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RNS Number : 9884Y
Syncona Limited
14 May 2019
Syncona Limited
Autolus reports Q1 2019 Financial Results
14 May 2019
Syncona Ltd, a leading healthcare company focused on founding,
building and funding global leaders in life science, notes the
announcement that its portfolio company, Autolus Therapeutics Plc
(NASDAQ: AUTL) (Autolus), reports its first quarter 2019 financial
results and operational progress today, 14 May 2019.
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.
[S]
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About Syncona
Syncona is a leading FTSE250 healthcare company focused on
founding, building and funding global leaders in life science. Our
vision is to deliver transformational treatments to patients in
truly innovative areas of healthcare while generating superior
returns for shareholders.
We seek to partner with the best, brightest and most ambitious
minds in science to build globally competitive businesses.
We take a long-term view, underpinned by a deep pool of capital,
and are established leaders in gene and cell therapy. We focus on
delivering dramatic efficacy for patients in areas of high unmet
need.
Autolus Therapeutics Reports First Quarter 2019 Financial
Results and Operational Progress
- Conference Call to be held on May 14, 2019 at 8:30 am EST/1:30
pm BST-
LONDON, May 14, 2019 -- Autolus Therapeutics plc (Nasdaq: AUTL),
a clinical-stage biopharmaceutical company developing
next-generation programmed T cell therapies, today announced its
financial and operational results for the first quarter ended March
31, 2019.
Key first quarter highlights include:
Clinical and Regulatory
-- In April, Autolus announced the presentation of initial data
from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute
lymphoblastic B cell leukemia (ALL) at the American Association for
Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia. As
of the data cutoff date of March 18, 2019, 13 patients were
leukapheresed, and products for 12 patients were manufactured,
including 7 with Autolus' semi-automated, fully enclosed
manufacturing process. Using the Lee criteria, there were no
patients with severe cytokine release syndrome (CRS) (>= Grade
3), and only 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab
was used in 2 of 10 patients (20%). None of the patients were
admitted to intensive care due to CRS. One patient developed
delayed Grade 3 neurotoxicity following high levels of CAR T
expansion, which resolved promptly following administration of
steroids. Four patients died while enrolled in the trial, two due
to progression of the disease and two due to sepsis, a common
complication of advanced ALL. Nine patients were evaluable for
response at 1 month with 9 (88%) achieving a molecular complete
response. One patient died of sepsis before the one-month
evaluation point. At a median follow up of 5 months (range
0.62-10.6 months), 6/10 patients are alive and continue to be in
molecular remission and there continues to be evidence of ongoing B
cell aplasia and CAR T persistence.
-- In April, Autolus announced that the United States Food and
Drug Administration granted orphan drug designation to autologous
enriched T-cells genetically modified with a retroviral vector to
express two chimeric antigen receptors targeting CD19 and CD22
(AUTO3) for the treatment of ALL.
-- Autolus hosted an R&D Day in New York City in March for
the investment community. The event provided an update on Autolus'
current clinical programs and highlighted the company's approach to
drive molecular innovation and next-generation programed T cell
products for hematological and solid tumor indications.
-- During the March R&D Day, Autolus provided updated data
from the ongoing AMELIA Phase 1/2 study of AUTO3 in pediatric ALL
which demonstrated that 6 out of 6 (100%) patients treated at the
highest dose (>=3 x10(6) /kg) achieved minimal residual disease
(MRD) negative complete responses (CR). Ongoing MRD negative CR
remissions were noted in 4 out of 6 (67%) patients, with duration
of up to 10 months as of February 2019, the date of latest data
follow-up. There have been no reported CD19 or CD22 negative
relapses in CAR T naïve patients. Data also showed that AUTO3
continues to be generally well tolerated with no >= Grade 3 CRS,
no intensive care admission, and no pressors or critical care
support for CRS required.
Manufacturing and Product Delivery
-- In March, manufacturing for clinical studies commenced at the
Cell and Gene Therapy Catapult Manufacturing Centre in Stevenage,
United Kingdom.
Corporate Highlights
-- In April, Autolus completed an underwritten public offering
of 4,830,000 American Depositary Shares ("ADSs") representing
4,830,000 ordinary shares, at a public offering price of $24.00 per
ADS, which includes an additional 630,000 ADSs issued upon the
exercise in full of the underwriters' option to purchase additional
ADSs. Aggregate net proceeds to Autolus, after underwriting
discounts but before estimated offering expenses, were $108.9
million. Proceeds from this public offering are not included in the
March 31, 2019 financial statements.
Anticipated Milestones
-- Presentation of a data update from the ALEXANDER Phase 1/2
trial of AUTO3 in adult relapsed/refractory diffuse large B cell
lymphoma (DLBCL) in the third quarter of 2019.
-- Initiation of the Phase 2 portion of the AMELIA trial of
AUTO3 in pediatric ALL in the second half of 2019.
-- Initiation of a Phase 2/registration trial of AUTO1 in adult
ALL in the second half of 2019 (pending regulatory feedback).
-- Presentation by the end of 2019 of data updates from the
following trials: AUTO1 in adult ALL and pediatric ALL; AUTO3 in
DLBCL and pALL and AUTO2 in multiple myeloma.
"In the first quarter of 2019, we made good progress in all
aspects of the business. Important was the first presentation of
clinical data from AUTO1 in adult patients with acute lymphoblastic
leukemia, which points to a differentiated profile for AUTO1,"
stated Dr. Christian Itin, chairman and chief executive officer of
Autolus. "For the remainder of 2019, we are placing particular
focus on advancing our clinical programs, specifically AUTO3 in
DLBCL and AUTO1 in adult ALL, towards registrational trials."
Financial results for first quarter 2019:
-- Cash and equivalents at March 31, 2019 totaled $187.7
million, compared with $217.5 million at December 31, 2018.
-- Net total operating expenses for the three months ended March
31, 2019 were $30.2 million, net of grant income of $2.0 million,
as compared to net operating expenses of $15.5 million, net of
grant income of $0.4 million, for the same period in 2018. The
increase was due, in general, to the increase in clinical trial
activity, which is expected to deliver on key milestones throughout
the rest of 2019; increased headcount; and the cost of being a
public company.
-- Research and development expenses increased to $22.6 million
for the three months ended March 31, 2019 from $11.6 million for
the three months ended March 31, 2018. Cash costs, which exclude
depreciation as well as share-based compensation, increased to
$17.5 million from $10.6 million. The increase in research and
development cash costs of $6.9 million consisted primarily of an
increase of compensation-related costs of $5.6 million primarily
due to an increase in headcount to support the advancement of our
product candidates in clinical development, an increase of $2.7
million in facilities costs supporting the expansion of our
research and translational science capability and investment in
manufacturing facilities and equipment, and an increase of $0.8
million in research and development program expenses related to the
activities necessary to prepare, activate, and monitor clinical
trial programs, offset by a decrease of $1.9 million in
professional fees primarily related to the UCL license fees
expensed for the three months ended March 31, 2018, and other
reductions of $0.3 million.
-- General and administrative expenses increased to $9.6 million
for the three months ended March 31, 2019 from $4.3 million for the
three months ended March 31, 2018. Cash costs, which exclude
depreciation as well as share-based compensation, increased to $6.3
million from $3.5 million. The increase of $2.8 million consisted
primarily of an increase in compensation-related expense of $1.2
million due to an overall increase in headcount, and an increase in
legal and professional fees of $0.9 million related to insurance
and patent costs.
-- Net loss attributable to ordinary shareholders was $27.2
million for the three months ended March 31, 2019, compared to
$16.7 million for the same period in 2018.
-- The basic and diluted net loss per ordinary share for the
three months ended March 31, 2019 totaled $(0.69) compared to a
basic and diluted net loss per ordinary share of $(0.58) for the
three months ended March 31, 2018.
-- Autolus anticipates that cash on hand provides a runway into the second half of 2021.
Conference Call and Presentation Information
Autolus management will host a conference call today, May 14, at
8:30 a.m. EST/ 1:30pm BST, to discuss the company's financial
results and operational update.
To listen to the webcast and view the accompanying slide
presentation, please go to:
https://www.autolus.com/investor-relations/news-events/events.
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 7358198. 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
7358198.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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