Adaptimmune Reports First Quarter Financial Results and Business Update
May 06 2021 - 7:30AM
Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell
therapy to treat cancer, today reported financial results for the
first quarter ended March 31, 2021 and provided a business
update.
“We will present initial data at ASCO from our SPEARHEAD-1 trial
that will support BLA submission in 2022. We have seen good
enrollment in the SURPASS and ADP-A2AFP trials and will present
data later this year,” said Adrian Rawcliffe, Adaptimmune’s Chief
Executive Officer. “We continue to deliver against our ambitions
laid out in our 2-2-5-2 strategic plan to bring products forward
for clinical development and launch. At ASGCT next week, we will
present preclinical data from our first HiT product targeting
mesothelin. Results indicate that this HiT works as well or better
than similar cell therapy constructs targeting the same antigen in
in vitro killing assays as well as an animal model.”
Upcoming confirmed data updates
- Data from the Company’s HiT mesothelin program, being
co-developed with Astellas, to be presented at the American Society
of Gene & Cell Therapy (ASGCT), in a poster presentation that
will be available on the conference’s website May 11 at 8:00 a.m.
EDT
- Important progress towards achievement of preclinical pipeline
milestones laid out in the Company’s strategic five-year “2-2-5-2”
product development plan presented at Investor Day in November
2020
- Preclinical data validate that human T-cells expressing a TCR
that targets mesothelin independent of peptide-HLA recognition, can
kill human tumor cells
- Presentation will include animal model data that demonstrate
superiority of the Company’s HiT targeting mesothelin over a
comparator T-cell therapy construct targeting the same antigen in
an in vivo tumor xenograft study
- This product was nominated by Astellas as the first candidate
under the agreement to co-develop and co-commercialize iPSc
(stem-cell) derived allogeneic CAR-T and TCR T-cell therapies
- Oral presentation of initial data from the SPEARHEAD-1 trial
with afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) for
people with synovial sarcoma and MRCLS at the American Society of
Clinical Oncology (ASCO) on June 4th during the Sarcoma Session
starting at 1:30 p.m. EDT (abstract # 11504)
- At time of data cut-off for the abstract1, 32 patients had
received afami-cel. Twenty-five patients were evaluable for
preliminary efficacy and 7 patients had insufficient
follow-up
- On May 19, 2021 at 5:00 p.m. EDT,
abstracts will be released on ASCO's Meeting Library and the
Company plans to issue a press release2
- The Phase 2 SPEARHEAD-1 trial was initiated after promising
results from the Phase 1 trial showed durable responses with
afami-cel in synovial sarcoma with confirmed responses in 44% of
patients, disease control rate of 94%, and median duration of
response of 28 weeks presented at CTOS 2020
- The Company will submit an abstract with a further update for
consideration at CTOS 2021
Planned data updates 3
- SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product
targeting MAGE-A4) at European Society for Medical Oncology
(ESMO) in September
- ADP-A2AFP Phase 1 trial for people with liver cancer at the
International Liver Cancer Association (ILCA) in September
- Radiation sub-study of the ADP-A2M4 Phase 1 trial at
American Society for Radiation Oncology (ASTRO) in October
- Afami-cel translational data update at Society for
Immunotherapy of Cancer (SITC) in November
Other Corporate News
- Astellas has nominated the second
target as part of the co-development and co-commercialization
agreement signed with Adaptimmune in January 2020
Financial Results for the first quarter ended March 31,
2021
- Cash / liquidity position: As of March 31,
2021, Adaptimmune had cash and cash equivalents of $32.4 million
and Total Liquidity4 of $317.9 million.
- Revenue: Revenue for the first quarter ended
March 31, 2021 was $0.4 million, compared to $0.8 million for the
same period in 2020.
- Research and development (R&D) expenses:
R&D expenses for the first quarter ended March 31, 2021 were
$24.5 million compared to $21.3 million for the same period in
2020. R&D expenses increased in the quarter ended March 31,
2021 due to an increase in the number of employees engaged in
research and development, and increases in costs related to the
development of a companion diagnostic assay and our Phase 2
clinical trial associated with ADP-A2M4CD8. These increases were
offset by an increase in reimbursements receivable for research and
development tax and expenditure credits.
- General and administrative (G&A) expenses:
G&A expenses for the first quarter ended March 31, 2021 were
$13.8 million compared to $9.3 million for the same period in 2020
due to an increase in share-based compensation expense and an
increase in employee related costs.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the first quarter ended March 31,
2021 was $37.8 million ($(0.04 per ordinary share), compared to
$28.2 million ($(0.04) per ordinary share) for the same period
in 2020.
Financial GuidanceThe Company believes that its
existing cash, cash equivalents and marketable securities will fund
the Company’s current operations into early 2023, as further
detailed in the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2021, 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 9:00 a.m. EDT (2:00 p.m. BST) today, May 6, 2021. A live
webcast of the conference call and replay can be accessed at
https://bit.ly/2Ry9DdR. 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 (9271335).
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 (SEC) on
February 25, 2021 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
(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, |
|
2021 |
|
2020 |
Cash and cash equivalents |
$ |
32,432 |
|
$ |
56,882 |
Marketable securities -
available-for-sale debt securities |
|
285,512 |
|
|
311,335 |
Total
Liquidity |
$ |
317,944 |
|
$ |
368,217 |
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 liquidity,
financial flexibility, capital structure and leverage.
Condensed Consolidated Statement of
Operations(unaudited, in thousands, except per share
data)
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2021 |
|
|
2020 |
|
|
Revenue |
|
$ |
434 |
|
|
$ |
761 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
|
(24,506 |
) |
|
|
(21,264 |
) |
|
General and
administrative |
|
|
(13,817 |
) |
|
|
(9,261 |
) |
|
Total operating
expenses |
|
|
(38,323 |
) |
|
|
(30,525 |
) |
|
Operating
loss |
|
|
(37,889 |
) |
|
|
(29,764 |
) |
|
Interest income |
|
|
425 |
|
|
|
730 |
|
|
Other (expense) income,
net |
|
|
(1 |
) |
|
|
937 |
|
|
Loss before income
taxes |
|
|
(37,465 |
) |
|
|
(28,097 |
) |
|
Income taxes |
|
|
(298 |
) |
|
|
(70 |
) |
|
Net loss attributable
to ordinary shareholders |
|
$ |
(37,763 |
) |
|
$ |
(28,167 |
) |
|
|
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
|
931,088,810 |
|
|
|
739,753,371 |
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands, except share data)
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
32,432 |
|
|
$ |
56,882 |
|
Marketable securities - available-for-sale debt securities |
|
285,512 |
|
|
|
311,335 |
|
Other current assets and prepaid expenses |
|
41,349 |
|
|
|
29,935 |
|
Total current
assets |
|
359,293 |
|
|
|
398,152 |
|
|
|
|
|
|
|
Restricted cash |
|
4,604 |
|
|
|
4,602 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
18,326 |
|
|
|
18,880 |
|
Property, plant and
equipment, net of accumulated depreciation of $32,703 (2020:
$31,097) |
|
27,739 |
|
|
|
27,778 |
|
Intangibles, net of
accumulated amortization |
|
1,619 |
|
|
|
1,730 |
|
Total
assets |
$ |
411,581 |
|
|
$ |
451,142 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
4,116 |
|
|
$ |
6,389 |
|
Operating lease liabilities, current |
|
2,845 |
|
|
|
2,773 |
|
Accrued expenses and other accrued liabilities |
|
22,263 |
|
|
|
27,079 |
|
Deferred revenue, current |
|
2,083 |
|
|
|
2,832 |
|
Total current
liabilities |
|
31,307 |
|
|
|
39,073 |
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
19,897 |
|
|
|
20,938 |
|
Deferred revenue,
non-current |
|
50,565 |
|
|
|
49,260 |
|
Other liabilities,
non-current |
|
655 |
|
|
|
644 |
|
Total
liabilities |
|
102,424 |
|
|
|
109,915 |
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,038,249,630
authorized and 932,817,168 issued and outstanding (2020:
1,038,249,630 authorized and 928,754,958 issued and
outstanding) |
|
1,331 |
|
|
|
1,325 |
|
Additional paid in capital |
|
941,569 |
|
|
|
935,706 |
|
Accumulated other comprehensive loss |
|
(10,224 |
) |
|
|
(10,048 |
) |
Accumulated deficit |
|
(623,519 |
) |
|
|
(585,756 |
) |
Total stockholders'
equity |
|
309,157 |
|
|
|
341,227 |
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
$ |
411,581 |
|
|
$ |
451,142 |
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
|
Cash flows from
operating activities |
|
|
|
|
|
|
Net loss |
$ |
(37,763 |
) |
|
$ |
(28,167 |
) |
|
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation |
|
1,436 |
|
|
|
1,711 |
|
|
Share-based compensation expense |
|
5,334 |
|
|
|
1,448 |
|
|
Unrealized foreign exchange losses (gains) |
|
1,249 |
|
|
|
(1,745 |
) |
|
Amortization on available-for-sale debt securities |
|
1,499 |
|
|
|
150 |
|
|
Other |
|
1,299 |
|
|
|
175 |
|
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
Increase in receivables and other operating assets |
|
(11,155 |
) |
|
|
(3,193 |
) |
|
Increase in non-current operating assets |
|
— |
|
|
|
(259 |
) |
|
Decrease in payables and other current liabilities |
|
(8,601 |
) |
|
|
(2,708 |
) |
|
Increase in deferred revenue |
|
162 |
|
|
|
49,445 |
|
|
Net cash (used in)
provided by operating activities |
|
(46,540 |
) |
|
|
16,857 |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
(1,152 |
) |
|
|
(192 |
) |
|
Acquisition of intangibles |
|
(133 |
) |
|
|
(152 |
) |
|
Maturity or redemption of marketable securities |
|
84,646 |
|
|
|
26,364 |
|
|
Investment in marketable securities |
|
(61,599 |
) |
|
|
(97,967 |
) |
|
Net cash provided by
(used in) investing activities |
|
21,762 |
|
|
|
(71,947 |
) |
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
— |
|
|
|
90,550 |
|
|
Proceeds from exercise of stock options |
|
534 |
|
|
|
894 |
|
|
Net cash provided by
financing activities |
|
534 |
|
|
|
91,444 |
|
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
(204 |
) |
|
|
(502 |
) |
|
Net (decrease) increase in
cash, cash equivalents and restricted cash |
|
(24,448 |
) |
|
|
35,852 |
|
|
Cash, cash equivalents and
restricted cash at start of period |
|
61,484 |
|
|
|
54,908 |
|
|
Cash, cash equivalents
and restricted cash at end of period |
$ |
37,036 |
|
|
$ |
90,760 |
|
|
|
|
|
|
|
|
|
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 Data cut-off for the abstract was February 4, 2021. 2 “Once an
abstract has been publicly released by ASCO and the embargo has
lifted, authors and research sponsors may widely distribute a press
release containing the full data, including any additional or
updated data that will be presented at the meeting even if not
included in the abstract itself.” (https://bit.ly/3dHgOcn) 3 All
data updates subject to congress acceptance4 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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