Adaptimmune Reports Second Quarter 2017 Financial Results
August 03 2017 - 7:30AM
– A registered direct offering in April combined
with a public offering in March raised net proceeds of $103.2
million; operations funded through to late 2019 –
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today reported financial results and
business updates for the quarter ended June 30, 2017.
“This was a very exciting quarter for Adaptimmune,” commented
James Noble, Adaptimmune’s Chief Executive Officer. “We made
significant progress clinically by initiating our first trials with
two proprietary programs, MAGE-A4 and AFP, and also initiated our
first combination study with NY‑ESO. We presented data in an oral
presentation at ASCO, showing responses in all four cohorts in our
NY-ESO synovial sarcoma study. And, importantly, we also extended
our cash runway to late 2019, well past the expected data points on
all three of our proprietary programs. We are now focused on
delivering clinical data across multiple tumor types as we move
through the second half of this year and into 2018. We are also
very encouraged by FDA’s Oncology Drug Advisory Committee’s recent
unanimous endorsement of Novartis’s anti-CD19 CAR-T therapy, with
which we share common manufacturing process elements, as this is a
positive review of the first gene therapy cell product in the
US.”
Recent Corporate Highlights:
- Completed April 2017 registered direct offering to Matrix
Capital Management Company, LP, which combined with March 2017
public offering, raised total net proceeds of $103.2
million;
- Initiated AFP SPEAR T-cell therapy clinical trial in
hepatocellular carcinoma;
- Initiated MAGE-A4 SPEAR T-cell therapy clinical trial in
urothelial (bladder), melanoma, head & neck, ovarian, non-small
cell lung cancer (NSCLC), esophageal, and gastric cancers;
- Initiated clinical trial of NY-ESO SPEAR T‑cells in combination
with KEYTRUDA® (pembrolizumab), an anti-PD-1 inhibitor marketed by
Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside
the US and Canada), in patients with multiple myeloma;
- Presented data during an oral presentation at ASCO from ongoing
study of NY-ESO SPEAR T-cells in synovial sarcoma indicating that:
- Initial anti-tumor activity observed in all ongoing cohorts
including low expressors of NY‑ESO
- Fludarabine appears to be an important component of the
lymphodepletion regimen
- NY-ESO continues to be generally well-tolerated:
- All reported events of cytokine release syndrome resolved, and
the majority of events were Grade 1 or 2
- There were no reported events of seizure, cerebral edema, or
encephalopathy
- Survival and response data in Cohort 1 (non-modified
fludarabine / cyclophosphamide [“Flu/Cy”] lymphodepletion regimen)
continue to be promising (data cutoff March 30, 2017):
- Of the 12 patients treated, 5 remain alive with a median
predicted overall survival of 120 weeks (~28 months), and 6
responses were observed
- 10 patients received the target dose of 1 billion transduced
NY‑ESO SPEAR T-cells, and the median predicted overall survival for
those patients is 159 weeks (~37 months)
Financial Results for the Three Months ended June 30,
2017
- Cash / liquidity position: As of June 30,
2017, Adaptimmune had cash and cash equivalents of
$122.0 million and Total Liquidity1 of $220.0 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 June 30, 2017 was $3.5 million. The increase in revenue is
due to the revenue in the three months ended June 30, 2016 being
adversely impacted by a change in estimate of the period over which
revenue is being recognized, which reduced revenue in that quarter
by $2.8 million.
- Research and development (“R&D”) expenses:
R&D expenses for the three months ended June 30, 2017 were
$19.6 million, compared to $16.9 million for the same period of
2016. The increase was primarily due to increased costs associated
with clinical trials; costs of developing manufacturing capability
in the Company’s U.S. facility and increased personnel
expenses.
- General and administrative (“G&A”)
expenses: G&A expenses for the three months ended June
30, 2017 were $7.7 million, compared to $6.2 million for the same
period of 2016. The increase was primarily due to increased
personnel costs consistent with our planned growth.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three months ended June 30,
2017 was $20.2 million ($(0.04) per ordinary share or $(0.24) per
American Depositary Share (“ADS”) compared to $22.1 million
($(0.05) per ordinary share or $(0.31) per ADS) in the same period
of 2016.
Financial GuidanceThe Company believes that its
existing cash and cash equivalents, short-term deposits and
marketable securities will fund the Company’s current operating
plan through to late 2019.
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.
Conference Call InformationThe Company will not
be holding a conference call this quarter.
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 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 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 Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 10, 2017, 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, short-term deposits 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) |
|
June 30, 2017 |
|
|
December 31, 2016 |
Cash and cash
equivalents |
$ |
121,998 |
|
$ |
158,779 |
Short-term
deposits |
|
18,000 |
|
|
22,694 |
Marketable
securities |
|
80,023 |
|
|
- |
Total Liquidity |
$ |
220,021 |
|
$ |
181,473 |
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 June
30, |
|
Six months ended June 30, |
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenue |
$ |
3,521 |
|
|
$ |
328 |
|
|
$ |
6,378 |
|
|
$ |
3,246 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and
development(1) |
|
(19,591 |
) |
|
|
(16,856 |
) |
|
|
(38,206 |
) |
|
|
(31,332 |
) |
General and
administrative(1) |
|
(7,710 |
) |
|
|
(6,172 |
) |
|
|
(14,173 |
) |
|
|
(11,439 |
) |
Total operating
expenses |
|
(27,301 |
) |
|
|
(23,028 |
) |
|
|
(52,379 |
) |
|
|
(42,771 |
) |
Operating
loss |
|
(23,780 |
) |
|
|
(22,700 |
) |
|
|
(46,001 |
) |
|
|
(39,525 |
) |
Interest income |
|
512 |
|
|
|
291 |
|
|
|
752 |
|
|
|
550 |
|
Interest expense |
|
(6 |
) |
|
|
- |
|
|
|
(6 |
) |
|
|
- |
|
Other income, net |
|
3,224 |
|
|
|
607 |
|
|
|
3,654 |
|
|
|
1,656 |
|
Loss before
income taxes |
|
(20,050 |
) |
|
|
(21,802 |
) |
|
|
(41,601 |
) |
|
|
(37,319 |
) |
Income taxes |
|
(165 |
) |
|
|
(293 |
) |
|
|
(396 |
) |
|
|
(352 |
) |
Net loss
attributable to ordinary shareholders |
$ |
(20,215 |
) |
|
$ |
(22,095 |
) |
|
$ |
(41,997 |
) |
|
$ |
(37,671 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
ordinary share basic and diluted |
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted(2) |
556,776,430 |
|
|
424,711,900 |
|
|
493,392,465 |
|
|
424,711,900 |
|
(1) 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 $637,000 and $1,225,000
in the three and six months ended June 30, 2016, respectively.
(2) The effect of 67,082,914 and 46,127,274 share options, which
are potentially dilutive equity instruments, have been excluded
from the diluted loss per share calculation for the three months
ended June 30, 2017 and 2016, respectively, because they would have
an antidilutive effect on the loss per share for the period.
Condensed Consolidated Balance Sheets(unaudited,
in thousands) |
June 30, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
121,998 |
|
|
$ |
158,779 |
|
Short-term deposits |
|
18,000 |
|
|
|
22,694 |
|
Marketable securities - available for sale debt securities |
|
80,023 |
|
|
|
- |
|
Accounts
receivable, net of allowance for doubtful accounts of $- and
$- |
|
1,406 |
|
|
|
1,480 |
|
Other
current assets and prepaid expenses (including current portion of
clinical materials) |
|
16,317 |
|
|
|
15,798 |
|
Total current assets |
|
237,744 |
|
|
|
198,751 |
|
|
|
|
|
|
|
Restricted cash |
|
4,156 |
|
|
|
4,017 |
|
Clinical
materials |
|
2,026 |
|
|
|
2,580 |
|
Property,
plant and equipment, net |
|
38,922 |
|
|
|
27,899 |
|
Intangibles, net |
|
1,431 |
|
|
|
1,268 |
|
Total assets |
|
284,279 |
|
|
|
234,515 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
4,577 |
|
|
|
11,350 |
|
Accrued
expenses and other accrued liabilities |
|
13,372 |
|
|
|
17,528 |
|
Deferred
revenue |
|
12,304 |
|
|
|
11,392 |
|
Total current liabilities |
|
30,253 |
|
|
|
40,270 |
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
20,754 |
|
|
|
24,962 |
|
Other
liabilities, non-current |
|
3,777 |
|
|
|
3,141 |
|
|
|
|
|
|
|
Total liabilities |
|
54,784 |
|
|
|
68,373 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common
stock - Ordinary shares par value £0.001, 703,103,126 authorized
and 561,103,126 issued and outstanding (2016: 574,711,900
authorized and 424,775,092 issued and outstanding) |
|
853 |
|
|
|
683 |
|
Additional paid in capital |
|
448,985 |
|
|
|
341,200 |
|
Accumulated other comprehensive loss |
|
(16,854 |
) |
|
|
(14,249 |
) |
Accumulated deficit |
|
(203,489 |
) |
|
|
(161,492 |
) |
Total stockholders’ equity |
|
229,495 |
|
|
|
166,142 |
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
284,279 |
|
|
$ |
234,515 |
|
Condensed
Consolidated Cash Flow Statement(unaudited, in
thousands) |
Six months ended June 30, |
|
2017 |
|
|
2016 |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(41,997 |
) |
|
$ |
(37,671 |
) |
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
Depreciation |
|
2,023 |
|
|
|
1,512 |
|
Amortization |
|
159 |
|
|
|
82 |
|
Share-based compensation expense |
|
4,757 |
|
|
|
4,541 |
|
Loss on
disposal of property, plant and equipment |
|
194 |
|
|
|
- |
|
Unrealized foreign exchange gains |
|
(3,206 |
) |
|
|
(2,004 |
) |
Changes in operating
assets and liabilities: |
|
|
|
|
|
Increase
in receivables and other operating assets |
|
2,301 |
|
|
|
601 |
|
(Increase) decrease in non-current operating assets |
|
(554 |
) |
|
|
2,041 |
|
Decrease
in payables and deferred revenue |
|
(10,125 |
) |
|
|
(4,274 |
) |
Net cash used in operating activities |
|
(46,448 |
) |
|
|
(35,172 |
) |
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
Acquisition of property, plant and equipment |
|
(21,188 |
) |
|
|
(2,910 |
) |
Acquisition of intangibles |
|
(266 |
) |
|
|
(861 |
) |
Proceeds
from disposal of property, plant and equipment |
|
550 |
|
|
|
- |
|
Maturity
of short-term deposits |
|
22,857 |
|
|
|
41,661 |
|
Investment in short-term deposits |
|
(18,000 |
) |
|
|
(42,837 |
) |
Investment in marketable securities |
|
(79,774 |
) |
|
|
- |
|
Net cash used in investing activities |
|
(95,821 |
) |
|
|
(4,947 |
) |
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
Proceeds
from issuance of common stock, after offering expenses of
$4,774 |
|
103,167 |
|
|
|
- |
|
Proceeds
from exercise of stock options |
|
31 |
|
|
|
- |
|
Net cash provided by financing activities |
|
103,198 |
|
|
|
- |
|
|
|
|
|
|
|
Effect of
currency exchange rate changes on cash, cash equivalents and
restricted cash |
|
2,290 |
|
|
|
(3,529 |
) |
Net
decrease in cash and cash equivalents |
|
(36,642 |
) |
|
|
(43,648 |
) |
Cash,
cash equivalents and restricted cash at start of period |
|
162,796 |
|
|
|
198,771 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash at end of
period |
$ |
126,154 |
|
|
$ |
155,123 |
|
Adaptimmune Contacts
Investor Relations
Juli P. Miller, Ph.D.
T: (215) 825-9310
E: juli.miller@adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Cell: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
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