ABLYNX PROVIDES BUSINESS UPDATE FOR THE FIRST NINE MONTHS OF 2015


REGULATED INFORMATION

  • Clinical pipeline further advanced with one Phase III and four Phase II studies currently on-going in-house, and first potential product launch in 2018
  • Significant expansion of major alliance in immuno-oncology with Merck & Co, Inc.
  • Strong financial position with €262 million in cash
  • Positive outlook for the next 12 months with a number of important milestones

GHENT, Belgium, Nov. 18, 2015 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its business update, summarising the non-audited financial position for the first nine months of 2015, material events since 30 September 2015 and the outlook for the next period.

Operating highlights - third quarter 2015

  • Significant expansion of the immuno-oncology collaboration with Merck & Co., Inc., (known as MSD outside the United States and Canada) which now includes 17 programmes, with a focus on multi-specific Nanobodies® directed towards immune modulator targets.
  • Initiation of the Phase III HERCULES study with the anti-vWF Nanobody, caplacizumab, in patients with acquired TTP, for which results are expected in H2 2017. Preparations continue for the filing for conditional approval of caplacizumab in Europe in H1 2017.
  • Initiation of the Phase II STEADY study with the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie, in patients with moderate to severe active SLE, for which results are expected in 2018.
  • Continued progress in recruitment for both Phase IIb studies with ALX-0061 in RA patients and the Phase IIa study with ALX-0171 (anti-RSV) in infected, hospitalised infants.
  • Important advances in a number of the >25 pre-clinical proprietary and partnered programmes.

Financial highlights - year-to-date 30 September 2015

  • Revenues up 52% to €53.6 million (2014: €35.2 million)
  • Investment in R&D up 50% to €58.5 million (2014: €39.1 million)
  • Operating result of -€13.3 million (2014: -€11.7 million)
  • Net cash inflow of €56.0 million (2014: €21.1 million)
  • Strong financial position with €262.2 million in cash, cash equivalents, restricted cash and short-term investments (2014: €221.5 million)

Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:

"I am very pleased to report excellent progress and strong growth during the past nine months across our entire business. Ablynx is maturing towards a late-stage clinical development company with one Phase III and four Phase II studies on-going in-house that have a total enrolment target of nearly 900 patients. Furthermore, we are making good progress in our evolution into a vertically-integrated company to enable us to lead the commercialisation of our first product, caplacizumab, in Europe and the USA."

"The attractiveness of our Nanobody platform as an engine to produce a unique and powerful new class of drugs was emphasised by the expansion of our collaboration with Merck & Co., Inc., in the area of immuno-oncology. We have recently received our first milestone of €3.5 million under this collaboration, demonstrating again that Nanobodies, with their powerful multi-functional capability, may have the potential to offer an additional dimension compared to existing therapeutic agents."

"We ended the first nine months of 2015 in a strong financial position, and look forward to the rest of the year and continuing important developments throughout 2016."

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 30 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 and Taisho Pharmaceutical Co., Ltd. The Company is headquartered in Ghent, Belgium. 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

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 Instinctif Partners:
Sue Charles, Daniel Gooch
London office
t:   +44 (0)20 7866 7905
e:  ablynx@instinctif.com

Belgium/Dutch and French language
Jim Rusagara
Brussels office
t:   +32 (0)2 626 9500
e:  ablynx@instinctif.com

complete version of the press release http://hugin.info/137912/R/1967519/718820.pdf

HUG#1967519