LUND, Sweden, Feb. 23, 2021 /PRNewswire/ -- "BioInvent has
started 2021 with significant positive momentum We reported
promising interim efficacy data from the ongoing Phase I/IIa trial
of our lead drug candidate BI-1206.The company also closed a
successful SEK 962 million financing
round, expanding our institutional shareholder base. Furthermore,
we announced the expansion of our clinical pipeline to include two
further drug candidates for the treatment of solid tumors."
- Martin Welschof, CEO BioInvent
Financial
information
Fourth quarter 2020
- Net sales SEK 98.7
(25.4) million.
- Profit/loss after
tax SEK 28.5 (-40.9) million.
- Profit/loss after
tax per share before and after dilution SEK 0.74
(-2.04).
- Cash flow from
operating activities and investment activities SEK 27.6
(-28.5) million.
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January -
December 2020
- Net sales SEK 147.4
(93.7) million.
- Loss after tax SEK
-76.3 (-138.6) million.
- Loss after tax per
share before and after dilution SEK -2.66 (-7.64).
- Cash flow from
operating activities and investment activities SEK -69.3
(-129.3) million. Liquid funds as of December 31, 2020:
SEK 729.3 (154.0) million.
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Financial
information first quarter
2020
- Net sales SEK 16.7
(17.4) million.
- Loss after tax SEK
-32.6 (-27.8) million.
- Loss after tax per
share before and after dilution SEK -0.07 (-0.08).
- Cash flow from
operating activities and investment activities SEK -35.4
(-40.5) million. Liquid funds as of March 31, 2020: SEK 117.1
(28.5) million.
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Events in the fourth quarter
- BI-1206 was out-licensed to CASI Pharmaceuticals for the
Greater China region. The
collaboration accelerates and expands BioInvent's global
development plans for BI-1206. BioInvent received $12 million upfront in combination of cash and
equity investment and is eligible to receive up to $83 million in milestone payments, plus tiered
royalties. The equity investment was approved at an EGM held on
November 27, 2020. (R)
- BioInvent received a $3 million
milestone payment related to selection of antibodies under its
collaboration with Pfizer. (R)
- Approval of a CTA was received in Denmark for the Phase I/IIa study of BI-1808,
as monotherapy and in combination with the anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) for the treatment of solid
tumors and cutaneous T-cell lymphoma (CTCL).
- BioInvent and Transgene received CTA approval for Phase l/lla
trial of oncolytic virus BT-001 in solid tumors.
- New preclinical data was presented on BI-1808 and BT-001 at the
SITC 35th Anniversary Annual Meeting. New promising clinical and
preclinical data on BI-1206 was also presented at the ASH Annual
Meeting.
- BioInvent received 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)
- BioInvent and Cantargia signed a manufacturing agreement, which
may generate revenue for BioInvent of up to SEK 30 million.
- BioInvent announced the appointment of Cecilia Hofvander as Senior Director Investor
Relations, a new position at BioInvent starting mid-February 2021.
- The EGM held on November 27, 2020
approved 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 4,375,121 shares (after the
reverse share split). (R)
Events after the reporting period
- In January 2021, BioInvent
announced that Phase I/IIa data suggest that BI-1206 restores
activity of rituximab in relapsed non-Hodgkin's lymphoma patients.
Responses in 6 out of 9 patients evaluated provide exciting
evidence that BI-1206 has the potential to restore activity of
rituximab in non-Hodgkin's lymphoma patients who have relapsed
after treatment with rituximab. Long-lasting complete responses
observed in two patients beyond 12 months. (R)
- On February 23, 2021, BioInvent
successfully completed a directed share issue of approximately
SEK 962 million before transaction
costs. Investors in the directed share issue are a range of
international and Swedish investors, including Redmile Group, LLC.,
Invus, HBM Healthcare Investments, The Fourth National Swedish
Pension Fund, Swedbank Robur Fonder and Van Herk Investments.
2,834,399 new shares were issued based on the authorization granted
by the EGM on November 27, 2020, and
16,260,601 new shares were issued subject to the approval of an EGM
to be held on 23 March 2021. (R)
- In January 2021, BioInvent
announced that it had restructured a clinical development agreement
with Cancer Research UK (CRUK) for BI-1206. In exchange for a
one-time payment of £2.5 million, the revised deal simplifies and
reduces Bioinvent's obligations to CRUK. (R)
- BioInvent announced in January
2021, enrollment of the first patient in a Phase I/IIa study
of BI-1808.
- o In January 2021,
BioInvent announced that An van Es Johansson should resign as a
director of the board effective as of 15
February 2021, due to personal reasons. (R)
(R)= Regulatory event
Comments from the CEO
BioInvent has started 2021 with significant positive momentum.
Promising interim efficacy data from the ongoing Phase I/IIa
trial of our lead drug candidate BI-1206 was followed by a
successful financing round, adding another specialized
institutional owner to the company. Furthermore, we announced the
expansion of our clinical pipeline to include two further drug
candidates.
The data from the study of BI-1206, in combination with
rituximab in patients with indolent relapsed or refractory B-cell
non-Hodgkin's lymphoma (NHL), are very encouraging. The responses
in these severely ill patients suggest that BI-1206 may
restore the response to rituximab in patients who have few
treatment alternatives. Furthermore, the duration of complete
response in two patients are particularly impressive and indicate
that BI-1206 has the potential to significantly improve the lives
of NHL patients who have progressed after previous lines of
treatment.
We were proud to host a key opinion leader (KOL) event on these
results with renowned lymphoma expert Professor Mats Jerkeman, MD, of Lund University. Based on these results, we
will now move to identify the recommended dose for the Phase IIa
part of the study. We also presented new data on BI-1206 at the ASH
Annual Meeting in December and are excited to further evaluate its
potential to bring much needed innovation to lymphoma patients.
This progress is reinforced by our partnership with CASI
Pharmaceuticals for the development and commercialization of
BI-1206 in mainland China,
Taiwan, Hong Kong and Macau. Under this agreement for both liquid
and solid cancers, BioInvent received $12
million upfront in combination of cash and equity investment
and is eligible to receive 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. CASI is a proven leader in China and their clinical development and
regulatory expertise will be important in generating additional
data on BI-1206.
We have simplified and reduced our obligations to CRUK related
to BI-1206 by restructuring our clinical development agreement with
CRUK (Cancer Research UK) for BI-1206, in exchange for a one-time
payment. This provides us with further flexibility to carry out
development and partnering activities with BI-1206.
Our innovative pipeline is expanding beyond BI-1206. We now have
three products in clinical development, underlining the ability of
our n-CoDeR®/F.I.R.S.T™ platforms to produce novel,
differentiating drug candidates.
In January, we enrolled the first patient in a Phase I/IIa,
first-in-human study of BI-1808, a first-in-class anti-TNFR2
antibody, as monotherapy and in combination with the anti-PD-1
therapy Keytruda® (pembrolizumab) for the treatment of
solid tumors and CTCL. This is based on a solid preclinical data
set for BI-1808, including the new data presented at the 35th
Annual Meeting of SITC in November.
We have now received CTA approval to start a Phase I/IIa
clinical trial of the novel oncolytic vaccinia virus BT-001 in
solid tumors, through our collaboration with Transgene. BT-001
combines multiple mechanisms of action and has outstanding
potential in a wide range of indications due to its combination of
multiple anti-cancer properties. We also presented new data on
BT-001 at SITC.
On February 23, we further
reinforced our financial position with a directed share issue that
raised approximately SEK 962 million
before transaction costs. These proceeds intend to fund the
continued transformation of BioInvent and expansion of our clinical
programs. Assuming continued generation of positive data, we plan
to in particular use the funds to prepare a pivotal clinical trial
of BI-1206 for the treatment of NHL, with the aim of receiving an
accelerated regulatory pathway. We also expect to expand the
clinical programs of BI-1206 in combination with
Keytruda® and BI-1808 as monotherapy and in combination
with Keytruda®.
Our partner Pfizer has selected antibodies, directed at a
previously selected target, under our agreement covering developing
antibodies from the F.I.R.S.TTM drug discovery platform
targeting tumor-associated myeloid cells. This is an impressive
example of the productivity of our platform and further strengthens
our financial position by $3 million.
We may now move forward to develop other antibodies internally or
with other partners.
We also generated important revenue from a €2 million milestone
payment under a collaboration with Daiichi Sankyo and we signed a
new manufacturing agreement with Cantargia, under which BioInvent
may generate revenue of up to SEK 30
million.
As previously communicated, BioInvent has taken all the
necessary precautions with regards to managing the impact of
Covid-19. Although we still observe viral spread throughout the
community, which is of course terrible for all those affected and
their families, we remain on track with our clinical trials and
results. As the situation is still evolving, timelines may be
impacted in geographic areas most severely affected. We will
provide updates as necessary.
The company has made significant progress in delivering on our
strategy in 2020 and this has set us up for a number of important
milestones as we progress our portfolio through clinical
development. 2021 promises to be a very exciting year for
BioInvent.
Martin Welschof, CEO
Read the complete report in the attached pdf.
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
interim report.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/bioinvent/r/bioinvent-international-financial-statement-january-1---december-31--2020,c3293713
The following files are available for download:
https://mb.cision.com/Main/583/3293713/1377403.pdf
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BioInvent
International Financial Statement January 1 - December 31,
2020
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SOURCE BioInvent