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considering the ongoing COVID-19 outbreak.
Summary
BerGenBio’s priority remains the safety and health of its employees and their
families, and to continue the Company’s clinical trials as far as is feasibly
possible whilst protecting enrolled patients. Overall, the Company believes it
is in a robust financial condition, with good control of expenses and is well
positioned to weather the current global disruption.
Detailed update
BerGenBio’s lead product candidate bemcentinib is currently under assessment in
Phase II clinical trials at a number of sites across Europe and the USA.
BerGenBio has been closely monitoring the COVID-19 situation for operational,
clinical and regulatory implications related to the pandemic and the resultant
public health responses world-wide. A comprehensive impact analysis has been
undertaken by senior management with the following conclusions:
· The ongoing safety of the vulnerable patients participating in BerGenBio’s
clinical trials is of paramount concern. The Company can confirm that all
patients currently enrolled into BerGenBio’s clinical trials can remain on study
and continue their treatment. As bemcentinib is orally administered once-a-day
and it is very well tolerated by patients, the Company can ensure that patients
are able to be issued with several months of dosage, negating the need to visit
hospital pharmacies.
· Patients enrolled in combination trials with low dose chemotherapy or
checkpoint inhibitor drugs currently require redosing every three or six weeks
respectively. However, the Company can confirm that dose adjustments will be
made where labels permit, and this should not adversely impact the efficacy
signal of the combination trials.
· Robust measures taken by authorities across many jurisdictions to reduce the
spread of COVID-19 have increased the risk of delays to clinical trials
throughout the sector and will invariably impact patient recruitment into
BerGenBio clinical studies and extend previously anticipated timelines.
Management will be continuously reviewing timelines for the progression of
studies and data readouts and will update the market accordingly.
· BerGenBio is in a robust financial position and has immediately taken
appropriate cost control measures, meaning the Company is well positioned to
continue operations throughout and beyond the current health crisis. The
Company’s reported cash position at 2019 Year End was NOK 253.6m (USD 28.9m) and
completion of a private placement in January 2020, contributed a further NOK
219.9m, (USD 24.0m), such that the business remains well financed beyond its
current operational milestones.
· Business continuity protocols have been implemented to ensure the safety of
BerGenBio’s employees whilst core operational activities continue. As a result,
the Company’s day to day activities remain largely unaffected.
The Company will inform shareholders and the wider market in the event of any
further changes or developments deemed material to the Company’s operations.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “While our
foremost thoughts are with those directly affected by the COVID-19 outbreak
across the world, I would also like to reassure our shareholders that BerGenBio
remains well positioned operationally and financially in the wake of this
ongoing crisis. We are particularly pleased to be able to ensure that the dozens
of patients currently participating in clinical trials with our lead candidate
bemcentinib will be able to continue their treatment. Management has a number of
risk mitigation strategies in place and will continue to monitor the situation
closely, updating the market in the event of any material change to the
Company’s circumstances.”
About BerGenBio
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers. The
company’s proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking anti-AXL antibody, tilvestamab,
is undergoing Phase I clinical testing. In parallel, BerGenBio is developing
companion diagnostic tests to identify those patient populations most likely to
benefit from bemcentinib: this is expected to facilitate more efficient
registration trials supporting a precision medicine-based commercialisation
strategy.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The
company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more
information,
visit www.bergenbio.com (https://c212.net/c/link/?t=0&l=en&o=2716942
-1&h=2445426226&u=http%3A%2F%2Fwww.bergenbio.com%2F&a=www.bergenbio.com)
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891
Forward looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
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