Diskusjon Triggere Porteføljer Aksjonærlister

PCI Biotech Småprat (PCIB)

Status er selvsagt at folk er usikre på om emisjonen blir fulltegnet, og i så fall er det ikke noen grunn til å betale mer enn 30kr per aksje.

Hvis tegningsrettighetene når de kommer på markedet fortsetter å ha en verdi (mer enn ett par kroner), så vil bildet fort endre seg.

kan ikke annet enn å si gratulerer til de kyniske jævlene som klarer å kjøre denne aksjen 12 kr under TERP kurs på 45,6 kursen som er lik verdien av selskapet før og etter emisjonen.
(Dvs med 12 millioner nye aksjer og innhenting av 340 millioner kr.)

12kr tilsvarer 300 millioner lavere Mcap !

Så markedet er nådeløst og sier at ved nyheter som suverene data fra FaseI/II studiet og nå som finansieringsrisikoen er tatt bort sammen med at usikkerheten knyttet til Pivotal Fase 2 studie-designet nå oxo er borte med godkjent PF2 av FDA og EMA (størrelse,omfang og interimavlesnings med endpoints) er bekreftet samt gjentatt behandling blir det oxo
så er altså selskapet verdt 300 millioner mindre… javel…!!!
Forstå det den som kan :crazy_face:

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Hvorfor skal folk være usikre når garantisyndikatet faktisk garanterer for at emisjonen blir fulltegnet?

Merker selv at det ikke er moro at aksjen faller, men det fundamentale er fortsatt intakt. Anbefaler folk å bruke kalkulatoren, så ser man at PCIB er latterlig lavt priset.

Som vi ser så er det primært småsparere som solgte unna forrige uke også:


Kilde: Stocktalk.no

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Jeg uttrykte meg upresist. Jeg mente av eksisterende aksjonærer eller andre som fører til at garantistene ikke får aksjer, men må kjøpe i markedet.

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A good bed time story for tonight:

Deloitte 2018 Global Life Sciences Outlook both report and info-graphic below:

Qutoes:

Page: 5
Orphan drugs
The orphan drug market is expected to almost double in the next five years, reaching US$209 billion in 2022. It’s expected that these high-cost, specialized drugs have and will continue to face pricing scrutiny by policymakers. Of the top 100 drugs in the United States, the average cost
per patient per year for an orphan drug was US$140,443 in 2016, compared to US$27,756 for a non-orphan.

According to the US Food & Drug Administration (FDA), 75 orphan drugs were approved in the United States in 2017, compared to a total of 27 in 2016 and 56 in 2015.

The 50 highest-selling orphan drugs each averaged approximately US$637 million in sales. While only about 600 treatments are approved, 7,000 conditions are designated as rare in the United States.

Major scientific advances will lead to even more rare diseases being identified and even more drugs seeking approval despite pricing pressures.

The passage of the new US tax law reduces the orphan-drug credits that biopharma
companies can claim by effectively 40 percent.However, the reduction is not likely to change life sciences companies’ strategies. The orphan drug market is a strategic market that solves unmet needs. The key benefits are not just the tax credit, but the other important aspects such as the seven-year market exclusivity, faster FDA review and waived fees, and exception from the ACA branded drug pharma fee for orphan-only drugs.

Page: 6
Therapeutic focus trends
Oncology leads therapy areas in sales (Figure 4) and is likely to account for 17.5 percent of prescription drug and OTC sales by 2022, more than the next three highest therapy areas combined.
In addition to oncology, the largest CAGR growth in the top 15 therapy categories will come from
immunosuppressants, dermatologicals, and anti-coagulants.

Page: 7
Personalized medicine
The global personalized medicine market is forecast to reach $2.4 trillion in 2022 at a CAGR of 11.8 percent, more than double the projected 5.2 percent annual growth for the overall health care sector.

Growth will be driven by advancements in technology and targeted therapies that are more efficient, and can provide more value. The focus is on prevention and early intervention, rather than advanced disease. More than 40 percent of all compounds and 70 percent of oncology compounds have the potential to be personalized medicines.

Page:8
M&A investment trends
Life sciences
2017 saw a further decline in deal value from 2016, resulting from global economic and political uncertainty. Large deals that were announced in 2017 tended to be focused on traditional acquisitions that were within the core competencies of the acquirer. According to Thomson Reuters data, the largest deal through Q3 2017 is Becton Dickinson & Co. acquiring CR Bard in April, in a deal worth $24.2 billion. In biotech, Gilead Sciences Inc. acquired Kite Pharma Inc. for
$11.1 billion. In pharmaceuticals, Thermo Fisher Scientific, Inc. acquired Patheon NV (99.0066 percent interest) for $7.2 billion.

We believe 2018 will see an uptick in deal volume as well as value, and an increase in mega deals, for a number of reasons:
• The passage of tax reform in the US, the progress of the Brexit negotiations, and the maturation of policy with respect to outbound deal-making from China clears up some of the uncertainty that was constraining M&A in 201 7 . US tax reform offers some incentives to repatriating monies back to the United States, which could spur additional high value M&A transactions.
• Capital markets remain strong. A weak M&A deal environment across industries in 2016 has resulted in pent-up demand to create value through M&A transactions going forward.
• The life sciences sector remains fragmented. Additional value can be captured via further industry consolidation. Non-traditional, technology-oriented adjacencies represent an important aspect of M&A strategy for life sciences companies in 2018. The convergence of tech with other sectors has been, to this point, largely driven by tech industry players themselves. However,we are now seeing consumer health,health plan,medical technology, and pharmaceutical sector participants pursuing M&A transactions that either directly or indirectly respond to tech
advances and tech investment.

Page:9
Gene therapy
Gene therapy may disrupt the sector by offering customized, targeted patient treatment, including newly approved CAR-T therapies (Figure 7). While adoption is still low due to availability, insights from human genetics and precision medicine have transformed health care, bringing value through innovative biotechnology.

Page: 31
Regulatory partnerships
Strong partnerships with regulators are fundamental to creating sustainable innovation, ensuring new products progress efficiently through the pipeline. For the past decade, most life sciences and health care companies have highlighted that a risk averse approach to regulation has impeded
adoption of innovation.

The evidence today and predictions for tomorrow illustrate that this is changing. For example, the FDA’s new early approval process for CAR-T cancer treatments reflects efforts by the new cross-cutting Oncology Center for Excellence to implement a more collaborative review model for innovative medicines.

The FDA’s 21st Century Cures Act offers another opportunity to be proactive and take advantage of the agency’s flexibility by discussing novel approaches to drug development and medical device
innovation.

Greater harmonization between regulators is increasingly seen as a key enabler in maintaining compliance while securing supply to markets. By building engagement with regulators into their innovation models, new regulations for innovative treatments, such as 3D printing of drugs or gene editing, can be developed contemporaneously rather than retrospectively using enhanced regulatory pathways.

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Du får kanskje bedre svar her om det er teknisk du er ute etter:

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Terp doesnt really mean anything. They slso came with news. Delay into next year, no partnership (which many had hoped for), very slow enrollment of extension, larger piv stage (than many hoped for) etc etc. If they had announced the capital raising but at the same time gave us the extension results and said piv stage 2 was to begin in 2H 2018, I personally feel we wouldnt be at low 30s. Thats the market unfortunately.

I am still positive, its still my largest position, how can you be mad when you bought at 5,6, 7 and 20kr? Just really disappointed at myself for not selling a few thousand earlier to free up capital for the emisjon. Now i will be stuck with a lot of worthless t-retter and not much cash to buy more shares at 30…

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Regarding FimaNAC collaboration with top 10 large pharma,

it seems that PCI Biotech was part of the MEDITRANS project sponsored by EU that took place in the Netherlands between 2007-2011 (EUR 14 839 172 total cost) this project is called Targeted delivery of nanomedicine.
https://cordis.europa.eu/project/rcn/81544_en.html

The interesting thing is that both Merk and Bayer were involved in this project (look at participant list in the link above). and you can read the short final report summary in this link below:

https://cordis.europa.eu/result/rcn/52960_en.html

Quote:

"The objectives of the MEDITRANS project have been:

  • to demonstrate the potential of emerging materials (carbon-based nanoparticles) for use as carrier materials in targeted nanomedicines;
  • to develop highly effective nanomedicines based on candidate materials (already used in proof-of-concept drug delivery studies in animals) by virtue of improved targeting and drug release properties;
  • to promote the entry of nanomedicines based on established materials into industrial exploitation activities and clinical proof-of-concept studies;
  • to develop high-sensitivity imaging probes properly designed for guiding drug delivery processes in vivo;
  • to formulate proprietary industrial drug molecules, already established drugs, and DNA- or RNA-based drugs into targeted nanomedicines with well-characterised and optimised physicochemical properties;
  • to optimise the targeting efficiency of the nanomedicines under development by in vitro target recognition studies;
  • to improve the intracellular targeting of siRNA / pDNA-loaded nanomedicines in cancer and endothelial cells;
  • to maximise the drug availability at the target site by means of external physical stimuli that induce drug release from the targeted nanoparticles ‘on demand’;
  • to develop targeted nanomedicines from which release of drug/imaging probe is promoted by physiochemical characteristics of the pathological microenvironment;
  • to develop imaging procedures for the monitoring of the various steps in the targeted drug delivery process (nanoparticle targeting and accumulation, drug release, local level of drug and of biomarkers in response to therapy) by means of ‘smart’ imaging probes;
  • to optimise biodistribution, targeting efficiency, and therapeutic activity of the nanomedicines under development in suitable animal models of rheumatoid arthritis, Crohn’s disease, multiple sclerosis and cancer;
  • to assess the toxicological aspects of selected MEDITRANS nanomedicines;
  • to enter selected prototype nanomedicines into an industrial exploitation phase to evaluate their potential to be developed into a marketable product;
  • to provide training courses, and access to the Galenos-network, provided for consortium scientists, Small and medium-sized enterprises (SMEs), and key stakeholders;
  • to provide effective and efficient dissemination, and demonstration, of the project’s results across Europe."

Also see MEDITRANS- Results in Brief from the EU page

https://cordis.europa.eu/result/rcn/89755_en.html

Pci biotech was part of work package 5 (WP5) and below you ll find the full final report for the project where there are many references to pci biotech

2011-12-08 26668 1231694 P4 PUBLISHABLE FINAL ACTIVITY REPORT.pdf (7,5 MB)

for example
page 21
Brief description of methodologies and approaches employed
The main techniques used are flow cytometry (cellular uptake, determination of endocytic pathways, determination of biological activity), Fluorescence Correlation Spectroscopy (siRNA loading in nanogels, nanogel stability in blood, pDNA stability and pDNA complexation), Single Particle Tracking(dual-color colocalization studies for the endocytic ‘fingerprinting’, following pDNA complexation and dissociation of pDNA from the carrier, following pDNA degradation in buffer and following pDNA protection when complexed to certain gene delivery vehicles).
Photochemical internalisation (PCI) is used to elucidate the effect of an enhanced endosomal escape on the biological activity of nanogels or to enhance the contrast of magnetic resonance imaging”


Now, why am I bringing this up?

Both Merk and Bayer are top 10 large pharma and they both have interacted with pci biotech from 2007 to 2011 through out the MEDITRANS project where FimaNAC was used for the active targeting approach.

I believe they both have deep knowledge of the technology and one of them is likely to be our top 10 pharma partner in the collaboration agreement. although that if you read in the final report that Merck dropped out from the project due to challenges with organisational restructuring/aquiring a company bla bla

I havent digged into a company before like I did for pci biotech, every day I learn something new and I haven’t been any closer to the top 10 pharma name like I feel today. So I am dropping my AstraZeneca theory for now and probably go for Bayer or Merk (to a less extent :slight_smile: ).

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Godt skrevet @Morgo26! Hvis du ser på hva du selv skriver, så er det jo lett å se at emisjonen legger et negativt press på aksjen ettersom folk selger for å kunne bruke de resterende tegningsrettighetene. Jeg tror derfor det vil komme et skikkelig rally etter emisjonen. :slight_smile:

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Hvis garantistene ønsker aksjer av betydelig volum, er de tjent med kurs under 30. Noe å tenke på?

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Når blir t rettene notert ?

Har hørt st det er den 18.

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Onsdag 19 vel?

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Sakset fra @Savepig sitt innlegg i Fundametale forhold-tråden image

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Det ser ut som at emisjonen blir en soergelig affaere. I hvertfall for de som kjopte paa 40+++. Men som vi ser har PW brukt sterke ord om FimaVacc og fimaNac. I tillegg kommer extension resultatene snart. Noen skriver som om dette er over, men det er det langt i fra. P2 er paa plass, og etter det skal det skrives en fimaVacc og fimaNac historie som vil strekke langt utover Norges grenser.

FimaVacc og fimaNac kommer til aa bli mye stoerre enn fimaChem. Noe som snart vil gjenspeile seg i PCIB kursen. Og komme inn paa dette kursnivaaet, blir som aa plukke penger paa gata. Det er selvfoelgelig de nye investorene veldig happy for. Tipper det blir mange som vil angre paa sine aksjesalg etthvert. Unnskyldt er selvfoelgelig de som ikke har raad til aa innfri tegningsrettene.

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Vi får t-rettene Onsdag så da kan vel massakren fortsette, eller? :thinking:

Det er desverre slikt spillet er. Mye psykologi på børsen. De store eierne sitter nok fremdeles i ro samt de av oss som har et snitt langt under 30 NOK.

Det er i slike stunder man bør ta et realt magadrag og slutte å se på hvordan markedet reagerer, se over det fundamentale og ut i fra det ta en beslutning som baserer seg på fakta og ikke frykt/panikk.

Det er nå man kan tape mye penger ved å selge, men dette må hver enkelt vurdere. Man må huske at store investorer som vil inn vil ha aksjene billigst mulig før og under emisjonen.

Etter emisjonen vil de, på lik linje med eksisterende aksjonærer, ha kursen opp og hvis man mikser det med noen gode nyheter, hva tror dere skjer da? :joy:

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Da styret valgte å ikke utlisensiere selskapets behandlingsløsning for inoperabel gallegangskreft, gjensto to muligheter for å gjennomføre den siste kliniske etappen av studien; en retta eller en fortrinnsretta emisjon. Førstnevnte ville gitt full utvanning av nåværende aksjonærer (med mindre man hadde fulgt opp med en liten reparasjonsemisjon som plaster på såret). Som vi nå vet og snart står midt oppi, sistnevnte ble valgt. I utgangspunktet en mer aksjonærvennlig løsning, men da delvis etter Matteusprinsippet.

I utgangspunktet var dette et sympatisk valg av styret, men emisjonen bærer etter mitt syn et sterkt preg av den situasjonen selskapet befant seg i ved halvårsskiftet; mager kontantbeholdning og ikke i mål med den utvida studien. Dette har åpenbart garantistene forholdt seg til.
At utlisensiering ikke ble valgt, tror jeg må ses i lys av de samme forholdene. Liebhaberen så selvsagt det samme og hadde tro på at her kunne de gjøre en svært god deal. Men der tok de heldigvis feil. Styret ville ikke selge Amphinex for pCCA billig – i særdeleshet fordi dette er selskapets første produkt. Det lønner seg sjelden, verken i det korte eller lange løp, å selge seg billig. Her har jeg derfor full tillit til at styret, i den situasjonen en befant seg i, gjorde en klok beslutning. Trolig ble liebhaberen sendt hjem i juni/juli.

Når det er sagt, ser jeg heller ikke bort fra at den uforståelige svikten i rekruttering til den utvida studien, kan ha spilt inn. De engasjerte klinikkene rekrutterte 4 pasienter i løpet av perioden fra 11. august til 20. desember 2017 (15 uker) til tross for at helsemyndighetene i ett av de aktuelle landene ikke hadde gjort det de skulle. I løpet av perioden fra 20. desember 2017 til 24. august 2018 (nesten 36 uker) var det bare rekruttert 3 nye pasienter. Klart dette er blitt lagt merke til – og ikke minst; det har gitt mange en uro for rekrutteringen av pasienter til den pivotale fasen.

Få dager etter at emisjonen var kunngjort og aksjekursen hadde falt kraftig, uttalte ledelsen at en var overraska over kursfallet. Jeg er langt fra så undrende. Med et fantastisk unntak for stadig bedre overlevelsesdata fra doseeskaleringsstudien, kvartal for kvartal, har markedet inneværende år ikke mottatt noen kursdrivende nyheter verken fra det kliniske eller regulatoriske området.

De kliniske dataene fra doseeskaleringsstudien er imidlertid knallsterke, og ved hver oppdatering framstår de enda sterkere. Ved ESMO i München om en drøy måned vil vi forhåpentlig få ny oppdatering og enda bedre tall. Sikkerheten for de fire første pasientene i den utvida studien er kvittert OK, og ledelsen antesiperer trygt at de to siste vil være det samme. Derfor tror jeg at vi slett ikke skal utelukke at vi seinhøstes får melding om at de første pasientene har fått sin første behandling.

Pengene er på konto, studieoppsettet er klart og et antall av klinikkene vil høyst sannsynlig være det samme. Da er det ikke mer en trenger å vente på. Toget kan rulle ut fra perrongen.

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Delay into next year

  • yes a small delay but dose that really matter when u end up at the same endpoint timevice.

no partnership

  • i guess the deal pobably wasent good enough for PCIB, and that is fair enough for me.

very slow enrollment of extension study

  • True! but remember very few sites and strickt inclusion terms.
    Four patients have so far passed the safety window, which includes approx. 3 weeks after the second fimaCHEM treatment and with that they have proven enough to get it apporved for PF2. The pivotal study will commence with up to two scheduled treatments with Independent Data Monitoring Committee performing a safety review when eight pivotal study patients have received two treatments.

larger piv stage

  • i think u will have a hard time finding a more streamlined,cheeper or smaller PF2 study than this.
  • Randomisation (1:1) of 186 patients to treatment with
    either fimaCHEM + SoCc or SoC only
    • Primary endpoint: Progression Free Survival (PFS),
    with Overall Survival (OS) as key secondary
    • Interim analysis primary endpoints: PFS followed by
    Objective Response Rate (ORR)

The net proceeds and the existing cash is expected to finance the Company well into 2022, which is beyond the anticipated interim read-out of the planned pivotal fimaCHEM study in inoperable bile ductcancer in 2021 and potential regulatory submission for accelerated/conditional marketing authorisation in 2022.

Godt innlegg og enig i det meste, men oppstart seinhøstes tror jeg man skal se langt etter. Hvor mye skal man like å plage investorene sine om man melder emisjon og forsinkelse i samme melding, for så å noen måneder senere komme med en “kødda, var visst ikke forsinka lell”.

Begynner å se smått attraktiv ut, men jeg tror enda ikke markedets usynlige hånd har satt sin pris.

Noen som har en formening om hva som skjedde med rekrutteringa fra og med august 2017 til i dag? Jeg leser om det engelske(?) postverket, men finner ikke årsaken altfor troverdig.

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Heh, holder du på med dette enda?