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RNS Number : 6855H
Syncona Limited
05 August 2021
Syncona Limited
Autolus reports Q2 2021 Financial Results
05 August 2021
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 quarter ended June 30, 2021.
The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations and full text of the
announcement from Autolus is contained below. Autolus management
will host a conference call today, at 8:30 a.m. EDT/ 1:30pm GMT 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
Annabel Clay / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / 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 Second Quarter 2021 Financial
Results and Operational Progress
- Conference call to be held on August 5, 2021 at 8:30 am
ET/1:30 pm BST -
LONDON , August 5, 2021 -- 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 June 30,
2021.
"We are very encouraged by the obe-cel data in adult acute
lymphoblastic leukemia (ALL) and in B-cell non-Hodgkins Lymphoma
(B-NHL) presented at the European Hematology Association (EHA)
Virtual Congress in June. In adult patients with ALL, event-free
survival stabilized at 50% with 12 months follow up and was
sustained at 24 months. These data indicate that obe-cel may be the
first stand-alone therapy in adult ALL with curative potential in a
last line setting. The FELIX trial is progressing well, and we
expect pivotal data during 2022," said Dr. Christian Itin, chief
executive officer of Autolus. "Additional data were presented at
EHA for obe-cel in indolent B-NHL indicating a high level of
clinical activity combined with a well manageable safety profile.
Further data in patients with aggressive B-NHL and chronic
lymphocytic leukemia (CLL) are expected by the end of the
year."
Key Pipeline Updates:
-- Obe-cel in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL) .
o Data presented at EHA in June 2021 from the ALLCAR19 trial in
r/r adult ALL patients demonstrated that obe-cel was generally well
tolerated, with no patients experiencing Grade 3 or higher cytokine
release syndrome (CRS). Three patients (15%), all of whom had high
leukemia burden (>50% blasts), experienced Grade 3 immune
effector cell-associated neurotoxicity syndrome (ICANS) that
resolved swiftly with steroids. Of the 20 patients treated with
obe-cel, 17 (85%) achieved minimum residual disease (MRD)-negative
complete remission (CR) at one month. Most notably, as of the data
cutoff date of May 17, 2021, the durability of remissions is
encouraging. Across all treated patients, event free survival (EFS)
at twelve months and twenty-four months was 50.2% with median EFS
not being reached.
-- Obe-cel in other relapsed/refractory B-NHL - ALLCAR19 extension (Cohort D)
o Data presented at EHA in June 2021 in r/r B-NHL (Follicular
Lymphoma (FL) and Mantle Cell Lymphoma (MCL)) patients demonstrated
that, as of the data cut-off date of May 17, 2021, 9 r/r B-NHL
patients (7 FL, 2 MCL) infused with obe-cel achieved a complete
metabolic remission and, apart from one, all evaluable patients
remained in CR. Obe-cel has a tolerable safety profile in adult
patients with r/r FL and MCL, despite high disease burden. Grade 1
CRS was reported in 4 patients and Grade 2 CRS in 1 patient. No
ICANS of any grade was observed in the trial.
-- Obe-cel in high grade B-NHL and CLL - ALLCAR19 extension (Cohorts B & C)
o The ALLCAR extension trial also involves two cohorts of
patients with high grade B-NHL (DLBCL) and CLL. These cohorts are
progressing well and Autolus plans to present updated data at the
63rd American Society of Hematology (ASH) Meeting in December
2021.
-- Autolus received preferred regulatory access for obe-cel from
UK Medicines and Healthcare products Regulatory Agency (MHRA) and
European Medicines Agency (EMA):
o Autolus received an innovative licensing and access pathway
(ILAP) designation from the MHRA for obe-cel being investigated in
the ongoing FELIX trial in ALL.
o Autolus received PRIority MEdicines (PRIME) designation from
the EMA.
o These designations are designed to accelerate the review of a
promising therapy targeting an unmet medical need. Data from the
FELIX trial is expected in 2022, which, if positive, could enable
Autolus to file for accelerated approval.
-- AUTO4 in Peripheral T Cell Lymphoma (PTCL).
o Autolus received ILAP designation from the MHRA for AUTO4
being investigated in PTCL.
o AUTO4 Phase 1 clinical trial is progressing through dose
escalation and Autolus expects to provide a next data update in the
first half of 2022.
Operational Highlights:
-- Post the period end, in July 2021, Autolus announced an
agreement with Moderna, Inc., a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, granting Moderna an
exclusive license to develop and commercialize mRNA-based
therapeutics incorporating Autolus' proprietary binders to up to
four immuno-oncology targets. Under the terms of the agreement,
Autolus would be eligible to receive an upfront payment for each
target licensed by Moderna and development and commercial milestone
payments for each product successfully commercialized. In addition,
Autolus will be entitled to receive royalties on net sales of all
products commercialized under the agreement. The use of the
technology in Moderna's mRNA platform underscores Autolus'
leadership in the development of innovative differentiated binder
and cell programming technologies.
-- Post the period end, in July 2021, Autolus announced the
appointment of Edgar Braendle M.D., Ph.D., as chief development
officer. Dr Braendle is an experienced oncologist who joined
Autolus from Sumitomo Dainippon Pharma Oncology, where he held the
position of Chief Medical Officer and Global Head of Development
and was responsible for leading the global oncology development
programs of Sumitomo Dainippon. He is part of Autolus' executive
team and is leading the company's development organization. In
addition, Wolfram Brugger M.D., Ph.D. joined Autolus as VP, Head of
Clinical Development in June 2021. Wolfram is a highly experienced
hematologist, medical oncologist, and internal medicine specialist
with 21 years of academia and hospital-based clinical physician
experience in hematological malignancies in Germany, including 15
years of leadership as Chief Medical Director at the teaching
hospital of Freiburg University. Wolfram joined Autolus from
MorphoSys, where he was Head of Global Clinical Programs and
oversaw the development of Monjuvi (tafasitamab).
Key Upcoming Clinical Milestones:
-- Obe- cel updates from the ALLCAR19 extension trial in
patients with r/r B-NHL and longer term follow up of the fully
enrolled r/r aALL cohort in H2 2021
-- Obe- cel - currently enrolling the FELIX trial in r/r adult
ALL patients with pivotal data expected in 2022
-- Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022
-- Updates on the AUTO1/22 CARPALL extension trial in pediatric ALL in Q4 2021
-- Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL in H1 2022
-- Phase 1 trials are expected to be initiated in H2 2021 with AUTO8 in Multiple Myeloma
-- Phase 1 trials are expected to be initiated in H1 2022 with
AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL
-- First exploratory allogeneic development candidate expected to enter the clinic in 2021
Financial Results for the Quarter Ended June 30, 2021
Cash at Ju ne 30, 2021, totaled $216.4 million, as compared to
$239.0 million at March 31, 2020. During the three months ended
June 30, 2021, the company issued an aggregate of 2,069,466 ADSs
under its Sales Agreement with Jefferies for net proceeds, after
underwriting discounts and offering expenses, of $14.3 million.
Net total operating expenses for the three months ended June 30,
2021 were $37.7 million, net of grant income and license revenue of
$1.6 million, as compared to net operating expenses of $39.5
million, net of grant income of $0.3 million, for the same period
in 2020.
Research and development expenses increased to $32.1 million for
the three months ended June 30, 2021, from $31.3 million for the
three months ended June 30, 2020. Cash costs, which exclude
depreciation and amortization as well as share-based compensation,
increased to $29.2 million from $26.5 million. The increase in
research and development cash costs of $2.7 million consisted
primarily of (i) an increase in compensation and employment related
costs of $0.7 million due to severance payments related to the
reduction in workforce that started in the first quarter, and
offset by a reduction in employment costs due to a decrease in
headcount, (ii) an increase of $1.0 million in facilities costs
related to the continued scaling of manufacturing operations, (iii)
an increase of $0.9 million related to purchased materials, (iv) an
increase of $0.3 million related to cell logistics, and (v) an
increase of $0.3 million related to IT infrastructure and support
for information systems related to the conduct of clinical trials
and manufacturing operations. This was offset by a decrease of $0.4
million in clinical costs and $0.1 million of legal expenses.
Non-cash costs decreased to $2.9 million for the three months
ended June 30, 2021, from $4.8 million for the three months ended
June 30, 2020. The decrease is primarily related to share-based
compensation expense included in research and development expenses,
which decreased by $2.8 million as a result of the lower fair value
of stock options recognized during the period, combined with
forfeitures of incentive share options and unvested RSUs related to
employees affected by the reduction in workforce. This was offset
by an increase in depreciation of $0.9 million.
General and administrative expenses decreased to $7.2 million
for the three months ended June 30, 2021, from $8.5 million for the
three months ended June 30, 2020. Cash costs, which exclude
depreciation expense as well as share-based expense compensation
decreased to $6.6 million from $6.7 million. The decrease in
general and administrative cash costs of $0.1 million related to
decreases of (i) $0.3 million related to the reduction in workforce
that began to take place in the first quarter, which reduced the
headcount, and (ii) $0.3 million of expenses related to
preparations for becoming a commercial stage company. These
decreases were offset by an increase of $0.5 million in legal fees
and directors & officers liability insurance premiums.
Non-cash costs decreased to $0.6 million for the three months
ended June 30, 2021, from $1.8 million for the three months ended
June 30, 2020. The decrease is mainly attributed to share-based
compensation expense as a result of the lower fair value of stock
options recognized during the period, combined with forfeitures of
incentive share options and unvested RSUs related to employees
affected by the reduction in workforce.
Other income/(expense) decreased by $2.3 million for the three
months ended June 30, 2021, from other income of $0.5 million for
the three months ended June 30, 2020, to an other expense of $1.8
million. The decrease was primarily due to the weakening of the
U.S. dollar exchange rate relative to the pound sterling during the
three months ended June 30, 2021 as compared to the three months
ended June 30, 2020.
Income tax benefit decreased to $6.4 million for the three
months ended June 30, 2021 from $7.0 million for the three months
ended June 30, 2020 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 our net
loss before income tax, this led to a lower effective tax rate.
Research and development credits are obtained at a maximum rate of
33.35% of our qualifying research and development expenses, and the
increase in the net credit was primarily attributable to an
increase in our eligible research and development expenses.
Net loss attributable to ordinary shareholders was $33.2 million
for the three months ended June 30, 2021, compared to $32.1 million
for the same period in 2020. The basic and diluted net loss per
ordinary share for the three months ended June 30, 2021 totaled
$(0.47) compared to a basic and diluted net loss per ordinary share
of $(0.62) for the three months ended June 30, 2020.
Autolus estimates that its current cash on hand will provide the
Company with a cash runway into H1 2023.
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 9757293. 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
9757293.
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 our academic partner,
UCL, obe-cel is currently being evaluated in a Phase 1 clinical
trial in adult ALL and B-NHL. The company has also progressed
obe-cel to the FELIX trial, a potential pivotal trial.
About Obe-cel FELIX trial
The FELIX clinical trial is enrolling adult patients with
relapsed / refractory ALL. The trial has a short Phase 1b component
prior to proceeding to a single arm Phase 2 clinical trial. The
primary endpoint is overall response rate, and the key secondary
endpoints include duration of response, MRD negative CR rate and
safety. The trial will enroll approximately 100 patients across 30
of the leading academic and non-academic centers in the United
States, United Kingdom and Europe.
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.
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 future clinical development, efficacy, safety, and therapeutic
potential of obe-cel, including progress, expectations as to the
reporting of data, conduct and timing and potential future clinical
activity and milestones, expectations regarding the initiation,
design and reporting of data from clinical trials . 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 4, 2021, 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:
Lucinda Crabtree, PhD
Vice President, Business Strategy and Planning
+44 (0) 7587 372 619
l.crabtree@autolus.com
Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com
Susan A. Noonan
S.A. Noonan Communications
+1-212-966-3650
susan@sanoonan.com
Financial Results for the three months ended June 30, 2021
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended Six Months Ended June
June 30, 30,
2021 2020 2021 2020
------------- ------------ --------------- --------------
Grant income $ 138 $ 293 $ 407 $ 631
License revenue 1,507 - 1,507 -
Operating expenses:
Research and development (32,131) (31,328) (62,862) (62,615)
General and administrative (7,237) (8,509) (15,975) (16,123)
Loss on disposal of leasehold
improvements - - (672) -
------------- ------------ --------------- ------------
Total operating expenses, net (37,723) (39,544) (77,595) (78,107)
Other (expense) income:
Interest income (expense) 42 (47) 85 463
Other (expense) income (1,849) 525 (1,011) 5,009
------------- ------------ --------------- ------------
Total other (expense) income,
net (1,807) 478 (926) 5,472
------------- ------------ --------------- ------------
Net loss before income tax (39,530) (39,066) (78,521) (72,635)
Income tax benefit 6,357 7,021 12,081 10,717
------------- ------------ --------------- ------------
Net loss attributable to ordinary
shareholders (33,173) (32,045) (66,440) (61,918)
Other comprehensive income (loss):
Foreign currency exchange translation
adjustment 1,542 (1,819) 2,815 (19,520)
------------- ------------ --------------- ------------
Total comprehensive loss (31,631) (33,864) (63,625) (81,438)
============= ============ =============== ============
Basic and diluted net loss per
ordinary share $ (0.47) $ (0.62) $ (1.00) $ (1.22)
Weighted-average basic and diluted
ordinary shares 70,832,077 52,041,340 66,663,003 50,956,566
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
June 30, December
2021 31, 2020
----------- -------------
Assets
Current assets:
Cash $ 216,352 $ 153,299
Restricted cash 210 786
Prepaid expenses and other assets, current 52,944 42,899
----------- -----------
Total current assets 269,506 196,984
Non-current assets:
Property and equipment, net 34,190 38,046
Right of use assets, net 20,598 51,637
Long-term deposits 1,846 2,625
Prepaid expenses and other assets, non-current 2,760 3,033
Deferred tax asset 1,643 1,754
Intangible assets, net 112 158
----------- -----------
Total assets $ 330,655 $ 294,237
======= =======
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 1,119 2,263
Accrued expenses and other liabilities 23,173 27,781
Lease liabilities 3,895 3,590
----------- -----------
Total current liabilities 28,187 33,634
Non-current liabilities:
Lease liabilities 18,786 50,571
----------- -----------
Total liabilities 46,973 84,205
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized as of June 30, 2021 and December
31, 2020; 72,742,582 and 52,346,231, shares issued
and outstanding at June 30, 2021 and December 31,
2020, respectively 3 3
Deferred shares, GBP0.00001 par value; 34,425 shares
authorized, issued and outstanding at June 30,
2021 and December 31, 2020 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at June
30, 2021 and December 31, 2020 118 118
Deferred C shares, GBP0.000008 par value; 1 share
authorized, issued and outstanding at June 30,
2021 and December 31, 2020 - -
Additional paid-in capital 732,290 595,016
Accumulated other comprehensive loss (3,046) (5,861)
Accumulated deficit (445,683) (379,244)
----------- -----------
Total shareholders' equity 283,682 210,032
----------- -----------
Total liabilities and shareholders' equity $ 330,655 $ 294,237
======= =======
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