Interessant publikasjon.
Ble litt overrasket da jeg så at mpfs når Cm 511,067,069 var slått sammen n = 587, var 11.86 mndr. Det betyr vel ut fra vektet snitt beregninger, at CM-069 har en mpfs på ca 17 mndr. Dog en vektet snitt beregning er selvsagt ikke det samme som den avanserte beregningen som er benyttet i publikasjonen, men en pekepinn gir det vel.
Da venter jeg i spenning på om Ketilaaj kommer med en oppdatert kurve.
I CM-069 er mPFS oppgitt til 8.9mnd. Det er ikke klart for meg hvordan du kommer til 11.86.
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Ser ut som et n-vektet gjennomsnitt av mpfs i de 3 studiene
11,86 er ikke for 069, men det som er oppgitt i figur 2 rett over figur 3 som Polygon kopierte inn hit, i publikasjonen når 511 067 og 069 ble rekalkulert sammen, jeg kom vel til 17 som jeg ser er helt feil, ergo vektet snitt er ubrukelig.
Takk for nye plott.
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Helt korrekt, men ubrukelig i forhold til det Ketilaaj oppgir. Jeg prøvde å finne mpfs i cm069, men er ikke flink nok til å finne fram i slike publikasjoner!
Har grublet over helga, skjønner ikke helt hvordan de i nevnte undersøkelse kommer fram til en mpfs på 11.86 mndr n =587 når de benytter sin statistiske metode på å samle Checkmate 511 n = 178, 067 n=314 og 069 n = kun 95 med mpfs på henholdsvis ca 10, 11.5 og 8.9. Beregning relaterer seg til figur 2 over figur 3 som du laget en ny kurve fra.
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Jeg vet ikke og synes også det er rart.
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Glem det.
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De fleste av oss assosierer biotekinvesteringer med høy risiko/høy reward. Sektoren virker også å oppføre seg delvis syklisk; når investorsentimentet er godt, strømmer det generalister og institusjonelle til, kursene når nye høyder og det er “lett” å hente penger. Det motsatte, når syklusen er i en dal blir det å ha nok penger et evig problem. Biotek er nå i en slik dyp dal hvor tilstanden nærmest er Darwinistisk; kun de som har nok penger eller har tilgang overlever.
Biotekselskapene har, som kjent, et stort behov for penger upfront; store R&D kostnader løper før man får svar på om man får et godt legemiddel verdig et partnerskap eller godkjennelse. Per i dag, kun i USA alene, er det omlag 660 biotekselskaper notert totalt hvor 33% av disse trades under cashbeholdning og 358 har cash mindre enn 2 års burnrate (tall hentet fra VC fondet RA-Capital).
Med dette som bakteppe er det derfor ekstra viktig for oss småaksjonærer å velge investeringen ikke kun på bakgrunn av god biologi, godt management med ditto god kommersiell og klinisk strategi, men også ha et godt grep over selskapenes muligheter til å hente penger og hvor lang man kommer med kontaktbeholdning. I norsk bioteksammenheng har nok dette siste poenget, evnen og muligheten til å hente penger, vært en sårt tema. Ingen hemmelighet at de fleste selskaper på OSE har en relativ kort runway.
Å få tilgang til frisk kapital gjøres mest elegant ved oppnå såkalte “value inflection points”. At selskapet oppnår verdidrivende milepæler slik at man kan hente penger på høyere verdi. Slike milepæler kan være av klinisk karakter feks vise klinisk Proof of Concept (PoC = vise effektsignal i pasienter i en studie), av regulatorisk karakter (Fast Track, Orphan Drug Designaton, AA), inngå vikige parterskap eller andre oppnådde milepæler som fører selskapets legemiddel nærmere suksess.
Med dette som bakteppe, la oss titte litt på Ultimovacs. Har tidligere skrevet litt om biologien så tenkte å omtale her hvordan selskapet er stilt mtp value inflection points.
- Selskapet har i sine fase I studier på sin universielle cancer vaksine vist god safety profil samt antydning til vedvarende effektsignal → ergo, noe risk (for å vise toksisitet) er kvittert ut
- Har nærstående readouts på to nøkkel fase II studier som har som hensikt å vise effekt på toppen av moderne immuno-onkologi - begge forventes å ha data ila 1. halvår i år. I tillegg til dette er det også 3 andre fase II studier i andre lovende indikasjoner → ergo, før vi går ut i sommerferie ventes selskapet å dele resultater de viktigste effektstudiene på legemiddlet så langt
- Fast track designasjon fra FDA i melanom på toppen av dagens beste cancer behandling (CPI) → ergo, selskapet har fått gode signaler hos regulatoriske myndigheter
- Selskapet har en klar strategi for en pipeline (TET-plattform) → ergo, hvis selskapets hypotese stemmer har man en god plan for å hvordan skap merverdi
- Selskapet hentet 270mill NOK i slutten av 2021 → ergo, selskapet har nok penger til å avlese de viktiste nøkkelstudiene sine.
Oppsummert så kan man si at selskapet og management 1) har til nå vist god track record i å oppnå definerte value inflections og 2) pt har nok penger i kassa til å fullføre pågående studier som vil på kort sikt skape høyest potensiell merverdi, nemlig vise effektdata fra sine 2 pågående fase II studier som begge er i rute og venter avlesning ila 1H 2023.
Nå kan noen av oss aksjonærer erge oss over at kursen er komparativt lav hvis man sammenlikner med andre selskaper som har nærstående fase II readout, spesielt hvis selskapene er notert i USA. Jeg tror de som erger seg mest er de som har kjøpt de aksjene de ønsket, er «ferdig lastet». For de andre som fremdeles ønsker å kjøpe litt mer er dagens prising egentlig ikke så ille; hadde man vært priset selskapet mye høyere hadde det blitt dyrere å kjøpe mer aksjer 
BP betaler som regel benchmarked pris ved oppkjøp eller partnerskap, så hvis fase 2 dataene blir bra så kommer prisen å bli justert opp eventually. Dog historisk har amerikanske selskap oppnådd litt høyere pris enn europeiske ved BP M&A, men vi snakker om så høye summer at forskjellen blir liten hvis dette går den rette veien. Skal ikke så alt for mye til å holde oss nordmenn happy, vi er tross alt ikke dansker 
Disclaimer: er long ULTI.
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Jeg tror heller at de som ergrer seg mest, er de som kun har til hensikt å trade på FOMO, og som aldri har tenkt å bli med til fasit blir servert.
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Transcript : Ultimovacs ASA, Q4 2022 Earnings Call, Feb 16, 2023
02/16/2023 | 08:00am EST
Presenter Speech
Carlos de Sousa (Executives)
Good afternoon, everybody, and welcome to Ultimovacs Fourth Quarter 2022 Results. As usual, I have with me our Chief Medical Officer, Jens Bjorheim; and our Chief Financial Officer, Hans Vassgard Eid.
We have received a lot of questions, but feel free to – while we present, to send your questions as usual to the links that you have received with the details of the webcast.
And with this, let’s move to the next slide. We have to show you this, but let’s talk about Q4, 2022 highlights. Again, a very busy, but successful quarter for Ultimovacs and the team. I think the news that everybody is waiting is, of course, are we as a company on track and prepared for the readouts that we are going to have during the first half of 2023 in the first 2 of our 5 Phase II studies with universal cancer vaccine UV1.
And I can tell, yes, we are on track, and we are prepared for these potential key value inflection points that we are expecting during the first half of 2023.
The top line results, we will inform you very soon after we receive these results from the contract research organizations. So just stay with us, and we will continue to keep you informed. But I would like to emphasize again, as previously communicated, that we will not be providing any more details about these studies until we have the data, and we will give you the details at that time. So stay tuned.
Overall, we have a very good progress in our clinical program. We are very happy that we completed patient enrollment also very recently in the NIPU study, but also at the end of the quarter in the TENDU study. We are also very pleased that recruitment continues to progress with the other studies.
As you know, we had some delays that were primarily during the initial phases of these studies where we had this administrative process with the health authorities and the ethical committees, different hospital centers that, for instance, in the DOVACC are quite complex. Because, as you know, we have more than 40 centers in 10 countries, so that takes a long time. But we are very happy that now, as you could see, where the patient enrollment is picking up.
LUNGVAC, also, due to the changes in the reimbursement of standard of care by the Norwegian authorities that moved from pembrolizumab to cemiplimab, we had to – the centers had to adapt. As a company, the protocol was already basically flexible enough to anticipate this potential change. But, of course, the centers are now to adapt and they are doing it. And we are pleased that the first 2 patients with cemiplimab were also enrolled.
Very exciting that has been happening in the last months, one of them, and I will talk a little bit about that is now the renewed interest and the buzz around cancer vaccines, what we see quite positively. Part of it is because some of the news you saw of the agreement between Moderna and MSD. But also in general, we see and hear a lot more interest for cancer vaccines, what, of course, we believe is very positive for Ultimovacs.
We also extended our runway to the mid-2024, what is a good place to be for us as a company being funded during these volatile times, while we basically expect all these results to come through. We received a lot of questions around end points. What is the difference between primary endpoints, secondary endpoints, what do they mean? And Jens will have a couple of slides on these specific topics.
And we also received a lot of – questions about what is the process, what is the normal process from when companies are informed about the number of end points, basically when the database for the clinical study is locked and the sponsor received data to clean the process, what we call, clean the data until the information is provided to the sponsors. So there is a period of time that is very variable. And Jens, we also cover this.
So there is a little bit more of clarity around what does it mean, how long does it take? There are, of course, different periods of time depending on the studies and Jens will cover that. So we will be talking in more detail about the operations, the financials by Hans, but we will also be addressing some of your questions and then talking a little bit about the next stage and next phase for Ultimovacs.
So with this, I give the word to Jens and moving to the next slide.
Presenter Speech
Jens Bjørheim (Executives)
Thank you, Carlos, and good afternoon to everyone. So in this part of the presentation, and as Carlos said, we will touch upon some of the questions that have arrived and there are some background slides for the vaccine, as usual, and then we will also present the data and some of you at least have seen before, and a short discussion around this cleanup period after you have the endpoints in a study.
So if we can move to the next slide, Hans. This one is the one you have seen several times before, its showing the clinical development program ongoing in Ultimovacs as of today. The upper 3 lines represent our sponsored indication, malignant melanoma, where we have 3 completed trials as of now, and we are waiting for the readout in the Phase II trial first half of this year.
Also, as we have said earlier, there has been a lot of interest around UV1 vaccine to combine that with different checkpoints in different indications. As you know, we are part of 4 other Phase II trials, one in pleural mesothelioma; one in head and neck cancer; one in ovarian cancer and latest now one in non-small cell lung cancer. The common denominator for all these trials is that the patients with these indications express telomerase, which is our antigen for the vaccine.
If you move on to the next slide, we will go into the numbers for recruitment in the different trials. So as you know, both INITIUM and NIPU trials are completed and with expected readout first half of this year.
In the FOCUS trial, in head and neck cancer, that is metastatic or recurrent head and neck cancer, where we combine with pembrolizumab, 50 out of 75 or 2/3 of the patients are now enrolled in the study. Expected readout of this trial is the first half of 2024, changed from 2023 earlier.
The DOVACC trial is in ovarian cancer patients, women that are BRCA-negative that respond to chemotherapy as second-line treatment. In this trial, inclusion has gained some speed lately, and we have now 17 out of 184 patients included in the study versus 7 at last report. Expected readout in this trial is second half of 2024.
The LUNGVAC study in non-small cell lung cancer patients with PD-L1 expression 50% or above and without the mutations. In this trial, 2 patients have been included with cemiplimab. Earlier, we included 3 patients with pembrolizumab before the change of reimbursed drug to this patient group in Norway happened last autumn. Expected readout second half of 2025.
And then for the other program, we are developing the tech platform, the TENDU trial in prostate cancer patients. All patients there are – have been recruited to the study and we expect a read out in this study second half of this year.
If you move on to the next slide, we will – I will say a few words regarding the vaccine as such, because discussing the antigen is important to get also the understanding of the general aspects of this – of the UV1 vaccine.
So for normal tissue to develop into cancer tissue there need to be different changes or mutations in place that leads to the development of a tumor cell. One of these features is that cell need to be – had opportunity to have internal cell division. It can continue to divide in theory forever.
And one of the strategies cells use to come into this position is to activate an enzyme called telomerase. Telomerase is activated in 85% to 90% of all cancer indications, and it’s something that happens early on in the development of the cancer. You can see it from early Stage 1 and throughout the course of the cancer.
The telomerase activation is also an essential thing to the tumor. It’s something that happens early and followed all parts of the tumor. So if you look at the different parts of the tumor, like the primary and the metastasis, you will see expression of the telomerase.
By this, you can say that the telomerase antigen is a general and relevant antigen in all parts of the tumor and through the different stages of a tumor development.
Moving on to the results from the second Phase I trial that was presented at the SMR Conference in Edinburgh, last autumn in November. So this study is a study with the UV1 vaccine in combination with pembrolizumab in first-line treatment of patients with metastatic melanoma.
As you know from earlier, the median PFS has readout in this trial at 18.9 months, and we have followed the patients for 2 years. And after 1 year, the overall survival was 86% versus 73% after 2 years of observation.
On the next slide, you can also see how the responses in these patients developed through the course of this study. Each line here represents a patient, and each box represents an image of the patient. There is, also 2 stippled lines, and the lower one, minus 30%, represent level where you say that the patient has a partial response, meaning that parts of the tumor is gone.
A complete response is when all signs of the tumor has disappeared. We follow these patients for 2 years, as I said, and we see that after 1 year, 94% of all the patients that had a partial or complete response, they remain in such response after 1 year.
Moving on to the next slide, the same patients presented in a waterfall plot. So here, you can see that each column represents a patient. And you can also see the stage of the cancer in each patient. And also, there is information about different biomarkers that are used when you treat or not used – you don’t need to use them in melanoma, but they are investigated by the researchers, because if you have different levels of different biomarkers, it might indicate that you have a different response to treatment.
In our study with 30 patients, 10 of the patients had a complete response and 7 had a partial response. We also did this biomarker analysis of the patients like tumor mutation burden and PD-L1 status.
What we saw in this trial was that when patients were PD-L1 negative, and the same observation was complete response rate and a response rate, was observed in that group.
In the box between – below the waterfall plot, you can see historical data from the KEYNOTE-006 trial. The numbers to the left represent the whole group of patients with a response rate of between 34% and 42% and a complete response rate between 5% and 14%.
To the right, you can see the response rate in those patients that are PD-L1 negative, 24.3% and complete responders, 5.8%. So in our small trial with 30 patients, we did not see this difference even – also in the patients with a PD-L1 negative status, the frequency of response was the same as in the whole study altogether.
Moving on to the next slide, this is a picture of the 2 trials that are now fully enrolled, so the INITIUM trial to the left, where we have combined the Nivo+Ipi plus/minus the vaccine on top. In this trial, 156 patients are included. And the NIPU trial to the right, this is a second-line pleural metastatic mesothelioma patients, nivolumab, ipilimumab plus/minus the vaccine on top and 118 patients are recruited.
As we have discussed earlier, both this trial has a so-called endpoint-driven design, meaning that we are waiting for 70 endpoints. And what we are waiting for is this progression-free survival. So progression-free survival, as such, is an endpoint that have 2 components. The one component is progression of the tumor, meaning that the tumor is growing. And the other component is death. So the combination of, these 2 events make up the progression-free survival end point.
The whole statistics in such trials like this are designed around the primary endpoint. So there is a connection between the number of patients that needs to be included, the number of endpoints you need to reach and the statistics in the study that gives you an answer to the progression-free survival, if that is different between the 2 arms or identical.
And then we have something called secondary endpoints, like overall survival, objective response rate, duration of response and safety. So for the secondary endpoints in a trial like this, the trial is not designed statistically to give the same kind of statistics as you’d have with the primary endpoint. Upon, for example, a positive study, meaning that you have a positive primary endpoint, the secondary endpoints will be supportive information that you can use in your further development of a medical product.
We can see that in the next slide. But first, before we move there, I just want to say a few words about safety as well. So safety is also very important. So as you might know, with the CPIs, there has been a lot of safety events within the field of autoimmunity. That the immune system gets supported so much that it start to attack different tissues in your own body.
So when we are here combining with 2 checkpoint inhibitors, it’s very important that, that we do have a safety profile of the third component, the UV1 vaccine, that doesn’t harm the safety profile further. This is also important so that the patients are kept on the treatment with the checkpoint inhibitors, in this case, nivolumab and ipilimumab.
But back to the endpoints on progression-free survival versus overall survival. So if we look at the next slide here. For all patients with cancer, of course, the gold standard and also for the medical community – overall survival is the gold standard. So you want to help the patients, so they survive their cancer.
In some indications, and if you treat in an early line, it will be in some indications several years until patients eventually die from the disease. To be in a position where we can do clinical trials that have – goes over a relevant number of years, not take too long, so-called surrogate endpoints are developed. And one of these endpoints, are PFS.
So for – when you develop the drug, it’s important to understand how the PFS, for example, associates or correlates with the overall survival in the end. We have an example of that here to the right. In the upper part of this figure, you can see the progression-free survival of the control arm in the red and the intervention arm in blue from the registration study of ipilimumab and nivolumab in mesothelioma.
So the red line represents chemotherapy, which was the control arm and standard of care for these patients at the time study was conducted, and the blue arm represents the patients that received nivolumab and ipilimumab.
If you look at the I-axis in the upper part of this figure at 50% and make a line – take a line horizontally out there, you will see that 50%, which represents the median PFS. The median PFS was better with chemotherapy as compared with ipi and nivolumab.
And thereafter, if you go to the lower part of this figure, you can see that here in the overall survival readout, the CPIs, ipilimumab and nivolumab actually had a better overall survival than the chemotherapy group. So if you select a trial and your final endpoint was progression-free survival only and you conclude on that without having additional secondary endpoint information to look at, you might conclude that the upper part of the study or upper picture here concludes that the study is a negative one.
But if you look further to overall survival, in this case, was also an endpoint in this study, you can see that there is actually an overall survival benefit in this study. So it’s important to understand the association between surrogate endpoints and overall survival in the end.
Moving on to the next slide, a few comments regarding the cleaning process of data from clinical trials. So in our trials, we have a so-called central review of the images. This means that there is a third-party that is evaluating the CT scans from the patients before the data are entered the data file or this eCRF.
So to get pictures from the hospital to the central review, takes time and also the review itself and it also needs to be verified that everything around the scan is in place like correct dates, et cetera.
All slides are sent to this third-party vendor, and this takes time, and it also some kind of backlog because all the slides come through a central institution that will read the slides if something is missing – some information is missing. There will be a question regarding that, that needs to be solved before the conclusion on each individual scan can be taken.
Also, after you have the endpoints reached in a study, there will be – all the sites, which participate in the clinical trial, will be monitored by the CRO and all the databases that are connected or used in the trial needs to be compiled or put together, so we have the full data picture from individual parts of the study, like laboratory, imaging, clinical evaluation, et cetera.
Before you go on to the statistical analysis of the data in your database, you also need to have all queries solved. So all data or missing data should be there and verified before you are going into the statistics. And thereafter, the statistics is performed in the INITIUM trial. It’s performed according to our predefined statistical analysis plan, meaning that prior to inclusion of – there is already now a set of tables, figures and listings that will in way be populated with the data from the study.
Thereafter, when the statistics is conducted and checked and reviewed, the top line data can be communicated to the sponsor of the study. Based on the complexity of different studies, like few centers, many centers, few countries, many countries, et cetera, this process can take from a few weeks up to a couple of months in different studies.
If you move on to the next slide, just a very short update on the TET platform. So the TENDU Phase I trial in prostate cancer patients. This is the first trial where we evaluated the TET adjuvant technology. As you know, this trial is fully enrolled. All patients were enrolled at the Oslo University Hospital, and we expect readout from this study second half of 2023. This is the first trial where we have this new asset.
And the endpoints in this trial is to have some initial understanding of the safety, the immune responses generated with this new molecule and also a better understanding of the doses we need to use moving forward with this platform technology. As of today, there is no safety concerns seen in this trial.
Moving on to the next slide, you will also move on to the next presenter. Please, Hans.
Presenter Speech
Hans Eid (Executives)
Thank you, Jens. I’m happy to go through the key financial elements from this report. Yes, when we now report from the Q4, 2022 period, we do see a certain increase in operating expenses. That is as expected and also as previously guided.
Looking at the full financial year 2022, we had operating expenses in total of NOK 184 million, and that is a 12% increase from 2021. It reflects a general increased activity level.
But it’s fair to say that the increase in R&D costs has actually been lower than we have indicated earlier. And this is due to some of these delays that we have spoken about in clinical trials like DOVACC and LUNGVAC, so the start-up time has been somewhat longer. It means that some of these costs will come later than we have assumed.
If we look specifically at the fourth quarter 2022 and compare that with the same period in 2021, we see a higher increase of actually 42% from NOK 51 million to NOK 72 million. So that’s percentage-wise quite a big increase, but it’s driven mainly by share option expenses and related to social security tax accruals, and this fluctuates with the company’s share price. So the difference is quite big NOK 17 million higher in Q4, 2022 than in Q4, 2021.
And there are also some significant non-cash cost elements in this and that I will come back to look at the cash flow in a slide later on.
If we look at the cash position, at the end of Q4, 2022, we had a total cash position of NOK 425 million or around USD 42 million, and that gives an expected financial runway to mid-2024. This is an extension of the guidance we have given earlier when we have indicated that we have cash until the first half of 2024.
We see that we, as I mentioned, have some delays in R&D costs, so they will come somewhat later. And we also have some cost savings that we can capture. So based on this, we are able to guide on an extended financial runway to mid '24.
Going forward, we should expect the operating expense level to be higher than we have seen so far, but we will clearly continue to see quarterly variations. As I said several times before, it’s easier to estimate in these large R&D projects the total cost than actually the exact timing of the cost.
So the increase is driven by further progress in the Phase II trials, further development in the CMC area, which is the manufacturing development and also other R&D activities.
Then move on to look a little bit more into detail on the different operating expense elements and also the net financial items. The payroll expenses, looking at Q4, '22 versus Q4, '21, the regular salary costs were approximately at the same level. But as I said, there has been a significant increase in the total payroll expenses due to the share option costs.
In fact in Q4 '21, there was a reversal of such costs, so a negative number, whereas we had some significant costs here in Q4, '22 with an increasing share price. So the difference is actually quite big looking at Q4 '22 versus Q4 '21.
If we look at the full year payroll costs, the regulatory costs were somewhat higher with 2 more FTEs added during the year. And the share option costs for the full year were also slightly higher in '22 than in '21.
Moving on to the R&D expenses, the R&D costs were approximately at the same level in Q4 versus – '22 versus Q4 '21 and the same goes for the full year comparison. For other operating expenses, we do see higher expenses, reflecting a higher activity level. We are preparing actively for the readouts from the Phase II trials.
We do spend more time on traveling, coming out of the pandemic. We spend more time on business development and different activities related to the readouts and activities thereafter. So it implies a certain increase in these costs.
Looking at the net financial items, we also have quite a significant income element in the full year 2022, over NOK 15 million or NOK 16 million. That is comprised of interest income of NOK 9 million and also net foreign exchange gain of NOK 7 million from some of the hedging positions we have in euros.
Okay. Then I will move quickly to the cash flow overview. We have seen an increased negative cash flow during the last quarters. In Q4, specifically, there is quite a significant deviation between the negative operating cash flow and the operating expenses.
As mentioned, the operating expenses were around NOK 70 million, but due to some significant non-cash elements related to the option scheme and also some year-end accruals, the net operating cash flow is negative NOK 50 million compared to the NOK 70 million expense level. Yes.
We have also this time included a more detailed quarter-by-quarter overview of the key financials so that, that may help those of you wanting to dig a little bit more into the details of the cost development.
With that, I give the word back to Carlos for the last section.
Presenter Speech
Carlos de Sousa (Executives)
Thanks, Jens, and thanks Hans. So if we move to the next slide.
As I mentioned, cancer vaccines are now on the agenda. What is very rewarding because, as you know has not been the case for many years so it’s good for the patients. It’s good for the space, and of course, it’s good for Ultimovacs.
As you see there, now the – and it’s circled, more effective cancer vaccines are now one of the hot topics in immunotherapy in 2023 by – selected by the American Association for Cancer Research. Cancer vaccines: the next immunotherapy frontier, from Nature Cancer. Cancer Vaccines: What’s Hot in 2023. So hot, hot, hot. And we also have some publications.
So clearly, this is an ideal time for Ultimovacs to come out with data that, of course, we all hope for the benefit of patients that is positive, because it means that the space is more aware and more open to listen to this data.
And to help them really hear about Ultimovacs, small biotech from a small country in the north of Europe, in the next slide, you’ll see that we are quite busy spreading the word. Since the beginning of the year, we have been participating in different conferences, presenting the company.
We are participating in different panels. We have been invited by banking conferences to present what is very rewarding. And so, from a perspective of medical, where we will also be participating in several conferences, investor conferences, business development conferences.
You see here that the first half of the year is quite a busy period for the team. And that, of course, we try to maximize as I mentioned, raising awareness of Ultimovacs and what we are doing in anticipation of a positive data.
So, very important to spread the message. At the moment, as you can imagine, we are relatively well known in Norway. And in the Nordic countries, we are focusing more in the rest of Europe and in the U.S. But of course, we haven’t forgotten you, and we are planning when the activities will slow down a little bit to also do some more of these Meet the Team events.
So if we move to the next slide. You see here basically, the expect – the excitement that we are all having – as receiving the data from the CROs and informing you very soon after that happens.
So as I said, we maintained the guidance for the time being that both INITIUM and NIPU top line results will be available during the first half of 2023. And as I mentioned, that will be the next update that you’ll have on the data for these 2 studies.
We will, after this, assuming positive data, where we have a series of plans in place that then will have to be executed from regulatory activities, investor activities, partnering activities. So the team is, again continuing to be very excited and busy for the anticipated future, again, assuming positive data.
But of course, we are not just INITIUM and NIPU, it’s rewarding to see that now we are continuing to have enrollment of patients in the other clinical programs. And FOCUS is slightly delayed up to 6 months. So we, as you see, continues to enroll patients.
And as I mentioned, very pleased that DOVACC catching up and LUNGVAC very important studies. But also showing that as a company, we are not just a one-trick pony, we have different data points and potentially significant events coming not only very soon, but also in the next 6 to 30 months.
And of course, we shouldn’t forget about our TET vaccine adjuvant technology and the TENDU study. We are doing several non-clinical and CMC production activities. We will have the – data from the TENDU study. So we will be keeping you informed and giving you more details about this program later in the year.
So let’s move to the next slide, and I think doing a wrap-up of this webcast and the quarter. Very, very successful as we complete the enrollment in the 3 of the studies despite the challenges of the pandemic.
You know that has been a big effort from the team to deliver this. The fact that we are on track to the expected top line readouts during the first half of the year for INITIUM and NIPU. That we in anticipation of positive results as a team and as a company, we have different activities planned to be activated if the data is positive.
The fact that the space is being now recognized as more important, and in the cancer vaccine space, we believe that we are very well positioned in this emerging cancer vaccine landscape due to different factors.
One is the fact that we call it, as we believe UV1 is a universal vaccine. And we classified its universal, because it’s a universal target that can be used across multiple cancer indications.
The fact that we don’t need to do any screening of patients. We can be used right away. It’s also quite universal. And the fact that the universal usage have the vaccine because we can be used from early stage to late stages of the cancer.
And other very important benefits that for the ones that are now more familiar with vaccines and some of the challenges, and some of the COVID vaccines. The fact that we are a truly off-the-shelf product, just kept in the normal fridge, ready to be administered when needed, the fact that there are simple logistics, we don’t need any complex infrastructures to administer the vaccine. We don’t need very complex cold chain distribution to send the UV1 around. And the fact also that is easy to use, it’s intradermal injections. So we don’t need to do biopsies. We don’t need to access – have access direct to the tumor.
So I think it’s important and is a key topic that is now more and more is access. So we need to facilitate access of medication, in this case, UV1 to patients. And we think that we have several important characteristics that facilitate the access of patients to UV1.
Also, the exciting part not only of the cancer landscape, but also we have received a lot of attention and comments from this exciting data regarding the biomarker analysis, because it has been one of the challenges. If the patients have a low expression of PD-L1, treatment with CPI is not most effective.
So there is an enthusiasm of exploring more the results that we have found in our 103 study.
And for the ones who view that are also more close to the sector and the challenge that is happening overall in the biotech, not only in Europe, but also particularly in the U.S., the volatility. Then how difficult it is to raise cash during these times.
We are very pleased that not only we are solidly financial, we have a solid group of key owners. But we were able also through discipline and also, of course, some of these [ licensed ] groups that we were able to extend the runway to meet 2024, what is very, very good for us as a company.
So with this, I want to again thank you for all your time, your attention, and we can move now to the Q&A part of this webcast.
Answer
Hans Eid (Executives)
Thank you, Carlos. I will then take us through the questions we have received. We have received – also there’s some – quite a few questions related to the process in INITIUM and NIPU towards readout.
Jens addressed that in quite some detail today, so that should be well covered based on Jens’ presentation. I think these questions were mainly posted before Jens shared these perspectives. So I will not repeat those questions, because they should be well covered.
Then the first question is when will the vaccine be available to everyone?
Answer
Carlos de Sousa (Executives)
Excellent question, of course, we wanted to be available as soon as possible, but we need to understand that there are very clear processes and regulations on how to develop the vaccine. So we – what we can assure you is that as a company and as a team, we are doing our best not to waste any time in the development and the activities.
And then it’s going to really be depending on, is it going to be the normal time lines, is the data going to be so positive that we may explore and discuss with the authorities for what we call a conditional or accelerated approval in specific indications. So a very, very difficult to give you a precise timeline, a lot of factors are around it. But I can assure you that as a team, we have been dedicating our time and investments to make sure that these timelines are as fast as possible.
Answer
Hans Eid (Executives)
Thank you, Carlos. Next question, is there a possibility that the readout in INITIUM and/or NIPU will come first in the third quarter of this year?
Answer
Carlos de Sousa (Executives)
Well, the only thing we can answer to that is maintaining for the time being, on the guidance that we have promised and I’ll repeat again. We expect top line results in the first half of 2023. Any changes, we will inform the market.
Answer
Hans Eid (Executives)
Thank you. Next question related to TENDU. In TENDU the enrollment of all 12 patients is completed, but readout is expected in the second half of '23. Why is the readout taking so long time for so few patients?
Answer
Jens Bjørheim (Executives)
Yes, so in the TENDU trial, in that study, we vaccinated 12 patients, 3 different dose levels. And that one of the endpoints in that trial is immune responses from the vaccination. And the vaccination – the immune response towards the vaccination will be followed for a certain time for each patient.
So even if a patient was enrolled a short period and back, we will follow the immune responses in such patients for a bit longer time over months. So in that sense, even if the patients are there now, we need also to follow the patients for a while before we have the complete data set.
Answer
Hans Eid (Executives)
Thank you, Jens. Then we have a question on safety that we probably can’t answer too much, but I’ll leave that to you Jens. Can you comment on the blinded adverse events that you are seeing reported, for example, are there notably more in the CPI combo studies?
Answer
Jens Bjørheim (Executives)
So regarding safety from the Phase II trials, that needs to be reported when we have the data. From the Phase I trials, in general, we have seen that most safety that we see is linked to the CPIs. For example, in the 103 trial, the safety profile has been characterized as expected for pembrolizumab alone, except for injection side reactions on top.
And also remember that all data from the Phase I trials with melanoma has been reviewed by the FDA and we received back this Fast Track designation for both combinations and also orphan drug status. So that also means that the authorities have looked into the data in these trials.
And third, but also important is that we have been allowed to start studies in new indications directly in Phase II with new CPI and the vaccine combinations without having safety run-ins et cetera, prior to start-up.
So safety, in general, has not stopped us conducting trials this far in the development. And we are very happy for that, both for the patients and the development of the vaccine.
Answer
Hans Eid (Executives)
Thanks, Jens. Then a question probably to Carlos how is the pricing strategy for UV1?
Answer
Carlos de Sousa (Executives)
Well, the pricing strategy, as you can imagine, is not yet defined. If you want to have some ideas, you can look at the analyst reports, they make their assumptions for us. As a company, pricing is always going to be dependent on how strong is the data, what is going to be the market situation. And ultimately, we have been public about that, that if we license out to UV1 to a strategic partner that is going to be defined by the company that will take ownership for continue to develop and commercialize UV1.
Answer
Hans Eid (Executives)
Thanks, Carlos. Then patent question. We understand that last year, you received a notice of allowance from the USPTO, which should help you extend the UV1 patent to 2037. What is the latest status on that?
Answer
Carlos de Sousa (Executives)
Well, that patent is granted and we continue to pursue the same in other regions. So the team and the external advisers are very busy pursuing not only those ones, but continuously looking for opportunities to file new patents, what we are doing and extending the patent situation not only for UV1, but also for overall the TET platform and products.
So as everybody knows, IP patents is very important – very important for the company, for the biotech and we put the efforts and the dedication to really expand as much as we can the IP portfolio that is in the company.
Answer
Hans Eid (Executives)
Thank you. Then we have received a couple of questions related to the Merck, Moderna results. We can take them in combination.
One question is, what are your thoughts about the Merck, Moderna results in the KEYNOTE-942 trial? And how does the Moderna readout impact the interest for cancer vaccines more broadly?
And I’d like to add to that another question. Could you provide us some – details on how UV1 potentially differentiates from the mRNA vaccine used in the Merck, Moderna study?
Answer
Carlos de Sousa (Executives)
Maybe I can address the first ones, I think clearly, the results and primarily the deal between Moderna and Merck has been, as I mentioned, definitely raising awareness and the interest for cancer vaccine. So we see that as very positive. The data even mentioned by both Moderna and MSD is still not fully mature. So most probably, we are going to hear more details of the data in a medical conference soon.
So I think it’s better to wait for that, because they – it also mentioned that it’s not mature enough. And Jens can give you a couple of more comments on that, but also address the latest question between the difference between mRNA vaccines and UV1 but also, of course, these are totally different indications.
The ones that they are using in adjuvant setting versus our advanced setting. But also the fact that we are universal vaccine, they are a personalized vaccine. So there are basic differences, but I think that Jens can complement this with a little bit more information.
Answer
Jens Bjørheim (Executives)
Yes, thank you, Carlos. So remember that the on lead molecules that are presented to the immune system are peptides. So the antigen presenting cells present peptides to the immune system, which can lead to activation of the immune system. So it is, of course, different ways of delivering the sequences that we want the immune system to react to. You can do it as a peptide, mRNA, DNA, and we have selected to use peptides. So we have in a way, a direct control over the dosing we give to the patient, and we are not dependent on any intrabody metabolism to produce the peptides.
Having that said, it’s likely if the concept of vaccines works, it’s likely that different modalities can trigger such immune responses. So in general, we are welcoming all kind of methodology that will lead to relevant immune activation for patients.
So one aspect that might be tougher with the vaccines that are individualized or personalized vaccines is the production time. I guess they have a lot of plans how to reduce that, but it’s quite long today. I said this in the context that we see that the clinical field development of checkpoint inhibitors and immune therapy is now moving earlier. So for example, if you want to do a neoadjuvant treatment of patients, that means that you give the patients a medical treatment prior to an operation.
You have a few weeks there before you need to operate the patient. But it is evident that if you give drugs – medication to such patients, it might be easier to operate. So the neoadjuvant field is gaining a lot of attention these days.
With our vaccine, which is an off-the-shelf vaccine, we can directly vaccinate these patients without any delay with some other assets, you need weeks of development before the vaccine is ready to give to the patient, and that might be too long as of now.
So we will come different methodologies to the field and we do hope that there will be more than one opportunity for the doctors to select vaccination of patients. We need this field to not only be – have few companies, but to develop, so it’s improving over the years.
Answer
Hans Eid (Executives)
Okay, thank you, Jens and Carlos, and then there are no further questions.
Answer
Carlos de Sousa (Executives)
Right so, thank you, Jens. Thank you, Hans. And of course, thank you all of you that participated for your questions and attended this webcast.
And again, we are entering very exciting periods, and we hope that you followed us and you walk with us, because we are all in the company, outside, but also in the world, hopeful that we will get positive data because that will be very important for cancer vaccines. And of course, ultimately for cancer patients that need as many alternatives as available to them and to help them extend and survive for a longer period of time.
So thank you, everybody, and have a good rest of the day.
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Selskapet har aldri siden notering meldt generisk deltakelse på konferanse. Min første tanke er at denne deltakelsen indirekte forteller oss at Cowen initierer analysedekning.
hosted by members of the Cowen research team
Edit:
Den 2. mars i fjor innledet Cowen dekning av 4 selskaper, som samtlige deltok på konferansen uken etterpå.
Kan godt hende de “bare” har invitert både CEO og CMO fordi de synes UV1 er så spennende. Det er fjær i hatten i seg selv. Det sagt er det ikke utenkelig at man ser et første større US-hus ta opp dekning.
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Kan du utdype hva du tenker dette vil gjøre med kursen?
Det vil være positivt for omsetning og interesse dersom et amerikansk analysehus som Cowen tar opp dekning. Å spekulere i kurs ønsker jeg ikke å gjøre, men negativt er det evt. ikke.
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Personlig tror jeg en eventuell analyse vil gi høyere kursmål og at dette er et lite Obs! til oss om at snart kommer amerikanerne.
Innlegg fra Polygon i oktober 2022. Snart på 42/28. Hva er kommentaren din til dette nå Polygon?
Hvis populasjonen er lik, vil en avlesning nå straks sannsynligvis være svært uheldig.
Ref :
Greit å se på alle mulige utfall, men kanskje greit å ta med det mest sannsynlige ut ifra det vi vet og ikke bare glansbildeutliggerene 
Min kommentar til det er at for dem som klarer å forholde seg til en verden av sannsynligheter fremfor binære datoer, så er det voldsomt mye mer fornuftig å forholde seg til @ketilaaj sine plot fremfor mine tabeller.
For å repetere: datoen @ketilaaj sine plot krysser 0.5 i sannsynlighet tilsvarer datoene i min tabell.
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Ja jeg synes denne ikke er så dum.
Du fikk jo støtte av Boble gutten i hans lange utredning 22 oktober.
Han hadde jo en HR under 0,6 pr 26.02 så jeg tenker at Jens på presentasjonen i går kan ha hatt lignede tanker - særlig om 70 events ikke var varslet pr. I går.
Her er et lite klipp fra Boblegutten:
Nedenfor er en figur for en normal populasjon, der mPFS i utgangspunktet er 11.5 mnd.
Det kan også nevnes at når jeg tas median av alle simuleringene som gir 41/29 fordeling av events, gir det avlesning 9.januar 2022. Det er en uke før @Polygon sitt estimat. Jeg synes det er en fin validering av hverandres modeller at de kommer så nærme hverandre for dette estimatet.