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BerGenBio

Regulatory Filings Mar 8, 2017

3555_rns_2017-03-08_02e0ea27-d1b3-42b8-b4d7-f6ae7d40b7e0.html

Regulatory Filings

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BerGenBio announces its intention to launch an Initial Public Offering and apply for a listing on Oslo Børs

BerGenBio announces its intention to launch an Initial Public Offering and apply for a listing on Oslo Børs

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN

OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE HONG KONG

SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF

CHINA, SOUTH AFRICA OR JAPAN OR ANY OTHER JURISDICTION IN

WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER

RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE

AT THE END OF THE PRESS RELEASE.

Bergen, 8 March 2017: BerGenBio ASA ("BerGenBio" or

the "Company") today announces its intention to launch an

Initial Public Offering (the "IPO") and to apply for a

listing on Oslo Børs. Completion of the IPO will be subject

to receiving the relevant approvals from Oslo Børs as well

as prevailing equity capital market conditions.

BerGenBio is a clinical-stage biopharmaceutical company

focused on developing a pipeline of first-in-class drug

candidates to treat multiple aggressive cancers. The Company

has pioneered the research and understanding of the central

role of Axl kinase in a broad range of aggressive cancers

that spread, avoid the immune system and are resistant to

existing drugs. Tumours with these characteristics are the

cause of the majority of cancer deaths.

BerGenBio is developing a number of Axl kinase inhibitors,

which represents a novel approach to address the key

mechanisms leading to tumours becoming malignant and

aggressive. This approach presents the Company with an

opportunity to create new therapeutic options for cancer

patients.

BerGenBio's lead compound BGB324 is a highly selective,

orally bioavailable small molecule Axl inhibitor, currently

in Phase II clinical development. It is the only selective

Axl inhibitor in clinical development. BGB324 has already

delivered encouraging clinical data in patients with acute

myeloid leukemia (AML) and myeloid dysplastic syndrome

(MDS), and non-small cell lung cancer (NSCLC), which suggest

that this novel drug candidate could represent an attractive

treatment option for patients with these diseases.

BerGenBio intends to develop BGB324 itself and through

strategic partnerships. The clinical development plan for

BGB324 focuses on three cancer indications, namely AML/MDS,

NSCLC and triple negative breast cancer (TNBC). BGB324 will

be evaluated as monotherapy, as well as in combination with

other cancer drugs including immune checkpoint inhibitors.

On 8 March, the Company announced an important clinical

collaboration with Merck & Co., Inc. (known as MSD outside

the U.S. and Canada), a leading global pharmaceutical

company, which would allow BGB324 to be tested in

combination with MSD's immune checkpoint inhibitor KEYTRUDA®

in patients with NSCLC and TNBC. These studies are due to

begin in 2017 (see separate announcement made today).

The Company is also developing a pipeline of additional Axl

inhibitors, including an anti-Axl kinase antibody and

antibody drug conjugate (ADC), which are currently in

preclinical stage. In addition, BerGenBio is developing

companion diagnostics to identify cancer patients whose

tumours express Axl kinase and are therefore more likely to

respond to treatment with Axl inhibitors.

Not for distribution in or into the United States, Canada,

Australia, the Hong Kong Special

Administrative Region of the People's Republic of China,

South Africa or Japan

Richard Godfrey, CEO of BerGenBio, commented:

"BerGenBio is pioneering a new approach to treating

aggressive cancers based on its deep understanding of Axl

biology. Our lead compound, BGB324, the only highly

selective Axl inhibitor in clinical development, has already

delivered encouraging clinical data in patients with AML/MDS

and NSCLC, indicating it could provide an important new

improved treatment option for these indications. The

clinical collaboration with MSD announced today will allow

us to assess BGB324 in combination with its immune

checkpoint inhibitor KEYTRUDA. Our planned IPO will provide

BerGenBio with the funds needed to develop BGB324 through to

regulatory trials and to generate significant value for

shareholders. We will continue to evaluate the optimal

strategy for further development and commercialisation of

BGB324, either alone or in conjunction with partners."

Stein H. Annexstad, Chairman of the Board, commented:

"The IPO is a natural next step in the Company's development

that will help it secure a broader, long-term shareholder

base. In addition, the listing will enhance BerGenBio's

visibility among potential partners, ensure organised and

regulated trading of the shares as well as provide access to

the capital markets."

Offering Highlights

The IPO will comprise a public offering to institutional and

retail investors in Norway and Sweden, and a private

placement to certain institutional investors

internationally. The largest existing shareholder has

indicated that it will offer strong support through the IPO

of the Company.

ABG Sundal Collier, Arctic Securities and DNB Markets are

acting as Joint Global Coordinators and Joint Bookrunners in

the IPO.

Further announcements relating to the process will be made

in due course.

Enquiries

Richard Godfrey, CEO

[email protected], +47 917 86 304

Petter Nielsen, CFO

[email protected], +47 922 47 464

For International media enquiries

David Dible / Mark Swallow / Marine Perrier, Citigate Dewe

Rogerson

[email protected], +44 207 638 9571

For media enquiries in Norway

Mitra Hagen Negård, Kari Holm Hejna, First House

[email protected], [email protected], +47 957 936 31

Important Notice

The information contained in this announcement is for

background purposes only and does not purport to be full or

complete. No reliance may be placed for any purpose on the

information contained in this announcement or its accuracy,

fairness or completeness.

Not for distribution in or into the United States, Canada,

Australia, the Hong Kong Special

Administrative Region of the People's Republic of China,

South Africa or Japan

These materials do not constitute or form a part of any

offer or solicitation to purchase or subscribe for

securities in any jurisdiction where such offer or sale

would be unlawful and the announcement and the information

contained herein are not for distribution or release,

directly or indirectly, in or into such jurisdictions.

United States

These materials may not be published, distributed or

transmitted in the United States, Canada, Australia, the

Hong Kong Special Administrative Region of the People's

Republic of China, South Africa or Japan. These materials do

not constitute an offer of securities for sale or a

solicitation of an offer to purchase securities

(the "Shares") of BerGenBio ASA (the "Company") in the

United States, Norway or any other jurisdiction. The Shares

of the Company may not be offered or sold in the United

States absent registration or an exemption from registration

under the U.S. Securities Act of 1933, as amended

(the "Securities Act"). The Shares of the Company have not

been, and will not be, registered under the Securities Act.

Any sale in the United States of the securities mentioned in

this communication will be made solely to "qualified

institutional buyers" as defined in Rule 144A under the

Securities Act.

European Economic Area

Any offering of securities will be made by means of a

prospectus to be published that may be obtained from the

issuer or selling security holder, once published, and that

will contain detailed information about the Company and its

management, as well as financial statements.

These materials are an advertisement and not a prospectus

for the purposes of Directive 2003/71/EC, as amended

(together with any applicable implementing measures in any

Member State, the "Prospectus Directive"). Investors should

not subscribe for any securities referred to in these

materials except on the basis of information contained in

the prospectus.

In any EEA Member State other than Norway (from the time the

prospectus has been approved by the Financial Supervisory

Authority of Norway, in its capacity as the competent

authority in Norway, and published in accordance with the

Prospectus Directive as implemented in Norway) that has

implemented the Prospectus Directive, this communication is

only addressed to and is only directed at "qualified

investors" in that Member State within the meaning of

Article 2(1)(e) of the Prospectus Directive ("Qualified

Investors"), i.e., only to investors to whom an offer of

securities may be made without the requirement for the

Company to publish a prospectus pursuant to Article 3 of the

Prospectus Directive in such EEA Member State.

United Kingdom

In the United Kingdom, these materials are only being

distributed to and are only directed at Qualified Investors

who (i) are investment professionals falling within Article

19(5) of the Financial Services and Markets Act 2000

(Financial Promotion) Order 2005 (as amended) (the "Order")

or (ii) are persons falling within Article 49(2)(a) to (d)

of the Order (high net worth companies, unincorporated

associations, etc.) (all such persons together being

referred to as "Relevant Persons"). These materials are

directed only at Relevant Persons and must not be acted on

or relied on by persons who are not Relevant Persons. Any

investment or investment activity to which this document

relates is available only to Relevant Persons and will be

engaged in only with Relevant Persons.

Matters discussed in this announcement may constitute

forward-looking statements. Forward-looking statements are

statements that are not historical facts and may be

identified by words such

as "believe", "expect", "anticipate", "strategy", "intends",

"estimate", "will", "may", "continue", "should" and similar

expressions. The forward-looking statements in this

announcement are based upon various assumptions, many of

which are based, in turn, upon further assumptions. Although

the Company believes that these assumptions were

Not for distribution in or into the United States, Canada,

Australia, the Hong Kong Special

Administrative Region of the People's Republic of China,

South Africa or Japan

reasonable when made, these assumptions are inherently

subject to significant known and unknown risks,

uncertainties, contingencies and other important factors

which are difficult or impossible to predict and are beyond

its control. . 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.

The IPO may be influenced by a range of circumstances, such

as market conditions, and there is no guarantee that the IPO

will proceed and that the listing will occur.

The information, opinions and forward-looking statements

contained in this announcement speak only as at its date,

and are subject to change without notice. The Company does

not undertake any obligation to review, update, confirm, or

to release publicly any revisions to any forward-looking

statements to reflect events that occur or circumstances

that arise in relation to the content of this announcement.

Not for distribution in or into the United States, Canada,

Australia, the Hong Kong Special

Administrative Region of the People's Republic of China,

South Africa or Japan

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