LUND, Sweden, Feb. 25, 2019 /PRNewswire/ --
Fourth quarter 2018, October – December
- Net sales amounted to SEK 10.4 (13.5) million.
- Loss after tax SEK -32.7 (-33.3) million.
- Loss after tax per share before and after dilution SEK -0.09 (-0.11).
- Cash flow from operating activities and investment activities SEK -38.2 (-28.8) million.
Full year report 2018, January - December
- Net sales amounted to SEK 38.5 (45.0) million.
- Loss after tax SEK -123.2 (-100.5) million.
- Loss after tax per share before and after dilution SEK -0.36 (-0.33).
- Cash flow from operating activities and investment activities SEK -145.2 (-92.4) million. Liquid funds as of December 31, 2018: SEK 68.9 (133.8) million.
Important events in the fourth quarter and after the reporting period
- A manufacturing agreement was signed in November 2018 with an undisclosed U.S. cell therapy company for the production of cGMP compliant material to support its clinical development programs. The manufacturing agreement is expected to generate revenue of approximately USD 1.5 million, mainly in 2019.
- In January 2019, BioInvent announced that the U.S. Food and Drug Administration had granted the Company orphan designation for its proprietary antibody BI-1206 for the treatment of mantle cell lymphoma.
- Today BioInvent has resolved on a fully underwritten rights issue of SEK 210 million and a directed issue of SEK 30 million with a Swedish pension fund and a Swedish life science fund. Additionally, it is proposed that the board of directors is authorized to resolve on an over-allotment option for up to SEK 70 million, that can be exercised if the rights issue is over-subscribed. The rights issue and the over-allotment option are subject to approval by an extraordinary general meeting to be held on 20 March 2019. The completion of the directed share issue is subject to the EGM approval of the rights issue.
Comments from the CEO
Martin Welschof, CEO of BioInvent, says "We are pleased to have secured the financing announced today since it provides us with the opportunity to accelerate our drug development pipeline. Clinical results will drive the value of our pipeline. The financing consists of a fully underwritten rights issue of SEK 210 million and a directed issue of SEK 30 million at equal terms, and in addition an over-allotment option for up to SEK 70 million, that can be exercised if the rights issue is over-subscribed.
We intend to use the net proceeds to mainly expand the clinical development of BI-1206 for treatment of hematological cancers, which is currently in a Phase l/lla study with topline results expected in H1 2020, as well as advancing three compounds into the clinic in solid cancer indications. These are an anti FcγRllB antibody in combination with an anti-PD1 antibody, BI-1607 in combination with a check point inhibitor, BI-1808 as a single agent and in combination with an anti-PD1 antibody. The funds will also be used to continue development of the Company's prioritized preclinical projects, including the collaboration with Transgene.
If the over-allotment option is utilized in full, the net proceeds hereof is intended to be used towards the activities described above and is estimated to take the anti-FcγRllB antibody in combination with an anti-PD1 antibody to topline results by H2 2020.
The financing followed a few months of strong progress for BioInvent. Last month, we received orphan designation from the FDA for BI-1206 in mantle cell lymphoma, and we are looking forward to generating data from our Phase I/IIa trial to support the use of BI-1206 in combination with rituximab in this indication.
Also, we presented two back-to-back posters at the annual meeting of the Society for Immunotherapy of Cancer (SITC) together with Transgene, featuring positive data supporting our ongoing collaboration to develop a novel oncolytic virus encoding for an anti-CTLA-4 antibody. We published data in the leading cancer journal Immunity on the cellular and molecular mechanism-of-action of antibodies to the co-stimulatory immune checkpoint receptor 4-1BB; and lastly we presented our discovery platform F.I.R.S.T.™ at the Society for Laboratory Automation and Screening (SLAS) 2019 in Washington, D.C..
In addition, we signed a manufacturing agreement with an undisclosed U.S. cell therapy company for the production of cGMP compliant material to support their clinical development programs, which is expected to generate revenue of approximately USD 1.5 million, mainly in 2019.
With financing in place, we will continue to focus on opportunities to partner our product candidates. We look forward to the opportunity to deliver medical solutions to meet patient needs and value to our shareholders."
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The following files are available for download:
BioInvent Financial Statement January 1 â€" December 31, 2018 (PDF)