Mange småaksjonærer har blitt ufrivillig langsiktige og sitter med enorme urealiserte tap. Tror ikke de bryr seg lenger, ellers så tenkte de kanskje at deres lille stemme ikke spilte nevneverdig rolle? Uansett mye større oppslutning enn normalt - og det viktigste var å få stoppet fusjonsforslaget.
Vi får håpe at Asmyr & co klarer å snu skuta.
Ved Årsmøte 2021 og 2022 var det ca 21-22 millioner aksjer representert, hvorav trygda er ca halvparten. I tillegg var Healthcap en stor eier som nå har solgt seg ut.
Det betyr at ved EGM i dag har deltakelsen fra små og mellomstore aksjonærer vært mange-mange ganger større en det som har vært vanlig ved årsmøter.
Men mindre kapital i kroner og øre er representert pga. kursen, mange måter å se det på 
Uansett, de som er igjen i aksjen nå har vist handlekraft langt utover det normale for småsparere, så nå gjenstår det at de viser at de klarer å styre et selskap også. Blir spennende å følge med framover.
Hen som satt i transkriberingssboksen tok notater av denne Q & A som altså var 31. august i år.
[…]
Unknown Attendee (Attendees)
[…] Some quarters ago, you were asked why you didn’t recruit more patients into the Archer study, and then [ one couldn’t ] all the answer because you have got the answer you needed already. Could you be a bit more specific about what types of answers you got from those 7 patients, which as far as I can see now have obtained a median duration of response of 3 years?
Answer
Jan Egberts (Executives)
Before you answer that, I want to make some comments. In the pharmaceutical industry, when we look at a new drug or treatment, we have different phases. And the objective of each phase is different. A Phase I study is a very early exploratory small study for relatively modest cost, typically 10 to 15, anywhere depending on the indication, from 8 to 20 patients. And really, you’re trying to test what kind of results they’d yield.
In the Phase II, which this study essentially was a Phase IIa or IIb, you’re really starting to look for efficacy, does the compound work and some safety data. And then the Phase III, which sometimes you have to do, particularly in chronic treatments, you look for safety data. And the results vary very significantly.
So typically, about 60% of the compounds don’t make it past Phase I. Then between Phase I and Phase II, there’s another drop of, depending on the therapeutic indication, of about 50% to 60% of the compound. So the fact that Betalutin didn’t work out is very customary – not customary, is very unfortunate, but it’s still very much in line with what the industry is. It’s about 50%.
And then the Phase III studies, which you tend to do in more chronic diseases, there, the drop-off is often less. And if there’s a drop-off, it tends to be more because of safety issues than of efficacy issues. And safety issues are typically less relevant in oncology because these patients are already really sick. So that’s kind of to put the perspective what the, yes, the role of the different phases in the clinical results are or the clinical studies are.
So now I’d like to give over to Lars to answer your question.
Answer
Lars Nieba (Executives)
So yes, kind of what Jan pointed out, we had 8 patients in the Archer-1 study, and we show some good indications for efficacy. And that is why we went forward with that 8-patient number to the health authorities to discuss with them what is the best way forward. And as mentioned, we have a synopsis, and that synopsis was discussed with the FDA to say how fast can we move ahead into a Phase II/III study. And that is why we said, yes, we do have enough data to move ahead into the next phase, as pointed out by Jan.
Answer
Jan Egberts (Executives)
Yes. So the thing you need to keep in mind, each phase, obviously, as a Board, you have to weigh the expenses against the potential results. So if you make a very large Phase I study and knowing that a lot of compounds fail, in essence, you “waste a lot of study.” And you always need a Phase II or a Phase III for approval. So it doesn’t make sense to make it to a large Phase I clinical study.
Answer
Unknown Attendee (Attendees)
Well, could you still be more specific about what type of answers you got from those 7 patients? I just referred to [ Renoldi ].
Answer
Lars Nieba (Executives)
As mentioned, we have seen good efficacy. I need to – honestly, I don’t have it now directly at hand. To my knowledge, we have still 5 patients in response out of the – sorry, it was 7 patients, not 8. So out of the 7 patients, so median duration of response, honestly, I haven’t done my analysis yet. But the complete response rate was pretty good. So that is why we moved ahead, and that was the most important part for us.
Answer
Unknown Attendee (Attendees)
The last quarter, you said that you had shared clinical data with a potential partner. Are you still in dialogue with that potential partner?
Answer
Jan Egberts (Executives)
What are you referring to? I’m not aware. I’m not aware of that statement, to be honest, so I cannot comment on that. And I’m not sure who made that statement.
Answer
Unknown Attendee (Attendees)
But it’s in your report.
Answer
Jan Egberts (Executives)
I’m not aware of that.
Answer
Malene Brondberg (Executives)
I think…
Answer
Unknown Attendee (Attendees)
Or maybe Skullerud said it on the presentation, but I’m sure he did. I’m sure either it was in the report or Skullerud said it on the last presentation.
Answer
Jan Egberts (Executives)
I’m not aware of that statement, so I cannot comment on that. I was in that presentation, but I don’t recall it.
Answer
Malene Brondberg (Executives)
I think what Erik might have alluded to is that there is a constant, of course, outreach both from the company and also coming in. Of course, that’s just nature of the business.
Answer
Unknown Attendee (Attendees)
Yes, that you had said many times. But the last quarter, he said that you also had shared data with a potential partner.
Answer
Malene Brondberg (Executives)
I can’t recall that. But yes, there are discussions all the time, of course. If that’s…
Answer
Unknown Attendee (Attendees)
I suppose that you’re not sharing data with everybody all the time.
Answer
Malene Brondberg (Executives)
No, I don’t think…
Answer
Unknown Attendee (Attendees)
I guess that’s in the nondisclosure environment?
Answer
Malene Brondberg (Executives)
No, no, no, we can’t, so we are not – no, we are not – we haven’t – there’s, of course, discussions with companies, but no, we’re not sharing the data.
Answer
Jan Egberts (Executives)
I mean also remember, very important, we don’t have any additional clinical data until 2 months ago beyond the interim analysis from 2020. Again, I start to repeat myself, my apologies, but it’s not like on a day-to-day basis, we know how the clinical study is going. There are very distinct moments. When you start the study, you don’t know anything. You’re completely black in the fog until you do an interim analysis.
When an outside review board looks at the data, then you don’t know anything for the whole period until the Board decided to do the second analysis. But it’s not like every day you open your laptop like you look at your revenue, as an example, as a company. That’s not the way it works. It’s all confidential. In a confidential database, nobody from management or the Board has access to that. That is a requirement of the FDA, the Food and Drug Administration.
Answer
Unknown Attendee (Attendees)
Okay. Since you mentioned it, I find it a bit hard to believe because I see some inconsistency between your statement right now and Lars Nieba some quarters ago because I gave him the question, if somebody in the company had access to the clinical data in the PARADIGME study, and Lars Nieba said, just a few people had access to that study.
Answer
Jan Egberts (Executives)
Yes, let’s clarify that because I don’t want a misconception to exist.
Answer
Lars Nieba (Executives)
So as Jan pointed out and also how the interim analysis went forward, yes, there was an independent, also the review board where we had a statistical analysis plan called SAP. And that one was then evaluated by the independent review board and the results from that board. We as a leadership team and the Board, only a few people, not the whole leadership team, very few selected people got access to make a decision…
Answer
Jan Egberts (Executives)
To the results.
Answer
Lars Nieba (Executives)
To the results…
Answer
Jan Egberts (Executives)
Not the raw data.
Answer
Lars Nieba (Executives)
Not the raw data.
Answer
Jan Egberts (Executives)
To be very clear, not the raw data. So you have to remember, there are literally 10,000 individual scans of all the patients being made. And those get reviewed by an outside physician, and he basically says, is there still cancer or has the cancer gone away, in remission. We don’t have access to that data. That’s an outside independent physician. Then basically, they do the analysis.
And they haven’t – before you start a clinical study, you have a so-called SAP, statistical analysis plan. So before you start it, you need to agree that with the FDA, and that’s what you execute. An external statistician executes it and then writes the report, which summarizes the data. So it doesn’t say Mrs. A has cancer and Mrs. B does not have cancer, et cetera. It says X percent of patients have this, Y percent of patients have that.
Answer
Unknown Shareholder (Shareholders)
I have to come back to the Carnegie study. It seems to me to be very open-ended. There must be some deadline. What is the – what are you actually – I asked the mandate and you said – gave me 3 or 4 points. There must be some more written statement in this agreement. We can’t accept some open-ended study from the Board. That is…
Answer
Jan Egberts (Executives)
It’s not an open-ended study. It is…
Answer
Unknown Shareholder (Shareholders)
Then give me a date.
Answer
Jan Egberts (Executives)
I’m not giving you a date.
Answer
Unknown Shareholder (Shareholders)
What is the agreement with Carnegie then?
Answer
Jan Egberts (Executives)
Carnegie is helping us evaluate strategic options for the company.
Answer
Unknown Shareholder (Shareholders)
That’s words. Give me some more.
Answer
Jan Egberts (Executives)
It’s all I can give you.
Answer
Unknown Shareholder (Shareholders)
This is not typical, Jan. This is ridiculous.
Answer
Jan Egberts (Executives)
Okay, are there any questions in the audience? Or otherwise, we go to the online. How do we conduct those questions? Are you reading them?
Står AG og North skulder ved skulder i dette nå eller vil det bli en drakamp der også om hvem som skal sitte i ett styre i fremtiden og hvordan agendaen skal se ut?
Men ærlig talt. Prøver ledelsen og styret å kuppe Betalutin?
Ikke sett på makan til rabalder.
Vil bli overrasket hvis ikke de har sikret seg. Styre og ledelse også. Vi får se. Med deres holdning til aksjonærene og måten de har snakket om oss i det siste, vil jeg bli overrasket hvis de ikke tar det de kan få.
Altså, det er vel konspirasjonsteorien akkurat nå. Ikke det de fleste oppriktig tror, tror jeg?
Men det er jo en av mange mulige forklaringer på hvorfor Betalutin plutselig ikke var så hot lenger i deres øyne. Men må si den teorien lukter litt av copium.
Det store er misnøyen med hvordan ledelsen og styret har gjort jobben med å sikre verdiene i Betalutin og Nordic Nanovector. Og at aksjonærene nå vil ta styring selv for å sikre disse verdiene på en bedre måte. I et sånt miljø får man grobunn for mye rart av teorier og historier, hvor noe er sant og annet er rykter/en manns ide.
Mitt råd ville vært å flytte diskusjon/kommunikasjon over til et forum som ikke bygger på en algoritme som viser alle postene med mye krangling og nesten ingen av de ukontroversielle postene. På Facebook blir det fort mye splid i sånne grupper pga. det.
Bruland var ikke på GF. NB!
Men de nekter å legge fram resultater fortsatt?
Så vidt jeg forsto kommer det Q1 2023 eller H1 2023 ifølge dem. Men det medisinske er ikke jeg best på eller har best oversikt over, så du bør nok høre på callet selv for svar.
De er forpliktet, bl.a. fra FDA, å presentere dataene de har hentet inn før studiet ble avsluttet, så dette sa de var på vei. Mye data å gå gjennom og vaske, men kan jo hende at analyse av disse dataene prioriteres høyere når man klinikerne får dykket ned i materien i større grad. Men veldig rart at ledelsen bare valgte å kaste alt på bålet før man i det hele tatt fikk disse dataene. Det er grunnproblemet til AG også: Hvorfor har ledelsen tilsynelatende så kontant og brutalt mistet all tro på Betalutin som medisin?
Den troen ble kanskje kunstig liten etter hvert som rekruttering stoppet opp, utgiftene fortsatte å løpe løpsk og emisjonene ble mer og mer brutale…? Les: økonomi > medisin.
Oslo, Norway, 1 December 2022
An Extraordinary General Meeting (the “EGM”) of Nordic Nanovector ASA (the “Company”) (OSE: NANOV) was held today on 1 December 2022 in Oslo, Norway.
The matters under item 3, the proposed transaction with APIM Therapeutics AS, did not obtain sufficient majority of votes and was thus voted down. Due to the results under item 3, the EGM did not vote for the matters under item 4, 5, 6 and 7. The complete minutes of the EGM are attached to this release, and are available on www.nordicnanovector.com.
For further information, please contact:
IR enquiries
Malene Brondberg, interim CEO and CFO
… not for long!
Helt enig!
De innser nok dette selv nå som de overraskende nok ble overkjørt.
En person jeg gjerne skulle sett tilbake i ledelsen er Skullerud.
Jeg tror han ganske naivt gikk inn som CEO i selskapet ut ifra foreliggende informasjon fra selskapet, ganske likt som endel av oss naive småaksjonærer.
Han gjorde en god jobb og sitt beste ut fra forutsetningene og nederlaget var veldig tydelig før han gikk.
Dette er høyst bekymringsfullt, når kan noen huske sist gang nano steg på nyheter, Q presentasjoner eller EGF/GF?
Et kanskje naivt spørsmål men, hvem er det nå i praksis som holder i pipen og sikrer at den på best mulig måte forvaltes videre? Er det ikke ganske avgjørende at kompetansen ikke renner ut av selskapet? Det virker å være ganske kritisk at Jostein Dale fortsetter. Det blir svært spennende å høre om Jonas har noen betraktninger rundt dette på Radium til uka.
Det kommer ganske klart frem av rapporten AG utarbeidet på Betalutin at de snakker med personer med særdeles god innsikt i pipe og Betalutin spesifikt.
Asmyr regner med å navngi de som skrev den om ikke så lenge.
Vi har kanskje noen gode kandidater der som kan ta over etter world class managementet som nå pakker sammen?