BioInvent Interim Report 1 January – 30 September 2015

BioInvent expands two planned clinical trials

LUND, Sweden--(BUSINESS WIRE)--Regulatory News:

Third quarter 2015, July - September

· Net sales for July-September 2015 amounted to SEK 1.7 (11) million.

· Earnings after tax for July-September 2015: SEK -23 (-10) million.

· Earnings after tax per share for July-September 2015 before and after dilution: -0.14 (-0.09) SEK.

· Cash flow from current operations and investment activities for July-September 2015: SEK -12 (-3.9) million.

Nine-month report 2015, January – September

· Net sales for January-September 2015 amounted to SEK 5.9 (45) million.

· Earnings after tax for January-September 2015: SEK -70 (-26) million.

· Earnings after tax for January-September 2015 before and after dilution: SEK -0.51 (-0.26).

· Liquid funds as of 30 September 2015: SEK 51 (70) million. Cash flow from current operations and investment activities for January-September 2015: SEK -63 (-52) million.

Important events in the third quarter and after the reporting period

· BioInvent announced in July that the upcoming phase I/IIa study of TB-403 will be expanded to include children with Ewing’s sarcoma and neuroblastoma in a dose escalation phase of the trial, in addition to the already announced indication medulloblastoma. Further it was announced that late stage negotiations are on-going with a leading clinical network in the US to conduct the trial. The study is planned to commence in Q4 2015.

· BioInvent announced in September that the company and its partner, the University of Pennsylvania, had decided to expand the planned clinical Phase II study with the antibody BI-505 by, among other things, now also include a control group. This will increase the study data quality and accelerate the path for approval of a potential new drug for multiple myeloma.

Comments from the CEO “In the past quarter we decided to expand the upcoming clinical studies and thereby get more solid data for two of our projects that have advanced the furthest: BI-505 and TB-403. We are pleased that our discussions with potential partners regarding preclinical and clinical projects have become more concrete. BI-505 is a potentially groundbreaking treatment for the haematological disease multiple myeloma. Researchers and clinicians at the University of Pennsylvania have shown great interest in our project and are therefore offering to support its continued development with significant resources. The TB-403 project has also attracted a lot of interest among clinicians, and as a result we have succeeded, in cooperation with our commercial partner Oncurious BV, in attracting a leading clinical network in the US to implement an important efficacy and safety study. It will be conducted on children with life-threatening cancers where current treatments are inadequate. In July we announced that the planned clinical trial would be expanded to include, in addition to the original indication medulloblastoma, also children with Ewing’s sarcoma and children with neuroblastoma. The interest that leading clinicians who have good knowledge of the needs of healthcare and patients for improved treatments are showing in BI-505 and TB-403 is a strong indication of the project’s commercial potential. In a short time we have transformed BioInvent from a preclinical company into a company with three clinical projects: BI-505, TB-403 and BI-1206, which all are close to launching important clinical trials. All of the planned studies are so-called “open studies” making it possible to follow the results continuously during the course of the study. The new clinical studies have great potential to increase the projects’ commercial attractiveness significantly over the next few years,” says Michael Oredsson, CEO of BioInvent.

Contact Any questions regarding this report will be answered by Michael Oredsson, CEO, phone.+46 (0)46 286 85 67, mobile +46 (0)707 18 89 30. The report is also available at www.bioinvent.com

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 22 October, 2015.

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