- Delivering on our goals and anticipating important
milestones in 2020
LUND, Sweden, Feb. 27, 2020 /PRNewswire/ -- "We are proud
that we have delivered on our goals for the year and feel confident
that we will continue to do so in 2020, with a number of important
milestones approaching. Our cooperation with Merck & Co is our
second large pharma collaboration and an excellent validation of
BioInvent's work, as we develop BI-1206 in solid tumors as well as
in haematological cancers."
Martin Welschof, CEO BioInvent
Financial information
Fourth quarter
2019
- Net sales SEK 25.4 (10.4)
million.
- Loss after tax SEK -40.9 (-32.7)
million.
- Loss after tax per share before and after dilution SEK -0.08
(-0.09).
- Cash flow from operating activities and investment activities
SEK -28.5 (-38.2) million.
January - December,
2019
- Net sales SEK 93.7 (38.5)
million.
- Loss after tax SEK -138.6
(-123.2)
million.
- Loss after tax per share before and after dilution SEK -0.31
(-0.36).
- Cash flow from operating activities and investment activities
SEK -129.3 (-145.2) million. Liquid
funds as of December 31, 2019:
SEK 154.0 (68.9) million.
Events in the fourth
quarter
- BioInvent entered into a clinical trial collaboration and
supply agreement with Merck & Co to evaluate BI-1206 in
combination with KEYTRUDA® in advanced solid tumors.
(R)
- Selection of second target and extension of the research
collaboration and license agreement with Pfizer Inc. announced.
(R)
- BioInvent and Transgene announced compelling preclinical data
for BT-001 in solid
tumors.
- Manufacturing agreement signed with Cancer Research UK expected
to generate approximately SEK 30
million (~$3 million).
(R)
- BI-1206 preclinical data in mantle cell lymphoma presented at
ASH 2019.
(R)= Regulatory event
Comments from the CEO
As we look back at 2019 for BioInvent, we can be proud of the
delivery on our goals for the year. It is particularly exciting to
pursue our lead clinical candidate BI-1206 in solid tumors as well
as in hematological cancers.
In December, we concluded an agreement with Merck & Co. to
evaluate the combination of BI-1206 and Merck's anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) in a Phase l/lla
clinical trial for the treatment of advanced solid tumors. This
expands BI-1206 clinical development and builds on preclinical data
that demonstrates its ability to address an important
mechanism of resistance to PD-1 inhibition, in combination, with
one of the most successful immune-oncology drug. The collaboration
is an excellent validation of our work and scientific
excellence, as Merck has carefully evaluated the pre-clinical data
and mode of action that Bioinvent has generated. They have provided
insightful feedback on the clinical protocol, and provided input on
the strategy for the development of BI-1206 before concluding this
agreement.
Our partnership with Pfizer is also progressing well, and
further validates the high scientific quality of the work performed
by the team at BioInvent. Pfizer has now selected the second target
under our cancer immunotherapy research collaboration and license
agreement, and we have extended the research term by six
months.
These agreements with two of the largest and most
highly-respected pharmaceutical companies in the world strongly
endorse BioInvent's proprietary F.I.R.S.T™ platform. The platform
enables us to simultaneously identify targets and high-quality
antibodies that bind to them and generates promising new drug
candidates that broaden our pipeline and create licensing and
partnering opportunities.
Importantly, we also presented pre-clinical data indicating a
broad and clinically relevant role of FcγRIIb in mantle cell
lymphoma and highlight the potential of BI-1206 to help overcome
resistance to treatment in this disease. This further reinforces
our belief that FcγRIIb will become a key component for the
treatment of advanced hematological and solid malignancies.
We have made important strategic advances in our collaboration
with Cancer Research UK (CRUK). Given the overlap with BioInvent's
own Phase I/IIa trial of BI-1206 in combination with rituximab in
Non-Hodgkin Lymphoma (NHL), and the fact that standard of care for
patients with chronic lymphocytic leukemia (CLL) has dramatically
evolved over the last few years, recruitment in the UK study has
become increasingly challenging - in particular since CRUK can only
carry out trials in the UK. For these reasons we have agreed to
limit the CRUK study to monotherapy, which is almost
completed. This will result in a more complementary work and
more efficient use of resources. BioInvent and CRUK look forward to
explore the possibilities for a continued collaboration as we move
forward.
We reported compelling results from extensive in
vitro and in vivo preclinical studies
with BT-001, an oncolytic virus expressing our proprietary
anti-CTLA4 antibody and the cytokine GM-CSF. We are developing
BT-001 in collaboration with Transgene and intend to submit a
clinical trial application in Q1 2020. Preclinical data on
BT-001 will be presented at scientific meetings in the coming
months.
We anticipate several important milestones in 2020. This will
include early results from the Phase I open label study with a
combination of BI-1206 and rituximab in indolent NHL in the second
half of the year. We will also be initiating the Phase l/lla study
of BI-1206 in combination with pembrolizumab, as mentioned above,
with early results from the Phase I study expected in the second
half of 2021. We are expecting to advance two compounds into
clinical programs in solid cancer: in 2020 the anti-TNFR2 antibody
BI-1808, as single agent and in combination with an anti-PD1
antibody; and in 2021 the anti-FcγRllB antibody BI-1607 in
combination with a checkpoint inhibitor.
As BioInvent continues to bring new opportunities and programs
towards clinical development, financing is of course, a focus and
priority for us, and we will continue to use a combination of
sources for funding. Firstly, we are engaged in several business
development discussions with the aim of partnering one or more of
the programs in our portfolio. Secondly, the collaboration with
Pfizer, which is also a model for other potential collaborations
which commercialize our platform. Thirdly, our manufacturing
capabilities generate revenue, with the most recent agreement with
CRUK expected to generate SEK 30
million. CRUK has the potential to become a long-term
strategic partner, as it works with a number of small- to mid-sized
companies that need manufacturing support. And our fourth option is
to use capital markets for financing. Based on the support from our
large institutional investors and increased interest in our
programs we feel optimistic that a combination of these four
sources will continue to support BioInvent financially.
BioInvent consistently delivered on its strategy in 2019 and
this is continuing into 2020. We are looking forward to keeping you
updated on the exciting developments ahead.
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.
Forward looking information
This financial statement 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.
This information is information that BioInvent International
AB (publ) is obliged to make public pursuant to the EU Market Abuse
Regulation and the Securities Markets Act. The information was
submitted for publication, through the agency of the contact person
set out above, at 7.30 a.m. CET, on
February 27, 2020.
BioInvent International AB (publ)
Co. reg. no. 556537-7263
Address: Sölvegatan 41, 223 70 Lund
Tel.: +46-(0)46-286-85-50
info@bioinvent.com
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BioInvent Financial
Statement January 1 â€" December 31, 2019 (PDF)
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