BergenBio Fundamentale Forhold (BGBIO)

anon21766851 · juni 14, 2019, 6:02pm

@larsmkn og @Flottesen, kunne dere sagt noe rundt mei pharma, pracinostat og deres phase III som har pågått i to år?

Gjerne konkurransen også, sånn grovt regna ihvertfall.

larsmkn · juni 14, 2019, 6:03pm

Har du noe oppdaterte resultater fra dem? Kan slenge det inn på MEI tråden

anon21766851 · juni 14, 2019, 6:07pm

Nei, det er null resultater. Fase III studien virker å tusle avgårde i total stillhet, foruten en ct.gov-oppdatering i februar. Spent på utfallet, og ingen sier noe om tidspunkt for readout.

Biotop20 · juni 14, 2019, 6:10pm

Mye snakk om mei tidligere. Fint om du bytter ut den Flyers-drakta, sesongen er over og Blues vant

anon21766851 · juni 14, 2019, 6:14pm

Haha, tar nok med meg den i graven dessverre.

Flottesen · juni 14, 2019, 9:36pm

Litt skuffet over at vi ikke fikk biomarkørdata i dag. Det viser seg at heller ikke BGBIO er immun mot forsinkelser.

Blir spennende å høre hva som kommer fra selskapet fremover, studiedesign for AML bør jo være rett rundt hjørnet.

Lungekreftdata blir vel rapportert utover høsten.

De investigator-sponsede studiene kan vel også komme med spennende data, selv om man ikke vet hvor langt de er kommet i disse studiene.

Den utlisensiert anti-AXL ADC ser ut til å ha rekruttert raskt(milestone utbetaling ved n=5 i Q1), kanskje kommer det mer info rundt denne studien ila. året.

Alt i alt er jeg litt skuffet av den siste tids kursfall, den lave omsetninger i aksjen har jo lenge vært bekymringsfull. Samtidig så er det, når man tenker over det, ingenting ved det fundamentale som er svekket. At innsiderne kjøper er jo også betryggende.

tcb888 · juni 17, 2019, 11:58am

Er emisjonselgere ferdig snart tro?

larsmkn · juni 17, 2019, 12:43pm

Små molekylære hemmere er tingen! BerGenBio utvikler en hemmer mot tyrosin kinasen AXL, og er det noe BP er glad i så er det spesifikke hemmere

Dette er en liste over oppkjøp i sektoren for spesifikke hemmere de siste 30 mnd.

larsmkn · juni 17, 2019, 1:27pm

Siden Array blir kjøpt i dag så har Nature rev Drug Disc en artikkel på kinase hemmere og “the road ahead” hvor TAM familien med AXL inkludert (som bemcentinib hemmer) er nevnt
https://www.nature.com/articles/nrd.2018.21

BerGenBio får også spesifikk oppmerksomhet i artikkelen hvor flere av programmene er vist frem i en tabell:

Alltid hyggelig med oppmerksomhet fra store annerkjente tidsskrifter som nature

TekBot · juni 17, 2019, 9:47pm

14/06-2019 00:03:20: (BGBIO) BerGenBio ASA - Successfully Completed Private Placement

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO U.S. NEWS WIRE
SERVICES, OR IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE HONG KONG
SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA OR
…

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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, 13 June 2019: Reference is made to the stock exchange announcement by
BerGenBio ASA (OSE:BGBIO) (“BerGenBio” or the “Company”) on 13 June 2019
regarding a contemplated private placement of new shares in the Company (the
“Private Placement”).

The Company is pleased to announce that the Private Placement has been
successfully completed, raising gross proceeds of NOK 74,184,444 through the
allocation of 5,495,144 new shares (the “New Shares”) at a subscription price of
NOK 13.50 per share. The Private Placement, that was substantially over
subscribed, took place through an accelerated book building process after close
of market on 13 June 2019.

Arctic Securities AS and Carnegie AS acted as Joint Bookrunners and H.C.
Wainwright & Co., LLC acted as Financial Advisor (together the “Managers”) in
connection with the Private Placement. The Private Placement attracted strong
interest from existing shareholders and new institutional investors.

The Company intends to use the net proceeds from the Private Placement to
advance the Company’s clinical programs, with its lead candidate bemcentinib in
Acute Myeloid Leukaemia and lung cancer, as well as for general corporate
purposes.

The Private Placement and the issuance of the New Shares was resolved by the
Company’s board of directors at a board meeting held on 13 June 2019, based on
the authorization granted to the board of directors at the Company’s annual
general meeting held on 13 March 2019.

Completion of the Private Placement implies a deviation from the existing
shareholders’ pre-emptive rights to subscribe for and be allocated new shares.
The board of directors of the Company has carefully considered such deviation
and has resolved that the Private Placement is in the best interests of the
Company and its shareholders. In reaching this conclusion the board of directors
has inter alia considered the implications of an underwritten rights issue given
the volatility and negative development in the Company’s share price,
alternative financing sources, the dilutive effect of the share issue, the
CompanyŽs need for additional liquidity and that the subscription price in the
Private Placement was set with a premium of 2.12% to last closing price on 13
June 2019 on Oslo Stock Exchange. Existing shareholders subscribing in the
transaction have been allocated at least their pro-rata share of the
transaction, to the extent subscribed.

Notification of allocation of the New Shares and payment instructions is
expected to be sent to the applicants through a notification from the Managers
on 14 June 2019. Settlement of the New Shares towards investors will be made on
a delivery versus payment basis on 18 June 2019 (T+2 settlement), by delivery of
existing and unencumbered shares in the Company that are already listed on the
Oslo Stock Exchange, pursuant to a share lending agreement between the Managers,
the Company and Meteva AS. The shares delivered to the subscribers will thus be
tradable from allocation. The Managers will settle the share loan with Offer
Shares upon issuance of these. Following registration of the new share capital
in the Company with the Norwegian Register of Business Enterprises, which is
expected to take place on or about 20 June 2019, the Company will have an issued
share capital of NOK 6,044,659 divided into 60,446,590 shares, each with a par
value of NOK 0.10.

The following primary insiders have been allocated New Shares in the Private
Placement at a subscription price of NOK 13.50 per New Share (with new holding
of shares in the Company in brackets):

Meteva AS 1,496,250 (16,458,750)

Altitude Capital AS (Grunde Eriksen) 65,000 (715,000)

Svev AS (Sveinung Hole) 44,000 (104,444)

Stener Kvinnsland 44,000 (104,444)

Gnist Holding AS (Richard Godfrey) 7,407 (167,815)

Sveinung Hole, Chairman of BerGenBio ASA, commented, “BerGenBio continues to
deliver promising data from its clinical development programme which we believe
has the potential to provide much needed additional treatment options for cancer
patients in the future. The Company has a clear strategy to progress its lead
asset, bemcentinib, in Acute Myeloid Leukaemia (AML) and Lung Cancer and
management remains focused on meeting its operational, regulatory and strategic
goals. We are grateful to existing shareholders for their continued support and
welcome a few new international specialist investors to our Company. We look
forward to providing further reports of progress in the coming months.”

For further information, please contact:

Richard Godfrey, CEO

+47 917 86 304

Rune Skeie, CFO

rune.skeie@bergenbio.com

+47 917 86 513

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 and
leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL
-ADC (ADCT-601) are 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). www.bergenbio.com

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.

IMPORTANT INFORMATION -

This document is not an offer to sell or a solicitation of offers to purchase or
subscribe for shares. Copies of this document may not be sent to jurisdictions,
or distributed in or sent from jurisdictions, in which this is barred or
prohibited by law. The information contained herein shall not constitute an
offer to sell or the solicitation of an offer to buy, in any jurisdiction in
which such offer or solicitation would be unlawful prior to registration,
exemption from registration or qualification under the securities laws of any
jurisdiction.

This communication may not be published, distributed or transmitted 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 and it does not
constitute an offer or invitation to subscribe for or purchase any securities in
such countries or in any other jurisdiction. In particular, the document and the
information contained herein should not be distributed or otherwise transmitted
into the United States of America or to U.S. persons (as defined in the U.S.
Securities Act of 1933, as amended (the “Securities Act”)) or to publications
with a general circulation in the United States of America. This document is not
an offer for sale of securities in the United States. The securities referred to
herein have not been and will not be registered under the Securities Act, or the
laws of any state, and may not be offered or sold in the United States of
America absent registration under or an exemption from registration under
Securities Act. BerGenBio does not intend to register any part of the offering
in the United States. There will be no public offering of the securities in the
United States of America.

The information contained herein does not constitute an offer of securities to
the public in the United Kingdom. No prospectus offering securities to the
public will be published in the United Kingdom. This document is only being
distributed to and is only directed at (i) persons who are outside the United
Kingdom or (ii) to investment professionals falling within article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the
“Order”) or (iii) high net worth entities, and other persons to whom it may
lawfully be communicated, falling within article 49(2)(a) to (d) of the Order
(all such persons together being referred to as “relevant persons”). The
securities are only available to, and any invitation, offer or agreement to
subscribe, purchase or otherwise acquire such securities will be engaged in only
with, relevant persons. Any person who is not a relevant person should not act
or rely on this document or any of its contents.

Any offer of securities to the public that may be deemed to be made pursuant to
this communication in any member state of the European Economic Area (each an
“EEA Member State”) that has implemented Directive 2003/71/EC (together with the
2010 PD Amending Directive 2010/73/EU, including any applicable implementing
measures in any Member State, the “Prospectus Directive”) is only addressed to
qualified investors in that Member State within the meaning of the Prospectus
Directive. This announcement is not a prospectus within the meaning of the
Prospectus Directive, as implemented in each member State of the European
Economic Area. With respect to the EEA Member States, no action has been
undertaken or will be undertaken to make an offer to the public of the
securities referred to herein requiring a publication of a prospectus in any
Member State. As a result, the securities of the Company may not and will not be
offered in any Member State except in accordance with the exemptions set forth
in Article 3 of the Prospectus Directive.

Investing in securities involves certain risks.

This publication may contain specific forward-looking statements, e.g.
statements including terms like “believe”, “assume”, “expect”, “forecast”,
“project”, “may”, “could”, “might”, “will” or similar expressions. Such forward
-looking statements are subject to known and unknown risks, uncertainties and
other factors which may result in a substantial divergence between the actual
results, financial situation, development or performance of BerGenBio and those
explicitly or implicitly presumed in these statements. Against the background of
these uncertainties, readers should not rely on forward-looking statements.
BerGenBio assumes no responsibility to update forward -looking statements or to
adapt them to future events or developments.

http://quotes.hegnar.no/release.php?id=20190614.OBI.20190614S2

TekBot · juni 17, 2019, 9:47pm

14/06-2019 12:00:52: (BGBIO) BerGenBio presents preliminary Phase II clinical data at EHA 24: bemcentinib in combination with low dose chemotherapy yields durable responses in AML patients unfit for intensive chemotherapy

Amsterdam, Netherlands, 14 June 2019 - BerGenBio ASA (OSE:BGBIO) today presents data showing significant efficacy in a Phase II clinical trial (BGBC003, NCT02488408) evaluating bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with low-dose cytarabine (LDAC) as a potential new treatment regimen for AML patients unfit for intensive therapy. The data will be presented by Professor Bjørn Tore Gjertsen MD PhD, Haukeland University Hospital and University of Bergen, at the 2019 annual congress of the European Hematology Association (EHA24), in Amsterdam, The Netherlands, Friday, June 14, 2019.

In total, 16 patients were enrolled into the trial. Among the 14 patients evaluable for efficacy, 6 responses have been reported; 4 patients achieved complete remission / complete remission with incomplete hematologic recovery (CR/CRi) and 2 patients achieved partial remission (PR). Five of the six responses occurred among elderly AML patients (>75 years). Furthermore, two patients achieved durable stable disease for more than 3 months. The relapse-free survival rate for patients with CR/CRi is 7.9 months (range: 0.7 to 9.6 months) and continues to mature. The combination treatment of bemcentinib and LDAC was overall well-tolerated; the most common adverse events (>15% of patients) included anaemia, neutropenia and diarrhoea. Soluble protein (e.g. sAXL) and gene expression biomarker data is still maturing and will be reported in due course. A second biomarker poster from Prof. Gjertsen’s group, to be presented on June 15th, examined the effect of bemcentinib monotherapy from a phase 1b/2 clinical trial on patient AML cell signal transduction using mass cytometry. The high-dimensional single cell-level signalling analysis of AML blasts from 6 evaluable patients revealed significant effects already at 4 hours post-dosing of bemcentinib
…

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Professor Bjørn Tore Gjertsen commented: “These early results are encouraging, especially among less fit AML patients with comparatively poor prognosis. Bemcentinib in combination with LDAC resulted in a substantially higher ORR than expected for single-agent cytarabine and clearly warrant further investigation of bemcentinib in an expansion cohort of AML patients unfit for intensive chemotherapy. Our signal cell-level biomarker analysis of AML blasts from patients indicates a substantial effect on cell signalling and represents a potential new biomarker strategy.”

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "There are currently limited treatment options for AML patients unable to tolerate intensive chemotherapy, particularly those with relapsed and refractory disease. These promising preliminary data with bemcentinib in combination with low-dose cytarabine, reinforce data we recently at presented at ASCO, and suggests that the addition of our selective AXL inhibitor can substantially improve AML patient outcomes. I am particularly encouraged by the high response rate observed in all patient groups studied, the extended duration of responses seen, which is still maturing, and how well the combination therapy was tolerated. We are still waiting on much of our biomarker data before we can report that and are very excited by cell signalling data presented by our collaborators at the University of Bergen. We will expand this study to include more patients and report more complete data in the coming months.š

The posters presented at EHA will be made available at www.bergenbio.com in the Investors / Presentations section to coincide with the following conference sessions:

Friday 14 June, 17:30 - 19:00 Central European Time

The Combination of bemcentinib, a novel, oral, selective AXL-Inhibitor and Low-Dose Cytarabine yields Durable Responses in AML patients Unfit for Intensive Chemotherapy

· Author: Sonja Loges et al.
· Abstract: PF259
· Location: Poster area

Saturday 15 June, 17:30 - 19:00 Central European Time

Single Cell Signaling Pharmacodynamics in a Phase 1b Clinical Trial of the AXL inhibitor bemcentinib in Acute Myeloid Leukemia and Myelodysplastic Syndrome

· Author: Monica Hellesøy et al.
· Abstract: PS999
· Location: Poster area

END -

About AML and the BGBC003 trial

Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. AML is the most common form of acute leukaemia in adults, where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant.

The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and decitabine (part B3) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities. Up to 28 patients will be enrolled at centres in the US, Norway, Germany and Italy.

For more information please access trial NCT02488408 at www.clinicaltrials.gov.

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

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 and leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601) are 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). 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 Elliott, Chris Welsh, Jessica Hodgson, 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.

http://quotes.hegnar.no/release.php?id=20190614.Cision.20190614:BIT:9456:0

drdr · juni 19, 2019, 3:03pm

BerGenBio neste?!

‘ Merck Seeks More Deals as It Expands Its Cancer Treatments Portfolio
Company is expected to outline its strategy Thursday at its first investor day in five years

larsmkn · juni 19, 2019, 4:18pm

I dag kom det ut en ny review i Nature Reviews Cancer. Dette er et av de mest prestisjefylte tidsskriftene innen kreftforskning!

Denne artikkelen tar for seg hvordan melanoa (føflekkreft) kan bli resistent mot behandling. Spennende nok så nevnes AXL i artikkelen, og svulster med høy AXL ser ut til å oftere bli motstandsdyktig (70%). Jeg har ikke fått lest hele da jeg nå jobber hjemmefra, men skal kikke på den når jeg kommer tilbake på jobb.

Dette er superrelevant for BerGenBio fordi Haukeland sykehus i samarbeid med BerGenBio kjører en studie innen melanom hvor bemcentinib blir kombinert med målrettet terapi og/eller immunterpien keytruda: https://clinicaltrials.gov/ct2/show/NCT02872259?term=BerGenBio&rank=6

Forhåpentligvis så vil vi se oppdaterte resultater fra denne studien senere i år ved SITC.

drdr · juni 19, 2019, 7:07pm

‘Considering Bemcentinib/chemo as 1st line treatment of young AML patients in Germany!’

https://ecancer.org/conference/1132-asco-2019/video/7911/axl-inhibitor-bemcentinib-in-combination-with-chemotherapy-exerts-anti-leukaemic-activity-in-aml-patients.php

Dormancy · juni 20, 2019, 11:57am

Kan man spekulere i at ledelsen blir tvunget til å finansiere deres neste studier gjennom en partner hvis aksjekursen holder seg så lav?

Dagens markedsverdi til BGBIO er 730 MNOK og det er kanskje så mye penger de faktisk trenger til studiene sine også. De har jo muligheten til å starte med en mindre emisjon på 300-400 millioner, men da har de ikke fullfinansiert studiene sine heller. Er vanskelig å se hvordan de skal skaffe nok penger uten en partner i det sure norske biotek markedet.

Boms · juni 20, 2019, 1:23pm

De trenger heldigvis ikke å hente inn alt de trenger av midler i dag. De vil jo komme med ytterligere data før de trenger mer penger, og med gode resultater vil kursen også stige (jeg velger i hvert fall å tro at ikke dagens depresjon er en evigvarende situasjon).
Merck er jo for øvrig den åpenbare kandidaten til å kjøpe selskapet eller gjøre en partneravtale med ett eller flere produkter.

TekBot · juni 20, 2019, 2:48pm

20/06-2019 16:47:54: (BGBIO) BerGenBio ASA: Primary Insider notification

Savepig · juni 20, 2019, 2:50pm

Attaboy sveinung!

larsmkn · juni 20, 2019, 3:17pm

Godt å se at noen som sitter på toppen har troa

Det har vært litt insider action i det siste, noe pga nye folk i styret, men greit å se at de tar mulighet og fyller på og at ikke alt kommer fra opsjoner

Jeg lurer på hvor mye de egentlig kan vite når de gjør slike kjøp. De må jo sitte på kunnskap vi ikke har, som f.eks dealmaking, progresjon og strategi.

drdr · juni 20, 2019, 6:27pm

Lurer på om du fikk se sending av Merck investor seminaren? De er ganske bestemte og aktivt på jakt etter nye medisiner selv på tidlig fase! De forbereder seg på perioden etter Keytruda!
Jeg er i tvil de ikke har begynt å flørte med BgBio