Adaptimmune Reports Third Quarter 2018 Financial Results and Business Update
November 06 2018 - 7:30AM
Progressed to expansion phase for MAGE-A10 triple
tumor and MAGE-A4 basket studies after favorable safety review of
Cohort 3 data with target doses of 5 billion cells
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, 2018, and provided a business
update.
“We have now completed the three dose escalation cohorts of the
studies with MAGE‑A4 and MAGE‑A10, our leading wholly owned
programs. The Safety Review Committee has agreed that the higher
pre‑conditioning regimen and cell doses are tolerable and there
were no dose limiting toxicities. These studies will now move into
the expansion phase, which allows us to treat patients with up to
ten billion cells, without a pre-determined stagger across a broad
range of tumor types. We have also continued dosing patients in the
AFP study with 100 million cells and anticipate escalating to
Cohort 2 in early 2019. We expect to report our next clinical data
by no later than our first quarter financial results in May 2019,”
said James Noble, Chief Executive Officer.
Clinical momentum in wholly owned programs
Ongoing MAGE-A10 and MAGE-A4 studies
- There are three ongoing studies with MAGE-A10 and MAGE-A4 SPEAR
T-cells - Two MAGE-A10 studies: one in non-small cell lung
cancer (NSCLC) and a triple tumor study in bladder, melanoma, and
head & neck cancers - A MAGE-A4 basket study in NSCLC,
bladder, melanoma, synovial sarcoma, myxoid/round cell liposarcoma
(MRCLS), head & neck, ovarian, gastric, and esophageal
cancers
- All three studies are first-in-human trials utilizing a
modified 3+3 design with escalating target doses of 100 million
(Cohort 1), 1 billion (Cohort 2), and 5 billion (Cohort 3)
transduced SPEAR T‑cells to evaluate safety, including dose
limiting toxicities (DLTs)
- The preconditioning regimen in the first two cohorts was
cyclophosphamide (600mg/m2/day) and fludarabine (30 mg/m2/day) on
days -7, -6 and -5, and an extra day of fludarabine was added to
the third cohorts and expansion phases, as clinical and
translational data indicate that this extra day may be important
for optimal T-cell expansion post infusion
- Following the initial three cohorts, the Safety Review
Committee (SRC) meets to decide whether to progress to the
expansion phase, which has a target dose of 5 billion cells (range
1.2 to 10B) without pre-determined intervals between patient
dosing
- The SRC recommended moving into the expansion phase for the
MAGE-A10 triple tumor and MAGE-A4 basket studies
- As in the first two cohorts of these studies, there was no
evidence of toxicity related to off-target binding or
alloreactivity in the third cohorts at target doses of 5
billion cells
- Most adverse events were consistent with those experienced by
cancer patients undergoing chemotherapy or other
immunotherapies
ESMO data
- Initial safety data from the first two cohorts of the MAGE-A10
and MAGE-A4 studies were presented at the European Society for
Medical Oncology (ESMO) 2018 Congress (https://bit.ly/2PdB3CR)
- In brief, these data showed: - Disease progressed for all
eight patients treated in the first dose cohorts of the two
MAGE-A10 studies (five patients with lung cancer, two with head
& neck cancer, and one with melanoma) - For the three
patients treated in Cohort 2 of the MAGE-A10 study (all lung cancer
patients), one patient died of pneumonia (unrelated to therapy) and
two had stable disease (SD), albeit transient - Of the six
patients treated in Cohorts 1 and 2 of the MAGE-A4 basket study,
best response was SD in four patients and progressive disease (PD)
in two patients - One patient in the MAGE-A4 basket study with
SD had an overall 27% reduction of target lesions observed at Week
6, and was assessed as PD at the time of the second scan, which
took place after the ESMO poster cut-off date - No evidence of
toxicity related to off-target binding or alloreactivity at target
doses of 100 million or 1 billion cells - Most
adverse events consistent with those experienced by cancer patients
undergoing chemotherapy or other immunotherapies - Transduced
cells detectable in peripheral blood at levels consistent with
dose.
Data from ongoing AFP study
- Dosing in Cohort 1 of AFP study is ongoing
- Anticipate dose escalation to Cohort 2 in early 2019.
NY-ESO data updates to be presented at SITC
- The NY-ESO program transitioned to GSK in July 2018
- An abstract summarizing NY-ESO SPEAR T-cells in MRCLS was
accepted for presentation at SITC, and is available online
today
- Data in the abstract state that out of ten MRCLS patients,
there were four with partial responses (PRs) and four with SD, as
per investigator assessment
- These data will be updated in a poster at SITC
- Overall, there was evidence of reduction in target lesions in
seven patients out of eight evaluable patients
- The data submitted in the abstract included investigator
assessments. These assessments showed a best response of four
confirmed PR, one unconfirmed PR, and three patients with SD
out of eight evaluable patients
- Two of the responses were confirmed before the minimum 28 days
required by RECIST v1.1 (22 and 25 days), and the patients
subsequently progressed
- Therefore, the response rate by RECIST, which will be presented
in the poster, is two confirmed PRs and six patients with SD out of
the eight evaluable patients
- Patients in the MRCLS study received the same preconditioning
regimen as was used in Cohort 4 of the synovial sarcoma study, and
these patients had less durable responses compared to Cohort 1
patients in the synovial sarcoma study, who received a more intense
preconditioning regimen
- The most frequent AEs were consistent with those experienced by
patients with cancer who are undergoing cytotoxic chemotherapy or
other immunotherapies
- A second poster with NY-ESO data will also be presented at SITC
summarizing translational research conducted in the context of the
NY-ESO synovial sarcoma study examining serum factors that lead to
T-cell expansion with different preconditioning regimens (including
the impact of fludarabine), tumor micro-environment analyses pre-
and post-infusion, and SPEAR T-cell functionality post‑infusion.
This abstract is also available online.
ManufacturingAdaptimmune on its way to becoming
a fully integrated cell therapy company
- 2018 has been a successful year for manufacturing with the Navy
Yard facility regularly producing target cell doses > 1 billion
cells with more than 50% producing > 5 billion cells
- Producing cell doses across multiple solid tumor
indications
- Cells have been manufactured for a number of patients who could
enter the MAGE-A4 and/or MAGE-A10 expansion phases, once
eligible
Other corporate newsAdaptimmune is focused on
its next stage of development and in a strong position to deliver
success with SPEAR T-cell therapies
- Announced the closing of a registered direct offering of
Adaptimmune’s American Depositary Shares (“ADSs”)
(https://bit.ly/2MZFEIH) with net proceeds of approximately $100
million
- Adaptimmune intends to use the net proceeds from this offering
to advance the Company’s wholly owned pipeline of SPEAR T-cell
candidates through clinical trials as well as for other general
corporate purposes
- Completed transition of NY-ESO IND to GSK and received
approximately $26 million in milestone payments
- Funded through to late 2020 with cash and cash equivalents of
$153.1 million and total liquidity1 of $237.7 million
- Held annual Scientific Advisory Board meeting in October with
Adaptimmune R&D leaders and external experts in immunology and
oncology (bios available here: https://bit.ly/2PvHH4w); focused on
optimal employment of NY-ESO learnings in ongoing and future
studies as well as strategies for novel target identification.
Financial Results for the three and nine month period
ended September 30, 2018
- Cash / liquidity position: As of September 30,
2018, Adaptimmune had cash and cash equivalents of
$153.1 million and Total Liquidity1 of $237.7 million.
- Revenue: Revenue for the three and nine months
ended September 30, 2018 was $40.8 million and $58.0 million,
respectively, compared to $27.2 million and $33.6 million for the
same periods of 2017. The revenue in the three and nine
months ended September 30, 2018 includes $39.1 million of revenue
for the license to NY-ESO, which commenced in September 2018.
- Research and development (“R&D”) expenses:
R&D expenses for the three and nine months ended
September 30, 2018 were $23.5 million and $75.5 million,
respectively, compared to $24.0 million and $62.2 million for the
same periods of 2017. The R&D expenses in the nine months ended
September 30, 2018 has increased compared to the same period in
2017 due to increased clinical trial and related manufacturing
activities. R&D expenses in the three months ended
September 30, 2018 compared to the same period in 2017 decreased
due to the transfer of the NY-ESO program to GSK.
- General and administrative (“G&A”)
expenses: G&A expenses for the three and nine months
ended September 30, 2018 were $10.3 million and $32.8 million,
respectively, compared to $8.1 million and $22.3 million for the
same periods of 2017. The increase was primarily due to increased
personnel costs consistent with the Company’s planned
infrastructure growth.
- Other (expense) income, net: Other expense for
the three and nine months ended September 30, 2018 was $2.2 million
and $10.5 million, respectively, compared to an income of $3.6
million and $7.2 million for the same periods 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 income (loss): Net income (loss)
attributable to holders of the Company’s ordinary shares for the
three and nine months ended September 30, 2018 was an income of
$5.2 million and a loss of $59.3 million, respectively, ($0.01 and
$(0.10) per ordinary share) compared to a loss of $0.9 million and
$42.9 million, respectively, ($(0.00) and $(0.08) per ordinary
share) in the same periods of 2017.
______________________________________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.
Financial guidanceThe Company believes that its
existing cash, cash equivalents and marketable securities will fund
the Company’s current operations through to late 2020.
Conference call information
The Company will host a live teleconference and webcast at 8:00
a.m. EST (1:00 p.m. GMT) today. 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, please dial (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 (2458438).
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. 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 August 2, 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) |
|
September, 2018 |
|
|
December 31, 2017 |
Cash and cash equivalents |
$ |
153,081 |
|
$ |
84,043 |
Marketable securities |
|
84,652 |
|
|
124,218 |
Total Liquidity |
$ |
237,733 |
|
$ |
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
September 30, |
|
Nine months ended
September 30, |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenue |
$ |
40,792 |
|
|
$ |
27,185 |
|
|
|
58,026 |
|
|
|
33,563 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
(23,484 |
) |
|
|
(24,034 |
) |
|
|
(75,500 |
) |
|
|
(62,240 |
) |
General and administrative |
|
(10,290 |
) |
|
|
(8,111 |
) |
|
|
(32,785 |
) |
|
|
(22,284 |
) |
Total operating expenses |
|
(33,774 |
) |
|
|
(32,145 |
) |
|
|
(108,285 |
) |
|
|
(84,524 |
) |
Operating income (loss) |
|
7,018 |
|
|
|
(4,960 |
) |
|
|
(50,259 |
) |
|
|
(50,961 |
) |
Interest income |
|
606 |
|
|
|
705 |
|
|
|
1,805 |
|
|
|
1,465 |
|
Other (expense) income, net |
|
(2,249 |
) |
|
|
3,602 |
|
|
|
(10,525 |
) |
|
|
7,242 |
|
Income (loss) before income taxes |
|
5,375 |
|
|
|
(653 |
) |
|
|
(58,979 |
) |
|
|
(42,254 |
) |
Income taxes |
|
(133 |
) |
|
|
(225 |
) |
|
|
(362 |
) |
|
|
(621 |
) |
Net income (loss) attributable to ordinary
shareholders |
$ |
5,242 |
|
|
$ |
(878 |
) |
|
$ |
(59,341 |
) |
|
$ |
(42,875 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.01 |
|
|
$ |
- |
|
|
$ |
(0.10 |
) |
|
$ |
(0.08 |
) |
Diluted |
|
0.01 |
|
|
|
- |
|
|
|
(0.10 |
) |
|
|
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
582,004,954 |
|
|
|
561,239,864 |
|
|
|
573,796,275 |
|
|
|
516,352,141 |
|
Diluted |
|
621,764,201 |
|
|
|
561,239,864 |
|
|
|
573,796,275 |
|
|
|
516,352,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands)
|
September 30,
2018 |
|
December 31,
2017 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
cash equivalents |
$ |
153,081 |
|
|
$ |
84,043 |
|
Marketable securities - available-for-sale debt securities |
|
84,652 |
|
|
|
124,218 |
|
Accounts
receivable, net of allowance for doubtful accounts of $- and
$- |
|
2,031 |
|
|
|
206 |
|
Other
current assets and prepaid expenses (including current portion of
clinical materials) |
|
21,841 |
|
|
|
21,716 |
|
Total
current assets |
|
261,605 |
|
|
|
230,183 |
|
|
|
|
|
|
|
Restricted
cash |
|
4,163 |
|
|
|
4,253 |
|
Clinical
materials |
|
4,205 |
|
|
|
4,695 |
|
Property,
plant and equipment, net |
|
38,137 |
|
|
|
40,679 |
|
Intangibles,
net |
|
1,515 |
|
|
|
1,337 |
|
|
|
|
|
|
|
Total
assets |
|
309,625 |
|
|
|
281,147 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts
payable |
|
3,907 |
|
|
|
8,378 |
|
Accrued
expenses and other accrued liabilities |
|
24,314 |
|
|
|
27,201 |
|
Deferred
revenue |
|
1,345 |
|
|
|
38,735 |
|
Total
current liabilities |
|
29,566 |
|
|
|
74,314 |
|
|
|
|
|
|
|
Other
liabilities, non-current |
|
3,904 |
|
|
|
3,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
33,470 |
|
|
|
78,163 |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 701,103,126
authorized and 627,222,076 issued and outstanding (2017:
701,103,126 authorized and 562,119,334 issued and
outstanding) |
|
939 |
|
|
|
854 |
|
Additional paid in capital |
|
570,355 |
|
|
|
455,401 |
|
Accumulated other comprehensive loss |
|
(12,813 |
) |
|
|
(21,641 |
) |
Accumulated deficit |
|
(282,326 |
) |
|
|
(231,630 |
) |
Total
stockholders’ equity |
|
276,155 |
|
|
|
202,984 |
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
$ |
309,625 |
|
|
$ |
281,147 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
Nine months ended
September 30, |
|
2018 |
|
|
2017 |
|
Cash flows from operating
activities |
|
|
|
|
|
Net loss |
$ |
(59,341 |
) |
|
$ |
(42,875 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
Depreciation |
|
5,248 |
|
|
|
3,418 |
|
Amortization |
|
464 |
|
|
|
267 |
|
Share-based compensation expense |
|
12,453 |
|
|
|
7,956 |
|
Realized loss on available-for-sale debt
securities |
|
2,473 |
|
|
|
- |
|
Unrealized foreign exchange gain (losses) |
|
4,921 |
|
|
|
(6,886 |
) |
Other |
|
262 |
|
|
|
606 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
(Increase) decrease in receivables and other
operating assets |
|
(4,140 |
) |
|
|
4,180 |
|
Decrease (increase) in non-current operating
assets |
|
490 |
|
|
|
(484 |
) |
(Decrease) increase in payables and deferred
revenue |
|
(35,533 |
) |
|
|
859 |
|
Net cash used in operating
activities |
|
(72,703 |
) |
|
|
(32,959 |
) |
|
|
|
|
|
|
Cash flows from investing
activities |
|
|
|
|
|
Acquisition of property, plant and
equipment |
|
(3,823 |
) |
|
|
(22,791 |
) |
Acquisition of intangibles |
|
(666 |
) |
|
|
(288 |
) |
Proceeds from disposal of property, plant and
equipment |
|
- |
|
|
|
550 |
|
Maturity of short-term deposits |
|
- |
|
|
|
40,645 |
|
Investment in short-term deposits |
|
- |
|
|
|
(18,000 |
) |
Maturity or redemption of marketable securities |
|
114,988 |
|
|
|
7,032 |
|
Investment in marketable securities |
|
(75,545 |
) |
|
|
(93,218 |
) |
Net cash provided by (used in)
investing activities |
|
34,954 |
|
|
|
(86,070 |
) |
|
|
|
|
|
|
Cash flows from financing
activities |
|
|
|
|
|
Proceeds from issuance of common stock, net of
issuance costs $347 and $4,774 |
|
99,653 |
|
|
|
103,167 |
|
Proceeds from exercise of stock options |
|
2,933 |
|
|
|
401 |
|
Net cash provided by financing
activities |
|
102,586 |
|
|
|
103,568 |
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash,
cash equivalents and restricted cash |
|
4,111 |
|
|
|
2,223 |
|
Net increase (decrease) in cash, cash
equivalents and restricted cash |
|
68,948 |
|
|
|
(13,238 |
) |
Cash, cash equivalents and restricted cash at
start of period |
|
88,296 |
|
|
|
162,796 |
|
Cash, cash equivalents and restricted
cash at end of period |
$ |
157,244 |
|
|
$ |
149,558 |
|
|
|
|
|
|
|
|
|
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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