Adaptimmune Reports Fourth Quarter and Full Year 2016 Financial Results
(Thomson Reuters ONE) -
- Opened two new INDs for wholly-owned SPEAR® T-cell therapies; Company now has
four open INDs in 11 indications -
- Received orphan designation, PRIME regulatory support and Breakthrough Therapy
designation for NY-ESO SPEAR T-cell -
- Received FDA notification of permission to proceed with new cell manufacturing
process -
- Conference call to be held today at 8:00 a.m. EDT (12:00 p.m. GMT) -
PHILADELPHIA and OXFORD, United Kingdom, March 13, 2017 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat
cancer, today reported financial results for the fourth quarter and year ended
December 31, 2016.
"2016 was an important year for Adaptimmune during which we established
substantial clinical momentum and significantly advanced our commercial-ready
cell manufacturing process," commented James Noble, Adaptimmune's Chief
Executive Officer. "We now have four open INDs, including three for our wholly-
owned SPEAR T-cells, for studies in 11 indications, 10 of which are solid
tumors. This illustrates the breadth of our proprietary platform and marks
further progress since the end of 2015 when we had two open INDs and studies
ongoing in four indications. Given this progress, we are increasing our focus on
our wholly-owned SPEAR T-cells, in particular the multi-tumor studies with our
wholly-owned MAGE-A10 and MAGE-A4 SPEAR T-cell therapies, and we intend to
deliver initial data from these studies beginning later this year."
Mr. Noble continued, "With respect to our NY-ESO program, I am delighted to
confirm that the FDA has completed its review of our commercial-ready
manufacturing process and permitted us to proceed with implementation of the
process in our existing NY-ESO trials. We plan to implement this new process in
our pilot clinical trials this year. And, we also continue to plan for
initiation of the first registration study with a SPEAR T-cell therapy in
sarcoma. In doing so, we will move ever closer to our goal of transforming the
treatment of patients with serious diseases."
Full Year 2016 and Recent Highlights:
* Opened two new INDs for wholly-owned SPEAR T-cell therapies (AFP, MAGE-A4);
four INDs are now open, enabling a total of nine studies across 11
indications;
* Opened two new clinical studies of SPEAR T-cell therapies (MAGE-A10 triple
tumor study and a pilot study of NY-ESO in myxoid/round cell liposarcoma
[MRCLS])
* Received orphan designation in the United States (US) and European Union
(EU), and EU Priority Medicines (PRIME) regulatory support for NY-ESO SPEAR
T-cell in soft tissue sarcoma; and US Breakthrough Therapy Designation for
NY-ESO SPEAR T-cell in synovial sarcoma;
* Received FDA notification of permission to proceed with new cell
manufacturing process for NY-ESO phase I/II studies;
* Presented clinical data including updated median survival data for synovial
sarcoma Cohort 1 (~18 months [80 weeks]), compared to ~13 months (56 weeks)
as previously reported (CTOS 2016); Fludarabine requirement for
preconditioning (ESMO 2016); and responses in synovial sarcoma patients with
low NY-ESO expression (ESMO 2016);
* Formed strategic alliance with MD Anderson Cancer Center to develop SPEAR T-
cell therapies, including clinical studies of MAGE-A10 and MAGE-A4 SPEAR T-
cell therapies;
* Entered strategic collaboration with Merck to evaluate KEYTRUDA®
(pembrolizumab) in combination study with NY-ESO SPEAR T-cell therapy in
multiple myeloma, with first site initiation anticipated in the first half
of 2017;
* Initiated strategic collaboration with Bellicum Pharmaceuticals to evaluate
Bellicum's GoTCR technology (inducible MyD88/CD40 co-stimulation) with
Adaptimmune's affinity-optimized SPEAR T-cells; and
* Expanded strategic immunotherapy collaboration with GSK and announced GSK's
nomination of a second target, PRAME.
Financial Results for the Three and Twelve Month Period ended December 31, 2016
* Cash / liquidity position: As of December 31, 2016, Adaptimmune had
$158.8 million of cash and cash equivalents, and $22.7 million of short-term
deposits representing a total liquidity position(1) of $181.5 million. For
the three months ended December 31, 2016, the increase in cash and cash
equivalents was $18.3 million and the decrease in short-term deposits was
$24.3 million, representing a decrease in total liquidity position of $6.0
million.
* Revenue: Revenue represents the upfront and milestone payments, which are
recognized over the period the Company delivers services to GSK. Revenue for
the three months ended December 31, 2016 was $8.5 million compared to $4.0
million in the same quarter of the prior year. The increase in revenue was
driven by achieving $17.4 million of milestones in the fourth quarter, which
are recognized over the period the Company delivers services to GSK. Revenue
for the twelve months ended December 31, 2016 was $14.2 million compared to
$14.5 million in the prior year.
* Research and development ("R&D") expenses: R&D expenses for the three and
twelve months ended December 31, 2016 were $16.8 million and $63.8 million,
respectively, compared to $16.6 million and $40.5 million for the three and
twelve months ended December 31, 2015. The increases compared to both prior
periods were 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 studies with the Company's SPEAR T-cell
therapy targeting AFP and MAGE-A4; and increased personnel expenses.
* General and administrative ("G&A") expenses: G&A expenses for the three and
twelve months ended December 31, 2016 were $6.3 million and $23.2 million,
respectively, compared to $5.5 million and $17.2 million for the three and
twelve months ended December 31, 2015. The increases compared to both prior
periods were primarily due to increased personnel costs.
* Net loss: Net loss attributable to holders of the Company's ordinary shares
for the three and twelve months ended December 31, 2016 was $15.4 million
($(0.04) per ordinary share or $(0.22) per American Depositary Share) and
$71.6 million ($(0.17) per ordinary share or $(1.01) per American Depositary
Share), respectively.
(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
As of December 31, 2016, Adaptimmune had a total liquidity position(1) of $181.5
million, made up of $158.8 million of cash and cash equivalents and $22.7
million of short-term deposits. The Company believes that this balance will fund
operations through mid-year 2018. 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. EDT (12:00 p.m. GMT)
today, March 13, 2017. 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 1912 or 0800 279 4992 (United Kingdom). After placing the call,
please ask to be joined into the Adaptimmune conference call and provide the
confirmation code (7287304).
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the
development of novel cancer immunotherapy products. The Company's unique SPEAR®
(Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the
engineering of T-cells to target and destroy cancer, including solid tumors.
Adaptimmune has a number of proprietary clinical programs, and is also
developing its NY-ESO SPEAR T-cell program under a strategic collaboration and
licensing agreement with GlaxoSmithKline. The Company is located in
Philadelphia, USA and Oxfordshire, U.K. For more information, please
visit 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 November
10, 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.
December 31, December 31,
(in thousands) 2016 2015
----------------------------- ---------------- ----------------
Cash and cash equivalents $ 158,779 $ 194,263
Short-term deposits 22,694 54,620
---------------- ----------------
Total Liquidity Position $ 181,473 $ 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 Twelve months ended
Operations Three months ended December 31, December 31,
----------------------------------- -----------------------------------
(unaudited, in
thousands, except
per share data) 2016 2015 2016 2015(1)
----------------- ----------------- ----------------- -----------------
Revenue $ 8,536 $ 4,031 $ 14,198 $ 14,490
Research and
development(2) (16,847 ) (16,619 ) (63,789 ) (40,457 )
General and
administrative(2) (6,345 ) (5,513 ) (23,208 ) (17,156 )
----------------- ----------------- ----------------- -----------------
Total operating
expenses (23,192 ) (22,132 ) (86,997 ) (57,613 )
Operating loss (14,656 ) (18,101 ) (72,799 ) (43,123 )
Interest income 271 254 1,110 787
Other income
(expenses), net (593 ) 1,015 1,002 2,967
----------------- ----------------- ----------------- -----------------
Loss before income
taxes (14,978 ) (16,832 ) (70,687 ) (39,369 )
Income taxes (436 ) 75 (892 ) (143 )
----------------- ----------------- ----------------- -----------------
Net loss (15,414 ) (16,757 ) (71,579 ) (39,512 )
----------------- ----------------- ----------------- -----------------
Deemed dividend on
convertible
preferred shares - - - (8,663 )
----------------- ----------------- ----------------- -----------------
Net loss
attributable to
ordinary
shareholders $ (15,414 ) $ (16,757 ) $ (71,579 ) $ (48,175 )
----------------- ----------------- ----------------- -----------------
Net loss per
ordinary share,
basic and diluted
(3) $ (0.04 ) $ (0.04 ) $ (0.17 ) $ (0.14 )
----------------- ----------------- ----------------- -----------------
Weighted average
ordinary shares
outstanding,
Basic and diluted 424,720,404 424,711,900 424,713,997 337,375,528
----------------- ----------------- ----------------- --------------
(1) The statement of operations for the twelve months ended December 31, 2015
has been recast from our prior period financial statements to conform with our
newly adopted calendar year end for comparative purposes
(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 $651,000 and $1,833,000 in the three and twelve months ended December
31, 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 December
31, Year ended December 31,
----------------------------- -------------------------
2016 2015 2016 2015
------------ ---------------- ------------- -----------
Weighted average number
of Share options 45,882,791 31,280,588 48,707,123 27,448,649
------------ ---------------- ------------- -----------
Condensed Consolidated Balance Sheets December 31, December 31,
(unaudited, in thousands) 2016 2015
-------------- --------------
Assets
Current assets
Cash and cash equivalents $ 158,779 $ 194,263
Short-term deposits 22,694 54,620
Accounts receivable, net of allowance for
doubtful accounts of $- and $- 1,480 744
Other current assets and prepaid expenses
(including current portion of clinical
materials) 15,798 13,420
-------------- --------------
Total current assets 198,751 263,047
Restricted cash 4,017 4,508
Clinical materials 2,580 4,736
Property, plant & equipment, net 27,899 13,225
Intangibles, net 1,268 305
Total assets $ 234,515 $ 285,821
-------------- --------------
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 11,350 $ 7,884
Accrued expenses and other accrued
liabilities 17,528 7,518
Deferred revenue 11,392 12,487
-------------- --------------
Total current liabilities 40,270 27,889
Deferred revenue, non-current 24,962 22,939
Accrued expenses, non-current 3,141 -
-------------- --------------
Total liabilities 68,373 50,828
Stockholders' equity
Common stock - Ordinary shares par value
£0.001, 574,711,900 authorized and
424,775,092 issued and outstanding (2015:
574,711,900 authorized and 424,711,900 issued
and outstanding) 683 682
Additional paid in capital 341,200 332,363
Accumulated other comprehensive loss (14,249 ) (8,139 )
Accumulated deficit (161,492 ) (89,913 )
-------------- --------------
Total stockholders' equity 161,142 234,993
-------------- --------------
Total liabilities and stockholders' equity $ 234,515 $ 285,821
-------------- --------------
Twelve months ended
Condensed Consolidated Cash Flow Statement December 31,
--------------------------
(unaudited, in thousands) 2016 2015
------------- ------------
Cash flows from operating activities
Net loss $ (71,579 ) $ (39,512 )
Adjustments for:
Depreciation 3,126 1,539
Amortization 160 71
Loss on disposal 122 -
Share-based compensation expense 8,821 9,858
Unrealized foreign exchange (gains) losses (1,314 ) (632 )
Changes in operating assets and liabilities:
Increase in receivables and other operating assets (6,533 ) (9,231 )
Decrease (increase) in non-current operating
assets 2,221 (4,736 )
Increase in payables and deferred revenue 16,808 11,036
------------- ------------
Net cash used in operating activities (48,168 ) (31,607 )
Cash flows from investing activities
Acquisition of property, plant & equipment (11,506 ) (12,745 )
Acquisition of intangibles (1,279 ) (210 )
Proceeds from sale of property, plant & equipment - 122
Maturity of short-term deposits 73,377 -
Investment in short-term deposits (42,837 ) (28,594 )
Net cash provided by (used in) investing
activities 17,755 (41,427 )
Cash flows from financing activities
Proceeds from issuance of common stock upon
initial public offering - 175,989
Proceeds from exercise of stock options 17 -
------------- ------------
Net cash used in financing activities 17 175,989
Effect of currency exchange rate changes on cash
and cash equivalents and restricted cash (5,579 ) (5,848 )
------------- ------------
Net (decrease) increase in cash, cash equivalents
and restricted cash (35,975 ) 97,107
Cash, cash equivalents and restricted cash at
start of period 198,771 101,664
------------- ------------
Cash, cash equivalents and restricted cash at end
of period $ 162,796 $ 198,771
------------- ------------
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: 13.03.2017 - 12:30 Uhr
Sprache: Deutsch
News-ID 529787
Anzahl Zeichen: 24774
contact information:
Town:
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Kategorie:
Business News
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