REGULATED INFORMATION
GHENT, Belgium, 11 May 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its non-audited financial results for the first three months of 2017, a business update for the year-to-date and the outlook for the next period.
Operational highlights year-to-date
- Caplacizumab - wholly-owned first-in-class anti-vWF Nanobody®
- Submitted a marketing authorisation application (MAA) to the European Medicines Agency for approval in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
- Completed patient recruitment in the multi-national, double-blind, placebo-controlled Phase III HERCULES study. A total of 145 patients with aTTP have been enrolled. The study is on track to report topline results in H2 2017.
- ALX-0171 - wholly-owned inhaled anti-RSV Nanobody
- Initiated the global Phase IIb RESPIRE dose-ranging efficacy study in 180 infants hospitalised as a result of a respiratory syncytial virus (RSV) infection. Patient recruitment is currently on track to enable reporting of topline results in H2 2018.
- Vobarilizumab - anti-IL-6R Nanobody
- Received scientific advice and held “end-of-Phase II” meetings with regulators in Europe and the USA to discuss the Phase IIb data in rheumatoid arthritis (RA) and the design of a potential Phase III programme.
- Continued discussions with AbbVie and other potential pharmaceutical partners to determine the best options for advancing vobarilizumab in RA.
- Advanced the Phase II study in patients with systemic lupus erythematosus (SLE), with topline results expected to be reported in H1 2018.
- ALX-0761 - anti-IL17A/F Nanobody
- Promising results reported by our partner Merck KGaA with the bi-specific Nanobody anti-IL-17A/F in patients with moderate-to-severe chronic plaque psoriasis. Data from the Phase Ib study demonstrated very encouraging efficacy and a favourable safety and tolerability profile. Merck KGaA subsequently partnered with Avillion to advance a potential Phase II study with the bi-specific Nanobody in plaque psoriasis.
- Good progress in multiple additional proprietary and partnered programmes.
Financial highlights - first quarter 2017
- Revenues were €9.1 million (2016: €27.4 million)
- Investment in R&D was €25.7 million (2016: €24.9 million)
- Operating result of -€20.2 million (2016: -€0.7 million)
- Net cash outflow of €26.2 million (2016: €2.5 million)
- €209.2 million in cash, cash equivalents, restricted cash and short-term investments (2016: €233.7 million)
Commenting on today’s update, Dr Edwin Moses, CEO of Ablynx, said:
“We have had a positive start to the year. Filing for regulatory approval of caplacizumab in Europe to treat aTTP was a very important milestone for the Company, as was completion of patient recruitment in the Phase III HERCULES study. We are now establishing a commercial infrastructure to launch caplacizumab and are committed to making it accessible to patients as soon as possible.
Initial recruitment for the Phase IIb study of our anti-RSV Nanobody in infants is progressing as planned and we continue to prepare for a trial of this Nanobody in patients who have undergone a stem cell transplantation and have become infected with RSV.
Discussions with regulatory authorities on our Phase IIb data in RA with vobarilizumab and the design of a potential Phase III programme have been informative in our evaluation of how to move the molecule forward in this indication. We still expect to report data from our 300 patient study in SLE with vobarilizumab in H1 2018.
Our partners have also made good progress in developing Nanobodies that we have jointly discovered. In particular in this period, Merck KGaA’s results from a Phase Ib study in psoriasis with our anti-IL-17A/F bi-specific Nanobody were very exciting.
With now more than 45 R&D proprietary and partnered R&D programmes, of which 8 are in clinical development, we look forward to important progress throughout 2017.”
Financial review
