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ABLYNX ANNOUNCES BUSINESS UPDATE AND FINANCIAL RESULTS FOR THE FIRST THREE MONTHS OF 2015

REGULATED INFORMATION

  • Total revenue and grant income up 26% to €14.1 million
  • Key clinical programmes moving forward
  • More than 20 collaborative programmes advancing with all six existing pharma partners
  • Successfully renegotiated the Strategic Collaboration Agreement with Merck Serono
  • 2015 outlook confirmed

GHENT, Belgium, May 13, 2015 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its non-audited business update, summarising Ablynx's financial position and operational activities for the first three months of 2015 and the outlook for the full year.

"Ablynx has had a strong start to the year, with both our partnered and wholly-owned programmes making good progress," said Dr Edwin Moses, CEO of Ablynx. "The Company's evolution into a clinical-stage biopharmaceutical company continues, with one Phase III and four Phase II studies on track to be running by the second half of 2015. We look forward to continuing positive developments in 2015 and beyond."

Operating highlights - January 1st 2015 to date

Wholly-owned product pipeline is advancing:

  • Caplacizumab, anti-vWF Nanobody for the treatment of acquired TTP: the decision was made to file for conditional approval in Europe in 2017 following consultations with regulatory agencies and preparations continue to enable initiation of the Phase III study in H2 2015 to support the BLA submission in the US.
  • ALX-0171, for the treatment of RSV infection in infants: five patient lead-in part of the Phase IIa paediatric study was successfully completed and the independent Data Monitoring Committee recommended initiating the 30 patient placebo-controlled phase of the study. Recruitment for this placebo-controlled phase has already started in the Northern Hemisphere and, in order to address RSV seasonality, preparations are ongoing to open clinical centres in parts of the Asia-Pacific region with the goal to complete recruitment of 30 infants by the end of 2015.

More than 20 pre-clinical and clinical programmes continue to progress with partners AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co, Inc., Merck Serono and Novartis:

  • Phase IIb combination therapy and monotherapy studies with ALX-0061 (anti-IL-6R Nanobody partnered with AbbVie) were initiated by Ablynx in two trials with a target enrollment of 558 patients with active RA; results are anticipated in H2 2016.
  • Under all four agreements between Merck Serono and Ablynx (signed in 2008, 2010, 2011 and 2013), six collaborative programmes are being pursued by both parties:
    • The most advanced programme is in Phase Ib clinical development in psoriasis patients (ALX-0761, bi-specific Nanobody targeting IL-17A/F), for which study completion is expected later this year.
    • In the full-year results published in February 2015, it was announced that the Strategic Collaboration Agreement with Merck Serono, signed in September 2013, might not proceed beyond the end of its second year. However, both parties have since mutually agreed to amend the Strategic Collaboration Agreement to focus on two particular bi-specific Nanobody programmes going forward. Ablynx will, at no cost, regain full ownership of three other promising pre-clinical programmes which have been generated under this Strategic Collaboration Agreement in various therapeutic areas, including immuno-oncology. Merck Serono has provided full financial support for this Strategic Collaboration Agreement, with €11.5 million in non-refundable cash paid to Ablynx so far and approximately €1.0 million to be paid before the end of this year. In addition, Ablynx is eligible to receive future milestone payments and royalties related to the two specific programmes being pursued in this partnership.
    • Merck Serono has also decided to extend one of the programmes in osteoarthritis, under the agreement signed in November 2011, to include a tri-specific Nanobody, resulting in a €1.0 million fee for Ablynx to be paid before the end of this year.
  • The ion channel drug discovery collaboration with Merck & Co, Inc. was further extended.

Ablynx successfully opposed the appeal lodged by Domantis, now a member of the GlaxoSmithKline (GSK) group of companies, in 2010 against the decision by the Opposition Division of the European Patent Office to revoke Domantis' European Patent 1 517 921 which related to one specific technique for half-life extension of immunoglobulin single variable domains.

The Company further strengthened its Board of Directors with the appointment of Professor Dr Baroness Lutgart Van den Berghe as an Independent Director.

Financial highlights - January 1st to March 31st 2015

Total revenue and grant income for the first three months of 2015 increased by 26% to €14.1 million. Operating expenses increased to €19.1 million (up 28%) due to higher R&D costs. Both revenue and cost increases were primarily driven by activities under the AbbVie contract for ALX-0061. The net loss for the period increased to €4.0 million.

The Company had an operational cash burn of €12.9 million in Q1 2015 compared to an operational cash inflow of €2.8 million in the same period last year, which was mainly due to the upfront payment of €20 million from Merck & Co, Inc. paid as part of the immuno-oncology deal signed in February 2014.

The Company ended the period with €193.3 million in cash, cash equivalents, restricted cash and short-term investments.

(€ million) Q1 2015 Q1 2014 % change
Total revenue and grant income 14.1 11.2 26%
R&D income 13.9 10.8 29%
Grant income 0.2 0.4 (50%)
Operating expenses (19.1) (14.9) 28%
R&D (16.7) (12.5) 34%
G&A (2.5) (2.3) 9%
Operating result (5.0) (3.6) 39%
Net financial result 1.1 0.8 38%
Net result (4.0) (2.8) 43%
Net operational cash flow (12.9) 2.8 --
Cash at 31st March (1) 193.3 203.2 (5%)
(1) including €2.0 million restricted cash

2015 outlook confirmed

2015 is an important operational year for Ablynx's lead clinical programmes: caplacizumab for the treatment of acquired TTP; ALX-0171 for the treatment of RSV infection in infants; and ALX-0061 for the treatment of inflammatory diseases including RA and SLE.

Ablynx expects to start the Phase III registration study for caplacizumab, its wholly-owned anti-vWF Nanobody, in Europe, the US and Canada, in H2 2015. In parallel, the Company will make further preparations to file for conditional approval for caplacizumab in Europe in 2017. At the same time, Ablynx is exploring the optimal value-creating commercial strategy for this asset and expects to announce its conclusions later this year.

Ablynx also intends to start a Phase II study in H2 2015 in SLE patients with its anti-IL-6R Nanobody (ALX-0061), partnered with AbbVie.

The Phase IIa study with the anti-RSV Nanobody, ALX-0171, will continue during the rest of 2015 in parts of the Asia-Pacific region and in Europe, with the goal to complete recruitment of the study before year-end.

The Company believes that up to three programmes from its partnered collaborations could enter Phase I clinical development this year, which would result in milestone payments to Ablynx. In addition, the Phase I study with the bi-specific anti-IL-17A/F Nanobody, partnered with Merck Serono, could be completed by year-end, and the first programme in immune-oncology with Merck & Co, Inc. could achieve in vivo proof-of-concept.

As a consequence of its significant current investment in later stage clinical programmes, the Company currently expects net cash burn in 2015 to be approximately €70-80 million.

Financial calendar 2015

27 August 2015 - Half-year results
18 November 2015 - Q3 results

Shareholders' clubs @ Ablynx

20 May at 17h45 - in Dutch
17 June at 17h45 - in French
16 September at 17h45 - in Dutch

If you would like to attend, please contact us via investors@ablynx.com.

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 various therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co, Inc., 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: +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, Jonathan Birt, 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/1921222/688474.pdf

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Source: Ablynx