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ThromboGenics - Business Update and Interim Results for the Seven Month Period Ending 30 June 2007
LEUVEN, Belgium, August 24 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company
focused on vascular diseases, today announces a business update and
its financial results for the seven month period ending 30 June 2007. During
this period, ThromboGenics has raised additional funds to invest in its
development pipeline and has continued to make good progress with its
clinical programs.
Highlights
- Successful placing of a total of 5,166,517 shares, which
increased the company's free float to 70%, and led to an improvement in
stock liquidity. As part of this placement, ThromboGenics issued
2,214,030 new shares raising a total of EUR23.9m. These new funds have
strengthened ThromboGenics financial position, and will allow it to
continue to advance the development of its product portfolio and
strengthen its operations. The company's cash position amounted to
EUR49.3m as of 30 June 2007.
- Further progress with microplasmin for ophthalmic indications.
Initiation of a Phase IIb clinical trial of microplasmin in vitrectomy
(MIVI III - Microplasmin for Vitreous Injection) in the United States, as
well as the initiation of two Phase IIa clinical trials of microplasmin
in Europe, for Vitreomacular traction and diabetic macular edema (MIVI
IIT and MIVI II, respectively).
- Progressed TB-402 (anti-factor VIII) into man, in collaboration
with BioInvent International. TB-402 is being developed as a potential
anti-coagulant for the treatment and prevention of deep vein thrombosis
(DVT) and atrial fibrillation.
Financial summary
- For the December 2006 to June 2007 period, revenues amounted
to EUR1.3m, mainly coming from out-licensing. Operating expenses were
EUR10.5m, the majority of which were due to R&D expenses related to the
microplasmin clinical development program. The net loss for the period
was EUR8.6m.
- As of 30 June 2007, ThromboGenics had EUR49.3m in cash and cash
equivalents. This compared to EUR33.7m on 30 November, 2006, and results
from the fundraising that the company completed in May 2007.
- The Group streamlined its organization with the absorption of the
fully owned subsidiary Thromb-X.
Prof Desire Collen, CEO of ThromboGenics, commenting on
today's announcement, said: "I am very pleased with the all-round progress
that we have made during the first half of 2007. We have been able to attract
additional funding to advance our product portfolio, and to broaden our
shareholder base. I am particularly excited with the very encouraging results
we have obtained with microplasmin in clinical trials targeting back of the
eye diseases, and with the good progress in our early clinical programs such
as with the anti-coagulant TB-402."
Product Pipeline Overview
Microplasmin for eye disease
- Presentation of the positive results from the MIVI I trial
(microplasmin in vitrectomy) at the annual ARVO and Euretina congresses
The MIVI-I trial was a Phase IIa, open-label, dose-ranging
trial evaluating the effect of intraocular injection of recombinant
microplasmin in 60 patients undergoing vitrectomy (surgery that removes the
vitreous to induce posterior vitreous detachment, or PVD). Vitrectomy is an
increasingly used surgical technique to treat a number of important
vitreoretinal "back of the eye" disorders, such as retinal detachment,
diabetic vitreous hemorrhage and macular hole.
Results presented at ARVO (the Association of Research in
Vision and Ophthalmology) and Euretina congresses in May, showed that
microplasmin was well-tolerated and can induce spontaneous PVD without the
need of suction at all before vitrectomy. The ability to achieve spontaneous
PVD was most evident at the lowest dose (25μg) after 7 days exposure, in
which 5 out of 10 patients had a total PVD before vitrectomy. These data
support the view that microplasmin alone may be sufficient to induce a PVD.
In addition, most patients in the study were able to have PVD induced with
relatively low amounts of suction and without the need for mechanical
intervention.
- Initiation of MIVI III (microplasmin in vitrectomy) clinical
trial in the United States.
In January 2007, ThromboGenics began the MIVI III trial. This
trial is a Phase IIb multi-center, randomized, placebo-controlled,
double-masked, dose-ranging clinical trial evaluating the safety and efficacy
of microplasmin intravitreal injection prior to vitrectomy. The trial will
enroll 120 patients in approximately 15 sites throughout the U.S. and assess
the following doses of microplasmin: 25, 75, 125 μg. The results of this
trial are expected to allow dose selection for subsequent Phase III clinical
development. Patient recruitment expected to complete late 2007/early 2008
and the study will be completed in mid 2008.
Based on the results of this trial, an optimal dose of
microplasmin will be selected for use in two separate Phase III trials. The
total number of patients expected to be treated in the microplasmin Phase III
program will be approximately 750 patients. At present, the company plans to
enter into a partnership to commercialize microplasmin in the field of eye
disease before this Phase III program which is expected to start in the
second half of 2008.
- Initiation of two Phase IIa trials microplasmin for
non-surgical treatment of back of the eye diseases.
In early 2007, ThromboGenics started the MIVI-IIT
(Vitreomacular Traction) trial to evaluate the safety and efficacy of
microplasmin for treatment of Vitreomacular traction, including macular
holes. Vitreomacular traction is a condition in which the vitreous gel has an
abnormally strong adhesion to the retina and could lead to decreased or
distorted central vision. These conditions are currently treated by surgical
vitrectomy to release the traction. Therefore, a drug that could facilitate
the induction of PVD or induce spontaneous PVD may be able to relieve the
traction or prevent the need for surgery.
MIVI-IIT is a Phase IIa, sham injection controlled, dose
ascending (75, 125 μg) trial that is expected to enroll 30 patients across 4
sites in Europe. As of the end of June, 15 patients had been recruited and
ThromboGenics received the recommendation from the trial's Independent Safety
Committee to continue enrolment into the final cohort.
Top line results of MIVI-IIT are expected by the end of 2007
and will be presented at the major retina meeting, ASRS, American Society of
Retina Specialists, on December 4, 2007, Indian Wells, CA, USA.
In addition, ThomboGenics has also started a MIVI-II Phase IIa
trial in Europe to evaluate microplasmin injection for the non-surgical
treatment of diabetic macular edema (DME). DME is a complication of diabetic
retinopathy and is in fact the leading cause of vision loss in diabetic
retinopathy patients.
MIVI-II (DME) is a Phase IIa, sham injection controlled, dose
ascending (25, 75, 125 μg) trial evaluating the safety and efficacy of
microplasmin in 60 patients across 8 sites in Europe. Top line results of
MIVI-II are expected to be available by mid 2008.
Eye disease - a significant market opportunity for microplasmin
In current clinical practice, PVD is induced via surgical vitrectomy, a
procedure which involves removing the vitreous (the gel-like substance in the
center of the eye) via suction (surgical intervention). The procedure is
carried out for the treatment of a variety of retinal conditions including
retinal detachment, diabetic vitreous hemorrhage and macular hole, conditions
which can seriously affect vision and, in some cases, lead to blindness.
Microplasmin is a proteolytic enzyme that cleaves the important molecules
that link the vitreous to the retina (the back of the eye). Microplasmin
could therefore facilitate vitrectomy and induce PVD, overcoming difficulties
and risks inherent in detachment by surgical vitrectomy, which include
alteration of vision, bleeding, retinal detachment, and development of
glaucoma.
Approximately 600,000 surgical vitrectomies are performed annually
worldwide. The U.S. market accounts for more than 40% of treatments, and is
growing at 6-8% per annum.
In addition to its potential benefits in the setting of vitrectomy,
induction of PVD has been shown to demonstrate beneficial effects in
preventing blinding eye diseases, such as diabetic macular edema (DME) and
diabetic retinopathy (DR). It is thought that these disorders rely on the
connection of the vitreous to the retina. Therefore, by separating the
vitreous from the retina in a non-surgical way, microplasmin could prevent
the development or progression of these important back of the eye diseases.
DR represents a market of over $1bn annually.
Microplasmin for vascular disease
ThromboGenics is currently conducting multiple Phase II trials
with microplasmin in a number of vascular diseases, including acute ischemic
stroke (both intra-arterial and intravenous application), deep vein
thrombosis and in acute peripheral arterial occlusion (PAOD) where
interesting individual results have been seen, but where patient recruitment
has been slower than expected. Steps have now been taken to improve
recruitment rates in these trials.
Staphylokinase
In December 2006, ThromboGenics entered into a partnership
with Bharat Biotech International Ltd (India) to continue the clinical
development and to commercialize THR-100, a novel variant of Recombinant
Staphylokinase, for the treatment of acute myocardial infarction (AMI), or
heart attack. The deal covers the developing world as well as certain
industrialized countries. Previous studies have shown that THR-100 is as good
or better than tPA as a thrombolytic agent for the treatment of AMI, and will
be available at much lower cost, thereby making it a promising therapy for
the developing world. Clinical trials needed to obtain marketing approval for
THR-100 in the US and Europe would be prohibitively expensive, given the need
to do a large, comparative non-inferiority study against tPA. As a result,
commercialization of THR-100 is focused on the developing world.
TB-402 (anti-factor VIII)
ThromboGenics is developing TB-402 in collaboration with
BioInvent International. TB-402 is a novel human antibody binding to factor
VIII, an essential blood clotting factor. TB-402 is being developed as an
anti-coagulant for the treatment and prevention of deep vein thrombosis (DVT)
and atrial fibrillation.
A Phase I clinical trial started in February 2007. The study
is a randomized, placebo-controlled, dose escalation trial in healthy
volunteers, and the objective is to investigate safety, tolerability and
pharmacokinetic properties of the candidate drug. ThromboGenics has now
completed the recruitment of the 56 volunteers planned for this trial which
was conducted in Denmark. Results are expected to be announced within a few
months.
Pre-clinical pipeline
- TB-403 (anti-PlGF) is a humanized monoclonal antibody that
blocks the formation of new blood vessels in solid tumors. By blocking the
formation of new blood vessels (anti-angiogenesis), TB-403 has the potential
to reduce the growth and spread of cancer cells. TB-403 also has the
potential to block uncontrolled blood vessel growth in some back of eye
diseases, such as in age-related macular degeneration and diabetic
retinopathy. TB-403 is being developed in collaboration with BioInvent
International and is expected to proceed into Phase I clinical trials by the
end of this year. Key preclinical data on this approach to blocking
angiogenesis have been accepted for publication in a leading journal later
this year.
- In May 2007, ThromboGenics out-licensed its anti-thrombotic
agents, platelet glycoprotein Ib (anti-GPIb) and von Willebrand Factor
(anti-vWF), currently in preclinical development.
ThromboGenics NV
Unaudited Consolidated Profit & Loss Statement
In '000 Euros, except
per share amounts 6 months 7 months 13 months
According to IFRS June - Nov. Dec. - Jun. June 2006
2006 2007 - June 2007
Revenues 691 1,310 2,001
Royalty income 484 0 484
Other income 207 1,310 1,517
Cost of sales -225 -119 -344
Gross profit 466 1,191 1,657
Research and development
Expenses -5397 -9,340 -14,737
General and Administrative
Expenses -812 -1,328 -2,140
Selling expenses -107 -258 -365
Other Operating Expenses -4 -4
Other Operating income 180 405 585
OPERATING LOSS -5,669 -9,334 -15,003
Financial Income 354 825 1,179
Financial Expense -76 -81 -157
Loss before taxes -5,391 -8,591 -13,982
Income taxes -4 -9 -13
Net loss for the period -5,395 -8,599 -13,994
Attributable to:
Equity holder of the parent -5,395 -8,599 -13,994
Minority interests 0 0 0
Loss per share
Basic and diluted -0.24 -0.35 -0.57
ThromboGenics NV 30/11/2006 30/06/2007
in 000's in 000's
Unaudited Consolidated Balance Sheet Euro Euro
Assets:
Property plant and equipment 535 706
Intangible Assets 0 0
Goodwill 2,586 2,586
Non-Current Assets: 3,121 3,292
Inventories 0 0
Trade and other receivables 1,403 587
Current tax recoverable 26 152
Investments 25,000 45,530
Cash and cash equivalents 8,677 3,741
Current Assets 35,106 50,010
Total Assets 38,227 53,302
EQUITY AND LIABILITIES
Share Capital 95,974 119,116
Share Premium Account 0 0
Cumulative translation adjustments 0 -4
Other reserves -22,035 -21,482
Retained earnings -31,533 -36,928
Result of the period -5,395 -8,599
Equity attributable to equity holders of the parent 37,012 52,103
Minority interests 0 0
Total Equity 37,012 52,103
Retirement benefit obligations 9 9
Non-Current Liabilities 9 9
Trade payables 887 540
Other current liabilities 319 649
Current Liabilities 1,206 1,189
Total Equity and Liabilities 38,227 53,302
ThromboGenics NV
Unaudited Consolidated Statement of Cash Flows
For the period ended 6 months 7 months 13 months
June FY 2006
June - Nov. Dec -June - June FY
In '000 Euros, except per share
amounts 2006 2007 2007
According to IFRS
Operating activities
Operating loss for the year -5,395 -8,599 -13,994
Financial income -354 -825 -1,179
Financial expenses 76 81 157
Depreciation of property,
plant and equipment 129 136 265
Amortisation of
intangible assets 181 0 181
Gain on disposal of property,
plant and equipment 1 0 1
Share based payment expenses 644 479 1,123
Operating cash flows before
movements in working capital -4,718 -8,728 -13,446
Decrease in inventory 0 0 0
(Increase) / decrease in receivables -981 690 -291
Increase / (decrease) in payables -658 -17 -675
Cash absorbed by operations -6,357 -8,055 -14,412
Income taxes (paid)/received 0 0 0
Net cash used in operating
activities -6,357 -8,055 -14,412
Investing activities
Proceeds on disposal of
current investments 49 0 49
Proceeds on disposal of property,
plant and equipment 5 0 5
Interest and similar income 327 817 1,144
Purchases of property, plant
and equipment -26 -297 -323
Purchases of current investments 0 0 0
Net cash (used) from
investing activities 355 520 875
Financing activities
Proceeds on issue of shares,
net of issue costs 31,331 23,141 54,472
Interest paid 0 0 0
Net cash (used) from finance
activities 31,331 23,141 54,472
Net decrease/(increase) in cash
and cash activities 25,329 15,606 40,935
Cash and cash equivalents at
the beginning of the year 8,399 33,677 8,399
Effect of foreign rate changes -51 -12 -63
Cash and cash equivalents at
the end of the year 33,677 49,271 49,271
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery
and development of biopharmaceuticals for the treatment of a range of
vascular diseases. The Company has several programs in Phase II clinical
development including microplasmin, which is being evaluated as a treatment
for vitreoretinal disorders and as a thrombolytic agent for vascular
occlusive diseases, including acute stroke. ThromboGenics also has one
program, TB-402 (Anti-Factor VIII), in Phase I clinical trials, and three
other drug candidates in preclinical development with preclinical
proof-of-principle demonstrated. ThromboGenics has built strong links with
the University of Leuven and has exclusive rights to certain therapeutics
developed at the University. ThromboGenics is headquartered in Leuven,
Belgium and has subsidiaries in Dublin, Ireland and New York, U.S. The
Company is listed on Eurolist by Euronext Brussels under the symbol THR.
More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered
"forward-looking". Such forward-looking statements are based on current
expectations, and, accordingly, entail and are influenced by various risks
and uncertainties. The Company therefore cannot provide any assurance that
such forward-looking statements will materialize and does not assume an
obligation to update or revise any forward-looking statement, whether as a
result of new information, future events or any other reason. Additional
information concerning risks and uncertainties affecting the business and
other factors that could cause actual results to differ materially from any
forward-looking statement is contained in the prospectus.
For further information please contact:
ThromboGenics
Prof. Desire Collen, CEO
Chris Buyse, Chief Financial Officer
Tel: +32-(0)-16-34-61-94
Fax: +32-(0)-16-34-61-34
Citigate Dewe Rogerson
Valerie Auffray/ David Dible
Tel: +44-(0)-207-638-95-71
Mobile:+44-(0)-790-373-77-13
valerie.auffray@citigatedr.co.uk
