BerGenBio

Earnings Release • Aug 19, 2019

BerGenBio ASA: Results for the Second Quarter and First Half 2019

BerGenBio ASA: Results for the Second Quarter and First Half 2019

· Acute Myeloid Leukaemia (AML): Preliminary Phase II clinical shows promising

efficacy for bemcentinib in combo with low-intensity chemo in elderly AML

patients unfit for intensive therapy

· Non small cell lung cancer (NSCLC): Phase II clinical data continues to show

promising clinical activity and improved overall survival, particularly in

patients with AXL positive tumours including those with low or no PD-L1

expression.

· Recruitment completed for second stage Phase II bemcentinib and KEYTRUDA®

combo trial in patients with advanced NSCLC (BGB008)

· Private placement completed, raising gross proceeds of NOK 74.2 million

· Cash and Cash equivalents at end of Q2 2019 NOK 324.4 million

· Operating loss of NOK 52.0 million in Q2 2019 (NOK 50.7 in Q2 2018) and NOK

97.1 million in H1 2019 (NOK 105.5 H2 2018).

Bergen, Norway, 19 August 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, announces its results for the second quarter and

first half 2019.

A presentation and live webcast by the Company's management will take place

today at 10.00 am CEST in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We are pleased to report a period of continued encouraging clinical data and

validation of our lead candidate bemcentinib in our AML and NSCLC programmes. We

are particularly excited by the LDAC combination data in second line AML

patients.

Our focus is now on refining and preparing our late stage clinical trials in

light of our recent clinical data and emerging market opportunities, as we

continue to leverage our significant scientific and R&D leadership to develop

this potentially transformative therapy. We are committed to progressing

bemcentinib through to regulatory approval and, in turn, addressing the

significant unmet need among AML and NSCLC patients in order to improve outcomes

for these patients and create value for stakeholders."

Operational Highlights - second quarter and first half 2019

Acute Myeloid Leukaemia (AML)

- Preliminary Phase II clinical data from AML trial presented at EHA 24 and ASCO

2019

· Phase II trial evaluating bemcentinib in combination with low-intensity

chemotherapy in elderly AML patients unfit for intensive therapy shows promising

efficacy

· 6 out of 14 patients receiving LDAC combination achieved an Overall Response

Rate (ORR) of 43%, with encouraging duration of response - this data is still

maturing.

· ORR significantly higher than previously reported/historical benchmarks

(18%) with single-agent low dose cytarabine

· Favourable safety profile continues to be seen in LDAC combination

· Initiated preparation of expansion cohort to confirm the clinical signal

from bemcentinib in combination with LDAC in elderly relapse/refractory AML

patients.

Non-Small Cell Lung Cancer (NSCLC)

- New clinical data from BGB324 in NSCLC presented at ASCO 2019

· Completed recruitment for second stage of Phase II trial evaluating

bemcentinib and KEYTRUDA in previously treated NSCLC patients post chemotherapy

(NCT03184571 (BGB008, cohort A)

· First stage previously met efficacy endpoint, and reported encouraging

median overall survival of 12.2 months

· Preliminary Overall Response Rate of 40% continues to be seen in patients

with AXL positive tumours including those with weak or no PD-L1 expression

· Encouraging safety profile continues to be seen in combination

- Initiation of additional cohort in combination with KEYTRUDA in previously

treated NSCLC patients post immunotherapy (NCT03184571, BGB008, cohort B)

Completed private placement, raising gross proceeds of NOK 74 million

· Net proceeds from the Private Placement to be used to advance the Company's

clinical programs in AML and lung cancer, as well as for general corporate

purposes

· The Private Placement attracted strong interest from existing shareholders

and new specialist institutional investors

Presentation and Webcast Details

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

10:00 am CEST at:

Carnegie AS

Fjordalleen 16, 5. floor,

Aker Brygge,

Oslo

The presentation will webcast live and the link will be available

at www.bergenbio.com in the section Investors/Financial Reports. A recording

will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in

the section: Investors/Financial Reports from 7:00 am CET the same day.

-END-

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 is undergoing

Phase I clinical testing. In parallel, BerGenBio is developing a companion

diagnostic test 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

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, Nicholas Brown, Carina Jurs &

Taiana De Ruyck Soares, 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.