Adaptimmune Reports First Quarter 2016 Financial Results
(Thomson Reuters ONE) -
PHILADELPHIA and OXFORD, United Kingdom, May 12, 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 first quarter ended March 31, 2016.
As of March 31, 2016, Adaptimmune had a total liquidity position(1) of $226.1
million. The Company is reiterating its cash burn guidance and expects its total
liquidity position at December 31, 2016, including cash, cash equivalents and
short term deposits, to be at least $150 million.
"As we described at our Investor and Analyst meeting in April, we have made
substantial progress toward our goal of delivering the first affinity optimized
T-cell therapy to market," commented James Noble, Adaptimmune's Chief Executive
Officer. "The first quarter of 2016 was marked by strong momentum as we
continued development of our comprehensive pipeline of SPEAR(TM) T-cell
therapies covering solid and hematologic cancers. In addition to our ongoing
clinical activities, we received orphan drug designation and breakthrough
therapy designation for our NY-ESO SPEAR T-cell therapy. We also opened our IND
for our therapeutic candidate targeting AFP in liver cancer and announced MAGE-
A4 as our next target with the goal of achieving IND acceptance in 2017."
Recent Corporate and Clinical Highlights:
* Hosted inaugural Investor and Analyst Day on April 22, 2016;
* Received orphan drug designation from U.S. Food and Drug Administration
("FDA") for NY-ESO SPEAR T-cell therapy in soft tissue sarcoma;
* Received breakthrough therapy designation from FDA for NY-ESO SPEAR T-cell
therapy in synovial sarcoma;
* Received FDA acceptance of investigational new drug ("IND") application for
AFP SPEAR T-cell therapy in liver cancer;
* Announced that the Company's next IND would be for its MAGE-A4 SPEAR T-cell
therapy, with the goal of achieving IND acceptance in 2017;
* Announced update on NY-ESO SPEAR T-cell data in patients with multiple
myeloma, including a 90 percent response rate in conjunction with autologous
stem cell transplant and median overall survival of approximately three
years (as of January 2016);
* Filed patents on over 60 targets expressed on multiple cancers;
* Presented overview of commercial-ready manufacturing process, including
progress toward opening of manufacturing facility in 2017;
* Expanded terms of strategic collaboration agreement with GSK in February
2016 to accelerate Adaptimmune's lead clinical cancer program, a SPEAR T-
cell therapy targeting NY-ESO, with goal of initiating pivotal trials in
4Q16/1Q17;
* Established Scientific Advisory Board of leading immunotherapy experts; and
* Adopted brand of SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells
to describe proprietary technology that uniquely delivers correctly
identified targets and enhanced affinity T-cell receptors with potency to
attack tumors, but optimum specificity to minimize risks of cross-
reactivity.
Financial Results for the three-month period ended March 31, 2016
* Cash / liquidity position: As of March 31, 2016, Adaptimmune had a total
liquidity position of $226.1 million, consisting of $163.8 million of cash
and cash equivalents and $62.3 million of short-term deposits. As of
December 31, 2015, Adaptimmune had a total liquidity position of $248.9
million, consisting of $194.3 million of cash and cash equivalents and $54.6
million of short-term deposits.
* Cash burn: The net decrease in the total liquidity position was $22.8
million for the three months ended March 31, 2016, consisting of a $30.5
million decrease in cash and cash equivalents and a $7.7 million increase in
short-term deposits.
* Revenue: For the three months ended March 31, 2016, revenue was $2.9 million
compared to $2.7 million for the three months ended March 31, 2015. This
increase was primarily due to revenue relating to development milestones
related to the GSK Collaboration and License Agreement achieved in August
and December 2015, which is being recognized over the period in which we are
delivering services.
* Research and development ("R&D") expenses: R&D expenses increased to $13.9
million for the three months ended March 31, 2016 from $6.0 million for the
three months ended March 31, 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 $5.9 million
for the three months ended March 31, 2016 compared to $2.4 million for the
three months ended March 31, 2015. The increase was primarily due to
increased personnel costs, increased share-based payment expenses, increased
property costs and other costs associated with being a public company.
* Net loss: Net loss attributable to holders of the Company's ordinary shares
was $15.6 million for the three months ended March 31, 2016. This equates to
$(0.04) per ordinary share or $(0.22) per American Depositary Share.
The Company will not hold a conference call to discuss these results having
provided a full update during its 2016 Investor and Analyst Day held on April
22, 2016. A replay of the webcast from the event will be available on the
Company's website for 30 days following the event at ir.adaptimmune.com
Financial Guidance
Adaptimmune is reiterating its cash burn guidance. For the full year 2016, the
Company expects its cash burn 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 any
cash burn associated with potential new business development activities.
As previously announced, in order to align more closely with many of its peer
group of biotechnology companies, the Company has changed its fiscal year to a
calendar year and is reporting its financial results in U.S. dollars under U.S.
GAAP, effective from January 2016. Further information on these changes is set
forth below under 'Initial Adoption of U.S. GAAP'. The Company's next fiscal
year end will be December 31, 2016.
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel
cancer immunotherapy products based on its SPEAR(TM) (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. 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 200 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 Annual Report on Form
20-F filed with the Securities and Exchange Commission (SEC) on October
13, 2015, 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.
We believe 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 March 31,
-----------------------------------------------
(unaudited, in thousands,
except per share data) 2016 2015
----------------- -----------------------------
Revenue $ 2,918 $ 2,728
Research and development (13,888 ) (5,976 )
General and administrative (5,855 ) (2,359 )
----------------- -----------------------------
Total operating expenses (19,743 ) (8,335 )
Operating loss (16,825 ) (5,607 )
Interest income 259 110
Other income, net 1,049 3,603
----------------- -----------------------------
Total other income, net 1,308 3,713
----------------- -----------------------------
Loss before income taxes $ (15,517 ) $ (1,894 )
Income taxes (59 ) (51 )
----------------- -----------------------------
Net loss $ (15,576 ) $ (1,945 )
----------------- -----------------------------
Deemed dividend on
convertible preferred
shares - (6,434 )
----------------- -----------------------------
Net loss available to
ordinary shareholders $ (15,576 ) $ (8,379 )
----------------- -----------------------------
Net loss per ordinary
share, basic and diluted
(2) $ (0.04 ) $ (0.05 )
----------------- -----------------------------
Weighted average ordinary
shares outstanding,
Basic and diluted 424,711,900 181,370,100
----------------- -----------------------------
(2) The effects 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 March 31,
-----------------------------------------------
2016 2015
----------------- -----------------------------
Number Number
Share options 44,159,031 29,951,662
Preferred shares - 175,841,800
Condensed Consolidated Balance Sheets December
March 31, 31,
-------------- ------------
(unaudited, in thousands) 2016 2015
-------------- ------------
Assets
Current assets
Cash and cash equivalents $ 163,766 $ 194,263
Short-term deposits 62,337 54,620
Accounts receivable, net of allowance for
doubtful accounts of $- and $- 1 744
Other current assets and prepaid expenses
(including current portion of clinical
materials) 12,457 13,420
-------------- ------------
Total current assets $ 238,561 $ 263,047
-------------- ------------
Restricted cash 4,413 4,508
Clinical materials 3,601 4,736
Property, plant & equipment, net 13,845 13,225
Intangibles, net 1,140 305
-------------- ------------
Total assets $ 261,560 $ 285,821
-------------- ------------
Liabilities and Stockholders' equity
Current liabilities
Accounts payable $ 2,440 $ 7,884
Accrued expenses and other accrued liabilities 5,321 7,518
Deferred revenue 12,077 12,487
-------------- ------------
Total current liabilities 19,838 27,889
Deferred revenue, less current portion 22,776 22,939
-------------- ------------
Total liabilities 42,614 50,828
Equity
Common stock - Ordinary shares par value
£0.001, 574.7 million authorized and
424,711,900 issued and outstanding (2015:
574.7 million authorized and 424,711,900 issued
and outstanding) 682 682
Additional paid in capital 334,258 332,184
Accumulated other comprehensive loss (10,684 ) (8,139 )
Accumulated deficit (105,310 ) (89,734 )
-------------- ------------
Total equity 218,946 234,993
-------------- ------------
Total liabilities and stockholders' equity $ 261,560 $ 285,821
-------------- ------------
Condensed Consolidated Cash Flow Statement Three months ended March 31,
-----------------------------
(unaudited, in thousands) 2016 2015
--------------- -------------
Cash flows from operating activities
Net loss $ (15,576 ) $ (1,945 )
Adjustments for:
Depreciation 707 68
Amortization 38 -
Share-based compensation expense 2,074 1,482
Unrealized foreign exchange gains (1,608 ) (3,604 )
Changes in operating assets and liabilities:
(Decrease)/increase in receivables and other
operating assets (489 ) 573
Decrease in non-current operating assets 1,835 -
Decrease in payables and deferred revenue (5,660 ) (2,217 )
--------------- -------------
Net cash used in operating activities (18,679 ) (5,643 )
Cash flows from investing activities
Acquisition of property, plant & equipment (1,708 ) (672 )
Acquisition of intangibles (861 ) -
Maturity of short-term deposits 7,993 -
Investment in short-term deposits (15,988 ) -
--------------- -------------
Net cash used in investing activities (10,564 ) (672 )
Cash flows from financing activities
Net cash used in financing activities - -
Effect of currency exchange rate changes on
cash and cash equivalents (1,254 ) (2,750 )
--------------- -------------
Net decrease in cash and cash equivalents (30,497 ) (9,065 )
Cash and cash equivalents at start of period 194,263 101,664
--------------- -------------
Cash and cash equivalents at end of period $ 163,766 $ 92,599
--------------- -------------
Initial adoption of U.S.GAAP
The Company is reporting under U.S. GAAP in U.S. dollars from January 1, 2016.
The Company has previously prepared financial statements in accordance with
International Financial Reporting Standards (IFRS) in pounds sterling. For the
purpose of analyzing comparative periods, the Company has provided the quarterly
income statement (unaudited) and the Total Liquidity Position (a non-GAAP
measure) for the four quarters of the 2015 calendar year under U.S. GAAP below
(in thousands):
(unaudited, in
thousands, except March June September December
per share data) 31, 2015 30, 2015 30, 2015 31, 2015
-------------- ------------- ------------- --------------
Revenue $ 2,728 $ 2,783 $ 4,948 $ 4,031
Operating expenses
Research and
development (5,976 ) (8,404 ) (8,276 ) (15,968 )
General and
administrative (2,359 ) (5,486 ) (4,979 ) (6,166 )
-------------- ------------- ------------- --------------
Total operating
expenses (8,335 ) (13,890 ) (13,255 ) (22,134 )
Operating loss (5,607 ) (11,107 ) (8,307 ) (18,103 )
Interest income 110 188 235 254
Other
income/(expense),
net 3,603 (3,502 ) 1,851 1,015
-------------- ------------- ------------- --------------
Total other
income/(expense),
net 3,713 (3,314 ) 2,086 1,269
-------------- ------------- ------------- --------------
Loss before taxes (1,894 ) (14,421 ) (6,221 ) (16,834 )
Income taxes (51 ) (147 ) (20 ) 75
-------------- ------------- ------------- --------------
Net loss
$ (1,945 ) $ (14,568 ) $ (6,241 ) $ (16,759 )
-------------- ------------- ------------- --------------
Deemed dividend on
Preferred Shares (6,434 ) (2,229 ) - -
-------------- ------------- ------------- --------------
Net loss available
to ordinary
shareholders $ (8,379 ) $ (16,797 ) $ (6,241 ) $ (16,759 )
-------------- ------------- ------------- --------------
Net loss per
ordinary share,
basic and diluted $ (0.05 ) $ (0.05 ) $ (0.02 ) $ (0.04 )
Cash and cash
equivalents $ 92,599 $ 229,046 $ 217,218 $ 194,263
Short-term
deposits 24,580 55,292 54,873 54,620
-------------- ------------- ------------- --------------
Total liquidity
position $ 117,179 $ 284,338 $ 272,091 $ 248,883
-------------- ------------- ------------- --------------
(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.
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
This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
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#2012053]
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Datum: 12.05.2016 - 13:30 Uhr
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News-ID 470728
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