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RNS Number : 3912V
Syncona Limited
06 August 2020
Syncona Limited
Autolus reports Q2 2020 Financial Results
06 August 2020
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 financial and operational results
for the second quarter ended 30 June 2020.
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 BST to
discuss the company's financial results and operational update. To
access the live and subsequent replay, as well as dial in
information of this webcast and view the accompanying slide
presentation, please register here.
[S]
Enquiries
Syncona Ltd
Annabel Clay
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona is a leading FTSE250 healthcare company focused on
founding, building and funding a portfolio of global leaders in
life science. Our vision is to build a sustainable, diverse
portfolio of 15 - 20 companies focused on delivering
transformational treatments to patients in truly innovative areas
of healthcare, through which we are seeking to deliver strong
risk-adjusted 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 strategic capital base which
provides us with control and flexibility over the management of our
portfolio. We focus on delivering dramatic efficacy for patients in
areas of high unmet need.
Autolus Therapeutics Reports Second Quarter 2020 Financial
Results and Operational Progress
- Conference call to be held on August 6, 2020 at 8:30 am
EDT/1:30 pm BST -
LONDON , August 6, 2020 -- 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 second quarter ended June
30, 2020.
"We have had a busy second quarter with data updates across our
portfolio at key medical and scientific conferences," said Dr
Christian Itin, chairman and chief executive officer of Autolus.
"Both our later stage programs, AUTO1 and AUTO3, continue to show
encouraging clinical activity with tolerable safety in adult
patients with ALL and DLBCL, respectively, and we are excited by
the potential for these product candidates to have differentiated
profiles addressing indications with high unmet needs. We look
forward to providing further updates in H2 2020, starting with
AUTO3 ALEXANDER data at a mini oral session at ESMO in
September."
"At AACR we presented data across a number of next generation
programs," said Dr Martin Pule, chief scientific officer of
Autolus. "These data demonstrate the strength of our binder
discovery capabilities with highly selective targeting in AUTO5 for
T Cell lymphoma, as well as the ability of our cell programming
modules to address the hostile solid tumor microenvironment as
shown for AUTO6NG and AUTO7 for small cell lung cancer and prostate
cancer, respectively. We are excited to be progressing these next
generation programs into Phase 1 in 2021."
Pipeline Updates:
-- AUTO1 in acute lymphocytic leukemia (ALL). Positive data were
presented at the European Hematology Association (EHA) meeting in
June 2020. These data showed an encouraging durability of response
without subsequent stem cell transplant and confirmed the safety
profile. Autolus has now started enrolment of adult patients with
relapsed / refractory ALL in its pivotal Phase 1b/2 AUTO1 program
and is targeting to have full data by the end of 2021.
-- AUTO3 in diffuse large B-cell lymphoma (DLBCL). Positive data
were presented at the American Society of Clinical Oncology (ASCO)
meeting in June 2020. These data showed a high level of complete
remissions and a safety profile supportive of evaluation of
outpatient use. Based on these data, Autolus selected its
recommended Phase 2 dose range of 150 - 450 x 10(6) cells, with a
single dose of pembrolizumab during preconditioning. In addition,
the company has also commenced an outpatient cohort as an extension
to its ongoing Phase 1/2 ALEXANDER study, with results expected in
the second half of 2020. The data from this outpatient cohort will
provide important insights that will be used to refine the design
of the potential pivotal Phase 2 part of the ALEXANDER study.
Autolus expects to present next updated data from the study at ESMO
in September 2020.
-- AUTO5 in T cell lymphoma . Positive preclinical data were
presented at the American Association for Cancer Research II (AACR)
Meeting in June 2020. The data highlight the specificity and
selectivity of the company's T-cell lymphoma product candidate,
AUTO5.
-- AUTO6NG in small cell lung cancer (SCLC). Positive
preclinical data were presented at the AACR Meeting in June 2020.
Autolus has designed enhancing modules to specifically overcome
tumor microenvironment (TME) defenses in solid tumor settings. The
new data suggest that AUTO6NG can overcome the immune suppressive
mechanisms in the TME.
-- AUTO7 in prostate cancer . Positive preclinical data were
presented at an oral presentation at the AACR Meeting in June 2020.
The program builds on a novel and optimized CAR to PSMA designed to
be highly active, even in an acidic environment, and combines
modules introduced in AUTO6NG with a novel low level secretion of
IL-12 to change the prostate tumor from an immunologically cold to
an immunologically supportive environment.
Operational Highlights:
-- Appointment of Dr Jay T Backstrom to Autolus' Board of
Directors, effective August 1, 2020. Dr Backstrom currently serves
as EVP, Head of Research & Development at Acceleron Pharma Inc.
and prior to that served as CMO and Head of Regulatory Affairs at
Celgene Corporation.
-- Dr Nushmia Khokhar promoted to Senior Vice President,
Clinical Development. Dr Khokhar will take over the clinical
leadership role at Autolus. She is a board-certified oncologist
with extensive early and late stage clinical development
experience, having led several successful registration trials
within the industry in both solid tumors and hematologic
malignancies, including the global daratumumab program at Janssen
Oncology. Dr Vijay Peddareddigari, Senior Vice President, Chief
Medical Officer will be leaving the Company to return to the United
States.
-- Expanded manufacturing capacity at the Cell and Gene Therapy
Catapult to secure initial commercial launch capability.
Key Upcoming Clinical Milestones:
-- Further update for AUTO3 at ESMO in Q3 2020.
-- Further data updates for both AUTO1 and AUTO3 in Q4 2020.
-- First data from outpatient cohort in the AUTO3 ALEXANDER study in H2 2020.
-- Interim Phase 1 data for AUTO4 in T cell lymphoma in H1 2021 .
-- Initiation of Phase 1 study for AUTO1NG in pediatric ALL in H2 2020.
-- Initiation of Phase 1 study for AUTO8 in multiple myeloma in H2 2020.
-- Progression of additional next generation programs from
preclinical stages to Phase 1 throughout 2021.
-- Expansion of the company's suite of cell programming
technologies to include additional modules designed for allogeneic
applications, with the first novel allogeneic program expected to
enter the clinic in Q4 2020.
Financial Results for the Quarter Ended June 30, 2020
Cash and equivalents at June 30, 2020 totaled $212.0 million,
compared with $243.3 million at March 31, 2020.
Net total operating expenses for the three months ended June 30,
2020 were $39.5 million, net of grant income of $0.3 million, as
compared to net operating expenses of $37.2 million, net of grant
income of $0.3 million, for the same period in 2019.
Research and development expenses increased to $31.3 million for
the three months ended June 30, 2020 from $26.2 million for the
three months ended June 30, 2019. Cash costs, which exclude
depreciation and amortization as well as share-based compensation,
increased to $26.5 million from $20.2 million. The increase in
research and development cash costs of $6.3 million consisted
primarily of (i) an increase in compensation and employment related
costs, net of lower travel costs as a result of the ongoing
pandemic, of $1.8 million due to an increase in employee headcount
to support the advancement of our product candidates in clinical
development, (ii) an increase of $3.0 million in project expenses
as a consequence of the advancement of our clinical portfolio which
includes research and process development and manufacturing
activities necessary to prepare, activate, and monitor clinical
trial programs, (iii) an increase of $1.3 million in facilities
costs related to the commencement of a lease for an additional
manufacturing suite and the continued scaling of operations in the
manufacturing facility, and (iv) an increase in IT and telecoms,
general office expense, and professional fees of $0.6 million,
which is offset by a decrease in materials purchases of $0.4
million.
Non-cash costs decreased to $4.8 million for the three months
ended June 30, 2020 from $6.0 million for the three months ended
June 30, 2019. The decrease is primarily related to share-based
compensation expense included in research and development expenses,
which decreased by $1.3 million as a result of a lower fair value
of stock options recognized in the period, offset by a small
increase in depreciation.
General and administrative expenses decreased to $8.5 million
for the three months ended June 30, 2020 from $11.4 million for the
three months ended June 30, 2019. Cash costs, which exclude
depreciation expense as well as share-based expense compensation
decreased to $6.7 million from $7.3 million. Compensation related
expenses decreased by $0.1 million aided by lower travel costs as
described above. Further there was a decrease of $0.7 million in
commercial activities. These decreases were offset by an increase
of $0.1 million in legal and professional fees.
Non-cash costs decreased to $1.8 million for the three months
ended June 30, 2020 from $3.9 million for the three months ended
June 30, 2019. The decrease is attributed to share-based
compensation expense as a result of the lower fair value of stock
options recognized during the period.
Interest income decreased by $1.1 million for three months ended
June 30, 2020 due to lower interest rates.
Other income decreased to $0.5 million for the three months
ended June 30, 2020 from other income of $4.4 million for the three
months ended June 30, 2019 primarily due to a decrease of the U.S.
dollar exchange rate relative to the pound sterling during the
three months ending June 30, 2020 as compared to the three months
ended June 30, 2019.
Income tax benefit increased to $7.0 million for the three
months ended June 30, 2020 from $3.3 million for the three months
ended June 30, 2019 due to increased R&D expenses, which led to
a higher 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 $32.0 million
for the three months ended June 30, 2020, compared to $28.5 million
for the same period in 2019.
The basic and diluted net loss per ordinary share for the three
months ended June 30, 2020 totaled $(0.62) compared to a basic and
diluted net loss per ordinary share of $(0.65) for the three months
ended June 30, 2019.
The Company anticipates that cash on hand is sufficient to fund
operations into 2022.
Conference Call and Presentation Information
Autolus management will host a conference call today, August 6,
at 8:30 a.m. EDT/ 1:30pm BST, to discuss the company's financial
results and operational update.
To access the live and subsequent replay, as well as dial in
information of this webcast and view the accompanying slide
presentation, please register here .
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.
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
Autolus' financial condition and results of operations, including
its expected cash runway; the development of Autolus' product
candidates, including statements regarding the timing of
initiation, completion and the outcome of preclinical studies or
clinical trials and related preparatory work, and the periods
during which the results of the studies and trials will become
available; Autolus' plans to research, develop, manufacture and
commercialize its product candidates; the potential for Autolus'
product candidates to be alternatives in the therapeutic areas
investigated; and Autolus' manufacturing capabilities and strategy.
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. For
a discussion of other risks and uncertainties, and other important
factors, any of which could cause our 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 3, 2020, as
amended, as well as discussions of potential risks, uncertainties,
and other important factors in Autolus' future filings with the
Securities and Exchange Commission from time to time. All
information in this press release is as of the date of the release,
and the company 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, Investor Relations and Corporate
Communications
+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
# # #
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,
2020 2019 2020 2019
Grant income $ 293 $ 338 $ 631 $ 2,302
Operating expenses:
Research and development (31,328) (26,173) (62,615) (48,738)
General and administrative (8,509) (11,370) (16,123) (20,926)
Total operating expenses, net (39,544) (37,205) (78,107) (67,362)
Other income (expense):
Interest (expense) income (47) 1,073 463 1,615
Other income 525 4,380 5,009 3,396
Total other income, net 478 5,453 5,472 5,011
Net loss before income tax (39,066) (31,752) (72,635) (62,351)
Income tax benefit 7,021 3,274 10,717 6,696
Net loss attributable to ordinary
shareholders (32,045) (28,478) (61,918) (55,655)
Other comprehensive (loss) income:
Foreign currency exchange translation
adjustment (1,819) (8,872) (19,520) (3,821)
Total comprehensive loss (33,864) (37,350) (81,438) (59,476)
Basic and diluted net loss per
ordinary share $ (0.62) $ (0.65) $ (1.22) $ (1.34)
Weighted-average basic and diluted
ordinary shares 52,041,340 43,611,531 50,956,566 41,552,718
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
June 30, December
2020 31, 2019
Assets
Current assets:
Cash $ 212,044 $ 210,643
Restricted cash 786 787
Prepaid expenses and other assets, current 35,901 37,826
Total current assets 248,731 249,256
Non-current assets:
Property and equipment, net 30,954 28,164
Right of use assets, net 25,100 23,409
Long-term deposits 2,354 2,040
Prepaid expenses and other assets, non-current 2,813 -
Deferred tax asset 410 410
Intangible assets, net 186 254
Total assets $ 310,548 $ 303,533
Liabilities and shareholders' equity
Current liabilities:
Accounts payable 626 1,075
Accrued expenses and other liabilities 22,753 21,398
Lease liabilities 3,888 2,511
Total current liabilities 27,267 24,984
Non-current liabilities:
Lease liabilities 24,329 23,710
Total liabilities 51,596 48,694
Shareholders' equity:
Ordinary shares, $0.000042 par value; 200,000,000
shares authorized as of June 30, 2020 and December
31, 2019; 52,250,404 and 44,983,006, shares issued
and outstanding at June 30, 2020 and December 31,
2019, respectively 3 2
Deferred shares, GBP0.00001 par value; 34,425 shares
authorized, issued and outstanding at June 30, 2020
and December 31, 2019 - -
Deferred B shares, GBP0.00099 par value; 88,893,548
shares authorized, issued and outstanding at June
30, 2020 and December 31, 2019 118 118
Deferred C shares, GBP0.000008 par value; 1 share
authorized, issued and outstanding at June 30, 2020
and December 31, 2019 - -
Additional paid-in capital 586,110 500,560
Accumulated other comprehensive loss (28,211) (8,691)
Accumulated deficit (299,068) (237,150)
Total shareholders' equity 258,952 254,839
Total liabilities and shareholders' equity $ 310,548 $ 303,533
======= =======
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END
PFUGZGGRMVKGGZM
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