Bli medlem
Bli medlem

Du är här

2016-11-10

Adaptimmune Reports Third Quarter 2016 Financial Results

rts Third Quarter 2016 Financial Results

– U.S. Food and Drug Administration (FDA) lifted partial clinical hold of
myxoid/round cell liposarcoma (MRCLS) study of NY-ESO SPEAR™ 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, 2016-11-09 21:51 CET (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 position
1
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.

(in thousands) September 30, December 31,
2016 2015

Cash and cash equivalents $ 140,440 $ 194,263
Short-term deposits ...

Författare SSE

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.