GHENT, BELGIUM--(Marketwire - May 16, 2012) -
REGULATED INFORMATION
GHENT, Belgium, 16(th) May 2012 - Ablynx [Euronext Brussels: ABLX], the
Belgian-
based biopharmaceutical company focused on the discovery and
development of
Nanobodies® for the treatment of serious life-threatening
diseases, today
announced its business update for the three-month period ending 31(st)
March
2012.
Operating highlights
* Seven Nanobody-based assets in clinical development across multiple
disease areas
* Second pre-clinical candidate selected as part of the Strategic Alliance
with Boehringer Ingelheim, triggering a EUR5 million milestone
* Strategic Alliance with Boehringer Ingelheim extended for two years to
September 2014, worth an extra EUR6.6 million to Ablynx
* Management team strengthened with the appointment of Dr Andreas Menrad,
Chief Scientific Officer
* Extended GMP certificate granted for new GMP unit
Financial highlights
* Revenues up 159% to EUR10.1 million
* Net result for the period improved by 55% to -EUR6.2 million
* Positive net cash flow of EUR1.3 million
* Strong financial position with EUR85.1 million in cash at period end
including, cash, cash equivalents, restricted cash and short-term
investments
Commenting on today's update, Dr Edwin Moses, Chairman and CEO of Ablynx,
said:
"We have had an excellent start to the year and we are seeing good progress
on a
number of fronts. Perhaps the most significant news occurred after the
period
end, when Novartis presented data at the AACR conference in Chicago in
April
that demonstrated that a Nanobody, TAS266, was able to elicit superior
anti-tumour efficacy compared to conventional monoclonal antibodies, which
is a major
endorsement for our whole Nanobody approach. An IND has been filed by
Novartis
for TAS266 and a Phase I trial is expected to start imminently. We also
made
strong progress in the clinic in the first quarter, with six
wholly-owned
programmes in clinical development and the first programme partnered
with
Boerhinger Ingelheim advancing well towards the clinic."
"We were very pleased to welcome Dr Andreas Menrad as our Chief
Scientific
Officer in March. We ended the period in a strong financial position
with
positive net cash flow for the quarter and EUR85 million in cash
and cash
equivalents at the period end. The Company is making strong progress
during
2012 and we expect further news of developments in our partnered and
proprietary
product pipeline, as well as additional collaborations and milestones."
Financial review
+------------------------------------------+---------+---------+----------+
| (EUR million) | Q1 2012 | Q1 2011 | % change |
+----------------------------------------------+
---------+---------+----------+
| Revenues | 10.1 | 3.9 | 159% |
+---------------------------------------- -+---------+---------+----------+
| R&D income | 9.7 | 3.4 | 185% |
+------------------------------------------+
---------+---------+----------+
| Grants | 0.3 | 0.5 | (40%) |
+------------------------------------------+---------+---------+----------+
| Operating expenses | 16.7 | 18.1 | (8%) |
+------------------------------------------+
---------+---------+----------+
| R&D | 14.4 | 15.9 | (9%) |
+------------------------------------------+---------+---------+----------+
| G&A | 2.3 | 2.2 | 5% |
+------------------------------------------+
---------+---------+----------+
| Operating result | (6.7) | (14.2) | 53% |
+------------------------------------------+---------+---------+----------+
| Finance income (net) | 0.4 | 0.4 | 0% |
+------------------------------------------+
---------+---------+----------+
| Net result | (6.2) | (13.8) | 55% |
+------------------------------------------+---------+---------+----------+
| | |
+------------------------------------------+
---------+---------+----------+
| Cash flow | 1.3 | (8.6) | 115% |
+------------------------------------------+---------+---------+----------+
| Cash at 31(st) March( (1)) | 85.1 | 107.3 | (21%) |
+------------------------------------------+
---------+---------+----------+
((1) )including EUR3 million restricted cash
Revenues increased 159% to EUR10.1 million (2011: EUR3.9 million) mainly
driven by
the milestone payment from Boehringer Ingelheim and recognised income
from the
upfront fee of the third co-discovery co-development deal signed with
Merck
Serono in November 2011. Operating expenses decreased 8% to EUR16.7 million
(2011:
EUR18.1 million) due to lower R&D expenses mainly as a result of
re-focusing of
resources within the product pipeline. As a result of the above, the
Company had
a positive net cash inflow of EUR1.3 million (2011: cash burn of -EUR8.6
million),
and the loss for the period was reduced by 55% to EUR6.2 million
(2011: EUR13.8
million).
Operational review
During the past three months, Ablynx continued to focus on its most
advanced
clinical assets ALX-0081/ALX-0681, currently in Phase II for the
treatment of
TTP; ALX-0061 currently in Phase II in patients with RA; and the
anti-RSV
Nanobody ALX-0171, currently in Phase I. As a result of a strategic
review, it
was decided not to pursue with ALX-0651 (anti-CXCR4) beyond Phase I.
Business
development activities continued for ATN-103 (anti-TNFα; POC
achieved) and
ALX-0141 (anti-RANKL; Phase I successfully completed) as both these
programmes
require a partner to take them to the next stage of clinical
development. The
Strategic Alliance with Boehringer Ingelheim advanced further with the
Company
selecting a second Nanobody for pre-clinical development in oncology,
which
triggered a EUR5 million milestone payment. In addition, this Strategic
Alliance
with Boehringer Ingelheim was extended for two years, running to
September
2014. The extension will provide Ablynx with an extra EUR6.6 million in
additional
research funding. Finally, during the past quarter, Ablynx appointed Dr
Andreas
Menrad as Chief Scientific Officer and received an extended GMP
certificate for
its new GMP unit.
Important events after 31(st) March 2012 and outlook for the remainder of
2012
On 2(nd) April 2012, Ablynx announced that Novartis had received IND
approval
for a novel tetrameric Nanobody agonist, TAS266, targeting DR5, a key
receptor
target on cancer cells across a number of tumour types. The event
triggered a
EUR0.4 million milestone payment to Ablynx. On 3(rd) April, Novartis
presented
pre-clinical data for TAS266 at the AACR conference in Chicago,
which
demonstrated that the Nanobody can elicit superior anti-tumour efficacy
compared
to conventional antibodies. The ability of TAS266 to efficiently '
cross-link'
DR5 receptor targets, apparently not achievable with conventional
monoclonal
antibodies, results in the controlled death of cancer cells.
On 25(th) April 2012, Ablynx reported that its partner Boehringer
Ingelheim had
submitted a CTA to the European regulatory authorities to start a
Phase I
clinical trial with a Nanobody for the treatment of Alzheimer's
disease. The
event triggered a EUR1 million milestone payment to Ablynx.
Before year end, Ablynx expects potential proof-of-concept from the
ongoing
Phase II study with ALX-0061 in RA patients and Phase I data for the
anti-RSV
Nanobody ALX-0171. The results from the open label extension of the
Phase II
study with the anti-TNFα Nanobody, ATN-103, are anticipated in the
coming
months. The results will provide additional efficacy and safety data on
monthly
treatment with ATN-103 in patients with RA for up to 48 weeks.Both
Novartis and
Boehringer Ingelheim are also expected to enter the clinic with
Nanobody-based
products in 2012. In addition, Ablynx expect to establish new
partnerships for
target-based programmes and/or (pre-)clinical assets. Strong cash
management
will remain of key importance and the net cash burn target for 2012
remains in
the range of EUR20-25 million.
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 and life-threatening human
diseases,
including inflammation, haematology, oncology and pulmonary disease.
Today, the
Company has over 25 programmes in the pipeline and seven Nanobodies at
clinical
development stage. Ablynx has ongoing research collaborations and
significant
partnerships with major pharmaceutical companies, including
Boehringer
Ingelheim, Merck Serono, and Novartis. The Company is headquartered in
Ghent,
Belgium. More information can be found on www.ablynx.com.
Complete version of the press release:
http://hugin.info/137912/R/1612942/513582.pdf
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Source: Ablynx via Thomson Reuters ONE
[HUG#1612942]
