OREANDA-NEWS. Ablynx today announced its financial results for the six-month period ending 30 June 2016, which have been prepared in accordance with the IAS 34 "Interim Financial Reporting" as adopted by the European Union, a business update for the year-to-date and the outlook for the next period.

R&D highlights year-to-date

  • Delivered compelling efficacy and safety results from both Phase IIb RA monotherapy and combination therapy studies of vobarilizumab
  • Reported encouraging data from  the Phase I/IIa study of inhaled ALX-0171 in infants hospitalised with an RSV infection
  • Good progress in the recruitment of patients in the Phase III HERCULES study with caplacizumab in acquired TTP
  • Three partnered Nanobody® programmes began Phase I clinical development
  • Initiated >15 new wholly-owned and partnered pre-clinical programmes bringing the total active programmes in the R&D pipeline to >45

Financial highlights first six months of 2016

  • Total revenues were €53.5 million, a 39% increase compared with 2015
  • Operating loss reduced to €2.0 million, compared with €7.4 million in 2015
  • Net profit of €22.8 million, mainly driven by the accounting treatment of the convertible bond
  • Cash position of €288.7 million, strengthened by the successful private placement of new shares (raising €71.4 million in net proceeds)
  • Outlook for the remainder of the year confirmed

"It has been a hugely productive year so far for us," said Dr Edwin Moses, CEO of Ablynx. "We successfully completed three clinical trials in RSV and RA and the results provide an excellent platform for the continued development of both ALX-0171 and vobarilizumab. With ALX-0171, we are now preparing for a worldwide Phase II efficacy study in hospitalised infants with an RSV infection which is expected to start before the end of the year. The Phase IIb data for vobarilizumab give us great confidence that the molecule should move into Phase III development as soon as possible. We are now preparing the complete data package from the Phase IIb vobarilizumab studies for AbbVie and we expect them to decide before the end of the year if they wish to opt-in and license the product for RA. In parallel, we are starting preparations for a Phase III programme with vobarilizumab in RA and we plan to move forward with this in the event AbbVie do not opt-in, while then at the same exploring new relationships which will allow us to maximize the potential of this exciting drug candidate."

"We continued to make good progress in our most advanced clinical programme, where we are developing caplacizumab for the treatment of acquired TTP, and are on track to file the dossier for conditional approval in Europe early next year. Recruitment for the HERCULES Phase III trial with caplacizumab in acquired TTP patients is proceeding well and we now intend to increase the power of the key secondary efficacy endpoint by recruiting about 40% more patients than originally planned while still aiming to meet our original goal to report the study results before the end of 2017."

"Our R&D pipeline is developing very encouragingly and now includes more than 45 proprietary and partnered programmes. Three new programmes entered clinical development with our partners and >15 new wholly-owned and partnered discovery programmes have been initiated since the beginning of the year, demonstrating our commitment to continue to fuel our product pipeline."

"In June, we further strengthened our cash position through a €74.2 million (gross) oversubscribed private placement of new shares with existing and new investors, and we remain focused on delivering sustainable value to all our stakeholders."

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 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.