUARTER FINANCIAL RESULTS
- Total 2seventy bio revenues were $12.0 million for the three
months ended September 30, 2023, compared to $13.4 million for the
three months ended September 30, 2022. Total revenues were $89.7
million for the nine months ended September 30, 2023, compared to
$35.3 million for the nine months ended September 30, 2022.
- Research and development expenses were $51.3 million for the
three months ended September 30, 2023, compared to $58.2 million
for the three months ended September 30, 2022. Research and
development expenses were $179.5 million for the nine months ended
September 30, 2023, compared to $188.6 million for the nine months
ended September 30, 2022.
- Selling, general and administrative expenses were $13.0 million
for the three months ended September 30, 2023, compared to $19.6
million for the three months ended September 30, 2022. Selling,
general and administrative expenses were $53.2 million for the nine
months ended September 30, 2023, compared to $60.7 million for the
nine months ended September 30, 2022.
- Net loss was $71.6 million for the three months ended September
30, 2023, compared to $67.9 million for the three months ended
September 30, 2022. Net loss was $160.7 million for the nine months
ended September 30, 2023, compared to $231.0 million for the nine
months ended September 30, 2022.
Conference Call Information
2seventy bio will host a conference call and live webcast today,
November 14, at 8:00 a.m. ET to discuss 3Q 2023 financial results
and recent business highlights. To join the live conference call,
please register at:
https://register.vevent.com/register/BI2148ebda1eeb4055a857a3dbe4e61710.
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/k9zuv9vr/. 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.
ABECMA U.S. INDICATION
ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen
(BCMA)-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with
relapsed or refractory multiple myeloma after four or more prior
lines of therapy, including an immunomodulatory agent, a proteasome
inhibitor, and an anti-CD38 monoclonal antibody.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC
TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients following
treatment with ABECMA. Do not administer ABECMA to patients with
active infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening,
occurred following treatment with ABECMA, including concurrently
with CRS, after CRS resolution, or in the absence of CRS. Monitor
for neurologic events after treatment with ABECMA. Provide
supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation
Syndrome (HLH/MAS) including fatal and life-threatening reactions,
occurred in patients following treatment with ABECMA. HLH/MAS can
occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including
fatal outcomes following stem cell transplantation for
hematopoietic recovery, occurred following treatment with
ABECMA.
- ABECMA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA
REMS.
Warnings and Precautions:
Cytokine Release Syndrome (CRS): CRS, including fatal or
life-threatening reactions, occurred following treatment with
ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred
in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%)
patient. The median time to onset of CRS, any grade, was 1 day
(range: 1 – 23 days) and the median duration of CRS was 7 days
(range: 1 – 63 days). The most common manifestations included
pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and
headache. Grade 3 or higher events that may be associated with CRS
include hypotension, hypoxia, hyperbilirubinemia,
hypofibrinogenemia, acute respiratory distress syndrome (ARDS),
atrial fibrillation, hepatocellular injury, metabolic acidosis,
pulmonary edema, multiple organ dysfunction syndrome, and
HLH/MAS.
Identify CRS based on clinical presentation. Evaluate for and
treat other causes of fever, hypoxia, and hypotension. CRS has been
reported to be associated with findings of HLH/MAS, and the
physiology of the syndromes may overlap. In patients with
progressive symptoms of CRS or refractory CRS despite treatment,
evaluate for evidence of HLH/MAS.
Fifty four percent (68/127) of patients received tocilizumab
(single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of
patients received at least 1 dose of corticosteroids for treatment
of CRS. All patients that received corticosteroids for CRS received
tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are
available prior to infusion of ABECMA.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs or
symptoms of CRS and monitor patients for signs or symptoms of CRS
for at least 4 weeks after ABECMA infusion. At the first sign of
CRS, institute treatment with supportive care, tocilizumab and/or
corticosteroids as indicated.
Counsel patients to seek immediate medical attention should
signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, which may
be severe or life-threatening, occurred following treatment with
ABECMA in 28% (36/127) of patients receiving ABECMA, including
Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2
neurotoxicity at the time of death. Two patients had ongoing Grade
1 tremor at the time of data cutoff. The median time to onset of
neurotoxicity was 2 days (range: 1 – 42 days). CAR T
cell-associated neurotoxicity resolved in 92% (33/36) of patients
with a median time to resolution of 5 days (range: 1 – 61 days).
The median duration of neurotoxicity was 6 days (range: 1 – 578) in
all patients including 3 patients with ongoing neurotoxicity.
Thirty-four patients with neurotoxicity had CRS with onset in 3
patients before, 29 patients during, and 2 patients after CRS. The
most frequently reported manifestations of CAR T cell-associated
neurotoxicity include encephalopathy, tremor, aphasia, and
delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient,
Grade 3 myelitis, and Grade 3 parkinsonism have been reported with
ABECMA in another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs or
symptoms of neurologic toxicities and monitor patients for signs or
symptoms of neurologic toxicities for at least 4 weeks after ABECMA
infusion and treat promptly. Rule out other causes of neurologic
symptoms. Neurologic toxicity should be managed with supportive
care and/or corticosteroids as needed.
Counsel patients to seek immediate medical attention should
signs or symptoms occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage
Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of
patients receiving ABECMA. One patient developed fatal multi-organ
HLH/MAS with CRS and another patient developed fatal
bronchopulmonary aspergillosis with contributory HLH/MAS. Three
cases of Grade 2 HLH/MAS resolved. All events of HLH/MAS had onset
within 10 days of receiving ABECMA with a median onset of 7 days
(range: 4 – 9 days) and occurred in the setting of ongoing or
worsening CRS. Two patients with HLH/MAS had overlapping
neurotoxicity. The manifestations of HLH/MAS include hypotension,
hypoxia, multiple organ –dysfunction, renal dysfunction, and
cytopenia. HLH/MAS is a potentially life-threatening condition with
a high mortality rate if not recognized early and treated.
Treatment of HLH/MAS should be administered per institutional
guidelines.
ABECMA REMS: Due to the risk of CRS and neurologic
toxicities, ABECMA is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
ABECMA REMS. Further information is available at www.AbecmaREMS.com
or 1-888-423-5436.
Hypersensitivity Reactions: Allergic reactions may occur
with the infusion of ABECMA. Serious hypersensitivity reactions,
including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in
ABECMA.
Infections: ABECMA should not be administered to patients
with active infections or inflammatory disorders. Severe,
life-threatening, or fatal infections occurred in patients after
ABECMA infusion. Infections (all grades) occurred in 70% of
patients. Grade 3 or 4 infections occurred in 23% of patients.
Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%)
had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5
bronchopulmonary aspergillosis, and 1 patient (0.8%) had
cytomegalovirus (CMV) pneumonia associated with Pneumocystis
jirovecii. Monitor patients for signs and symptoms of infection
before and after ABECMA infusion and treat appropriately.
Administer prophylactic, pre-emptive, and/or therapeutic
antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in 16% (20/127) of patients
after ABECMA infusion and may be concurrent with CRS. In the event
of febrile neutropenia, evaluate for infection and manage with
broad-spectrum antibiotics, fluids, and other supportive care.
Viral Reactivation: CMV infection resulting in pneumonia
and death has occurred following ABECMA administration. Monitor and
treat for CMV reactivation in accordance with clinical guidelines.
Hepatitis B virus (HBV) reactivation, in some cases resulting in
fulminant hepatitis, hepatic failure, and death, can occur in
patients treated with drugs directed against plasma cells. Perform
screening for CMV, HBV, hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) in accordance with clinical guidelines
before collection of cells for manufacturing.
Prolonged Cytopenias: In the clinical study, 41% of
patients (52/127) experienced prolonged Grade 3 or 4 neutropenia
and 49% (62/127) experienced prolonged Grade 3 or 4
thrombocytopenia that had not resolved by Month 1 following ABECMA
infusion. In 83% (43/52) of patients who recovered from Grade 3 or
4 neutropenia after Month 1, the median time to recovery from
ABECMA infusion was 1.9 months. In 65% (40/62) of patients who
recovered from Grade 3 or 4 thrombocytopenia, the median time to
recovery was 2.1 months.
Three patients underwent stem cell therapy for hematopoietic
reconstitution due to prolonged cytopenia. Two of the three
patients died from complications of prolonged cytopenia. Monitor
blood counts prior to and after ABECMA infusion. Manage cytopenia
with myeloid growth factor and blood product transfusion
support.
Hypogammaglobulinemia: Hypogammaglobulinemia was reported
as an adverse event in 21% (27/127) of patients; laboratory IgG
levels fell below 500 mg/dl after infusion in 25% (32/127) of
patients treated with ABECMA.
Monitor immunoglobulin levels after treatment with ABECMA and
administer IVIG for IgG <400 mg/dl. Manage appropriately per
local institutional guidelines, including infection precautions and
antibiotic or antiviral prophylaxis.
The safety of immunization with live viral vaccines during or
after ABECMA treatment has not been studied. Vaccination with live
virus vaccines is not recommended for at least 6 weeks prior to the
start of lymphodepleting chemotherapy, during ABECMA treatment, and
until immune recovery following treatment with ABECMA.
Secondary Malignancies: Patients treated with ABECMA may
develop secondary malignancies. Monitor life-long for secondary
malignancies. If a secondary malignancy occurs, contact
Bristol-Myers Squibb at 1-888-805-4555 to obtain instructions on
patient samples to collect for testing of secondary malignancy of T
cell origin.
Effects on Ability to Drive and Operate Machinery: Due to
the potential for neurologic events, patients receiving ABECMA are
at risk for altered or decreased consciousness or coordination in
the 8 weeks following ABECMA infusion. Advise patients to refrain
from driving and engaging in hazardous occupations or activities,
such as operating heavy or potentially dangerous machinery, during
this initial period.
Adverse Reactions: The most common nonlaboratory adverse
reactions include CRS, infections – pathogen unspecified, fatigue,
musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper
respiratory tract infection, nausea, viral infections,
encephalopathy, edema, pyrexia, cough, headache, and decreased
appetite.
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide.
About Bristol Myers Squibb and 2seventy bio
Abecma is being jointly developed and commercialized in the U.S.
as part of a Co-Development, Co-Promotion, and Profit Share
Agreement between Bristol Myers Squibb and 2seventy bio. Bristol
Myers Squibb assumes sole responsibility for Abecma drug product
manufacturing and commercialization outside of the U.S. The
companies’ broad clinical development program for Abecma includes
ongoing and planned clinical studies (KarMMa-2, KarMMa-3, KarMMa-9)
in earlier lines of treatment for patients with multiple myeloma.
For more information visit clinicaltrials.gov.
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 concerning our expected
revenues and net cash spend for 2023; statements about our
financial position and cash runway; statements about the expected
cash savings resulting from the recent restructuring of our
business operations and research and development model; 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, including the expected MUC-16
IND filing and initiation of an investigator-initiated study of our
MAGE-A4 TCR program; 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; 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 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.
2seventy bio, Inc.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except per
share data)
For the three months
ended
September 30,
For the nine months
ended
September 30,
2023
2022
2023
2022
Revenue: Service revenue
$
4,948
$
4,642
$
20,796
$
14,363
Collaborative arrangement revenue
5,859
7,903
64,265
18,425
Royalty and other revenue
1,227
863
4,642
2,531
Total revenues
12,034
13,408
89,703
35,319
Operating expenses: Research and development
51,315
58,155
179,541
188,591
Cost of manufacturing for commercial collaboration
4,408
3,584
11,672
10,832
Selling, general and administrative
13,004
19,610
53,213
60,749
Share of collaboration loss
-
-
-
9,642
Restructuring expenses
8,614
-
8,614
-
Cost of royalty and other revenue
551
377
2,099
1,252
Change in fair value of contingent consideration
54
50
180
181
Goodwill impairment charge
12,056
-
12,056
-
Total operating expenses
90,002
81,776
267,375
271,247
Loss from operations
(77,968
)
(68,368
)
(177,672
)
(235,928
)
Interest income, net
3,626
1,113
8,765
1,441
Other income (expense), net
2,704
(624
)
8,159
3,477
Loss before income taxes
(71,638
)
(67,879
)
(160,748
)
(231,010
)
Income tax (expense) benefit
-
-
-
-
Net loss
$
(71,638
)
$
(67,879
)
$
(160,748
)
$
(231,010
)
Net loss per share - basic and diluted
$
(1.40
)
$
(1.76
)
$
(3.31
)
$
(6.67
)
Weighted-average number of common shares used in computing net loss
per share - basic and diluted
51,179
38,573
48,566
34,612
2seventy bio, Inc.
Condensed Consolidated Balance
Sheet Data
(unaudited)
(in thousands)
As of September 30,
2023
As of December 31,
2022
Cash, cash equivalents and marketable securities
$
284,278
$
267,684
Total assets
640,806
656,665
Total liabilities
334,384
346,199
Total stockholders' equity
306,422
310,466
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114877233/en/
Investors: Elizabeth Pingpank Hickin, 860-463-0469
elizabeth.pingpank@2seventybio.com
Media: Morgan Adams Shields, 774-313-9852
morgan.adams@2seventybio.com
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