0H22 Bioinvent International Ab

LUND, Sweden, Aug. 22, 2019 /PRNewswire/ -- "We are executing according to plan. Our lead candidate BI-1206 has shown encouraging initial data in hematological cancers, and has now also entered clinical trials in solid cancer," Martin Welschof, CEO BioInvent

Financial information
Second quarter 2019

• Net sales SEK 32.9 (9.8) million.
• Loss after tax SEK -32.8 (-43.2) million.
• Loss after tax per share before and after dilution SEK -0.07 (-0.12).
• Cash flow from operating activities and investment activities SEK -35.3 (-40.1) million.

January – June, 2019

• Net sales SEK 50.3 (21.1) million.
• Loss after tax SEK -60.6 (-68.1) million.
• Loss after tax per share before and after dilution SEK -0.15 (-0.21).
• Cash flow from operating activities and investment activities SEK -75.8 (-69.4) million. Liquid funds as of June 30, 2019: SEK 210.3 (144.7) million.

Events in the second quarter

• Publication of first data from two parallel Phase l/lla clinical trials of BI-1206.
• €0.75 million milestone payment from Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in a Phase II clinical trial of an antibody identified from BioInvent's proprietary n-CoDeR® antibody library. (R)
• The rights issue and directed issue completed in April, amounted to in total SEK 220.0 million after issue expenses.

Events after the reporting period

• Acceptance by FDA of an IND (Investigational New Drug) application for a Phase I/IIa clinical trial of BI-1206 in combination with pembrolizumab in solid tumors.
• Selection of the first target discovered by BioInvent's proprietary F.I.R.S.T™ technology platform under the collaboration with Pfizer Inc, triggering a payment from Pfizer to BioInvent of $0.3 million. (R)
• $0.5 million milestone payment from XOMA Corporation related to the acceptance by FDA of an IND application for TAK-169.
• Notice of allowance from the USPTO for patent application relating to the lead program BI-1206. (R)
• BioInvent's partner Oxurion reported topline month 3 results of Phase lla Study Evaluating THR-317 in Combination with Ranibizumab, for Diabetic Macular Edema.
  (R)= Regulatory event

Comments from the CEO

BioInvent made significant progress in the second quarter and we executed our activities according to plan.

In particular, initial data from the two parallel Phase I/IIa trials of our lead product BI-1206 further supported its development as a potential first-in-class therapeutic with a unique mechanism of action. It was encouraging to see that the analysis at current doses showed depletion of peripheral B cells. The next step is now to define the optimal dose.
   
We are encouraged by the current data for our lead compound BI-1206 in hematological cancer, but it is important to emphasize that BioInvent is much more than just one program. We have put tremendous efforts into our pre-clinical portfolio and especially into our BI-1206 program in solid tumors. Therefore, it was very rewarding that the FDA approved our IND application for a Phase I/IIa study and I am pleased that this program now has advanced into clinical stage.

These efforts targeting solid tumor indications demonstrate the depth of our pipeline and the productivity of our proprietary F.I.R.S.T™ platform technology. Through our technology we can simultaneously identify targets and high-quality antibodies that bind to them, generating potentially promising new drug candidates.

In the quarter our n-CoDeR® antibody library and our F.I.R.S.T™ platform received further validation when Pfizer selected its first target under the agreement signed in December 2016. Furthermore, the acceptance by the FDA of an IND application for TAK-169 was another recognition for our technology.

Taken together, these milestones demonstrate the strength of our platform – producing novel antibody-based cancer therapies, broadening our own pipeline and opening up for more licensing and partnering.

Martin Welschof
CEO 

Contact
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0)46 286 85 50, martin.welschof@bioinvent.com. 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
info@bioinvent.com

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 August 22, 2019.

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