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."
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.
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BioInvent Financial
Statement January 1 â€" December 31, 2018 (PDF)
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