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Ablynx (ABLYF) Announces Q1 2014 Business Update


5/14/2014 9:08:29 AM

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GHENT, Belgium, May 14, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced its non-audited business update, summarising Ablynx's financial position for the first three months of 2014, material events post 31 March 2014 and guidance for the full year.

Operating highlights

-- Signed a major discovery collaboration and licensing agreement with Merck & Co, with an upfront payment of [Eur]20 million, [Eur]10.7 million in research funding and up to [Eur]1.7 billion in milestones plus royalties, to discover and develop Nanobody(R) immuno-therapeutics for the treatment of various cancers.

-- Obtained encouraging pre-clinical proof-of-concept data with the anti-RSV Nanobody, ALX-0171, in a neonatal lamb model, demonstrating that daily inhalation of ALX-0171 resulted in a reduction of viral titres and lung inflammation, and was effective in alleviating various clinical signs and symptoms.

-- Recruitment of the worldwide Phase II TITAN study with the anti-vWF Nanobody, caplacizumab, to treat acquired TTP was stopped to allow early analysis of the clinical data which are expected to be released in June 2014. If these results are encouraging, then a Phase III study is planned to start in 2015.

-- After completing pre-clinical studies with the anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, Ablynx announced it would not progress this programme into Phase I studies because of insufficient differentiation from the competition.

Financial highlights

-- Revenues of [Eur]11.2 million (2013: [Eur]5.2 million)

-- Net loss for the quarter of [Eur]2.8 million (2013: [Eur]6.7 million)

-- Positive net cash inflow of [Eur]2.8 million, resulting in [Eur]203.2

million in cash, cash equivalents, restricted cash and short-term investments at 31st March 2014

Post 31st March 2014

-- In April, Ablynx initiated a Phase I clinical study in healthy volunteers as part of the evaluation of the subcutaneous (s.c.) route of administration of its anti-IL-6R Nanobody, ALX-0061, being developed for the potential treatment of inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) as part of the collaboration with AbbVie signed in 2013.

-- In May, Ablynx announced positive results from two additional Phase I studies on its wholly-owned anti-RSV Nanobody, ALX-0171, designed for the treatment of Respiratory Syncytial Viral (RSV) infections.

-- In May, Boehringer Ingelheim (B.I.) terminated a Phase I study initiated in October 2013, with a Nanobody designed to treat Alzheimer's disease, and is now reviewing the programme.

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

"Ablynx has had a strong start to the year. The immune-oncology deal with Merck & Co was a positive endorsement of our unique Nanobody platform and helped contribute to a strong financial performance. The additional pre-clinical data for our first inhaled Nanobody, ALX-0171, were very encouraging, as were results from the additional two Phase I studies with this Nanobody, and we expect to enter a Phase II paediatric study in RSV infected infants and toddlers in Q4 2014. The TITAN study remains on track to deliver Phase II data in June 2014 for caplacizumab and work in our major collaboration with AbbVie on the anti-IL-6R Nanobody, ALX-0061, is going to plan."

Revenues were [Eur]11.2 million (2013: [Eur]5.2 million) and mainly included FTE and contract income, with the higher R&D income due to new collaborations. Operating expenses increased to [Eur]14.9 million (2013: [Eur]12.1 million) due to higher external R&D costs. As a result of the above, the loss for the period was [Eur]2.8 million (2013:

[Eur]6.7 million).

The Company had a positive net cash inflow of [Eur]2.8 million (2013:

[Eur]19.4 million), largely influenced by the upfront payment of [Eur]20 million from Merck & Co paid as part of the immune-oncology deal, and Ablynx ended the period with [Eur]203.2 million in cash, cash equivalents, restricted cash and short-term investments.

Operational review

Pipeline update

Some improvement in recruitment of the worldwide Phase II TITAN study with the anti-vWF Nanobody, caplacizumab, to treat acquired TTP, was seen after amending the clinical protocol in September 2013.

Nevertheless, prior to reaching the target of 110 patients, Ablynx decided to stop recruitment for the trial in January 2014 to allow early analysis of the clinical data for potential proof-of-concept.

These results will be released in June 2014. If the data are encouraging, then a Phase III study is planned to start in 2015.

In order to support the start of a first-in-infant study during Q4 2014 with the anti-RSV Nanobody, the Company carried out an additional pre-clinical study in neonatal lambs together with two additional Phase I studies - one focussing on safety and the other on pharmacokinetics (PK). The neonatal lamb study successfully demonstrated that daily inhalation of ALX-0171 resulted in a reduction of viral titres and lung inflammation, and was effective in alleviating various clinical signs and symptoms. The new Phase I results were announced on 6 May 2014. The Phase I safety study demonstrated that in patients with hyper-reactive airways, if bronchoconstriction occurred after inhalation of ALX-0171, then it could be reversed with standard bronchodilators. The Phase I PK study in healthy volunteers showed again that ALX-0171 was well tolerated and that once-daily administration resulted in rapid attainment of clinically relevant Nanobody levels in the lung.

As a result of the global license agreement entered into with AbbVie in September 2013 for ALX-0061, its anti-IL-6R Nanobody, Ablynx is responsible for managing the next stages of clinical development for this programme. The data generated to date for ALX-0061 have been with an intravenous (i.v.) route of administration but a subcutaneous (s.c.) route of administration will be used for the next patient studies.

Ablynx announced in April 2014 that it had initiated a Phase I study in healthy volunteers to determine the bioavailability of this route of administration. Results of this trial are anticipated by the end of 2014, with the goal to start Phase II clinical development of ALX-0061 s.c. in both RA and SLE patients in 2015.

After completing pre-clinical studies with the anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, Ablynx has decided not to move forward with this programme into Phase I studies because of insufficient differentiation from the competition.

In May, Boehringer Ingelheim (B.I.) terminated a Phase I study initiated in October 2013, with a Nanobody designed to treat Alzheimer's disease, prior to completion of volunteer recruitment. The study was stopped according to the protocol and B.I. is now reviewing the programme.

Partnerships update

On 3 February 2014, Ablynx announced that it had entered into a second research collaboration and licensing agreement with a subsidiary of Merck & Co (known outside the US and Canada as MSD). This new exclusive collaboration and licensing agreement is focused on the discovery and development of several predefined Nanobody candidates (including bi- and tri-specifics) directed toward so called "immune checkpoint modulators," proteins believed to provide potential targets for the development of cancer immunotherapies, a rapidly emerging approach to the treatment of a wide range of cancer types.

Under the terms of the agreement, Ablynx received an upfront payment of [Eur]20 million and will receive up to [Eur]10.7 million in research funding during the initial three year research term of the collaboration. In addition, Ablynx is eligible to receive development, regulatory and commercial milestone payments on achieved sales thresholds for a number of products with the ultimate potential to receive as much as [Eur]1.7 billion plus tiered royalties. Merck & Co will be responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.

Outlook for the remainder of 2014

It is anticipated that top-line Phase II data from the TITAN study with caplacizumab will be reported in June 2014. The Phase II paediatric study with the anti-RSV Nanobody, ALX-0171, is expected to commence in Q4 2014. Data from the ALX-0061 s.c. Phase I study are planned to be available in Q4 2014.

Ablynx expects further advances in both pre-clinical and clinical stage partnered programmes during the rest of 2014, some of which may result in payment to the Company of milestones. Further progress is also expected in the search for partners in emerging markets for some of the Company's clinical assets.

Initiation of new wholly-owned discovery programmes will continue, as will technology developments, both in-house and in collaboration with partners, to exploit the Nanobody platform even more broadly.

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 in the [Eur]30-[Eur]35 million range for 2014.

Financial calendar 2014

28 August 2014 - Half-year results13 November 2014 - Q3 results

Shareholders' clubs @ Ablynx (Dutch only)

The next shareholders' club at Ablynx will take place on 21 May 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 activitiesPK pharmacodynamics - the action or effect of drugs on living organismsRA rheumatoid arthritisRSV respiratory syncytial virus - virus that infects the lungs and respiratory tractTTP 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(R), 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 over 30 programmes in the pipeline and seven Nanobodies in clinical development. Ablynx has on-going research collaborations and significant partnerships with 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 MosesCEOt: +32 (0)9 262 00 07m: +44 (0)7771 954 193 / +32 (0)473 39 50 68e: edwin.moses@ablynx.com

Marieke VermeerschAssociate Director Investor Relationst: +32 (0)9 262 00 82m: +32 (0)479 49 06 03e: marieke.vermeersch@ablynx.comFollow us on Twitter @AblynxABLX

Ablynx media relations Consilium Strategic Communications:

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

pdf version of the press release http://hugin.info/137912/R/1785150/611984.pdf

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