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PCI Biotech Småprat (PCIB)

PCI Biotech: Last day of subscription period

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO UNITED STATES NEWS WIRE SERVICES OR FOR DISSEMINATION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, HONG KONG OR SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER OF ANY OF THE SECURITIES DESCRIBED HEREIN.

Oslo, Norway, 03 October 2018. Reference is made to the previous announcements by PCI Biotech Holding ASA (“PCI Biotech” or the “Company”) in respect of the fully underwritten rights issue of 12,000,000 new shares (.Offer Shares.) in the Company (the “Rights Issue”). The terms of the subscription rights are described in PCI Biotech.s prospectus dated 17 September 2018. The subscription period in the Rights Issue expires at 16:30 CET today, 03 October 2018.

Note that Subscription Rights that are not used to subscribe for Offer Shares before the end of the subscription period 03 October 2018 at 16:30 CET will lapse without compensations and consequently be of no value.

Subscription procedure
Holders of subscription rights (whether granted or acquired) must, in order to subscribe for Offer Shares, submit a correctly completed subscription form for the Rights Issue (.Subscription Form.) to the Managers, ABG Sundal Collier ASA or Arctic Securities AS, as outlined below and included in the Prospectus. Subscribers who are Norwegian residents with a Norwegian personal identification number may also subscribe for Offer Shares through the VPS online subscription system or by following the link on the following websites: www.abgsc.com or www.arctic.com, which will direct the subscriber to the VPS online system. For further information about the Subscription procedure, see section 15.9 in the Prospectus. The Subscription Form can be found in Appendix B in the Prospectus and at the managers website www.abgsc.com and www.arctic.com.

ABG Sundal Collier ASA
P.O. Box 1444 Vika
NO-0115 Oslo, Norway
E-mail:                    
website:

or

Arctic Securities AS
P.O. Box 1833 Vika
NO-0123 Oslo, Norway
E-mail:                 
website:

Contact information:
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 9400 5757
For more information visit: www.pcibiotech.com
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, Oslo, NO-0379 Norway

Important Notice
The contents of this announcement have been prepared by, and are the sole responsibility of, the Company. The Company’s financial advisors are acting exclusively for the Company and no one else, and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients, or for advice in relation to the Rights Issue, the contents of this announcement or any of the matters referred to herein.

The information in this announcement is for information purposes only and does not purport to be accurate or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.

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 release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were 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 information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. Neither the publication and/or delivery of this announcement shall under any circumstances imply that there has been no change in the affairs of the Company or that the information contained herein is correct as of any date subsequent to the earlier of the date hereof and any earlier specified date with respect to such information.

A prospectus approved by the competent authority in Norway has been published by the Company) and can be obtained on the Company’s website, subject to regulatory restrictions. Investors should not subscribe for any securities referred to in this announcement except on the basis of information contained in the prospectus.

Restrictions
Neither this announcement nor any copy of it may be made or transmitted directly or indirectly into the United States, Australia, Canada, Japan, Hong Kong or South Africa or any other jurisdiction where to do so would be unlawful. The Rights Issue (if made) and the distribution of this announcement and other information in connection with the Rights Issue may be restricted by law in certain jurisdictions. Any failure to comply with such restrictions may constitute a violation of applicable securities laws. Persons into whose possession this announcement or other information should come are required to inform themselves about and observe any such restrictions. The Company assumes no responsibility in the event there is a violation by any person of such restrictions.

This announcement does not in itself constitute, and should not be construed as, an offer for sale or subscription of or solicitation or invitation of any offer to subscribe for or purchase any securities of the Company or its affiliates in any jurisdiction. The Rights Issue will  not be made in any jurisdiction or in any circumstances in which such offer or solicitation would be unlawful. No steps have been taken or will be taken relating to the Rights Issue in any jurisdiction outside of Norway in which such steps would be required.

The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), or any securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with applicable state law. There will be no public offer of the securities in the United States.

This announcement is only being distributed to and is only directed at persons in the United Kingdom that are (i) 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) high net worth entities, and other persons to whom this announcement 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”). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this announcement must satisfy themselves that it is lawful to do so.

Further information regarding restrictions applicable for the Rights Issue will be set out in the prospectus prepared for the Rights Issue.

About PCI Biotech
PCI Biotech is a biopharmaceutical 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 fimaCHEM programme consists of a clinical Phase I/II clinical 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.

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

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.

Nyheten er levert av GlobeNewswire.

http://www.netfonds.no/quotes/release.php?id=20181003.GlobeNewswire.GNW1000101097-en

today is the day, exciting times ahead. Good luck to all

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Kilde på det? Meg bekjent har de guidet 2H18.

Litt mye fantasi og drømmer?

De ønsker å presentere resultatene på relevante konferanser. Jeg tenker da at vi får noen resultater på ESMO i desember. Det er en liten stund til, dessverre. Dog er det vel mer realistisk.

Umulig å si.

Hva er din kilde for at okt ESMO er drømmer? Like realistisk som alt annet. Vi er langt inne i andre halvår og basert på kommentarer vedrørende fimavacc og chem ggk på presentasjoner antar jeg det kommer noe på førstkommende og neste.

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Førstkommende er relevant konferanse!

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Fra Q2

"Status:

  • More than 90 subjects have so far been treated
  • Part 1 is completed
  • Part 2 is completed
    • Initial data suggest enhancement of antigen specific T-cell response at tolerable doses, with earlier responses and higher response rates
    • Vast number of study samples available – near-term focus on characterisation of the immune response
  • Part 3 TBD
  • Expected study completion: 2H 2018"

I tillegg har PW sagt at det er svært tidkrevende å analysere prøvene.

At noe er mulig, betyr ikke at det er sannsynlig.

Keep it real, ESMO i desember et den mest relevante konferansen. Hadde det vært i ESMO i oktober så hadde du funnet det på hjemmesiden til konferansen nå.
Og med tanke på PW sin historikk i forhold til guiding, så er presentasjon i av fimaVACC i desember best case!:wink:

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Ja men CEO har også sagt at resultatene på et ikke veldig detaljert nivå vil komme når de foreligger. Detaljene kommer på konferanser. Det er slik pcib har gjort det så lenge jeg har fulgt aksjen.

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@Chrkni I agree with you regarding ESMO Geneva December and as i have said before:

I strongly believe (99,999%) that PCI biotech will present the FimaVACC data during the following event: ESMO Immuno Oncology Congress, Geneva, December 13-16, 2018

My reasons to say this are:

1- PW already confirmed that the FimaVACC data will be presented in a scientific conference and this must be unpublished / virgin data never presented before. Although he has said the the company could update the market with a “high level” update on the results, which may be used as a compassionate move towards disappointed shareholders to give the share price some momentum, but personally I fail to see how this “high level” update will sound like as the company already communicated through quarterly presentations that Phase I interim data suggests enhancement of several parameters of importance for vaccination also in Q2 2018 report page 6:
"The interim clinical results on antigen-specific T-cell responses indicate that vaccination with well tolerated doses of fimaVACC enhance cellular immune responses important for therapeutic effect of vaccines. The data also suggests that fimaVACC triggers early T-cell responses and provides response in a high proportion of individuals, which are two highly sought-after features of vaccination platforms. The dose-finding part of the study is now completed, with more than 90 subjects included. The study has provided a vast number of clinical test samples and the focus for the coming months is to characterise the fimaVACC immune response by targeted in-depth immune analysis of relevant samples. "

2- The company confirmed attendance in the event: http://pcibiotech.no/partnering/

3- PCI Biotech has already used the same congress in 2016 to present (link below): Clinical validation of photochemical internalization (fimaVacc) - A novel technology for enhancing cellular immune responses to peptide and protein …

Link:https://oncologypro.esmo.org/Meeting-Resources/Immuno-Oncology-2016/Clinical-validation-of-photochemical-internalisation-fimaVacc-A-novel-technology-for-enhancing-cellular-immune-responses-to- peptide-and-protein-based-therapeutic-cancer vaccines.

Therefore, it will only be natural to use the same ground to update the scientific community on the progress with the FimaVACC program.

Regarding where we are now with FimaVACC: see my post below.

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Hva menes med completion i denne sammenheng? Hvis det er siste forsøksperson som har fått sin dose så snakker vi ikke om ferdig analyse av disse dataene i 2018. Det vil egentlig ligne på mønsteret til PCIB sin tidsbruk egentlig.

Dette er bare vås. Tidsbruken og burnrate for PCIB er helt suveren. Tenk hvor «billig» teknologien i chem, vacc og Nac har vært. Finnes det ett biotekselskap i verden med fase tre tog leveringsteknologi, så mange samarbeidspartnere priset til under milliarden? Klarer ikke finne noen. Nå er det gitt pivotal fase II, mulig AA basert på interim resultater, ferdig godt studieoppsett, fullfinansiert, ODD, blockbuster mulighet, kort tid til data fra vacc og extended behandling som hvis gode danner grunnlag for mulig life C management.

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Jubel: Det er lov å være realist.

  1. Extensionstudien til PCIB ble aldri ferdig.
  2. Pivotal studien er ikke starta.

Jeg baisser ikke. Jeg har aksjer og skal tegne meg i emisjonen. Men det er lov å stikke fingeren i jorda.

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En kan jo lure litt hva som er utfordringen til pcib. Er de rett og slett for få personer? Nå får de anledning til å ansatte litt flere.

Jeg vet ikke.

Men de prøvde seg på en hvit løgn og snakka om at de hadde postproblemer i et land ved første utsettelse. Resultatet har vist at de har fundamentale problemer med innrulleringstakten sin.

Når det kommer til completion er det snakk om ferdig analyse. Per nevnte det i sammenheng med en radium podcast om jeg minnes korrekt.

Pcib har altså fundamentale problemer i ifølge deg selv, men allikevel tegner du deg i emisjonen? Spesielt…

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Realistisk jeg, det er allerede skapt store verdier i svært gode data. Pasienter lever lenger og regulatoriske myndigheter i EU og USA har gitt go for pivotal fase II (fase tre tog), ODD, AA basert på interim resultater. Glimt av lovende data på gjentakende behandling ble vel vist i dokumentasjon til emisjon. Den andre store risk i biotek, finansiering er i boks. Risiko er redusert mye. Sten for sten. Klart det også er lov å være svært fornøyd med rikets tilstand. Noen mnd utsettelse er null problem for investorer, men selvsagt et problem for pasienter som burde kunne benyttet seg av PCIB teknoligien. I tillegg har vacc og Nac lovende indikasjoner i form av mange samarbeid og vacc sitt studie som vi snarlig bet mer om! Realist og optimist!

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InVivo:

Jeg gikk noen runder med meg selv og gav PCIB en siste sjanse. Er godt i pluss siden forrige emisjon, men er strukket langt i tålmodighet.

Jeg gjentar at det er lov å ha andre tilstander enn euforisk.

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Helt enig at det er lov å ha et balansert syn.

Men når du forfekter et syn dere du mener at Pcib har fundamentale problemer, for så å ha handle aksjer, ja da tror jeg du bør stikke fingeren i jorden… Fordi det henger jo ikke på greip!

Droppet selv å tegne meg emisjonen, avventer til data fra extension studiet foreligger før jeg laster opp med mer aksjer.

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Hva er negativt med chem, vacc og Nac teknologien annet enn at chem er noen mnd forsinket? Hvis lykkes vet alle i biotek hvor store verdier som skapes i fase tre tog! PCIB chem er der nå. Studieoppsett mm er godkjent av reg myndigheter!

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