- Enrollment on track for Phase 3 ADAPT trial of efgartigimod
(ARGX-113) in generalized myasthenia gravis (gMG) patients with
topline results expected in 2H20
- First of two registration trials from Phase 3 program of
efgartigimod in primary immune thrombocytopenia (ITP) patients
expected to start in 2H19
- First patient dosed in Phase 1 healthy volunteer (HV) trial
evaluating ENHANZE® subcutaneous (SC) formulation of
efgartigimod
- Management to host conference call today at 3:00 pm CEST (9:00
am ET); details provided below
August 1, 2019 Breda,
the Netherlands / Ghent, Belgium – argenx (Euronext &
Nasdaq: ARGX), a clinical-stage biotechnology company developing a
deep pipeline of differentiated antibody-based therapies for the
treatment of severe autoimmune diseases and cancer, today announced
its financial results for the first half of 2019 and provided its
second quarter business update and the outlook for the remainder of
the year.
"We continue to execute on accelerating and
expanding our robust, late-stage innovative clinical development
programs, as we invest in forward integration across our
organization to maximize value. Efgartigimod is the most advanced
and also the broadest FcRn antagonist program with four indications
and both intravenous and subcutaneous formulations. Enrollment for
the Phase 3 ADAPT trial in generalized myasthenia gravis is
progressing as planned, and we are on track to initiate before the
end of the year the first of two pivotal Phase 3 trials, ADVANCE,
for our global primary immune thrombocytopenia program, as well as
a Phase 2 trial in chronic inflammatory demyelinating
polyneuropathy. Our Phase 2 trial of efgartigimod in pemphigus
vulgaris remains a priority, and we expect to report topline data
in the first half of 2020," commented Tim Van Hauwermeiren, CEO of
argenx. "As we move towards becoming a fully-integrated
biotechnology company, we continue to invest in commercial
infrastructure with the build-out of our neuromuscular and
hematology franchises and the expansion of our global supply chain
through our longstanding collaboration with Lonza, which is
expected to support the commercial launch of efgartigimod in
generalized myasthenia gravis in 2021."
SECOND QUARTER 2019 AND RECENT
HIGHLIGHTS During its 2019 R&D Day in May, argenx
announced its plan to become a fully integrated, global immunology
company in accordance with its “argenx 2021” vision, which includes
building two successful commercial franchises in neuromuscular and
hematological disorders.
Efgartigimod (ARGX-113): Potential to be
best-in-class with broad applicabilityEfgartigimod is a
human IgG1 Fc fragment engineered to increase affinity for FcRn
versus endogenous IgG, whilst preserving characteristic
pH-dependent binding, which may contribute to efgartigimod’s
relatively long serum half-life and pharmacodynamic effect, and may
promote tissue penetration. Treatment with efgartigimod results in
a targeted reduction of IgG autoantibodies and is a rational
approach to diseases where IgGs are directly pathogenic. argenx is
evaluating efgartigimod as a potential treatment for four
high-value indications, including:
- Generalized Myasthenia Gravis (gMG)
- Global, multi-center Phase 3 ADAPT clinical trial, including
ADAPT+ one-year open-label extension study, currently ongoing
- With current enrollment on track, topline data are expected in
second half of 2020
- Results from completed Phase 2 clinical trial were published in
Neurology
- Primary Immune Thrombocytopenia (ITP)
- Global Phase 3 program to include two registration trials that
will be run concurrently
- First trial (ADVANCE) to evaluate 10 mg/kg intravenous (IV)
efgartigimod on top of standard of care medication, with enrollment
up to 158 patients; primary endpoint includes achieving sustained
platelet count response of at least 50×109/L
- Second trial to evaluate 10 mg/kg IV induction period followed
by subcutaneous (SC) injections, all on top of standard of care
medication, to evaluate potential of SC product to maintain
clinical benefit
- Phase 3 program was developed following consultation with key
regulatory agencies
- ADVANCE Phase 3 clinical trial expected to start in second half
of 2019
- Pemphigus Vulgaris (PV)
- Phase 2 proof-of-concept clinical trial ongoing and currently
enrolling patients in third cohort with extended dosing of
efgartigimod
- Data from Phase 2 clinical trial expected in first half of
2020
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Phase 2 clinical trial on track to start in second half of
2019
- Key opinion leader (KOL) event planned for fourth quarter 2019
to discuss Phase 2 trial design and unmet needs in CIDP
argenx
entered into a global collaboration with Halozyme in February 2019
to develop a SC formulation of efgartigimod using Halozyme’s
proprietary ENHANZE® drug delivery technology, gaining exclusive
rights to the technology for the FcRn target.
- First subject dosed in Phase 1 healthy volunteer (HV) trial
evaluating safety, pharmacokinetics, pharmacodynamics and
bioavailability of ENHANZE® SC formulation of efgartigimod
- Initiation of study triggered $5 million milestone payment to
Halozyme
- Data from Phase 1 HV trial are expected by end of 2019 after
which argenx will disclose a path forward in patients for ENHANZE®
SC formulation of efgartigimod
Cusatuzumab (ARGX-110): First-in-class
opportunity in acute myeloid leukemia
(AML)Cusatuzumab is a first-in-class monoclonal
antibody inhibiting CD70, a target that is uniquely present on both
leukemic stem cells and AML blasts but not healthy cells. It is
being developed under an exclusive global collaboration and license
agreement with Janssen for the treatment of AML, high-risk
myelodysplastic syndromes and other hematological malignancies.
- Phase 2 and registration-directed clinical trial in AML on
track to start in second half of 2019
- Trial to enroll up to 150 patients with previously untreated
AML and who are not eligible for intensive chemotherapy
- In this two-part trial, patients will first be randomized to
receive one of two dose levels of cusatuzumab (10 mg/kg and 20
mg/kg) in combination with azacytidine (75 mg/m2) followed by an
expansion cohort to evaluate efficacy of the selected dose of
cusatuzumab
Early Development Programs
argenx announced during its R&D Day the
expansion of its product pipeline with the addition of two new
proprietary therapeutic candidates, ARGX-117 and ARGX-118. Both
emerged from argenx’s Innovative Access Program, in which it
collaborates closely with disease biology experts, bringing the
argenx cutting-edge antibody discovery and engineering technologies
to the heart of novel target research.
- ARGX-117 is a complement-targeting antibody against C2, a
component of both the classical and lectin pathways in the
complement cascade
- Potential therapeutic applications in multiple autoimmune
diseases
- argenx exercised its second exclusive license to Halozyme’s
ENHANZE® technology for use with this molecule
- Expected to file Clinical Trial Application (CTA) by end of
2019 with first-in-human trial expected to start in first quarter
of 2020
- ARGX-118 is a highly differentiated antibody against
Galectin-10, the protein of Charcot-Leyden crystals (CLCs), which
play a major role in severe asthma and the persistence of mucus
plugs
- Immunology breakthrough in airway inflammation
- SIMPLE Antibody™ observed to have unique crystal-dissolving
properties
- Currently in final stages of lead optimization work
- Data were published in Science by argenx collaborator Dr. Bart
Lambrecht from VIB Inflammation Research Center supporting role of
CLCs and potential of ARGX-118 in airway inflammation
Corporate Update
- Appointed Wim Parys, M.D. as Chief Medical Officer effective
July 1, 2019. Most recently, Dr. Parys served as Head of R&D of
the Global Public Health group of Janssen.
HALF YEAR 2019 FINANCIAL RESULTS
(CONSOLIDATED)
|
|
|
Six Months Ended |
|
|
|
|
|
June 30 |
|
|
(in thousands of €) |
|
2019 |
|
2018 |
|
Variance |
Revenue |
|
€ |
43,532 |
|
€ |
17,910 |
|
€ |
25,622 |
Other operating income |
|
|
7,767 |
|
|
2,588 |
|
|
5,179 |
Total operating income |
|
|
51,299 |
|
|
20,498 |
|
|
30,801 |
Research and development expenses |
|
|
(78,304) |
|
|
(34,371) |
|
|
(43,933) |
Selling, general and administrative expenses |
|
|
(27,462) |
|
|
(11,514) |
|
|
(15,948) |
Operating loss |
|
€ |
(54,467) |
|
€ |
(25,387) |
|
€ |
(29,080) |
Financial income |
|
|
7,210 |
|
|
1,256 |
|
|
5,954 |
Exchange gains |
|
|
2,486 |
|
|
4,024 |
|
|
(1,538) |
Loss before taxes |
|
€ |
(44,771) |
|
€ |
(20,107) |
|
€ |
(24,664) |
Income tax (expense)/benefit |
|
€ |
(350) |
|
€ |
31 |
|
€ |
(381) |
Loss for the period and total comprehensive
loss |
|
€ |
(45,121) |
|
€ |
(20,076) |
|
€ |
(25,045) |
|
|
|
|
|
|
|
|
|
|
Net
increase/(decrease) in cash, cash equivalents and current financial
assets compared to year-end 2018 and 2017 |
|
€ |
379,714 |
|
€ |
(20,922) |
|
|
|
Cash, cash equivalents and current financial assets at the end of
the period |
|
€ |
944,283 |
|
€ |
338,852 |
|
|
|
On June 30, 2019, cash, cash equivalents and
current financial assets totaled €944.3 million, compared to €564.6
million on December 31, 2018. The increase in cash, cash
equivalents and current financial assets resulted primarily from
the closing of the exclusive global collaboration and license
agreement for cusatuzumab with Janssen which resulted in a $300
million upfront payment and a $200 million equity investment in
January 2019.
Total operating income increased by €30.8
million for the six months ended June 30, 2019 to reach €51.3
million, compared to €20.5 million for the six months ended June
30, 2018. The increase is primarily related to (i) a €16.0 million
increase in the recognition of milestone payments following the
initiation of a first-in-human clinical trial with ABBV-151
(formerly named ARGX-115) under the AbbVie collaboration, which
triggered a $30 million milestone payment, (ii) an increase of €7.8
million related to the recognition of research and development
service fees under the Janssen collaboration and (iii) an increase
of €5.2 million, mainly driven by higher payroll tax rebates for
employing certain research and development personnel.
Research and development expenses totaled €78.3
million and €34.4 million for the six months ended June 30, 2019
and 2018, respectively. The increase in the first six months of
2019 resulted primarily from higher external research and
development expenses and personnel expenses, reflecting higher
clinical trials costs and manufacturing expenses related to the
development of argenx’s product candidate portfolio and the
recruitment of additional employees to support research and
development activities.
Selling, general and administrative expenses
totaled €27.5 million and €11.5 million for the six months ended
June 30, 2019 and 2018, respectively. The increase of €16.0 million
in selling, general and administrative expenses for the six months
ended June 30, 2019 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, 2019,
financial income amounted to €7.2 million, compared to €1.3 million
for the six months ended June 30, 2018. The increase of €5.9
million in the first six months of 2019 related primarily to an
increase in the interest received on cash, cash equivalents and
current financial assets.Exchange gains totaled €2.5 million for
the six months ended June 30, 2019, compared to the €4.0 million
for the six months ended June 30, 2018 and were mainly attributable
to unrealized exchange rate gains on argenx’s cash and current
financial assets position in U.S. Dollars due to the favorable
fluctuation of the EUR/USD exchange rate in the first six months of
2019.
The total comprehensive loss for the six months
ended June 30, 2019 was €45.1 million, compared to €20.1 million
for the six months ended June 30, 2018.
The 90 day average number of shares outstanding
per June 30, 2019 was 38,026,040.
Financial OutlookBased on the
current objectives of the Company’s business plan, argenx expects
that its existing cash, cash equivalents and investments will fund
planned operating and capital expense requirements into 2021. With
the launch of a second global Phase 3 trial for efgartigimod, the
execution of the development plan for cusatuzumab, the build-out of
the commercial organization, and the expansion of the Company’s
ambition level within its growing business plan, argenx expects
operating and capital expense requirements to continue to increase
year-over-year.
U.S. SEC and Statutory Financial
Reportingargenx’s primary accounting framework is
International Financial Reporting Standards (IFRS) as issued by the
International Accounting Standards Board (IASB). Unaudited
condensed half yearly interim financial statements prepared in
accordance with International Accounting Standards IAS 34 Interim
Financial Reporting are available on www.argenx.com.
In addition to reporting financial figures in
accordance with IFRS as issued by the IASB, argenx also reports
financial figures in accordance with IFRS as adopted by the
European Union (EU) for statutory purposes. The unaudited condensed
consolidated statement of financial position, the unaudited
condensed consolidated statements of profit and loss and other
comprehensive income, the unaudited condensed consolidated
statements of cashflow, and the unaudited condensed consolidated
statement of changes in equity are not affected by any differences
between IFRS as issued by the IASB and IFRS as adopted by the
EU.
The condensed consolidated statement of profit
and loss and other comprehensive income for the six months ended
June 30, 2019 presented in this press release is unaudited.
2019 FINANCIAL CALENDAR
- October 24, 2019: Q3 2019 business update and financial
results
CONFERENCE CALL DETAILSThe half
year results will be discussed during a conference call and webcast
presentation today at 3:00 pm CEST/9:00 am ET. To participate in
the conference call and Q&A session, please select your phone
number provided below and use the confirmation code
7539308. The live webcast may be accessed on the
homepage of the argenx website at www.argenx.com or by clicking
here.
Belgium
+32 (0)2 400 9874
Belgium
0800 48740France
+33 (0)1 767 00794France
0805 103028
Netherlands
+31 (0)20 714 3545Netherlands
0800 0249557United
Kingdom +44 (0)844
571 8892United Kingdom
0800 376 7922United States
+1 (631) 510 7495United States
+1 (866) 966
1396
About argenxargenx is a
clinical-stage biotechnology company developing a deep pipeline of
differentiated antibody-based therapies for the treatment of severe
auto-immune diseases and cancer. The company is focused on
developing product candidates with the potential to be either
first-in-class against novel targets or best-in-class against
known, but complex, targets in order to treat diseases with a
significant unmet medical need. argenx’s ability to execute on this
focus is enabled by its suite of differentiated technologies. The
SIMPLE AntibodyTM Platform, based on the powerful llama immune
system, allows argenx to exploit novel and complex targets, and its
three complementary Fc engineering technologies are designed to
expand the therapeutic index of its product candidates.
www.argenx.com
For further information, please
contact: Beth DelGiacco, Vice President, Investor
Relations+1 518 424 4980bdelgiacco@argenx.com
Marieke Vermeersch, Corporate Communications & Investor
Relations Consultant+32 (0)479 490 603+32 (0)3 290 00
50mvermeersch@argenx.com
Forward-looking StatementsThe
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
financial condition, results of operation and business outlook; the
sufficiency of its cash, cash equivalents and current financial
assets; its 2019 business and financial calendar and related plans;
the clinical data of its product candidates; the intended results
of its strategy; the momentum of its product candidate pipeline as
well as 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; and interaction with regulators,
including the potential approval of its current or future drug
candidates. 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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