ABLYNX ANNOUNCES Q1 2012 BUSINESS UPDATE
(Thomson Reuters ONE) -
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 ?5 million milestone
* Strategic Alliance with Boehringer Ingelheim extended for two years to
September 2014, worth an extra ?6.6 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 ?10.1 million
* Net result for the period improved by 55% to -?6.2 million
* Positive net cash flow of ?1.3 million
* Strong financial position with ?85.1 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 ?85 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
+----------------------------------------------+---------+---------+----------+
| (? 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 ?3 million restricted cash
Revenues increased 159% to ?10.1 million (2011: ?3.9 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 ?16.7 million (2011:
?18.1 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 ?1.3 million (2011: cash burn of -?8.6 million),
and the loss for the period was reduced by 55% to ?6.2 million (2011: ?13.8
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 ?5 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 ?6.6 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
?0.4 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 ?1 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 ?20-25 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.
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(at)ablynx.com
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch(at)ablynx.com
M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx(at)mcomgroup.com
Complete version of the press release:
http://hugin.info/137912/R/1612942/513582.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
[HUG#1612942]
Unternehmensinformation / Kurzprofil:
Datum: 16.05.2012 - 18:00 Uhr
Sprache: Deutsch
News-ID 147462
Anzahl Zeichen: 11573
contact information:
Town:
Ghent
Kategorie:
Business News
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