PCI Biotech - Fundamentale forhold (PCIB)

[Savepig]

Ahh nå ble jeg glad, dette er det lavest hengende eplet som har frustrert meg enormt at ikke selskapene våre har plukket for årevis siden.

Så det kom sent men veldig veldig godt, hjemmesiden til RELEASE-studiet ble superbra.

PCI Biotech - Småprat 3 2020 (PCIB)

Utrolig bra jobbet PCIB, Nå snakker vi markedsføring av Release!

Egen nettside og greier!

https://www.release-trial.eu/

[TekBot]

PCI Biotech: Employee share option scheme

Oslo, 06 October 2020

In accordance with the authorisation granted by the Annual General Meeting 27
…

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May 2020, the Board of Directors of PCI Biotech Holding ASA has awarded a total
of 540,000 share options to key employees. Each share option gives the right to
subscribe for or acquire one share per option (after PCI Biotech Holding ASA’s
choice), at a strike price of NOK 50.36, equal to the volume weighted average
share price (VWAP) for the last 5 days of trade prior to the grant date.

The share options can be exercised with 1/3 of the options after approximately
one year, further 1/3 after approximately two years and the last third after
approximately three years. To ensure long term ownership by executive
management, shares shall be held for at least three years after exercise, except
shares to be sold immediately to cover transaction costs and tax under a so
called cash less exercise. The share options are subject to other customary
terms and conditions for employee incentive programs and the share options are
lapsing in Q3 2025.

Of the 540,000 share options, 400,000 share options were allotted to the
following primary insiders:
90,000 share options were allotted to Amir Snapir, CMO. After the allotment,
Amir Snapir holds a total portfolio of 90,000 unexercised share options and 0
shares.
90,000 share options were allotted to Ludovic Robin, CBO. After the allotment,
Ludovic Robin holds a total portfolio of 90,000 unexercised share options and 0
shares.
70,000 share options were allotted to Per Walday, CEO. After the allotment, Per
Walday holds a total portfolio of 225,000 unexercised share options and 72,700
shares.
50,000 share options were allotted to Anders Høgset, CSO. After the allotment,
Anders Høgset holds a total portfolio of 150,000 unexercised share options and
64,800 shares.
50,000 share options were allotted to Ronny Skuggedal, CFO. After the allotment,
Ronny Skuggedal holds a total portfolio of 140,000 unexercised share options and
55,000 shares.
50,000 share options were allotted to Lucy Wabakken, CDO (acting). After the
allotment, Lucy Wabakken holds a total portfolio of 120,000 unexercised share
options and 0 shares. Her related parties holds 10,008 shares.

The current authorisation, as of 27 may 2020, allows for a total of 2,790,000
share options, of which 1,245,500 now have been granted by the Board of
Directors.

For more information, please contact:
Per Walday, CEO, [email protected], Mobile: +47 917 93 429

This information is subject to the disclosure requirements pursuant to sections
5-12 and 4-2 of the Norwegian Securities Trading Act.

Kilde

[Morgo26]

Not sure i understand the Rocket and party faces being dealt out this announcement…but must admit i always get a bit of a heart flutter when i see an announcement in the PCIB chat…

[Jubel]

It is as «always» speculation until some kind of fundamentals are being announced by the company.

History is interesting though with regards of the timing of granting options and hence strike price to insiders.

Stats in general of this practise would have been nice! Do insiders get a nice deal and so to say good timing in most of the time with regards to the timing og option granted?

StockDZ found company specific dates for PCI Biotech:

06/10/2020
21/06/2019
17/10/2017
05/05/2017

[StockDZ]

recommend to watch. AZ on mRNA. watch from 01:10.

quote:
" what is good with mRNA is: when it come into the cell it will work"

she also talks about delivery hurdle. very interesting! shows how delivery is as important as the mRNA molecule

[solskimm]

PCI Biotech - Småprat 3 2020 (PCIB)

Clinicaltrials oppdatert. Sites er iallefall oppdatert med taiwan + korea + en ny i Italia + mayo i US såvidt jeg kan se.

PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in...

[Tek]

Mayo høres bra ut - de har bra renomme. Pluss alt det andre seff.

[Temlor]

Står fortsatt PFS som primary outcome, skulle det inte ändras till ORR (Overall Response Rate)?

[Savepig]

Godt å se litt outreach

Five for Friday - 5 exciting events that are happening soon -...

Cholangiocarcinoma Foundation (curecc)

[Logdec]

Jeg tipset Allison for en tid siden, har du også hatt kontakt med henne?

[Bonusfrelst]

@FiloD

På spørgsmål vedr. AZ svarede han bla følgende :

“Last year we announced that we had very promesing results in onchology”,

Dett er interessant. PW sier her at PCIB synes resultatene i onkologi er “very promising”, samsvarer det med at AZ også synes dette:

“Astra Zeneca has said that the results from their tests of fimaNAc look very promising in the oncology area. Now, they wish to see if the same technology can work in other disease areas”.

astrazeneca

Videre

"it is a very good research collaboration , where we work together to get the best out of this research eksperiments. "

I Radium episode 140 fra 23:40 sier også PW at PCIB har god interaksjon med AZ.

Jeg ser frem til en avklaring her og tenker fortsatt at jo lenger tid dette tar jo “bedre”. Husk at det skal meldes markedet umiddelbart hvis AZ ikke har noe interesse av samarbeid videre jf Radium podcast.

[TekBot]

PCI Biotech: Preclinical research collaboration with big pharma ended

Oslo (Norway), 21 October 2020 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today informed that AstraZeneca has elected not to
enter into a definitive agreement for the fimaNAc technology.
…

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Encouraging preclinical results have continued to be achieved with the fimaNAc
platform in this collaboration and the decision not to enter into a definitive
agreement is primarily based on a strategic evaluation of current development
needs. The companies plan to work together to publish the preclinical results
from this collaboration.

Per Walday, CEO of PCI Biotech, comments: “This is of course disappointing news,
but the collaboration has provided PCI Biotech with valuable scientific knowhow
from working with a big biopharma company over the last 5 years. We will utilise
this important knowhow, together with the generated preclinical results, for the
further development of the fimaNAc asset. We see great potential for further
development of our intracellular delivery technology, not least within the
emerging field of mRNA.”

The preclinical research collaboration was initiated in September 2015 to
determine whether PCI Biotech’s fimaNAc technology had the potential to enhance
the delivery of the collaborator’s nucleic acid therapeutic compounds. The
experimental collaboration ended in December 2019, with an additional 12 months
evaluation period until the end of 2020 to determine the potential for a further
collaboration.

Contact information:
Per Walday, CEO
[email protected] (mailto:[email protected])
Mobile: +47 917 93 429

About PCI Biotech
PCI Biotech is a biopharmaceutical late stage clinical development company
focusing on development and commercialisation of novel therapies for the
treatment of cancer through its innovative photochemical internalisation (PCI)
technology platform. PCI is applied to three distinct anticancer paradigms:
fimaChem (enhancement of chemotherapeutics for localised treatment of cancer),
fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc
(nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used
to unlock the true potential of a wide array of therapeutic modalities. The
company’s lead programme fimaChem consists of a pivotal study in bile duct
cancer, an orphan indication with a high unmet need and without approved
products. fimaVacc applies a unique mode of action to enhance the essential
cytotoxic effect of therapeutic cancer vaccines, which works in synergy with
several other state-of-the-art vaccination technologies. fimaNAc utilises the
endosomal release to provide intracellular delivery of nucleic acids, such as
mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks
facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
(http://www.pcibiotech.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.
PCI Biotech disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.

This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.

Kilde

[anon99163478]

Nice

[strongbuy]

skal vel godt ned på 20-tallet nå da som samarbeidet endte uten avtale? var jo der kursen kom fra.

[Shqipe]

Denne bør ligge her:

Webinar: The RELEASE trial and the technology behind

[Longtrader]

Takker, på småprat bare drukner infoen. Så denne tråden blir nok høyaktuelt fremover

[Kreft]

Ja, etter frustrasjonen er det nok ( bør det være) det fundamentale i Pcib sin forskning og resultater som har betydning. ( Som ikke har forandret seg i negativ retning. )

[Investor]

Fikk hørt Webinaret i helga.

Syns det var interessant at det ble nevnt at de nå åpner opp for pasienter som har hatt max 2 cycler med gem-cis.

Før var det krav om ingen behandling overhodet.

Forhåpentligvis er sånne tiltak som dette webinaret det som skal til for å trigge pasientinklusjon i Usa.

[TekBot]

PCI Biotech: First patient enrolled in Asia in the fimaCHEM pivotal RELEASE study

Oslo (Norway), 26 October 2020 - PCI Biotech (OSE: PCIB), a clinical-stage
biopharma company developing innovative therapeutics that address significant
unmet medical needs in cancer today announced that the first Asian patient in
…

Vis børsmeldingen

the fimaChem pivotal RELEASE study with registration intent in inoperable bile
duct cancer patients has been enrolled in South Korea. The RELEASE study spans
across Europe, USA and Asia, following the recent opening of several clinical
sites in both South Korea and Taiwan.

Contact information:
Per Walday, CEO
[email protected] (mailto:[email protected])
Mobile: +47 917 93 429

About the RELEASE study
The pivotal RELEASE study design is based on the outcome of meetings with the
two leading regulatory authorities European Medicines Agency (EMA) and the U.S.
Food and Drug Administration (FDA). The study programme consists of a single
open randomised two-arm study with 186 patients (93 patients per arm), having a
control arm with the standard of care (SoC) treatment of up to eight cycles of
the chemotherapies gemcitabine and cisplatin, and an experimental arm with up to
two fimaChem treatments in addition to SoC. The study’s primary endpoint is
progression free survival (PFS), with overall survival (OS) as a key secondary
endpoint. The study includes an interim analysis of objective response rate
(ORR), with the potential of accelerated/conditional marketing approval. In
addition, the study contains several other secondary endpoints that provide the
opportunity to generate robust comparative data of importance for market
acceptance of fimaChem as a first-line treatment for inoperable bile duct
cancer. The study is done at clinical sites across Europe, USA and Asia.

About PCI Biotech
PCI Biotech is a biopharmaceutical late stage clinical development company
focusing on development and commercialisation of novel therapies for the
treatment of cancer through its innovative photochemical internalisation (PCI)
technology platform. PCI is applied to three distinct anticancer paradigms:
fimaChem (enhancement of chemotherapeutics for localised treatment of cancer),
fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc
(nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used
to unlock the true potential of a wide array of therapeutic modalities. The
company’s lead programme fimaChem consists of a pivotal study in bile duct
cancer, an orphan indication with a high unmet need and without approved
products. fimaVacc applies a unique mode of action to enhance the essential
cytotoxic effect of therapeutic cancer vaccines, which works in synergy with
several other state-of-the-art vaccination technologies. fimaNAc utilises the
endosomal release to provide intracellular delivery of nucleic acids, such as
mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks
facing this emerging and promising field.

For further information, please visit: www.pcibiotech.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.
PCI Biotech disclaims any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.

This information is subject to the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.

Kilde