REG - Syncona Limited - Autolus reports Q1 2025 Financial Results
08/05/2025 16:30
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RNS Number : 9510H Syncona Limited 08 May 2025
08 May 2025
Syncona Limited
Autolus Therapeutics Reports First Quarter 2025 Financial Results and Business
Updates
Syncona Ltd, (the "Company"), a leading life science investor focused on
creating, building and scaling a portfolio of global leaders in life science,
notes that its portfolio company, Autolus Therapeutics plc (Nasdaq: AUTL)
("Autolus"), announced its operational and financial results for the first
quarter ended 31 March 2025. Key highlights are as follows:
· The company has reported Q1 2025 AUCATZYL® net product revenue
of $9.0 million
· U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
granted conditional marketing authorization for AUCATZYL® for the treatment
of adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (r/r B-ALL)
· Encouraging preliminary data reported in Phase 1 CARLYSLE trial
in systemic lupus erythematosus (SLE); planned Phase 2 pivotal clinical trial
in lupus nephritis (LN) and Phase 1 clinical trial in progressive forms of
multiple sclerosis (MS) initiating before year-end 2025
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations/news/
(https://www.autolus.com/investor-relations/news/) and the full text of the
announcement from Autolus is contained below.
Autolus management hosted a conference call today, at 8:30am EST / 13:30pm
GMT, to discuss the company's financial results and provide business updates.
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 / Tim Stamper
Tel: +44 (0) 20 3981 7912
FTI Consulting
Ben Atwell / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life. We do this by
creating, building and scaling companies to deliver transformational
treatments to patients in areas of high unmet need.
We aim to build and maintain a diversified portfolio of 20-25 globally leading
life science businesses, across development stage, modality and therapeutic
area, for the benefit of all our stakeholders. We focus on developing
treatments that deliver patient impact by working in close partnership with
world-class academic founders and experienced management teams. Our balance
sheet underpins our strategy, enabling us to take a long-term view as we look
to improve the lives of patients with no or poor treatment options, build
sustainable life science companies and deliver strong risk-adjusted returns to
shareholders.
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 First Quarter 2025 Financial Results and Business
Updates
· Company reports Q1 2025 AUCATZYL® net product revenue of $9.0
million
· U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
granted conditional marketing authorization for AUCATZYL® for the treatment
of adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (r/r B-ALL)
· Encouraging preliminary data reported in Phase 1 CARLYSLE trial in
systemic lupus erythematosus (SLE); planned Phase 2 pivotal clinical trial in
lupus nephritis (LN) and Phase 1 clinical trial in progressive forms of
multiple sclerosis (MS) initiating before year-end 2025
· Conference call to be held today at 08:30 am EDT/13:30 pm GMT:
conference call participants should pre-register using the link at the bottom
of this press release
LONDON, May 8, 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 first quarter ended March 31, 2025.
"We had a great first quarter of launch and are highly encouraged by physician
enthusiasm for AUCATZYL in the U.S. We believe this speaks to the product
profile and significant unmet need for patients," said Dr. Christian Itin,
Chief Executive Officer of Autolus. "Building on that momentum in the U.S., we
recently obtained marketing authorization from the UK's MHRA, and we are
working in collaboration with National Institute for Health and Care
Excellence (NICE) to bring this much-needed therapy to patients in the UK. Our
goal to expand into new markets is underpinned by our proprietary
manufacturing and commercial infrastructure which has positioned us for strong
execution."
"In the second quarter we are planning to share longer-term follow-up data
from the FELIX study, and in the second half of the year we plan to announce
data from the pediatric PY1 trial. Building on strong data with obe-cel in r/r
B-ALL, we are looking beyond ALL and recently highlighted at an R&D
investor event our potential for value creation driven by obe-cel in
autoimmune diseases, including lupus nephritis (LN) and multiple sclerosis
(MS). Supporting our plans to pursue LN, we reported encouraging early
clinical data that show obe-cel's potential to treat advanced and relapsed
lupus patients. We have aligned with the U.S. Food and Drug Administration
(FDA) on a compact Phase 2 trial design and potential registrational path to
approval and we look forward to dosing the first patient in the Phase 2 trial
before year-end."
Key updates and anticipated milestones:
· AUCATZYL® Launch
o Autolus reported Q1 2025 net product sales of $9.0 million.
o The Company has 39 centers fully activated in the U.S. as of May 7, 2025.
o Patient access to AUCATZYL continues to increase, with coverage secured for
approximately 90% of total U.S. medical lives.
o On April 1, 2025, the Centers for Medicare and Medicaid Services (CMS)
included AUCATZYL in their published Healthcare Common Procedure Coding System
(HCPCS) coding determinations and Hospital Outpatient Prospective Payment
System (OPPS) payment rates, formalizing reimbursement for patients on
government programs. The CMS policy splits the therapeutic dose of AUCATZYL
into two administrations for coding and billing purposes. The Company is
working with the treatment centers on implementing the coding and payment
policy from CMS and is assessing any potential impact on the timing of revenue
recognition.
o On April 25, 2025, the UK Medicines and Healthcare products Regulatory
Agency (MHRA) granted conditional marketing authorization for
AUCATZYL(®) (obecabtagene autoleucel) for the treatment of adult patients
with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r
B-ALL). The Company will work with the National Institute for Health and Care
Excellence (NICE) on patient access to therapy and a meeting is planned for
May 2025.
o Obe-cel is under regulatory review in the EU and the Company expects to
receive notification of approval status from the European Medicines Agency
(EMA) in the second half of 2025.
· 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. Out of six patients in the cohort, three patients had
complete renal response, all by month three. Complement normalized in all
patients by month one. Rash, alopecia and mucosal ulcers resolved by month
three and arthritis resolved by month one in all patients. Data show high peak
expansion and deep B cell aplasia consistent with known obe-cel
characteristics in oncology indications. No dose limiting toxicities (DLTs) or
immune effector cell-associated neurotoxicity syndrome (ICANS) were observed
in the study to date. Grade one cytokine release syndrome (CRS) was observed
in three out of six patients. Hypertension, a typical sign of advanced lupus
nephritis, pre-existed in three patients. On study, five of six patients
experienced a transient hypertension, including Grade 3, well managed by
anti-hypertensive agents.
o The Company has aligned with U.S. Food and Drug Administration (FDA) on the
Phase 2 trial design and potential registrational path to approval and
anticipates dosing the first patient in a Phase 2 trial before the end of
2025.
o Full data with longer term follow-up from the Phase 1 CARLYSLE clinical
trial is targeted 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 clinical development in progressive
MS. The Company expects 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: FELIX clinical trial longer-term follow up Mid-Year
ALL: Notification from EU EMA regarding approval in r/r adult ALL H2 2025
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 March 31, 2025
Product revenue, net for the three months ended March 31, 2025 was $9.0
million.
Cost of sales for the three months ended March 31, 2025 totaled $18.0 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 $30.7 million to $26.7
million for the three months ended March 31, 2025, compared to the same period
in 2024. This change was primarily due to commercial manufacturing related
employee and infrastructure cost shifting to cost of sales and inventory,
partially offset by an increase in obe-cel clinical trial and supply costs.
Selling, general and administrative expenses increased from $18.2 million to
$29.5 million for the three months ended March 31, 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 U.S.
commercialization activities.
Loss from operations for the three months ended March 31, 2025 was $65.2
million, as compared to $38.8 million for the same period in 2024.
Net loss was $70.2 million for the three months ended March 31, 2025, compared
to $52.7 million for the same period in 2024. Basic and diluted net loss per
ordinary share for the three months ended March 31, 2025, totaled $(0.26),
compared to basic and diluted net loss per ordinary share of $(0.24) for the
same period in 2024.
Cash, cash equivalents and marketable securities at March 31, 2025, totaled
$516.6 million, as compared to $588.0 million at December 31, 2024. The
decrease was primarily driven by net cash used in operating and investing
activities and impacted by a delayed cash receipt of approximately $20 million
in R&D tax credit expected from the UK HMRC.
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 March 31, 2025
Selected Consolidated Balance Sheet Data
(In thousands)
March 31 December 31
2025 2024
Assets
Cash and cash equivalents $ 95,799 $ 227,380
Marketable securities - Available-for-sale debt securities $ 420,776 $ 360,643
Total current assets $ 615,773 $ 660,929
Total assets $ 746,338 $ 782,725
Liabilities and shareholders' equity
Total current liabilities $ 66,615 $ 60,743
Total liabilities $ 375,230 $ 355,400
Total shareholders' equity $ 371,108 $ 427,325
Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)
Three months ended March 31,
2025 2024
Product revenue, net $ 8,982 $ -
License revenue - 10,091
Cost and operating expenses:
Cost of sales (17,951) -
Research and development expenses, net (26,734) (30,671)
Selling, general and administrative expenses (29,534) (18,177)
Loss on disposal of property and equipment (3) -
Loss from operations (65,240) (38,757)
Total other expenses, net (2,696) (13,941)
Net loss before income tax (67,936) (52,698)
Income tax (expense) benefit (2,225) 8
Net loss attributable to ordinary shareholders (70,161) (52,690)
Other comprehensive income, net of tax 11,068 58
Total comprehensive loss $ (59,093) $ (52,632)
Basic and diluted net loss per ordinary share $ (0.26) $ (0.24)
Weighted-average basic and diluted ordinary shares 266,126,548 222,170,707
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://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fedge.media-server.com%2Fmmc%2Fp%2Fcg7km8oz&data=05%7C02%7CO.Manser%40autolus.com%7C7ca0ee2262684230b7d408dd71fc755a%7C06f3f6f517844916bbafe6d128062fc9%7C1%7C0%7C638792051309255037%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rgJXVU2LPpp6otawKVT4d8AzucX5xXHFHAERakyhYwQ%3D&reserved=0)
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
biopharmaceutical company developing, manufacturing and delivering
next-generation T cell therapies 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, controlled and highly
active T cell therapies that are designed to better recognize target cells,
break down their defense mechanisms and eliminate these cells. Autolus has an
FDA approved product, 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)
Olivia Manser
+44 7780 471 568
o.manser@autolus.com (mailto:o.manser@autolus.com)
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