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Ablynx [Euronext Brussels: ABLX] today announced its results for the six-month period ending 30 June 2014, which have been prepared in accordance with the IAS 34 "Interim Financial Reporting" as adopted by the European Union. The Company's operational highlights are also reported.

Operational news

  • Achieved clinical proof-of-concept with the anti-vWF Nanobody®, caplacizumab, in patients with acquired TTP. Preparations to start the Phase III study in 2015 have been initiated and exploratory discussions with potential partners are taking place
  • Signed major discovery collaboration and licensing agreement in the field of cancer immunotherapy with Merck & Co, with an upfront payment of €20 million, €10.7 million in research funding and up to €1.7 billion in potential milestone payments plus royalties
  • Announced positive results from two Phase I clinical inhalation studies with the anti-RSV Nanobody, ALX-0171, in healthy volunteers and subjects with hyper-reactive airways. In addition, ALX-0171 achieved in vivo proof-of-concept in an RSV animal model. Preparations continue to allow the initiation of a paediatric study with ALX-0171 in Q4 2014
  • Initiated a Phase I bioavailability study with the subcutaneous formulation of the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie. Continued preparations to start Phase II studies in RA and SLE in 2015
  • Ablynx's partner, Merck Serono, completed the single ascending dose study in healthy volunteers and initiated a Phase Ib study with the bi-specific anti-IL-17A/F Nanobody, ALX-0761, in subjects with moderate to severe psoriasis
  • Ablynx exercised an opt-out option for to the co-development project ALX-0751, a Nanobody in pre-clinical development against an undisclosed target in oncology. Merck Serono is now solely responsible for the research and development strategy and all costs associated with this programme while Ablynx has the potential to receive milestones and royalties
  • After completing pre-clinical studies with the anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, a decision was made not to progress this programme into Phase I studies because of insufficient differentiation from the competition
  • Following the termination of the Phase I study with BI 1034020 in Alzheimer's disease, and after a full review of the programme, Boehringer Ingelheim (BI) decided not to move forward with the development of this anti-Abeta Nanobody, thereby ending the collaboration in Alzheimer's disease that both companies entered into in January 2007

Financial news

  • Raised €41.7 million in a private placement of new shares (accelerated book building procedure, ABO)
  • Significant increase in cash income to €26.8 million (2013: €0.9 million)
  • Revenue growth of 72% to €22.2 million (2013: €12.9 million)
  • Net loss for the period reduced by 40% to €6.3 million (2013: €10.5 million)
  • Net operational cash burn well-controlled at €3.9 million (2013: €21.6 million)
  • Strong financial position with €196.0 million in cash, cash equivalents, restricted cash and short-term investments (cash from the ABO was received in the third quarter and hence did not contribute to the cash position for the first six months ending 30 June 2014)

Commenting on the half-year 2014 results, Dr Edwin Moses, CEO of Ablynx, said:

"We are very pleased with the progress we have made during the first six months of the year, both operationally and financially. We delivered our third clinical proof-of-concept and now have a Phase III ready asset, demonstrating an important transition for Ablynx into a late-stage clinical development company. We continued to advance the other lead clinical programmes, ALX-0171 for the treatment of RSV infection in infants and ALX-0061 for the treatment of RA and SLE. Our partner Merck Serono has further progressed ALX-0761, the bi-specific anti-IL-17A/F Nanobody, and started a Phase I/II study in patients with psoriasis."

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