- Biologics License Application for efgartigimod in generalized
myasthenia gravis on track to be submitted to U.S. Food and
Drug Administration by end of year
- Full data from ADAPT trial to be presented at upcoming medical
meeting in 2020
- Cusatuzumab development strategy aligned with evolving AML
treatment landscape to focus on combination with venetoclax and
azacitidine
- €1.9 billion in cash and cash equivalents and current financial
assets strongly support commercial launch preparation of
efgartigimod
- Management to host conference call today at 2:30 pm CEST (8:30
am ET)
July 30, 2020 Breda,
the Netherlands / Ghent, Belgium – argenx (Euronext &
Nasdaq: ARGX), a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases and
cancer, today announced its half year 2020 financial results and
provided a second quarter business update and outlook for the
remainder of the year.
“We are proud of the progress we have made
during the first half of 2020 to advance our immunology pipeline
and validate our first-in-class FcRn antagonist, efgartigimod. We
announced positive topline results from the Phase 3 ADAPT trial,
furthering our conviction that efgartigimod has the potential to
significantly improve the standard of care for people with gMG as
well as several other autoantibody-driven diseases. We are focused
on our planned 2021 U.S. commercial launch of efgartigimod to bring
this therapy to patients as quickly as possible and to advance on
our ‘argenx 2021’ vision,” said Tim Van Hauwermeiren, CEO of
argenx.
"We also remain committed to advancing our
robust pipeline, including our late-stage efgartigimod trials in
additional autoimmune indications and our early-stage candidates
from our Immunology Innovation Program. Regarding cusatuzumab,
which we are currently developing in a global collaboration with
Janssen, as clinical trial sites re-open, we are taking the
opportunity to evaluate the most appropriate development strategy
given the rapidly evolving treatment landscape, ” continued Mr. Van
Hauwermeiren.
SECOND QUARTER 2020 AND RECENT BUSINESS
UPDATE
argenx continues to execute on its “argenx 2021”
vision to become a fully integrated, global immunology company. The
company continues to implement measures across the organization and
in the operations of globally run clinical trials to minimize the
impact of COVID-19 on employees, patients and their communities,
physicians and ongoing business priorities.
Commercial preparations underway to
support potential approval and launch of argenx’s first-in-class
FcRn antagonist, efgartigimod, in its first indication, generalized
myasthenia gravis (gMG).
- Biologics License Application (BLA) on track to be filed with
the U.S. Food and Drug Administration (FDA) by the end of 2020 with
an expected U.S. commercial launch in 2021
- Japanese Marketing Authorization Application (J-MAA) expected
to be filed with the Pharmaceuticals and Medical Devices Agency
(PMDA) in the first half of 2021 with an expected efgartigimod
launch in gMG in Japan following the U.S. commercial launch
- Commercial infrastructure readiness activities, including with
global supply chain, are on track for launch timeline in the U.S.
and Japan
In May, argenx reported positive topline
data from the Phase 3 ADAPT trial showing efgartigimod was
well-tolerated and able to drive responses that support plans to
offer individualized dosing to gMG
patients.
- ADAPT met its primary endpoint showing 67.7% of acetylcholine
receptor-antibody positive (AChR-Ab+) gMG patients were responders
on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
compared with 29.7% on placebo (p<0.0001)
- 63.1% of AChR-Ab+ gMG patients responded to efgartigimod
compared with 14.1% on placebo on the Quantitative Myasthenia
Gravis (QMG) score (p<0.0001)
- 40.0% of efgartigimod-treated AChR-Ab+ patients achieved
minimal symptom expression defined as MG-ADL scores of 0 (symptom
free) or 1, compared to 11.1% treated with placebo
- In AChR-Ab+ patients who met the primary endpoint, the majority
showed a sustained response, including 88.6% who achieved a
response for at least six weeks, 56.8% for at least eight weeks and
34.1% for at least 12 weeks
- Safety profile of efgartigimod was comparable to placebo
- Detailed data set to be presented at upcoming medical meeting
in 2020
- argenx plans to meet with FDA in fourth quarter of 2020 to
discuss bridging strategy for subcutaneous (SC) efgartigimod
Positive ADAPT data support continued
progress of efgartigimod in additional severe autoimmune
indications within key commercial franchises.
- Primary immune thrombocytopenia (ITP) registrational program
includes ongoing ADVANCE trial evaluating 10mg/kg IV efgartigimod
in up to 156 patients
- Enrollment delays in the program have been observed due to
COVID-19
- Discussions ongoing with FDA on how to bring forward SC
components of program to meet COVID-19 enrollment challenges
- Chronic inflammatory demyelinating polyneuropathy (CIDP) Phase
2 ADHERE trial ongoing evaluating SC efgartigimod
- Due to COVID-19 enrollment delays, potential decision to expand
trial up to 130 patients now expected in 2021
- Pemphigus vulgaris (PV) registrational trial to start in second
half of 2020 following proof-of-concept data from adaptive Phase 2
trial that showed fast onset of disease control and deep responses
with potential for steroid sparing
- Fifth indication to be announced by end of 2020
Cusatuzumab development strategy aligned
with evolving treatment landscape and anticipated global adoption
of venetoclax in acute myeloid leukemia (AML)
clinical practice.
- Development plan, in collaboration with Cilag GmbH
International, an affiliate of the Janssen Pharmaceutical Companies
of Johnson & Johnson, to now focus on cusatuzumab in
combination with venetoclax, including in the Phase 1b ELEVATE
combination trial of cusatuzumab with venetoclax and azacitidine in
newly diagnosed, elderly patients with AML who are ineligible for
intensive chemotherapy
- Trial enrolling again after pause due to COVID-19
- Maturing data from Phase 2 CULMINATE trial of cusatuzumab in
combination with azacitidine in newly diagnosed, elderly patients
with AML who are ineligible for intensive chemotherapy suggest that
complete response rates are not likely to exceed those from the
VIALE-A trial of venetoclax in combination with azacitidine
presented at the European Hematology Association (EHA) Annual
Congress in June 2020
- Based on enrollment to date, dose selected to be 20mg/kg
- CULMINATE trial will continue to evaluate responses and
durability for existing patients but will not enroll new
patients
- Topline data to be reported in early 2021
- Registration strategy to be determined following evaluation of
maturing data across cusatuzumab program and AML treatment
landscape
- Phase 1 trial of cusatuzumab in combination with azacitidine
trial in Japan evaluating newly diagnosed, elderly AML patients who
are ineligible for intensive chemotherapy remains ongoing
- Phase 2 BEACON trial of cusatuzumab in combination with
azacitidine versus azacitidine alone in higher-risk patients with
myelodysplastic syndromes (MDS) who are ineligible for intensive
chemotherapy remains paused for enrollment
- Part 1 dose escalation of Phase 1 study of cusatuzumab in
combination with azacitidine in newly diagnosed, elderly patients
with AML who are ineligible for intensive chemotherapy, published
in Nature Medicine
argenx continues to advance its
early-stage pipeline of first-in-class antibodies against
immunologic targets.
- ARGX-117 targeting complement C2 to be evaluated in Phase 1
healthy volunteer trial starting in third quarter of 2020
- Following analysis of Phase 1 data, argenx plans to launch
Phase 2 proof-of-concept trials in severe autoimmune diseases,
including multifocal motor neuropathy (MMN)
- Single-center Phase 1 trial remains open for enrollment to
evaluate ARGX-117 as a potential treatment for acute respiratory
distress syndrome (ARDS), a frequent and serious complication
associated with COVID-19
- ARGX-118 targeting Galectin-10 is undergoing lead optimization
work as a potential treatment for airway inflammation
- ARGX-119 on track to be announced in 2020
Partnered antibody candidates that
emerged from argenx’s Immunology Innovation Program continue to
have the potential to bring non-dilutive capital in the form of
milestone payments and future royalties
- AbbVie’s ongoing Phase 1 trial of ABBV-151 (formerly ARGX-115)
in solid tumors remains open for enrollment
- LEO Pharma plans to reopen sites in late August for enrollment
in ongoing Phase 1 trial of LP0145 (formerly ARGX-112) for the
treatment of atopic dermatitis
- Staten initiated dosing in first-in-human clinical trial of
STT-5058 (formerly ARGX-116) targeting apoC3 for the potential
treatment of dyslipidemia
HALF
YEAR 2020 FINANCIAL RESULTS (CONSOLIDATED)
|
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
|
|
(in thousands of € except for shares and EPS) |
|
2020 |
|
2019 |
|
Variance |
Revenue |
|
€ |
22,388 |
|
€ |
43,532 |
|
€ |
(21,143) |
Other operating income |
|
|
8,729 |
|
|
7,767 |
|
|
961 |
Total operating
income |
|
|
31,117 |
|
|
51,299 |
|
|
(20,182) |
|
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
|
(171,718) |
|
|
(78,304) |
|
|
(93,414) |
Selling, general and
administrative expenses |
|
|
(61,644) |
|
|
(27,462) |
|
|
(34,181) |
Total operating
expenses |
|
|
(233,362) |
|
|
(105,767) |
|
|
(127,595) |
|
|
|
|
|
|
|
|
|
|
Change in fair value on
non-current financial assets |
|
|
848 |
|
|
— |
|
|
848 |
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
€ |
(201,397) |
|
€ |
(54,467) |
|
€ |
(146,929) |
|
|
|
|
|
|
|
|
|
|
Financial
income/(expense) |
|
|
(2,178) |
|
|
7,210 |
|
|
(9,388) |
Exchange gains/(losses) |
|
|
199 |
|
|
2,486 |
|
|
(2,287) |
|
|
|
|
|
|
|
|
|
|
Loss before
taxes |
|
€ |
(203,376) |
|
€ |
(44,771) |
|
€ |
(158,605) |
Income tax
(expense)/benefit |
|
€ |
(2,261) |
|
€ |
(350) |
|
€ |
(1,911) |
Loss for the year and
total comprehensive loss |
|
€ |
(205,637) |
|
€ |
(45,121) |
|
€ |
(160,516) |
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash, cash equivalents and current
financial assets compared to year-end 2019 and 2018 |
|
|
596,977 |
|
|
1,368,229 |
|
|
|
Cash, cash equivalents and current financial assets at the end
of the period |
|
|
1,932,798 |
|
|
944,283 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS On June 30, 2020, cash and cash equivalents and
current financial assets totaled €1,932.8 million, compared to
€1,335.8 million on December 31, 2019. The increase in cash and
cash equivalents and current financial assets resulted primarily
from the closing of a global offering, including a U.S. offering
and a European private placement, which resulted in the receipt of
€730.7 million net proceeds in June 2020.
Total operating income decreased by €20.2
million for the six months ended June 30, 2020 to €31.1 million,
compared to €51.3 million for the six months ended June 30, 2019.
This decrease is primarily related to the milestone payments
following the first-in-human clinical trial with ABBV-151 under the
AbbVie collaboration which was achieved in the first six months of
2019, partly offset by the revenue recognition of the transaction
price related to the Janssen collaboration and the increase in
other income mainly driven by higher payroll tax rebates for
employing certain research and development personnel.
Research and development expenses in the first
six months of 2020 amounted to €171.7 million, compared to €78.3
million for the first six months of 2019. The increase resulted
primarily from higher external research and development expenses
primarily related to the efgartigimod program in various
indications, the cusatuzumab program and other clinical and
preclinical programs. Furthermore, the personnel expenses increased
due to the planned increase in headcount.
Selling, general and administrative expenses
totaled €61.6 million in the first six months of 2020, compared to
€27.5 million for the first six months of 2019. This increase
primarily resulted from higher personnel expenses and consulting
fees related to the preparation of a possible future
commercialization of argenx’s lead product candidate,
efgartigimod.
For the six months ended June 30, 2020,
financial expenses, which primarily relate to interest received and
changes in fair value of current financial assets, amounted to €2.2
million compared to a financial income of €7.2 million for the six
months ended June 30, 2019. Financial expenses corresponded mainly
to a decrease in net asset value on its current financial assets
following the impact of the COVID-19 outbreak on the financial
markets.
Exchange gains totaled €0.2 million for the six
months ended June 30, 2020, compared to €2.5 million for the six
months ended June 30, 2019 and were mainly attributable to
unrealized exchange rate gains on cash, cash equivalents and
current financial assets.
A net loss of €205.6 million and an operating
loss of €201.4 million were realized for the six months ended June
30, 2020, compared to a net loss of €45.1 and operating loss of
€54.5 million for the six months ended June 30, 2019.
EXPECTED 2020 FINANCIAL
CALENDAR:
·October 22,
2020: Q3 financial results & business update
CONFERENCE CALL DETAILSThe half
year 2020 results and second quarter business update will be
discussed during a conference call and webcast presentation today
at 2:30 pm CET/8:30 am ET. To participate in the conference call,
please select your phone number below and use the confirmation code
7470386. The webcast may be accessed on the
Investors section of the argenx website at
argenx.com/investors.
Dial-in numbers:Please dial in
5–10 minutes prior to 2:30 p.m. CET/ 8:30 a.m. ET using the number
and conference ID below.
Confirmation Code:
7470386Belgium
+32 (0)2 793 3847Belgium
0800 484 71France
+33 (0)1 7070
0781France
0805 101 465 Netherlands
+31 (0)20 0795
6614Netherlands
0800 023 5015United Kingdom
+44 (0) 844 481 9752United Kingdom
0800 279 6619United
States
+1 (646) 741 3167United
States
+1 (877) 870 9135
About argenxargenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases and cancer. Partnering
with leading academic researchers through its Immunology Innovation
Program (IIP), argenx is translating immunology breakthroughs into
a world-class portfolio of novel antibody-based medicines. argenx
is evaluating efgartigimod in multiple serious autoimmune diseases,
and cusatuzumab in hematological cancers in collaboration with
Janssen. argenx is also advancing several earlier stage
experimental medicines within its therapeutic franchises. argenx
has offices in Belgium, the United States and Japan. For more
information, visit www.argenx.com and follow us on LinkedIn at
https://www.linkedin.com/company/argenx/.
For further information, please contact:
Beth DelGiacco, Vice President, Investor Relations (US)+1 518
424 4980bdelgiacco@argenx.com
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)+32 (0)477 77 29 44+32 (0)9 310 34
19jcomijn@argenx.com
Forward-looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
“believes,” “estimates,” “anticipates,” “expects,” “intends,”
“may,” “will,” or “should” and include statements argenx makes
concerning its 2020 business and financial outlook and related
plans; the therapeutic potential of its product candidates;
the intended results of its strategy and argenx’s, and its
collaboration partners’, advancement of, and anticipated clinical
development, data readouts and regulatory milestones and plans,
including the timing of planned clinical trials and expected data
readouts; the design of future clinical trials and the timing of
regulatory filings and regulatory approvals. By their nature,
forward-looking statements involve risks and uncertainties and
readers are cautioned that any such forward-looking statements are
not guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including
argenx’s expectations regarding its the inherent uncertainties
associated with competitive developments, preclinical and clinical
trial and product development activities and regulatory approval
requirements; argenx’s reliance on collaborations with third
parties; estimating the commercial potential of argenx’s product
candidates; argenx’s ability to obtain and maintain protection of
intellectual property for its technologies and drugs; argenx’s
limited operating history; and argenx’s ability to obtain
additional funding for operations and to complete the development
and commercialization of its product candidates. A further list and
description of these risks, uncertainties and other risks can be
found in argenx’s U.S. Securities and Exchange Commission (SEC)
filings and reports, including in argenx’s most recent annual
report on Form 20-F filed with the SEC as well as subsequent
filings and reports filed by argenx with the SEC. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. argenx undertakes no obligation to publicly update or
revise the information in this press release, including any
forward-looking statements, except as may be required by law.
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