BerGenBio

Earnings Release • Feb 10, 2021

BERGENBIO ASA: RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2020

BERGENBIO ASA: RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2020

Bergen, Norway, 10 February 2021 - 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 fourth quarter and full

year 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 - fourth quarter (including post-period end)

· First patient enrolled in South Africa and India as part of Company

sponsored randomised Phase II trial assessing bemcentinib as a potential

treatment for COVID-19 (October)

· Randomised Phase II study will recruit 120 hospitalised COVID-19 patients

across five sites in South Africa and seven sites in India

· Post period-end, the trial's independent data monitoring committee has met

twice and confirmed no safety concerns and recommended the continuation of

patient recruitment into the study

· First patient dosed with bemcentinib in combination with pembrolizumab in

relapsed malignant pleural mesothelioma investigator sponsored Phase IIa study

(October)

· Trial assessing bemcentinib in combination with pembrolizumab, in relapsed

malignant pleural mesothelioma patients, sponsored by the University of

Leicester and in collaboration with Merck.

· Part of world's first molecularly stratified umbrella study in

mesothelioma named Mesothelioma Stratified Therapy (MiST)

· Updated clinical and translational analysis from Phase II bemcentinib

combination study in NSCLC (BGBC008) Cohort B presented at annual SITC meeting

(November)

· The combination with pembrolizumab was shown to be well tolerated and

signs of clinical activity were observed in evaluable CPI-refractory composite

AXL (cAXL) positive NSCLC patients

· Median progression-free survival among cAXL positive patients was reported

as 2.5 fold greater than cAXL-negative patients

· Updated clinical data from two Phase II studies of bemcentinib in AML and

MDS patients presented at ASH 2020 (December)

· In relapsed AML patients, interim data from an ongoing study (BGBC003

cohort B5, bemcentinib combination with LDAC) reported clinical benefit rate of

8/11 (73%) in evaluable patients, with encouraging duration of treatment of 6.2

months in CR/CRi patients.

· In the High Risk MDS patient cohort of the BERGAMO investigator led study,

an Overall Response Rate of 36% and CR/CRi rate of 18% was reported, median

response duration was reported as over 8 months with some patients remaining on

study, and encouraging biomarker correlation was also reported.

· ACCORD 2 clinical trial in the UK in hospitalised COVID-19 patients

reinitiated patient recruitment

· Funding for the study was suspended by UKRI in July due to the falling

number of hospitalised COVID-19 patients, but reinstated in September following

a rise in UK cases, and the trial recruitment resumed in December.

Q4 2020 / FY 2020 Financial Highlights

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

· Revenue amounted to NOK 0.6 million (NOK 0.2 million) for the fourth quarter

and NOK 0.6 million (NOK 8.9 million) for the full year 2020

· Total operating expenses for the fourth quarter were NOK 72.4 million (NOK

59.3 million) and total operating expenses for the full year 2020 amounted to

261.7 million (NOK 213.3 million)

· The operating loss for the quarter came to NOK 71.8 million

(NOK 59.1 million) and NOK 261.1 million (NOK 204.4 million) for the full year

2020

· Cash and cash equivalents amounted to NOK 721.6 million at the end of

December 2020 (NOK 253.6 million by end of December 2019)

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"In the final quarter of 2020, we maintained our focus on progressing the broad

Phase II clinical development programme investigating our lead product candidate

bemcentinib, a highly selective, potent, once-a-day oral inhibitor of AXL

kinase, in several indications and settings.

During the period we continued to make progress in our clinical trials,

presenting new data and translational research at several leading international

congresses. As reported in November at The Society for Immunotherapy of Cancer

(SITC) conference, the combination of bemcentinib and CPI pembrolizumab

continued to report encouraging clinical activity, the median progression-free

survival was 2.5 times greater for cAXL positive patients. At the American

Society of Hematology conference (ASH) in December, we were pleased to share

updated preliminary clinical data from two ongoing Phase II studies of

bemcentinib in acute myeloid leukaemia (AML) and high-risk myelodysplastic

syndrome (MDS), in particular the clinical benefit rate of over 70% in relapsed

AML patients. Collectively, these continuing promising data readouts strengthen

our confidence in bemcentinib as a potential therapy in these relapsed

haematological cancer indications.

In addition, we have been able to push ahead with two trials assessing the

potential of bemcentinib as a treatment for hospitalised patients with COVID-19.

We remain optimistic that bemcentinib could play an important role in the global

effort to combat the disease.

I am encouraged by our continued research and clinical development progress

which has of course been achieved against the backdrop of the COVID-19 pandemic.

I am pleased to report that our operations and trials have all been able to

remain active throughout the year and our mitigation plans have been successful

in limiting the impact of the pandemic on operations."

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/20210210_5

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 Q4 2020 Financial 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.