TIDMSYNC
RNS Number : 4805K
Syncona Limited
05 May 2022
Syncona Limited
Autolus Reports Q1 2022 Financial Results
05 May 2022
Syncona Ltd, a leading healthcare company focused on founding,
building and funding 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 March 31, 2022.
Key highlights include two updates from the FELIX Phase II study
in obe-cel in relapsed / refractory (r/r) adult acute lymphoblastic
leukaemia (ALL):
-- The study passed its futility analysis following a review by
an independent response review committee. Initial data from the
study remains on track to be released in H2 CY2022 with full data
set to follow in H1 CY2023.
-- The company plans to evaluate a separate cohort of up to 50
patients with Minimal Residual Disease (MRD). This will further
enable Autolus to establish the profile of obe-cel in patients
across all levels of disease burden in adult ALL.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and the full text of the
announcement from Autolus is contained below. Autolus management
will host a conference call today, at 8:30 am ET/ 1:30 pm BST, to
discuss the company's financial results and provide a general
business update. To listen to the webcast and view the accompanying
slide presentation, please go to:
https://www.autolus.com/investor-relations/news-and-events/events
.
[S]
Enquiries
Syncona Ltd
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / Julia Bradshaw / 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 founding and building a portfolio of global leaders
in life science to deliver transformational treatments to patients
in areas of high unmet need.
Our strategy is to found, build and fund companies around
exceptional science to create a diversified portfolio of 15-20
globally leading healthcare businesses for the benefit of all our
stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and
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.
Autolus Therapeutics Reports First Quarter 2022 Financial
Results and Operational Progress
- Conference call to be held on May 5, 2022 at 8:30 am ET/1:30
pm BST -
LONDON , May 5, 2022 - Autolus Therapeutics plc (Nasdaq: AUTL),
a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announced its
operational and financial results for the quarter ended March 31,
2022.
"The momentum at Autolus has continued during the first quarter.
We are delighted to note that the FELIX clinical trial of obe-cel
in patients with relapsed/refractory (r/r) adult B-cell Acute
Lymphoblastic Leukemia (ALL) passed its futility analysis during
the period and we continue to enroll patients as planned, with
initial data expected in the second half of 2022, with the full
data in the first half of 2023 , " said Dr. Christian Itin, Chief
Executive Officer of Autolus. "obe-cel recently received
Regenerative Medicine Advanced Therapy (RMAT) designation from the
U.S. Food and Drug Administration (FDA), supporting our drive to
bring this innovative therapy to patients as quickly as
possible."
"We also have updates at the European Hematology Association
(EHA) Congress in early June from four Phase 1 clinical trials. Two
trials are evaluating obe-cel in B-Cell Non-Hodgkin's Lymphoma
(B-NHL) and primary CNS lymphoma (PCNSL). In addition, two oral
presentations will cover the first clinical data for AUTO4 in
TRBC1+ Peripheral T cell lymphoma (PTCL) and data for the dual
targeting AUTO1/22 in pediatric ALL patients."
Key Pipeline Updates:
-- Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL
o During the quarter, the FELIX study passed its pre-specified
futility analysis based on the results assessed by an independent
response review committee. As previously guided, the morphological
cohort is expected to complete enrollment in 2022 with initial data
from the FELIX study expected to be reported in H2 2022 and full
data in H1 2023. Assuming a positive outcome from the FELIX study,
this data is expected to form the basis of a planned Biologics
License Application (BLA) submission by the Company.
o Autolus plans to evaluate a separate cohort of up to 50
additional patients with Minimal Residual Disease (MRD). The
additional data aims to establish the profile of obe-cel in
patients across all levels of disease burden in adult ALL .
o In March 2022 obe-cel was granted Orphan Medical Product
Designation by the European Medicines Agency (EMA) for the
treatment of ALL, having previously received Orphan Drug
Designation by the U.S. Food & Drug Administration (FDA) for
B-ALL.
-- Obe-cel in r/r B-NHL - ALLCAR19 Extension Trial
o Subjects continue to be enrolled into the Phase 1 ALLCAR19
extension trial. The latest data readout from this extension study
of obe-cel in patients with r/r B-Cell Non-Hodgkin's Lymphoma
(B-NHL) and Chronic Lymphocytic Leukemia (CLL) were presented at
ASH in December 2021. Updated data from the trial will be presented
as a poster at the EHA Congress in June.
-- Obe-cel in PCNSL - CAROUSEL Trial
o Subjects continue to be enrolled into the Phase 1 CAROUSEL
trial. Data from the trial will be presented as a poster at the EHA
Congress in June.
-- AUTO1/22 in pediatric ALL - CARPALL Trial
o Autolus continues to enroll patients into the AUTO1/22 Phase 1
CARPALL trial. Initial clinical data from the trial will be
presented as an oral presentation at the EHA Congress in June.
-- AUTO4 in Peripheral T Cell Lymphoma - LibrA T1 Trial
o Autolus continues to enroll patients into the AUTO4 Phase 1
clinical trial, which is progressing through its dose escalation
phase. Interim Phase 1 data will be presented as an oral
presentation at the EHA Congress in June.
-- AUTO6NG in Neuroblastoma
o Autolus plans to initiate a Phase 1 clinical trial of AUTO6NG
in patients with neuroblastoma in H2 2022.
-- AUTO8 in Multiple Myeloma - MCARTY Trial
o During the period, Autolus initiated a Phase 1 clinical trial
of AUTO8, the Company's next-generation product candidate for
multiple myeloma. AUTO8 comprises two independent CARs targeting
BCMA and CD19 designed to induce deep and durable responses and
extend the durability of effect.
Key Operational Updates during Q1 2022
-- Effective March 31, 2022, Dr. Lucinda Crabtree was appointed
as Chief Financial Officer succeeding Andrew J. Oakley upon his
retirement. Dr. Crabtree served as SVP Finance prior to her
promotion.
-- Good progress is being made in the build phase of the
Company's new 70,000 square foot commercial manufacturing facility
in Stevenage, UK. This facility is expected to be ready for GMP
operations by H2 2023 and is designed for a capacity of 2,000
batches a year with the option to expand.
Post Period Updates:
-- On 25 April, the FDA granted Regenerative Medicine Advanced
Therapy (RMAT) designation to obe-cel, in recognition of the
therapy's potential to address significant unmet medical needs in
patients with serious or life-threatening conditions. RMAT
designation provides important benefits in the drug development
process, designed to facilitate and expedite development and
regulatory review. Obe-cel also received PRIME designation from EMA
and ILAP from MHRA.
-- On 2 May, Autolus announced the online publication of three
abstracts submitted to the American Society of Gene & Cell
Therapy (ASGCT) to be held May 16-19, 2022. The three abstracts
focus on Autolus' modular approach to CAR T product development,
using innovative technology to improve our pipeline of precise,
controlled and highly active products. The three abstracts cover:
1) enhancing CAR T therapy using constitutively active cytokine
receptors, 2) engineering CAR T cells to express a Fas-CD40 to
increase its persistence and tumor cytotoxicity and 3) developing a
minocycline mediated protein-protein displacement platform to make
cell therapies tunable, dose dependent and reversible.
Key Anticipated Clinical Milestones:
-- Initial clinical data from the FELIX Phase 2 trial in H2 2022 and full data in H1 2023.
-- Updated Phase 1 data from the ALLCAR19 extension trial in
patients with r/r B-NHL and CLL presented as a poster at the EHA
Congress in June 2022.
-- Updates on the obe-cel Phase 1 CAROUSEL trial in Primary CNS
Lymphoma presented as a poster at the EHA Congress in June
2022.
-- Initial clinical data from the AUTO1/22 CARPALL extension
trial in pediatric ALL presented as an oral presentation at the EHA
Congress in June 2022, with longer follow up in H2 2022.
-- Initial clinical data from AUTO4 LibraT1 Phase 1 trial in
TRBC1+ Peripheral TCL presented as an oral presentation at the EHA
Congress in June 2022.
-- AUTO6NG Phase 1 clinical trial in neuroblastoma expected to
start H2 2022. Expect first data in H2 2023.
-- AUTO8 Phase 1 clinical trial in patients with multiple
myeloma has started, expect first data in H2 2023.
Financial Results for the Quarter Ended March 31, 2022
Cash at March 31, 2022, totaled $268.6 million, as compared to
$310.3 million at December 31, 2021.
Total operating expenses, net of grant income of $0.2 million,
for the three months ended March 31, 2022, were $41.8 million, as
compared to total operating expenses, net of grant income of $0.3
million, of $39.9 million for the same period in 2021.
Grant income decreased by $0.1 million to $0.2 million for the
three months ended March 31, 2022, as compared to $0.3 million for
the same period in the prior year. The decrease is due to a
corresponding decrease in reimbursable expenditures.
Research and development expenses increased to $34.0 million for
the three months ended March 31, 2022, as compared to $30.7 million
for the three months ended March 31, 2021. Cash costs decreased to
$30.6 million from $30.7 million. The decrease in research and
development cash costs of $0.1 million consisted primarily of (i)
$2.8 million decrease in compensation and employment related costs
which was due to a combination of lower retention, severance
payments and timing and salary mix of new employee hires, (ii) $0.9
million decrease in facilities costs related to the termination and
exit of the Company's US manufacturing facility in 2021 and shift
in its manufacturing strategy, and (iii) $0.2 million in research
and development costs related to cell logistics.
This was offset by an increase of (i) $2.9 million in clinical
costs and manufacturing costs primarily relating to the Company's
obe-cel clinical product candidate, (ii) $0.8 million increase in
legal fees and professional consulting fees in relation to our
research and development activities, and (iii) $0.1 million
increase related to information technology infrastructure and
support for information systems related to the conduct of clinical
trials and manufacturing operations .
Non-cash costs increased to $3.4 million for the three months
ended March 31, 2022 from $36,000 for the three months ended March
31, 2021. The increase is primarily attributable to an increase of
$3.1 million in share-based compensation expense included in
research and development expenses as a result of retention of
employees post the reduction of workforce that was implemented
during the three months ended March 31, 2021. In addition,
depreciation and amortization expense increased by $0.3
million.
General and administrative expenses decreased by $0.7 million to
$8.0 million for the three months ended March 31, 2022, from $8.7
million for the three months ended March 31, 2021. Cash costs,
which exclude depreciation and amortization as wells as share-based
compensation decreased to $7.0 million from $7.6 million. The
decrease in general and administrative cash costs of $0.6 million
related to decreases of (i) $0.5 million in facilities costs
related to the termination and exit of the Company's lease
agreements in the prior year, (ii) $0.4 million of commercial
preparation costs due to the timing of related activities and (iii)
$0.3 million associated with compensation expense due to fewer
contracted staff. These decreases were offset by increases of $0.5
million primarily related to higher directors' and officers'
liability insurance premiums and professional fees in relation to
business development opportunities and $0.1 million in costs
related to information technology infrastructure and support for
information systems.
Non-cash costs decreased by $0.1 million to $1.0 million for the
three months ended March 31, 2022 from $1.1 million for the three
months ended March 31, 2021. The decrease of $0.1 million primarily
related to a decrease in depreciation and amortization expense.
There were no disposals of leasehold improvements for the three
month period ended March 31, 2022. For the three months ended March
31, 2021, the Company incurred a loss on disposal of leasehold
improvements of $0.7 million related to the leasehold improvements
no longer being utilized in its facility in White City, London.
Other income, net for the three months ended March 31, 2022, was
consistent with the three months ended March 31, 2021. During the
three months ended March 31, 2022 there was a strengthening of the
U.S. dollar exchange rate relative to the pound sterling resulting
in a foreign exchange gain of $0.8 million. This compares to the
three months ended March 31, 2021 where there was a gain on lease
terminations of $2.0 million offset by other expenses of $1.2
million related to a foreign exchange loss.
Interest expense increased to $1.8 million for the three months
ended March 31, 2022 and relates to the liability related to sales
of future royalties and sales milestones which arose upon entering
into the Blackstone Strategic Collaboration and Financing Agreement
with BXLS V - Autobahn L.P., in November 2021. There was no
interest expense during the comparable period in 2021.
Income tax benefit decreased by $0.1 million to $5.6 million for
the three months ended March 31, 2022 from $5.7 million for the
three months ended March 31, 2021 due to a decrease in the research
and development expenditures which were qualifying for the quarter.
As research and development credits fell at a faster rate than the
Company's net loss before income tax, this led to a lower effective
tax rate.
Net loss attributable to ordinary shareholders was $37.1 million
for the three months ended March 31, 2022, compared to $33.3
million for the same period in 2021. The basic and diluted net loss
per ordinary share for the three months ended March 31, 2022,
totaled $(0.41) compared to a basic and diluted net loss per
ordinary share of $(0.53) for the three months ended March 31,
2021.
Autolus estimates that its current cash on hand and anticipated
milestone payments from Blackstone extends the Company's runway
into 2024 .
Unaudited Financial Results for the Quarter Ended March 31,
2022
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
March 31, December
2022 31, 2021
---------- ----------
Assets
Current assets:
Cash $ 268,558 $ 310,338
Restricted cash 334 338
Prepaid expenses and other assets, current 40,571 36,276
---------- ----------
Total current assets 309,463 346,952
Property and equipment, net 31,017 33,541
Prepaid expenses and other non-current assets 2,119 2,362
Operating lease right-of-use assets 17,366 18,775
Long-term deposits 1,983 2,039
Deferred tax asset 2,000 1,826
Intangible assets, net 46 65
---------- ----------
Total assets $ 363,994 $ 405,560
========== ==========
Liabilities and shareholders' equity
Current liabilities:
Accounts payable $ 153 $ 431
Accrued expenses and other liabilities 24,513 23,667
Operating lease liabilities 4,174 4,453
---------- ----------
Total current liabilities 28,840 28,551
Operating lease liabilities, net of current
portion 15,081 16,545
Liability related to sale of future royalty
and sales milestones, net 48,806 47,016
Other long-term payables 124 128
---------- ----------
Total liabilities 92,851 92,240
Commitments and contingencies (Note 11)
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized as of March 31, 2022 and
December 31, 2021; 90,907,941 and 90,907,830,
shares issued and outstanding at March 31,
2022 and December 31, 2021, respectively 4 4
Deferred shares, GBP0.00001 par value; 34,425
shares authorized, issued and outstanding at
March 31, 2022 and December 31, 2021 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at
March 31, 2022 and December 31, 2021 118 118
Deferred C shares, GBP0.000008 par value; 1
share authorized, issued and outstanding at
March 31, 2022 and December 31, 2021 - -
Additional paid-in capital 845,448 843,108
Accumulated other comprehensive loss (16,025) (8,570)
Accumulated deficit (558,402) (521,340)
---------- ----------
Total shareholders' equity 271,143 313,320
---------- ----------
Total liabilities and shareholders' equity $ 363,994 $ 405,560
========== ==========
Condensed Consolidated Statements of Operations and
Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended
March 31,
2022 2021
----------- -----------
Grant income $ 166 $ 269
Operating expenses:
Research and development (33,963) (30,731)
General and administrative (7,987) (8,738)
Loss on disposal of leasehold improvements - (672)
----------- -----------
Total operating expenses, net (41,784) (39,872)
Other income (expense):
Interest income 28 44
Other income, net 860 838
Interest expense (1,790) -
----------- -----------
Total other (expense) income, net (902) 882
----------- -----------
Net loss before income tax (42,686) (38,990)
Income tax benefit 5,624 5,724
----------- -----------
Net loss attributable to ordinary shareholders (37,062) (33,266)
Other comprehensive (loss) income:
Foreign currency exchange translation adjustment (7,455) 1,273
----------- -----------
Total comprehensive loss $ (44,517) $ (31,993)
=========== ===========
Basic and diluted net loss per ordinary share $ (0.41) $ (0.53)
=========== ===========
Weighted-average basic and diluted ordinary
shares 90,914,175 62,447,606
=========== ===========
Conference Call
Management will host a conference call and webcast today at 8:30
am ET/1:30 pm BST to discuss the Company's financial results and
provide a general business update. To listen to the webcast and
view the accompanying slide presentation, please go to the events
section of Autolus' website.
The call may also be accessed by dialing (866) 679-5407 for U.S.
and Canada callers or (409) 217-8320 for international callers.
Please reference conference ID: 3245616. After the conference call,
a replay will be available for one week. To access the replay,
please dial (855) 859-2056 for U.S. and Canada callers or (404)
537-3406 for international callers. Please reference conference ID:
3245616.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing
next-generation, programmed T cell therapies for the treatment of
cancer. Using a broad suite of proprietary and modular T cell
programming technologies, the Company is engineering precisely
targeted, controlled and highly active T cell therapies that are
designed to better recognize cancer cells, break down their defense
mechanisms and eliminate these cells. Autolus has a pipeline of
product candidates in development for the treatment of
hematological malignancies and solid tumors. For more information,
please visit www.autolus.com.
About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to
overcome the limitations in clinical activity and safety compared
to current CD19 CAR T cell therapies. Designed to have a fast
target binding off-rate to minimize excessive activation of the
programmed T cells, obe-cel may reduce toxicity and be less prone
to T cell exhaustion, which could enhance persistence and improve
the ability of the programmed T cells to engage in serial killing
of target cancer cells. In collaboration with Autolus' academic
partner, UCL, obe-cel is currently being evaluated in a Phase 1
clinical trials for B-NHL. Autolus has progressed obe-cel to the
FELIX trial, a potential pivotal trial for adult ALL.
About obe-cel FELIX clinical trial
Autolus' Phase 1b/2 clinical trial of obe-cel is enrolling adult
patients with relapsed / refractory B-precursor ALL. The trial had
a Phase 1b component prior to proceeding to the single arm, Phase 2
clinical trial. The primary endpoint is overall response rate, and
the secondary endpoints include duration of response, MRD negative
CR rate and safety. The trial is designed to enroll approximately
100 patients across 30 of the leading academic and non-academic
centers in the United States, United Kingdom and Europe.
[NCT04404660]
About AUTO1/22
AUTO1/22 is a novel dual targeting CAR T cell based therapy
candidate based on obe-cel. It is designed to combine the enhanced
safety, robust expansion & persistence seen with the fast off
rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to
reduce antigen negative relapses. This product candidate is
currently in a Phase 1 clinical trial for patients with r/r
pediatric ALL. [ NCT02443831 ]
About AUTO4
AUTO4 is a programmed T cell product candidate in clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO4 is
specifically designed to target TRBC1 derived cancers, which
account for approximately 40% of T cell lymphomas, and is a
complement to the AUTO5 T cell product candidate, which is in
pre-clinical development.
About AUTO5
AUTO5 is a programmed T cell product candidate in pre-clinical
development for T cell lymphoma, a setting where there are
currently no approved programmed T cell therapies. AUTO5 is
specifically designed to target TRBC2 derived cancers, which
account for approximately 60% of T cell lymphomas, and is a
complement to the AUTO4 T cell product candidate currently in
clinical development.
About AUTO6NG
AUTO6NG is a next generation programmed T cell product candidate
in pre-clinical development. AUTO6NG builds on preliminary proof of
concept data from AUTO6, a CAR targeting GD2-expression cancer cell
currently in clinical development for the treatment of
neuroblastoma. AUTO6NG incorporates additional cell programming
modules to overcome immune suppressive defense mechanisms in the
tumor microenvironment, in addition to endowing the CAR T cells
with extended persistence capacity. AUTO6NG is currently in
pre-clinical development for the potential treatment of both
neuroblastoma and other GD2-expressing solid tumors.
About AUTO8
AUTO8 is our next-generation product candidate for multiple
myeloma which comprises two independent CARs for the multiple
myeloma targets, BCMA and CD19. We have developed an optimized BCMA
CAR which is designed for improved killing of target cell that
express BCMA at low levels. This has been combined with fast off
rate CD19 CAR from obe-cel. We believe that the design of AUTO8 has
the potential to induce deep and durable responses and extend the
durability of effect over other BCMA CARs currently in
development.
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 development of Autolus' product candidate pipeline and
achievement of expected near- and long-term milestones; the
development of the obe-cel program including planned readouts after
the completed futility analysis and completion of patient
enrollment; the future clinical development, efficacy, safety and
therapeutic potential of its other product candidates such as
AUTO1/22, AUTO4. AUTO5, AUTO6NG, and AUTO8, including progress,
expectations as to the reporting of data, conduct and timing and
potential future clinical activity and milestones; expectations
regarding regulatory approval process for any product candidates;
Autolus' eligibility for potential milestone and royalty payments,
and the Company's anticipated cash runway. 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
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; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; and the impact of the ongoing COVID-19 pandemic
on Autolus' business. 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 20-F filed with the Securities
and Exchange Commission on March 10, 2022, 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.
Contact:
Olivia Manser
+44 (0) 7780 471568
o.manser@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com
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