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ABLYNX ANNOUNCES ITS BUSINESS UPDATE FOR THE FIRST NINE MONTHS OF 2014

REGULATED INFORMATION

A period of good pipeline progress towards later stage clinical trials, a major alliance in the field of immuno-oncology and a strengthened financial position

GHENT, Belgium, Nov. 13, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced its non-audited business update, summarising Ablynx's financial position for the first nine months of 2014, material events post 30th September 2014 and the outlook for the rest of 2014 and 2015.

Operating highlights - third quarter-to-date

  • Preparations to start the Phase III study in mid-2015 with the anti-vWF Nanobody, caplacizumab, in patients with acquired TTP, are well underway following compelling Phase II clinical proof-of-concept results from the TITAN study announced in June. In addition, results from the post-hoc analysis of this study will be presented at the upcoming American Society of Haematology (ASH) meeting in San Francisco, USA, on 8th December at 7am Pacific Standard Time (PST) (16h CET)
  • The Paediatric Investigation Plan (PIP) for the anti-RSV Nanobody, ALX-0171, was approved by the EMA and Ablynx is on track to treat the first infant in the Phase IIa study before the end of 2014
  • The Company announced results from a Phase I study of the subcutaneous administration of the anti-IL-6R Nanobody, ALX-0061, demonstrating more than 80% bioavailability. Ablynx is on track to start the next Phase II studies with the subcutaneous formulation of ALX-0061 in RA and SLE in 2015
  • Ablynx expanded its relationship with a leading Chinese pharmaceutical company, Eddingpharm, by granting them a license to develop and commercialise the anti-TNFa Nanobody, ozoralizumab, in mainland China, Hong Kong, Macao and Taiwan

Financial highlights - first nine months ending 30th September 2014

  • Raised €41.7 million through a private placement of new shares
  • More than doubled revenues to €35.2 million (2013: €16.7 million)
  • Reduced the net loss for the period to €9.1 million (2013: €18.9 million)
  • Net operational cash burn well under control at €17.8 million (2013: €30.9 million)
  • Strong financial position with €221.5 million in cash, cash equivalents, restricted cash and short-term investments (2013: €63.0 million)
  • Launched Spotlight Options on the Derivatives Market of Euronext Brussels and Sponsored Level I ADRs on the OTC Market in the USA

Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:

"I am pleased to report continued good progress during the past nine months across the entire business. It has been an exciting year as we have focussed on implementing our strategy to develop the Company into a clinical stage biopharmaceutical company with later-stage products. With caplacizumab, we now have a Phase III ready asset for which we have the necessary resources and expertise to further develop the product towards commercialisation. We are on track to start the Phase IIa study, in infants with an RSV infection, using our first inhaled Nanobody, ALX-0171, which has first-in-class potential. We continued to make encouraging progress with our partnered programmes and were successful in the signing of our second deal with Merck & Co, in the field of immune-oncology."

"We further strengthened our financial position through an oversubscribed private placement of new shares, raising €41.7 million, whilst continuing to focus on prudent cash management. We look forward to the rest of 2014 and continuing important developments throughout 2015."

Financial review

(€ million) First 9 months of 2014 First 9 months of 2013 % change
Revenues 35.2 16.7 111%
R&D income 34.1 15.7 117%
Grants 1.1 0.9 22%
Operating expenses (46.9) (36.2) 30%
R&D (39.1) (29.7) 32%
G&A (7.8) (6.4) 22%
Operating result (11.7) (19.5) 40%
Net financial result 2.6 0.6 333%
Net result (9.1) (18.9) 48%
Net operational cash burn (17.8) (30.9) 42%
Net cash inflow/(burn) 21.1 (0.2) --
Cash at 30th September 221.5(1) 63.0(2) 252%
(1) including €2.0 million restricted cash
(2) including €2.3 million restricted cash

Revenues more than doubled to €35.2 million (2013: €16.7 million) mainly driven by higher FTE and recognised upfront payments from on-going collaborations. Operating expenses increased to €46.9 million (2013: €36.2 million) due primarily to higher external R&D costs. The net loss for the period reduced by more than 50% to €9.1 million (2013: €18.9 million).

Following the successful placement completed on 3rd July 2014, the Company had a positive net cash inflow of €21.1 million for the first 9 months of 2014 and ended the period with €221.5 million in cash, cash equivalents, restricted cash and short-term investments.

Events after 30th September 2014 and outlook for the remainder of 2014 and 2015

On 21st October, Ablynx announced the issuance of an additional 12,500 common shares in exchange for €22,500, as the result of the exercise of warrants by some employees and consultants of the Company. As a result of this transaction, Ablynx now has 54,014,159 shares outstanding.

On 23rd October, Ablynx announced positive results from the Phase I study of the subcutaneous formulation of its anti-IL-6R Nanobody, ALX-0061. Bioavailability after subcutaneous administration was higher than 80% and there were no significant safety or tolerability signals observed.

As planned, Ablynx expects to start the first-in-infant Phase IIa study with the anti-RSV Nanobody, ALX-0171, before the end of 2014. Results from the Phase I study with the anti-vWF Nanobody, caplacizumab, to demonstrate bioequivalence between the lyophilised and liquid formulations of caplacizumab are also anticipated before year-end. On 8th December 2014, Dr Peyvandi, Principal Investigator of the Phase II TITAN trial, will present results from the post-hoc analysis of this study at the ASH Annual Meeting. For the full year 2014, Ablynx reiterated its net cash burn guidance (excluding the proceeds from the private placement) to be in the in the range of €30-35 million.

In 2015, the Company anticipates various value enhancing events, including: potential proof-of-concept results from the Phase IIa study with ALX-0171 in RSV infected infants; the start of the Phase II studies with ALX-0061 in RA and SLE; the start of a Phase III study with caplacizumab in patients with acquired TTP; the start of multiple Phase I studies with partners; results from various technology feasibility studies across multiple applications and; milestone payments from on-going partnerships.

Financial calendar 2015

26 February - Full-year results 2014
30 April - Annual General Meeting
13 May - Q1 results 2015
27 August - Half-year results 2015
18 November - Q3 results 2015

Shareholders' clubs @ Ablynx (Dutch only)

The next shareholders' club at Ablynx will take place on 10th December 2014 at 5.45pm CET. If you would like to attend, please contact us via investors@ablynx.com.

Glossary

IL-6R receptor of interleukin-6 - a cytokine involved in a wide range of biological activities
EMA European Medicines Agency
RA rheumatoid arthritis
RSV respiratory syncytial virus - virus that infects the respiratory tract, including the lungs
SLE systemic lupus erythematosus
TTP thrombotic thrombocytopenic purpura - rare disorder of the blood coagulation system that causes extensive microscopic thromboses in the small blood vessels throughout the body

About Ablynx

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 30 proprietary and partnered programmes in development in therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations and significant partnerships with 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

pdf format of the press release http://hugin.info/137912/R/1870863/658054.pdf

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Source: Ablynx