LEUVEN, Belgium, August 24 /PRNewswire/ -- ThromboGenics NV , 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
ThromboGenics NV
CONTACT: 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.c
