Diskusjon Triggere Porteføljer

PCI Biotech Fundamentale Forhold (PCIB)

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Jubel, det der sier meg ikke så mye om når resultatene vil bli publisert. De har et par kohorter til som skal analyseres ? Det kan vel ikke ta så lang tid. Men hvis det skal publiseres i et tidsskrift vil det ikke da også fort gå et par-tre måneder bare for å få det igjennom en prosess der ?


Fra presentasjon Q4:
Completion of Phase I immune analyses (timeline adjusted from 2H 2018)
1H 2019 fimaVACC

Fra rapport Q4 prel FY 2018

In-depth characterisation of T-cell responses – preliminary positive findings
The in-depth characterisation of the T-cells (CD4 and CD8) involved in the fimaVACC immune response is done in collaboration with a renowned international expert institute; the laboratory of Experimental Cancer Immunology and Therapy of the department of Medical Oncology at Leiden University Medical Center in the Netherlands under the leadership of Professor Sjoerd van der Burg.
The two HPV peptide antigens chosen for the Phase I study were derived from the E7 protein of the human papillomavirus (HPV). A very high response hurdle was set by this choice, as it is notoriously difficult to induce CD8 T-cell responses in man with peptides from the HPV E7 protein. In the two dose groups analysed to date and which were demonstrated to be well tolerated, the numbers of volunteers showing CD8 responses upon completion of the vaccination schedule were higher in the two fimaVACC treated groups (5 of 6 subjects) than in the control group (2 of 6 subjects). Analyses of further groups will be completed with the aim of confirming these preliminary positive findings prior to publication.


On average the entire review process takes about 17 weeks. It takes the longest for economists (on average about 25 weeks). The fastest review is that for medics (on average about 12 weeks). Despite this, the medics are least satisfied with the process.


Analyses of further groups will be completed with the aim of confirming these preliminary positive findings prior to publication.

Completion of Phase I immune analyses (timeline adjusted from 2H 2018)
1H 2019 fimaVACC


Denne er høyst aktuell i dag

17.12.2017 kl 22:17

På sin plass å repetere følgende artikkel:

"Clinical development success rates for investigational drugs

Michael Hay, David W Thomas, John L Craighead, Celia Economides & Jesse Rosenthal

Volume 32 Number 1 JANUARY 2014 Nature Biotechnology"

En statistikker som Kjetil Myrlid Aasen skjønner selvsagt signifikansen av innholdet i den review-artikkelen.

Det som er minst like interessant er jo at Arctic Aurora Life Science tydeligvis også har gjort leksen sin, og deres strategi er slik jeg ser det å kjøre fase-3-toget (eller som det ofte blir i cancer pivotal-fase-2-toget). Og den strategien er svært gjenkjennelig i Nature-artikkelen, og hvordan biotek faktisk utvikler seg på børsen. Som det mest kjente eksemplet, for norske invesorer, tok fase-3-toget Algeta fra 12 til 362 kroner.

Har understreket det i en annen tråd men gjentar det gjerne absolutt se intervjuet med Dr. Bjerke linket av Eder:

"Her er intervju med Dr. Torbjørn Bjerke i Arctic Fund Management fra mars i år. Interessant å høre hva han har å si og hva de ser etter når de velger ut selskap.

http://www.hegnar.no/TV/video/a105d923-00080348-37a5ec87 "

Jeg gjetter på at Arctic skal ta inn PCIB i AALS som første norske biotek, deretter slippe en solid analyse og bruke “fase-3-toget” til å selge fondsandeler.

AALS sin “fase-3-tog-strategi” har forøvrig gitt en meravkastning på 50% sammenlignet med indeks (NASDAQ Biotec, 75% av AALS sine aksjer er i US).


Updated May 28, 2018

The science and business of biotechnology is complex and uncertain, and trying to figure out biotech companies’ prospects for success no easy task. Because many ventures are in the development stage, they often confound traditional financial analysis: With little or no cash flow, earnings or even revenues, putting numbers on a firm – while not entirely impossible – can be awfully tricky.

TUTORIAL: Investing 101

So, when sizing up a biotech company’s strategic and financial health, analysis often relies heavily on qualitative analysis rather than quantitative, financial methods of valuation. Here are a few non-numerical items to consider when analyzing biotech companies. (To learn more about the sector itself first, check out The Ups And Downs Of Biotechnology .)

Products and Pipeline

Naturally, a biotech company’s product portfolio and research pipeline are the lifeblood of its success. That means you need to take a close look at the company’s key products and the features of its biotechnology. Ideally, the company should be developing a technology platform with multiple – rather than single – treatment opportunities. Importantly, the company should be working on a large number of products that target diseases and conditions with large patient populations.

Keep an eye out for biotech firms developing products for big treatment areas – such as cancer, cardiovascular diseases and central nervous system disorders – where potential return on investment is greatest. Stay clear of companies developing “me-too” treatments for disease areas that already well served by existing technologies in the market.

At the same time, find out where the company’s products are situated in the development pipeline. The later the product’s stage of clinical development, the greater the chances of regulatory approval, market launch and commercial success. (For more on the connection between research and profits, read R&D Spending And Profitability: What’s The Link? )


A biotech company’s technology and products might have great potential, but does the company possess patents to protect its technology? By giving the firm exclusive rights to its technology, patent protection increases the value of that technology and of the company itself. The company can pursue research and development (R&D) and commercial development with less fear of competitors “stealing” or infringing on their technology. Most importantly, patents can attract royalties-paying commercial partners with the financial clout to fund R&D, clinical trials, product development and marketing.


Does the company have a track record of productive research and development? Mature biotech companies spend about a fifth of total revenue on R&D, while early-stage biotech ventures typically spend well in excess of hundred percent of revenues on R&D. Not surprisingly, the outcome of R&D spending can vary wildly, especially for early-stage ventures.

A key factor in success is the ability to develop cost-effective drugs that represent breakthrough therapies. R&D that delivers similar results to those already on the market is less likely to translate into successful products. Look for companies with R&D programs focused on diseases that aren’t currently well-treated. (To learn more about the research and development process, check out Buying Into Corporate Research & Development (R&D) .)


Talent and experience of management is critical for long term success. Ideally, the biotech company should be run by executives who have developed and commercialized treatments before. It’s a good idea to look for management teams with a track record of meeting publicly-stated goals and development milestones. Meanwhile, be wary of companies that regularly miss their targets. Executives must have an excellent understanding of the clinical and commercial development process, appreciate the costs involved, and have a record of putting company’s resources into projects that offer high returns on investment.


These days, biotech companies can rarely succeed alone. Given the big costs of drug development, a biotech company will be held back from reaching its full potential unless it can find partners to help fund clinical trials and commercialization . So, it’s important to find out if the company has secured promising collaborations and licensing partnerships. Look for partners that show lasting commitment – remember, the product-development process can be a very long and expensive one . Also, keep an eye on deal terms, as they offer a reliable indication of value that the market gives to the technology . A good licensing partnership agreement will include not only a generous royalty rate on future sales but also healthy upfront payments, plus milestone payments for achieving development targets. (Management can play a huge role in a company, for more read Evaluating A Company’s Management .)

Financial Resources

Finally, it’s important to know whether the company is well-financed. After all, funding is the fuel of the biotech industry. Without funding, a biotech company will be forced to cut back on R&D, and clinical and commercial activities – reducing its chances of maximizing return on investment. It’s reassuring to see enough cash on the balance sheet to cover expenses for at least a year or two. A solid cash position means that the company can strike up favorable partnerships without having to accept the first deal on offer. Of course, the hope is that the biotech company won’t have to rely on external financing and cash reservesto keep R&D and commercial development going and will eventually be able to run profitably from high-margin revenues.

Mye stemmer for PCIB, men det finnes ingen 100% fasit! Lovende er understatement når det kommer til PCIB. Check, check, …, check


Nedenfor plottet Kaplan-Meier plot for data så langt i doseeskaleringsstudien og extensions studien. Overlevelsestall i sistnevnte studie er estimert utfra det lille selskapet har rapportert (se tidligere innlegg).

For å forenkle har jeg delt pasientene i to grupper. De som har fått dose mindre enn 0.25 mg/kg og de som har fått 0,25 mg/kg. I sistnevnte gruppe er inkludert pasienten i kohort 2 som fikk 2 behandlinger, den siste med 0.25 mg/kg

Merk at kryssene representerer pasienter i live. Totalt 7 personer, hvorav 6 i extension studien. VI har en ganske klar signifikant effekt av dose her, p-verdi 0,036.


Så du har funnet frem til p=0,036 effekt av dose og enda lavere p verdi på OS vs SOQ?


Det stemmer.

For SoC har jeg ikke rådata på pasientnivå, men har laget et datasett basert på Kaplan-Meier plottet fra studien.

Problemet med å bruke de dataene er at det omfatter alle pasienter i studien.

Vi vet jo ikke overlevelse på de 13 som Valle definerte som sammenliknbare. Vi vet at ORR var kun 1/13, så det er vel sannsynlig at mOS ialfall ikke er over 12 mnd.


Litt flere Kaplan-Meier plots.

Her er ABC-02* vs cohort 4 og pasienten cohort 2 som fikk 2 behandlinger, den siste med cohort 4 dosen.

*ikke rådata på pasientnivå, lest av graf og laget en omtrentlig datafil på pasientene


Og her tilsvarende bare at Extension pasientene er lagt til sammen med cohort 4 pasientene.


Veldig interessant! Hvor sikker er du på hvor lenge ekstensjonsstudie pasientene har overlevd uten event, og hvor mange som har gjort det. Jeg synes det er vanskelig å få hodet rundt det.


Helt sikker kan man ikke være. Jeg har basert meg på dette innlegget.


Solid argumentasjon. Jeg tror du har fatt i den lange ende! Det innlegget hadde jeg ikke sett tidl. Veldig positivt!


Hadde Pcib gått for partner fremfor emisjon ville kursen sikkert ligget å ± 100kr.
De velger emisjon, kursen ligger på 26kr.
Dette valget er det desidert beste for oss langsiktige som ikke har maur i Raua.
Og vil utgjøre milliarder senere.
Som stuffers sier, Totalt misforstått!!
Er noen prosent opp til Artics kurs!

del opp dette emnet #269

3 posts were merged into an existing topic: PCI Biotech Småprat 2019 (PCIB)


Mine statistikkunnskaper er meget rustne, men dette er da ekstremt gode resultater @Investor !! Om jeg husker riktig har PCIB bestilt en gjennomgang av kliniske data fra IDMC til sommeren…(?)

Fortsetter data fra extension-studiet å utvikle seg positivt, snakker vi vel om en reell mulighet for at PF2 kan bli avbrutt før oppstart.

Dersom dine 2 Kaplan-Meier plott skiller helt lag (dvs ingen overlapp mellom lysegult og lyseblått plott) kan man vel si at behandlingsmetodene har statistisk signifikant forskjell. Ergo…Hva er da poenget med PF2??? Da har vel IDMC fått noe å tygge på i forhold til etisk forsvarlighet av å kjøre PF2…?

Jeg bare spør i all min enfoldighet😏


PF2 blir kjørt uansett, men IDMC har mandat til å avbryte kontrollarmen.
Dette skjedde med Algeta sitt Xofigo studie.


Hvor mange pasienter hadde Algeta i kontrollarmen før termineringen?


Fra toppen av hodet, ca 200…?