Hello, and welcome to the Immunovia Q1 conference call. My name is Jess, and I'll be your coordinator for today's event. For the duration of the call, your lines will be on listen only. However, there will be the opportunity to ask questions, and this can be done by pressing star one to register your question at any time. If at any point you require assistance, please press star zero on your telephone keypad, and you will be connected to an operator. I will now hand you over to your host, Mats Grahn, CEO, to begin today's call. Thank you.
Yeah. Good afternoon or good morning, wherever you are. It is a pleasure to welcome you to this quarter one report from Immunovia. We will today, after this slide, also go through the agenda, which is the first quarter highlights, of course. It's our response to the ongoing pandemic. We'll talk about the remaining steps to launch of IMMray PanCan-d, our test for early detection of pancreas cancer. Touch on the commercial launch preparation activities, the prospective studies. There will be some short information about the upcoming AGM, and we'll finish off with questions. The first thing is the highlights that we have had in quarter one. The most important thing is, of course, that the verification study of IMMray PanCan-d proceeds as planned. We did receive all the required blood samples and actually more from our network for the verification study.
The commercial team also worked hard with preparing the detailed plans for the launch, particularly during January and February. When the pandemic hit in March, these plans had to be adapted significantly to accommodate the situation. I will touch upon that later in the presentation. Of course, what happened was that in-person activities such as conferences and patient organization meetings, both very, very important for awareness and knowledge about the test, were canceled and now has been turned into digital activities in a successful way. Furthermore, an important step in quarter one was that we welcomed our new Senior Vice President of Sales for North America, Mike Pettigrew, to the team. Also we proceeded with our discovery study in lung cancer, even after the partner on pharma side decided not to continue.
We have all the control over samples and continues as planned, and we'll be reporting that in quarter two. Shortly on there, before I move on to the COVID-19 situation in the Q1 report, you can also see that our cash flow for the quarter was about SEK 40.5 million. Most importantly, we have SEK 223 million at hand, which means we have over a year with the current business plan moving forward, which is great in these times of corona unrest on the market. Let's move to the response to the pandemic. This is, of course, extremely important for all companies right now, and I'm happy to say that we are pretty well off, and I'll talk about the impact that has happened. We have, of course, work-from-home policies introduced for the employees.
Even if you're healthy and you can work from home, they are doing so to minimize the risk of infections. If people have symptoms, cold and so forth, then it's of course mandatory to stay at home. This leads to some reshuffling in tasks, of course, when people have to stay at home and so forth, but we have been able to manage that well this far. When it comes to activities that require that staff is in place, the R&D labs in Sweden, the clinical lab in Sweden, and the production facilities still fully operational. We have managed very well during this first period of the pandemic thanks to the loyal and flexibility of the staff, which we are really happy about.
The COVID-19 also, for the ones who are not familiar to the local situation, in South Sweden hasn't had any major impact yet, as opposed to the Stockholm area, for example. In that sense, we are also fortunate to be located here in the South of Sweden. None of our employees are infected this far here or in U.S. or elsewhere. We, of course, constantly follow the guidelines and changes or orders from authorities in the geographies where we are active. Particularly focusing on U.S. in the right corner of this slide, the clinical lab is well prepared with detailed plans for the sales part. However, as we reported 1st of April, the state went into a shutdown and stay-at-home orders for all people. 1st to April 7th, that has during the last weeks have been prolonged to May 4th.
That, of course, is a challenge for us where our staff in the lab are not allowed to go to work and has to stay at home. We'll touch more upon this later in the presentation. When it comes to other activities to mitigate COVID-19, we were successful during Q1 to stock reagents, consumables, and chemicals required for our work leading up to the launch, and also having all instrumentation in place and installed the last things right before things got a little bit difficult. We are very well-equipped on that side and have been able to continue to fill up with what we need. That is fully under control. Moving forward then to our clinical collaborations with all the hospitals across the world.
They are, of course, following the national guidelines and local guidelines or regulations, which means that many of our sites, or most of them actually, have stopped clinical trials in general, including sample collaboration. This is because they, of course, have reallocated resources, clinicians and staff to COVID-19 care. Some places, it's not even possible to get into the hospitals to pick up, for example, collected samples that are there. Also individuals that are in the clinical programs, even if they would like to, they may not be able to travel or come to the hospital given the situation. That's why the sites are affected in that sense. However, there are also a good situation for us because we managed to get all the samples we needed and even more for the verification studies delivered to our sites in Lund before any of this shutdown.
We are in a good situation compared to many others there, and we are working hard in various ways to also secure the last ones for the validation, which we'll come back to as well during the presentation. Let's move over to the remaining steps to launch and the details of some of the challenges we have and how we work with them. As you're aware, we are at the verification study. That is important to verify the functionality and the performance of the locked test, IMMray PanCan-d, both the signature algorithm and so forth. This is done on the known samples, and we are working hard to complete that one. That leads over to this next step, the validation study. We have come this far, and we have over the years overcome numerous obstacles, now finally, we have to overcome the corona situation as well.
We will. We will be the first to market with this test that no one else has been able to do before. We are still on the same path here. We are working hard to overcome the last hurdles caused by the corona. Everybody else is affected by that as well. I'm very confident that we'll be the first to market. Let's look into a little bit to the details of what's happening in Massachusetts, specifically where we are located outside Boston. This is now our main time risk, so to say, for our plan for the launch in Q3.
That is because the lab, as we have stated in the press release and also in the update of the 1st of April, is fully ready with the plans, what needs to be done from now until launch, including accreditations and sales starts and practical setups and so forth. However, since as of today, Massachusetts has extended this statewide mandatory closure of what they call non-essential to COVID-19 businesses and also stay at home guidelines all the way until May 4th. Losing more than a month of practical work there is a challenge, which we meet by doing replanning for different scenarios. We are reallocating tasks between Massachusetts, the lab in Marlborough, and our team here in Lund as far as possible. We are reallocating samples that are required and everything that is possible.
It is a critical activity and we need to get the lab opened, but we are in the hands of the authorities there. It's still possible to move to the targets, but it's the main risk. I want you to be aware of that. Looking a little bit into the detail here of these two last steps, the verification study followed by the validation study. The validation is done on locked signature analysis on blinded samples. We have most samples in-house, but specifically for the U.S. launch. We are focusing to secure transfer of some samples that are already collected but are at hospitals where we currently can't get in. We are although confident that we will be able to access them as soon as things ease up a little bit, just especially in U.S. hospitals.
We are also getting positive feedback on collection of remaining samples, mainly for the CE marking that will happen in parallel. We also, of course, use the mitigation of excess samples for the validation collection and reallocate it as much as possible to the activities in validation. This is important to understand, and we are working really hard to meet this. I also want to make sure that you understand that the subset of the studies, particularly the validation, has to be performed in the CLIA/CAP laboratory in Marlborough for the U.S. accreditation to CLIA/CAP. We are, of course, doing everything we can to minimize the impact of this close down and are ready to go as soon as possible after the opening, as soon as our people get into the lab.
However, we have worked hard on reallocating tasks, and our team in the U.S. are actually doing great work from home, even though they can't be in the lab, even supporting with digital tasks the people in here in Lund facilities and vice versa. For example, doing important work on results coming from the scanners overnight, so they're ready when the people here in Lund come to work in the morning and so forth. It's a constant replanning, reshuffling. We've been successful this far, but it is very tight, and we really need the authorities to open up the ability to go to work in Massachusetts. Okay. Let's move over to the commercial side and talk about the commercial launch preparation activities.
I mentioned in the beginning here that the pre-launch activities that was planned in detail and ready to go had to be replanned in March because of important clinical conferences, which are really important to meet the key opinion leaders, the clinicians, the gastro people, and so forth, to introduce the test, and make them really aware in a broader sense than we have now when we are closing in to launch. That is not possible face-to-face because the conferences have been canceled during foreseeable months here after launch. Same thing we have had in the last years, extensive collaborations with the patient organization and taking part in numerous, what they call walks or patient meetings, in all the major cities, basically in the U.S.
Since these ones were also canceled because you can't gather thousands of people in that way either, digital plans have been put in place, and we also increased activities in a very innovative way from our launch team and our commercial organizations. Example of this are that conferences where we will present are now step by step getting turned into digital conferences. The latest example here is that the big and very important, most important key opinion leader meeting in Europe, called EPC, it was planned to be in Paris, now will be a digital full meeting where Immunovia is presenting the test and other things. That's now set in stone and will happen. Even more important, in collaborations with one of the major patient organizations, the patient organization meetings that normally take place physically in different cities.
There was a plan for a huge one outside the U.S. in London this summer. That one has now been turned into a virtual digital walk, and we have, I think today, announced it on our homepage, when and how it will happen. That means that even U.S. investors are interested in the company, and the test will be able to take part in that one that way. This is something we worked on our initiatives from our team with the patient organization in U.K. It's first of its kind ever globally, and we believe this is a great concept that we will try to move further into other countries as well and other languages. If you are interested to take part in a virtual walk with patient organizations, check it out on our homepage, and it will happen in June. Right. That was some examples.
When it comes to the sales preparation and launch preparation activities that are maintained, that relates to, for example, setting up the sales system, building the sales training packages for people they are onboarding right now, completing sales tools, and do a lot of target mapping, meaning that we, in detail, continue to map up each individual in key hospitals and gastro centers that we want the salesforce to pay visits to and target. They will be extremely well prepared and targeted to maximize the use of their time. That's short about the commercial launch preparations. Been a lot of work to reshuffle, but we believe we're in a successful path in this area. Next slide is about the prospective studies.
I mentioned in the beginning here that the sites, the hospitals that take part in this, and there are many, as you know, in the three studies we run. We run the PanFAM for the hereditary familiar risk group. We run the PanDIA-1 for the people who are over 50 and get the first diagnosis of diabetes, and PanSYM for differential diagnosis and a rule out of pancreas cancer. All the three ones have been running. As you know, the one that is affected by this situation the most is the PanFAM, because risk people have difficulties or cannot come to the hospitals for their checkups or leave the blood sample right now, and/or the hospitals are reallocating resources to the COVID-19. That means that the PanFAM 1 will be postponed even interim, at least to next year, 2021, Q1, Q2. That's for sure.
PanDIA-1, the big study that we run here in Scandinavia, in Sweden particularly will not be affected as the sample collection is very well advanced already stage, and actually it's still ongoing, has not been closed down since it's running here in the south of Sweden, where the infection of COVID-19 has been very low thus far. When it comes to PanSYM-1, we are confident that the intervention phase which is planned to start early 2021 will be planned accordingly and move on there. It's really only PanFAM that is affected. This is a much, much better situation than any clinical trials, for example, in the pharma side, which is very difficult if it's interrupted. This is also under circumstances, under control.
Next area, this is just a summary, the slide of the pre-prospective studies as you have known them from before. It is the ones we just talked about. Finally, here now the AGM announcement and details. For that, I will leave the word to Julie Silver, our IR Director.
Hi, thank you again for joining us. This is Julie Silver, the Director of IR. I wanted to just do a brief announcement on our annual general meeting. As previously announced, the AGM will take place on Thursday, May 7th, 2020 at 4:00 P.M. Details can be found for this on the press release for the AGM that was dated April 3rd, as well as on our website. I wanted to take this time to just assure people that we are taking every precaution necessary in accordance with COVID-19 safety requirements. The meeting will be kept as short as possible. No refreshments will be served. Seating will also accommodate the COVID-19 safety requirements. Shareholders, agents, and/or assistants who feel the slightest bit ill or who have the relatives that are sick or belong to the COVID-19 risk group should not attend the meeting.
Shareholders should consider voting by proxy. The company, if necessary, may actually take further precautions at short notice, depending on what is happening with the pandemic. We urge you, all shareholders, anyone who is interested in attending this meeting, to follow the company's website at www.immunovia.com for any updates to this information. Now I will turn this back for Q&A.
Right. Just before we start the Q&As, I will just have a few summaries on this one. Actions taken successfully to date to combat the situation with the pandemic. We are on a critical timeline, but still on the timeline. We remain focused on the launch of IMMray PanCan-d. We will be the first to market. We are ready to adjust to any unforeseen circumstances. We know there will be more of that going forward, of course. Specifically, the Massachusetts closure is the current main risk. We will work hard on that and update you as soon as we have a clear picture of what that means. We will be the first to market solution for early detection of pancreatic cancer. This, don't forget about it, is major market opportunity exceeding $4 billion over time.
This is a great place to be in, and we are sure we will take the chance to meet the remaining obstacles to get to that position. With that, I'd like to open up for questions.
Thank you. If you would like to ask a question, please press star one on your telephone keypad. Please ensure your line remains unmuted locally as you will be advised when to ask your question. Once again, that's star one if you would like to ask a question over the phone. We have just had a question come through. This comes from the line of Michael Löfman. Please go ahead.
Hi, Mats. I was just wondering about the discovery studies of RA and Lung. Are they still on schedule for Q2?
Right. I suspected I would get that question. We actually prepared a slide for that as well, which you hopefully can see now. This is the general path of all studies all the way from very early stage all the way to commercialization. As you know, we are at the end of that now for IMMray PanCan-d. When it comes to lung cancer, it's in the analysis phase, actually. We have run the samples that we did achieve from our previous collaborator, and that's now in our ownership and use. We will conclude that as we have announced earlier in Q2. When it comes to RA, we have the samples at hand, we have the clinical data. I can't be 100% sure when, so we will announce it when it's ready.
The reason for that is that we are now really allocating all the resources we have to the PanCan-d to make sure that we meet our objectives and targets on the PanCan-d side, because the key value in the company right now and for the foreseeable future is to succeed and to capture the pancreas cancer diagnostic market here, and really meet the timelines on this one. We are doing a lot of reallocation of people just to meet the effects of the corona, and so forth, for different tasks day by day. At any case, we will always prioritize PanCan-d. That's why I cannot be sure to promise when the RA data will be ready.
Okay, great. Thanks.
The next question comes from the line of Oscar Milner. Please go ahead.
Hi, Mats. Thank you for the update today, and good to hear that you're all in good health. Last year, around this time, I think you estimated that Immunovia had connected with some 24,000 people via different patient organizations.
Yes.
Could you give an update on where you stand in numbers and so today?
Yeah. The figures you referred to were 2018, approximately, what I can remember. 2019, we had even more meetings. I believe it was around 35,000 people that attended these meetings, in U.S. particularly. We spent the last two years in close collaboration with the patient organizations, and we visited and informed and met people and took contact details of people who wanted to be on our waiting lists and information lists and so forth from these ones. It was about 25,000 in 2018 and 35,000 in 2019. We had planned for this year even more on these visits. We did some of them this year as well before the corona shut all of them down.
That's why we now have this initiative with doing digital walks. It's actually our idea that our commercial team has come up with and worked with the first patient organization here to run the big one in London. We also hope that the U.S. side will jump onto that train and we can continue with digital ones this year. This is important to continue to build awareness and demand from the self-pay group of particularly the hereditary familial group.
Yep. Great. I have a second question. A term I hear often is golden standard when it comes to these tests. Could you speak a little bit about what that is, what that means?
Oh, yeah. It's very nice to do that in this area. The problem with pancreatic cancer is that there is nothing really that functions when it comes to a blood-based test or a simple test for early detection. There is one single marker called CA19-9. You measure one thing, which is a standard test. That's actually most often in the guidelines should only be used for recurrence monitoring. It's anyway measured on many patients. I wouldn't call it a golden standard. It's the only thing that's there. It's not really working very well by itself. The other golden standard you can say in this area would be imaging then, which is the current way to diagnose, only way to diagnose pancreatic cancer and will continue to be important. That consists not only of CT, the standard CT, but it's more MRI and endoscopic ultrasound.
In other areas of diagnosis, there may be golden standards of other blood-based or simpler tests and so forth. In this area has been unmet clinical need, and that's one of the strategic reasons why we picked this one as a target for our first product.
Thank you.
There are currently no questions in the queue. As another reminder, please press star one if you would like to ask a question.
We do have some questions that have come in via the web section of this call. I can actually ask some of those at this moment while we're waiting for more call-in questions.
Great.
The first one is the EU launch postponed? When do you expect the EU launch?
Yeah. As we have said before, the U.S. launch comes first. Then we will in parallel continue with the validation part that belongs to the CE marking. It will come a number of months after, simply as we have said before. It's not postponed in that sense at all. It's just as planned as before.
Great. Here's question number 2. When will Immunovia be comfortable enough to provide medium, long-term financial guidance and discussions on market penetration?
Yeah. That we will do once we have got into a sales situation and seen the uptake. It is very difficult to predict the uptake before. We have great hopes, great feedback this far, and we will do that when we are in a sales mode.
Great. Thanks. Question number 3 is, in the Q1 report, it says that you increased your staff by four people. Can you tell us what additional positions you have filled other than adding Michael Pettigrew?
Aha. Okay. That is great that someone is reading the details. I like that. Yes. We are hiring. One of the few companies that are hiring in these times, I guess, but it is great because we are following our plan to increase and prepare the commercial organizations particularly. There has also been some additions to the production to make sure we have the ample capacity needed. We will continue to do that as we move forward. It is actually, believe it or not, a pretty good time, especially on the commercial side, to hire very qualified salespeople and commercial staff, given that unfortunately, quite a lot of other companies have issues, and there is a strong interest for us then. Particularly this is important in U.S. right now that we can have great discussions with very strong candidates.
Great. Thanks, Mats. Here is another question coming from the web. When will you be able to update on the situation in Massachusetts?
Yeah. We anticipate that the governor has to, of course, come up with a decision how to move now after the 4th of May, when the current rules that apply are going out, so to say. There are the stay-at-home guidelines, and also non-essential to COVID-19 business are allowed to be open until May 4th. As soon as we get that information, together with our own planning, we'll be able to update what the impact is. We hope that it will mean that our staff can get back to our lab. That would be ideal, of course.
Great. Then the last question we have from the web is, how are you actually allocating the time or the use of the lab in Lund now that the lab in Massachusetts is closed?
Yeah. Just to add to the previous question before I take this one, is that unfortunately, if you look upon what's happening in Massachusetts, it's really the state that is right now in the center of the COVID-19 with the highest increase. On the other hand, there are discussions even in New York about opening up step by step here. They are close to each other and follow each other. We'll see. The question you asked now was about how do we allocate the resources between the labs and the tasks. Well, there are some tasks that have to be done in a particular lab for regulatory reason, and then we can't move, of course.
We try to, as I mentioned before as well, there are activities that once you have done the wet running of the work in the laboratory, running the samples, then you recreate these pictures, as you may, from the scanner that scans our slides. These ones in a research mode has to be worked upon digitally, and that our team in U.S. is doing when it's night here in Lund, and when the staff in Lund comes back, it's ready for further analysis work. That's very efficient. That's what can be done from home, of course. There is a lot of, you say, standard operating procedures and guidelines and things that are important for the accreditations and so forth that are updated and maintained and changed and adapted and some new created that are still missing.
That is work that is exchanged between the labs and also between the U.S. clinical lab here. We have introduced some and installed some new equipment before the corona, and they are, of course, validated that they work as they should, and that work can be shared between how to do it and so forth between the labs. Anything that can be done from home, our team in U.S. is helping out with or doing for their own needs later on, and preparing everything until they come back. Of course, the key thing, as I mentioned before, the focus is priority is on everything has to do with the PanCan-d launch. That's why, as I mentioned before, I cannot promise any RA data. We don't seem to know. We have it and it can be run and so forth.
We will do it once there is a time slot available. PanCan-d goes first in the Lund lab.
Great. Thanks. I think I will turn this back to the operator now to take any more calls, questions from callers.
Thank you. We have another question in the queue, and this comes from the line of Lars Hedren. Please go ahead with your question.
Yes. Thank you. Can you just remind us about the publication strategy, et cetera? I was thinking in particular about the commercial test model study you press-released in December 2019, a fairly significant one. What's the strategy behind that and also for the upcoming test results that you will achieve?
No, this is a very relevant question because publications are a crucial element for the commercial process going forward. As we talked about before, we are now intensely working in the last parts of the patenting process that became more extensive than we thought, which is a good thing from a protection point of view. Once that is finished, we will combine data also from the optimization study and the CTMS and potentially some other steps going forward with the verification. There will be as much as possible when it comes to publications there. It's very important for commercial reasons moving forward. We will then, of course, also make smaller publication of activities that will happen in the lab in the U.S. to have local data from there and so forth moving forward.
We have a data plan of publications that we need during the year and onwards for market reasons.
Okay. Is there any opportunities to maybe post-launch to produce real-world data, so to say, or how will that be monitored from a public?
Absolutely
could be published, yeah.
Absolutely. The biggest things are, of course, the prospective studies, interim results of them, and later on, full results as well. That's going to be made later. We are also working with quite a few of our key opinions to define what we would call market studies, that are smaller studies but can be very important for support of the sales process, that are much faster and that we may publish in publications that time-wise fits us as well.
Okay. Thank you.
Yeah. More important is that these ones are interventional, and that is really, I guess, what you're after, because that's really important moving forward. Okay. Do we have other questions?
We currently have no questions in the queue over the phones. As a final reminder, please press star one if you would like to ask a question. There are no further questions over the phone lines.
I'm going to just finish by reminding you of the summary. I believe our team and all our staff is doing a fantastic job to mitigate the current hurdles with the pandemic. Very focused team on the launch of PanCan-d and all activities that needs to happen to get there. We currently have the main risk at the Massachusetts closure. We will overcome that one as well, and we'll give you update as soon as we have clarity on that moving forward. The most important thing to remember, even though this COVID-19 is in the way right now, we will be first in the market for a solution for early detection of pancreatic cancer, addressing a huge market opportunity of over $4 billion. It's a great time for the company, even though there are difficult times for the world at the moment.
As we all come out of this, we will have a great situation moving forward. Thanks a lot for listening, and we'll be back as soon as possible we have new updates. Thanks for listening.
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