BioInvent Interim Report January 1 - March 31, 2020

LUND, Sweden, April 28, 2020 /PRNewswire/ --

Promising progress reported for BI-1206 in combination with rituximab

"We have made a strong start to 2020 and remain on track to deliver on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners."

Martin Welschof, CEO BioInvent

Financial information first quarter 2020           

• Net sales SEK 16.7 (17.4) million.           
• Loss after tax SEK -32.6 (-27.8) million.           
• Loss after tax per share before and after dilution SEK -0.07 (-0.08).           
• Cash flow from operating activities and investment activities SEK -35.4 (-40.5) million. Liquid funds as of March 31, 2020: SEK 117.1 (28.5) million.

Events in the first quarter           

• BioInvent and Transgene announced that the first clinical trial application for BT-001 was submitted and that the first-in-human trial is expected to start before the end of 2020 in Europe and the US.           
• BioInvent announced an agreement with SkylineDx to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206.

Events after the reporting period           

• In April 2020, promising progress was reported in the Phase I/lla trial of lead program BI-1206 in combination with rituximab. A complete response was observed in one follicular lymphoma patient and complete depletion of circulating tumoral cells in a mantle cell lymphoma patient. (R)
              (R)= Regulatory event

Comments from the CEO

BioInvent has made a strong start to 2020 and remains on track for delivery on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners.

It was very pleasing to report promising progress in the Phase I/lla trial of BI-1206 in combination with rituximab for the treatment of Non-Hodgkin Lymphoma (NHL). Three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. Particularly notable was that one patient in the 70mg cohort achieved a complete response and another patient had complete depletion of circulating mantle cell lymphoma cells. Of course, this is a very early stage in the study, and this part of it is designed to evaluate safety and tolerability. All the same, these initial signs of efficacy are very encouraging.

We have also concluded an agreement with SkylineDx, a molecular diagnostics company focusing on discovery of novel gene-based biomarkers, to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206. This is particularly interesting because identifying the right patients who are likely to respond to treatment with BI-1206 will constitute a major asset in the development of this promising treatment and, along with FcγRIIB expression levels, should support the extension of its use to other malignancies.

Further along our pipeline, BioInvent and our partner Transgene have submitted the first clinical trial application for BT-001, a multifunctional oncolytic virus which was engineered to encode a Treg-depleting, anti-CTLA4 antibody from our proprietary n-CoDeR^®/F.I.R.S.T^TM  platforms. The first-in-human trial is expected to start before the end of 2020 in Europe and the U.S. and we believe that the potential to combine anti-CTLA4, anti-PD-1/PD/L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors.

Thus, our technology platform continues to produce exciting potential new treatments, ready for developing through clinical trials and to address important unmet medical needs.

As BioInvent continues to bring new programs towards clinical development, financing is of course a priority and we will continue to use a combination of sources for funding. Firstly, we are engaged in several business development discussions with the aim of partnering one or more of the programs in our portfolio. Secondly, the collaboration with Pfizer, which is also a model for other potential collaborations which commercialize our platform. Thirdly, our manufacturing capabilities generate revenue, with the most recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become a long-term strategic partner, as it works with a number of small- to mid-sized companies that need manufacturing support. And our fourth option is to use capital markets for financing. Based on the support from our large institutional investors and increased interest in our programs we feel optimistic that a combination of these four sources will continue to support BioInvent financially. The Board of Directors follows the financing situation and is working on a plan to ensure the Group's continued financing.

The spread of COVID-19 has changed all our lives and BioInvent is no exception. We are taking all the necessary precautions and continue to monitor its spread and associated measures closely. BioInvent has clinical trials in process and clinical trials soon to be initiated and the global measures against COVID-19 and the need to prioritize healthcare resources will likely affect the timelines for these studies.

The precise impact is difficult to assess at this stage, given the rapidly developing situation. Currently, we still expect the early results from the Phase I open label study with a combination of BI-1206 and rituximab for treatment of NHL in H2 2020. Early clinical trial results for BI-1206 in combination with pembrolizumab and clinical trial initiations in other programs also remain on track. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.

BioInvent is delivering consistently on its strategy as we progress through 2020, despite the disruption caused to the world by the spread of COVID-19. We wish you and your families the best of health, and will continue to keep you up to date on our exciting progress.

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)
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Address: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50

Forward looking information
This financial statement 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.

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