- 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||%|
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 investments. 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 1 st of June 2016. Financial calendar 2017 23 February 2017 - full year results 201627 April 2017 - Annual General Meeting11 May 2017 - Q1 results 201724 August 2017 - half year results 201716 November 2017 - Q3 results 2017 Shareholders' clubs @ Ablynx 7 December 2016 at 5.45pm - in Dutch8 March 2017 at 5.45pm - in DutchIf you would like to attend, please contact us via email@example.com. Glossary EMA European Medicines AgencyFDA U.S. Food and Drug Administration IL-6R receptor of interleukin-6 RA rheumatoid arthritisRSV respiratory syncytial virus SLE systemic lupus erythematosusaTTP acquired thrombotic thrombocytopenic purpura
About AblynxAblynx 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 45 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 Ablynx:Dr Edwin MosesCEOt: +32 (0)9 262 00 07m: +32 (0)473 39 50 68e: firstname.lastname@example.org Marieke VermeerschDirector IR & Corporate Communicationst: +32 (0)9 262 00 82m: +32 (0)479 49 06 03 e: email@example.comFollow us on Twitter @AblynxABLX Ablynx media/analyst relations FTI Consulting:Julia Phillips, Brett Pollard, Mo Noonan, Matthew Mosst: +44 20 3727 1000e: firstname.lastname@example.org Attachments: http://www.globenewswire.com/NewsRoom/AttachmentNg/fc10fa18-ec0b-4806-b2e5-48e31721fac8