BioInvent Financial Statement 1 January - 31 December 2017

BioInvent to co-develop dual mechanism anti-cancer drug with Transgene.

BioInvent to co-develop dual mechanism anti-cancer drug with Transgene

Fourth quarter 2017,
October – December

  • Net sales amounted to SEK 14 (31) million.
  • Earnings after tax SEK -33 (-7.3) million.
  • Earnings after tax per share before and after dilution SEK -0.11 (-0.03).
  • Cash flow from operating activities and investment activities SEK -29 (-24) million.

Full year report 2017,
January - December

  • Net sales amounted to SEK 45 (71) million.
  • Earnings after tax SEK -101 (-63) million.
  • Earnings after tax per share before and after dilution SEK -0.33 (-0.25).
  • Cash flow from operating activities and investment activities SEK -92 (-77) million. Liquid funds as of 31 December 2017: SEK 134 (226) million.

Important events in the fourth quarter and after the reporting period

  • BioInvent announced in October 2017 that Michael Oredsson will resign as CEO of BioInvent on 31 December 2017. Michael took office as CEO of BioInvent in 2013 to restructure the company and refocus on oncology. From 1 January 2018, BioInvent’s Chief Scientific Officer, Björn Frendéus, is serving as acting CEO until a new CEO has been appointed and taken office.
  • BioInvent and Transgene, a company that designs and develops viral-based immunotherapies, announced in December 2017 that they had entered a collaboration to co-develop next generation oncolytic virus (OV) candidates encoding an anti-CTLA-4 antibody sequence - potentially with additional transgenes - capable of treating multiple solid tumours.
  • 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.

Comments from the CEO
“In December 2017, we announced that our preclinical portfolio will be expanded with a project where BioInvent and Transgene will co-develop potentially more efficacious and safe treatments of solid tumours by combining oncolytic viruses and anti-CTLA-4 antibodies. The collaboration underpins BioInvent’s attractiveness as a partner to other leading developers of cancer immunotherapies. Combining oncolytic viruses with checkpoint inhibitors is a clinically proven concept, and CTLA-4 antibodies have a documented effect in cancer patients promoting immune system activation against tumours. The oncolytic virus will preferentially replicate in cancer cells enabling targeted expression of the CTLA-4 antibody. This will potentially avoid the side effects associated with systemic exposure and improve efficacy of this class of antibodies. Encoding a human anti-CTLA-4 antibody into the oncolytic virus’ genome therefore provides a potentially useful immunotherapy combination strategy for cancer patients. In 2016, global revenues of the first approved CTLA-4 inhibitor, Yervoy®, exceeded USD 1 bn.

During the fourth quarter of 2017, BioInvent continued its preparations for an expansion of the BI-1206 clinical trial program, aiming at broadening its potential use and bringing benefits to additional patient populations. An open, single-arm Phase I/IIa clinical study with a combination of BI-1206 and rituximab is planned to start in H1 2018. This study will complement the on-going CRUK funded clinical trial, and is estimated to enroll approximately twenty patients with indolent B-cell Non-Hodgkin Lymphoma (NHL) relapsed or refractory to rituximab, including patients with Mantle Cell Lymphoma, Follicular Lymphoma, and Marginal Zone Lymphoma. The new study will give BioInvent an opportunity to more rapidly investigate safety, therapeutic dose for BI-1206 and efficacy of the combination treatment.

Our strategic collaboration with Pfizer to develop antibodies targeting tumour-associated myeloid cells is progressing well. A pool of antibodies has been generated, and will now be characterized for functional activity.

In January 2018, I took up the position as acting CEO, and I am looking forward to leading our business activities until a permanent successor has been nominated and taken office,” 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 30 January, 2018.

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