Adaptimmune Reports Q2 Financial Results and Business Update
August 06 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 second quarter ended June 30,
2020.
“We reported responses in multiple solid tumor types during the
second quarter of 2020 demonstrating the potential of
SPEAR T‑cells to deliver benefit to people with cancer. We
also raised capital, placing us in a solid financial position to
continue executing on our strategic plans,” said Adrian Rawcliffe,
Adaptimmune’s Chief Executive Officer. “Despite the impact of the
COVID-19 pandemic on the biotech industry, we made good progress in
our preparations toward launching our first product in the US in
2022 for patients with sarcoma, whilst initiating and planning new
Phase 2 clinical trials. However, as we enter the second half of
the year, we expect COVID-19 to continue to have an impact and are
monitoring this evolving situation closely.”
PLANNED MILESTONES 2H 2020
- Update on ADP-A2AFP Phase 1 trial at the International Liver
Congress to be held virtually from August 27 to 29- An oral
presentation entitled “Data from the third dose cohort of an
ongoing study with ADP‑A2AFP SPEAR T-cells” will be presented by
Dr. Bruno Sangro of Clinica Universidad de Navarra- A poster
summarizing data from the first two cohorts of the ADP-A2AFP Phase
1 trial will be presented by Dr. Tim Meyer of University College
London
- Updates on dose escalation cohorts from the SURPASS trial at a
medical conference
- Durability and translational data from patients with synovial
sarcoma from the ADP-A2M4 Phase 1 trial at a medical
conference
- Investor Day to be held on November 20, 2020
CLINICAL
UPDATES
- With timeline continuing to support 2022 launch in the US,
enrollment in the Phase 2 SPEARHEAD-1 trial of ADP-A2M4, for
patients with synovial sarcoma or myxoid / round cell liposarcoma
(MRCLS), continues to progress
- The evolving COVID-19 pandemic continues to have an impact on
clinical trials varying site-by-site and among countries
- Phase 1 trials (ADP-A2AFP, radiation sub-study, and SURPASS)
continue and patients are being enrolled and treated
- First site has been initiated and has started screening
patients for the SPEARHEAD-2 Phase 2 clinical trial, combining
ADP‑A2M4 with pembrolizumab for people with head and neck
cancer
- Protocol design for the Phase 2 trial with ADP-A2M4CD8 in
gastroesophageal cancers has commenced and sites are being
identified. The Company plans to initiate this trial in the first
half of 2021
PROGRESS TOWARD GOAL OF LAUNCHING ADP-A2M4 IN SARCOMA IN
THE US IN 2022
- Granted access to PRIME regulatory support by the EMA further
confirming the potential of ADP‑A2M4 to treat people with advanced
sarcoma, along with the previously granted Orphan Drug Designation
(ODD) in Europe, as well as the FDA’s ODD and Regenerative Medicine
Advanced Therapy designation
MANUFACTURING AND SUPPLY
- The Company has focused on manufacturing SPEAR T-cells for
patients in the SPEARHEAD-1 trial and increasing capacity to
provide for all ongoing and planned trials
- Scaling up personnel, manufacturing processes and IT systems,
and optimizing space in our Navy Yard facility in preparation for
commercial launch in sarcoma
- Following receipt of a Certificate of GMP Compliance from the
MHRA for its vector manufacturing operations in July, the Company
began using lentiviral vector produced in-house at its dedicated
manufacturing space within the Cell and Gene Therapy Catapult
Manufacturing Centre at Stevenage, UK for select clinical
trials
FUNDING
- Underwritten public offering closed on June 4, 2020
generating net proceeds of approximately $244 million
Financial Results for the three and six month periods
ended June 30, 2020
- Cash / liquidity position: As of June 30,
2020, Adaptimmune had cash and cash equivalents of $122.4 million
and Total Liquidity1 of $419.0 million.
- Revenue: Revenue for the three and six months
ended June 30, 2020 was $0.5 million and $1.3 million,
respectively, compared to $0.2 million for both of the same periods
in 2019. The increase in revenue is mainly due to further
development of the third target nominated by GSK under the GSK
Collaboration and License Agreement.
- Research and development (R&D) expenses:
R&D expenses for the three and six months ended June 30,
2020 were $20.5 million and $41.7 million, respectively, compared
to $25.5 million and $47.5 million for the same periods in 2019.
The decreases in both periods are primarily due to lower
development costs brought about by COVID-19 delays, a reduction in
the average number of employees engaged in research and
development, and in-process research and development costs of $2.0m
in 2019 as a result of entering into a collaboration agreement with
Alpine Immune Sciences, Inc.
- General and administrative (G&A) expenses:
G&A expenses for the three and six months ended June 30,
2020 were $10.3 million and $19.6 million, respectively, compared
to $10.1 million and $21.9 million for the same periods in 2019.
The decrease in the six months ended June 30, 2020 was primarily
driven by reduced travel costs and share-based compensation
expense, partially offset by an increase in costs associated with
commercialization. We expect that our general and administrative
expenses will increase in the future as we expand our operations
and move towards commercial launch.
- Other (expense) income, net: Other (expense)
income, net for the three and six months ended June 30, 2020 was an
expense of $0.7 million and income of $0.2 million, respectively,
compared to expenses of $6.3 million and $0.8 million for the same
periods in 2019. Other (expense) income, net primarily comprises
unrealized foreign exchange movements, which fluctuate depending on
exchange rates and the amount of foreign currency assets and
liabilities.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three and six months
ended June 30, 2020 was $29.9 million and $58.0 million,
respectively, and $(0.04) and $(0.07) per ordinary share,
respectively, compared to $41.1 million and $68.5 million and
$(0.07) and $(0.11) 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 June 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.
EDT (1:00 p.m. BST) today, August 6, 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 (5488705).
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 May 14, 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):
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Cash and cash equivalents |
|
$ |
122.4 |
|
$ |
50.4 |
Marketable securities |
|
|
296.6 |
|
|
39.1 |
Total
Liquidity |
|
$ |
419.0 |
|
$ |
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 |
|
Six months ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
Revenue |
|
$ |
502 |
|
|
$ |
157 |
|
|
$ |
1,263 |
|
|
$ |
157 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(20,460 |
) |
|
|
(25,511 |
) |
|
|
(41,724 |
) |
|
|
(47,530 |
) |
|
General and
administrative |
|
|
(10,295 |
) |
|
|
(10,148 |
) |
|
|
(19,556 |
) |
|
|
(21,921 |
) |
|
Total operating
expenses |
|
|
(30,755 |
) |
|
|
(35,659 |
) |
|
|
(61,280 |
) |
|
|
(69,451 |
) |
|
Operating
loss |
|
|
(30,253 |
) |
|
|
(35,502 |
) |
|
|
(60,017 |
) |
|
|
(69,294 |
) |
|
Interest income |
|
|
1,147 |
|
|
|
757 |
|
|
|
1,877 |
|
|
|
1,709 |
|
|
Other (expense) income,
net |
|
|
(749 |
) |
|
|
(6,277 |
) |
|
|
188 |
|
|
|
(847 |
) |
|
Loss before income
taxes |
|
|
(29,855 |
) |
|
|
(41,022 |
) |
|
|
(57,952 |
) |
|
|
(68,432 |
) |
|
Income taxes |
|
|
(25 |
) |
|
|
(65 |
) |
|
|
(95 |
) |
|
|
(67 |
) |
|
Net loss attributable
to ordinary shareholders |
|
$ |
(29,880 |
) |
|
$ |
(41,087 |
) |
|
$ |
(58,047 |
) |
|
$ |
(68,499 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
822,725,556 |
|
|
|
629,355,975 |
|
|
|
781,235,457 |
|
|
|
628,655,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands, except share data)
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
122,359 |
|
|
$ |
50,412 |
|
Marketable securities - available-for-sale debt securities |
|
|
296,629 |
|
|
|
39,130 |
|
Other current assets and prepaid expenses (including current
portion of clinical materials) |
|
|
39,099 |
|
|
|
30,947 |
|
Total current assets |
|
|
458,087 |
|
|
|
120,489 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
4,324 |
|
|
|
4,496 |
|
Clinical materials |
|
|
1,744 |
|
|
|
2,503 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
|
18,892 |
|
|
|
20,789 |
|
Property, plant and
equipment, net of accumulated depreciation of $26,100 (2019:
$23,649) |
|
|
27,020 |
|
|
|
31,068 |
|
Intangibles, net of
accumulated amortization |
|
|
2,134 |
|
|
|
2,198 |
|
Total
assets |
|
$ |
512,201 |
|
|
$ |
181,543 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
|
8,766 |
|
|
|
6,357 |
|
Operating lease liabilities, current |
|
|
2,493 |
|
|
|
2,493 |
|
Accrued expenses and other accrued liabilities |
|
|
23,836 |
|
|
|
23,363 |
|
Deferred revenue, current |
|
|
3,464 |
|
|
|
2,128 |
|
Total current liabilities |
|
|
38,559 |
|
|
|
34,341 |
|
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
|
20,814 |
|
|
|
22,966 |
|
Deferred revenue,
non-current |
|
|
44,651 |
|
|
|
— |
|
Other liabilities,
non-current |
|
|
592 |
|
|
|
598 |
|
Total
liabilities |
|
|
104,616 |
|
|
|
57,905 |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,038,249,630
authorized and 927,668,946 issued and outstanding (2019:
785,857,300 authorized and 631,003,568 issued and
outstanding) |
|
|
1,324 |
|
|
|
943 |
|
Additional paid in capital |
|
|
928,777 |
|
|
|
585,623 |
|
Accumulated other comprehensive loss |
|
|
(8,805 |
) |
|
|
(7,264 |
) |
Accumulated deficit |
|
|
(513,711 |
) |
|
|
(455,664 |
) |
Total stockholders'
equity |
|
|
407,585 |
|
|
|
123,638 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
512,201 |
|
|
$ |
181,543 |
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
Cash flows from
operating activities |
|
|
|
|
|
|
|
Net loss |
|
$ |
(58,047 |
) |
|
$ |
(68,499 |
) |
|
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation |
|
|
3,583 |
|
|
|
3,642 |
|
|
Amortization |
|
|
464 |
|
|
|
333 |
|
|
Share-based compensation expense |
|
|
4,072 |
|
|
|
6,675 |
|
|
Unrealized foreign exchange (gains) losses |
|
|
(2,004 |
) |
|
|
1,048 |
|
|
Other |
|
|
718 |
|
|
|
(166 |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Increase in receivables and
other operating assets |
|
|
(10,104 |
) |
|
|
(16,851 |
) |
|
Decrease in non-current operating assets |
|
|
615 |
|
|
|
1,263 |
|
|
Increase (decrease) in payables and other current liabilities |
|
|
3,571 |
|
|
|
(876 |
) |
|
Increase in deferred revenue |
|
|
49,074 |
|
|
|
3,060 |
|
|
Net cash used in
operating activities |
|
|
(8,058 |
) |
|
|
(70,371 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(460 |
) |
|
|
(1,202 |
) |
|
Acquisition of intangibles |
|
|
(407 |
) |
|
|
(922 |
) |
|
Maturity or redemption of marketable securities |
|
|
39,931 |
|
|
|
54,324 |
|
|
Investment in marketable securities |
|
|
(298,016 |
) |
|
|
(15,983 |
) |
|
Net cash (used in)
provided by investing activities |
|
|
(258,952 |
) |
|
|
36,217 |
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
334,388 |
|
|
|
— |
|
|
Proceeds from exercise of stock options |
|
|
5,075 |
|
|
|
366 |
|
|
Net cash provided by
financing activities |
|
|
339,463 |
|
|
|
366 |
|
|
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
|
(678 |
) |
|
|
289 |
|
|
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
71,775 |
|
|
|
(33,499 |
) |
|
Cash, cash equivalents and
restricted cash at start of period |
|
|
54,908 |
|
|
|
72,476 |
|
|
Cash, cash equivalents
and restricted cash at end of period |
|
$ |
126,683 |
|
|
$ |
38,977 |
|
|
About Adaptimmune
Adaptimmune 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 May 14, 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.
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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