Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell
therapy to treat cancer, today reported financial results for the
fourth quarter and year ended December 31, 2020, and provided
a business update.
“We are building the cell therapy company of the future for
people with cancer. With our ‘2-2-5-2’ by 2025 strategic plan, we
will deliver value with marketed SPEAR T-cell products starting
with ADP-A2M4 for people with synovial sarcoma,” said Adrian
Rawcliffe, Adaptimmune’s Chief Executive Officer. “We completed
enrollment in our SPEARHEAD-1 trial in approximately 12 months
to support our first BLA, which is strong evidence of our ability
to execute rapidly. We are focusing the SURPASS trial, using our
next-generation ADP-A2M4CD8 product, on lung, gastroesophageal,
head and neck, and bladder cancers to identify new indications to
take forward to late-stage development.”
Planned 2021 data updates1
- SPEARHEAD-1 trial with ADP-A2M4 for people with synovial
sarcoma
- June: preliminary data at American Society of Clinical Oncology
(ASCO)
- November: full update at Connective Tissue Oncology Society
(CTOS)
- SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product
targeting MAGE-A4)
- September: update at European Society for Medical Oncology
(ESMO)
- Additional clinical updates
- September: update at International Liver Cancer Association
(ILCA) conference for ADP-A2AFP Phase 1 trial for people with
liver cancer
- October: update at American Society for Radiation Oncology
(ASTRO) for radiation sub-study of the ADP-A2M4 Phase 1 trial2
- November: ADP-A2M4 translational data update at Society for
Immunotherapy of Cancer (SITC)
“2-2-5-2” by 2025 strategic planAt an Investor
Day held in November 2020, the Company outlined its “2-2-5-2” by
2025 strategic plan encompassing:
“2” - Two marketed products targeting
MAGE-A4Estimated potential addressable population in tumor
types with significant MAGE-A4 expression, factored for HLA-A23, is
~39,000 patients per year in the US and EU
Durable responses in synovial sarcoma – on track to file a
Biologics License Application (BLA) for ADP-A2M4 in 2022
- The first commercial opportunity for SPEAR T-cells targeting
MAGE-A4 will be in synovial sarcoma with plans to file a BLA in the
US in 2022
- In 2020, the Company received positive endorsements from
regulatory authorities with Regenerative Medicine Advanced Therapy
(RMAT) designation and Orphan Drug Designation (ODD) in the US, and
access to PRIority MEdicines (PRIME) regulatory support and ODD in
the EU
- Data from the Phase 1 trial with ADP-A2M4 (presented at CTOS
2020)
- In 16 patients with synovial sarcoma, there was an Overall
Response Rate of 44% and a Disease Control Rate of 94%
- Responses were durable with a median duration of response of 28
weeks with ongoing responses beyond 72 weeks in two patients
(median overall survival had not been reached)
- These data are considerably superior4 to response rates
observed with available second line therapies in synovial
sarcoma
SURPASS-2 in esophageal and esophagogastric junction (EGJ)
cancers in 1H 2021
- The Company will initiate a Phase 2 trial, SURPASS-2, with
ADP-A2M4CD8 (next-generation SPEAR T-cells targeting MAGE-A4 that
co-express CD8α intended to increase potency) for patients with
esophageal or EGJ cancers in 1H 2021
- SURPASS-2 is supported by encouraging data from the Phase 1
SURPASS trial (presented at SITC 2020) with one confirmed partial
response (PR) in a patient with EGJ cancer and tumor reductions in
two additional patients (1 with esophageal and 1 with EGJ
cancer)
- The trial will be conducted at multiple centers in North
America and the EU, and is intended to enroll 45 people with
esophageal or EGJ cancers to be treated with doses up to 10 billion
SPEAR T-cells
- The Company also presented preclinical data at SITC 2020
indicating that AKT inhibition during the manufacture of SPEAR
T-cells results in a more consistent expansion and phenotype of the
final product. This process is currently being used for the Phase 1
SURPASS trial.
“2” - Two additional BLAs for SPEAR
T-cell products
- Adaptimmune’s Phase 1 SURPASS trial with ADP-A2M4CD8 continues
to enroll patients, focusing on lung, gastroesophageal, head and
neck, and bladder cancers – indications for which the Company has
reported responses or signs of efficacy with its MAGE-A4 targeted
products
- In 2020, Adaptimmune initiated SPEARHEAD-2 with its
first-generation SPEAR T-cells targeting MAGE-A4 in
combination with pembrolizumab for people with head and neck
cancers
- The Phase 1 trial with ADP-A2AFP for people with liver cancer
is ongoing. As presented at ILC 2020, nine patients were treated as
of the data cut-off and best responses were:
- One patient with a complete response, one with stable
disease (SD), and two with progressive disease (PD) among the four
patients who received ~5 billion or more SPEAR T-cells
- Five patients with SD who received doses of
100 million and 1 billion SPEAR T-cells in the first two dose
cohorts
“5” - Five new autologous products in
the clinic
- Adaptimmune has a deep preclinical pipeline from which it
expects to bring five new products into the clinic.
- These include multiple possibilities for next-generation
autologous SPEAR T-cells such as:
- ADP-A2AFP SPEAR T-cells co-expressing CD8α
- ADP-A2M4 SPEAR T-cells co-expressing IL-7, IL-15, dnTGFβ, and/
or PDE7
- Enhancing SPEAR T-cells with IL-7 for proliferation and
survival and CCL19 for migration into tumor in collaboration with
Noile-Immune Biotech, Inc.
- Enhancing SPEAR T-cells using transmembrane and surface
immunoregulatory mechanisms with Alpine Immune Sciences, Inc.
- The Company is also developing new products, including:
- Expanding into HLAs beyond HLA-A2 to increase the addressable
patient population
- HLA-independent TCR (HiT) candidates for multiple targets
including GPC3
- A new program for next-generation TILs co-expressing IL-7 in
melanoma in collaboration with leading TIL therapy center (CCIT,
Denmark)
“2” - Two allogeneic products in the
clinic
- In January 2020, Adaptimmune announced it had entered into an
agreement to co-develop and co-commercialize stem-cell derived
allogeneic cell therapies with Astellas
- The first target nominated is a HiT targeting mesothelin
- At ASGCT 2020, Adaptimmune presented data with evidence of its
allogeneic platform demonstrating differentiation of functional
T-cells from human-induced pluripotent stem cells (hiPSCs) that can
kill MAGE-A4 expressing target cells in vitro –targeted to become
the Company’s first allogeneic product in the clinic
Corporate updates from 2020
- Despite the impact of the COVID-19 pandemic on the
biotechnology industry, Adaptimmune continued to see improved
enrollment in its clinical trials
- In Q1, the Company received an upfront payment of $50 million
from Astellas. The Company is also entitled to receive research
funding of up to $7.5 million per collaboration target per
year
- Underwritten public offering in Q1 generated net proceeds of
approximately $90 million
- Underwritten public offering in Q2 generated net proceeds of
approximately $244 million
Financial Results for the fourth quarter and year ended
December 31, 2020
- Cash / liquidity position: As of December 31,
2020, Adaptimmune had cash and cash equivalents of $56.9 million
and Total Liquidity5 of $368.2 million.
- Revenue: Revenue for the fourth quarter and
year ended December 31, 2020 was $1.5 million and $4.0 million,
respectively, compared to $0.7 million and $1.1 million for the
same periods in 2019. The increase was due to revenue arising under
the collaboration agreement with Astellas, which was entered into
in January 2020.
- Research and development (R&D) expenses:
R&D expenses for the fourth quarter and year ended December 31,
2020 were $25.8 million and $91.6 million, respectively, compared
to $20.4 million and $97.5 million for the same periods in 2019.
R&D expenses in the year ended December 31, 2019 included the
accrual of a purchase commitment and higher costs for in-process
research and development; excluding the impact of these, research
and development expenses have increased as the Company progresses
development of its cell therapies.
- General and administrative (G&A) expenses:
G&A expenses for the fourth quarter and year ended December 31,
2020 were $13.2 million and $45.8 million, respectively, compared
to $10.7 million and $43.4 million for the same periods in 2019.
The increase in G&A expenses was due to an increase in general
corporate costs, including professional fees and insurance.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the fourth quarter and year ended
December 31, 2020 was $36.6 million and $130.1 million ($(0.15 per
ordinary share), compared to $29.4 million and $137.2 million
($(0.22) per ordinary share) for the same periods in 2019.
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 Annual Report on Form 10-K for the year
ended December 31, 2020, 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. EST (1:00 p.m. GMT) today, February 25, 2021.
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 (2099860).
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 November 5, 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
(available-for-sale debt securities). Each of these components
appears separately in the consolidated balance sheet. The US 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
millions):
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash and cash equivalents |
|
$ |
56,882 |
|
$ |
50,412 |
Marketable securities -
available-for-sale debt securities |
|
|
311,335 |
|
|
39,130 |
Total
Liquidity |
|
$ |
368,217 |
|
$ |
89,542 |
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.
Consolidated Statement of Operations(unaudited,
in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
Year ended |
|
|
December 31, |
|
|
|
|
December 31, |
|
|
2020 |
|
2019 |
|
|
|
|
2020 |
|
2019 |
Revenue |
|
|
1,502 |
|
|
|
728 |
|
|
|
|
|
|
3,958 |
|
|
|
1,122 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
(including losses accrued on firm purchase commitments of $0, $0,
$0 and $5,000) |
|
|
(25,777 |
) |
|
|
(20,354 |
) |
|
|
|
|
|
(91,568 |
) |
|
|
(97,501 |
) |
General and
administrative |
|
|
(13,238 |
) |
|
|
(10,729 |
) |
|
|
|
|
|
(45,795 |
) |
|
|
(43,391 |
) |
Total operating
expenses |
|
|
(39,015 |
) |
|
|
(31,083 |
) |
|
|
|
|
|
(137,363 |
) |
|
|
(140,892 |
) |
Operating
loss |
|
|
(37,513 |
) |
|
|
(30,355 |
) |
|
|
|
|
|
(133,405 |
) |
|
|
(139,770 |
) |
Interest income |
|
|
538 |
|
|
|
448 |
|
|
|
|
|
|
2,313 |
|
|
|
2,772 |
|
Other income (expense),
net |
|
|
414 |
|
|
|
631 |
|
|
|
|
|
|
1,162 |
|
|
|
75 |
|
Loss before income
taxes |
|
|
(36,561 |
) |
|
|
(29,276 |
) |
|
|
|
|
|
(129,930 |
) |
|
|
(136,923 |
) |
Income taxes |
|
|
(52 |
) |
|
|
(88 |
) |
|
|
|
|
|
(162 |
) |
|
|
(242 |
) |
Net loss attributable
to ordinary shareholders |
|
$ |
(36,613 |
) |
|
$ |
(29,364 |
) |
|
|
|
|
$ |
(130,092 |
) |
|
$ |
(137,165 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
$ |
(0.15 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
928,676,161 |
|
|
|
630,994,079 |
|
|
|
|
|
|
854,783,763 |
|
|
|
629,805,218 |
|
Consolidated Balance Sheets(unaudited, in
thousands, except share data)
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
56,882 |
|
|
$ |
50,412 |
|
Marketable securities - available-for-sale debt securities |
|
|
311,335 |
|
|
|
39,130 |
|
Accounts receivable, net of allowance for doubtful accounts of $0
and $0 |
|
|
139 |
|
|
|
— |
|
Other current assets and prepaid expenses (including current
portion of clinical materials) |
|
|
29,796 |
|
|
|
30,947 |
|
Total current
assets |
|
|
398,152 |
|
|
|
120,489 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
4,602 |
|
|
|
4,496 |
|
Clinical materials |
|
|
— |
|
|
|
2,503 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
|
18,880 |
|
|
|
20,789 |
|
Property, plant and
equipment, net of accumulated depreciation |
|
|
27,778 |
|
|
|
31,068 |
|
Intangibles, net of
accumulated amortization |
|
|
1,730 |
|
|
|
2,198 |
|
Total
assets |
|
$ |
451,142 |
|
|
$ |
181,543 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,389 |
|
|
$ |
6,357 |
|
Operating lease liabilities, current |
|
|
2,773 |
|
|
|
2,493 |
|
Accrued expenses and other accrued liabilities |
|
|
27,079 |
|
|
|
23,363 |
|
Deferred revenue, current |
|
|
2,832 |
|
|
|
2,128 |
|
Total current
liabilities |
|
|
39,073 |
|
|
|
34,341 |
|
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
|
20,938 |
|
|
|
22,966 |
|
Deferred revenue,
non-current |
|
|
49,260 |
|
|
|
— |
|
Other liabilities,
non-current |
|
|
644 |
|
|
|
598 |
|
Total
liabilities |
|
|
109,915 |
|
|
|
57,905 |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,038,249,630
authorized and 928,754,958 issued and outstanding (2019:
785,857,300 authorized and 631,003,568 issued and
outstanding) |
|
|
1,325 |
|
|
|
943 |
|
Additional paid in capital |
|
|
935,706 |
|
|
|
585,623 |
|
Accumulated other comprehensive loss |
|
|
(10,048 |
) |
|
|
(7,264 |
) |
Accumulated deficit |
|
|
(585,756 |
) |
|
|
(455,664 |
) |
Total stockholders'
equity |
|
|
341,227 |
|
|
|
123,638 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
451,142 |
|
|
$ |
181,543 |
|
Consolidated Cash Flow Statement(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
Year ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash flows from
operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(130,092 |
) |
|
$ |
(137,165 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation |
|
|
6,627 |
|
|
|
7,172 |
|
Amortization |
|
|
967 |
|
|
|
838 |
|
Share-based compensation expense |
|
|
10,414 |
|
|
|
11,053 |
|
Unrealized foreign exchange (gains) losses |
|
|
(1,333 |
) |
|
|
1,076 |
|
Amortization (accretion) on available-for-sale debt securities |
|
|
3,836 |
|
|
|
(185 |
) |
Other |
|
|
(55 |
) |
|
|
(13 |
) |
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
Decrease (increase) in receivables and other operating assets |
|
|
1,747 |
|
|
|
(1,436 |
) |
Decrease (increase) in non-current operating assets |
|
|
2,458 |
|
|
|
(1,450 |
) |
Increase (decrease) in payables and other liabilities |
|
|
3,867 |
|
|
|
5,508 |
|
Increase (decrease) in deferred revenue |
|
|
47,973 |
|
|
|
2,095 |
|
Net cash used in
operating activities |
|
|
(53,591 |
) |
|
|
(112,507 |
) |
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(2,341 |
) |
|
|
(1,592 |
) |
Acquisition of intangibles |
|
|
(565 |
) |
|
|
(1,482 |
) |
Maturity or redemption of marketable securities |
|
|
105,022 |
|
|
|
125,303 |
|
Investment in marketable securities |
|
|
(381,040 |
) |
|
|
(27,284 |
) |
Net cash (used in)
provided by investing activities |
|
|
(278,924 |
) |
|
|
94,945 |
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
Proceeds from issuance of shares in the January offering |
|
|
78,616 |
|
|
|
— |
|
Proceeds from issuance of shares upon exercise of the overallotment
for the January Offering |
|
|
11,938 |
|
|
|
— |
|
Proceeds from issuance of shares in the June Offering |
|
|
209,986 |
|
|
|
— |
|
Proceeds from issuance of shares upon exercise of the overallotment
for the June Offering |
|
|
33,848 |
|
|
|
— |
|
Proceeds from exercise of stock options |
|
|
5,663 |
|
|
|
366 |
|
Net cash provided by
financing activities |
|
|
340,051 |
|
|
|
366 |
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
|
(960 |
) |
|
|
(372 |
) |
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
6,576 |
|
|
|
(17,568 |
) |
Cash, cash equivalents and
restricted cash at start of period |
|
|
54,908 |
|
|
|
72,476 |
|
Cash, cash equivalents
and restricted cash at end of period |
|
$ |
61,484 |
|
|
$ |
54,908 |
|
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 All data updates subject to congress acceptance2 The main
portion of the ADP-A2M4 Phase 1 trial is closed for enrollment 3
Mortality figures based on American Cancer Society 2020 (US) and
Global Can (EU) – synovial sarcoma data based on internal market
research; MAGE-A4 expression ranges based on Adaptimmune samples
and expression cut-off criteria of ≥30% tumor cells at ≥2+
intensity; HLA-A2 expression of 41% based on Adaptimmune samples
(1,043 patient samples); serum AFP expression ranges based on
internal samples (62 patients) and expression cut off >100ng/mL4
Pollack S, et al. Cancer Medicine. 2020; 9:4593–4602; Seto T, et al
Med. Sci. 2019, 7, 48; van der Graaf WT, et al. 2012, Lancet,
379(9829), 1879-18865 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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Adaptimmune Therapeutics (NASDAQ:ADAP)
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