Press release

BioInvent Interim Report 1 January - 30 June 2018

Second quarter 2018,
April – June 

• Net sales amounted to SEK 9.8 (11.4) million.
• Loss after tax SEK -43.2 (-23.5) million.
• Loss after tax per share before and after dilution SEK -0.12 (-0.08).
• Cash flow from operating activities and investment activities SEK 36.5 (-23.3) million.

Half year report 2018,
January - June 

• Net sales amounted to SEK 21.1 (24.3) million.
• Loss after tax SEK -68.1 (-45.8) million.
• Loss after tax per share before and after dilution SEK -0.21 (-0.15).
• Cash flow from operating activities and investment activities SEK -69.4 (-33.3) million. Liquid funds as of 30 June 2018: SEK 144.7 (192.8) million.

Important events in the second quarter and after the reporting period 

• On 12 April 2018, Dr Martin Welschof was appointed President and Chief Executive Officer of Bioinvent. He takes office as of 1 September. Martin combines a strong track record as an executive in the biotech industry with a solid scientific background in the field of antibody technology. Previously he was CEO of Affitech (Nasdaq Copenhagen) and currently he is CEO of Opsona Therapeutics, based in Dublin, Ireland.

• In April 2018 BioInvent’s partner ThromboGenics announced initial data from a Phase l/ll study of THR-317 for the treatment of diabetic macular edema. The study, evaluating safety and efficacy of two dose levels, showed that THR-317 was safe and well tolerated. No dose-limiting toxicities or relevant safety events were reported at either dose level. Subsequently, ThromboGenics initiated a Phase II study in April with THR-317 in combination with ranibizumab (Lucentis®, Novartis) to evaluate the efficacy and safety of the combination.

• In July 2018, the Japanese patent office decided that the Company’s patent application for its unique, function-based F.I.R.S.T.™ platform can proceed to grant.

• In July 2018, the U.S. Food and Drug Administration (FDA) accepted BioInvent’s Investigational New Drug (IND) Application for its new Phase I/IIa clinical study that will explore the activity of its proprietary monoclonal antibody BI-1206 in combination with rituximab. In May 2018 the Swedish Medical Product Agency approved the initiation of the same study.

• In July 2018 BioInvent announced that no dose limiting toxicity had been reported in the ongoing Phase I/IIa study of BI-1206 in patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL) conducted in the UK by the Cancer Research UK. The ongoing study is currently testing single agent activity and is open for enrollment of additional patients.

• In July 2018, the Company signed a production agreement with the Swedish biopharmaceutical company ITBMed AB. The production agreement is expected to generate revenue of at least SEK 17 million in 2018 and 2019.

Comments from the CEO
Björn Frendéus, acting CEO of BioInvent since 1 January, 2018, says, “We are excited to have received the go ahead from regulatory authorities in the U.S. and Sweden to start the new BioInvent sponsored Phase I/IIa study of BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell NHL. The aim of the study is to show that BI-1206 may enhance the activity of rituximab, as has been demonstrated in preclinical studies. Rituximab is a mainstay in the current standard of care in NHL, and a blockbuster drug. Success in this program may open up a substantial commercial opportunity for Bioinvent.

We are highly encouraged by the fact that to date no dose limiting toxicity has been reported in the ongoing Phase I/II study of BI-1206 in patients with NHL and CLL, conducted by Cancer Research UK.

Having our own production facility provides BioInvent great flexibility and efficiency in accelerating our proprietary immuno-oncology drug programs, while it also gives us an opportunity to generate near-term revenue from external partners. The recent production agreement with ITBMed AB is a good example of this.

On 1 September Martin Welschof will take up his role as CEO of the company. Martin has a broad international experience as chief executive driving business development, partnering, and financing. As I return to my role as Chief Scientific Officer, I look forward to start a new chapter in the development of Bioinvent, with the rest of the leadership team.” 

Contact 
Any questions regarding this report will be answered by Björn Frendéus, acting CEO, phone +46 (0)46 286 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 July, 2018.