BioInvent Interim Report January 1 - September 30, 2020

LUND, Sweden, Oct. 29, 2020 /PRNewswire/ --

China licensing agreement further validates technology and strategy

"The exclusive licensing agreement with CASI Pharmaceuticals for BI-1206 in China is an important validation of BioInvent's technology, expertise and business model. It provides further impetus to our lead drug candidate and reinforces our financial position with $12 million upfront in cash and equity investment, plus potential future milestones and royalties."

Martin Welschof, CEO BioInvent
 

Financial information
Third quarter 2020           

• Net sales SEK 16.3 (18.1) million.
• Loss after tax SEK -32.9 (-37.1) million.
• Loss after tax per share before and after dilution SEK -0.04 (-0.07).
• Cash flow from operating activities and investment activities SEK -33.1 (-25.0) million.

January - September 2020           

• Net sales SEK 48.6 (68.4) million.
• Loss after tax SEK -104.9 (-97.7) million.
• Loss after tax per share before and after dilution SEK -0.16 (-0.22).
• Cash flow from operating activities and investment activities SEK -96.9 (-100.8) million. Liquid funds as of September 30, 2020: SEK 642.1 (183.9) million.

Events in the third quarter           

• 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)
• 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. The repair rights issue followed the successfully completed directed share issues of approximately SEK 487 million before transaction costs. (R)

Events after the reporting period

• In October 2020, BioInvent licensed the anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals, Inc (NASDAQ: CASI) for the Greater China region. The collaboration accelerates and expands BioInvent's global development plans for BI-1206. BioInvent is to receive $12 million upfront in combination of cash and equity investment and eligible to receive up to $83 million in milestone payments, plus tiered royalties. The equity investment is subject to the approval of an Extraordinary Shareholders' Meeting (EGM) to be held on 27 November 2020. (R)
• The Board of Directors has also proposed that the EGM approves the proposal on a reverse share split 1:25, a reduction of the share capital to adjust the share capital to the Company's operations, and an updated authorization for the Board to decide on a new issue of shares comprising 109,378,025 new shares (corresponding to 4,375,121 shares after the reverse share split). (R)
• BioInvent announced, in October 2020, regulatory authority approval of a clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda^® (pembrolizumab) for the treatment of solid tumors and CTCL.
• In October 2020, BioInvent announced that it will receive a €2 million milestone payment under its collaboration with Daiichi Sankyo related to the initiation of a global Phase I clinical trial with a GARP directed antibody. (R)

          
(R)= Regulatory event
              

Comments from the CEO
BioInvent took a significant step forward with the signing of an exclusive licensing agreement with CASI Pharmaceuticals for the development and commercialization of our novel anti-FcγRIIB antibody, BI-1206, in mainland China, Taiwan, Hong Kong and Macau. It is an important validation of BioInvent's technology, expertise and business model and provides further impetus to our lead drug candidate.

This agreement will further accelerate the development and commercialization preparations for BI-1206, based on CASI's clinical and regulatory expertise and strong presence across this major market. Their established commercial infrastructure and medical marketing team, together with their wide access to a strong network of investigators across Greater China, make them an ideal partner to expand our global development footprint in this important region.

The agreement also further reinforces our financial position, as BioInvent receives $12 million upfront as a combination of cash and equity investment. We are eligible for up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206.

In short this collaboration adds significant value to our overall BI-1206 program, through the leveraging of CASI's capabilities in this major market and the financial terms.

The clinical development of BI-1206 in both hematological cancers and solid tumors is progressing well. A Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy Keytruda^® (pembrolizumab) in solid tumors is continuing as planned, as is the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL). With this exciting agreement with CASI now in place, we anticipate there could be further interest in similar partnerships for BI-1206 in other regional markets, or a license of the rest of the world.

Beyond BI-1206, BioInvent's pipeline is expanding further based on the productivity of our proprietary n-CoDeR^®/F.I.R.S.T^TM platforms and ability to generate antibodies to novel targets with potent anti-tumoral activity to address major unmet medical needs.

We have received regulatory authority approval of our clinical trial application in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda^® (pembrolizumab) for the treatment of solid tumors and CTCL. BI-1808 will be the first anti-TNFR2 antibody to enter clinical development, and we believe this is a very promising approach for cancer therapy. We expect to enroll the first patient before the end of the year and to submit an investigational new drug (IND) application in the U.S. in the coming weeks. Together with our partner Transgene, we also continue to expect to initiate a Phase I clinical trial with the multifunctional oncolytic virus BT-001 before the end of 2020.

We continue our value-creating collaborations with various partners and most recently announced receipt of a €2 million milestone payment under our collaboration with Daiichi Sankyo, related to the initiation of a global Phase I clinical trial with a GARP directed antibody.

This all adds up to further substantial progress for BioInvent, across the pipeline, and I look forward to continuing to keep you up to date with further developments through the rest of 2020 and beyond.

As previously informed, BioInvent has taken necessary precautions with regards to the corona virus. Although we see an increase of cases, which is of course terrible for all those affected and their families, we still remain on track with our clinical trials and results. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.

With financing in place, a new partnering collaboration and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline.

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 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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