Adaptimmune Reports Third Quarter 2016 Financial Results
(Thomson Reuters ONE) -
- U.S. Food and Drug Administration (FDA) lifted partial clinical hold of
myxoid/round cell liposarcoma (MRCLS) study of NY-ESO SPEAR(TM) T-cell therapy;
initiation of screening expected in 4Q 2016 -
- Initiated first site for triple tumor study with wholly-owned MAGE-A10 SPEAR
T-cells -
- Initiated new patient cohort in synovial sarcoma NY-ESO program -
- Started recruitment of additional patients under amended protocol in ovarian
NY-ESO program -
- Executed key agreements with Merck, PCT, and The MD Anderson Cancer Center -
- Adaptimmune reaffirms financial guidance -
- Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT) -
PHILADELPHIA and OXFORD, United Kingdom, Nov. 10, 2016 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat
cancer, today reported financial results for the third quarter ended September
30, 2016.
"Adaptimmune has delivered strong momentum since our last update," said James
Noble, Adaptimmune's Chief Executive Officer. "We have initiated the first site
for a triple tumor study with our wholly-owned MAGE-A10 SPEAR T-cells under our
new partnership with MD Anderson, and initiated Cohort 4 in our NY-ESO synovial
sarcoma study, as well as commenced recruitment of new patients in our NY-ESO
ovarian cancer study under an amended protocol. In addition, we have executed a
number of strategic agreements to accelerate our ability to develop, evaluate,
and manufacture our affinity enhanced T-cell therapies for patients suffering
from a wide array of solid tumor cancers. We are well placed for continued
execution and to generate data from studies in multiple cancers with our SPEAR
T-cell therapies in 2017."
Mr. Noble continued, "As we recently announced, the FDA has lifted the partial
clinical hold on the planned NY-ESO MRCLS study, and we expect to start
screening patients shortly. Our goal remains to be the first company to file for
approval with a TCR therapy."
Recent Corporate and R&D Highlights:
* Partial clinical hold lifted by FDA of NY-ESO SPEAR T-cell therapy study in
MRCLS;
* Initiation of screening in up to 15 MRCLS patients expected in 4Q 2016 with
results from this revised study informing a potential future registration
trial;
* Established collaboration and supply agreement for combination study of
Merck's PD-1 inhibitor and the Company's NY-ESO SPEAR T-cell therapy in
multiple myeloma; initiation expected in 1H 2017;
* Secured strategic agreement with PCT for dedicated manufacturing capacity;
* Entered strategic alliance with MD Anderson to expedite T-cell therapy
development;
* Initiated MD Anderson as the first site for MAGE-A10 SPEAR T-cell therapy
triple tumor study in urothelial cancer, melanoma, or squamous cell
carcinoma of the head and neck;
* Presented data demonstrating response to NY-ESO SPEAR T-cell therapy in
synovial sarcoma patients with low NY-ESO expression (Cohort 2) (ESMO 2016);
* Presented data indicating that fludarabine is required in preconditioning
(Cohort 3) (ESMO 2016);
* Commenced enrollment in NY-ESO synovial sarcoma Cohort 4 with a modified
preconditioning regimen including fludarabine;
* Started recruitment of additional ovarian cancer patients under an amended
protocol using NY-ESO SPEAR T-cell therapy with a modified preconditioning
regimen including fludarabine;
* Completed preclinical evaluation of MAGE-A4 SPEAR T-cells, with data
demonstrating that MAGE-A4 is an attractive target with widespread
expression in multiple tumor types; IND planned to be filed in 2017 (data to
be presented at SITC 2016); and
* Completed initial evaluation of a second generation NY-ESO SPEAR-T cell
expressing a dominant negative TGF-Beta receptor, with data indicating that
these SPEAR T-cells may overcome TGF-Beta tumor-mediated immunosuppression
(to be presented at SITC 2016).
Financial Results for the Three-Month Period ended September 30, 2016
* Cash / liquidity position: As of September 30, 2016, Adaptimmune had
$140.4 million of cash and cash equivalents and $47.1 million of short-term
deposits representing a total liquidity position1 of $187.5 million. For the
three months ended September 30, 2016, the decrease in cash and cash
equivalents was $10.5 million and the decrease in short-term deposits was
$7.9 million, representing a decrease in total liquidity position of $18.4
million.
* Revenue: For the three months ended September 30, 2016, revenue was $2.4
million compared to $4.9 million for the three months ended September
30, 2015. This decrease was primarily due to the impact of development
milestones achieved in the three months ended in September 30, 2015 under
the GSK Collaboration and License Agreement.
* Research and development ("R&D") expenses: R&D expenses increased to $15.6
million for the three months ended September 30, 2016 from $8.9 million for
the three months ended September 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 increased
personnel expenses.
* General and administrative ("G&A") expenses: G&A expenses were $5.4 million
for the three months ended September 30, 2016 compared to $4.4 million for
the three months ended September 30, 2015. The increase was primarily due to
increased personnel costs.
* Net loss: Net loss attributable to holders of the Company's ordinary shares
was $18.5 million for the three months ended September 30, 2016. This
equates to $(0.04) per ordinary share or $(0.26) 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.
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 a.m. EST (1:00 p.m. GMT)
today, November 10, 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 1906 or 0800 279 4977 (United Kingdom).
After placing the call, please ask to be joined into the Adaptimmune conference
call and provide the confirmation code (3960227).
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 preclinical 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 August
8, 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 Balance Sheet. 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.
September 30, December 31,
(in thousands) 2016 2015
----------------------------- ----------------- ----------------
Cash and cash equivalents $ 140,440 $ 194,263
Short-term deposits 47,064 54,620
----------------- ----------------
Total Liquidity Position $ 187,504 $ 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
Statement of
Operations Three months ended September 30, Nine months ended September 30,
----------------------------------- ------------------------------------
(unaudited, in
thousands, except
per share data) 2016 2015 2016 2015
----------------- ----------------- ----------------- ------------------
Revenue $ 2,416 $ 4,948 $ 5,662 $ 10,459
Research and
development(2) (15,610 ) (8,853 ) (46,942 ) (23,838 )
General and
administrative(2)
(5,424 ) (4,403 ) (16,863 ) (11,643 )
----------------- ----------------- ----------------- ------------------
Total operating
expenses (21,034 ) (13,256 ) (63,805 ) (35,481 )
Operating loss (18,618 ) (8,308 ) (58,143 ) (25,022 )
Interest income 289 235 839 533
Other income
(expenses), net (61 ) 1,851 1,595 1,952
----------------- ----------------- ----------------- ------------------
Loss before
income taxes (18,390 ) (6,222 ) (55,709 ) (22,537 )
Income taxes (104 ) (20 ) (456 ) (218 )
----------------- ----------------- ----------------- ------------------
Net loss (18,494 ) (6,242 ) (56,165 ) (22,755 )
----------------- ----------------- ----------------- ------------------
Deemed dividend
on convertible
preferred shares - - - (8,663 )
----------------- ----------------- ----------------- ------------------
Net loss
attributable to
ordinary
shareholders $ (18,494 ) $ (6,242 ) $ (56,165 ) $ (31,418 )
----------------- ----------------- ----------------- ------------------
Net loss per
ordinary share,
basic and diluted
(3) $ (0.04 ) $ (0.01 ) $ (0.13 ) $ (0.10 )
----------------- ----------------- ----------------- ------------------
Weighted average
ordinary shares
outstanding,
Basic and diluted 424,711,900 424,711,900 424,711,900 307,943,490
----------------- ----------------- ----------------- --------------
(2) Certain costs have been reclassified in prior periods to conform to the
current period presentation. The net effect is to reduce G&A and increase R&D
by $576,000 and $1,182,000 in the three and nine months ended September
30, 2015, respectively.
(3) 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 Nine months ended
September 30, September 30,
------------------------- ------------------------
2016 2015 2016 2015
------------ ------------ ------------ -----------
Weighted average number of
Share options 47,392,118 31,432,048 44,951,407 27,541,366
------------ ------------ ------------ -----------
Condensed Consolidated Balance Sheets September 30, December 31,
(unaudited, in thousands) 2016 2015
---------------- ---------------
Assets
Current assets
Cash and cash equivalents $ 140,440 $ 194,263
Short-term deposits 47,064 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) 12,040 13,420
---------------- ---------------
Total current assets $ 199,544 $ 263,047
---------------- ---------------
Restricted cash 4,146 4,508
Clinical materials 2,741 4,736
Property, plant & equipment, net 15,086 13,225
Intangibles, net 1,127 305
---------------- ---------------
Total assets $ 222,644 $ 285,821
---------------- ---------------
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 3,193 $ 7,884
Accrued expenses and other accrued
liabilities 9,954 7,518
Deferred revenue 9,514 12,487
---------------- ---------------
Total current liabilities 22,661 27,889
Deferred revenue, less current portion 19,335 22,939
Other liabilities 644 -
---------------- ---------------
Total liabilities 42,640 50,828
Stockholders' equity
Common stock - Ordinary shares par value
£0.001, 574,711,900 authorized and
424,711,900 issued and outstanding 682 682
(2015: 574,711,900 authorized
and424,711,900 issued and outstanding)
Additional paid in capital 339,188 332,363
Accumulated other comprehensive loss (13,788 ) (8,139 )
Accumulated deficit (146,078 ) (89, 913 )
---------------- ---------------
Total stockholders' equity 180,004 234,993
---------------- ---------------
Total liabilities and stockholders' equity $ 222,644 $ 285,821
---------------- ---------------
Condensed Consolidated Cash Flow Statement Nine months ended September
30,
-------------------------------
(unaudited, in thousands) 2016 2015
--------------- ---------------
Cash flows from operating activities
Net loss $ (56,165 ) $ (22,755 )
Adjustments for:
Depreciation 2,290 828
Amortization 122 25
Share-based compensation expense 6,825 7,694
Unrealized foreign exchange (gains) losses (1,943 ) 329
Changes in operating assets and liabilities:
Increase in receivables and other operating
assets (912 ) (5,327 )
Decrease in non-current operating assets 2,041 -
(Decrease) increase in payables and deferred
revenue (2,796 ) 5,385
--------------- ---------------
Net cash used in operating activities (50,538 ) (13,821 )
Cash flows from investing activities
Acquisition of property, plant & equipment (4,840 ) (10,095 )
Acquisition of intangibles (1,024 ) (31 )
Proceeds from sale of property, plant &
equipment - 122
Maturity of short-term deposits 49,497 -
Investment in short-term deposits (42,837 ) (28,594 )
Investment in restricted cash - (3,065 )
--------------- ---------------
Net cash provided by (used in) investing
activities 796 (41,663 )
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 (4,081 ) (4,951 )
--------------- ---------------
Net decrease in cash and cash equivalents (53,823 ) 115,554
Cash and cash equivalents at start of period 194,263 101,664
--------------- ---------------
Cash and cash equivalents at end of period $ 140,440 $ 217,218
--------------- ---------------
Adaptimmune Contacts
Investor Relations
Will Roberts
T: (215) 825-9306
E: will.roberts(at)adaptimmune.com
Juli P. Miller, Ph.D.
T: (215) 825-9310
E: juli.miller(at)adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Mobile: +44 (0)7710 304249
E: margaret.henry(at)adaptimmune.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Adaptimmune Therapeutics plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 10.11.2016 - 12:30 Uhr
Sprache: Deutsch
News-ID 506254
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Town:
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Kategorie:
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