Adaptimmune Reports Second Quarter 2016 Financial Results
(Thomson Reuters ONE) -
- Conference call to be held today at 8:00 AM ET (1:00 PM BST) -
PHILADELPHIA and OXFORD, United Kingdom, Aug. 08, 2016 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq:ADAP) ("Adaptimmune" or the "Company"), a
leader in T-cell therapy to treat cancer, today reported financial results for
the second quarter ended June 30, 2016.
Recent Corporate and Clinical Highlights:
* Received access to Priority Medicines (PRIME) regulatory support from the
European Medicines Agency for NY-ESO SPEAR® (Specific Peptide Enhanced
Affinity Receptor) T-cell therapy;
* Received orphan medicinal product designation for SPEAR T-cell therapy
targeting NY-ESO for the treatment of soft tissue sarcoma in the European
Union from the European Commission;
* Received orphan drug designation for SPEAR T-cell therapy targeting NY-ESO
for the treatment of soft tissue sarcoma from the U.S. Food and Drug
Administration (FDA);
* Finalized commercial development and supply agreement for Thermo Fisher
Scientific's DynaBeads® CD3/CD28 Cell Therapy System(TM) for use in
manufacturing Adaptimmune's SPEAR T-cell therapies;
* Announced new preclinical and clinical data at the 2016 American Society of
Clinical Oncology (ASCO) meeting, including: data showing that the incidence
of cytokine release syndrome appears to be of lower frequency and severity
with NY-ESO SPEAR T-cell therapy compared to that reported with CD19 CAR-T
therapy; data describing robust clinical responses including a 50 percent
response rate (60 percent at the target dose) in synovial sarcoma, and a 91
percent response rate in multiple myeloma; and that Adaptimmune's extensive
preclinical safety package is capable of preclinically validating TCRs with
enhanced affinity for target proteins; and
* Expanded synovial sarcoma trials to sites outside of the United States with
submissions made to the Medicines and Healthcare Products Regulatory Agency
(MHRA) in the United Kingdom, and to Health Canada which has now approved
the clinical trial application.
"The last six months were a period of strong progress for Adaptimmune on a
number of fronts," commented James Noble, Adaptimmune's Chief Executive Officer.
"Among our accomplishments, we continued to advance our NY-ESO SPEAR T-cell
program toward pivotal studies in sarcoma, received orphan drug and Breakthrough
Therapy designation in the U.S. and received both PRIME regulatory eligibility
and orphan medicinal product designation in Europe. We also presented important
new clinical data at the 2016 ASCO meeting and at our analyst and investor day
in April 2016 that continue to differentiate our SPEAR T-cell products from
other therapies in the space."
Mr. Noble continued, "Still, this period has not been without its challenges. As
we previously announced, the FDA placed a partial clinical hold on our planned
pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma
and requested additional information prior to trial commencement. We will
provide a full response to the FDA shortly. Separately, the initiation of the
pivotal study in synovial sarcoma has been delayed until mid-2017. In addition,
slower than anticipated enrollment in non-small cell lung cancer (NSCLC) for our
MAGE-A10 and NY-ESO SPEAR T-cell therapies has also pushed the timelines for
these data readouts into 2017. Notwithstanding these challenges, the breadth and
depth of our clinical pipeline mean that, by early 2017, our clinical efforts
could involve SPEAR T-cell therapies directed against four separate targets in
as many as 10 different tumor types; we anticipate that our data readouts
throughout 2017 may validate the targets themselves and, more broadly, our SPEAR
T-cell platform in additional solid tumors beyond sarcoma."
Financial Results for the three-month period ended June 30, 2016
* Cash / liquidity position: As of June 30, 2016, Adaptimmune had
$150.9 million of cash and cash equivalents and $55.0 million of short-term
deposits representing a total liquidity position(1) of $205.9 million. For
the three months ended June 30, 2016, the decrease in cash and cash
equivalents was $12.9 million and the decrease in short-term deposits was
$7.3 million, representing a decrease in total liquidity position of $20.2
million.
* Revenue: For the three months ended June 30, 2016, revenue was $0.3 million
compared to $2.8 million for the three months ended June 30, 2015. This
decrease was primarily due to a change in the estimate of the period over
which the revenue relating to the GSK Collaboration and License Agreement is
being recognized.
* Research and development ("R&D") expenses: R&D expenses increased to $16.2
million for the three months ended June 30, 2016 from $8.4 million for the
three months ended June 30, 2015, primarily due to increased period-over-
period costs associated with: ongoing clinical trials of the Company's NY-
ESO and MAGE-A10 SPEAR T-cell therapies; preparation for a study with the
Company's SPEAR T-cell therapy targeting AFP; and personnel expenses for an
increased number of employees engaged in R&D.
* General and administrative ("G&A") expenses: G&A expenses were $6.8 million
for the three months ended June 30, 2016 compared to $5.5 million for the
three months ended June 30, 2015. The increase was primarily due to
increased personnel costs, increased property costs and other costs
associated with being a public company, partially offset by a decrease in
share-based compensation expenses.
* Net loss: Net loss attributable to holders of the Company's ordinary shares
was $22.1 million for the three months ended June 30, 2016. This equates to
$(0.05) per ordinary share or $(0.31) per American Depositary Share.
(1) Total liquidity position is a non GAAP financial measure, which is explained
and reconciled to the most directly comparable financial measures prepared in
accordance with GAAP below.
Financial Guidance
Adaptimmune is reiterating its guidance. For the full year 2016, the Company
expects its decrease in total liquidity position to be between $80 and $100
million and expects its total liquidity position at December 31, 2016, including
cash, cash equivalents and short term deposits, to be at least $150 million.
This guidance excludes the effect of any potential new business development
activities.
Pipeline Review
Adaptimmune is providing an update below on each cohort of its clinical pipeline
and the timing of anticipated milestones.
NY-ESO SPEAR T-cell Therapy
Synovial sarcoma:
Cohort 1 (high NY-ESO expression, cyclophosphamide + fludarabine) is complete,
and was initially reported at the 2015 American Association for Cancer Research
(AACR) meeting. Updates on cohorts 2 (low NY-ESO expression, cyclophosphamide +
fludarabine) and 3 (cyclophosphamide) will be presented at the 2016 European
Society of Medical Oncology (ESMO) meeting. Cohort 4 (modified cyclophosphamide
+ fludarabine) is on schedule to initiate in 2H 2016.
The Company submitted to the IND its proposed pivotal study in myxoid round cell
liposarcoma and received a partial clinical hold notice from the FDA. The notice
was received prior to the study being opened at any clinical site. This
communication from the FDA was not related to concerns on safety, but rather to
the request for additional information on CMC about manufacturing changes
introduced in the pivotal program, and information on and modification of some
clinical trial design features. The Company intends to submit its full response
shortly; the agency will then have 30 days to respond. In addition, enrollment
into the pivotal synovial sarcoma study will begin in mid-2017 to allow for the
submission of a Special Protocol Assessment requested by FDA and
characterization of the revised commercial manufacturing process to be employed
in the pivotal studies. If the discussions with the FDA on MRCLS are concluded
within the 30-day review window, the Company would expect to initiate the study
as planned in Q4 2016/Q1 2017; if it takes longer, then this study will be on a
similar timeline to the synovial sarcoma study.
Multiple myeloma:
The 25-patient study with autologous stem cell transplant is complete and has
been published (Rapoport; Nat Med, 2015). The Company expects to agree terms for
a combination study with a PD-1 receptor inhibitor using cyclophosphamide and
fludarabine conditioning in 2016, with initiation of the study occurring in
1H 2017.
Ovarian cancer:
The Company reported data from this six-patient study at the 2016 ASCO meeting
showing no objective response in the absence of fludarabine. The Company is
evaluating a preconditioning regimen consisting of modified doses of
cyclophosphamide and fludarabine and intends to enroll patients in 2H 2016 with
this regimen.
Melanoma:
The Company reported data at the 2016 ASCO meeting showing no objective response
in the absence of fludarabine in six patients who had progressed after treatment
with immune check point inhibitors. The Company is considering a study with a
new preconditioning regimen including fludarabine in combination with check
point inhibitors in 2017.
Non-small cell lung cancer:
A study is open and actively screening patients; data are anticipated in 2017.
The chemotherapy conditioning for this trial is being modified in an amendment
to consist of cyclophosphamide and fludarabine instead of cyclophosphamide
alone.
MAGE-A10 SPEAR T-cell Therapy
Non-small cell lung cancer:
A study is open and actively screening patients; data are anticipated in 2017.
Chemotherapy conditioning for this trial is being modified in an amendment to
consist of cyclophosphamide and fludarabine instead of cyclophosphamide alone.
Bladder, melanoma, and ovarian cancer:
The Company is on track to initiate this study, including a preconditioning
regimen of cyclophosphamide and fludarabine, in 2016 with data anticipated in
2017.
AFP SPEAR T-cell Therapy
Hepatocellular cancer:
The investigational new drug application (IND) is open, and the Company
anticipates that enrollment will begin in 1H 2017.
MAGE-A4 SPEAR T-cell Therapy
Multiple tumor types:
The Company is on track for an IND submission in 1Q 2017.
Generation 2 TCRs
Multiple tumor types:
The Company is on track to submit INDs from 2017 onwards.
Conference Call Information
The Company will host a live teleconference and webcast to provide an overview
of its financial results and a business update at 8:00 AM ET (1:00 PM BST)
today, August 8, 2016. The live webcast of the conference call will be available
via the events page of Adaptimmune's corporate website at www.adaptimmune.com.
An archive will be available after the call at the same address. To participate
in the live conference call, if preferred, please dial (877) 280-2296 (U.S.) or
+44(0)20 3427 1901 or 0800 279 4841 (United Kingdom). After placing the call,
please ask to be joined into the Adaptimmune conference call and provide the
confirmation code (7948131).
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel
cancer immunotherapy products based on its SPEAR® (Specific Peptide Enhanced
Affinity Receptor) T-cell platform. Established in 2008, the company aims to
utilize the body's own machinery - the T-cell - to target and destroy cancer
cells by using engineered, increased affinity TCRs as a means of strengthening
natural patient T-cell responses. Adaptimmune's lead program is a SPEAR T-cell
therapy targeting the NY-ESO cancer antigen. Its NY-ESO SPEAR T-cell therapy has
demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid
tumors and in hematologic cancer types, including synovial sarcoma and multiple
myeloma. Adaptimmune has a strategic collaboration and licensing agreement with
GlaxoSmithKline for the development and commercialization of the NY-ESO TCR
program. In addition, Adaptimmune has a number of proprietary programs. These
include SPEAR T-cell therapies targeting the MAGE-A10 and AFP cancer antigens,
which both have open INDs, and a further SPEAR T-cell therapy targeting the
MAGE-A4 cancer antigen that is in pre-clinical phase with IND acceptance
targeted for 2017. The company has identified over 30 intracellular target
peptides preferentially expressed in cancer cells and is currently progressing
12 through unpartnered research programs. Adaptimmune has over 250 employees and
is located in Oxfordshire, U.K. and Philadelphia, USA. For more
information: http://www.adaptimmune.com
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking
statements involve certain risks and uncertainties. Such risks and uncertainties
could cause our actual results to differ materially from those indicated by such
forward-looking statements, and include, without limitation: the success, cost
and timing of our product development activities and clinical trials and our
ability to successfully advance our TCR therapeutic candidates through the
regulatory and commercialization processes. For a further description of the
risks and uncertainties that could cause our actual results to differ materially
from those expressed in these forward-looking statements, as well as risks
relating to our business in general, we refer you to our Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC) on May
12, 2016, and our other SEC filings. The forward-looking statements contained in
this press release speak only as of the date the statements were made and we do
not undertake any obligation to update such forward-looking statements to
reflect subsequent events or circumstances.
Total Liquidity Position (a non-GAAP financial measure)
Total liquidity position (a non-GAAP financial measure) is defined as cash and
cash equivalents plus short-term deposits. Each of these components appears in
the Consolidated Statements of Financial Position. The U.S. GAAP financial
measure most directly comparable to total liquidity position is cash and cash
equivalents as reported in the Consolidated Financial Statements.
(in thousands) June 30, December 31,
2016 2015
Cash and cash equivalents $ 150,894 $ 194,263
Short-term deposits 55,031 54,620
Total Liquidity Position $ 205,925 $ 248,883
The Company believes that the presentation of total liquidity position provides
useful information to investors because management reviews total liquidity
position as part of its management of overall liquidity, financial flexibility,
capital structure and leverage.
Condensed
Consolidated Three months ended June 30, Six months ended June 30,
Statement of
Operations
(unaudited, in
thousands,
except per
share data) 2016 2015 2016 2015
Revenue $ 328 $ 2,783 $ 3,246 $ 5,511
Research and
development (16,219 ) (8,404 ) (30,107 ) (14,380 )
General and
administrative (6,809 ) (5,486 ) (12,664 ) (7,845 )
Total
operating
expenses (23,028 ) (13,890 ) (42,771 ) (22,225 )
Operating loss (22,700 ) (11,107 ) (39,525 ) (16,714 )
Interest
income 291 188 550 298
Other income
(expenses),
net 607 (3,502 ) 1,656 101
Loss before
income taxes (21,802 ) (14,421 ) (37,319 ) (16,315 )
Income taxes (293 ) (147 ) (352 ) (198 )
Net loss (22,095 ) (14,568 ) (37,671 ) (16,513 )
Deemed
dividend on
convertible
preferred
shares - (2,229 ) - (8,663 )
Net loss
available to
ordinary
shareholders $ (22,095 ) $ (16,797 ) $ (37,671 ) $ (25,176 )
Net loss per
ordinary
share, basic $ (0.05 ) $ (0.05 ) $ (0.09 ) $ (0.10 )
and diluted
(2)
Weighted
average
ordinary
shares
outstanding,
Basic and 424,711,900 316,559,989 424,711,900 248,222,243
diluted
(2) The dilutive effect of the following potentially dilutive equity instruments have
been excluded from the diluted loss per share calculation because they would have an
antidilutive effect on the loss per share for the period
Three months ended June 30, Six months ended June 30,
----------------------------------- ----------------------------------
2016 2015 2016 2015
----------------- ----------------- ----------------- ----------------
Share options 46,127,274 31,473,477 46,127,274 31,473,477
----------------- ----------------- ----------------- ----------------
Condensed Consolidated Balance Sheets June 30, December 31,
(unaudited, in thousands) 2016 2015
Assets
Current assets
Cash and cash equivalents $ 150,894 $ 194,263
Short-term deposits 55,031 54,620
Accounts receivable, net of allowance for
doubtful accounts of $- and $- - 744
Other current assets and prepaid expenses
(including current portion of clinical
materials) 12,257 13,420
Total current assets $ 218,182 $ 263,047
Restricted cash 4,229 4,508
Clinical materials 2,695 4,736
Property, plant & equipment, net 13,444 13,225
Intangibles, net 1,010 305
Total assets $ 239,560 $ 285,821
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 2,474 $ 7,884
Accrued expenses and other accrued liabilities 7,723 7,518
Deferred revenue 9,940 12,487
Total current liabilities 20,137 27,889
Deferred revenue, less current portion 22,432 22,939
Total liabilities 42,569 50,828
Equity
Common stock - Ordinary shares par value
£0.001, 574,711,900 authorized and
424,711,900 issued and outstanding (2015:
574,711,900 authorized and 424,711,900
issued and outstanding) 682 682
Additional paid in capital 336,904 332,363
Accumulated other comprehensive loss (13,011 ) (8,139 )
Accumulated deficit (127,584 ) (89, 913 )
Total equity 196,991 234,993
Total liabilities and stockholders' equity $ 239,560 $ 285,821
Condensed Consolidated Cash Flow Statement Six months ended June 30,
(unaudited, in thousands) 2016 2015
Cash flows from operating activities
Net loss $ (37,671 ) $ (16,513 )
Adjustments for:
Depreciation 1,512 365
Amortization 82 -
Share-based compensation expense 4,541 6,292
Unrealized foreign exchange (gains) losses (2,004 ) 2,234
Changes in operating assets and liabilities:
Decrease/(increase) in receivables and other
operating assets 601 (4,989 )
Decrease in non-current operating assets 2,041 -
Decrease in payables and deferred revenue (4,274 ) (934 )
Net cash used in operating activities (35,172 ) (13,545 )
Cash flows from investing activities
Acquisition of property, plant & equipment (2,910 ) (3,117 )
Acquisition of intangibles (861 ) -
Proceeds from sale of property, plant & equipment - 122
Maturity of short-term deposits 41,661 -
Investment in short-term deposits (42,837 ) (28,594 )
Net cash used in investing activities (4,947 ) (31,589 )
Cash flows from financing activities
Proceeds from issuance of common stock upon
initial public offering - 175,989
Net cash used in financing activities - 175,989
Effect of currency exchange rate changes on cash
and cash equivalents (3,205 ) (3,473 )
Net decrease in cash and cash equivalents (43,369 ) 127,382
Cash and cash equivalents at start of period 194,263 101,664
Cash and cash equivalents at end of period $ 150,984 $ 229,046
Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 825-9306
E: will.roberts(at)adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mobile: +44 (0)7710 304249
E: margaret.henry(at)adaptimmune.com
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Adaptimmune Therapeutics plc via GlobeNewswire
[HUG#2033747]
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Datum: 08.08.2016 - 13:00 Uhr
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News-ID 487785
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