26.04.2016 09:43:00
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BioInvent Interim Report 1 January – 31 March 2016
Regulatory News:
BioInvent (STO:BINV)
Strong financial position and go-ahead for launch of two clinical trials First quarter 2016, January – March 2016
· Net sales for January - March 2016 amounted to SEK 29 (0.6) million.
· Earnings after tax for January - March 2016: SEK 0.3 (-22) million.
· Earnings after tax per share for January - March 2016 before and after dilution: SEK 0.00 (-0.19) SEK.
· Liquid funds as of 31 March 2016: SEK 41 (26) million. Cash flow from current operations and investment activities for January - March 2016: SEK 1.5 (-20) million.
Important events in the first quarter and after the reporting period
· The Board of Directors of BioInvent resolved in February 2016 on a private placement of SEK 43 million to the US-based healthcare investor Omega Funds and a rights issue of SEK 191 million. The rights issue has been completed and 85.4 percent of the new share issue was subscribed for with subscription rights. 7.8 percent of the share issue was subscribed for without subscription rights and 6.8 percent was subscribed for by guarantors.
· BioInvent announced in April 2016 that the BI-505 Phase II trial can now start in patients with multiple myeloma, as necessary regulatory approvals have been obtained. The first patient is expected to be dosed in May.
· BioInvent announced in March 2016 that the European Patent Office, EPO, has granted the company’s patent EP 1 960 432, relating to the immune-oncology antibody BI-505.
· In March 2016 BioInvent announced that a partnership with the Neuroblastoma and Medulloblastoma Translational Research Consortium has been initiated. Accessing the network of specialist clinicians will serve to accelerate the enrollment of patients to the planned Phase I/IIa trial of TB-403.
· BioInvent announced in February 2016 that a €2 million milestone payment had been received under the collaboration with Daiichi Sankyo pertaining to the progression of an anti-FGFR4 antibody into a Phase I clinical trial in the EU.
· In January 2016 BioInvent announced that the FDA had completed the review of its Investigational New Drug application for TB-403 and have concluded that the proposed pediatric clinical investigation can proceed.
Comments from the CEO
"BioInvent reported positive earnings during the period, as a result of income from licensing agreements and contract manufacturing of antibodies. We have made important operational progress in the preparations of the three clinical studies planned to start during the year. Moreover, we have ensured a continued solid financial platform for creating value through the successful implementation of the new share issues. The private placement to Omega Funds is an important validation of our research and its commercial potential. Omega Funds has deep knowledge of the immune oncology area and an extensive network among global investors and potential licensing partners.
In January, the FDA in the US gave go-ahead to start a Phase I/II clinical study in pediatric cancer using the TB-403 antibody and in April, we received a positive response for the launch of our phase II study of multiple myeloma using the BI-505 antibody. The first patients in both studies are expected to be dosed in May 2016. In partnership with BioInvent, Cancer Research UK submitted an application for a phase I clinical study in the UK – using the BI-1206 antibody for non-Hodgkin's lymphoma and chronic lymphocytic leukemia treatments.
Meanwhile, work continues in preclinical projects that focus on T-reg (regulatory T cells) and TAM (tumor-associated macrophages). We are continuously generating data that are crucial to be able to attract qualified partners for these projects. The interest from leading pharma companies for these types of immune oncology projects is large and we believe we have unique research to develop novel drug candidates to fight life-threatening cancers effectively.
Going forward, BioInvent will continuously have access to clinical data for three drug candidates – with potential for significantly improving treatment of many life-threatening cancers. This would have been impossible without BioInvent’s high level of internal drug development expertise, unique partnerships with leading researchers and specialists, and our capacity to produce antibodies for clinical trials. Building this foundation for value creation has been a long, resource-intensive process. Now our determined efforts are bearing fruit – with three independent projects in (or about to enter) clinical trials, BioInvent has secured a position on the cutting edge of immune oncology”, says Michael Oredsson, CEO of BioInvent.
BioInvent International AB develops immune oncology drugs. With one of the world’s largest antibody libraries, and a unique, proprietary discovery method, BioInvent can identify the optimal cellular targets and antibodies for the treatment of various tumor types. BioInvent has also considerable experience in and a facility for process development and production of antibodies for clinical studies. This makes it possible to develop proprietary drug projects, but also to supply leading international pharmaceutical companies with effective tools for their drug development. BioInvent currently has three proprietary projects in or close to clinical development and partnership agreements with seven global pharmaceutical and biotech companies.
Information disclosed in this interim report 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 8.40 a.m. CET, on 26 April, 2016.
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