YASTEST
REGULATED INFORMATION
Positive Phase III results with caplacizumab and a
successful U.S. IPO
GHENT, Belgium,
16 November 2017 - Ablynx NV [Euronext Brussels and Nasdaq:
ABLX] today announced its non-audited financial results for the
first nine months of 2017, a business update for the year-to-date
and the outlook for the next period.
Business
highlights for the year-to-date
-
Corporate
-
In October, successfully raised $230 million
(approximately €195 million) as part of an initial U.S. public
offering on Nasdaq
-
In October, established a U.S. subsidiary,
Ablynx Inc., and appointed a General Manager based in the U.S.A. to
lead the commercialisation of caplacizumab
-
Caplacizumab - wholly-owned anti-vWF Nanobody®
for the treatment of acquired thrombotic thrombocytopenic purpura
(aTTP)
-
In February, submitted a marketing authorisation
application (MAA) to the European Medicines Agency (EMA)
-
In July, received Fast Track designation from
the U.S. Food and Drug Administration (FDA)
-
In October, reported positive topline results
from the Phase III HERCULES study, meeting primary and key
secondary endpoints
-
In October, completed recruitment of eligible
HERCULES patients into the three-year follow-up study (85%
roll-over rate)
-
ALX-0171 - wholly-owned inhaled anti-RSV
Nanobody for the treatment of RSV infections
-
In August, completed the sequential dose
escalation part of the Phase IIb RESPIRE study in 36 infants and,
after receiving approval from the Data Monitoring Committee,
subsequently initiated the parallel dose part in 144 infants, with
topline results expected in H2 2018
-
Vobarilizumab - anti-IL-6R Nanobody for the
treatment of rheumatoid arthritis (RA) and systemic lupus
erythematosus (SLE)
-
Advanced the Phase II STEADY study in 312
patients recruited with SLE, with topline results expected in H1
2018
-
Continued the open-label extension study in RA
for those patients who had completed the Phase IIb studies (94%
roll-over rate), with topline results expected in H2 2018
-
Partnered programmes
-
In May, received a €15 million milestone payment
from Merck KGaA for the completion of a pre-clinical package for
ALX-1141 targeting ADAMTS-5 in osteoarthritis, with Merck KGaA
subsequently starting a Phase I study
-
In June, received a €2.5 million milestone
payment from Merck & Co., Inc. as a result of their initiation
of a toxicology study with a bi-specific Nanobody as part of our
immuno-oncology collaboration
-
In July, entered into a new research
collaboration with Sanofi on up to eight new programmes, focused
initially on immune-mediated inflammatory diseases, with €23
million in upfront payments and up to €2.4 billion in potential
milestones plus tiered royalties
Financial
highlights for the first nine months of 2017
-
Revenues of €44.7 million (2016: €68.9
million)
-
R&D expenditure of €73.1 million (2016:
€72.8 million)
-
Operating loss of €42.1 million (2016: €13.6
million)
-
Net cash burn[1] of €26.9
million (2016: €44.1 million)
-
Cash position of €208.6 million (2016: €263.6
million)
Commenting on
today's update, Dr Edwin Moses, CEO of Ablynx, said:
"We are very excited about the progress we have made over the
period. We successfully completed the Phase III HERCULES study of
our lead, wholly-owned product candidate, showing the great
potential that caplacizumab has to change the lives of patients
with aTTP, for which there is currently no approved therapeutic
drug available. We are now finalising the remaining analyses and
are working to complete the regulatory filings. Meanwhile, we have
strengthened our medical and commercial teams and have established
a U.S. subsidiary, underlining our commitment to rapidly bring this
treatment to patients."
"Beyond caplacizumab, we have
progressed vobarilizumab in SLE according to plan, and are moving
forward with ALX-0171 in RSV-infected hospitalised infants and in
RSV-infected stem cell transplant patients. Like caplacizumab in
aTTP, these three programmes are focussed on patients with a high
unmet medical need and with no or limited treatment options."
"Our recent, very successful
listing on Nasdaq was the biggest biotech IPO of the year in the
U.S.A. and has resulted in a significant increase in the quality
and breadth of our investor base. At the end of September,
including the net IPO proceeds, we have approximately €390 million
to drive our proprietary programmes forward while continuing to
expand and develop our pipeline."
Financial review
- 1 January 2017 to 30 September 2017
(€
millions) |
First nine months 2017 |
First nine months 2016 |
Revenue |
44.7 |
68.5 |
Grant income |
|
0.4 |
Total revenue and grant income |
44.7 |
68.9 |
Research and development expenses |
(73.1) |
(72.8) |
General and administrative expenses |
(13.7) |
(9.8) |
Operating result |
(42.1) |
(13.6) |
Financial income |
2.0 |
29.8 |
Financial expenses |
(5.6) |
(5.3) |
Profit/(loss) for the period |
(45.8) |
10.9 |
Net cash flow |
(26.9) |
(44.1)(1) |
Cash at 30 September |
208.6(2) |
263.6(3) |
(1)
excluding €71.4 million net proceeds from the private placement of
new shares (1 June 2016)
(2)
including €1.6 million in restricted cash
(3)
including €1.3 million in restricted cash
Total revenue and grant income was
€44.7 million (2016: €68.9 million) and the difference was driven
by comparatively lower recognition of upfront payments from the
ongoing collaboration with AbbVie and comparatively lower milestone
payments received in 2017. Operating expenses increased to €86.8
million (2016: €82.6 million) primarily due to higher general and
administrative expenses, including pre-commercialisation costs for
caplacizumab, and expenses related to the preparations for a U.S.
IPO. The net financial loss of €3.6 million and the variance versus
2016 primarily relate to the fair value impact and amortisation
(mainly non-cash) of the convertible bond. As a result of the
above, the Company ended the period with a net loss of €45.8
million (2016: net profit of €10.9 million).
The Company ended the period with
a total liquidity position of €208.6 million (2016: €263.6 million)
which consists of cash and cash equivalents of €20.4 million, other
financial assets of €186.5 million and restricted cash of €1.6
million. This does not include proceeds from the $230 million U.S.
public offering on Nasdaq which closed post period end.
Outlook for the
remainder of 2017 - progressing according to plan
-
Report on the results of the ongoing single and
multiple dose ethno-bridging Phase I study of caplacizumab in
healthy Japanese subjects
-
Aim to present the HERCULES data at a key
scientific conference and submit them to a peer-reviewed
journal
-
Continue the regulatory and commercial
preparations for the potential approval and launch of caplacizumab
in Europe in 2018 and the U.S.A. in 2019
-
Seek regulatory approval to enable a Phase II
study in Japan with ALX-0171 in infants hospitalised with a RSV
infection
-
Seek regulatory approval to enable a global
Phase II study with ALX-0171 in adults who have undergone stem cell
transplantation and have become infected with RSV
Next
shareholders' club at Ablynx (Dutch language only): 6 December
2017 at 5.30pm
To attend an event, please register via email:
investors@ablynx.com
Full year results
2017: 22 February 2018
Glossary of
terms
aTTP acquired thrombotic thrombocytopenic
purpura
EMA European Medicines Agency
FDA Food and Drug Administration
IPO initial public offering
MAA marketing authorisation application
RA rheumatoid
arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
About
Ablynx
Ablynx is a biopharmaceutical
company engaged in the development of Nanobodies, proprietary
therapeutic proteins based on single-domain antibody fragments,
which combine the advantages of conventional antibody drugs with
some of the features of small-molecule drugs. Ablynx is dedicated
to creating new medicines which will make a real difference to
society. Today, the Company has more than 45 proprietary and
partnered programmes in development in various therapeutic areas
including inflammation, haematology, immuno-oncology, oncology and
respiratory disease. The Company has collaborations with multiple
pharmaceutical companies including AbbVie; Boehringer Ingelheim;
Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, U.S.;
Merck KGaA; Novartis; Novo Nordisk; Sanofi and Taisho
Pharmaceuticals. The Company is headquartered in Ghent, Belgium and
listed on Euronext Brussels and NASDAQ. More information can
be found on www.ablynx.com.
For more
information, please contact
Ablynx:
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses@ablynx.com
Lies Vanneste
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
e: lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media
relations:
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Sukaina Virji
t: +44 (0)20 3709 5700
e: ablynx@consilium-comms.com
Disclaimer
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company or, as appropriate, the
Company directors' current expectations and projections about
future events. By their nature, forward-looking statements involve
a number of risks, uncertainties and assumptions that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements. These risks,
uncertainties and assumptions could adversely affect the outcome
and financial effects of the plans and events described herein. A
multitude of factors including, but not limited to, changes in
demand, competition and technology, can cause actual events,
performance or results to differ significantly from any anticipated
development. Forward looking statements contained in this press
release regarding past trends or activities should not be taken as
a representation that such trends or activities will continue in
the future. As a result, the Company expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or
representatives nor any of its parent or subsidiary undertakings or
any such person's officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in
this press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
[1] Net cash
burn is the difference between the liquidity position of the
current and the previous year minus the proceeds (net of issue
costs), if any, from the issuance of ordinary shares.
pdf version of the press
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Source: Ablynx via Globenewswire
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