Thank you, and good afternoon, everyone. Thank you for joining us today, and thank you for your continued interest in immunovia. My name is Patrick Dahlen. I am the CEO of IMUENOVIA, and I will be presenting the full year 2020 and quarter 4 results for IMUENOVIA. Next page, Page 2.
Here, you can read our disclaimers and forward looking statements, And I do encourage you to read these at your leisure. Next page, please, Page 3. Today's agenda is as follows. I will start by discussing the importance of early detection of pancreatic cancer. 2nd, I will give you a summary of the full year 2020 and the quarter four highlights.
Under this agenda point, I will discuss the status where we are right now with introduction of the IMRAPAN can D test and the road to reimbursement. I will then briefly touch upon our pipeline projects in discovery stage, And I will equally briefly touch upon the financials 2020. And following the summary, we will go into a question and answer session. Next page, please, Page 4. I wish to take this opportunity again today to remind everyone how important a mission we're on here at immunovia With our blood test IMRAPAN can D, we will provide an entirely new solution to early detection of pancreatic cancer.
Early detection of pancreatic cancer is critical for improving the survival of the pancreatic cancer patients. When pancreatic cancer is detected in Stage I and II, the 5 year survival significantly improves. It goes to 50% survival rate after 5 years compared to less than 5% when pancreatic cancer is detected at stage 3 or 4. Today, the median survival rate for a newly diagnosed pancreatic cancer patient in Europe is as low as 4.6 months. And the reason for this is simply that 80% of all pancreatic cancers today are detected too late.
They are detected in Stage 34. Next page please, Page 5. Now I will move into the full year 2020 summary and discuss quarter 4 highlights. In this section, I will also discuss the current status of IMbripen Candi and the road to reimbursement. Next page, Page 6, please.
Year 2020 was a very eventful year for IMUNovia. We saw many successes and one challenge. We saw outstanding results from the INRAPAN10 D verification study, and I will go into that further in my discussion as it requires a deeper dive than a one liner. In June, we had a very successful direct share issue. We raised SEK 400,000,000 in the direct issue, and I want to thank all our shareholders for the support to IMUENOVIA.
This capital increase will secure that we can successfully launch Imre Pancan D to the U. S. Market and beyond. In a webinar in June, we communicated our long term goal of achieving 30% market penetration in the clinically relevant areas where the IMRAE PANCKND test can be applied to detect early stage pancreatic cancer in 3 risk groups. These risk groups are familial hereditary group, symptomatic group and the new onset diabetics type 2 at age 50 or over.
We, like many other companies that conduct clinical studies, We're in 2020 affected by the COVID-nineteen pandemic in a way that one might not have anticipated. Many patient blood collection sites closed fully or partially in longer periods of time during the spring and the fall of 2020. This impacted our ability to get all the necessary blood samples for our studies in time. And thus, this impacted the launch on the Imbrey pan candi test from quarter 4 2020 to quarter 1 2021. On the 1st November, I became the CEO of IMUNovIA.
I do wish to thank the Board of Directors of IMUNovIA for the trust they have shown in me. I'm really, really excited to be here at this time. It's an important time in immunovia's history. We are right in the midst of commercial launch of our first test. Next page, Page 7.
In quarter 4, We will discuss the results from the verification study. This was a multicenter case control study covering more than 500 patients. Serum samples were collected from 9 different sites in the U. S. And in Europe.
We had 81 PDAC Stage 1 and 2 patient samples. We had 114 PDAC Stage 3 and 4 samples. We had 212 healthy controls and 100 and 12 symptomatic controls included. We obtained excellent results For the early stage 1 and 2 pediatric patients versus healthy controls, the accuracy was 94%, Specificity, 99% and the sensitivity, 78%. This is an absolutely outstanding result and shows that the test has a clinical performance that is meeting the market requirements.
For early stage 1 and 2 PDACs versus all controls, we saw an accuracy of 91%, Specificity of 93% and the sensitivity of 78%. We are very pleased with these results, And this shows that IMRAPAN10 D can detect in serum samples early stage 1 and 2 PDACs with a high accuracy. In a webinar in December, we discussed in more detail the results, and we concluded that we had seen a Slightly less specificity for the test when we tested against the symptomatic controls, 81% specificity, whilst we saw the same sensitivity, That is 78% in early stage PDEC-1 hundred and two patients were tested versus the symptomatic group. As concluded in the webinar, We're working on a small quality improvement to help step up the specificity when we measure serum samples from the symptomatic group. This work is progressing.
Continuous test quality improvements is routine in the development phase And even aftermarket launch, and is expected for any diagnostic test. Next page, Page 8. So where we are now is in the final steps of launching the test. The last and final milestone prior to launch is the validation study, which we will have results from by the end of this quarter, that is Q1, 2021. When we have that data, we will file for a CLIA license.
Next page, Page 9. We have been working towards the launch of IMUENOVIA PENKMD for many years, and we are excited that we now are so close to introduce the test to the market. The IMMANUVIA DX lab in Marlborough, Massachusetts, U. S. Is in its final preparations the blind validation study and applying for a clear license.
All the logistics for handling of reagents from Sweden to U. S. Is in place. The logistics for handling and collecting serum samples from patients is in place. We have a customer support and a sales support group in place in the U.
S, And everyone is getting ready and making final preparations. A final marketing and communication plan is in place, and we will just need to push the button. The sales rollout plan is in place And the key clinical target customers have been identified. As you know, we work with most of the clinicians who are engaged in pancreatic cancer in the clinical programs. So we know who the customers are.
And we also have worked then simply with patient advocacy groups in the U. S. And also through them, we will get an excellent communication support and awareness. And we have worked on a reimbursement program since 2015, and we have a clear path forward. I will discuss that on the next page.
Please turn to Page 10. Briefly stated, we will follow a route which is well established for lab developed tests in the U. S. This has a clear path and clear milestones. As you all know, we will launch a test as a self pay test.
This is very common in the U. S. And the people who order the test will pay out of pocket. In order to get the broadest possible utility, 1.6 reimbursement for the test. In our case, This means that we will seek a PLA code.
PLA is short for proprietary laboratory analysis code for the IMRADE PANKENTI test shortly following the data obtained from the Panfam study in the second half of this year. We will then conduct further studies as needed, illustrating analytical and clinical validity and utility. Furthermore, we will, of course, monitor and collect clinical data from our ongoing out of pocket commercial testing. We will obtain endorsement from key opinion leaders and leading institutions. We will then use all of this data and supporting evidence to build a dossier with which we can seek a local Coverage determination or LCD from the National Government Services or NGS, who is the Medicare Administrative Contractor or MAC for Medicare Services Providers in New England region of the U.
S. This is the process that many have followed before us and this is a well recognized path for our reimbursement. We have already, back in 2019, conducted 1 payer study. It gave us a lot of valuable information. However, we will now start a new payer study with a very specific focus on Medicare.
These studies, that is the payer studies, It's extremely important so that we get the latest and best possible feedbacks and understand the landscape best possible way. With that, I'd like to turn to Page 11. Our main focus, 100% focus is right now on the U. S. Launch.
The next wave will be Europe. As you all know, we have a fully built out Immunovia Tx lab also here in Lund in Sweden, and that lab will serve the European market. More details will follow on the timelines. With that, I would like to turn to Page 12. IMUNovia has been extremely active over several years, building a key opinion leader network that can
help us with large studies.
We are very grateful for the support from our key opinion leaders around the world. PANSIM-one is a study where serum samples are collected from individuals with early and wake symptoms. This collection is led by University College London, and they are collaborating with diagnostic centers around the U. K. We have already altogether more than 2,000 samples collected from this study and expect to report interim results in the second half of twenty twenty one.
The PANFAM-one study It's a study where samples are collected from individuals who are asymptomatic or in other words, healthy. However, they have a familiar and or a hereditary risk profile. 23 pancreatic disease reference centers from the U. S. And Europe are participating in this study.
We have collected more than 3,000 samples by now and have little less than 1300 individuals enrolled in the study. Interim analysis from this study is expected in the second half of twenty twenty one. PANDEIA-one is a study focused on the 3rd risk group that is the new onset diabetes type 2 at the age of 50 or over. It is a Swedish study with a collection at 3 hospitals in Sweden. We have more than 6,000 samples collected so far.
We expect an interim analysis in the second half of twenty twenty one. We're very excited about these studies as they represent individuals and patients from the 3 target groups we are aiming for. With that, I would like to move to the next page, Page 13. We have discussed in the past the size of the market. I just want to reiterate that the potential of the Imre Palcin D test is substantial.
We estimate that the total addressable market when all three risk groups are addressed is over $4,000,000,000 And this is only for the U. S. And European markets. We will continue to analyze The total world market over time as we progress. Next page, Page 14.
Now a few words on our pipeline of discovery projects. Next slide, Slide 15. Whilst our main focus is on the launch of IMRE PANCKEND for early detection of pancreatic cancer, We continue to perform early stage discovery studies in the area of rheumatoid arthritis and lung cancer. We have established key opinion leader networks for these discovery studies, both to secure we have the right knowledge mass and of course to secure high quality samples from well defined cohorts. As you know, collection Our samples has been affected by COVID-nineteen in 2020.
As these are discovery studies, Meaning they are in the early stage of our R and D model, it is not my intention to give timelines on these two discovery studies. We will report data when we have new data and information to share with you on these important discoveries projects. Next slide, please. Slide 16. Briefly a few words on the financials 2020.
Next slide, Slide 17. Our income in 2020 was INMONOVIA, SEK360,000. This is some minor royalty income that we have. Operating earnings We're a -1 100 and 34,000,000 in 2020. This should be compared to 2019, where we had an operating earnings of -one 114,000,000.
More importantly, Cash and cash equivalents at the end of the period was SEK 468,000,000. The direct share issue brought in SEK 400,000,000 in June 2020, as I stated earlier. Thus, we have a run rate over 3.5 years based on our last year cash burn. We are, however, communicating in our 2020 year report, a run rate of over 2 years based on our planned ramp up of commercial and development activities IMUENOVIA in the next years to come. If we now turn to the next page, Page 18, which is a summary slide.
And then turn again to the next page, Page 19. So in conclusion, when we launch In rate and Candid this quarter 1 in 2021, we introduced the first test Based on our serum samples for the early detection of Stage 1 and 2 pancreatic cancer, this is a major achievement for immunovia as a company. And it's, of course, a major achievement and will affect patients not the least. We will be the 1st to market in a very large market opportunity. We are fully on track for the launch in Q1.
We have the samples in house. We are ready. The final step is conducting and reporting the blind validation study. Furthermore, We are well funded. We have the means for a full commercial rollout.
And of course, we continue to stay committed and focused to obtain a 30% market penetration long term with IMRE and CANB. Next page, Page 20. Before we go to the question and answer sessions, I would just want to remind everyone that we have posted a series of new tutorials on our homepage. The Immunovia team has been extremely busy lately, as you will see. Hopefully, you will find these tutorials informative.
Thank you very much, Everyone, with that, we will go to the next page, and we will open up the call for question and answers.
Thank you. There will be a brief pause as we wait for questions to be registered. Our first question comes from Victor Sundberg from ABG. Please go ahead.
Good afternoon and thank you for taking my So first, you mentioned before that there's a waiting list of individuals that are interested in the ANGI test. Can you give any more details with regards to this list? And given the guidance, if you should expect the bolus effect when you get clear accredited In quarter 2, also on the topic of sales guidance, you talked in the report about your goal of 30% penetration in the long term. But do you still also reiterate the SEK 250,000,000 to SEK 300,000,000 sales based sales targets for next year? Reason why I'm asking is, of course, that Timelines have shifted a bit since you set that target back in 2018, 2019.
Thank you.
So with regards to the Individuals, I should call them, who have registered with us with their interest in being tested. That list exists. We have a database of that. We will contact these individuals now again to reassure and to update their interest. And they will, of course, be a target group in the beginning.
And it's a group of individuals in the sort of mid few thousands. With regards to this year's sales target, I've been in this industry for 35 years. I've been engaged in launching a number of diagnostic tests. It's always extremely difficult in the 1st year to predict the sales outcome. So I think from my point of view, what we will be So for it's really getting the right traction, getting the trajectory is more important than the Number of tests that we will be able to book, so to speak, in 2021.
It's really about the trajectory, the Acceptance from the key opinion leaders, it is being there to Hopefully, already in the 1st year, enable identification of an early stage, Stage 1 or 2 PDAC patient that has out of pocket enrolled in our program. Those are the types of things we will be looking for much more so than the dollars and cents target.
Okay. And then another question on the accreditation process as well. Your Medical Director, I think, alluded to the last webinar The cat back accreditation might come later than Kli accreditation. Do you still reiterate the time line of cat back In quarter 2 or when would that be finalized and perhaps what steps are left in that process? Also, of course, specific states in the U.
S. Also have their own accreditation Anders, I was wondering if you could give any guidance on the process with specific states and how we should think about the sales ramp up with regards to both the fact that The cap might come later, and that stage could be a bit slower on accrediting your lab. I'm guessing just trying to understand the sales growth here as we talked about in the previous question.
Sure, absolutely. From our point of view, obviously, the most important clear licenses, New England and Massachusetts clear license. And that we expect to routinely that would be 30 days to obtain that license. So that's pretty straightforward. You are right that there are some states like New York State where obtaining a clear license It's a little bit more time consuming, so that will come later for practical reasons.
But with a Massachusetts clear license, we will be able to cover the majority of the states and be active broadly in the U. S. TAP is something where in our thinking right now, sort of a 6 months Post clear license is a reasonable time point. It's not critical right now to obtain that. So right now, I think we think that sort of a 6 months time line for that Would be suitable.
Okay. And a final question here on self pay. I wonder if you could give an update as well on the European launch or the CE Mark process, I guess. When do you expect that to be finished? And when can we expect So that you will begin recording sales in Europe.
So right now, we are 120% focused on the U. S. Launch, and we will be regrouping, so to speak, post launch to look at the time lines for European rollout, and we will be communicating that later. It's premature for me to comment on that on this call.
Okay. Yes. And just Final, final question here also on the PANSSAM study and the path forward with reimbursement. First, Do you think the full results will be available in 2022 as previously communicated? And can you just highlight the road It's a reimbursement for screening test specifically.
Wouldn't that require also a congressional decision or a grade A or B recommendation from USBCTF in order for Medicare to go ahead with the coverage, if that would be local or national? I guess local, as you said here in the presentation.
It will definitely be local. And as you Unaware, we are going not for a general screening approach. We are not proposing general population screening. And therefore, we don't see a reason for choosing any other route than the route that I described. So that is how we see the situation.
And we think that path is actually Very straightforward and well understood not only by us, but largely by the community in the U. S.
Okay. Thank you very much.
Thank you. Thank you. Our next question comes from the line of Alex
And thank you for providing kind of a reimbursement plan for the U. S. But could you also give us a bit of a time line for all of these steps? And then I have a couple more questions.
Okay. Hi, Alex. I think with regards To the process and the steps that we need to take, I think I've been very clear today. In terms of What to expect from a timing point of view? In my experience, We should be able to obtain a PLA code, I would say, within the 1st 6 months of the source PAMFAM results.
And then to get to the actual coverage agreement with the payers. That can vary a bit. And we will get a better and a much Former idea of that when we get the feedback from the 2nd payer study to understand exactly what the payers are expecting the dossier to consist of. So it's a little bit premature. In my experience, That side of it can also go fairly quickly, but we do need to get the more specific and updated feedback from the payers to be very, very specific on that And I'll get back to you.
Sure. I appreciate that. Of course, with the Pan Am results, you mean the full results, not the interim analysis. And towards the interim analysis, which is now reiterated guidance to come in H2, Maybe just for Tantan since that was the press release you released a couple of days ago. What kind of analysis are you Performing, what data will you be reporting?
So most interestingly for us is that this is a cohort That's been put together based on exactly that we will be approaching. And it will provide us a very, very large database of samples where we directly can compare and contrast samples With a familiar and hereditary background, they are healthy. They have no symptoms. They're perfectly healthy, but they do have the genetic traits. We can compare and contrast that with individuals from the familiar and hereditary group with only PDAC Stage 1 and 2.
So it's extremely valuable for us in that sense to get that sort of Compare and contrast with the cohort that is in every sense of the word comparable to the target group, so to speak.
Yes. So this the interim is basically just your And comparing next to standard of care. And then the next step is observational, where it's basically routing patients based on IMUNAVIA cells only. Is that correct?
Yes, that's correct. And Alex, I do want to correct myself a little bit and say to say that In my opinion, this is my opinion and it's based on my discussions with experts in feel I do think that the even with the interim readout from Panofem study in the fall. Depending on again feedback from the payers, from the study that we do with the payer study. There is a possibility that we Could be approaching also and asking for a PLA code just based on that. It's something that we will need to investigate further.
Thank you, Alex.
Thank you. Our next question comes from Caroline Bannen from Zanske Bank. Please go ahead.
Patrick, thank you for taking my questions. Another question on the PANTSAN study. I believe you previously communicated that you plan on recruiting 2,000 subjects. And we recently communicated that you ended recruitment By end of October last year of 1265 subjects. I was just wondering if You could share some details on why it's not 2,000 subjects.
Yes. So Basically, some of that has to do again with COVID-nineteen. Unfortunately, that not all new patients So we're interested in enrolling in the study. So that is sort of the main deviation actually.
All right. Will there be any deviations in the Pansim and Pansim as well?
The Pansim, we already have 2,000 courses. I think we have indicated The Pansyin collection from UCL in London Was in fact also affected by COVID-nineteen. As you know, the U. K. Had a very and still continues to have a very heavy COVID-nineteen impact.
So yes, it is somewhat impacted, yes.
Okay. All right. Thank you, Patrick. Thank you.
Our next question comes from Jack Lynch from Morgan. Apologies, please. Jack's company has not been provided. Jack, please go ahead.
Thank you very much. Yes, a Private investor. Patrick, congratulations on getting the blood samples and for being on target for the end of Q1 with the validation and the commercialization very shortly after that of It's incredible technology. The question is really linked to America and the share price. If this stock is in America right now, I think it will be worth 10, 20, possibly even 30 times its current market valuation here in Europe.
So are you and as this is very much America orientated, particularly now, when are you going to go for an American listing, Use American Research Houses and also start using American Financial Institutions.
Yes. Hi, Jack. I think basically, We also think that the U. S. Financial market is very interesting.
There's obviously a number of peers in the U. S. To whom we compare and from that point of view would be a very interesting market. But I do think that it's a bit premature for us to discuss publicly. Our sort of long term plans for our future in terms of intentions in the U.
S. I think at this stage, we are Swedish listed company, we are launching the product in the U. S. We think the U. S.
Market So in many senses, the commercial market is extremely exciting for us. I myself has worked and lived in the U. S. For almost 10 years. So in many regards The U.
S. Obviously extremely interesting. However, I think at this stage, it's a A bit premature to start discussing sort of long term ambitions with regards to a dual listing or something like that in the U. S, But definitely an interesting thought.
Thank you. Our next question comes from Felicia Retzmeyer from Beitou Securities. Please go ahead.
So hi, Patrick. When you went through the reimbursement plan, so could you please allude a bit on the studies that you On the study to demonstrate health performance and clinical utility once you have already launched, do you expect any? And how And what is your plan regarding these?
Yes. We definitely expect to do Shorter studies in the U. S, the major one will actually be PenFam as The first one, I think, and I think that, that will be very much guiding with regards to what the next Steps are that it's clear that for some of the application areas or risk groups, We will need further studies and this needs to be run by key opinion leaders, American key opinion leaders need to be run local in the U. S. And they also Specifically, we need to have a focus based on the dossier feedback and the dossier requirements that we get.
So we have already 3 studies that we are discussing with key opinion leaders that would be run. And this will not be that long studies, but will be fairly targeted studies.
Okay. Thank you so much.
Thank you.
Thank you. There appears to be no further questions. So I'll hand back to the speakers for any of our remarks.
Well, thank you very much To all of you for your participation and for your interest in IMUENOVIA. As I said, I'm extremely Excited to be here at immunovia as the new CEO. We are on the brink of commercial launch on our first test in the U. S. And I'm extremely proud of the entire immunovia team and the hard, hard work that they have performed not only in 2020, but throughout the years to take us to this stage when we're ready to launch.
So thank you very much everyone and thank you for your interest. Thanks.