BioInvent Interim Report January 1 - June 30, 2020

Successful financing underpins exciting pipeline progress

LUND, Sweden, Aug. 27, 2020 /PRNewswire/ -- "BioInvent is fully focused on moving our clinical projects forward. Our successful financing of SEK 625 million has strengthened our institutional investor base and is truly transformative for the company as it allows us to broaden and develop our exciting pipeline and creates a solid financial base going forward."

Martin Welschof, CEO BioInvent

Financial information

Second quarter 2020

• Net sales SEK 15.6 (32.9) million.
• Loss after tax SEK -39.3 (-32.8) million.
• Loss after tax per share before and after dilution SEK -0.08 (-0.07).
• Cash flow from operating activities and investment activities SEK -28.4 (-35.3) million.

January - June 2020

• Net sales SEK 32.4 (50.3) million.
• Loss after tax SEK -72.0 (-60.6) million.
• Loss after tax per share before and after dilution SEK -0.14 (-0.15).
• Cash flow from operating activities and investment activities SEK -63.9 (-75.8) million.

          *Liquid funds as of June 30, 2020: SEK 182.3* (210.3) million.

*Liquid funds as of 30 June 2020 include SEK 95 million of the total net capital approx. SEK 589 million from the share issues. Remaining net capital SEK 494 million has been received in Q3 2020.

Events in the second quarter           

• BioInvent successfully completed a directed share issue of approximately SEK 487 million before transaction costs. Investors included new investors such as HBM Healthcare Investments Ltd., Swedbank Robur Medica and Invus Public Equities, L.P. as well as existing shareholders Van Herk Investments B.V., Omega Funds, The Fourth Swedish National Pension Fund and Handelsbanken Healthcare Fund. (R)           
• 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)           
• First patient enrolled in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA^® for patients with solid tumors.           
• BioInvent and Transgene presented preclinical data at AACR Virtual Session II, demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I clinical trial expected to start before the end of 2020.           
• BioInvent presented new proof-of-concept data at AACR Virtual Session II for BI-1808 and BI-1910, two different types of monoclonal antibodies targeting TNFR2. Both antibodies showed significant antitumor activity in several immunocompetent models.            
• A clinical trial application was submitted to begin a Phase I/IIa, first-in-human study of BI-1808 for the treatment of solid tumors or cutaneous T-cell lymphoma. The trial is expected to start before the end of 2020.           
• Manufacturing agreement signed with U.S. cell therapy company.

Events after the reporting period           

• In July 2020, BioInvent's agreement with Pfizer Inc. was further extended until the end of 2020 to permit the companies to further identify and characterize new targets and antibodies binding to these targets.           
• The Extraordinary General Meeting on July 3 resolved to increase the Board of Directors with one member through new election of Dr. Thomas Hecht as a Board member. (R)           
• In July 2020, BioInvent's Board of Directors resolved on a repair rights issue of a maximum of approximately SEK 139 million. It was completed in August and was heavily oversubscribed. (R)
              
  (R)= Regulatory event

Comments from the CEO

BioInvent is continuing to make good progress toward our targets as we move into the second half of 2020. In particular, we successfully completed a directed share issue, followed by a repair rights issue which was heavily oversubscribed.

We were pleased to see such strong interest in these share issues and are grateful for the continued support and trust of all our investors. In total these share issues raised approximately SEK 625 million before transaction costs, which not only gives us the means to continue the development of BI-1206 in both hematological cancers and solid tumors, but also enables the development of a number of exciting new drug candidates. In short, these financings enable us to broaden and develop our pipeline and are truly transformative for the company.

Our lead drug candidate BI-1206 is progressing well in hematological cancer and solid tumors. The first patient has been enrolled in a Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) in solid tumors. We believe BI-1206's potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as KEYTRUDA may be a powerful approach for the future treatment of a broad range of solid tumors and hematological cancer types. We are also progressing the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and are looking at the need to add additional sites to ensure good patient enrolment.

We hosted a successful virtual key opinion leader meeting in July with Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center and renowned expert in immunotherapy. At this meeting, Prof. Eggermont discussed the clinical challenges associated with the use of checkpoint inhibitors in solid tumors and the potential for an enhanced response with immune-modulatory antibodies, specifically those targeting FcγRIIB, such as BI-1206. He concluded that BI-1206 has the potential to be effective against multiple tumor types, much like KEYTRUDA, which is approved in over 20 different cancers.

Our pipeline is becoming increasingly broad and robust, based on the productivity of our proprietary n-CoDeR^®/F.I.R.S.T^TM platforms. In addition to BI-1206, we have a number of other candidates now progressing to clinical development.

Together with our partner Transgene, we presented preclinical data demonstrating high cure rates in solid tumors of BT-001 at AACR Virtual Session II. BT-001 is a multifunctional oncolytic virus which was engineered to encode a Treg-depleting anti-CTLA4 antibody from n-CoDeR^®/F.I.R.S.T^TM 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. This sets the stage for starting a Phase I clinical trial with BT-001 before the end of 2020.

We have submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). This trial is expected to start before the end of 2020. Meanwhile, new proof-of-concept data on BI-1808 and BI-1910, presented at the AACR Virtual Session II, showed that both these antibodies had significant antitumor activity in several immunocompetent models. 

As well as all this, our work with Pfizer continues and we have extended our cancer immunotherapy research collaboration and license agreement until the end of 2020.

All this exciting progress is underpinned by our technology platform, which continues to produce new potential treatments ready for clinical development to address major unmet medical needs. With financing in place and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline. 

We are now in a very strong position and I am confident we will be able to continue to add shareholder value going forward. We look forward to further updating you on all of our value adding projects next time and in the meantime, wish you all the best.

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

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.

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