• Reported positive top line results from first-in-infant Phase I/IIa study of the inhaled anti-RSV Nanobody® (ALX-0171)
  • Clinical product pipeline expanded with the initiation of three Phase I studies in partnered programmes - eight Nanobodies are now in clinical development
  • Early-stage product pipeline significantly expanded with the start of 10 new programmes
  • On-track for first potential launch of caplacizumab (anti-vWF for the treatment of acquired TTP) in 2018
  • Important catalysts expected before year-end

GHENT, Belgium, May 12, 2016 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its non-audited financial position for the first three months of 2016, a business update for the year so far and the outlook for the next period.

Business highlights year-to-date

  • Met primary endpoint of safety and tolerability for the inhaled anti-RSV Nanobody (ALX-0171) in a Phase I/IIa study in infants, aged 1-24 months, hospitalised with an RSV infection. In addition, inhaled ALX-0171 had an immediate impact on viral replication and also reduced viral load, as compared to placebo. There was also an encouraging initial indication of therapeutic effect. These results support the advancement of the programme into a Phase II efficacy study in infants in Q4 2016.
  • Ablynx's partner, Boehringer Ingelheim started two Phase I trials with Nanobodies triggering milestone payments to Ablynx totalling €16 million. The first trial is with a bi-specific anti-VEGF/Ang2 Nanobody, BI 836880, in patients with solid tumours. The second trial is with an anti-CX3CR1 Nanobody, BI 655088, in healthy volunteers - the initial target indication for this Nanobody will be chronic kidney disease.
  • Ablynx's partner, Novartis received clearance by the FDA to start a Phase I study with a Nanobody that binds to a GPCR target, which triggered an undisclosed payment to Ablynx.
  • Publication in The New England Journal of Medicine of the TITAN Phase II study of the wholly-owned anti-vWF Nanobody, caplacizumab, in patients with acquired TTP. Continued progress in recruitment for the Phase III HERCULES study with caplacizumab and preparations are underway to file for conditional approval in Europe in H1 2017.
  • On-track to communicate top line results in Q3 2016 from the Phase IIb RA monotherapy and combination therapy studies of the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie. Patients from both studies have continued to roll-over into the open-label extension study. Recruitment for the Phase II STEADY study of ALX-0061 in patients with moderate to severe active SLE continues to proceed well, with the goal to communicate initial results in 2018.
  • Initiated 10 pre-clinical proprietary and partnered programmes with now more than 40 programmes in the pipeline, of which 8 are in clinical development.

Financial highlights - first quarter 2016

  • Revenues up 94% to €27.4 million (2015: €14.1 million)
  • Investment in R&D up 49% to €24.9 million (2015: €16.7 million)
  • Operating result of -€0.7 million (2015: -€5.0 million)
  • Net cash outflow of €2.5 million (2015: €12.9 million)
  • €233.7 million in cash, cash equivalents, restricted cash and short-term investments (2015: €193.3 million)

Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:
"We are very pleased to report excellent progress since the beginning of the year. Our clinical product pipeline is rapidly expanding with eight programmes now in clinical development, of which two are bi-specific Nanobodies, two are Nanobodies against GPCRs and one is an inhaled product, demonstrating the broad potential of our platform to generate innovative therapeutics. With the positive outcome of the Phase I/IIa study of our wholly-owned inhaled anti-RSV Nanobody, ALX-0171, we have made an important step forward in the development of a possible breakthrough for the treatment of RSV infections in infants. This trial also illustrates the potential to use inhalation as the route of administration in the development of Nanobodies for the treatment of other important lung-based diseases."

"We look forward to continuing important developments throughout 2016."

Financial review

(€ million) First three months 2016 First three months 2015 % change
Total revenue and grant income 27.4 14.1 94%
R&D income 27.2 13.9 96%
Grants 0.2 0.2 -
Operating expenses (28.1) (19.1) 47%
R&D (24.9) (16.7) 49%
G&A (3.2) (2.5) 28%
Operating result (0.7) (5.0) 86%
Net financial result 17.5 1.1 >100%
Net result 16.8 (4.0) >100%
Net cash flow (2.5) (12.9) 81%
Cash at 31 March 233.7 (1) 193.3 (2) 21%

(1) including €1.3 million in restricted cash
(2) Including €2.0 million restricted cash

Revenues increased 94% to €27.4 million (2015: €14.1 million) mainly driven by higher milestones and recognition of upfront payments from on-going collaborations. As a result of the pipeline maturing with later-stage clinical assets, the operating expenses increased to €28.1 million (2015: €19.1 million) primarily due to higher external R&D costs. The net financial result increased to €17.5 million (2015: €1.1 million) mainly relating to the effect of the fair value calculation of the Convertible Bond. As a result of the above, the Company ended the period with a net profit of €16.8 million (2015: net loss of €4.0 million).

As of 31st March 2016, the Company had €233.7 million in cash, cash equivalents, restricted cash and short-term investments.

Financial guidance and 2016 outlook confirmed

In the third quarter of 2016, Ablynx expects to communicate top line results from the monotherapy and combination therapy studies with the anti-IL-6R Nanobody, ALX-0061, in patients with RA. Following a review of the complete RA data package, AbbVie is expected to decide, before the end of 2016, whether it intends to exercise its option to exclusively license ALX-0061 in RA, in which case Ablynx will receive a US$75 million milestone payment. AbbVie would then be responsible for providing all the resources to further develop and commercialise ALX-0061 in this indication and Ablynx would be eligible to receive regulatory and sales milestones plus double-digit royalties.

In the third quarter of 2016, the Company expects that the first patients from the Phase III HERCULES study of its wholly-owned anti-vWF Nanobody, caplacizumab, will have rolled-over into a three-year follow-up study to evaluate the long-term safety and clinical effects of the product.
In the fourth quarter 2016, Ablynx expects to start a Phase II efficacy study with the wholly-owned inhaled anti-RSV Nanobody, ALX-0171, in infants who are hospitalised as a result of an RSV infection.

The Company reiterates its net cash burn guidance for the full year 2016 of €65-75 million.

Financial calendar 2016

25 August 2016 - half-year results
23 November 2016 - Q3 results

Shareholders' clubs @ Ablynx

18 May at 5.45pm - in Dutch
14 September at 5.45pm - in Dutch
7 December at 5.45pm - in Dutch

If you would like to attend, please contact us via investors@ablynx.com.


FDA U.S. Food and Drug Administration
GPCR G-protein coupled receptor
IL-6R receptor of interleukin-6
RA rheumatoid arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
TTP thrombotic thrombocytopenic purpura

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 40 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, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

For more information, please contact
Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses@ablynx.com

Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com
Follow us on Twitter @AblynxABLX

Ablynx media relations
FTI Consulting:
Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000
e: ablynx@fticonsulting.com

pdf format of the press release http://hugin.info/137912/R/2011870/745003.pdf