- Dosing patients in MAGE-A10 lung cancer study
at one billion target cell dose -
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today reported financial results for the
first quarter ended March 31, 2018, as well as provided a
business update.
“2018 is off to an outstanding start, and the remainder of the
year promises to be even more exciting for Adaptimmune as we look
forward to response data from our wholly owned assets in a variety
of solid tumors,” commented James Noble, Adaptimmune’s Chief
Executive Officer. “The transition of the NY-ESO program to GSK is
progressing, our manufacturing capabilities are strengthening, and
we have a robust pipeline delivering novel therapeutic approaches
to cancer patients. We look forward to presenting further progress
in the coming months as we move towards our ambition to be the
first to market with an approved TCR T-cell therapy.”
Clinical momentumAdaptimmune continues to make
good progress across all trial cohorts. Clinical data highlights
include:
- Initial safety data (https://bit.ly/2HAuhTS) with Adaptimmune’s
wholly owned SPEAR T-cell therapy targeting MAGE-A10 reported in
January. These data will be presented and updated in a poster at
the upcoming American Society of Clinical Oncology (ASCO) annual
meeting in June.
- Dosing at the target dose of one billion transduced SPEAR
T-cells in the MAGE-A10 triple tumor study reported in January
(https://bit.ly/2HAuhTS).
- Dosing at the target dose of one billion transduced SPEAR
T-cells after recent recommendation from the scientific review
committee (SRC) to dose escalate in the MAGE-A10 non-small cell
lung cancer (NSCLC) study.
- Responses in a second solid tumor, myxoid round/cell
liposarcoma (MRCLS), with NY-ESO reported in March
(https://bit.ly/2HAluxz). These data will be presented and updated
at an oral presentation during ASCO.
Initial safety data from the MAGE-A4 “basket study” (required to
support dose escalation to one billion cells) is on track for the
second quarter of 2018. MAGE-A4 response data and initial AFP
safety data are anticipated throughout the second half of this
year.
Manufacturing progressIn another important step
towards its ambition to become a fully integrated cell therapy
company, Adaptimmune has now received regulatory approval to
produce SPEAR T-cells for all of its wholly owned programs
(MAGE‑A10, MAGE-A4, and AFP) at its Philadelphia Navy Yard
facility. The Company is routinely manufacturing SPEAR T-cells at
the Navy Yard, and achieving cell volumes in the range of the
therapeutic doses seen with NY‑ESO in synovial sarcoma.
In addition, Adaptimmune announced in January 2018
(https://bit.ly/2D8A52t ) that it had executed an agreement with
Cell and Gene Therapy (CGT) Catapult for its own dedicated
manufacturing space to secure vector supply for the medium term for
ongoing studies with all three wholly owned SPEAR T-cell therapies.
The Catapult space is now officially open.
Highlights
Wholly owned programs
Continued momentum towards safety and response readouts from
SPEAR T-cells targeting MAGE-A10 and MAGE-A4 in multiple solid
tumors throughout the second half of 2018, and initial safety data
from AFP in hepatocellular carcinoma anticipated in late 2018
- MAGE-A10 - Dosing at
one billion target cell dose in both pilot studies (NSCLC and
“triple tumor”) - To date, no evidence of
off-target toxicity in MAGE-A10 pilot studies in patients who
received 100 million cells - Response data
anticipated in the second half of 2018
- Preclinical data presented at the American Association
for Cancer Research (AACR) annual meeting in April 2018 support the
potential specificity and potency of Adaptimmune’s MAGE‑A10 SPEAR
T-cells (https://bit.ly/2HulQJG)
- MAGE-A4 - Basket
study: Dosing continues and on schedule to report initial safety
data in Q2 2018 - Response data are
anticipated throughout the second half of this year
- Preclinical safety data presented at AACR identified
no major safety concerns for MAGE-A4 SPEAR T‑cell, and analyses of
NSCLC tumor samples support the validity of MAGE‑A4 as a target in
this indication (https://bit.ly/2HulQJG)
- AFP
- Hepatocellular carcinoma: Study open
and enrolling with initial safety data anticipated in late
2018
- Next generation SPEAR T-cells
- Adaptimmune’s US patent US15/713464 covering
a “next generation” approach to making our T‑cells resistant to the
immunosuppressive environment of solid tumors, has been granted.
This approach is likely to be used in some of the Company’s future
clinical trials.
NY-ESO program (partnered with GSK)Compelling
clinical data supports the potential of Adaptimmune’s TCR T-cell
therapies to treat solid tumors
- MRCLS: Update will be presented in an oral
presentation at ASCO.
- GSK option exercise and transition: The
transition of the NY-ESO program to GSK is ongoing.
ManufacturingAdaptimmune is building a fully
integrated cell therapy company
- Received regulatory approval to produce SPEAR T-cells for all
of its wholly owned programs (MAGE-A10, MAGE-A4, and AFP) at its
Philadelphia Navy Yard facility.
- Routinely manufacturing SPEAR T-cells at the Navy Yard, and
achieving cell volumes in the range of the therapeutic doses seen
with NY ESO in synovial sarcoma.
- Announced in January 2018 (https://bit.ly/2D8A52t ) that it had
executed an agreement with CGT Catapult for its own dedicated
manufacturing space to secure vector supply for the medium term for
ongoing studies with all three wholly owned SPEAR T-cell
therapies.
- The Catapult space is now officially open.
- Had a US patent granted (US9932597), covering a “WPRE-free"
vector system, that will further optimize the vector system used
for manufacture of its SPEAR T-cells.
Other corporate newsAdaptimmune is in a strong
financial position to deliver success with SPEAR T-cell
therapies
- Funded through to early 2020 with cash and cash equivalents of
$53.4 million and total liquidity1 of $161.8 million
- Announced in April 2018 (https://bit.ly/2v7v3D3 ) that John
Furey, Chief Operating Officer at Spark Therapeutics, was appointed
as an independent Non‑Executive Director to Adaptimmune’s Board of
Directors (effective July 5, 2018)
Financial Results for the three-month period ended March
31, 2018
- Cash / liquidity position: As of March 31,
2018, Adaptimmune had cash and cash equivalents of
$53.4 million and Total Liquidity1 of $161.8 million that will
fund the Company through early 2020 based on management’s
estimates.
- Revenue: With effect from January 1, 2018, the
Company has adopted a new accounting standard2. Under this new
accounting standard, revenue represents the upfront payment and
milestones under the GSK Collaboration and License Agreement, which
are recognized based on the percentage completion of the NY-ESO and
PRAME development programs. Revenue for the three months ended
March 31, 2018 was $8.2 million. Revenue for the three months ended
March 31, 2018 under the previous guidance would have been $9.0
million, compared to $2.9 million for the same period of 2017. This
increase in revenue, compared to the same period in 2017, is
primarily due to a reduction in the period over which the Company
is recognizing revenue following GSK’s exercise of its option over
the NY-ESO program in September 2017 and additional development
milestones achieved.
- Research and development (“R&D”) expenses:
R&D expenses for the three months ended March 31, 2018
were $25.7 million, compared to $18.6 million for the same period
of 2017. The increase was primarily due to increased costs
associated with clinical trials, manufacturing for clinical trials,
and increased personnel costs.
- General and administrative (“G&A”)
expenses: G&A expenses for the three months ended
March 31, 2018 were $11.2 million, compared to $6.5 million
for the same period of 2017. The increase was primarily due to
increased personnel costs consistent with the Company’s planned
growth, an increase in costs associated with developing its IT
infrastructure and an increase in other corporate costs.
- Other income, net: Other income for the three
months ended March 31, 2018 was $7.1 million, compared to $0.4
million for the same period of 2017. Other income primarily
comprises unrealized foreign exchange gains, which fluctuate
depending on exchange rate movements and the amount of foreign
currency assets and liabilities.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three months ended March 31,
2018 was $21.1 million ($(0.04) per ordinary share) compared to
$21.8 million ($(0.05) per ordinary share) in the same period of
2017.
Financial guidanceThe Company believes that its
existing cash, cash equivalents, marketable securities and income
from GSK upon transition of the NY-ESO program will fund the
Company’s current operating plan through to early 2020.
_________________________________________1 Total liquidity is a
non-GAAP financial measure, which is explained and reconciled to
the most directly comparable financial measures prepared in
accordance with GAAP below. 2 ASC 606, Revenue from
Contracts with Customers.
Conference call informationThe Company will
host a live teleconference and webcast to provide additional
details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2018. 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 1-833-652-5917 (U.S.) or 1-430-775-1624
(International). After placing the call, please ask to be joined
into the Adaptimmune conference call and provide the confirmation
code (2967789).
About AdaptimmuneAdaptimmune 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 is currently conducting
clinical trials with SPEAR T-cells targeting MAGE-A4, -A10, and AFP
across several solid tumor indications. GlaxoSmithKline
plc (LSE:GSK) (NYSE:GSK) exercised its option to exclusively
license the right to research, develop, and commercialize
Adaptimmune’s NY-ESO SPEAR T-cell therapy program in September
2017. Transition of this program to GSK is ongoing. The
Company is located in Philadelphia, USA and Oxfordshire, U.K. For
more information, please visit http://www.adaptimmune.com
Forward-looking statementsThis 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
10-K filed with the Securities and Exchange
Commission (SEC) on March 15, 2018, 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 (a non-GAAP financial
measure)Total Liquidity is the total of cash and cash
equivalents, and marketable securities. Each of these components
appears in the Consolidated Balance Sheet. The U.S. GAAP financial
measure most directly comparable to Total Liquidity is cash and
cash equivalents as reported in the Consolidated Financial
Statements, which reconciles to Total Liquidity as follows:
(in thousands)(unaudited) |
|
|
March 31, 2018 |
|
|
December 31, 2017 |
Cash and cash
equivalents |
|
$ |
53,375 |
|
$ |
84,043 |
Marketable
securities |
|
|
108,459 |
|
|
124,218 |
Total Liquidity |
|
$ |
161,834 |
|
$ |
208,261 |
|
The Company believes that the presentation of Total Liquidity
provides useful information to investors because management reviews
Total Liquidity as part of its management of overall liquidity,
financial flexibility, capital structure and leverage.
Condensed Consolidated Statement of
Operations(unaudited, in thousands, except per share
data)
|
|
Three months ended March 31, |
|
|
2018 |
|
2017 |
Revenue |
|
$ |
8,196 |
|
|
$ |
2,857 |
|
Operating
expenses |
|
|
|
|
|
|
Research and
development |
|
|
(25,732 |
) |
|
|
(18,615 |
) |
General and
administrative |
|
|
(11,204 |
) |
|
|
(6,463 |
) |
Total operating
expenses |
|
|
(36,936 |
) |
|
|
(25,078 |
) |
Operating
loss |
|
|
(28,740 |
) |
|
|
(22,221 |
) |
Interest income |
|
|
659 |
|
|
|
240 |
|
Other income, net |
|
|
7,130 |
|
|
|
430 |
|
Loss before
income taxes |
|
|
(20,951 |
) |
|
|
(21,551 |
) |
Income taxes |
|
|
(127 |
) |
|
|
(231 |
) |
Net loss
attributable to ordinary shareholders |
|
$ |
(21,078 |
) |
|
$ |
(21,782 |
) |
|
|
|
|
|
|
|
Net loss per
ordinary share - Basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
Weighted
average shares outstanding - Basic and diluted |
|
|
562,381,995 |
|
|
|
428,961,818 |
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands)
|
March 31, 2018 |
|
December 31, 2017 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
53,375 |
|
|
$ |
84,043 |
|
Marketable securities - available-for-sale debt securities |
|
108,459 |
|
|
|
124,218 |
|
Accounts
receivable, net of allowance for doubtful accounts of $- and
$- |
|
5,052 |
|
|
|
206 |
|
Other
current assets and prepaid expenses (including current portion of
clinical materials) |
|
28,777 |
|
|
|
21,716 |
|
Total current assets |
|
195,663 |
|
|
|
230,183 |
|
|
|
|
|
|
|
Restricted cash |
|
4,360 |
|
|
|
4,253 |
|
Clinical
materials |
|
4,572 |
|
|
|
4,695 |
|
Property, plant and equipment, net |
|
41,235 |
|
|
|
40,679 |
|
Intangibles, net |
|
1,238 |
|
|
|
1,337 |
|
|
|
|
|
|
|
Total assets |
|
247,068 |
|
|
|
281,147 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
5,051 |
|
|
|
8,378 |
|
Accrued
expenses and other accrued liabilities |
|
19,650 |
|
|
|
27,201 |
|
Deferred
revenue |
|
27,221 |
|
|
|
38,735 |
|
Total current liabilities |
|
51,922 |
|
|
|
74,314 |
|
|
|
|
|
|
|
Other
liabilities, non-current |
|
3,884 |
|
|
|
3,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
55,806 |
|
|
|
78,163 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common
stock - Ordinary shares par value £0.001, 701,103,126 authorized
and 564,859,960 issued and outstanding (2017: 701,103,126
authorized and 562,119,334 issued and outstanding) |
|
858 |
|
|
|
854 |
|
Additional paid in capital |
|
461,603 |
|
|
|
455,401 |
|
Accumulated other comprehensive loss |
|
(27,136 |
) |
|
|
(21,641 |
) |
Accumulated deficit |
|
(244,063 |
) |
|
|
(231,630 |
) |
Total stockholders’ equity |
|
191,262 |
|
|
|
202,984 |
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
247,068 |
|
|
$ |
281,147 |
|
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
Three months ended March
31, |
|
2018 |
|
2017 |
Cash flows from operating activities |
|
|
|
|
|
Net loss |
$ |
(21,078 |
) |
|
$ |
(21,782 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
Depreciation |
|
1,740 |
|
|
|
986 |
|
Amortization |
|
143 |
|
|
|
60 |
|
Share-based compensation expense |
|
4,672 |
|
|
|
2,686 |
|
Realized
loss on available-for-sale debt securities |
|
1,163 |
|
|
|
- |
|
Unrealized foreign exchange gains |
|
(7,862 |
) |
|
|
(52 |
) |
Other |
|
124 |
|
|
|
- |
|
Changes in operating
assets and liabilities: |
|
|
|
|
|
Increase
in receivables and other operating assets |
|
(10,179 |
) |
|
|
(1,813 |
) |
Increase
in non-current operating assets |
|
(123 |
) |
|
|
(17 |
) |
Decrease
in payables and deferred revenue |
|
(15,879 |
) |
|
|
(8,507 |
) |
Net cash used in operating activities |
|
(47,279 |
) |
|
|
(28,439 |
) |
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
Acquisition of property, plant and equipment |
|
(1,904 |
) |
|
|
(12,249 |
) |
Acquisition of intangibles |
|
(10 |
) |
|
|
(242 |
) |
Maturity
of short-term deposits |
|
- |
|
|
|
7,854 |
|
Investment in short-term deposits |
|
- |
|
|
|
(18,000 |
) |
Maturity
or redemption of marketable securities |
|
28,043 |
|
|
|
- |
|
Investment in marketable securities |
|
(12,490 |
) |
|
|
- |
|
Net cash provided by (used in) investing
activities |
|
13,639 |
|
|
|
(22,637 |
) |
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
Proceeds
from issuance of common stock, net of issuance costs $4,774 |
|
- |
|
|
|
61,397 |
|
Proceeds
from exercise of stock options |
|
1,534 |
|
|
|
- |
|
Net cash provided by financing activities |
|
1,534 |
|
|
|
61,397 |
|
|
|
|
|
|
|
Effect of
currency exchange rate changes on cash, cash equivalents and
restricted cash |
|
1,545 |
|
|
|
1,491 |
|
Net
(decrease) increase in cash, cash equivalents and restricted
cash |
|
(30,561 |
) |
|
|
11,812 |
|
Cash,
cash equivalents and restricted cash at start of period |
|
88,296 |
|
|
|
162,796 |
|
Cash, cash equivalents and restricted cash at end of
period |
$ |
57,735 |
|
|
$ |
174,608 |
|
|
Adaptimmune Contacts:
Media Relations:Sébastien Desprez – VP,
Communications and Investor RelationsT: +44 1235 430 583M: +44 7718
453 176 Sebastien.Desprez@adaptimmune.com
Investor Relations: Juli P. Miller, Ph.D. –
Director, Investor RelationsT: +1 215 825 9310M: +1 215 460
8920Juli.Miller@adaptimmune.com
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