ABLYNX ANNOUNCES Q1 2013 BUSINESS UPDATE

Wed May 15, 2013 1:31am EDT

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REGULATED INFORMATION

GHENT, Belgium, 15 May 2013 - Ablynx [Euronext Brussels: ABLX], the Belgian-based biopharmaceutical company focused on the discovery and development of Nanobodies® for the treatment of serious diseases, today announced its business update for the three-month period ending 31st March 2013.

Operating highlights

  • Continued progress with the five Nanobody-based products in clinical development across multiple disease areas
  • Excellent Phase IIa efficacy and safety results with the anti-IL-6R Nanobody, ALX-0061, in RA patients
  • Signed research collaboration with Spirogen to evaluate the potential of novel Nanobody-toxin drug conjugates in cancer

Financial highlights

  • Successful private placement of new and existing shares, raising €31.5 million in cash, with a total of €45 million being placed
  • Revenues of €5.2 million (2012: €10.1 million)
  • Net loss for the quarter of €6.7 million (2012: €6.2 million)
  • Positive net cash inflow of €19.4 million resulting in a strong financial position of €82.2 million in cash, cash equivalents, restricted cash and short-term investments at 31st March 2013

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

"The highlight of the first quarter was the announcement in February of excellent Phase IIa efficacy and safety data for our anti-IL-6R Nanobody in rheumatoid arthritis patients.  Following these results, we started licensing discussions with a number of pharmaceutical companies. In parallel, we are also evaluating various possible scenarios for carrying out the next stage of clinical development of ALX-0061 internally, as an alternative strategy for creating value."

"In addition to the clinical progress, we successfully raised €31.5 million through a private placement which enhances our flexibility to choose the right strategic options as well as allowing us to expand and diversify our shareholder base. We expect to make further significant progress in developing our business during the remainder of the year."

Financial review

(€ million) Q1 2013 Q1 2012 % change
Revenues 5.2 10.1 (48%)
R&D income 4.7 9.7 (52%)
                        Grants 0.5 0.3 57%
Operating expenses 12.1 16.7 (28%)
                       R&D 9.7 14.4 (33%)
                       G&A 2.4 2.3 7%
Operating result (6.9) (6.7) (3%)
Finance income (net) 0.2 0.4 (50%)
Net result (6.7) (6.2) (8%)
Net cash inflow 19.4 1.3
Cash at 31st March (1) 82.2 85.1 (3.4%)
      (1)        including €2.4 million restricted cash

Revenues were €5.2 million (2012: €10.1 million) and included FTE and contract income from on-going collaborations, with lower R&D income due to variances in timing of milestone payments. Operating expenses decreased to €12.1 million (2012: €16.7 million) due to lower external R&D costs. As a result of the above, the loss for the period was €6.7 million (2012: €6.2 million).

Thanks to the successful private placement completed on 28th February, the Company had a positive net cash inflow of €19.4 million (2012: €1.3 million), and ended the period with a strong financial position of €82.2 million in cash, cash equivalents, restricted cash and short-term investments.

Operational review

During the first quarter, Ablynx continued to focus on its most advanced clinical assets, caplacizumab, currently in Phase II for the treatment of TTP; the anti-IL-6R Nanobody, ALX-0061, which successfully completed a Phase IIa study in patients with RA; and the anti-RSV Nanobody, ALX-0171.

Ablynx reported final, excellent safety and efficacy results from the Phase IIa study with ALX-0061 in patients with RA, which indicate that the Nanobody could potentially have a differentiating profile compared with the commercially available benchmark. Following the publication of these results, the Company started discussions with potential licensing partners to take the ALX-0061 programme further in development and, in parallel, the Company is evaluating scenarios for carrying out the next phase of clinical development internally as an alternative value creating strategy.

In order to meet regulatory safety requirements to start a first-in-infant study with ALX-0171 in 2014, the Company has started preparing additional Phase I studies in healthy volunteers (local and systemic PK study) and adults with hyper-responsive airways, and has also initiated a pre-clinical study in juvenile animals.

The challenging recruitment for the on-going worldwide Phase II trial with caplacizumab continued with all 55 sites now being active for enrolment.

To further expand the use of the Nanobody platform, Ablynx entered into a research collaboration with Spirogen to evaluate the potential of a novel anti-cancer drug conjugate combining Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBDs), and associated linker technology, with Nanobodies generated using Ablynx's proprietary technology platform.

Changes in the management team

Eva-Lotta Allan has resigned from her position as Chief Business Officer of the Company. After spending seven years at Ablynx, she returns to the UK, her home country. Progress is already well underway in the recruitment of a successor and two new members have been added to the business development team.

Important events after 31st March 2013 and outlook for the remainder of 2013

On 7th May 2013, Ablynx initiated pre-clinical development of its anti-IgE Nanobody, ALX-0962, for the treatment of severe allergic asthma, with the goal of commencing Phase I clinical development in the second half of 2014. ALX-0962 consists of a highly potent anti-IgE Nanobody with a unique dual mode of action (which refers to its ability to bind with high affinity to IgE while also displacing receptor-bound IgE), together with a serum albumin binding Nanobody for in vivo plasma half-life extension. It has been designed to be a potential best-in-class, next generation biologic for the treatment of severe allergic asthma with substantial potential benefits over available treatment options.

The Phase II trial with caplacizumab for the treatment of acquired TTP is expected to advance with the current goal to complete the recruitment of 110 patients by the end of 2013, although this remains very challenging.

During the course of 2013, two additional Phase I studies will be initiated with the anti-RSV Nanobody (ALX-0171) with the goal to initiate a first-in-infant Phase II study in 2014. A pre-clinical study with ALX-0171 in juvenile animals is currently on-going with the first results expected by the end of 2013.

Ablynx also expects important new partnering deals and advances in existing collaborations as some of its partnered programmes move into clinical development. Technology developments to exploit the Nanobody platform even more broadly will continue both in-house and in collaboration with partners.

Finally, good cash management will remain a key priority for the Company, with a strong focus on net cash burn and the generation of cash to support the on-going development of the business. The Company expects to keep net cash burn, excluding the proceeds of the private placement and a potential licensing deal, in the range €20-25 million, the same level as last year.

Glossary

IL-6R          receptor of interleukin-6 - a cytokine involved in a wide range of biological activities

PK              pharmacodynamics - the action or effect of drugs on living organisms

PBDs         pyrrolobenzodiazepines - DNA minor groove binding agents, which bind and cross-link specific sites of DNA of the cancer cell. This blocks the cancer cells' division without distorting its DNA helix, thus avoiding the common phenomenon of emergent drug resistance

RA              rheumatoid arthritis

RSV           respiratory syncytial virus - virus that infects the lungs and respiratory tract

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 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 approximately 25 programmes in the pipeline and five Nanobodies at clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co. 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
Chairman and 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

M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t:   +44 207 920 2330
e:  ablynx@mcomgroup.com

 





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