Q-2 transcript
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RELEASE ER HELT RÅ. Kan ikke finne ett biotek selskap i fase tre tog priset til milliarden!
So summarizing this. The pivotal study is progressing well. We had our first patient included in May. Recruitment is progressing according to plan. We have achieved safety endpoint in the extension study, the RELEASE initiated now – has been initiated now with up to 2 treatments. Regulatory and ethic approvals are progressing according into plan. By mid-August, we had approvals received for the U.S., which is important, of course, and 8 of the 11 planned European countries. That included Norway, Germany, France, Spain, Belgium, Poland, Sweden and Denmark. We’re still waiting for Finland, U.K. and Italy. So those are the 3 remaining.
Site initiations progressing according to plan with a total of 15 sites across 7 European countries open for enrollment and actively screening for patients now by mid-August. It’s been a lot of work over the summer of this PCI Biotech organization, the operational team. And I would like to use this opportunity to congratulate them on the good work that they’ve done actually because it’s been a lot of work during the summer.
And then we have had presentation of Phase I data at the CCA Foundation in Salt Lake City at the Asia Pacific CCA conference in Taipei, in Taiwan and also the International Photodynamic Organization World Congress (sic) [International Photodynamic Association World Congress] in the U.S. in June 2019. We were – I was present myself at the International Photodynamic Association World Congress in June where we were a sponsor of the meeting. We had separate seminar, which was very well attended and with a lot of questions and interaction with the audience. So there is a lot of interest in the technology.
Looking forward then, what are we doing? What is the pivotal study. It’s a randomized study, 1:1, with an interim analysis for a potential accelerated approval. We have orphan designation by regulatory authorities, EMA and FDA, granted in both U.S. and EU. The fastest way to market has been determined through regulatory interactions with both of those agencies and this is the result of those interactions. We can, with this, become a first-line treatment of patients with inoperable extrahepatic bile duct cancer by doing randomization study of 1:1 with approximately 186 patients. The primary end point being progression-free survival and overall survival, of course, as a key secondary in this population which has very poor survival. And then potential accelerated approval through interim analysis of primary endpoints PFS, progression-free survival, followed by objective response rate. And we are planning to do this in approximately 40 key hospitals across Europe and the U.S.
Now I mentioned also that the prevalence of this disease in Asia is higher than it is in the Western world. So it is an area where we need to have a presence and where we can actually speed up recruitment. So we have a feasibility study ongoing in Asia to select the most appropriate RELEASE study sites for patient recruitment and market impact, and the aim is then to open sites in Asia as well in 2020. It’s still in a feasibility study, so it’s too early to talk too much about which countries and how many sites and so on, we’ll have to come back to that one of the feasibility is done. But this is the aim: to open study sites in 2020. So that was fimaCHEM.
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«We have 6 different collaborations ongoing. They are at different activity levels and are differing results. But the most important ones of these, I can say, that we have good progress and quite exciting results without being able to go in any more detail on that afterwards, okay?»
WOW say no more!
Vedrørende konkurrenter! None
There is always competition for recruitment of patients either from investigative studies that academic centers are doing themselves because they want to publish specific results on new combinations that they’re testing and so on and also, to some extent, on commercial companies that are developing drugs for – generally for CCA. There is nothing specifically for our specific patient population, but there are umbrella studies that will include and compete for this.
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For min del er det to problemer her:
- En emisjon på disse nivåene vil også være en bekreftelse på at styret synes dagens børskurs er “fair”. Hvis de mener at kursen burde vært 50, 60 eller 100 kroner så selger man ikke en eierandel av selskapet til 15 - 25 kroner nå selv om formålet er aldri så godt.
- Hvis studien som skal finansieres er en kombinasjon med Ultimovacs sin medisin, blir sjansen for å lykkes for liten etter min vurdering. Hadde samarbeidet vært med en godkjent medisin, er veien til godkjennelse mye kortere og nåverdien av prosjektet tilsvarende stort. Ultimovacs har vel i tillegg knapt med kapital så et samarbeid med en etablert aktør hadde vært å foretrekke og langt mindre risikabelt.
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Unidentified Analyst, [45]
Okay. Regarding fimaVACC, you said you are doing partnering here. This is – what we are – you’re at least seeking partnering. Are you in some discussions with companies on fimaVACC?
Per Walday, PCI Biotech Holding ASA - CEO [46]
We are always in discussions with companies. We’re very active.
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Mistenker at de jobber ræva av seg for tiden
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Sherlock 
Denne krever kanskje litt utfyllende info… Det er hevet over en hver tvil at de jobber noe ekstremt om dagen.
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Jeg vil ikke ha emisjon. Jeg vil ha en giga-avtale med Topp-10 i Fimanacc
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@nordpolen : Sorry - da misforstod jeg. Ultimovacs var omtalt rett før ditt innlegg, så jeg trodde det var den det gjaldt.
De sa jo senest på q2 at det skal kjøres et proof of concept studie i egen regi med VACC.
Så jeg blir gjerne med på en 10% utvanning hvis pengene er øremerket et VACC studie.
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Jeg hadde og vært med på emisjon øremerket til FimaVACC. Hadde foretrukket en emisjon på 50-60 kroner (selv om kursen skulle være atskillig lavere på det tidspunktet man annonserte emisjon).
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Kan det være fordi de er ganske trygge på at penger er på vei inn ?
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Ingen dårlig spekulasjon 
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PCI Biotech: Exercise of employee share options, mandatory notification of trade and resolution to increase share capital
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CFO kjøper netto 14.700 aksjer. Positivt!
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Det var vel ikke helt det de sa!
De sa vel heller noe sånn som at neste steg for fimaVACC etter ett suksessfullt fase 1 studie hos friske frivillige med forbedret immunrespons som gav oss KLINISK BEVIS AV KONSEPTET med Svært etterspurte funksjoner - spesielt for terapeutisk vaksinasjon.
Ett proof of concept studie innen terapeutisk vaksinasjon vil være ett natulig neste steg med en partner eller i egen regi.
Nå skal fimaVACC endelig presenteres for verden iløpet av høsten og første stop er
The World Vaccine Congress 29-31 October 2019, Barcelona
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Får bruke hans egne CFO-ord fra radforsk-podden tilbake til ham:
“Men du er no ikke dum” 
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Spørsmål:
Betaler dei inn skatten no eller venter dei til neste år slik som oss vanlige investor?
Eller er dette noe med at det at det blir sett på som lønn og ein blir trekt for skatt på lønnslippen og kan ikkje bestemme når ein vil betale inn skatten?
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Dette er mest av alt positivt for Ronny Skuggedal. Ikke for aksjonærer. Jeg synes salget av 25 300 aksjer (nettoverdi på 685 124 kroner) var fryktelig mye for å finansiere “cash and tax impact of the transaction.” Jeg synes det virker unødvendig mye for å finansiere et totalinnskudd på 345 200 kroner (pluss skatteeffektene ? I min bok er dette mer negativt enn positivt men jeg er kanskje feilkonstruert? Ronny finner altså en middelvei mellom å dumpe alt (som Olivecrona gjorde) og en korrekt utregning av “cash/tax impact.” Det høres fint ut, men han trenger ikke selge for nesten 700 000 for å handle for 350 000 (så høy skatteprosent er det ikke)! Dette er “gamle opsjoner” så her står de imidlertid fritt frem til å gjøre det de vil.
Uansett, fremtidige opsjoner går heldigvis under nye forutsetninger: «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».
Ronny er en god mann - jeg unner ham dette. Men, det er ikke voldsomt positivt som enkelte hevder. Ikke i min bok i det minste 
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Jeg tenkte først som deg @Gunnersaurus men så fant jeg ut at opsjoner fra arbeidsgiver beskattes som lønn, inkludert trygdeavgift og trinnskatt. Ronny sitt salg sier at han har marginalskattesats på 46%.
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