ABLYNX ANNOUNCES HALF-YEAR RESULTS FOR 2014

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| Source: Ablynx

GHENT, Belgium, Aug. 28, 2014 (GLOBE NEWSWIRE) -- 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.

The results will be discussed during a webcast presentation today at 4pm CET, 10am EST
The webcast is accessible on the home page of Ablynx's website at www.ablynx.com or by clicking here
To participate in the Q&A, dial +32(0)2 789 21 26 with confirmation code 6222038

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."

"We signed a second deal with Merck & Co, this time in the field of cancer immuno-therapeutics, which was a further validation of the broad applicability of our technology and more specifically the potential of the platform to produce multi-specific combinations, which may offer key advantages in developing novel drugs."

"We successfully raised €41.7 million through an over-subscribed private placement of new shares with new and existing institutional investors both in the US and Europe, thereby further expanding and diversifying our shareholder base. The funds raised strengthen our financial position, allowing us to continue to invest in our technology platform and wholly-owned product pipeline and enabling us to make decisions on partnering of assets based on medium to long-term business considerations rather than short-term financial need."

"Finally, we are looking forward to continuing good progress in 2014 for the >30 Nanobody programmes in research and development both as part of our wholly-owned pipeline and through our partnerships. We will also continue to invest in new product and technology programmes in line with our overall business strategy."

Financial review

Key figures

(€ million) H1 2014 H1 2013 % change
Revenues 22.2 12.9 72%
  R&D income 21.8 12.0 82%
  Grants 0.4 0.9 (56%)
Operating expenses (29.8) (23.8) 25%
  R&D (24.5) (19.3) 27%
  G&A (5.3) (4.5) 18%
Operating result (7.6) (10.9) 30%
Net financial result 1.3 0.4 225%
Net result (6.3) (10.5) 40%
       
Net operational cash burn (3.9) (21.6) (82%)
Cash at June 30th 196.0 (1) (2) 72.0 (3) 172%

             (1)    Not including proceeds from the private placement completed on 3 July 2014 (€41.7 million raised)
             (2)    Including €2.0 million in restricted cash
             (3)    Including €2.3 million in restricted cash and including proceeds from private placement  closed on 28 February 2013 (€31.5 million raised)

About Ablynx

Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has more than 30 programmes in the pipeline and six Nanobodies in clinical development. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

For more information, please contact

Ablynx:

Dr Edwin Moses
CEO
t:   +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
     +32 (0)473 39 50 68
e:  edwin.moses@ablynx.com

Marieke Vermeersch
Associate Director Investor Relations
t:   +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e:  marieke.vermeersch@ablynx.com
Follow us on Twitter @AblynxABLX

Ablynx media relations Consilium Strategic Communications:

Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
t:   +44 203 709 5700
e:  ablynx@consilium-comms.com

complete version of the press release http://hugin.info/137912/R/1851555/646738.pdf

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