Leuven, Belgium – 27 August, 2009 – ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update and its half year results for the six month period ending 30 June, 2009.
During 2009, ThromboGenics has continued to focus on the activities which are key to its aim of becoming a profitable, integrated company focused on cutting edge ophthalmic medicines. Central to this plan is the Company’s lead product, microplasmin, which is in Phase III trials for the treatment of back of the eye disease. Patient recruitment in this Phase III program is running smoothly and the Company expects to report the first results from these studies by mid 2010. The clinical development of the Company’s unique long-acting anticoagulant TB-402, which is in Phase II trials for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery, has progressed more rapidly than originally expected.
Patrik De Haes, CEO of ThromboGenics, said: “ThromboGenics has seen most of its key programs make significant progress during the course of 2009. We are very happy with the speed of patient recruitment in the microplasmin Phase III program. Microplasmin is central to our aim of building a strong, profitable and integrated company centered on cutting edge ophthalmic medicines. Given our increasing confidence in the clinical merits of microplasmin we are now starting to develop our commercialization plans for this novel product. We are also very encouraged by the progress of the Phase II program for TB-402, as recruitment is ahead of schedule. This clinical study has reinforced our view that we have an attractive out-licensing opportunity for companies keen to enhance their position in the anti-coagulant therapy market. Our partnership with Roche for the novel anti-cancer antibody TB-403 is also going well, as evidenced by the success fee that we received from them earlier in the year.” “ThromboGenics’ business has never been so well placed. We have a clear strategy, an exciting lead product in microplasmin and two further assets in TB-402 and TB-403 which will provide us with further opportunities to deliver value for our shareholders."
Financial Update
o ThromboGenics achieved revenues of €3.6 million in the first half of 2009, nearly all of which came from a success fee from Roche, our partner for TB-403. R&D expenses were €8.8 million during this six month period. In addition €5.7 million of expenses related to the microplasmin Phase III clinical program (called MIVI TRUST) have been capitalized. General and administrative costs in the first half increased from €1.2 million to €1.7 million due to higher one-time legal costs, in part due to the merger of ThromboGenics NV and ThromboGenics Ltd. In the first half, ThromboGenics made a net loss of €4.7 million.
o As of June 30, 2009, ThromboGenics had €52.6 million in cash and cash equivalents. This compares to €40.4 million on June 30, 2008 and €58.9 million on December 31, 2008. The cash figure at the end of June includes the €3.1 million that ThromboGenics received in May as a result of the exercise of warrants. The Company’s cash resources are expected to allow ThromboGenics to execute its current operational plans for approximately the next two years.
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at 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 Company’s Annual Report.
During 2009, ThromboGenics has continued to focus on the activities which are key to its aim of becoming a profitable, integrated company focused on cutting edge ophthalmic medicines. Central to this plan is the Company’s lead product, microplasmin, which is in Phase III trials for the treatment of back of the eye disease. Patient recruitment in this Phase III program is running smoothly and the Company expects to report the first results from these studies by mid 2010. The clinical development of the Company’s unique long-acting anticoagulant TB-402, which is in Phase II trials for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery, has progressed more rapidly than originally expected.
Patrik De Haes, CEO of ThromboGenics, said: “ThromboGenics has seen most of its key programs make significant progress during the course of 2009. We are very happy with the speed of patient recruitment in the microplasmin Phase III program. Microplasmin is central to our aim of building a strong, profitable and integrated company centered on cutting edge ophthalmic medicines. Given our increasing confidence in the clinical merits of microplasmin we are now starting to develop our commercialization plans for this novel product. We are also very encouraged by the progress of the Phase II program for TB-402, as recruitment is ahead of schedule. This clinical study has reinforced our view that we have an attractive out-licensing opportunity for companies keen to enhance their position in the anti-coagulant therapy market. Our partnership with Roche for the novel anti-cancer antibody TB-403 is also going well, as evidenced by the success fee that we received from them earlier in the year.” “ThromboGenics’ business has never been so well placed. We have a clear strategy, an exciting lead product in microplasmin and two further assets in TB-402 and TB-403 which will provide us with further opportunities to deliver value for our shareholders."
Financial Update
o ThromboGenics achieved revenues of €3.6 million in the first half of 2009, nearly all of which came from a success fee from Roche, our partner for TB-403. R&D expenses were €8.8 million during this six month period. In addition €5.7 million of expenses related to the microplasmin Phase III clinical program (called MIVI TRUST) have been capitalized. General and administrative costs in the first half increased from €1.2 million to €1.7 million due to higher one-time legal costs, in part due to the merger of ThromboGenics NV and ThromboGenics Ltd. In the first half, ThromboGenics made a net loss of €4.7 million.
o As of June 30, 2009, ThromboGenics had €52.6 million in cash and cash equivalents. This compares to €40.4 million on June 30, 2008 and €58.9 million on December 31, 2008. The cash figure at the end of June includes the €3.1 million that ThromboGenics received in May as a result of the exercise of warrants. The Company’s cash resources are expected to allow ThromboGenics to execute its current operational plans for approximately the next two years.
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at 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 Company’s Annual Report.
