Adaptimmune Reports Third Quarter Financial Results and Business Update
04 November 2021 - 10:30PM
Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell
therapy to treat cancer, today reported financial results for the
third quarter ended September 30, 2021, and provided a business
update.
“We made excellent progress in Q3. The SURPASS data presented at
ESMO, the start of our first Phase 2 trial with ADP-A2M4CD8
next-gen SPEAR T-cells, and the announcement of our strategic
collaboration with Genentech all support our 2-2-5-2 strategy,”
said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer.
“Looking ahead, the SPEARHEAD-1 data that we will present at the
CTOS meeting will support a BLA for afami-cel in 2022. Next year,
we will initiate a Phase 2 trial with ADP-A2M4CD8 for patients with
ovarian cancer and evaluate the combination of this next-generation
therapy with checkpoint inhibitors. All these activities will
strengthen our leadership position with our MAGE-A4 franchise.”
Upcoming data updates and corporate
eventsConnective Tissue Oncology Society (CTOS)
Virtual Annual Meeting (November 10-13)
- Abstract Title: SPEARHEAD-1: A Phase 2 trial
of afamitresgene autoleucel (formerly ADP-A2M4) in patients with
advanced synovial sarcoma or myxoid/ round cell liposarcoma
(Abstract #1080870)
- Oral presentation: November 12, 2021, in the
Immunotherapy & Immune Microenvironment Session starting at
10:00 a.m. EST, Presenter: Dr. Brian Van Tine, Associate Professor
of Medicine at Washington University School of Medicine
- Abstract Title: SPEARHEAD-1 preliminary
translational insights from a Phase 2 trial of afamitresgene
autoleucel (formerly ADP-A2M4) in patients with advanced synovial
sarcoma or myxoid/round cell liposarcoma (Abstract #1080366)
- Poster Presentation: November 12, 2021, 2:30
p.m. – 3:15 p.m. EST during the Immunology & Immunotherapy
Session. Presenter: Dr. Sandra P. D’Angelo, Clinical Oncologist at
the Memorial Sloan Kettering Cancer Center
- The Company will issue a full data press release at the time of
embargo lift at 9:00 a.m. EST on November 11th
Society for Immunotherapy of Cancer (SITC) Annual
Meeting (November 10-14); Walter E. Washington Convention Center in
Washington D.C. or Virtual
- Abstract Title: Enhancement of TCR-engineered
T-cells targeting MAGE-A4 antigen by co-expression of CD8α and
inhibition of AKT signaling during ex vivo T-cell expansion
(Abstract #373)
- Poster presentation: November 12-14, 2021,
7:00 a.m. – 5:00 p.m. EST. Presenter: Alex Tipping,
Adaptimmune
- Abstract Title: Radiation sub-study to
characterize safety and tolerability of low-dose radiation in
combination with afami-cel in patients with advanced cancers.
(Abstract #376)1
- Poster Presentation: November 12-14, 2021,
7:00 a.m. - 5:00 p.m. EST. Presenter: Dr. James W. Welsh,
Professor, Department of Radiation Oncology, Division of Radiation
Oncology, The University of Texas MD Anderson Cancer Center
- The Company will issue a full data press release at the time of
embargo lift at 7:00 a.m. EST on November 12th
Highlights from clinical data updates in
Q3SURPASS Phase 1 trial at the European Society
for Medical Oncology (ESMO) virtual meeting (August 2, 2021 data
cut-off)
- Initial efficacy and durability data were encouraging with
responses across five different solid tumors (ovarian, head and
neck, esophagogastric junction, bladder, and synovial sarcoma);
refer to the press release for more detail
- The overall response rate was 36% and the disease control rate
was 86%, per Investigator Review
- There was a complete response reported in a patient with
ovarian cancer, which remains ongoing at 6 months
post-infusion
- Eleven patients remain on study. Of the 8 responders, 5
remain in response with some remaining progression free >24
weeks
- The safety profile of the next-generation ADP-A2M4CD8 cell
therapy was acceptable
- Data confirm preclinical observations that the enhanced TCR
interaction with next-generation ADP-A2M4CD8 SPEAR T-cells results
in a more potent product
- Safety and efficacy, will continue to be evaluated in the
ongoing SURPASS trial, which is enrolling eligible patients with
gastroesophageal, head and neck, lung, bladder, and ovarian
cancers
Further indications for late-stage clinical
development
- Initiated a Phase 2 trial, SURPASS-2, for patients with
esophageal and EGJ cancers
- Next year, the Company will initiate SURPASS-3, a Phase 2 trial
with ADP-A2M4CD8 for people with ovarian cancer based on the
initial responses seen in the SURPASS Phase 1 trial (presented at
ESMO 2021)
- The Company is planning to evaluate ADP-A2M4CD8 in combination
with a checkpoint inhibitor.
- The SPEARHEAD-2 trial has now closed to enrollment
ADP-A2AFP Phase 1 trial in liver cancer at the
International Liver Cancer Association (ILCA) meeting
- As of the April 5, 2021 data cut-off, antitumor activity, with
one complete response, sustained decreases in serum AFP, and best
overall response of stable disease observed in 6 patients with
liver cancer, indicating that ADP-A2AFP is an active product in
hepatocellular carcinoma (HCC); refer to the press release for more
detail
- ADP-A2AFP has been associated with an acceptable safety profile
with doses up to 10 billion transduced cells
- The trial is approaching 25 patients treated, which is
anticipated to be sufficient to assess the trial objectives
- The Company will close screening by the end of 2021, and focus
on other preclinical programs for liver cancer
Preclinical pipeline updatesAllogeneic
platform
- Adaptimmune intends to file its first IND for an allogeneic
therapy targeting MAGE-A4 (wholly owned) in 2023
- The Company announced a strategic collaboration with Genentech
to research, develop, and commercialize allogeneic T-cell
therapies. The Agreement became effective following expiry of all
applicable waiting periods under the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976, with Adaptimmune set to receive
the $150 million upfront payment
- This strategic collaboration builds on Adaptimmune’s cell
therapy expertise and progress with its allogeneic platform, which
was highlighted during a live virtual event held in September
- The collaboration covers the research and development of
“off-the-shelf” cell therapies for up to five shared cancer targets
and the development of a novel allogeneic personalized cell therapy
platform
Corporate
- The Company plans to open a new facility at Milton Park,
Oxfordshire, UK, by the end of 2022, where allogeneic products for
clinical trials will be manufactured
Financial Results for the three and nine months ended
September 30, 2021
Financial Results for the three and nine months ended September
30, 2021
- Cash / liquidity position: As of September 30,
2021, Adaptimmune had cash and cash equivalents of $42.9 million
and Total Liquidity2 of $240.1 million. In addition, under the
terms of the Genentech agreement, Adaptimmune is entitled to
receive $150 million as an upfront payment, which is anticipated to
be received in the fourth quarter of 2021.
- Revenue: Revenue for the three and nine months
ended September 30, 2021 was $1.2 million and $4.7 million,
respectively, compared to $1.2 million and $2.5 million for the
same periods in 2020. 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 and nine months ended September 30,
2021 were $28.2 million and $81.6 million, respectively, compared
to $24.1 million and $65.8 million for the same periods in 2020.
R&D expenses increased due to an increase in the number of
employees engaged in research and development, increases in costs
related to the development of a companion diagnostic assay, and
expansion of our clinical trials. These increases were partially
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 three and nine months ended September 30,
2021 were $15.1 million and $42.5 million, respectively, compared
to $13.0 million and $32.6 million for the same periods in 2020 due
to increases in employee-related costs, share-based compensation
expense, and professional fees.
- Net loss: Net loss attributable to holders of
the Company’s ordinary shares for the three and nine months ended
September 30, 2021 was $42.4 million and $119.3 million
respectively ($(0.05) and $(0.11) per ordinary share), compared to
$35.4 million and $93.5 million ($(0.04) and $(0.13) per ordinary
share) for the same periods in 2020.
Financial Guidance
The Company believes that its existing cash, cash equivalents
and marketable securities, together with the upfront and
exclusivity 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 and nine months ended
September 30, 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 8:00 a.m. EDT (12:00 p.m. GMT) today. A live
webcast of the conference call and replay can be accessed at
https://bit.ly/3utRMny. 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 (4557667).
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.
1 The Company ceased enrollment in the Radiation Sub-Study of
the afami-cel Phase 1 trial at the end of July 2021.2 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
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 Securities and Exchange Commission (SEC)
on August 9, 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):
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
Cash and cash equivalents |
|
$ |
42,918 |
|
$ |
56,882 |
Marketable securities -
available-for-sale debt securities |
|
|
197,202 |
|
|
311,335 |
Total
Liquidity |
|
$ |
240,120 |
|
$ |
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 |
|
Nine months ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
Revenue |
|
$ |
1,203 |
|
|
$ |
1,193 |
|
|
$ |
4,732 |
|
|
$ |
2,456 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(28,211 |
) |
|
|
(24,067 |
) |
|
|
(81,585 |
) |
|
|
(65,791 |
) |
|
General and
administrative |
|
|
(15,173 |
) |
|
|
(13,001 |
) |
|
|
(42,529 |
) |
|
|
(32,557 |
) |
|
Total operating
expenses |
|
|
(43,384 |
) |
|
|
(37,068 |
) |
|
|
(124,114 |
) |
|
|
(98,348 |
) |
|
Operating
loss |
|
|
(42,181 |
) |
|
|
(35,875 |
) |
|
|
(119,382 |
) |
|
|
(95,892 |
) |
|
Interest income |
|
|
225 |
|
|
|
2,147 |
|
|
|
916 |
|
|
|
4,024 |
|
|
Other income (expense),
net |
|
|
(237 |
) |
|
|
(1,689 |
) |
|
|
(184 |
) |
|
|
(1,501 |
) |
|
Loss before income
taxes |
|
|
(42,193 |
) |
|
|
(35,417 |
) |
|
|
(118,650 |
) |
|
|
(93,369 |
) |
|
Income taxes |
|
|
(208 |
) |
|
|
(15 |
) |
|
|
(582 |
) |
|
|
(110 |
) |
|
Net loss attributable
to ordinary shareholders |
|
$ |
(42,401 |
) |
|
$ |
(35,432 |
) |
|
$ |
(119,232 |
) |
|
$ |
(93,479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per ordinary
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
936,600,648 |
|
|
|
928,022,057 |
|
|
|
933,992,708 |
|
|
|
829,973,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(unaudited, in thousands, except share data)
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
42,918 |
|
|
$ |
56,882 |
|
Marketable securities - available-for-sale debt securities |
|
|
197,202 |
|
|
|
311,335 |
|
Accounts receivable, net of allowance for doubtful accounts of $0
and $0 |
|
|
1,641 |
|
|
|
139 |
|
Other current assets and prepaid expenses |
|
|
58,689 |
|
|
|
29,796 |
|
Total current
assets |
|
|
300,450 |
|
|
|
398,152 |
|
|
|
|
|
|
|
|
Restricted cash |
|
|
1,717 |
|
|
|
4,602 |
|
Operating lease right-of-use
assets, net of accumulated amortization |
|
|
21,481 |
|
|
|
18,880 |
|
Property, plant and
equipment, net of accumulated depreciation of $35,087 (2020:
$31,097) |
|
|
28,689 |
|
|
|
27,778 |
|
Intangibles, net of
accumulated amortization |
|
|
1,191 |
|
|
|
1,730 |
|
Total
assets |
|
$ |
353,528 |
|
|
$ |
451,142 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,784 |
|
|
$ |
6,389 |
|
Operating lease liabilities, current |
|
|
2,267 |
|
|
|
2,773 |
|
Accrued expenses and other accrued liabilities |
|
|
27,984 |
|
|
|
27,079 |
|
Deferred revenue, current |
|
|
6,102 |
|
|
|
2,832 |
|
Total current
liabilities |
|
|
41,137 |
|
|
|
39,073 |
|
|
|
|
|
|
|
|
Operating lease liabilities,
non-current |
|
|
23,704 |
|
|
|
20,938 |
|
Deferred revenue,
non-current |
|
|
47,040 |
|
|
|
49,260 |
|
Other liabilities,
non-current |
|
|
664 |
|
|
|
644 |
|
Total
liabilities |
|
|
112,545 |
|
|
|
109,915 |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Common stock - Ordinary shares par value £0.001, 1,240,853,520
authorized and 937,049,820issued and outstanding (2020:
1,038,249,630 authorized and 928,754,958 issued and
outstanding) |
|
|
1,337 |
|
|
|
1,325 |
|
Additional paid in capital |
|
|
954,732 |
|
|
|
935,706 |
|
Accumulated other comprehensive loss |
|
|
(10,098 |
) |
|
|
(10,048 |
) |
Accumulated deficit |
|
|
(704,988 |
) |
|
|
(585,756 |
) |
Total stockholders'
equity |
|
|
240,983 |
|
|
|
341,227 |
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
353,528 |
|
|
$ |
451,142 |
|
Condensed Consolidated Cash Flow
Statement(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
Cash flows from
operating activities |
|
|
|
|
|
|
|
Net loss |
|
$ |
(119,232 |
) |
|
$ |
(93,479 |
) |
|
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation |
|
|
4,333 |
|
|
|
5,151 |
|
|
Share-based compensation expense |
|
|
15,802 |
|
|
|
7,352 |
|
|
Unrealized foreign exchange gains |
|
|
(213 |
) |
|
|
(1,102 |
) |
|
Amortization on available-for-sale debt securities |
|
|
4,094 |
|
|
|
2,798 |
|
|
Other |
|
|
2,239 |
|
|
|
737 |
|
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
Increase/(decrease) in receivables and other operating assets |
|
|
(31,809 |
) |
|
|
3,345 |
|
|
Decrease in non-current operating assets |
|
|
— |
|
|
|
2,291 |
|
|
Decrease in payables and other current liabilities |
|
|
(109 |
) |
|
|
(117 |
) |
|
Increase in deferred revenue |
|
|
1,696 |
|
|
|
48,649 |
|
|
Net cash used in
operating activities |
|
|
(123,199 |
) |
|
|
(24,375 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
|
Acquisition of property, plant and equipment |
|
|
(4,558 |
) |
|
|
(1,174 |
) |
|
Acquisition of intangibles |
|
|
(181 |
) |
|
|
(496 |
) |
|
Maturity or redemption of marketable securities |
|
|
190,393 |
|
|
|
78,915 |
|
|
Investment in marketable securities |
|
|
(81,363 |
) |
|
|
(363,777 |
) |
|
Net cash provided by
(used in) investing activities |
|
|
104,291 |
|
|
|
(286,532 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
|
Proceeds from issuance of common stock from offerings, net of
commissions and issuance costs |
|
|
2,529 |
|
|
|
334,388 |
|
|
Proceeds from exercise of stock options |
|
|
707 |
|
|
|
5,541 |
|
|
Net cash provided by
financing activities |
|
|
3,236 |
|
|
|
339,929 |
|
|
|
|
|
|
|
|
|
|
Effect of currency exchange rate changes on cash, cash equivalents
and restricted cash |
|
|
(1,177 |
) |
|
|
(1,023 |
) |
|
Net (decrease) increase in
cash, cash equivalents and restricted cash |
|
|
(16,849 |
) |
|
|
27,999 |
|
|
Cash, cash equivalents and
restricted cash at start of period |
|
|
61,484 |
|
|
|
54,908 |
|
|
Cash, cash equivalents
and restricted cash at end of period |
|
$ |
44,635 |
|
|
$ |
82,907 |
|
|
|
|
|
|
|
|
|
|
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
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