REG - Syncona Limited - Autolus reports Q2 2025 Financial Results
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RNS Number : 2316V Syncona Limited 13 August 2025
13 August 2025
Syncona Limited
("Syncona" or the "Company")
Autolus Therapeutics Reports Second Quarter 2025 Financial Results and
Business Updates
Syncona Ltd, a leading life science investor, notes that its portfolio company
Autolus Therapeutics plc (Nasdaq: AUTL) ("Autolus") announced its operational
and financial results for the second quarter ended 30 June 2025. Key
highlights are as follows:
· The company reported Q2 2025 AUCATZYL(®) net product revenue of
$20.9 million, with $29.9 million in total for the first six months of 2025
· Company recently received conditional marketing authorisation from UK
Medicines and Healthcare products Regulatory Agency (MHRA) and conditional
European marketing authorisation from the European Commission (EC) for
AUCATZYL(®)
· Follow up data from the FELIX trial demonstrating obe-cel's potential
for long-term remission in r/r B-ALL was presented at the 2025 European
Hematology Association (EHA) Congress
· Company is on track to initiate Phase II pivotal clinical trial in
lupus nephritis (LN) and Phase I clinical trial in progressive forms of
multiple sclerosis (MS) by year-end 2025
Autolus' announcement is copied below and can be accessed at the company's
investor website at https://www.autolus.com/investor-relations/news
(https://www.autolus.com/investor-relations/news) . To listen to the webcast
and view the accompanying slide presentation, please go to:
https://www.autolus.com/investor-relations/events/
(https://www.autolus.com/investor-relations/events/) .
Enquiries
Syncona Ltd
Annabel Clark
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
Forward-looking statements - this announcement contains certain
forward-looking statements with respect to the portfolio of investments of
Syncona Limited. These statements and forecasts involve risk and uncertainty
because they relate to events and depend upon circumstances that may or may
not occur in the future. There are a number of factors that could cause actual
results or developments to differ materially from those expressed or implied
by these forward-looking statements. In particular, many companies in the
Syncona Limited portfolio are conducting scientific research and clinical
trials where the outcome is inherently uncertain and there is significant risk
of negative results or adverse events arising. In addition, many companies in
the Syncona Limited portfolio have yet to commercialise a product and their
ability to do so may be affected by operational, commercial and other risks.
Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment in
Syncona Limited, including the information in our published documentation,
before investing.
Autolus Therapeutics Reports Second Quarter 2025 Financial Results and
Business Updates
· Company reports Q2 2025 AUCATZYL® net product revenue of $20.9
million and $29.9 for the first six months of 2025
· Company recently received conditional marketing authorization from
U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and
conditional European marketing authorization from the European Commission (EC)
for AUCATZYL®
· Follow up data from the FELIX trial demonstrating obe-cel's potential
for long-term remission in r/r B-ALL presented at the 2025 European Hematology
Association (EHA) Congress
· Company is on track to initiate Phase 2 pivotal clinical trial in
lupus nephritis (LN) and Phase 1 clinical trial in progressive forms of
multiple sclerosis (MS) by year-end 2025
· Conference call to be held today at 08:30 am EDT/13:30 pm BST:
conference call participants should pre-register using the link at the bottom
of this press release
LONDON & Gaithersburg, MD, August 12, 2025 -- Autolus Therapeutics
plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company
developing, manufacturing and delivering next-generation programmed T cell
therapies, announces its operational and financial results for the second
quarter ended June 30, 2025.
"We are encouraged by AUCATZYL's early launch performance in the U.S., driven
by physician enthusiasm for the product profile, unmet need for r/r B-All
patients and favorable market access and reimbursement - supported by strong
execution on manufacturing and product delivery," said Dr. Christian Itin,
Chief Executive Officer of Autolus. "With recent approvals in the EU and UK
our focus shifts to market access on a country-by-country basis. In addition
to commercial progress in the adult setting, we look forward to reporting
clinical data from the pediatric PY1 trial of obe-cel in ALL in the second
half of the year and believe there is additional growth opportunity in
pediatric ALL."
"Beyond ALL, we believe obe-cel has 'pipeline-in-a-product' potential and
could deliver improved outcomes in autoimmune disease. We are excited about
the recently reported preliminary data from the Phase 1 CARLYSLE study in
systemic lupus erythematous (SLE). We look forward to reporting additional
Phase 1 data in SLE patients at a medical conference later this year; dosing
the first patient in our planned Phase 2 pivotal trial in LN and starting a
Phase 1 trial in progressive multiple sclerosis (MS) by year-end."
Key updates and anticipated milestones:
· AUCATZYL® Launch
o Autolus reported Q2 2025 net product sales of $20.9 million.
o The Company has 46 centers fully activated in the U.S. as of August 12,
2025.
o Patient access to AUCATZYL continues to increase, with coverage secured
for greater than 90% of total U.S. medical lives.
o On April 25, 2025, the UK Medicines and Healthcare products Regulatory
Agency (MHRA) granted conditional marketing authorization for AUCATZYL
(https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-announces-license-aucatzylr-obecabtagene)
for the treatment of adult patients age 18+ with relapsed or refractory
B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Following an
initial review and in line with prior practice for CAR T therapies the
National Institute for Health and Care Excellence (NICE) issued a preliminary
Appraisal Consultation Decision (ACD) recommending against funding for
AUCATZYL. Autolus plans to respond to NICE's questions and will continue to
work towards a pathway for patient access to therapy in the UK.
o On July 17, 2025, the European Commission (EC) granted conditional
marketing authorization for AUCATZYL
(https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-car-t-therapy-aucatzylr-obecabtagene)
in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential
pricing and feasibility of market entry opportunities in certain EU countries
is ongoing; however, at this time launch in Germany is on hold and the Company
does not anticipate any EU sales of AUCATZYL in 2025 and 2026.
· Obe-cel data in r/r B-ALL
o Autolus presented updated long-term data
(https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-presents-long-term-follow-felix-study)
from the FELIX study in adult patients with r/r B-ALL in an oral
presentation at the 2025 European Hematology Association (EHA) Congress in
June. For patients with a response, the updated median duration of response
(mDOR) is now 42.5 months. At the updated median follow up of 32.8 months,
38.4% of responders were in ongoing remission without consolidative stem cell
therapy or other therapies (versus the previously reported 40% at a median
follow-up of 21.5 months). The 24-month probability of Event Free Survival was
43%, and the Overall Survival was 46%, with a further consolidating long-term
plateau observed. No new safety signals or Grade ≥3 secondary malignancies
were observed at the extended follow-up. These results suggest that obe-cel
may be a durable treatment option for some patients with r/r B-ALL.
· Obe-cel in lupus nephritis (LN)
o Preliminary data from the Phase 1 dose confirmation clinical trial
(CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients were
reported on April 23, 2025, and support progressing into a planned Phase 2
pivotal study.
o The Company has aligned with the U.S. Food and Drug Administration (FDA)
on the Phase 2 trial design and potential registrational path to approval and
continues to anticipate dosing the first patient in a Phase 2 clinical trial
before the end of 2025.
o Data with longer term follow-up from the Phase 1 CARLYSLE clinical trial
is on track for presentation at a medical conference in the second half of
2025.
· Obe-cel in progressive MS
o Autolus plans to advance obe-cel into initial clinical development in
progressive MS. The Company continues to expect to dose its first patient in a
Phase 1 dose escalation study by year-end 2025.
· Early-stage pipeline programs and collaborations support longer-term
growth
o Autolus' translational programs with UCL continue to fuel its early-stage
pipeline, providing a cost-efficient path to development.
Summary of Anticipated News Flow:
ALL: PY01 trial in pediatric ALL first clinical data H2 2025
SLE: Phase 1 CARLYSLE trial presentation at medical conference H2 2025
LN: Expect to dose first patient in Phase 2 trial By year-end 2025
MS: Expect to dose first patient in Phase 1 trial in progressive MS By year-end 2025
ALA: Expect to dose first patient in Phase 1 trial in AL amyloidosis By year-end 2025
ALL: adult lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
MS: multiple sclerosis
ALA: light-chain amyloidosis
Financial Results for the Quarter Ended June 30, 2025
Product revenue, net for the three months ended June 30, 2025 was $20.9
million.
Cost of sales for the three months ended June 30, 2025 totaled $24.4 million.
This amount includes the cost of all commercial product delivered to the
authorized treatment centers, including product delivered but not yet recorded
as product revenue which is captured as deferred revenue. Additionally, cost
of sales includes any cancelled orders in the period, patient access program
product, and 3(rd) party royalties for certain technology licenses.
Research and development expenses decreased from $36.6 million to $27.4
million for the three months ended June 30, 2025, compared to the same period
in 2024. This change was primarily due to commercial manufacturing-related
employee and infrastructure costs shifting to cost of sales and inventory.
Selling, general and administrative expenses increased from $21.9 million to
$30.3 million for the three months ended June 30, 2025, compared to the same
period in 2024. This increase was primarily due to salaries and other
employment-related costs, driven by increased headcount supporting
commercialization activities.
Loss from operations for the three months ended June 30, 2025 was $61.2
million, as compared to $58.9 million for the same period in 2024.
Net loss was $47.9 million for the three months ended June 30, 2025, compared
to $58.3 million for the same period in 2024. Basic and diluted net loss per
ordinary share for the three months ended June 30, 2025, totaled $(0.18),
compared to basic and diluted net loss per ordinary share of $(0.22) for the
same period in 2024.
Cash, cash equivalents and marketable securities at June 30, 2025, totalled
$454.3 million, as compared to $588.0 million at December 31, 2024. The
decrease was primarily driven by net cash used in operating activities and
impacted by a delayed cash receipt of approximately $21.7 million in R&D
tax credit expected from the UK HMRC, which was expected to be received during
the six months ended June 30, 2025.
Autolus estimates that, with its current cash and cash equivalents and
marketable securities, the Company is well capitalized to drive the launch and
commercialization of obe-cel in r/r B-ALL and to obtain data in the LN pivotal
trial and MS Phase 1 trial.
Financial Results for the Period Ended June 30, 2025
Selected Consolidated Balance Sheet Data
(In thousands)
June 30, December 31,
2025 2024
Assets
Cash and cash equivalents $ 123,825 $ 227,380
Marketable securities - Available-for-sale debt securities $ 330,454 $ 360,643
Total current assets $ 574,250 $ 660,929
Total assets $ 720,981 $ 782,725
Liabilities and shareholders' equity
Deferred revenue $ 2,100 $ -
Total current liabilities $ 68,151 $ 60,743
Total liabilities $ 374,517 $ 355,400
Total shareholders' equity $ 346,464 $ 427,325
Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Product revenue, net $ 20,923 $ - $ 29,905 $ -
License revenue - - - - - 10,091
Operating expenses:
Cost of sales (24,445) - (42,396) -
Research and development expenses, net (27,430) (36,612) (54,164) (67,283)
Selling, general and administrative expenses (30,265) (21,903) (59,799) (40,080)
Loss on disposal of property and equipment - - (3) -
Impairment of operating lease right-of-use assets and related property and - (414) - (414)
equipment
Loss from operations (61,217) (58,929) (126,457) (97,686)
Foreign exchange gains (losses), net 1,634 1,226 2,942 (379)
Interest income (expenses), net 12,063 (518) 8,057 (12,854)
Total other income (expenses), net 13,697 708 10,999 (13,233)
Net loss before income tax (47,520) (58,221) (115,458) (110,919)
Income tax expense (397) (51) (2,623) (43)
Net loss attributable to ordinary shareholders (47,917) (58,272) (118,081) (110,962)
Other comprehensive income, net of tax 18,968 1,026 30,036 1,084
Total comprehensive loss $ (28,949) $ (57,246) $ (88,045) $ (109,878)
Basic and diluted net loss per ordinary share $ (0.18) $ (0.22) $ (0.44) $ (0.43)
Weighted-average basic and diluted ordinary shares 266,141,411 265,025,783 266,134,021 255,131,873
Conference Call
Management will host a conference call and webcast today at 8:30am EDT/13:30pm
BST to discuss the company's financial results. Conference call participants
should pre-register using this link
(https://register-conf.media-server.com/register/BI72e3c4a83c2a4fe1a89498d00dcd1334)
to receive the dial-in numbers and a personal PIN, which are required to
access the conference call. A simultaneous audio webcast and replay will be
accessible on the events section of Autolus' website at
https://www.autolus.com/investor-relations-media/events/
(https://www.autolus.com/investor-relations-media/events/) .
About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial-stage
biopharmaceutical company developing, manufacturing and delivering
next-generation T cell therapies and candidates for the treatment of cancer
and autoimmune disease. Using a broad suite of proprietary and modular T cell
programming technologies, Autolus is engineering precisely targeted and
controlled T cell therapies that are designed to better recognize target
cells, break down their defense mechanisms and eliminate these cells. Autolus
has a marketed therapy, AUCATZYL®, and a pipeline of product candidates in
development for the treatment of hematological malignancies, solid tumors and
autoimmune diseases. For more information, please visit www.autolus.com
(http://www.autolus.com/) .
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel enrolled adult patients with r/r
B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the
single arm, Phase 2 clinical trial. The primary endpoint in the pivotal cohort
was overall response rate, and the secondary endpoints included duration of
response, MRD negative complete remission rate and safety. The trial enrolled
over 100 patients across 30 of the leading academic and non-academic centers
in the United States, United Kingdom and Europe. NCT04404660
About AUCATZYL® (obecabtagene autoleucel, obe-cel, AUTO1)
AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR)
T cell therapy designed to overcome the limitations in clinical activity and
safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed
with a fast target binding off-rate to minimize excessive activation of the
programmed T cells. AUCATZYL was approved by the FDA for the treatment of
adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia on November 8, 2024, and was granted marketing
authorization by the MHRA in the UK on April 25, 2025. In the EU, a regulatory
submission to the EMA for AUCATZYL was accepted in April 2024.
INDICATION
AUCATZYL(®) is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY
HEMATOLOGICAL MALIGNANCIES
· Cytokine Release Syndrome (CRS) occurred in patients receiving
AUCATZYL. Do not administer AUCATZYL to patients with active infection or
inflammatory disorders. Prior to administering AUCATZYL, ensure that
healthcare providers have immediate access to medications and resuscitative
equipment to manage CRS.
· Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS),
including fatal and life-threatening reactions, occurred in patients receiving
AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for
neurologic signs and symptoms after treatment with AUCATZYL. Prior to
administering AUCATZYL, ensure that healthcare providers have immediate access
to medications and resuscitative equipment to manage neurologic toxicities.
Provide supportive care and/or corticosteroids, as needed.
· T cell malignancies have occurred following treatment of hematologic
malignancies with BCMA- and CD19-directed genetically modified autologous T
cell immunotherapies.
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS)
Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL.
CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of
patients. The median time to onset of CRS was 8 days following the first
infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to
21 days). The most common manifestations of CRS included fever (100%),
hypotension (35%), and hypoxia (19%).
Prior to administering AUCATZYL, ensure that healthcare providers have
immediate access to medications and resuscitative equipment to manage CRS.
During and following treatment with AUCATZYL, closely monitor patients for
signs and symptoms of CRS daily for at least 14 days at the healthcare
facility following the first infusion. Continue to monitor patients for CRS
for at least 4 weeks following each infusion with AUCATZYL. Counsel patients
to seek immediate medical attention should signs or symptoms of CRS occur at
any time. At the first sign of CRS, immediately evaluate the patient for
hospitalization and institute treatment with supportive care based on severity
and consider further management per current practice guidelines.
Neurologic Toxicities
Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity
Syndrome (ICANS), which were fatal or life-threatening, occurred following
treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100)
of patients, including Grade ≥ 3 in 12% of patients. The median time to
onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a
median duration of 13 days (range: 1 to 904 days). Among patients with
neurologic toxicities, the most common symptoms (> 5%) included ICANS
(38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%),
anxiety (9%), insomnia (9%), and delirium (8%).
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7%
(7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24)
experienced an onset after the first infusion, but prior to the second
infusion of AUCATZYL.
The median time to onset for ICANS events after the first infusion was 8 days
(range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second
infusion, with a median duration of 8.5 days (range: 1 to 53 days).
Eighty-eight percent (21/24) of patients received treatment for ICANS. All
treated patients received high-dose corticosteroids and 42% (10/24) of
patients received anti-epileptics prophylactically. Prior to administering
AUCATZYL, ensure that healthcare providers have immediate access to
medications and resuscitative equipment to manage ICANS.
Counsel patients to seek medical attention should signs or symptoms of
neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity
/ICANS, immediately evaluate patients for hospitalization and institute
treatment with supportive care based on severity and consider further
management per current practice guidelines.
Effect on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or
seizures, patients receiving AUCATZYL are at risk for altered or decreased
consciousness or coordination in the eight weeks following AUCATZYL infusion
or until resolution of the neurological event by the treating physician.
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.
Prolonged Cytopenias
Patients may exhibit cytopenias including anemia, neutropenia, and
thrombocytopenia for several weeks after treatment with lymphodepleting
chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade
≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were
observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and
thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted
beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of
patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%,
6/41). Monitor blood counts after AUCATZYL infusion.
Infections
Severe, including life-threatening and fatal infections occurred in patients
after AUCATZYL infusion. Non‑COVID-19 infections of all grades occurred in
67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred
in 41% (41/100) of patients. AUCATZYL should not be administered to patients
with clinically significant active systemic infections. Monitor patients for
signs and symptoms of infection before and after AUCATZYL infusion and treat
appropriately. Administer prophylactic antimicrobials according to local
guidelines.
Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients
after AUCATZYL 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 as medically indicated.
Viral reactivation, potentially severe or life-threatening, can occur in
patients treated with drugs directed against B cells. There is no experience
with manufacturing AUCATZYL for patients with a positive test for human
immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active
hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance
with clinical guidelines before collection of cells for manufacturing.
Hypogammaglobulinemia
Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL
infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients
treated with AUCATZYL including Grade 3 events in 2 patients (2%).
Immunoglobulin levels should be monitored after treatment with AUCATZYL and
managed per institutional guidelines including infection precautions,
antibiotic or antiviral prophylaxis, and immunoglobulin replacement.
The safety of immunization with live viral vaccines during or following
treatment with AUCATZYL has not been studied. Vaccination with live viral
vaccines is not recommended for at least 6 weeks prior to the start of
lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until
immune recovery following treatment with AUCATZYL.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)
HLH/MAS including fatal and life-threatening reactions occurred after
treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and
included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41,
respectively. One patient experienced a concurrent ICANS events after AUCATZYL
infusion and died due to sepsis with ongoing HLH/MAS that had not resolved.
Administer treatment for HLH/MAS according to institutional standards.
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, may occur due to
dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for
hypersensitivity reactions during and after AUCATZYL infusion.
Secondary Malignancies
Patients treated with AUCATZYL may develop secondary malignancies. T cell
malignancies have occurred following treatment of hematologic malignancies
with BCMA- and CD19-directed genetically modified autologous T cell
immunotherapies. Mature T cell malignancies, including CAR-positive tumors,
may present as soon as weeks following infusion, and may include fatal
outcomes. Monitor lifelong for secondary malignancies. In the event that a
secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting
and to obtain instructions on the collection of patient samples for testing.
Adverse Reactions
The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients
with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL)
received AUCATZYL at a median dose of 410 × 10(6) CD19 CAR-positive viable T
cells (range: 10 to 480 × 10(6) CD19 CAR-positive viable T cells with 90% of
patients receiving the recommended dose of 410 × 10(6) +/- 25%).
The most common serious adverse reactions of any Grade (incidence ≥ 2%)
included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS,
fever, bacterial infectious disorders, encephalopathy, fungal infections,
hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and
hypoxia. Nine patients (9%) experienced fatal adverse reactions which included
infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism,
acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients,
five patients who died from infections had pre-existing and ongoing
neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy
treatment and/or AUCATZYL.
Please see full Prescribing Information
(http://www.autolus.com/AUCATZYL-USPI/) , including BOXED WARNING and
Medication Guide.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are statements that are not historical
facts, and in some cases can be identified by terms such as "may," "will,"
"could," "expects," "plans," "anticipates," and "believes." These statements
include, but are not limited to, statements regarding the therapeutic
potential and expected clinical benefits of AUCATZYL/obe-cel (obecabtagene
autoleucel) for adult patients with r/r B-ALL and obe-cel in additional
indications including LN and progressive MS; Autolus' ability to generate
revenues from AUCATZYL, which is dependent upon maintaining significant market
acceptance among physicians, patients and healthcare payors; the effect of
payor reimbursement determinations and other market conditions on Autolus'
ability to recognize revenue from AUCATZYL sales; Autolus' ability to obtain
and maintain regulatory approval for obe-cel for adult r/r B-ALL in additional
territories and the timing thereof; expectations regarding the
commercialization and marketing of AUCATZYL for adult r/r B-ALL, including
expanding into additional territories and the related timing of reaching
patients in such territories; the development of obe-cel in autoimmune
indications and of additional product candidates, including statements
regarding the initiation, timing, progress and the results of clinical studies
or trials and related preparatory work; the period during which the results of
clinical studies or trials will become available; commercialization, marketing
and manufacturing capabilities and strategy for AUCATZYL; the timing or
likelihood of regulatory filings and approvals for product candidates, along
with regulatory developments in the US, EU, the UK and other foreign
countries; size and growth potential of the markets for AUCATZYL and product
candidates, if approved; and estimates regarding expenses, future revenue,
capital requirements and needs for additional financing. Any forward-looking
statements are based on management's current views and assumptions and involve
risks and uncertainties that could cause actual results, performance, or
events to differ materially from those expressed or implied in such
statements. These risks and uncertainties include, but are not limited to, the
risks that the impact of worsening macroeconomic conditions on Autolus'
business, financial position, strategy and anticipated milestones, including
Autolus' ability to conduct ongoing and planned clinical trials; Autolus'
ability to obtain a clinical supply of current or future product candidates or
commercial supply of AUCATZYL or any future approved products; Autolus'
ability to obtain and maintain regulatory approval of its product candidates,
including AUCATZYL and potential expansions into additional indications;
Autolus' ability and plans in continuing to establish and expand a commercial
infrastructure in the US and to successfully launch, market and sell AUCATZYL
and any future approved products; Autolus' ability to successfully expand the
approved indications for AUCATZYL or obtain marketing approval for AUCATZYL in
additional geographies in the future; the delay of any current or planned
clinical trials, whether due to patient enrollment delays or otherwise;
Autolus' ability to successfully demonstrate the safety and efficacy of its
product candidates and gain approval of its product candidates on a timely
basis, if at all; competition with respect to market opportunities; the risk
that Autolus' preclinical or clinical programs do not advance or result in
approved products on a timely or cost effective basis or at all; the results
of early clinical trials are not always being predictive of future results;
the cost, timing and results of clinical trials; that many product candidates
do not become approved drugs on a timely or cost effective basis or at all;
and possible safety and efficacy concerns. For a discussion of other risks and
uncertainties, and other important factors, any of which could cause Autolus'
actual results to differ from those contained in the forward-looking
statements, see the section titled "Risk Factors" in Autolus' Annual Report on
Form 10-K filed with the Securities and Exchange Commission, or the SEC, on
March 20, 2025 as well as discussions of potential risks, uncertainties, and
other important factors in Autolus' subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of the date
of the release, and Autolus undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events, or otherwise, except as required by law. You should, therefore, not
rely on these forward-looking statements as representing Autolus' views as of
any date subsequent to the date of this press release.
Contact:
Amanda Cray
+1 617-967-0207
a.cray@autolus.com (mailto:a.cray@autolus.com)
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