- 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 2018.
- 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.
- 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
|(€ million)||First nine months 2016||First nine months 2015||% change|
|Total revenue and grant income||68.9||53.6||29||%|
|Net financial result||24.5||(8.4||)||>100%|
|Net operational cash flow||(44.1) (1)||(41.3) (2)||7||%|
|Cash at 30 September||263.6 (3)||262.2 (4)||0.5||%|