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 31(st) 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 31(st) 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. Â 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%) |
+--------------------------------------+---------+---------+----------+
| Â R&D income | 4.7 | 9.7 | (52%) |
+--------------------------------------+---------+---------+----------+
| Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Grants | 0.5 | 0.3 | 57% |
+--------------------------------------+---------+---------+----------+
| Operating expenses | 12.1 | 16.7 | (28%) |
+--------------------------------------+---------+---------+----------+
| Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â R&D | 9.7 | 14.4 | (33%) |
+--------------------------------------+---------+---------+----------+
| Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 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 | Â |
+--------------------------------------+---------+---------+----------+
| Cash at 31(st) March( (1)) | 82.2 | 85.1 | (3.4%) |
| Â | | | |
+--------------------------------------+---------+---------+----------+
   ((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 28(th) 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 31(st) March 2013 and outlook for the remainder of 2013
On 7(th) 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-6RÂ Â Â Â Â Â Â Â Â receptor of interleukin-6 - a cytokine involved in a wide range
of biological activities
PKÂ Â Â Â Â Â Â Â Â Â Â Â Â 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
RAÂ Â Â Â Â Â Â Â Â Â Â Â Â rheumatoid arthritis
RSVÂ Â Â Â Â Â Â Â Â Â respiratory syncytial virus - virus that infects the lungs and
respiratory tract
TTPÂ Â Â Â Â Â Â Â Â Â Â 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:Â Â +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
    +32 (0)473 39 50 68
e:Â edwin.moses@ablynx.com
Marieke Vermeersch
Associate Director Investor Relations
t:Â Â +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e:Â marieke.vermeersch@ablynx.com
Follow us on Twitter @AblynxABLX
M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t:Â Â +44 207 920 2330
e:Â ablynx@mcomgroup.com
press release in pdf format:
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[HUG#1701734]