BioInvent Financial Statement 1 January - 31 December 2011

Press release

BioInvent Financial Statement 1 January - 31 December 2011

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Target enrolment in the GLACIER study, the phase II study with BI-204 in coronary artery disease, has been increased for technical reasons, improving the chances of a conclusive outcome. First results from the study are expected in Q3.
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Recruitment of patients for BioInvent's phase IIb study of TB-402 (thrombosis) was completed ahead of schedule. Results are expected in Q2.
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The phase Ib/II study with TB-403 (cancer) in patients with recurrent glioblastoma multiforme progresses according to plan. The smaller, exploratory phase Ib study with TB-403 in patients with liver cancer has been discontinued due to slow patient recruitment.
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BI-505 (cancer) is well tolerated in the expanded phase I study. Treatment has progressed to a higher dose level and a release of topline data is expected in late Q2.
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A preclinical collaboration with Servier on the development of an antibody based oncology treatment was entered into after the end of the period. The agreement is worth more than EUR 11 million assuming the successful launch of a product.
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A private placement of SEK 136 million before transaction costs was completed in June at a share price of SEK 22.30. The majority of the new shares were subscribed for by international investors.
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Net revenues for January - December 2011 amounted to SEK 125 million (83). Loss for January - December 2011: SEK -67 million (-128). Loss per share SEK -1.05 (-2.12).
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Current investments together with cash and bank balances as of 30 December 2011: SEK 174 million (106). Cash flow from current operations and investment activities for January - December 2011: SEK -60 million (-122).

BioInvent is a research-based pharmaceutical company that focuses on developing therapeutic antibodies. The Company is currently running innovative drug projects primarily in the areas of thrombosis, cancer, acute coronary syndrome and inflammation.

Comments by the CEO

At the outset of 2012 BioInvent is facing a number of exciting key events as we await the results from a phase II study for each of our cardiovascular antibodies BI-204 and TB-402, as well as the first clinical data on our candidate oncology antibody BI-505. The outcome of these events will be critical for the future development of the Company.

The increase in patient sample size in the phase IIa study with BI-204 improves chances of reaching a conclusive outcome and should be seen in light of new clinical data on the imaging technology applied in the study. I expect the last patient in the study to be included at the end of this month, which should allow us to report the first outcome data in the third quarter. The study has just recently been termed GLACIER in reference to the antibody's unique mode-of-action.

The swift recruitment of patients for the phase IIb study with TB-402, which we are conducting in collaboration with our partner Thrombogenics, puts us ahead of schedule. We aim to release the first data from the study in the second quarter. Our endeavours to find a commercial partner will be intensified during the course of this summer.

The phase Ib/II study with TB-403 in combination with Avastin in patients with glioblastoma multiforme progresses according to plan. The smaller, exploratory phase Ib study with TB-403 in combination with sorafenib is discontinued. In February our partner Roche concluded that the slow recruitment of patients for the first part of the study would make it difficult to complete the second part.

During the period's last quarter we engaged more clinics in the BI-505 study in order to speed up the process and make it possible to report also this study in the second quarter. So far we can conclude that the antibody is well tolerated.

Once the outcome of all these activities is established, we will be able to lay down a proper commercial strategy for all of our clinical projects for which we have retained marketing rights.

Svein Mathisen

 

Contact

Any questions regarding this report will be answered by:

BioInvent International AB (publ.)
Svein Mathisen, President & CEO, tel.+46 (0)46 286 85 67, mobile +46 (0)708 97 82 13

College Hill
Melanie Toyne Sewell, tel. +44 (0)20 7866 7856, [email protected]
Rebecca Skye Dietrich, tel: +1 857 241-0795.

The report is also available at www.bioinvent.com

Information disclosed in this press release is provided herein pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 8.30 a.m. CET, on 9 February, 2012.