|BioInvent International Financial Statement January 1 - December 31, 2020|
|By: PR Newswire Association LLC. - 23 Feb 2021||Back to overview list
LUND, Sweden, Feb. 23, 2021 /PRNewswire/ -- "BioInvent has started 2021 with significant positive momentum We reported promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206.The company also closed a successful SEK 962 million financing round, expanding our institutional shareholder base. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates for the treatment of solid tumors." - Martin Welschof, CEO BioInvent
Events in the fourth quarter
Events after the reporting period
(R)= Regulatory event
Comments from the CEO
BioInvent has started 2021 with significant positive momentum. Promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206 was followed by a successful financing round, adding another specialized institutional owner to the company. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates.
The data from the study of BI-1206, in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL), are very encouraging. The responses in these severely ill patients suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. Furthermore, the duration of complete response in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after previous lines of treatment.
We were proud to host a key opinion leader (KOL) event on these results with renowned lymphoma expert Professor Mats Jerkeman, MD, of Lund University. Based on these results, we will now move to identify the recommended dose for the Phase IIa part of the study. We also presented new data on BI-1206 at the ASH Annual Meeting in December and are excited to further evaluate its potential to bring much needed innovation to lymphoma patients.
This progress is reinforced by our partnership with CASI Pharmaceuticals for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau. Under this agreement for both liquid and solid cancers, BioInvent received $12 million upfront in combination of cash and equity investment and is eligible to receive 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. CASI is a proven leader in China and their clinical development and regulatory expertise will be important in generating additional data on BI-1206.
We have simplified and reduced our obligations to CRUK related to BI-1206 by restructuring our clinical development agreement with CRUK (Cancer Research UK) for BI-1206, in exchange for a one-time payment. This provides us with further flexibility to carry out development and partnering activities with BI-1206.
Our innovative pipeline is expanding beyond BI-1206. We now have three products in clinical development, underlining the ability of our n-CoDeR®/F.I.R.S.T™ platforms to produce novel, differentiating drug candidates.
In January, we enrolled the first patient in a Phase I/IIa, first-in-human study of BI-1808, a first-in-class anti-TNFR2 antibody, as monotherapy and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) for the treatment of solid tumors and CTCL. This is based on a solid preclinical data set for BI-1808, including the new data presented at the 35th Annual Meeting of SITC in November.
We have now received CTA approval to start a Phase I/IIa clinical trial of the novel oncolytic vaccinia virus BT-001 in solid tumors, through our collaboration with Transgene. BT-001 combines multiple mechanisms of action and has outstanding potential in a wide range of indications due to its combination of multiple anti-cancer properties. We also presented new data on BT-001 at SITC.
On February 23, we further reinforced our financial position with a directed share issue that raised approximately SEK 962 million before transaction costs. These proceeds intend to fund the continued transformation of BioInvent and expansion of our clinical programs. Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of BI-1206 for the treatment of NHL, with the aim of receiving an accelerated regulatory pathway. We also expect to expand the clinical programs of BI-1206 in combination with Keytruda® and BI-1808 as monotherapy and in combination with Keytruda®.
Our partner Pfizer has selected antibodies, directed at a previously selected target, under our agreement covering developing antibodies from the F.I.R.S.TTM drug discovery platform targeting tumor-associated myeloid cells. This is an impressive example of the productivity of our platform and further strengthens our financial position by $3 million. We may now move forward to develop other antibodies internally or with other partners.
We also generated important revenue from a €2 million milestone payment under a collaboration with Daiichi Sankyo and we signed a new manufacturing agreement with Cantargia, under which BioInvent may generate revenue of up to SEK 30 million.
As previously communicated, BioInvent has taken all the necessary precautions with regards to managing the impact of Covid-19. Although we still observe viral spread throughout the community, which is of course terrible for all those affected and their families, we remain on track with our clinical trials and results. As the situation is still evolving, timelines may be impacted in geographic areas most severely affected. We will provide updates as necessary.
The company has made significant progress in delivering on our strategy in 2020 and this has set us up for a number of important milestones as we progress our portfolio through clinical development. 2021 promises to be a very exciting year for BioInvent.
Martin Welschof, CEO
Read the complete report in the attached pdf.
BioInvent International AB (publ)
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 interim report.
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