BioInvent Interim Report 1 January - 31 March 2012
Report
Press release
BioInvent Interim Report 1 January - 31 March 2012
· Enrolment of patients in the phase II GLACIER study with BI-204 (acute coronary syndrome) was completed in March. The first results are expected to be published in the third quarter. · Treatment of all patients in BioInvent's phase II study with TB-402 (thrombosis) was completed in the quarter. First results are expected to be published later in Q2. · BI-505 (cancer) is well tolerated in the on-going phase I study. Treatment has progressed to a higher dose level and a release of data is expected in Q3. · A preclinical collaboration with Servier on the development of an antibody based oncology treatment was entered in January. The agreement is worth more than EUR 11 million upon the successful launch of a product. · A preferential rights issue of SEK 104.8 was concluded successfully in April. · Net revenues for January - March 2012 amounted to SEK 15 million (97). Earnings for January - March 2012: SEK -37 million (59). Earnings per share SEK -0.55 (0.97). · Current investments together with cash and bank balances as of 31 March 2012: SEK 138 million (68). Including the proceeds of the rights issue cash items pro forma would have amounted to SEK 235 million. Cash flow of current operations and investment activities for January - March 2012: SEK -36 million (-38).
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
During the course of the next four months BioInvent plans to report decisive results of the three clinical programs where we are playing an active role. I enter this exiting period with great confidence.
Firstly let me say that our financial situation has been reinforced by the 105 million SEK rights issue which was oversubscribed and concluded in April. We are now able to focus on business opportunities as they arise and on the strategic choices which we are facing.
Our clinical portfolio is thus approaching a number of milestone events in the near future. First in line is TB-402, which is expected to have final phase II data ready for publication later in this quarter. We believe TB-402 has all the attributes necessary to transform the hospital's treatment routines for patients at increased risk of venous thromboembolism, such as long-lasting single dose effect as well as better safety profile.
In a previous study it was shown that TB-402 has the potential to become a powerful prophylaxis of life-threatening blood clots in knee surgery patients. With our second phase II study we aim to show that our product candidate also has the prerequisites for efficiently prevent blood clotting in hip surgery patients in need of longer-term anti-coagulation.
We have raised the bar in this study by also including the new factor Xa inhibitor Xarelto as a study reference arm, an important step in positioning TB-402 as a paradigm shift in the hospital's routines for anti-coagulation.
In March we announced that the GLACIER study with BI-204 has been fully enrolled. BI-204 is our unique approach to an anti-inflammatory treatment of cardiovascular disease, one of the big challenges in modern healthcare. In the third quarter we anticipate to announce the first clinical data from the study with our partner Genentech, a subsidiary of Roche Group. GLACIER is designed to show the effect of BI-204 on vascular inflammation in the atherosclerotic blood vessel. This inflammation drives the pathological processes which lead to plaque ruptures causing myocardial infarction and stroke. Should GLACIER confirm that BI-204 alleviates the inflammation, as measured by FDG-PET, it would improve our chances to develop a product meeting a major unmet medical need.
BI-505 is in an earlier stage of clinical development, but in the third quarter we expect to be able to make the necessary conclusions on tolerability and report data which will determine the future development path of this innovative and exciting product candidate in cancer patients.
Once outcomes of these studies are on the table later this year we will assess the commercial strategy for all projects in which we retain marketing rights.
Finally, we continue to see strong interest in our technology platform. During the quarter the French pharmaceutical company Servier was added to the list of companies making use of the n-CoDeR library, our advanced tool for antibody drug development, to their drug discovery. BioInvent will receive substantial revenues upon successful development and commercial launch of n-CoDeR products from these programs. Our shares of other companies' product development alongside with our in-house development increase the likelihood of commercial success.
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, or
Sten Westerberg, Vice President, Investor Relations, tel. +46 (0)46 286 85 52, mobile +46 (0)768 68 50 09, [email protected].
College Hill
Melanie Toyne Sewell, tel. +44 (0)20 7866 7856, [email protected]
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 2 May, 2012.