Adaptimmune Reports First Quarter Financial Results and Business Update
09 Mai 2022 - 1:30PM
Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell
therapy to treat cancer, today reported financial results for the
first quarter ended March 31, 2022 and provided a business update.
“We have four clear areas of focus this year: to file the BLA
for afami-cel, continue to build our MAGE-A4 franchise, scale up
our manufacturing capabilities, and continue to advance our
allogeneic products. We have made good progress with each in 2022,”
said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. “We
remain funded into early 2024 and will continue to execute across
these objectives.”
Roadmap to BLA submission for
afami-cel1 in 2022
(first-generation product targeting MAGE-A4)
- Adaptimmune is preparing the BLA and targeting submission to
the US Food and Drug Administration (FDA) in Q4 2022 for the
treatment of synovial sarcoma.
- Updated data based on pooled analyses of characteristics
associated with clinical responses from Cohort 1 of the SPEARHEAD-1
trial and the Phase 1 trial of afami-cel in patients with advanced
synovial sarcoma or myxoid/round cell liposarcoma to be presented
in a poster at ASCO.
Preclinical data at the American Society for Cell and
Gene Therapy (ASGCT) annual conference
- Preclinical data from the next-generation SPEAR T-cell
targeting MAGE-A4 incorporating IL-7 and CCL19 (ADP-A2M4N7X19),
developed in collaboration with Noile-Immune, to be presented in a
poster; the Company plans to file an IND for this next-generation
SPEAR T-cell later this year.
- Preclinical data from tumor-infiltrating lymphocytes (TILs)
incorporating IL-7 (TIL-IL7), being developed in collaboration with
the Center for Cancer Immune Therapy in Denmark, to be presented in
a poster; a single-center clinical trial is planned for initiation
in 2022.
CorporateThe Company appointed Dr. Joanna (Jo)
Brewer as its Chief Scientific Officer effective May 4;
Dr. Brewer previously served as the Company’s SVP Allogeneic
Research.
Financial Results for the three months ended March 31,
2022
- Cash / liquidity position: As of March 31,
2022, Adaptimmune had cash and cash equivalents of $89.5 million
and Total Liquidity2 of $304.2 million, compared to $149.9 million
and $369.6 million, respectively, as of December 31, 2021.
- Revenue: Revenue for the three months ended
March 31, 2022 was $3.6 million, compared to $0.4 million for the
same period in 2021. Revenue has increased primarily due to an
increase in development activities under our collaboration
arrangements.
- Research and development (R&D) expenses:
R&D expenses for the three months ended March 31, 2022 were
$36.8 million, compared to $24.5 million for the same period in
2021. R&D expenses increased due to an increase in the number
of employees engaged in research and development, increases in
subcontracted expenditures, increases in in-process research and
development costs and a decrease in reimbursements receivable for
research and development tax and expenditure credits.
- General and administrative (G&A) expenses:
G&A expenses for the three months ended March 31, 2022 were
$16.8 million, compared to $13.8 million for the same period in
2021 due to increases in employee-related costs and other corporate
costs.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three months ended March 31,
2022 was $50.3 million ($(0.05) per ordinary share), compared to
$37.8 million ($(0.04) per ordinary share) for the same period in
2021.
Financial GuidanceThe Company believes that its
existing cash, cash equivalents and marketable securities, together
with the additional payments under the Strategic Collaboration and
License Agreement with Genentech, will fund the Company’s current
operations into early 2024, as further detailed in the Company’s
Quarterly Report on Form 10-Q for the three months ended March 31,
2022, to be filed with the Securities and Exchange Commission
following this earnings release.
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, 2022. 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 (833) 652-5917 (US 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 (6779362).
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 Annual Report on Form
10-K filed with the Securities and Exchange Commission for the year
ended December 31, 2021, our Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K, and other filings with the Securities
and Exchange Commission. 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.
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez — VP, Corporate Affairs and CommunicationsT:
+44 1235 430 583M: +44 7718 453
176Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. — VP, Investor RelationsT: +1 215 825
9310M: +1 215 460 8920Juli.Miller@adaptimmune.com
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
(available-for-sale debt 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):
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
Cash and cash equivalents |
|
$ |
89,539 |
|
$ |
149,948 |
Marketable securities -
available-for-sale debt securities |
|
|
214,679 |
|
|
219,632 |
Total
Liquidity |
|
$ |
304,218 |
|
$ |
369,580 |
The Company believes that the presentation of Total Liquidity
provides useful information to investors because management reviews
Total Liquidity as part of its assessment of overall solvency and
liquidity, financial flexibility, capital position and
leverage.
Condensed Consolidated Statement of
Operations(unaudited, in thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
Revenue |
|
$ |
3,575 |
|
|
$ |
434 |
|
Operating
expenses |
|
|
|
|
|
|
Research and development |
|
|
(36,752 |
) |
|
|
(24,506 |
) |
General and
administrative |
|
|
(16,804 |
) |
|
|
(13,817 |
) |
Total operating
expenses |
|
|
(53,556 |
) |
|
|
(38,323 |
) |
Operating
loss |
|
|
(49,981 |
) |
|
|
(37,889 |
) |
Interest income |
|
|
338 |
|
|
|
425 |
|
Other income (expense),
net |
|
|
12 |
|
|
|
(1 |
) |
Loss before income tax
expense |
|
|
(49,631 |
) |
|
|
(37,465 |
) |
Income tax expense |
|
|
(634 |
) |
|
|
(298 |
) |
Net loss attributable
to ordinary shareholders |
|
$ |
(50,265 |
) |
|
$ |
(37,763 |
) |
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
Basic and diluted |
|
|
940,029,247 |
|
|
|
931,088,810 |
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands, except share data)
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
89,539 |
|
|
$ |
149,948 |
|
Marketable securities - available-for-sale debt securities |
|
|
214,679 |
|
|
|
219,632 |
|
Accounts receivable, net of allowance for doubtful accounts of $0
and $0 |
|
|
1,826 |
|
|
|
752 |
|
Other current assets and prepaid expenses |
|
|
53,417 |
|
|
|
45,126 |
|
Total current
assets |
|
|
359,461 |
|
|
|
415,458 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
1,716 |
|
|
|
1,718 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
|
21,145 |
|
|
|
20,875 |
|
Property, plant and
equipment, net of accumulated depreciation of $36,671 and
$36,253 |
|
|
36,689 |
|
|
|
30,494 |
|
Intangible assets, net of
accumulated amortization of $4,209 and $4,051 |
|
|
788 |
|
|
|
1,000 |
|
Total
assets |
|
$ |
419,799 |
|
|
$ |
469,545 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,017 |
|
|
$ |
8,113 |
|
Operating lease liabilities, current |
|
|
2,735 |
|
|
|
2,320 |
|
Accrued expenses and other current liabilities |
|
|
31,627 |
|
|
|
29,909 |
|
Deferred revenue, current |
|
|
24,772 |
|
|
|
22,199 |
|
Total current
liabilities |
|
|
66,151 |
|
|
|
62,541 |
|
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
|
23,220 |
|
|
|
23,148 |
|
Deferred revenue,
non-current |
|
|
166,613 |
|
|
|
177,223 |
|
Other liabilities,
non-current |
|
|
670 |
|
|
|
673 |
|
Total
liabilities |
|
|
256,654 |
|
|
|
263,585 |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,240,853,520
authorized and 940,866,006 issued and outstanding (2021:
1,240,853,520 authorized and 937,547,934 issued and
outstanding) |
|
|
1,342 |
|
|
|
1,337 |
|
Additional paid in capital |
|
|
965,227 |
|
|
|
959,611 |
|
Accumulated other comprehensive loss |
|
|
(9,313 |
) |
|
|
(11,142 |
) |
Accumulated deficit |
|
|
(794,111 |
) |
|
|
(743,846 |
) |
Total stockholders'
equity |
|
|
163,145 |
|
|
|
205,960 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
419,799 |
|
|
$ |
469,545 |
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
Cash flows from
operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(50,265 |
) |
|
$ |
(37,763 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation |
|
|
1,386 |
|
|
|
1,436 |
|
Amortization |
|
|
209 |
|
|
|
— |
|
Share-based compensation expense |
|
|
5,586 |
|
|
|
5,334 |
|
Unrealized foreign exchange (gains)/losses |
|
|
(244 |
) |
|
|
1,249 |
|
Amortization on available-for-sale debt securities |
|
|
999 |
|
|
|
1,499 |
|
Other |
|
|
220 |
|
|
|
1,299 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
Increase in receivables and other operating assets |
|
|
(10,759 |
) |
|
|
(11,155 |
) |
Increase/ (decrease) in payables and other current liabilities |
|
|
964 |
|
|
|
(8,601 |
) |
(Decrease)/ increase in deferred revenue |
|
|
(2,497 |
) |
|
|
162 |
|
Net cash used in
operating activities |
|
|
(54,401 |
) |
|
|
(46,540 |
) |
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(7,114 |
) |
|
|
(1,152 |
) |
Acquisition of intangible assets |
|
|
— |
|
|
|
(133 |
) |
Maturity or redemption of marketable securities |
|
|
44,536 |
|
|
|
84,646 |
|
Investment in marketable securities |
|
|
(42,197 |
) |
|
|
(61,599 |
) |
Net cash (used in)/
provided by investing activities |
|
|
(4,775 |
) |
|
|
21,762 |
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
35 |
|
|
|
534 |
|
Net cash provided by
financing activities |
|
|
35 |
|
|
|
534 |
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
|
(1,270 |
) |
|
|
(204 |
) |
Net decrease in cash, cash
equivalents and restricted cash |
|
|
(60,411 |
) |
|
|
(24,448 |
) |
Cash, cash equivalents and
restricted cash at start of period |
|
|
151,666 |
|
|
|
61,484 |
|
Cash, cash equivalents
and restricted cash at end of period |
|
$ |
91,255 |
|
|
$ |
37,036 |
|
|
|
|
|
|
|
|
1 Afamitresgene autoleucel “afami-cel” (formerly ADP-A2M4)2
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
Adaptimmune Therapeutics (NASDAQ:ADAP)
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