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Strong clinical progress across our product portfolio

GHENT, Belgium, 23 November 2016 -
Ablynx[Euronext Brussels: ABLX; OTC: ABYLY]

today announced its financial results, summarising the non-audited financial
position for the first nine months of 2016, a business update for the
year-to-date and the outlook for the next period.

Operational highlights year-to-date

* Caplacizumab - wholly-owned anti-vWF Nanobody® for the treatment of
acquired TTP (aTTP) * Publication of the Phase II TITAN study results for
caplacizumab in The New England Journal of Medicine (NEJM). * Post-hoc
analyses of the TITAN study results demonstrated that caplacizumab has a
significant effect on clinically relevant endpoints showing a 71% reduction
in frequency of major thromboembolic events (e.g. stroke) and a dramatic
reduction in refractoriness to treatment; the latter is associated with a
very poor prognosis for survival of an acute episode of aTTP. * Initial
target recruitment of 92 patients in HERCULES Phase III study of
caplacizumab already achieved, 6 months ahead of schedule. Target enrolment
increased to 132 patients with results still expected in H2 2017. * Started
3-year follow-up study with patients who completed the HERCULES study to
evaluate the long-term safety and efficacy of caplacizumab, the safety and
efficacy of repeated use of caplacizumab and to characterise the severity
and long-term impact of aTTP. * On track to file for conditional approval
of caplacizumab in Europe in early 2017.
* ALX-0171 - wholly-owned inhaled Nanobody for the treatment of RSV
infections * Once daily inhalation, for 3 consecutive days, of ALX-0171 in
infants hospitalised with a RSV infection was safe and well tolerated, had
a significant and immediate impact on viral replication and an encouraging
initial therapeutic effect. * Phase IIb dose-ranging efficacy study in 180
hospitalised infants with a RSV infection on track to start by year-end.
* Vobarilizumab - anti-IL-6R Nanobody for the treatment of RA and SLE *
Delivered excellent efficacy and safety results from the Phase IIb
monotherapy and combination therapy studies of vobarilizumab in RA; AbbVie
subsequently decided not to exercise its right to opt-in and license
vobarilizumab in this indication. Ablynx has started the process of
identifying a new partner for vobarilizumab in RA. * Recruitment of 300
patients in SLE Phase II study ahead of schedule; results anticipated in H1
* Three partnered Nanobody programmes began Phase I clinical development,
which triggered>€16 million in success fees to Ablynx.
* Ion channel collaboration with Merck&Co., Inc. extended for the second
time, triggering a €1 million milestone payment to Ablynx.
* Initiated>15 new wholly-owned and partnered pre-clinical programmes
bringing the total number of active programmes in the R&D pipeline to>45.

Financial highlights - at 30 September 2016

* Successfully raised €74 million (gross) through an oversubscribed private
placement of new shares
* Total revenues were €68.9 million, a 29% increase compared with 2015
* Operating loss of €13.7 million, compared with €13.3 million in 2015
* Net profit of €10.9 million, mainly driven by the accounting treatment of
the outstanding convertible bond
* Cash position of €263.6 million compared to €262.2 at 30 September 2015
* Financial guidance for the full year 2016 reiterated

Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:
"Year-to-date, we have made tremendous progress in our R&D portfolio with
excellent results from three clinical studies, the expansion of our Nanobody
clinical pipeline with three new partnered Phase I programmes starting, and
the progression of wholly-owned and partnered early-stage programmes. Our
lead programme, caplacizumab, is advancing very well and we are on track to
commercialise this product ourselves with the first launch anticipated in
Europe in 2018. We were of course disappointed that AbbVie decided not to
exercise its right to license vobarilizumab after our Phase IIb results in RA
but we remain on track to organise the end-of-Phase II regulatory
consultations with the FDA and EMA in H1 2017. We have initiated the process
to identify a new partner for vobarilizumab in RA to help take this
innovative drug candidate through Phase III and into commercialisation.
Recruitment in the Phase II SLE study with vobarilizumab is progressing well.
We further strengthened our cash position through an oversubscribed private
placement of new shares and agreed a second extension of our ion channel
collaboration with Merck&Co."

"We look forward to reporting on important developments throughout 2016 and

Financial review - 1stJanuary 2016 to 30thSeptember 2016

| (€ million) First nine months 2016 First nine months 2015 % change |
| Total revenue and grant income 68.9 53.6 29% |
| R&D income 68.5 53.1 29% |
| Grants 0.4 0.5 (20%) |
| Operating expenses (82.6) (66.9) 23% |
| R&D (72.8) (58.5) 25% |
| G&A (9.8) (8.4) 17% |
| Operating result (13.6) (13.3) 2% |
| Net financial result 24.5 (8.4) >100% |
| Net result 10.9 (21.7) >100% |
| Net operational cash flow (44.1)(1) (41.3)(2) 7% |
| Cash at 30 September 263.6(3) 262.2(4) 0.5% |
(1) Excluding €71.4 million net proceeds from the private placement of new
shares (1 June 2016)

(2) Excluding €97.2 million net proceeds from the convertible bond (20 May

(3) Including €1.3 million in restricted cash

(4) Including €1.6 million restricted cash

Revenues increased 29% to €68.9 million (2015: €53.6 million) mainly driven by
milestone payments received from Boehringer Ingelheim and recognised income
from the upfront payments received from Merck&Co., Inc. and Novo Nordisk. As
a result of the pipeline maturing with later-stage clinical assets, the
operating expenses increased to €82.6 million (2015: €66.9 million),
primarily driven by higher R&D expenses attributable to investment in
personnel and external development costs. As a result of the above, the
operating loss was €13.6 million during the first nine months of 2016 (2015:
€13.3 million).

The net financial result of €24.5 million primarily relates to the fair value
impact (mainly non-cash) of the convertible bond (driven by the lower share
price on 30 September 2016 as compared to 31 December 2015).

As a result of the above, the Company ended the first nine months of 2016 with
a profit of €10.9 million (2015: loss of €21.7 million).

Following the successful private placement of new shares, raising €71.4
million in net proceeds, the Company had a positive net cash inflow of €27.4
million for the first nine months of 2016 and ended the period with €263.6
million in cash, cash equivalents, restricted cash and short-term

2016 outlook and financial guidance confirmed

Ablynx will attend the annual American Society of Hematology (ASH) meeting
being held on 3-6 December 2016, in San Diego, USA. Prior to the start of the
conference, a HERCULES investigator meeting will be hosted by Ablynx and the
first global aTTP workshop with key physicians in TTP will be held.

Before year-end, Ablynx expects to start a Phase IIb dose-ranging efficacy
study with inhaled ALX-0171 in 180 infants who have been hospitalised as a
result of a RSV infection. The results from this study are anticipated in the
second half of 2018.

The Company reiterates its net cash burn guidance for the full year 2016 of
€65-75 million, not including the net proceeds from the private placement of
new shares announced on the 1stof June 2016.

Financial calendar 2017

23 February 2017 - full year results 2016
27 April 2017 - Annual General Meeting
11 May 2017 - Q1 results 2017
24 August 2017 - half year results 2017
16 November 2017 - Q3 results 2017

Shareholders' clubs @ Ablynx

7 December 2016 at 5.45pm - in Dutch
8 March 2017 at 5.45pm - in Dutch
If you would like to attend, please contact us


EMA European Medicines Agency
FDA U.S. Food and Drug Administration
IL-6R receptor of interleukin-6
RA rheumatoid arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
aTTP acquired thrombotic thrombocytopenic purpura

About Ablynx

Ablynxis a biopharmaceutical company engaged in the development ofNanobodies®,
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 than45 proprietary and partnered programmesin 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, Genzyme, Merck&Co., Inc., Merck KGaA, Novartis, Novo Nordisk and
Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More
information can be found

For more information, please contact


Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68

Marieke Vermeersch
Director IR&Corporate Communications
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03

Follow us on Twitter @AblynxABLX

Ablynx media/analyst relations

FTI Consulting:

Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000

pdf format of the press release


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