LUND, Sweden, Aug. 27, 2020 /PRNewswire/ -- "BioInvent
is fully focused on moving our clinical projects forward. Our
successful financing of SEK 625
million has strengthened our institutional investor base and
is truly transformative for the company as it allows us to broaden
and develop our exciting pipeline and creates a solid financial
base going forward."
Martin Welschof, CEO BioInvent
Financial information
Second quarter 2020
- Net sales SEK 15.6 (32.9)
million.
- Loss after tax SEK -39.3 (-32.8)
million.
- Loss after tax per share before and after dilution SEK -0.08 (-0.07).
- Cash flow from operating activities and investment activities
SEK -28.4 (-35.3) million.
January - June 2020
- Net sales SEK 32.4 (50.3)
million.
- Loss after tax SEK -72.0 (-60.6)
million.
- Loss after tax per share before and after dilution SEK -0.14 (-0.15).
- Cash flow from operating activities and investment activities
SEK -63.9 (-75.8) million.
*Liquid
funds as of June 30, 2020:
SEK 182.3* (210.3) million.
*Liquid funds as of 30 June 2020
include SEK 95 million of the
total net capital approx. SEK 589
million from the share issues. Remaining net capital
SEK 494 million has been received in
Q3 2020.
Events in the second
quarter
- BioInvent successfully completed a directed share issue of
approximately SEK 487 million before
transaction costs. Investors included new investors such as HBM
Healthcare Investments Ltd., Swedbank Robur Medica and Invus Public
Equities, L.P. as well as existing shareholders Van Herk
Investments B.V., Omega Funds, The Fourth Swedish National Pension
Fund and Handelsbanken Healthcare Fund.
(R)
- Promising progress was reported in the Phase I/lla trial of
lead program BI-1206 in combination with rituximab. A complete
response was observed in one follicular lymphoma patient and
complete depletion of circulating tumoral cells in a mantle cell
lymphoma patient.
(R)
- First patient enrolled in a Phase I/IIa clinical trial of
BI-1206 in combination with anti-PD-1 therapy KEYTRUDA®
for patients with solid
tumors.
- BioInvent and Transgene presented preclinical data at AACR
Virtual Session II, demonstrating high cure rates in solid tumors
of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I
clinical trial expected to start before the end of
2020.
- BioInvent presented new proof-of-concept data at AACR Virtual
Session II for BI-1808 and BI-1910, two different types of
monoclonal antibodies targeting TNFR2. Both antibodies showed
significant antitumor activity in several immunocompetent
models.
- A clinical trial application was submitted to begin a Phase
I/IIa, first-in-human study of BI-1808 for the treatment of solid
tumors or cutaneous T-cell lymphoma. The trial is expected to start
before the end of
2020.
- Manufacturing agreement signed with U.S. cell therapy
company.
Events after the reporting
period
- In July 2020, BioInvent's
agreement with Pfizer Inc. was further extended until the end of
2020 to permit the companies to further identify and characterize
new targets and antibodies binding to these
targets.
- The Extraordinary General Meeting on July 3 resolved to increase the Board of
Directors with one member through new election of Dr. Thomas Hecht as a Board member.
(R)
- In July 2020, BioInvent's Board
of Directors resolved on a repair rights issue of a maximum of
approximately SEK 139 million. It was
completed in August and was heavily oversubscribed. (R)
(R)= Regulatory event
Comments from the CEO
BioInvent is continuing to make good progress toward our targets as
we move into the second half of 2020. In particular, we
successfully completed a directed share issue, followed by a repair
rights issue which was heavily oversubscribed.
We were pleased to see such strong interest in these share
issues and are grateful for the continued support and trust of all
our investors. In total these share issues raised approximately
SEK 625 million before transaction
costs, which not only gives us the means to continue the
development of BI-1206 in both hematological cancers and solid
tumors, but also enables the development of a number of
exciting new drug candidates. In short, these financings enable us
to broaden and develop our pipeline and are truly transformative
for the company.
Our lead drug candidate BI-1206 is progressing well in
hematological cancer and solid tumors. The first patient has been
enrolled in a Phase I/IIa trial of BI-1206 in combination with the
anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in solid
tumors. We believe BI-1206's potential ability to increase and
enhance the response rates to anti-PD1 targeting agents such as
KEYTRUDA may be a powerful approach for the future treatment of a
broad range of solid tumors and hematological cancer types. We are
also progressing the Phase I/IIa trial of BI-1206 in combination
with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and
are looking at the need to add additional sites to ensure good
patient enrolment.
We hosted a successful virtual key opinion leader meeting in
July with Alexander Eggermont, MD,
PhD, Chief Scientific Officer at the Princess Máxima Center and
renowned expert in immunotherapy. At this meeting, Prof. Eggermont
discussed the clinical challenges associated with the use of
checkpoint inhibitors in solid tumors and the potential for an
enhanced response with immune-modulatory antibodies, specifically
those targeting FcγRIIB, such as BI-1206. He concluded that BI-1206
has the potential to be effective against multiple tumor types,
much like KEYTRUDA, which is approved in over 20 different
cancers.
Our pipeline is becoming increasingly broad and robust, based on
the productivity of our proprietary
n-CoDeR®/F.I.R.S.TTM platforms. In
addition to BI-1206, we have a number of other candidates now
progressing to clinical development.
Together with our partner Transgene, we presented preclinical
data demonstrating high cure rates in solid tumors of BT-001 at
AACR Virtual Session II. BT-001 is a multifunctional oncolytic
virus which was engineered to encode a Treg-depleting anti-CTLA4
antibody from n-CoDeR®/F.I.R.S.TTM and
we believe that the potential to combine anti-CTLA4,
anti-PD-1/PD-L1 and oncolytic immunotherapy could change the
treatment paradigm for multiple solid tumors. This sets the stage
for starting a Phase I clinical trial with BT-001 before the end of
2020.
We have submitted a clinical trial application (CTA) to begin a
Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody
to tumor necrosis factor receptor 2 (TNFR2), as a single agent and
in combination with KEYTRUDA for the treatment of solid tumors and
cutaneous T-cell lymphoma (CTCL). This trial is expected to start
before the end of 2020. Meanwhile, new proof-of-concept data on
BI-1808 and BI-1910, presented at the AACR Virtual Session II,
showed that both these antibodies had significant antitumor
activity in several immunocompetent models.
As well as all this, our work with Pfizer continues and we have
extended our cancer immunotherapy research collaboration and
license agreement until the end of 2020.
All this exciting progress is underpinned by our technology
platform, which continues to produce new potential treatments ready
for clinical development to address major unmet medical needs. With
financing in place and the strong support of our investors,
BioInvent is well positioned to continue to deliver on the promise
of our pipeline.
We are now in a very strong position and I am confident we will
be able to continue to add shareholder value going forward. We look
forward to further updating you on all of our value adding projects
next time and in the meantime, wish you all the best.
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
BioInvent International AB (publ)
Co. reg. no. 556537-7263
Address: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50
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
press release.
This information was brought to you by Cision
http://news.cision.com
The following files are available for download:
https://mb.cision.com/Main/583/3182193/1298118.pdf
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BioInvent Interim Report January 1 â€" June 30,
2020 (PDF)
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SOURCE BioInvent