-
Topline data readout from Phase 3 ADAPT trial of efgartigimod in
generalized myasthenia gravis on track for mid-2020 and Biologics
License Application filing by end of year
- -
Enrollment paused in ongoing trials under Janssen and LEO
Pharma collaborations
- -
ARGX-117 being evaluated in COVID-19 patients with acute
respiratory distress syndrome in collaboration with UZ Gent –
-
Management to host conference call today at 3:00 pm CEST (9:00 am
ET) -
May 14, 2020 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 quarter ended March 31, 2020
and provided a business update.
“We are very excited to be approaching our first
pivotal Phase 3 data readout with topline data from the ADAPT trial
still on track for mid-year. This is an important milestone as it
will precipitate our transition from a late-stage development
company towards an integrated commercial organization. We have been
investing in the expansion of our commercial infrastructure and are
preparing for a 2021 launch of efgartigimod in gMG in the U.S., if
approved,” stated Tim Van Hauwermeiren, CEO of argenx.
“Over the last several months, the COVID-19
global pandemic has presented an unprecedented challenge, and as we
face uncertainty in the coming months, we are grateful to have
strong fundamentals across our business and the ability to fund our
deep antibody pipeline. I am most grateful, however, for the
continued support of our employees who have demonstrated
exceptional focus and an unwavering dedication to our mission of
developing therapies for the treatment of severe autoimmune
diseases and cancer. This commitment is underscored by our decision
to evaluate the potential of ARGX-117 to attenuate complement
activation in severe respiratory illness associated with COVID-19
while obtaining key metrics of our drug candidate in this
first-in-human trial.”
FIRST QUARTER 2020 AND RECENT
HIGHLIGHTS
argenx commitment to its people,
patients and businessDespite the challenges of the
COVID-19 pandemic, argenx remains focused on executing on its
“argenx 2021” vision to become a fully integrated, global
immunology company. In order to minimize impact on employees,
patients and their communities, physicians and ongoing business
priorities, argenx has implemented measures across its organization
and in the operation of its globally run clinical trials.
- A work-from-home mandate continues
for all employees in the U.S., Belgium and Japan, excluding those
providing essential services such as laboratory staff;
additionally, all work-related global and domestic travel are
suspended.
- In order to enable patients in its
clinical trials to receive study drug with continuity, argenx is
implementing telehealth, remote monitoring activities and more
flexible dosing schedules in its protocols where possible.
- argenx conducts clinical trials
globally, including in areas impacted by COVID-19 in North America,
Europe and Japan. Enrollment is expected to be delayed in ongoing
trials conducted by argenx, but the extent of the full impact is
not quantifiable until the trajectory of the pandemic is better
understood. The Company will continue to monitor the impact of
COVID-19 on all ongoing clinical trials and will implement changes
as necessary.
Efgartigimod trials remain open with
additional registrational trials expected to launch this
year
Efgartigimod is currently being evaluated in
four targeted indications where IgG autoantibodies are directly
pathogenic. A fifth indication is expected to be announced this
year.
- Generalized Myasthenia Gravis (gMG)
- Topline results from the pivotal
Phase 3 ADAPT clinical trial expected by mid-2020
- All patients have completed primary
26-week trial; patients continue to be dosed in the ADAPT+
one-year, open-label extension study
- If ADAPT data are positive, a
Biologics License Application (BLA) submission is expected to be
filed by end of 2020, with commercial launch planned in the U.S. in
2021
- Plans remain on track to engage
with the U.S. Food and Drug Administration (FDA) in 2020 on
potential bridging strategy for subcutaneous (SC)
ENHANZE®-efgartigimod
·Well-established
alliance with Lonza supports robust and flexible manufacturing
capabilities and supply chain remains on track to be
commercial-ready by end of 2020
- Primary Immune Thrombocytopenia
(ITP)
- Phase 3 ADVANCE trial ongoing and
expected to enroll approximately 150 primary ITP patients dosed
with 10mg/kg IV efgartigimod
- Confirmatory trial of IV
efgartigimod expected to initiate in the first half of 2020
- ADVANCE SC trial expected to
initiate in the second half of 2020 evaluating 10mg/kg IV
efgartigimod for induction of platelet response and 2mL fixed dose
of SC efgartigimod for maintenance
- Pemphigus Vulgaris (PV)
- Phase 3 registrational trial
expected to start in second half of 2020
- Detailed proof-of-concept data from
adaptive Phase 2 trial presented at Society for Investigative
Dermatology (SID) Virtual Annual Meeting; presentation currently
available on SID and argenx websites.
- Presentation includes updated data
from 31 evaluable patients treated with 10mg/kg or 25mg/kg of IV
efgartigimod (data as of cutoff date of March 25, 2020)
- 90% (28/31) achieved rapid disease
control; median time to disease control for monotherapy and
combination therapy is 15 and 22 days
- Complete clinical remission
observed in 70% (7/10) of patients receiving optimized dosing
regimen determined to be efgartigimod dosed at least every two
weeks in combination with oral prednisone (0.25-0.5mg/kg)
- 73% (11/15) of patients receiving
25mg/kg efgartigimod achieved end of consolidation, including
patients who preferred to taper steroid dose
- 11 patients currently still on
study
- Tolerability profile shown to be
favorable and consistent with data from previous efgartigimod
studies
- Chronic Inflammatory Demyelinating
Polyneuropathy (CIDP)
- Phase 2 ADHERE trial ongoing with
SC ENHANZE®-efgartigimod
Janssen and LEO Pharma have paused
enrollment of clinical trials of cusatuzumab and LP0145
(ARGX-112) Enrollment is paused in two ongoing clinical
trials initiated under the global cusatuzumab collaboration and
licensing agreement with Cilag GmbH International, an affiliate of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
Trials that have paused enrollment under the collaboration
include:
- Pivotal Phase 2 CULMINATE study
evaluating cusatuzumab in combination with azacitidine for the
treatment of newly diagnosed elderly acute myeloid leukemia (AML)
patients who are unfit for intensive chemotherapy;
- Phase 1b platform trial evaluating
cusatuzumab in combination with venetoclax and azacitidine
Additionally, LEO Pharma has paused enrollment
of the ongoing trial of LP0145 for the treatment of atopic
dermatitis.
Timing to restart enrollment of all trials will
depend on the trajectory of COVID-19 infection rates
ARGX-117 being evaluated as potential treatment for ARDS
in COVID-19 patients
ARGX-117 is a potentially first-in-class
complement-targeting antibody against C2 with potential therapeutic
applications in severe autoimmune diseases.
- argenx is sponsoring a Phase 1 trial in collaboration with
Ghent University Hospital to evaluate ARGX-117 as a potential
treatment for acute respiratory distress syndrome (ARDS), a
frequent and serious complication associated with COVID-19.
- Both classical and lectin pathways of complement system are
active in ARDS; by targeting C2, an important component of both
pathways, ARGX-117 could inhibit downstream inflammatory responses
associated with ARDS
- Collaboration leverages longstanding Immunology Innovation
Program relationships with Erik Hack, M.D., Ph.D., Professor
Emeritus, UMC Utrecht, and Bart Lambrecht, M.D., Ph.D., Director of
Inflammation at VIB, UZGent and Belgian National Commissioner on
the COVID-19 pandemic
- Key pharmacokinetic (PK), pharmacodynamic (PD), dose finding
and tolerability data to be gained during first-in-human trial
- Phase 1 trial in healthy volunteers to start by end of 2020
- Following analysis of Phase 1 data, argenx plans to launch
Phase 2 proof-of-concept trial in multifocal motor neuropathy (MMN)
within its neuromuscular franchise, and to develop in additional
indications
argenx
continues to expand its early-stage pipeline
- Lead optimization work ongoing for ARGX-118 as treatment for
airway inflammation
- New product candidate ARGX-119 expected to be announced in
2020
FIRST
QUARTER 2020 FINANCIAL RESULTS (CONSOLIDATED)
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
in thousands of € |
|
2020 |
|
2019 |
|
Variance |
Revenue |
|
€ |
19,171 |
|
€ |
36,453 |
|
€ |
(17,282) |
Other operating income |
|
€ |
4,237 |
|
€ |
3,564 |
|
€ |
673 |
Total operating income |
|
€ |
23,408 |
|
€ |
40,017 |
|
€ |
(16,609) |
Research and development expenses |
|
€ |
(94,917) |
|
€ |
(34,752) |
|
€ |
(60,165) |
Selling, general and administrative expenses |
|
€ |
(25,038) |
|
€ |
(11,306) |
|
€ |
(13,732) |
Operating loss |
|
€ |
(96,547) |
|
€ |
(6,041) |
|
€ |
(90,506) |
Financial income |
|
€ |
1,742 |
|
€ |
3,458 |
|
€ |
(1,716) |
Financial expense |
|
€ |
(4,998) |
|
€ |
— |
|
€ |
(4,998) |
Exchange gain/(losses) |
|
€ |
20,845 |
|
€ |
9,512 |
|
€ |
11,333 |
Profit/(Loss) before taxes |
|
€ |
(78,958) |
|
€ |
6,929 |
|
€ |
(85,887) |
Income tax expense |
|
€ |
(1,088) |
|
€ |
(180) |
|
€ |
(908) |
Profit/(Loss) for the period and total comprehensive
loss |
|
€ |
(80,046) |
|
€ |
6,749 |
|
€ |
(86,795) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding |
|
|
42,786,194 |
|
|
34,497,705 |
|
|
|
Basic profit/(loss) per share (in €) |
|
|
(1.87) |
|
|
0.18 |
|
|
|
Diluted profit/(loss) per share (in €) |
|
|
(1.87) |
|
|
0.17 |
|
|
|
Net increase in cash, cash equivalents and current financial assets
compared to year-end 2018 and 2017 |
|
€ |
(30,287) |
|
€ |
397,052 |
|
|
|
Cash, cash equivalents and current financial assets at the end of
the period |
|
€ |
1,305,534 |
|
€ |
961,621 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
Cash, cash equivalents and current financial assets totaled
€1,305.5 million on March 31, 2020, compared to €1,335.8 million on
December 31, 2019 and €961.6 million on March 31, 2019.
Operating income amounted to €23.4 million for
the three months ended March 31, 2020, compared to €40.0 million
for the three months ended March 31, 2019. The decrease in the
first three months of 2020 was primarily explained by the revenue
recognized in the first quarter of 2019, following a $30.0 million
development milestone payment received under the AbbVie
collaboration agreement.
Research and development expenses increased by
€60.1 million during the three months ended March 31, 2020 to reach
€94.9 million, compared to €34.8 million for the three months ended
March 31, 2019. This planned increase was mainly the result of (i)
increased external research and development expenses reflecting
higher clinical trial costs and manufacturing expenses related to
the development of the argenx product candidate portfolio and (ii)
higher personnel expenses as a result of increased costs of the
share-based payment compensation plans related to the grant of
stock options to argenx research and development employees and
increased costs associated with additional research and development
employees.
Selling, general and administrative expenses totaled €25.0
million and €11.3 million for the three months ended March 31, 2020
and 2019, respectively. The increase of €13.7 million was
principally linked to an increase of personnel expense, resulting
from (i) higher costs of the share-based payment compensation plans
related to the grant of stock options to its selling, general and
administrative employees and (ii) increased costs associated with
additional employees recruited to strengthen its selling, general
and administrative activities, notably in preparation of the
potential commercial launch of efgartigimod in the U.S., if
approved.
For the three months ended March 31, 2020, financial income,
which primarily relate to interests received on its cash and cash
equivalents and current financial assets, amounted to €1.7 million
compared to €3.5 million for the same period in 2019. Financial
expense amounted to €5.0 million for the three months ended March
31, 2020 and 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 €20.8 million for the
three months ended March 31, 2020 compared to €9.5 million for the
three months ended March 31, 2019 and were mainly attributable to
unrealized exchange rate gains on cash, cash equivalents and
current financial assets position in U.S. dollars due to the
favorable fluctuation of the EUR/USD exchange rate.
The total comprehensive loss for the three
months ended March 31, 2020 was €80.0 million compared to a total
comprehensive profit, which was principally due to the milestone
payment received from AbbVie as indicated above, of €6.7 million
for the three months ended March 31, 2019.
EXPECTED 2020 FINANCIAL
CALENDAR:
- July 30, 2020: HY 2020 financial results & business
update
- October 22, 2020: Q3 financial results & business
update
CONFERENCE CALL DETAILSThe
first quarter 2020 results will be discussed during a conference
call and webcast presentation today at 3 pm CET/9 am ET. To
participate in the conference call, please select your phone number
below and use the confirmation code 6736269. The
webcast may be accessed on the homepage of the argenx website at
www.argenx.com or by clicking here.
Dial-in numbers:Please dial in
5–10 minutes prior to 3 pm CET/ 9 am ET using the number and
conference ID below.
Confirmation Code:
6736269Belgium
+32 (0)2 793 3847Belgium
0800 48471France
+33 (0)1 7070
0781France
0805 101465Netherlands
+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 developing antibody-based medicines for patients
suffering from severe autoimmune diseases and cancer. By
translating immunology breakthroughs into innovative drug
candidates, argenx is building a world-class portfolio of
first-in-class antibodies in both early and late clinical-stages of
development. argenx is evaluating efgartigimod in multiple serious
autoimmune indications and cusatuzumab in hematological
malignancies in collaboration with Janssen, along with advancing
earlier stage assets within its therapeutic franchises.
www.argenx.com
For further information, please contact:
Beth DelGiacco, Vice President, Investor Relations +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 calendar and related
plans; the clinical data 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. 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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