BerGenBio

Earnings Release • Nov 17, 2020

BERGENBIO ASA: THIRD QUARTER 2020 RESULTS

BERGENBIO ASA: THIRD QUARTER 2020 RESULTS

Bergen, Norway, 17 November 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, announces its results for the third quarter of 2020.

A presentation and live webcast by BerGenBio's senior management will take place

at 10.00 am CET today, please see below for details.

Operational Highlights - third quarter of 2020 (including post-period end)

Oncology

· Primary endpoint met in BERGAMO Phase II Trial investigating bemcentinib in

patients with High Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid

Leukaemia (AML)

· The multicenter Phase II study evaluated the safety and efficacy of

bemcentinib monotherapy in 45 patients with HR-MDS or AML who had relapsed

following multiple rounds of prior treatment with hypomethylating agents (HMAs)

· The primary endpoint overall response rate (CR, Cri, PR or SD) assessed

after 4 treatment cycles was met,

· Data from this trial will be presented at ASH in December 2020.

· First patient dosed in investigator led study assessing bemcentinib in

recurrent glioblastoma (GBM)

· Increased expression of the receptor tyrosine kinase AXL is significantly

correlated with poor prognosis in GBM patients and preclinical data has

suggested that bemcentinib may be a promising therapeutic agent for GBM

· The study will enroll up to 20 recurrent GMB patients, at up to 15 sites

in the US

· First patient dosed in MiST3 trial assessing bemcentinib in relapsed

malignant pleural mesothelioma patients

· The investigator led study, sponsored by the University of Leicester, is

funded by the British Lung Foundation, and is in collaboration with MERCK; forms

part of the world's first molecularly stratified umbrella study in mesothelioma

designed to enable the acceleration of novel, effective personalised therapy as

a basis for improving survival outcomes for patients with mesothelioma

· The study will enroll up to 26 patients at three sites in the United

Kingdom

· Pre-clinical data on humanized anti-AXL antibody tilvestamab, presented at

virtual 32[nd] EORTC NCI AACR (ENA) Symposium

· The data, presented in an ePoster at ENA in October, showed that

tilvestamab prevents AXL mediated cell signalling in cancer cell lines, reduces

cell migration and invasion and shows anti-tumor efficacy in a panel of mouse

xenograft models

· Tilvestamab is currently being evaluated in a Phase I clinical study to

evaluate safety, tolerability and pharmacokinetics

· Selected for an oral presentation at the Society for Immunotherapy of Cancer

(SITC) 35[th] Annual Meeting

· BerGenBio presented clinical translational research updates from its Phase

II bemcentinib and pembrolizumab combination study (BGBC008) in advanced non

-small cell lung cancer (NSCLC)

COVID-19

· First patient enrolled in BerGenBio-sponsored Phase II clinical trial in

South Africa and India, assessing the efficacy and safety of bemcentinib for the

treatment of hospitalised COVID-19 patients

· The first patient was enrolled in South Africa in October. The Phase II

study will recruit 120 hospitalised COVID-19 patients across five sites in South

Africa and seven sites in India

· The primary endpoint of the trial will be time to clinical improvement of

at least two points (from randomisation) on a nine-point ordinal scale, or live

discharge from the hospital, whichever comes first

· UK Research and Innovation (UKRI) has reinstated funding for the COVID-19

ACCORD clinical study in which BerGenBio's bemcentinib is one of three drug

candidates to be evaluated

· The University Hospital Southampton NHS Trust remains the study sponsor,

and the trial will be managed by the Medicines Evaluation Unit at Manchester

University

· Several substantial administrative amendments were made, and these

required regulatory approval.

Q2 2020 Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

· Revenue for the third quarter of 2020 and the nine months ended 30 September

2020, respectively, amounted to NOK 0.0 million (NOK 0.0 million), and NOK 0.0

million (NOK 8.7 million).

· Total operating expenses for the third quarter and the nine months ended 30

September 2020, respectively, amounted to NOK 68.3 million (NOK 47.5 million)

and NOK 189 million (NOK 154.0 million).

· Cash and cash equivalents at the end of the third quarter amounted to NOK

777.9 million (NOK 289.5 million)

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "In this

quarter we have made solid progress with BerGenBio's primary development

objectives to confirm clinical safety and proof of concept efficacy for

bemcentinib in lung cancer and leukaemia. While the COVID-19 crisis has

continued to delay clinical trials, including our own, we are pleased that

hospitals have opened again for clinical trials and new patients continue to be

recruited. Already enrolled patients remain on study.

"Overall, we remain well positioned. With a NOK 520 million fundraising

completed in May this year our cash position is strong. We have a promising

pipeline with two drug candidates backed by pioneering biology and a growing

bank of favourable clinical data with further important readouts anticipated in

two major cancer indications, and strong science supporting ongoing COVID-19

trials in the UK, India and South Africa. As always, I am grateful to the

patients and their families for their trust in participating in our clinical

trials, our staff and collaborators for their dedication and to our shareholders

for their continued support. I look forward to providing further updates on our

progress in the coming months."

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place today at

10:00 am CET:

Webcast link:

https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20201117_1

Dial-in numbers:

NO: +47-21-956342

SE: +46-4-0682-0620

DK: +45 78768490

UK: +44-203-7696819

US: +1 646-787-0157

Pin: 712491

The third quarter report and presentation are available on the Company's website

in the Investors/Financial Reports section and a recording of the webcast will

be made available shortly after the webcast has finished.

-Ends-

About BerGenBio ASA

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,

leukaemia and COVID-19. 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 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

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 Elliot, 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.