BioInvent Financial Statement January 1 - December 31, 2019

- Delivering on our goals and anticipating important milestones in 2020

LUND, Sweden, Feb. 27, 2020 /PRNewswire/ -- "We are proud that we have delivered on our goals for the year and feel confident that we will continue to do so in 2020, with a number of important milestones approaching. Our cooperation with Merck & Co is our second large pharma collaboration and an excellent validation of BioInvent's work, as we develop BI-1206 in solid tumors as well as in haematological cancers."

Martin Welschof, CEO BioInvent

Financial information

Fourth quarter 2019           

• Net sales SEK 25.4 (10.4) million.           
• Loss after tax SEK -40.9 (-32.7) million.           
• Loss after tax per share before and after dilution SEK -0.08 (-0.09).           
• Cash flow from operating activities and investment activities SEK -28.5 (-38.2) million.

January - December, 2019           

• Net sales SEK 93.7 (38.5) million.           
• Loss after tax SEK -138.6 (-123.2) million.           
• Loss after tax per share before and after dilution SEK -0.31 (-0.36).           
• Cash flow from operating activities and investment activities SEK -129.3 (-145.2) million. Liquid funds as of December 31, 2019: SEK 154.0 (68.9) million.

Events in the fourth quarter           

• BioInvent entered into a clinical trial collaboration and supply agreement with Merck & Co to evaluate BI-1206 in combination with KEYTRUDA^® in advanced solid tumors. (R)           
• Selection of second target and extension of the research collaboration and license agreement with Pfizer Inc. announced. (R)           
• BioInvent and Transgene announced compelling preclinical data for BT-001 in solid tumors.           
• Manufacturing agreement signed with Cancer Research UK expected to generate approximately SEK 30 million (~$3 million). (R)           
• BI-1206 preclinical data in mantle cell lymphoma presented at ASH 2019.
  (R)= Regulatory event

Comments from the CEO

As we look back at 2019 for BioInvent, we can be proud of the delivery on our goals for the year. It is particularly exciting to pursue our lead clinical candidate BI-1206 in solid tumors as well as in hematological cancers.

In December, we concluded an agreement with Merck & Co. to evaluate the combination of BI-1206 and Merck's anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) in a Phase l/lla clinical trial for the treatment of advanced solid tumors. This expands BI-1206 clinical development and builds on preclinical data that demonstrates its ability to address an important mechanism of resistance to PD-1 inhibition, in combination, with one of the most successful immune-oncology drug. The collaboration is an excellent validation of our work and scientific excellence, as Merck has carefully evaluated the pre-clinical data and mode of action that Bioinvent has generated. They have provided insightful feedback on the clinical protocol, and provided input on the strategy for the development of BI-1206 before concluding this agreement.

Our partnership with Pfizer is also progressing well, and further validates the high scientific quality of the work performed by the team at BioInvent. Pfizer has now selected the second target under our cancer immunotherapy research collaboration and license agreement, and we have extended the research term by six months.

These agreements with two of the largest and most highly-respected pharmaceutical companies in the world strongly endorse BioInvent's proprietary F.I.R.S.T™ platform. The platform enables us to simultaneously identify targets and high-quality antibodies that bind to them and generates promising new drug candidates that broaden our pipeline and create licensing and partnering opportunities.

Importantly, we also presented pre-clinical data indicating a broad and clinically relevant role of FcγRIIb in mantle cell lymphoma and highlight the potential of BI-1206 to help overcome resistance to treatment in this disease. This further reinforces our belief that FcγRIIb will become a key component for the treatment of advanced hematological and solid malignancies.

We have made important strategic advances in our collaboration with Cancer Research UK (CRUK). Given the overlap with BioInvent's own Phase I/IIa trial of BI-1206 in combination with rituximab in Non-Hodgkin Lymphoma (NHL), and the fact that standard of care for patients with chronic lymphocytic leukemia (CLL) has dramatically evolved over the last few years, recruitment in the UK study has become increasingly challenging - in particular since CRUK can only carry out trials in the UK. For these reasons we have agreed to limit the CRUK study to monotherapy, which is almost completed. This will result in a more complementary work and more efficient use of resources. BioInvent and CRUK look forward to explore the possibilities for a continued collaboration as we move forward.

We reported compelling results from extensive in vitro and in vivo preclinical studies with BT-001, an oncolytic virus expressing our proprietary anti-CTLA4 antibody and the cytokine GM-CSF. We are developing BT-001 in collaboration with Transgene and intend to submit a clinical trial application in Q1 2020.  Preclinical data on BT-001 will be presented at scientific meetings in the coming months.

We anticipate several important milestones in 2020. This will include early results from the Phase I open label study with a combination of BI-1206 and rituximab in indolent NHL in the second half of the year. We will also be initiating the Phase l/lla study of BI-1206 in combination with pembrolizumab, as mentioned above, with early results from the Phase I study expected in the second half of 2021. We are expecting to advance two compounds into clinical programs in solid cancer: in 2020 the anti-TNFR2 antibody BI-1808, as single agent and in combination with an anti-PD1 antibody; and in 2021 the anti-FcγRllB antibody BI-1607 in combination with a checkpoint inhibitor.

As BioInvent continues to bring new opportunities and programs towards clinical development, financing is of course, a focus and priority for us, 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. 

BioInvent consistently delivered on its strategy in 2019 and this is continuing into 2020. We are looking forward to keeping you updated on the exciting developments ahead.

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.

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.

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 7.30 a.m. CET, on February 27, 2020.

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

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