Press release

Interim Report January 1 - September 30, 2019

Progressing through multiple clinical trials and developing a promising pre-clinical portfolio

"BioInvent continues to deliver on its stated goals for the year. Our lead clinical candidate BI-1206 now being investigated in solid tumors as well as in hematological cancers."
Martin Welschof, CEO BioInvent

Financial information

Third quarter 2019

• Net sales SEK 18.1 (7.0) million.
• Loss after tax SEK -37.1 (-22.4) million.
• Loss after tax per share before and after dilution SEK -0.07 (-0.06).
• Cash flow from operating activities and investment activities SEK -25.0 (-37.6) million.

January - September, 2019

• Net sales SEK 68.4 (28.2) million.
• Loss after tax SEK -97.7 (-90.5) million.
• Loss after tax per share before and after dilution SEK -0.22 (-0.27).
• Cash flow from operating activities and investment activities SEK -100.8 (-107.0) million. Liquid funds as of September 30, 2019: SEK 183.9 (107.1) million.

Events in the third quarter

• Received acceptance of an Investigational New Drug (IND) application from US FDA for a Phase I/IIa clinical trial of BI-1206 in combination with pembrolizumab (Keytruda) in solid tumors.
• Pfizer Inc. selected first target discovered by BioInvent's proprietary F.I.R.S.T™ technology platform under the collaboration, triggering a payment of $0.3 million. (R)
• Received $0.5 million milestone payment from XOMA Corporation related to the acceptance by US FDA of an IND application for TAK-169.
• The US Patent Office (USPTO) issued Notice of Allowance for patent application relating to our lead program BI-1206. (R)
• BioInvent's partner Oxurion reported topline month 3 results of Phase lla study evaluating THR-317 for Diabetic Macular Edema.

Events after the reporting period

• BioInvent signs manufacturing agreement with Cancer Research UK, CRUK, expected to generate revenue of SEK 30 million. (R)
  (R)= Regulatory event

Comments from the CEO

BioInvent continues to deliver on its stated goals for the year. Our lead clinical candidate BI-1206 now being investigated in solid tumors as well as in hematological cancers.

We are very pleased to have received approval from the FDA for a Phase l/lla clinical trial evaluating BI-1206 in solid cancer, and are very much looking forward to further study the potential of one of our proprietary anti-FcγRllB antibodies. Although PD-1 inhibitors have revolutionized cancer treatment, in some patients, who initially respond to this therapy, the disease will progress and are thus in need of an effective second-line approach. We hope that BI-1206 will have the ability to address an important mechanism of resistance to PD1 inhibition, and thus may present a powerful next line treatment. 

We are progressing BI-1206 through multiple clinical trials and continue to develop other candidates in our pre-clinical portfolio. Current data for BI-1206 in hematological cancer is encouraging as a potential first-in-class therapeutic with a unique mechanism of action.

BioInvent has a clear advantage in our in-house production facility. Hence, we are able to develop our proprietary clinical materials faster and cheaper. This is one of our differentiating factors compared to other companies. As a secondary benefit, we contract production for third parties, which generates revenues for the company.

On October 23 we announced a production agreement with Cancer Research UK, the world's largest independent funder of cancer research. Under the agreement BioInvent will produce anti-HER3 antibodies for Hummingbird Bioscience. The agreement is expected to generate revenue of SEK 30 million.

Our proprietary F.I.R.S.T™ platform is the foundation of our pipeline, enabling us to simultaneously identify targets and high-quality antibodies that bind to them. This unique technology generates potentially promising new drug candidates which broaden our pipeline and create licensing and partnering opportunities, with accompanying near-term revenue. A good example is that Pfizer selected the first target under our collaboration last July, resulting a payment to BioInvent of USD 0.3 million.

Martin Welschof
CEO

Contact
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0)46 286 85 50, [email protected]. The report is also available at www.bioinvent.com.

BioInvent International AB (publ)
Co. reg. no. 556537-7263
Address: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50
[email protected]

Forward looking information
This interim report contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual out-come may deviate significantly from the scenarios described in this press release.

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 October 24, 2019.