BergenBio Fundamentale Forhold (BGBIO)

[Morgo26]

Must say i am looking forward to this presentation to see what their plans are for the coming months with regards to financing studies. I hope we get some clarity because otherwise, i fear we just continue this trend of down, down, down…on absolutely no volume. Been a depressing summer it must be said.

[vcp]

Hva var utgangspunktet?

[vegar_beider]

Ha ha!

Løftet seg nesten 2% på siste handel fordi det ble solgt 1 (!) aksje i sluttauksjonen

[Ekornet]

Q2 på mandag, tanker/forventninger?

[anon80503862]

Totalen er viktig for å evaluere hvilke måneder / hvilket kvartal som er mest interessant for å spekulere i emisjon/partneravtale/oppkjøp basert på når forskningsdata blir presentert / burn rate / eventuell guiding for oppstart av nye dyre studier. Vet ikke om ett enkelt element er lett å se nå før vi har kvartalsrapporten.

[TekBot]

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
…

Vis børsmeldingen

· 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.

Kilde

[drdr]

…”Our focus is now on refining and preparing our late stage clinical trials in
light of our recent clinical data and emerging market opportunities”…

Blir ikke overrasket over en plutselig melding fra blåhimmel i H2 om partneravtale ( eller salg)

[larsmkn]

Noen i styre som også har kjøpt aksjer det siste året selv om de har vært involvert i lenger tid.

[Ekornet]

Selve meldingen var vel som forventet. Overrasket om aksjen går noe særlig idag/fremover. Spennende med positiv innside.

[larsmkn]

Det var noe nytt. At AML studien med LDAC ekspanderes var nytt, det samme med keytruda studien i NSCLC. Siden de ble ekspandert så blir start av pivotal fase forskøvet til H1 neste år, som jo er litt kjedelig, men sånn blir det når man holder på i et felt med rivende utvikling.

Ellers var det veldig betryggende å høre at biomarkørene er satt for AML og NSCLC og at de har alt klart på den fronten. At det nå ligger en kjøpspost på over 20K askjer på 12.00 gir også en fin støtte i en nedtrøkka aksje.

CEO virket også spent på resultatene fra melanomstudien, og vi vil få en liten oppdatering derfra på ESMO 26.-30. septmeber (abstract ute 23. september)

[anon80503862]

Siden de ble ekspandert så blir start av pivotal fase forskøvet til H1 neste år, som jo er litt kjedelig, men sånn blir det når man holder på i et felt med rivende utvikling.

Dette var årsaken til at jeg tok gevinst og solgte i dag. Med en utsettelse til oppstart neste halvår så ble mine tanker om at BGBio godt kan sitte og forhandle med Merck nå mens de venter på resultater litt ødelagt. Jeg anser det nå som mye større mulighet for at de ser for seg å først få resultatene, publisere dem, og så gå i gang med forhandlinger om mulig partneravtale eller oppkjøp som alternativ til emisjon før neste steg i utviklingen. Dvs, samtidig som de planlegger studiedesign og har dialog med regulatoriske myndigheter.

Det er en ryddig prosess, men det skyver litt på den interessante perioden. For min del anser jeg nå desember - mars/april som interessant, mens tidligere var det vel mer november - februar.

Ingen logisk grunn til at bgbio skal være preget av makro egentlig, men jeg ser for meg at det blir mer makrouro framover som gjør at jeg ikke ønsker å sitte stille i noen aksjer i 6 måneder.

Det er såpass lite volum i bgbio at i mitt hode virker det logisk at kursen kan holde seg under 13.5 i en lengre periode dessverre, da det sikkert er noen emisjonsfolk som vil ut i null / med ørliten gevinst.

[Flottesen]

Prøvde å følge presentasjonen men lyd og video kom ikke gjennom. Likevel får jeg en snikende følelse om at strategien nå er en utlisensiering istedenfor en fase3, når de er ferdige med disse ekspansjonskohortene(1H2020). De har jo da veldig omfattende data i både AML og NSCLC.

Hvis det går den veien så vil også dagens kontantbeholdning rekke fint.

[JAXI]

World Conference on Lunc Cancer 7.-10-september (abstract release 21. august)

noen forventninger om hva som kan komme i denne?

[Morgo26]

Has the video presentation been uploaded yet?

[Eder]

https://www.hegnar.no/TV/kvartalspresentasjon/98042710

[larsmkn]

Oppdaterte resultater fra NSCLC studien med bemcentinib + keytruda.

Flere pasienter er ongoing, og jeg tror ikke de har repsons fra alle 46 pasienter enda (35 ved ASCO), så håper at de nå kan vise resultater fra mer enn 35 pasienter.

[drdr]

Positiv analyse fra trinity! Det ser ut at det ikke blir behov for en ny emisjon

‘We estimate that the company has sufficient capital to operate into H220, though this could be extended significantly through a licensing deal.’

Refining the route ahead | Trinity Delta

[JAXI]

The revisions to the clinical trial plan add a minor delay to the start of the pivotal programme, but provide very valuable information, which will help BerGenBio maximise the value of bemcentinib.

We value BerGenBio at NOK53.13/share (NOK3.21bn or $378m). We estimate that the company has sufficient capital to operate into H220, though this could be extended significantly through a licensing deal.

Grei oppside det får man si - blir en spennende høst
• Abstract release allerede imorgen for WCLC - World Conference on Lunc Cancer 7.-10-september - Bemcentinib + Keytruda NSCLC

[drdr]

Abstrakt release Kl 17 i dag!

[larsmkn]

Jeg får opp at de blir lagt ut kl 23. Hvor så du at de ble lagt ut kl 17?