BerGenBio

Regulatory Filings • May 15, 2019

BerGenBio to present new NSCLC and AML clinical data and biomarker data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO 2019

BerGenBio to present new NSCLC and AML clinical data and biomarker data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO 2019

· Two peer reviewed abstracts on Phase II clinical data with bemcentinib

accepted for presentation at ASCO 2019

· Non-Small-Cell Lung Cancer (NSCLC) trial of bemcentinib in combination with

pembrolizumab, data to be presented includes safety, response rates and overall

survival

· Acute Myeloid Leukaemia (AML) trial of bemcentinib in combination with low

dose AraC chemotherapy or decitabine reported safety and rapid, durable complete

response rates

Bergen, Norway, 15 May 2019 - BerGenBio ASA (OSE: BGBIO) a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, notes the publication of abstracts relating to new

interim clinical and biomarker data that the company and its collaborators will

present from its extensive Phase II clinical development programme with

bemcentinib at the 2019 annual meeting of the American Society of Clinical

Oncology (ASCO) at McCormick Place in Chicago, Illinois (31 May - 4 June 2019).

The abstracts have been made available online at abstracts.asco.org today and

details of the presentations are below.

The posters presented at ASCO will be made available at www.bergenbio.com in the

Investors / Presentations section to coincide with the following conference

sessions:

Sunday 2 June, 8:00 AM - 11:30 AM Central Daylight Time

A Phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL

inhibitor, with pembrolizumab in patients with advanced NSCLC: OS for stage I

and preliminary stage II efficacy.

· Enriqueta Felip et al

· Session: Lung Cancer - Non-Small Cell Metastatic

· Location: Hall A, poster board #421, abstract 9098

Data highlights:

· Phase II clinical trial assessing bemcentinib in combination with

pembrolizumab (KEYTRUDA) in advanced lung cancer patients post chemotherapy.

· The combination treatment of bemcentinib and pembrolizumab was overall well

-tolerated.

· Promising clinical activity continues to be seen overall, particularly in

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

expression.

· Updated results will be reported at the meeting, including the 12-month

overall survival for stage 1 and preliminary efficacy of Stage 2.

Monday 3 June, 8:00 AM - 11:30 AM Central Daylight Time

First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with

low dose AraC (LDAC) or decitabine exerts anti-leukaemia activity in AML pts

unfit for intensive chemotherapy: Phase II open-label study.

· Dr Sonja Loges et al

· Session: Hematologic Malignancies - Leukaemia, Myelodysplastic Syndromes,

and Allotransplant

· Location: Hall A, poster board #418, abstract 7043

Data highlights:

· Bemcentinib in combination with LDAC exerted early onset and durable

responses in patients with both de novo and relapsed AML, whilst the combination

of bemcentinib and decitabine exerted comparably fewer and later responses in de

novo AML.

· Both combinations were generally well-tolerated.

· Updated results will be presented.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

encouraged by the promising data that continues to emerge from our clinical

development programme with bemcentinib in AML and NSCLC. Following the data that

was gathered in January, we have expanded our clinical programmes in both

indications and, together with our investigators, look forward to providing

further important findings at ASCO.

"Most NSCLC patients in Europe now receive anti-PD(L)-1 therapies like KEYTRUDA

as a first- or second-line treatment for their advanced disease. Improving

responses to these novel agents, particularly in patients with no or limited

expression of PD-L1, who may not have benefitted from such therapies, is

significant. Similarly, positive responses in a less fit AML patient population

considered to have unfavourable prognosis after the failure of first-line

therapies, or those with high risk cytogenetics is very encouraging."

-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 focussed 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 and Investor Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, 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.