Adaptimmune Reports Q3 Financial Results and Business Update
November 05 2020 - 7:30AM
Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell
therapy to treat cancer, today reported financial results and
provided a business update for the third quarter ended September
30, 2020.
“Later this month, we will present data at SITC and CTOS. Data
to be presented at SITC from the dose escalation cohorts of our
SURPASS trial confirm that ADP-A2M4CD8 is a highly active agent
across a range of tumors. At CTOS, we will present data regarding
the durability of responses in synovial sarcoma, which support our
ambition to market ADP‑A2M4 in 2022. And finally, at our Investor
Day, I will lay out our broader strategy including the opportunity
we see for our late-stage pipeline,” said Adrian Rawcliffe,
Adaptimmune’s Chief Executive Officer. “Recruitment into our
clinical trials has been steadily recovering following the first
wave of COVID-19 and projected patient numbers currently look good
for the remainder of this year and into 2021.”
PLANNED MILESTONES Q4 2020
- Four posters to be presented at the virtual SITC meeting
(November 9-14)
- Poster entitled “Initial safety, efficacy, and product
attributes from the SURPASS trial with ADP‑A2M4CD8, a SPEAR T-cell
therapy incorporating an affinity optimized TCR targeting MAGE-A4
and a CD8α co-receptor” with an update on the dose escalation
cohorts (6 patients in total)
- Poster entitled “Inhibition of AKT signaling during expansion
of TCR-Engineered T-Cells from patient leukocyte material generates
SPEAR T-Cells with enhanced functional potential in vitro” with
data indicating that AKT inhibition during manufacture of SPEAR
T-cells results in a more consistent expansion and phenotype of the
final product
- Two posters about the previously terminated ADP-A2M10 Phase 1
program: one for the lung cancer trial, and one for the triple
tumor trial in melanoma, urothelial, and head & neck
cancers
- Durability of response data from patients with synovial sarcoma
from the ADP-A2M4 Phase 1 trial to be presented in an oral
presentation at the virtual CTOS conference (“Immunotherapy in
Sarcoma” session on November 19, 2020 from 9 a.m. to 10 a.m.
EST)
- Investor Day to be held on November 20, 2020
CLINICAL UPDATES
- As the management of COVID-19 at clinical sites continues to
evolve, there has been an increase in recruitment and enrollment
during the latter part of Q3 and into Q4 for all ongoing clinical
trials
- SPEARHEAD-1 is recruiting well and remains on target to
complete enrollment in the first half of 2021
- On track to start a Phase 2 trial with ADP-A2M4CD8 in
gastroesophageal cancers (gastric, esophageal, and esophagogastric
junction) in the first half of 2021
- Data update from the Phase 1 ADP-A2AFP trial presented in an
oral presentation and poster, at the International Liver Congress,
confirmed safety profile and demonstrated potential benefit for
patients with hepatocellular carcinoma. Four patients were treated
with ~5 billion or more transduced cells with best responses of one
complete response, one patient with stable disease, and two
patients with progressive disease.
- Presented SPEARHEAD-2 trial-in-progress poster at ESMO
summarizing design for this first combination clinical trial with
ADP-A2M4 and pembrolizumab
Financial Results for the three and nine month periods
ended September 30, 2020
- Cash / liquidity position: As of September 30,
2020, Adaptimmune had cash and cash equivalents of $78.5 million
and Total Liquidity1 of $399.9 million.
- Revenue: Revenue for the three and nine months
ended September 30, 2020 was $1.2 million and $2.5 million,
respectively, compared to $0.2 million and $0.4 million for the
same periods in 2019. Revenue increased due to the commencement of
development activity under the Astellas Collaboration Agreement and
increased development activity under the GSK Collaboration and
License Agreement.
- Research and development (R&D) expenses:
R&D expenses for the three and nine months ended
September 30, 2020 were $24.1 million and $65.8 million,
respectively, compared to $29.6 million and $77.1 million for the
same periods in 2019. R&D expenses were higher in the three and
nine months ended September 30, 2019 due to recognition of accrued
purchase commitment expenses related to the supply of the
Dynabeads® CD3/CD28 technology of $5.0 million and in-process
research and development as a result of entering into a
collaboration agreement with Noile-Immune Biotech, Inc. in August
2019. The nine-month period ended September 30, 2019 also included
$2.0 million of in-process research and development as a result of
entering into a collaboration agreement with Alpine Immune
Sciences, Inc. in May 2019.
- General and administrative (G&A) expenses:
G&A expenses for the three and nine months ended
September 30, 2020 were $13.0 million and $32.6 million,
respectively, compared to $10.7 million and $32.7 million for the
same periods in 2019. The increase in the three months ended
September 30, 2020 was primarily driven by an increase in
professional fees, investment in our IT systems, and costs
associated with the buildout of our commercial capabilities.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three and nine months ended
September 30, 2020 was $35.4 million and $93.5 million,
respectively, and $(0.04) and $(0.11) per ordinary share,
respectively, compared to $39.3 million and $107.8 million and
$(0.06) and $(0.17) per ordinary share for the same periods in
2019.
Financial guidance
The Company believes that its existing cash, cash equivalents
and marketable securities will fund the Company’s current
operations into 2022, as further detailed in the Company’s
Quarterly Report on Form 10-Q for the fiscal quarter ended
September 30, 2020, to be filed with the Securities and Exchange
Commission following this earnings release.
Conference Call and Webcast Information The
Company will host a live teleconference at 8:00 a.m.
EST (1:00 p.m. GMT) today, November 5, 2020. The live
webcast of the conference call will be available in the investor
section 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 Canada) 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 (6183339).
About AdaptimmuneAdaptimmune is a
clinical-stage biopharmaceutical company focused on the development
of novel cancer immunotherapy products for people with cancer. The
Company’s unique SPEAR® (Specific Peptide Enhanced Affinity
Receptor) T-cell platform enables the engineering of T-cells to
target and destroy cancer across multiple solid tumors.
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 SEC on August 6, 2020, 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 (a non-GAAP financial measure) is
the total of cash and cash equivalents and marketable securities.
Each of these components appears separately in the condensed
consolidated balance sheet. The U.S. GAAP financial measure most
directly comparable to Total Liquidity is cash and cash equivalents
as reported in the condensed consolidated financial statements,
which reconciles to Total Liquidity as follows (in millions):
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash and cash equivalents |
|
$ |
78.5 |
|
|
50.4 |
Marketable securities –
available-for-sale debt securities |
|
|
321.4 |
|
|
39.1 |
Total
Liquidity |
|
$ |
399.9 |
|
|
89.5 |
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 |
|
Nine months ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue |
|
$ |
1,193 |
|
|
$ |
237 |
|
|
$ |
2,456 |
|
|
$ |
394 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
(including losses accrued on firm purchase commitments of $0,
$5,000, $0 and $5,000) |
|
|
(24,067 |
) |
|
|
(29,617 |
) |
|
|
(65,791 |
) |
|
|
(77,147 |
) |
General and
administrative |
|
|
(13,001 |
) |
|
|
(10,741 |
) |
|
|
(32,557 |
) |
|
|
(32,662 |
) |
Total operating
expenses |
|
|
(37,068 |
) |
|
|
(40,358 |
) |
|
|
(98,348 |
) |
|
|
(109,809 |
) |
Operating
loss |
|
|
(35,875 |
) |
|
|
(40,121 |
) |
|
|
(95,892 |
) |
|
|
(109,415 |
) |
Interest income |
|
|
2,147 |
|
|
|
615 |
|
|
|
4,024 |
|
|
|
2,324 |
|
Other (expense) income,
net |
|
|
(1,689 |
) |
|
|
291 |
|
|
|
(1,501 |
) |
|
|
(556 |
) |
Loss before income
taxes |
|
|
(35,417 |
) |
|
|
(39,215 |
) |
|
|
(93,369 |
) |
|
|
(107,647 |
) |
Income taxes |
|
|
(15 |
) |
|
|
(87 |
) |
|
|
(110 |
) |
|
|
(154 |
) |
Net loss attributable
to ordinary shareholders |
|
$ |
(35,432 |
) |
|
$ |
(39,302 |
) |
|
$ |
(93,479 |
) |
|
$ |
(107,801 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
928,022,057 |
|
|
|
630,866,800 |
|
|
|
829,973,177 |
|
|
|
629,403,293 |
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands, except share data)
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
78,466 |
|
|
$ |
50,412 |
|
Marketable securities - available-for-sale debt securities |
|
|
321,442 |
|
|
|
39,130 |
|
Other current assets and prepaid expenses (including current
portion of clinical materials) |
|
|
26,825 |
|
|
|
30,947 |
|
Total current
assets |
|
|
426,733 |
|
|
|
120,489 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
4,441 |
|
|
|
4,496 |
|
Clinical materials |
|
|
160 |
|
|
|
2,503 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
|
18,775 |
|
|
|
20,789 |
|
Property, plant and
equipment, net of accumulated depreciation of $28,503 (2019:
$23,649) |
|
|
26,943 |
|
|
|
31,068 |
|
Intangibles, net of
accumulated amortization |
|
|
1,970 |
|
|
|
2,198 |
|
Total
assets |
|
$ |
479,022 |
|
|
$ |
181,543 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,030 |
|
|
$ |
6,357 |
|
Operating lease liabilities, current |
|
|
2,619 |
|
|
|
2,493 |
|
Accrued expenses and other accrued liabilities |
|
|
24,615 |
|
|
|
23,363 |
|
Deferred revenue, current |
|
|
3,635 |
|
|
|
2,128 |
|
Total current
liabilities |
|
|
34,899 |
|
|
|
34,341 |
|
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
|
21,090 |
|
|
|
22,966 |
|
Deferred revenue,
non-current |
|
|
46,212 |
|
|
|
— |
|
Other liabilities,
non-current |
|
|
615 |
|
|
|
598 |
|
Total
liabilities |
|
|
102,816 |
|
|
|
57,905 |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,038,249,630
authorized and 928,525,410 issued and outstanding (2019:
785,857,300 authorized and 631,003,568 issued and
outstanding) |
|
|
1,325 |
|
|
|
943 |
|
Additional paid in capital |
|
|
932,518 |
|
|
|
585,623 |
|
Accumulated other comprehensive loss |
|
|
(8,494 |
) |
|
|
(7,264 |
) |
Accumulated deficit |
|
|
(549,143 |
) |
|
|
(455,664 |
) |
Total stockholders'
equity |
|
|
376,206 |
|
|
|
123,638 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
479,022 |
|
|
$ |
181,543 |
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
September 30, |
|
|
2020 |
|
2019 |
Cash flows from
operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(93,479 |
) |
|
$ |
(107,801 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation |
|
|
5,151 |
|
|
|
5,406 |
|
Amortization |
|
|
718 |
|
|
|
511 |
|
Share-based compensation expense |
|
|
7,352 |
|
|
|
8,495 |
|
Unrealized foreign exchange (gains) losses |
|
|
(1,102 |
) |
|
|
522 |
|
Other |
|
|
2,817 |
|
|
|
(208 |
) |
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
Decrease (increase) in
receivables and other operating assets |
|
|
3,345 |
|
|
|
(20,075 |
) |
Decrease in non-current operating assets |
|
|
2,291 |
|
|
|
1,468 |
|
(Decrease) increase in payables and other current liabilities |
|
|
(117 |
) |
|
|
8,879 |
|
Increase in deferred revenue |
|
|
48,649 |
|
|
|
2,824 |
|
Net cash used in
operating activities |
|
|
(24,375 |
) |
|
|
(99,979 |
) |
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(1,174 |
) |
|
|
(1,425 |
) |
Acquisition of intangibles |
|
|
(496 |
) |
|
|
(1,036 |
) |
Maturity or redemption of marketable securities |
|
|
78,915 |
|
|
|
92,803 |
|
Investment in marketable securities |
|
|
(363,777 |
) |
|
|
(19,080 |
) |
Net cash (used in)
provided by investing activities |
|
|
(286,532 |
) |
|
|
71,262 |
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
334,388 |
|
|
|
— |
|
Proceeds from exercise of stock options |
|
|
5,541 |
|
|
|
366 |
|
Net cash provided by
financing activities |
|
|
339,929 |
|
|
|
366 |
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
|
(1,023 |
) |
|
|
(398 |
) |
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
27,999 |
|
|
|
(28,749 |
) |
Cash, cash equivalents and
restricted cash at start of period |
|
|
54,908 |
|
|
|
72,476 |
|
Cash, cash equivalents
and restricted cash at end of period |
|
$ |
82,907 |
|
|
$ |
43,727 |
|
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez — VP, Communications and Investor RelationsT:
+44 1235 430 583M: +44 7718 453
176Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. — Senior Director, Investor RelationsT: +1
215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com
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.
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