LUND, Sweden, February 23, 2021 / PRNewswire / – “BioInvent has started 2021 with a significant positive momentum. We reported provisional efficacy data from the ongoing Phase I / IIa trial of our leading drug candidate BI-1206. The company also closed a successful 962 million crowns funding round, expanding our institutional shareholder base. Furthermore, we announced the expansion of our clinical pipeline to include two other drug candidates for the treatment of solid tumors. -Martin Welschof, CEO of BioInvent
Fourth quarter 2020
– Net sales SEK 98.7 (25.4) million.
– Profit / loss after tax 28.5 (-40.9) million SEK.
– Profit / loss after tax per share before and after dilution 0.74 SEK (-2.04).
– Cash flow from operating activities and investment activities SEK 27.6 (-28.5) million.
January – December 2020
– Net sales 147.4 SEK (93.7) million.
– Loss after tax -76.3 (-138.6) million SEK.
– Loss after tax per share before and after dilution SEK -2.66 (-7.64).
– Cash flow from operating activities and investment activities – 69.3 SEK (-129.3) million. Liquid funds until 31 December 2020: 729.3 SEK (154.0) million.
Financial information first quarter 2020
– Net sales 16.7 (17.4) million SEK.
– Tax loss -32.6 (-27.8) million SEK.
– Loss after tax per share before and after dilution SEK -0.07 (-0.08).
– Cash flow from operating and investment activities -35.4 (-40.5) million SEK. Liquid funds until March 31, 2020: 117.1 SEK (28.5) million.
Events in the fourth quarter
- BI-1206 was licensed under CASI Pharmaceuticals Greater China Region. Collaboration accelerates and expands BioInvent global development plans for BI-1206. BioInvent u mor $ 12 million in advance in the combination of cash and equity investments and is entitled to receive up to $ 83 million in historical payments, plus level fees. The capital investment was approved in a longer held EGM 27 November 2020. (R)
- BioInvent got one $ 3 million historical payments related to antibody selection under its collaboration with Pfizer. (R)
- Approval of a CTA was accepted at Denmark for the study of Phase I / IIa of BI-1808, as monotherapy and in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of solid tumors and cutaneous T cell lymphoma (CTCL).
- BioInvent and Transgene received CTA approval for the B / L Phase l / onla test of the BT-001 oncological virus in solid tumors.
- New preclinical data were presented for BI-1808 and BT-001 at the 35th Annual SITC Meeting. Promising new clinical and preclinical data on BI-1206 were also presented at the ASH Annual Meeting.
- BioInvent received a payment of 2 million points under its collaboration with Daiichi Sankyo in connection with the start of a Phase I global clinical trial with a GARP-led antibody. (R)
- BioInvent and Cantargia sign production agreement, which can generate revenue for BioInvent up to 30 million crowns.
- BioInvent announced the appointment of Cecilia Hofvander as Senior Director of Investor Relations, a new position at BioInvent starting mid-February 2021.
- EGM continued 27 November 2020 approved the proposal for a 1:25 reverse share split, a reduction in share capital to adjust share capital in the Company’s operations, and an updated authorization for the Board to decide on a new issue of shares comprising 4,375,121 shares (after conversely division of shares). (R)
Events after the reporting period
- IN January 2021, BioInvent reported that Phase I / IIa data suggest that BI-1206 restores rituximab activity in patients with recurrent non-Hodgkin lymphoma. Responses in 6 of 9 evaluated patients provide interesting evidence that BI-1206 has the potential to restore rituximab activity in patients with non-Hodgkin lymphoma who have returned after treatment with rituximab. Complete long-term responses observed in two patients after 12 months. (R)
- IN 23 February 2021, BioInvent successfully completed a live stock issue 962 million crowns before transaction costs. Investors in the issue of directed shares are a range of international and Swedish investors, including Redmile Group, LLC., Invus, HBM Health Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. 2,834,399 new shares were issued based on the authorization given by EGM on 27 November 2020, and 16,260,601 new shares were issued subject to the approval of an EGM to be held on March 23, 2021. (R)
- IN January 2021, BioInvent announced that it had restructured a clinical development agreement with Cancer Research UK (CRUK) for BI-1206. In exchange for a single payment of 2.5 million, the revised agreement simplifies and reduces Bioinvent’s liabilities to CRUK. (R)
- BioInvent announced at January 2021, enrollment of the first patient in a Phase I / IIa study of BI-1808.
- o In January 2021, BioInvent announced that An van Es Johansson should resign as effective board director from February 15, 2021, for personal reasons. (R)
(R) = Regulatory events
Comments from the CEO
BioInvent has started 2021 with an important positive moment. Promising data on the effectiveness of the ongoing Phase I / IIa trial of our leading BI-1206 drug candidate was followed by a successful round of financing, adding another specialized institutional owner to the company. Furthermore, we announced the expansion of our clinical pipeline to include two other drug candidates.
The data from the BI-1206 study, in combination with rituximab in patients with non-Hodgkin (NHL) recurrent or resistant B-cell indolent lymphomas, are very encouraging. Responses in these critically ill patients suggest that BI-1206 may reverse the response to rituximab in patients with limited treatment options. Moreover, the duration of the full response in two patients is particularly impressive and shows 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 major opinion event (KOL) on these results with the renowned lymphoma professor Mats Jerkeman, MD, e Lund University. Based on these results, we will now move on 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 assess 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 on the mainland China, Taiwan, Hong Kong AND Macau. Under this agreement for liquid and solid cancer, BioInvent received $ 12 million in advance in the combination of cash and equity investments and is entitled to receive up to $ 83 million in the development and payments of commercial milestones plus high-to-mid-level double-digit level fees in net sales. CASI is a proven leader in China and their clinical development and regulatory expertise will be relevant in generating additional data for BI-1206.
We have simplified and reduced our liabilities to CRUK in relation to BI-1206 by restructuring our clinical development agreement with CRUK (Cancer Research UK) for BI-1206, in exchange for a lump sum payment. This provides us with further flexibility to carry out development and partnership activities with BI-1206.
Our innovative pipeline is expanding beyond BI-1206. We now have three products in clinical development, highlighting the capability of our n-CoDeR/ FIRST platforms to produce new, differentiating drug candidates.
In January, we enrolled the first patient in a phase I / IIa, the first human study of BI-1808, a first-class anti-TNFR2 antibody, as monotherapy and in combination with anti-PD-1 Keytruda therapy (pembrolizumab) for the treatment of solid tumors and CTCL. This is based on a consistent set of preclinical data for BI-1808, including new data presented at the 35th Annual SITC Meeting in November.
We have now received CTA approval to begin a Phase I / IIa clinical trial of the new BT-001 oncolytic vaccine virus in solid tumors, through our collaboration with Transgene. BT-001 combines multiple mechanisms of action and has tremendous potential in a wide range of indications due to the combination of numerous anti-cancer properties. We also submitted new data for BT-001 to SITC.
IN 23 February, we further strengthened our financial position with a directed stock issue that raised approximately 962 million crowns before transaction costs. This revenue is intended to fund the ongoing transformation of BioInvent and the expansion of our clinical programs. Assuming the continued generation of positive data, we plan to specifically use the funds to prepare a key BI-1206 clinical trial for NHL treatment, with the aim of taking an accelerated regulatory pathway. We also look forward to expanding BI-1206 clinical programs in combination with Keytruda and BI-1808 as monotherapy and in combination with Keytruda.
Our partner Pfizer has selected antibodies, targeting a previously selected target, under our agreement covering antibody development by FIRSTTM Drug detection platform targeting tumor-associated myeloid cells. This is an impressive example of our platform productivity and further strengthens our financial position by $ 3 million. We can now move forward to develop other antibodies within or with other partners.
We also generated significant revenue from a payment of 2 million points under a collaboration with Daiichi Sankyo and we signed a new production agreement with Cantargia, under which BioInvent can generate revenue up to 30 million crowns.
As previously reported, BioInvent has taken all necessary precautions regarding Covid-19 impact management. Although we still observe viral spread throughout the community, which is of course appalling to all affected and their families, we remain on track with our evidence and clinical results. While the situation is still evolving, timelines may affect the most severely affected geographical areas. We will provide updates as needed.
The company has made significant progress in implementing our strategy in 2020 and this has set us up for a number of important points as we advance our portfolio through clinical development. 2021 promises to be a very exciting year for BioInvent.
Martin Welschof, CEO
Read the full report in the attached pdf.
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0) 46 286 85 50, [email protected]. The report is also available at www.bioinvent.com.
BioInvent International AB (publisher)
The regime of Co. jo 556537-7263
Address: Slvegatan 41, 223 70 Lund
Tel .: +46 (0) 46 286 85 50
Looking forward information
This interim report contains statements for the future, consisting of subjective assumptions and forecasts for future scenarios. Forecasts for the future apply only on the date when they are made and are, by their very nature, in the same way as research and development work in the biotechnology segment, associated with risk and uncertainty. Given this, the actual result may deviate significantly from the scenarios described in this interim report.
This information was provided to you by Cision http://news.cision.com
The following files are available for download:
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