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 purpuraEMA
European Medicines AgencyFDA Food and Drug
AdministrationIPO initial public
offeringMAA marketing authorisation
applicationRA rheumatoid
arthritisRSV respiratory syncytial
virusSLE 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
contactAblynx:Dr Edwin MosesCEOt: +32 (0)9
262 00 07m: +32 (0)473 39 50 68e: edwin.moses@ablynx.com
Lies VannesteDirector Investor Relationst: +32 (0)9
262 01 37m: +32 (0)498 05 35 79 e:
lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media relations:Consilium Strategic
CommunicationsMary-Jane Elliott, Philippa Gardner, Sukaina
Virjit: +44 (0)20 3709 5700e:
ablynx@consilium-comms.com
DisclaimerCertain 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.
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