Press release

BioInvent Interim Report 1 January - 31 March 2018

BioInvent completes share issue with significant interest from reputable institutions and sector specialist funds

January – March 2018

• Net sales amounted to SEK 11 (13) million.
• Earnings after tax SEK -25 (-22) million.
• Earnings after tax per share before and after dilution: SEK -0.08 (-0.07) SEK.
• Liquid funds as of 31 March 2018 amounted to SEK 108* (216) million. Cash flow from operating activities and investment activities amounted to SEK -106 (-10) million.

*Liquid funds as of 31 March 2018 include SEK 3.7 million of the total net capital SEK 80 million from the directed share issue. Remaining net capital SEK 77 million has been received in April 2018.

Important events in the first quarter and after the reporting period 

• BioInvent announced in January 2018 that the European Patent Office, EPO, had communicated its intention to grant the Company a patent relevant to its unique, function-based F.I.R.S.T.™ platform. More precisely, the patent builds on earlier F.I.R.S.T.™ patents, extending protection to combined use of differential biopanning and high throughput sequencing, such as Next Generation Sequencing in identification of antibodies to low expressed cell surface antigens.
• BioInvent announced in March 2018 that the Company successfully had completed a directed share issue of approximately SEK 85 million before transaction costs. The issue generated significant interest from reputable institutions and sector specialist funds, including Rhenman Healthcare Equity L/S and IMEurope (Institut Mérieux), not previously a shareholder in BioInvent, who was the largest participant in the issue and becomes one of the largest shareholders of the Company. The Company’s two largest current shareholders van Herk Investments B.V. and Omega Fund IV, LP also participated in the issue pursuant to the guarantee undertakings provided by them.
• In April 2018 BioInvent’s partner ThromboGenics announced initial data from a Phase l/ll, single-masked, multicentre study to evaluate the safety and efficacy of two dose levels of THR-317 for the treatment of diabetic macular edema. ThromboGenics reported initial data for the anti-VEGF treatment naive group (n=40) up to Day 90; 30 days after the last intravitreal (IVT) anti-PlGF administration. The primary focus of this study was safety outcomes. THR-317 was safe and well tolerated. No dose-limiting toxicities or relevant safety events were reported at either dose level.
• BioInvent announced in April 2018 that Dr Martin Welschof had been appointed new President and CEO. Martin has a broad international experience from executive positions within the biotech industry, including Director of Technology at Axaron Bioscience AG, Heidelberg, Germany and CEO of Affitech (Nasdaq Copenhagen). He is currently CEO of Opsona Therapeutics, based in Dublin, Ireland. In addition, he has a strong scientific background in the field of antibody technology.
     
  

Comments from the CEO
”Based on significant interest for BioInvent’s science and immune oncology pipeline from a number of reputable institutions and sector specialist funds, we were recently able to successfully complete a directed share issue of approximately SEK 85 million before transaction costs. This will strengthen us in our efforts to expand clinical development of our lead antibody BI-1206, developed to boost efficacy and overcome rituximab-resistance, as well as advancing our pipeline projects developed on our own or together with partners.

Our current focus within the clinical portfolio is to facilitate the initiation of a new clinical trial with BI-1206 in patients with hematological cancer, which is slated for the second quarter this year. This study complements the ongoing trial conducted by CRUK, and will give BioInvent a better opportunity to investigate the safety and efficacy of BI-1206 in combination with rituximab – the golden standard in the treatment of this patient population.

In the past quarter, ThromboGenics announced encouraging initial data from a phase I/II study with THR-317 – a candidate drug for the treatment of diabetic macular edema. ThromboGenics carries all costs for the development of THR-317 in non-oncology indications, and BioInvent is entitled to five percent of the project’s economic value. 

BioInvent is a frontrunner within the area of immuno-oncology, a position that was further underpinned by the publication in March of a paper in the prestigious scientific journal Cancer Cell. Together with researchers from University College in London, we presented new findings on the mechanism-of-action of clinically validated anti-CTLA-4 antibody ipilimumab (Vargas et al Cancer Cell, 2018 https://doi.org/10.1016/j.ccell.2018.02.010). The finding that FcgR-dependent mechanisms are associated with responses to ipilimumab in human subjects, suggests that Treg deletion contributes to the clinical activity of ipilimumab, and supports the notion that tumour targeted delivery of Treg deleting anti-CTLA-4 antibodies, e.g. through antibody-encoding oncolytic viruses, may be a tractable strategy to optimise anti-CTLA-4 based efficacy and tolerability. Our joint program with Transgene on anti-CTLA-4 antibody encoding oncolytic virus, besides virally mediated tumour cell lysis and triggering of immune activating “danger signals” aims to achieve exactly this. Incorporating our anti-CTLA-4 antibodies in Transgene’s virus vector has the potential for new efficacious and well-tolerated treatments of a range of cancer diseases.  

The recruitment of a new CEO to BioInvent has now been successfully completed, and I am happy to welcome Dr Martin Welshof on board. Martin has broad international experience from executive positions in the biotech industry, as well as business and scientific expertise from the antibody field – a solid background to lead our efforts to advance the Company, seek new alliances and improve BioInvent’s market recognition”, said Björn Frendéus, acting CEO of BioInvent.

Contact
Any questions regarding this report will be answered by Björn Frendéus, acting CEO, phone +46 (0)46 286 25 45, mobile +46 (0)708 11 25 45. The report is also available at www.bioinvent.com.
  

This information is information that BioInvent International AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 8.30 a.m. CET, on 24 April, 2018.