LUND, Sweden--()--Regulatory News:
Focus on cancer
· Clear focus on indication, since all in-house development of antibody-based drugs is dedicated to oncology
· Activities with the goal of achieving self-financing business model initiated
· Number of employees reduced to about 50 people
Important events in the fourth quarter and after the end of the reporting period
· The last patients were enrolled in the phase I study of BI-505 in patients with multiple myeloma. After the end of the period, the Company reported that the study achieved our objectives since the candidate drug was well tolerated with indications of therapeutic effect.
· CEO Svein Mathisen resigned and recruitment of new CEO and President has been initiated
Key financial points
· Net revenues for January – December 2012 amounted to SEK 43 (125) million, whereof the fourth quarter SEK 9.3 (1.8) million.
· Earnings for January – December 2012: SEK -188 (-67) million including restructuring costs of SEK 24 million and a provision of SEK 19 million for the termination of TB-402 and also a provision of SEK 6.2 million for dismissal and severance payments to the former CEO. Earnings for the fourth quarter: SEK -21 (-59) million.
· Earnings per share SEK -2.61 (-1.04), whereof the fourth quarter SEK -0.29 (-0.88).
· Liquid funds as of 31 December 2012: SEK 100 (174) million. Cash flow of current operations and investment activities for January – December 2012: SEK -170 (-60) million, whereof the fourth quarter SEK -52 (-43) million.
· A rights issue of SEK 105 million before transaction costs was successfully completed in April.
BioInvent (STO:BINV) is a research-based pharmaceutical company focused on discovery and development of innovative antibody-based drugs against cancer. The Company also develops antibody-based drugs in collaboration with partners who finance the development of the new drug, and provide BioInvent the right to milestone payments and royalties on sales.
Comments from the CEO BioInvent’s change management initiative, which focuses on a self-financing business model for the basic operation, is now producing rapid results, including lower costs and a stronger focus on new business. In just a few quarters, the Company will reduce its costs by more than 50 per cent from the previous annual rate of over SEK 200 million.
BioInvent is also continuing to develop its technology platform for the discovery and development of novel antibody-based drugs. The long list of partners we already work with within the framework of our n-CoDeR®-library is an important reference as we now increase our focus on new business. I am convinced that our strong offering will attract new partners, while our existing partners advance the positions of our collaborations on several fronts, with initiation of clinical trials expected this year.
We are pleased to see, most recently at scientific conferences in San Diego in December and Vancouver in January, that the Company's unique F.I.R.S.T™ technology, a further development of, and an important complement to, the n-CoDeR®platform, is garnering great interest. F.I.R.S.T™ is our new function-based platform for the simultaneous identification of disease-associated target structures and antibody-based drugs. F.I.R.S.T™ provides a unique method to make an early identification of the target structures associated with diseased tissues as opposed to healthy tissues, while simultaneously identifying the biologically most effective antibodies. In our opinion, the biological relevance of F.I.R.S.T™ will contribute to the strong development of the antibody-based drug market that is expected to continue during the upcoming decade, especially in the field of oncology.
BI-505 is one example of BioInvent's capability to initiate in-house clinical projects, based on our own F.I.R.S.T™ technology and biological expertise. It is therefore particularly satisfying to be able to conclude that our first human study of BI-505 achieved our goals. The candidate drug was well-tolerated and indicated therapeutic effect, since seven of a total of 29 patients with advanced multiple myeloma demonstrated stable disease for at least two months.
We have decided to continue our studies on BI-505 with a new smaller follow-up study that has already been approved by the Swedish Medical Products Agency. The efficacy and safety of BI-505 will be studied in patients with multiple myeloma who have not yet developed symptoms of the disease, known as asymptomatic multiple myeloma. At a conference in Japan in April we will also present interesting results from preclinical studies showing improved anti-tumour activity when combining BI-505 with previously approved drugs. These results lend support to continuing with a clinical trial in which BI-505 is combined with another drug, representing a logic continuation of the clinical development process in our hitherto most advanced project.
The significant medical need that the multiple myeloma market represents and the growing competition following in its wake will place special demands on the development of BI-505. Therefore, we believe that the most direct pathway forward for BI-505 is to join forces with a partner with extensive experience in studies supporting registration in the field of oncology.
Finally, I would like to thank my predecessor Svein Mathisen for his many years of outstanding effort as the CEO of the Company. Svein led BioInvent from a platform company to a product-focused enterprise. Despite the challenges of 2012, BioInvent is well-equipped to take advantage of new opportunities.
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 21 February, 2013.
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