Tja, der deler jeg ikke helt din oppfatning.
Han sa klart at han mente APIM-dealen var en god løsning den gang, og at han fortsatt står ved sin mening om det.
Han mente også at det ikke vil være mulig å oppta tråden siden verdien til nanov er halvert siden den gang.
Jeg tror derfor ikke en ny mulig deal vil se gullkantet ut i forhold til APIM-forslaget.
Synes dette var en positiv presentasjon av hva som muligens kan ligge foran Nanov og ikke minst at det kom frem at mulig partnerskap ikke ligger så langt unna i tid.
Positivt at de har cash til å drifte i et år uten tilførsel hvis det skulle være nødvendig.
Tror du tar feil.
Hvis noen kan anvende det fremførbare underskuddet utgjør det alene en verdi på kr. 4,74 per aksje.
Og siden kontantbeholdningen fortsatt er god, og det nå er stålkontroll på kostnadene, behøver man ikke å stresse frem en dårlig deal, som APIM-forslaget var. Aksjekursen falt jo fra 1,3 tallet nettopp fordi dealen/bytteforholdet var så dårlig for NANOV-aksjonærene. (Sandnes kan ikke motsi det han tidligere har sagt, av forståelige årsaker.)
Det har blitt spekulert litt i hvorvidt Carnegie har fått betalt for jobben de har gjort så langt…
Fra dagens presentasjon.
Nordic Nanovector has appointed Carnegie Investment Bank to explore strategic options for the company to optimise
shareholder value. The engagement is agreed to be on “no-cure – no pay” terms. If a transaction is completed Carnegie
is entitled to a payment as agreed in the contract. As per 31 December 2022, no provision has been made as the
proposed transaction was noted down on the extraordinary assembly 1 December 2022.
Så : Nordic Nanovector confirms that its stand-alone cash position at end December 2022 is expected to be approximately NOK 98m. Further commitments related to the closure of PARADIGME during 2023 and transaction costs related to the proposed APIM transaction brings the uncommitted net cash level to be approximately NOK 60m. This is in line with previous communication.
Hva er det som har kostet 38 millioner?
Malene meldte vel forventet kost på 25 millioner ifb med Paradigme Q1/23.
Er det APIM som har fått 13 millioner i kompensasjon da eller?
Det er ikke bare nedstengning av paradigme som koster, alle avtaler har blitt avsluttet og det har vært oppsigelsestid på enkelte ansatte som ikke har vært gratis.
Det viktige er at ryddejobben er gjort og selskapet har en meget forutsigbar økonomi som holder i 1 år +
Er ikke mange selskaper i norsk bio som kan si det samme…
… stærkt signal om at Carnegie kommer til at levere reelle resultater for aktionærerne, før der falder betaling, hvilket jeg personligt finder svært tilfredsstillende. Ser ud til at ledelsen for nærværende har kontrol over udgifterne og ikke lader sig dupere.
Vel, slik jeg leser det var 38 millioner relatert til Paradigme og APIM. Bemerket meg også denne :
Så da er jo spørsmålet om realiteten nå er 84-38 = 46 millioner igjen på bok, etter at utgifter relatert til oppsigelses OL som du referer til.
Samt, er dere nå tilfreds med : Hva gikk galt med Paradigme?
Som var en fanesak til AGNV.
Vi er tydeligvis opptatt av forskjellige faktorer når det gjelder Nanov . Det kommer veldig klart frem hvor mye som er igjen, at du ønsker å spekulere i grums etter dagens presentasjon er for meg veldig søkt.
Det kom også veldig klart frem hva som gikk galt med paradigme, ikke gode nok resultater…
Nei, faktum er at de hadde 99 mill på bok 31.12, men forventer ytterligere burn på 38 mill. Fra 99 til 84 er det 15 mill, så i januar gikk det med 15 mill til sluttpakker, kontraksbrudd osv…
Dette sier de jo klart og tydelig, så ingen vits i å spekulere i dette.
Ok, så hvor langt frem har de regnet på 38 millioner?
Er det forventet kost for hele Q1/23?
Selskapet har formidlet at de vil ha 60 millioner igjen etter alt av forpliktelser er nedbetalt, antar det skjer i løpet av Q1 ja.
Vel, håper jeg leser det hele feil.
Lett å anta at lønn i perioden fra Januar frem til eventuelt Mars bli bli spist av resterende 60.
Men vi får vente på Q2 å se.
Om de har bakt inn alt av børslistning - patenter - lønn - husleie - oppsigelse - pluss kontrakt avslutninger ifb med Paradigme/ APIM inn i regnestykket på 38. Så er jo dette Selvsagt positivt.
Eddie…?
Hvis du tar en titt i presentasjonen står det klart og tydelig…
Nei, tror det var mange som lurte på hvordan regnestykket var. Når de presenterte børsmeldingen 31.01.23
Det at Carneige ikke var en del av det regnestykket synes jeg var litt merkelig.
Trodde faktisk de hadde stukket av med 10.000.000.-
Ludvik virket til å spille med åpne kort.
De har ettergått Paradigme i sømmene og satt seg inn i styreprotokollene ( over 30 styremøter i 2022) og dialogen med FDA. Det samme gjelder for anbefalingene fra the independent review. Det VAR riktig å stenge ned Paradigme når det ble gjort.
I ettertiden mener jeg personlig at Skullerud oversolgte Betalutins plass i behandlingen når han snakket “ned” de andre behandlingsmetodikkene; de hadde egentlig ikke så mange konkurrenter til Betalutin slik han fremstilte det.
Det visste seg å være helt feil, konkurransen var og er beinhard i 3L.
Going forward er de i dialog med flere potensielle partnere, APIM er closed books. Det kommer ikke et nytt forslag i den retningen, nå ser de på andre typer utfall.
CEO sier at han håper at et mulig proposal vil bli godkjent når og hvis dette kommer, noe han håper å gjøre offentlig innen slutten av april senest, før AGM.
Da kan man antakeligvis setto to streker under svaret; hva mener andre partnere at NANOV er verdt? Å kjøre en repeat på nok en prosess vil være helt dødfødt, da er definitivt alle steiner snudd!
Sandnes sier de jobber videre med solid tumors, hele forskningsgjengen er dedikerte og håper på en fremtid for selskapet. Selskapet kan ikke stå videre på egne bein, de har ikke en hjørnesteinsinvestor eller flere som kan funde det, de trenger å gå i allianse med en partner som kan drive dette videre.
Det siste halvminuttet av callen opppsummerte alt ganske så greit:
“We hope there is a bright further here if we can only find a partner who is willing to finance us going forward”
Presenter Speech
Ludvik Sandnes (Executives)
Good morning, everyone, and thank you for joining this 2022 presentation. I’m Ludvik Sandnes, and I will, on behalf of the former Board of Directors and the CEO explain what happened last year. They had a very active year with 27 Board meetings. And my presentation will be recorded, so I therefore make questions at the end. And I hope the details given in this presentation will answer most of the questions you might have.
As an update, last year became an annus horribilis for Nordic Nanovector. Betalutin/PARADIGME had to be discontinued, as you know, due to continued severe difficulties in the enrolling of patients, the impact of COVID-19 as for many other studies, disappointing regulatory feasibility, evaluation and poor efficacy data; below threshold values set for the study and noncompetitive profile in the crowded market going forward. Independent review concluded that the efficacy data would not give Betalutin a competitive profile in third-line follicular lymphoma. The company restructure was initiated in the second half and nearly finalized before the year-end, and it’s all taken care of in the accounts, which I will show you later on. And Kanagi has explored strategic options, but the API merger deal was declined, as you know, at the EGM on the 1st of December. The cash at the end of the year was 98.7 million, but the free cash going forward is around 60 million and will last into '24.
I need to talk a little bit about the history of Paradigm, and I hope you will appreciate the line of details that we have presented in this presentation. There was an optimistic sentiment since 2020 based on LYMRIT 31-01, the Phase I/IIa trial. The Part I, I will show you later down on the page. On the 1st of April 2020, the new strategy was announced. All focus was directed on PARADIGME. The Type C meeting was requested with the FDA, protocol was amended to broaden the inclusion criteria and help enrollment, and staff was to be reduced by 20%. So they were cost conscious at that time, too. On the 29th of June, the FDA grants a fast track for marginal zone lymphoma and Set L for patients, which was an optimistic input. On the 6th of August interim analysis, recommended 1 arm 14/15 dose. And that’s what was then to become the PARADIGME study. And the Board of Directors was encouraged by the response data at the time, and was optimistic that the enrollment rate would increase.
On the 3rd of September same year, Arne Kolstad Costa presented Part A trial publications. That was the first part as you remember, and the efficacy rates were fantastic, 61 and 30, as you can see on the screen here. The medium duration was 13.6 months. And 18th of February, the year after, a significant increase in recruitment was reported. And I will, for the first time show you the recruitment rates on the next page. And you will see here how Part B and C of the patient accrual from January 2020 to July when it was stopped last year. Part A, the Arne Kolstad figures was ceased recruitment in February '18. So his publication was announced later on with those good results. But if you you look at these curves, the mid one is actually the PARADIGME with the 40/15. And you can see here half how it increased after the – when it says V-14 after was approved, that was the 14th amendment of the protocol, which was accepted by the FDA and the other government agencies, then the enrollment picked up. And even at the 15th at a later stage, it also kind of increased.
The top line is, as you will see from the ledger, how it was – the total number of patients were included, but it was actually the mid one, the green in the middle, who is the PARADIGME study with 72 patients at the end there. And at the far bottom, you can see how they tried actually at the time to include other groups of patients, but they didn’t succeed in recruitment. That was very flat in those Part C populations, which were maybe more fragile, older patients. But that was part of the kind of the end game in order to receive an approval. They would – they had to try to move over in that kind of type of patients because of the competition, which you will see on the next page.
Here, when I was responsible in 2015 as chairman to take the company to the stock exchange, in the prospectus, there were 4 approved products. In the prospectus, you saw last year in '22, there were 15 or 16 and including the last one there, who was approved in June '22 with a complete response rate of 60%. So no doubt, the competition had increased over the last quite a few years, actually.
I’ve also looked at the FDA interaction for Paradigm. I know many of you are very concerned about how the interaction went on and if things could have been different. And as you see here, in March, FDA recommended a randomized controlled trial adequate to characterize the efficacy and safety of Betalutin in September '17. Comparative study design was accepted, sustainability results and accelerated approval will depend on available therapy at the time of application. Yes, it will always depend on other available therapy, of course, the competition. And June '20, as late as that, there was a change in the independent assessment planning accepted. Regional trials for Phase III required maybe assess to progression free survival. And prior to this, the very pretreated patients, that was also accepted. That’s what you saw on the curves where they try to include other types of patients to pick up the enrollment.
As late as March '21, NANOV board was very encouraged by the results and still hoped to get a breakthrough therapy designation, but was told by the FDA that the bar is very high in terms of efficacy than the requirements for a potential accelerated approval. We say hopeful would come later. But for BDA, the drug need to be kind of landscape-changing. But then FDA gave feedback that they acknowledge the single administration, the toxicity profile, the activity in double refractory patients, and found that encouraging and gave us positive feedback that regardless of BTD, the agency was willing to support the drug and provide more frequent guidance to help us move forward in the program. So as late as that, kind of positive news. But of course, competition was increasing.
And the summary of this independent traffic light assessment, which was made by the Board last spring, there were 61 patients who received the 40/15 dose, that’s on the mid graph you saw, and they were included in this analysis. And 19 of those patients had an objective response at 3 months with an overall response rate of only 31.1, and the median duration was 6.4 months. And 9 out of the 61 had a complete response of only 14/8, and the median response complete was 8.5 months. The study met therefore one of the so-called red light criteria which has been put up and where the complete rate was below the 25 which they had set up as a threshold and the duration of response 8 5 compared to 9 months. So it appears highly unlikely it says in the report that the criteria for 1 green light where they could move on with a benefit risk ratio of 40 to 55, and a complete rate between 25 and 35 and duration of response 8 to 10 would be achieved in the future. It was highly unlikely because you would need then to see the 17th responders out of the remaining 26 patients would have to be an overall response rate of 65. Very unlikely. So that would double in the remaining patients.
These are the facts from the reports, which was made on the data with the independent committee, bringing that to the Board and to the Safety Committee of the Board that says, sorry, guys, this will not fly. So the PARADIGME conclusion was that there is no viable path to generate value from Betalutin in the third line follicular lymphoma. Although the primary results of Betalutin in non-Hodgkin’s lymphoma part A which Arne Kolstad conducted was very attractive, they were obtained at the time, treatment options were limited and minimally pretreated population at the time and that when the study started. That’s what gives us an optimism in many years, those very good results. It was good efficacy, it functioned. And Part B, the PARADIGME results over time due to lower enrollment rates, et cetera in heavily pretreated populations are not clinically meaningful considering the treatment or momentary now currently available, i.e., the competition that had come up from the big pharmas over the last very few years, a lot to say the last year.
So that was the conclusion the Board had to take. We need to stop this. It will cost too much money to actually continue enrolling patients, and it will take too long time. And as you remember also from the graph there were no patients enrolled hardly in the last spring. So yes, that was the conclusion as you all know. Sorry, as it was. But then the Board really had to take some actions to save money and to save the company, and they are not here to defend themselves, so I’d rather tell you what happened and show some figures there.
So the actions taken was that 34 staff members, out of the 40 was made redundant, 85% of the staff. Leadership team was reduced from 8 to 2, and there was an interim CEO, CFO and a CSO, Jostein Dahle is still there. On the 15th of December, the Board was reduced from 6 to 3. And more than 300 contracts and vendors were terminated. They closed down all international offices. Carnegie reviewed 25-plus strategic options, as you know, but on December 1st, API merger was declined at the AGM. And on the 9th of December, the new EGM was announced as the former Board would resign and the interim CEO, CFO, Malene, would transition out to the company.
Yes, here, you can see the number of employees, how that was taken care of. The red ones are the employed in termination. So that happened very quickly. And you can see these in the figures all the way through to April this year when the last people will leave now in March. And the 8 people there is actually not full-time employees. There’s also part-time employees, which we have now for the time being. And it’s only the research department, 5 people, and it’s the accounting and Secretary and myself.
Cash development. It picked up in January because of the issue, which was done at the time. And it came down to 99 million at the end of the year as you see. But since there are people redundant who will receive money and some contracts, which will also not expire until the end of March. Money is still running out. But as we’ve said in the report, there are around 60 million available for the budget of this year and into '24. Yes, these are the summary of the results, which you’ve seen many years, it was taken down quite heavily, net cash from operation activities compared to earlier. And the cash runway also came down. As you can see, the 99 million was the last around the year-end. And these are the financial figures, which you will find also in the report and explained in the notes to the report.
Yes, and going forward, we still have a CD-37 targeted immunotherapy pipeline, but none of them are in the clinical phase. It’s all preclinical. So it’s difficult to see that we will be able to raise money on this portfolio, but it can be out licensed and it can be developed if we and when we get a new partner in who can contribute to that development. And here are patents and the applications we’ve had over the years. So there is some value in the company, of course, but it’s hard to say how that can be kind of given the future as a stand-alone company.
In '23 events, on the 3rd of January, the EGM elects a new Board and on the 19th of January, one of the Board members resigned. And on 1st of February, I was appointed. And the new board, as you will see in the report and from the quotes of the Chairman also prioritized. Four important tasks was to get a new CEO, CFO in place, reduce burn rate, map the CD-37 platform and early-stage solid tumor projects and to find strategic solutions that safeguard the interest of the shareholders, together with Carnegie. I’m sorry to say that we can give our assurance to the outcome of the timing on the ongoing process. But the updates and recommendations will, of course, be put forward to shareholders when relevant and in due course, and the burn rate now has been significantly reduced and current cash is expected to finance an ongoing operations well into the 2024.
So that’s my presentation. And before you raise your questions, I can give you – I can read out a few of the questions we already received on the IR@nordicnanovector.com. And maybe that will answer some of your questions as well.
Answer
Unknown Attendee (Attendees)
I can start with 1 question saying, are you in any negotiations with any potential partners?
Answer
Ludvik Sandnes (Executives)
And yes, we are. I cannot tell you how many, but yes, we have interesting parties that we will see how we can manage to get a deal with.
And the next question is if you don’t find a new partner, can Nano operate on its own in the future? I can hardly see that because we are not able to raise money in this market. And I know I’d be criticized for saying that the market was closed, but then I can remind you that we’ve talked to a number of people in the market, and there was an interview recently with the partner, [indiscernible], who was interviewed in MedWatch at 24th of February. And he says also it’s impossible to find new investors to the biotech industry. We spent all our funds on existing portfolio companies. And when we talk to other people, we hear that there are 3 cases in the market or companies in the clinical stage where their key investors had to make convertible bond loans so that they could continue their investments. And where the exchange rate will be determined equal to the next issue price when the market again opens up. And sorry to say, Nano has no longer any key investors interested in the biotech or with the funds needed. So when other companies in our market struggle that much, I’m sure you will realize that we do the same for the time being. And if you want to listen in to Targovax’s death spiral lung, which they published a few days ago. There’s another webcast at 10:00, where you can hear muc about how they actually struggle to also finance their treatment.
And yes, then other questions say, why do you believe that you will be able to execute transactions with and will be more favorable to the shareholders than the APM deal? And that outcome of a strategic process is not possible to predict. e cannot predict that it will be more favorable. We just hope that we will bring along something that we think is sensible and that you, as shareholders, will hopefully understand and accept that the proposal will make the company survive.
Question again, do you believe that the APM proposal was sensible one? And would you have recommended it to the shareholders at the time? I think you will remember that I was at the December 1 EGM and couldn’t understand why they would close it down because it would give you at least a clinical trial company, 55 million more cash. And one of the major investors in Norway has a backbone. And hopefully, that will bring the company into times in a year or 2 when the stock market was back on track. So yes, I haven’t changed my mind. I think that was the best deal at least at the time. Now we’re looking for something else, and I hope I can come back in due course, i.e., hopefully, before the AGM in the – at the end of April.
Question, is there any chance the APM deal could resurrect? And I would say no. I mean, then when it was negotiated. The share price was NOK 1.5. Now it’s half that price. So and you declined the 24% shareholder for Nano investors. So of course, they wouldn’t improve the exchange rate. So that’s unrealistic.
And yes, a few other questions here. What will happen if no alternative deal can be found? Yes, we’ll run out of money in '24.
Do you think Nanovector has a future as a stand-alone company? No, hardly. Because of the market. If the market changes very quickly or we can find investors or some out there who is interested to buy or out-license our technologies, yes, can be, but we need new money coming in.
Yes, major question maybe: Do you agree with the decision to stop PARADIGME. I think I have explained and hopefully also through the facts that I’ve given you that I don’t think the Board had any choice in my opinion. I mean they tried for as long as they saw positive signs there. But I could also say that that when a study has failed, all companies, big or small, would say that they should have stopped earlier, but all continued hoping for success until hard facts and figures told them differently. In Nano’s case, I have a great respect for the very qualified experienced CMOs, the Board members, which I know personally and have spoken to recently, and the key opinion leaders who have followed the study for years. I mean so many really qualified people made those decisions going forward, but also finally had to accept when the figures really hit them hard that, yes, the study had to stop. And yes, it’s hindsight to say that, yes, they could have stopped earlier. Yes, everyone says that, even the big ones, who have more projects too or a bigger portfolio.
I also got a question on the solid tumor project and what that is. I can only say for the time being, it’s still in progress. We have no patent yet, but we continue to have a look at that as an interesting potential.
Yes, there was also a question why I took the job. Well, I was asked and I was available. And I think I was cheaper.
Anyway, also, why did Eddie Berglund resign as a Board member in January after such a short tenure? You need to ask him. I think he disagreed with the Board majority, but I don’t know any more reasons, so you have to put that question to him.
And last question, do you have contact with North Energy, and if so, what are their intentions? Yes, of course. I introduced myself the very first day I joined, and we have contact. And of course, we speak to our largest shareholders. And as soon as I have a proposal, I will talk to them again and see if they can support it. And I haven’t received any, let’s say, input from them. I’m very open, we are very open to see any good ideas that what we can do with the company.
And last question, what is your intention, or how will you regard a success from your tenure at Nordic Nanovector? And that is to make the company survive. Let’s hope we can do that together.
Thank you. If there are any other questions, I’m happy to try to answer them. But I would kindly ask you to send us your questions. If they are concerned with technology or any specific items, I will not pretend that I’m an expert on all that. So we would need to be able to also answer you in writing or at least prepare the answers, let’s say, for the next time we meet with you to publish our annual report on the 23rd, I think, of March. And then we meet again at the AGM on the 26th of April.
Are there any questions, Carly, on the screen?
Answer
Unknown Executive (Executives)
There’s only one question, actually, and that is how has the cooperation between the new board and the employees worked.
Answer
Ludvik Sandnes (Executives)
Oh, very well, very well. We have – it’s a very small company. It’s kind of funny to come into that beautiful surrounding in the cantina, and we make our own food and the Board when they visit. And there are good interactions between the Board and the members. So yes, we’re all very excited about doing this together. And the Board has been very active, I must say, and very constructive with our expertise within the biological industry has been very valuable. And Jon Magne as well, very active and taking care of certain aspects of the – so we’ve shared, let’s say, the burdens and work very well together. So I’m very pleased actually with the team and the employees. I’ve interviewed all of the employees, and I really must say they are a fantastically qualified group of people, very complementary to each other and very loyal to – and very enthusiastic about what they’re doing. And the labs we have are first class, and there seems to be a lack of labs in the country. So we hope also to kind of utilize that in a way to make money. So yes, we hope there’s a bright future here, if we can only find a partner who is willing to finance us going forward. Thank you.
Thank you for joining us, and looking forward to seeing you next time.
Skal bli deilig å få en avklaring på dette, vi har lidd nok nå 
