Du är här

2014-05-14

Ablynx: ABLYNX ANNOUNCES Q1 2014 BUSINESS UPDATE

REGULATED INFORMATION

GHENT, Belgium, 14 May 2014 -
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 €20 million, €10.7 million in research
funding and up to €1.7 billion in milestones plus royalties, to discover
and develop Nanobody® 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 €11.2 million (2013: €5.2 million)
* Net loss for the quarter of €2.8 million (2013: €6.7 million)
* Positive net cash inflow of €2.8 million, resulting in €203.2 million in
cash, cash equivalents, restricted cash and short-term investments at
31stMarch 2014

Post 31stMarch 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."

Financial review

---------------------------------------------------------
|(€ million) Q1 2014 Q1 2013 % change |
|Revenues 11.2 5.2 115% |
|R&D income 10.8 4.7 130% |
|Grants 0.4 0.5 (20%) |
|Operating expenses 14.9 12.1 23% |
|R&D 12.5 9.7 29% |
|G&A 2.3 2.4 (4%) |
|Operating result (3.6) (6.9) 48% |
|Net financial result 0.8 0.2 300% |
|Net result (2.8) (6.7) 58% |
|Net cash inflow/(burn) 2.8 19.4 (86%) |
|Cash at 31stMarch 203.2(1) 82.2(2) 147% |
|(1) including €2.0 million restricted cash |
| |
| (2) including €2.4 million restricted cash |
---------------------------------------------------------
Revenues were €11.2 million (2013: €5.2 million) and mainly included FTE and
contract income, with the higher R&D income due to new collaborations.
Operating expenses increased to €14.9 million (2013: €12.1 million) due to
higher external R&D costs. As a result of the above, the loss for the period
was €2.8 million (2013: €6.7 million).

The Company had a positive net cash inflow of €2.8 million (2013: €19.4
million), largely influenced by the upfront payment of €20 million from
Merck&Co paid as part of the immune-oncology deal, and Ablynx ended the
period with €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-0061s.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

On3 February
http://hugin.info/137912/R/1758542/594579.pdf
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 €20
million and will receive up to €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 €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-0061s.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 €30-€35 million range for 2014.

Financial calendar 2014

28 August 2014 - Half-year results
13 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 viainvestors@ablynx.com.

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
RA rheumatoid arthritis
RSV respiratory s...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.