LUND, Sweden, Oct. 29, 2020 /PRNewswire/ --
China licensing agreement
further validates technology and strategy
"The exclusive licensing agreement with CASI Pharmaceuticals
for BI-1206 in China is an
important validation of BioInvent's technology, expertise and
business model. It provides further impetus to our lead drug
candidate and reinforces our financial position with $12 million upfront in cash and equity
investment, plus potential future milestones and
royalties."
Martin Welschof, CEO BioInvent
Financial information
Third quarter
2020
- Net sales SEK 16.3 (18.1)
million.
- Loss after tax SEK -32.9 (-37.1)
million.
- Loss after tax per share before and after dilution SEK -0.04 (-0.07).
- Cash flow from operating activities and investment activities
SEK -33.1 (-25.0) million.
January - September
2020
- Net sales SEK 48.6 (68.4)
million.
- Loss after tax SEK -104.9 (-97.7)
million.
- Loss after tax per share before and after dilution SEK -0.16 (-0.22).
- Cash flow from operating activities and investment activities
SEK -96.9 (-100.8) million. Liquid
funds as of September 30, 2020:
SEK 642.1 (183.9) million.
Events in the third
quarter
- 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)
- 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. The repair rights issue followed the successfully
completed directed share issues of approximately SEK 487 million before transaction costs.
(R)
Events after the reporting period
- In October 2020, BioInvent
licensed the anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals,
Inc (NASDAQ: CASI) for the Greater
China region. The collaboration accelerates and expands
BioInvent's global development plans for BI-1206. BioInvent is to
receive $12 million upfront in
combination of cash and equity investment and eligible to receive
up to $83 million in milestone
payments, plus tiered royalties. The equity investment is subject
to the approval of an Extraordinary Shareholders' Meeting (EGM) to
be held on 27 November 2020. (R)
- The Board of Directors has also proposed that the EGM approves
the proposal on a reverse share split 1:25, a reduction of the
share capital to adjust the share capital to the Company's
operations, and an updated authorization for the Board to decide on
a new issue of shares comprising 109,378,025 new shares
(corresponding to 4,375,121 shares after the reverse share split).
(R)
- BioInvent announced, in October
2020, regulatory authority approval of a clinical trial
application (CTA) in Denmark for a
Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in
combination with the anti-PD-1 therapy Keytruda®
(pembrolizumab) for the treatment of solid tumors and CTCL.
- In October 2020, BioInvent
announced that it will receive a €2 million milestone payment under
its collaboration with Daiichi Sankyo related to the initiation of
a global Phase I clinical trial with a GARP directed antibody.
(R)
(R)= Regulatory event
Comments from the CEO
BioInvent took a significant step forward with the signing of an
exclusive licensing agreement with CASI Pharmaceuticals for the
development and commercialization of our novel anti-FcγRIIB
antibody, BI-1206, in mainland China, Taiwan, Hong
Kong and Macau. It is an
important validation of BioInvent's technology, expertise and
business model and provides further impetus to our lead drug
candidate.
This agreement will further accelerate the development and
commercialization preparations for BI-1206, based on CASI's
clinical and regulatory expertise and strong presence across this
major market. Their established commercial infrastructure and
medical marketing team, together with their wide access to a strong
network of investigators across Greater
China, make them an ideal partner to expand our global
development footprint in this important region.
The agreement also further reinforces our financial position, as
BioInvent receives $12 million
upfront as a combination of cash and equity investment. We are
eligible for up to $83 million in
development and commercial milestone payments plus tiered royalties
in the high-single to mid-double-digit range on net sales of
BI-1206.
In short this collaboration adds significant value to our
overall BI-1206 program, through the leveraging of CASI's
capabilities in this major market and the financial terms.
The clinical development of BI-1206 in both hematological
cancers and solid tumors is progressing well. A Phase I/IIa trial
of BI-1206 in combination with the anti-PD-1 therapy
Keytruda® (pembrolizumab) in solid tumors is continuing
as planned, as is the Phase I/IIa trial of BI-1206 in combination
with rituximab for the treatment of non-Hodgkin lymphoma (NHL).
With this exciting agreement with CASI now in place, we anticipate
there could be further interest in similar partnerships for BI-1206
in other regional markets, or a license of the rest of the
world.
Beyond BI-1206, BioInvent's pipeline is expanding further based
on the productivity of our proprietary
n-CoDeR®/F.I.R.S.TTM platforms and ability to
generate antibodies to novel targets with potent anti-tumoral
activity to address major unmet medical needs.
We have received regulatory authority approval of our clinical
trial application in Denmark for a
Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in
combination with the anti-PD-1 therapy Keytruda®
(pembrolizumab) for the treatment of solid tumors and CTCL. BI-1808
will be the first anti-TNFR2 antibody to enter clinical
development, and we believe this is a very promising approach for
cancer therapy. We expect to enroll the first patient before the
end of the year and to submit an investigational new drug (IND)
application in the U.S. in the coming weeks. Together with our
partner Transgene, we also continue to expect to initiate a Phase I
clinical trial with the multifunctional oncolytic virus BT-001
before the end of 2020.
We continue our value-creating collaborations with various
partners and most recently announced receipt of a €2 million
milestone payment under our collaboration with Daiichi Sankyo,
related to the initiation of a global Phase I clinical trial with a
GARP directed antibody.
This all adds up to further substantial progress for BioInvent,
across the pipeline, and I look forward to continuing to keep you
up to date with further developments through the rest of 2020 and
beyond.
As previously informed, BioInvent has taken necessary
precautions with regards to the corona virus. Although we see an
increase of cases, which is of course terrible for all those
affected and their families, we still remain on track with our
clinical trials and results. As the situation is still evolving,
timelines are still subject to potential changes and we will
provide updates as necessary.
With financing in place, a new partnering collaboration and the
strong support of our investors, BioInvent is well positioned to
continue to deliver on the promise of our pipeline.
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.
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The following files are available for download:
https://mb.cision.com/Main/583/3227476/1327592.pdf
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BioInvent Interim
Report January 1 â€" September 30, 2020 (PDF)
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