Good afternoon, welcome to our webcast where we are going to share with you the highlights of our Q1 report, and then we will take a Q&A session. The whole event is scheduled to last approximately 30 minutes. We have a presentation for 15 minutes and then 15 minutes Q&A. We are doing this today from Malmö in Sweden, where we have held our annual general meeting early this morning or early today. Together with me, as usual, I have Ole Thastrup, Founder and Chief Scientific Officer of 2cureX, and Kenneth Johansen, our Chief Financial Officer. I will start off with a presentation and then hand over to them.
We have structured the presentation so that we can update all of you in the three goals that you know we have set for 2022. These three goals are first one related to our geographic rollout. We said we wanted to have IndiTreat presence, IndiTreat activity in at least 20 countries. The second goal is the number of hospitals using IndiTreat, and in relation to this, our IGNITE program. The third goal is related to the development of our portfolio. The structure of the presentation is going to follow these three. Starting with the first one, which is our geographic rollout, I have to say that although you might have not seen additional countries coming in in the first quarter, actually it has been an extremely busy quarter for us.
Reason for this is, as you know, we closed a number of new deals at the end of last year and beginning of this year. Actually, the last three countries came in in January this year. This means that we have all these distributors that needed to be trained, and we need to set up all operations with them before they are ready to go. That takes a lot of time because each of them has their own sales teams, they have their own setups, and we need to take them one by one. Jesper has been traveling to the different countries, spending time with the sales teams, making the first visits with hospitals together with them.
That's taken time, so we decided that since we are very confident that the goal of being in 20 countries at the end of this year, this is a goal that we are pretty confident that we will achieve because of all the conversations that are already ongoing, et cetera. We decided to focus in the Q1 in getting up to speed all our distributors that we already have, and then start adding to the new countries to the list after that. Maybe worth mentioning that with the people that we have already trained and so the sales teams that are out there in the different countries, in these 14 countries, we have approximately 75 people who are promoting our products in hospitals across Europe, who are offering the IGNITE program, et cetera.
We are very satisfied with the development in Q1 regarding this goal. Although I have to mention because it's important also, we have realized that the hospitals and also our distributors have been on hold for the whole of the COVID crisis, so to say. Although the COVID crisis is over, but there is a lot of catch-up activities going on in the hospitals. Therefore, this means that we have to also position our products and our visits, et cetera, in the middle of this, which is not the optimal environment, so to say. As I said, we are very satisfied with how this is going.
The second goal is related to hospitals using IndiTreat. Here again, you have heard about the IGNITE program. This is the program where we offer hospitals across Europe to try the IndiTreat tests in their real-life conditions, in their environment. I want to emphasize that the goal of the IGNITE program is not to provide clinical evidence, where clinical evidence is already provided by the TICC trial, but it's more to test the IndiTreat in their environment. Now, this program, we are finding very good reception by the oncologists who we have been offering the participation. We have already enrolled eight hospitals, and most importantly, in five different countries.
I want to emphasize this because this means it's not just one or two of our distributors who has started with this, but actually five different countries have contributed hospitals to the program. As you see in the bottom of the screen, we have the goal of finishing Q2 with 12 hospitals. We have eight as of now, and we are confident with the goal of 12 because we have a number of additional, well, many conversations going on from in the same countries, but also from two additional countries. The goal for Q2 is within reach, and we certainly keep the goal of 30 hospitals towards the end of the year.
Next is the products in the portfolio, and here I'm going to hand over to Ole to take care of that one.
Thank you, Fernando. Let me show you what it is we have done with regard to the portfolio. As mentioned on this slide, we expected that three products would be out in 2022, and we actually reached that relatively early in the year. Now I just want to show you that we have these three products, and the latest product, it we call Explore. IndiTreat mCRC Explore, and that is the product that I will spend a little bit of time explaining how that product actually can help patients with metastatic colorectal cancer. You see this circle shows sort of the journey that patients will go through from their early diagnosis, where we have about half a million new cases a year in Europe.
You will see they sort of travel through this circle, and when they come to the red patient, they are all metastatic. There we have about, in total, 250,000 patients that hit what we call first-line treatment. These patients have not been medically treated before. I apologize. We have had a technical problem here that suddenly we dropped off the net. I hope you're all back on live again. Let me then just sort of repeat the last couple of seconds where I showed you that this circle indicates how a cancer patient may travel through the treatment journey that he or she will go through. About 500,000 people in Europe will be diagnosed with colorectal cancer.
The three products we have, mCRC Start, Extend, Explore, are all helping patients in the late and in patients that have got metastasis. Now you will see the first 125,000 patients. That is the number of patients that every year become metastatic. First-line treatment, that actually will be both patients that been diagnosed right away, but others that actually have been through the cycle. That sums up to 250,000 in Europe that every year needs first-line treatment for metastatic colorectal cancer. These are the patients that we help with our first product, the IndiTreat mCRC Start. The two next product will help them if they move to third line or beyond. These are patients that have received all the standard treatments. There we have the Explore, this new product that can help these patients.
Some of you may have seen this slide before. It has been used quite often just to show the whole process. Namely, that we start with little metastasis, run over the, our generation of our Tumoroids, the replicas of the patient's tumor, and then we in our drug delivery system, give them. We test these Tumoroids for all the guideline-based drugs. Now, in the Explore, the difference is that we are now looking at another panel of drugs. The whole test is the same, but we are now using other drugs that may not have been approved for colorectal cancer, but for other indications. Here I've just shown you three examples of drugs that are in this Explore product, namely, Gemcitabine, Temozolomide, and Mitomycin.
As you will see by the areas in which these are approved, with Gemcitabine, that's in lung cancer, breast cancer, and in pancreas, whereas for Temozolomide, it's different brain cancers and then we have the Mitomycin. This is allowed because the patients are this late in their disease state. Then let me show you the TICC trial because the TICC trial is addressing exactly those patients. You may have seen before that the TICC trial was very successful. We did not only meet our endpoint, we actually progressed beyond the endpoint of the trial. The endpoint was that 40% of the patients should be progression-free after eight weeks of treatment. We actually did hit 50%. Let me just show you a number here.
Namely, if we look only at the off-label use of drugs in TICC, in the TICC trial. It was actually not 50, but 56% of the patients that were progression free after eight weeks. That just shows that this new product really can help these patients that are that late in their disease state. With that, I will hand it back to Fernando to talk about the regulatory system.
Yes. Quickly, because this is a question that we are getting often, and especially lately, as most of you know, next week on the 26th of May, the new IVD regulation comes into force. What this means is that all companies have to be compliant with IVD regulation from that date. Now, where are we with this compliance? I'm glad to say that we are ready and in good order. Because in the last year, we have been adapting our quality management system, which as you know is ISO 13485 certified. We have been adapting it to the requirements of IVD regulation. We have everything that is new in the IVDR.
In terms of quality management system requirements, we have it in place. Also important is to highlight that the products that are in the market and CE marked under IVDD, so in our case, the products that allow IndiTreat Start, IndiTreat Extend, and IndiTreat Explore, these products can continue to be commercialized with any changes for three additional years until May 26, 2025. Before that, they need to be recertified by a notified body under IVDR. What is important to highlight here is there is no disruption to our commercial operations and commercial rollout because the products that we have in the market have three more years of life, so to say.
Of course, new IndiTreat tests that will be launched after May 26 th or after next week will have to undergo the new process where the main change is that they have to be certified by a notified body. This is a new process for the whole industry, and we will have to go through it with the new products. The other requirement that comes with the implementation of IVDR is that the products all need to have what is called a unique device identifier, and they have to be registered in EUDAMED, a European database with a lot of information about the product itself, but also the company, the distributors, et cetera. Our products, Class C devices under IVDR, have until May 26th, 2025 to be registered.
No, I think that's. Okay. We are in good shape regarding compliance with IVDR, and we are glad to say that there is no disruption. We, as we mentioned before, we think the effort that we have done in the last year and a half in terms of getting ready and setting up will pay off in terms of being one of the few companies that is going to be compliant in our space. With that, we are moving into the financial highlights.
Yes.
Kenneth.
Thank you so much. Hi to everyone here. I'll give you a quick overview of the financial highlights for our Q1 2022, and a quick highlight again of the annual report which was submitted on the 3rd of May, compiled in the next presentation slides. In financial highlights on our Q1 report 2022, which was released earlier today shows a cash position by the end of Q1 on March 1 st of SEK 63.3 million, which is approximately SEK 9 million more than we had last year due to our equity increase. Our equity ratio is 96% at the end of the Q1 2022.
The result per share in the period was SEK 0.45 compared to SEK 0.12 last year per share. The operating income in this quarter was SEK 0.4 million compared to SEK 3.9 million last year. The majority of the delta between that was the MicroCap grant, which stopped last year. Our operating expenses for the Q1 2022 was SEK 8.5 million, which compared to last year of SEK 6.5 million is SEK 2 million in additional spending for the quarter, also given the increase of the commercial activities that we have had over the last short time actually.
What we believe with this one here and our cash continues to be a strong component and supporting the runway that we have for the existing commercial plans. Here's a little overview to put the different quarters in perspective and an overview. As mentioned, the total earnings for the Q1 2022 was SEK 7.9 million compared to the same quarter last year, which was SEK 1.9 million.
Our total equity is SEK 66.7 million , and our total cash flow for the period was SEK 9.7 million in cash spending, leaving cash, as mentioned, at the end of March, as SEK 63.3 million . Of course, I would like to give the attention to that the quarterly report contains much more information, so I urge everyone to have a read of this, which also includes comments and more exciting stories from both Fernando and Ole as well. In the more graphical overview, it's just to give something different than numbers into it. You see the development at the cash being as presented in the numbers. A quick overview of the 221.
This was presented earlier with our annual report. The year as a whole in 2021 was a total earnings loss of SEK -18.9 million , and by the end of last year we had SEK 73.3 million in equity, and the total cash flow for 2021, which was SEK +14 million . In a graphical overview, so you see the increase for both the cash spending over the last four years, and the overview of our equity and the overview of our cash. With this in mind, I also would like to put the attention to our quarterly or to our annual report, which I know most of you probably have seen, but it's always a nice read.
It contains quite a lot of information of the operation and business of 2cureX as well, in addition always to the numbers and how we have performed. With this, that was the presentation on the quick highlights of the Q1 in 2021, and I think we would move to a Q&A if there are questions among the audience for today.
Yes. I shall try to sort of direct the questions that may come from you. Please use the chat function to forward any question you may have. We shall try to answer as good as we can. Before questions are rolling in, maybe I could. There's been a couple of asks before the meeting. One is actually that the board have nominated a new board member, Michael Schaefer. The question was, how do you think that will help 2cureX in moving forward? You know, being on the board, maybe I should say that Michael Schaefer have a very impressive history in the diagnostic industry. He's worked in diagnostics companies like Bayer and Sysmex.
He has a global experience with regard to developing these companies. That is both with regard to setting up distributors throughout Europe, Asia, and in other territories. The knowledge of how we actually can develop the company, both with regard to making our technologies more available in these different territories, but also to see sort of how these distributors made excited about our technologies and building that network. We certainly hope that the general assembly that you will be informed later will approve this suggestion by the board. Another sort of question that came in before the meeting was sort of. We have seen that before, and that relates to when do we expect sales will occur. I'll give that to Fernando.
Yeah. Thank you. To answer this question, I think I would like to emphasize that there is a process to get to sales, and this process starts with oncologists showing interest in the IndiTreat test, and after that, oncologist and the hospitals where they work agreeing to join the IGNITE program, and then getting some testing done under the umbrella of the IGNITE program, and then engaging in the commercial operations. This is a process that is more or less standard everywhere. Now, the steps in this process and the duration of the steps in this process is quite different. We have different countries, we have different environments. We have customers who are private hospitals or belong to private chains. We have public hospitals.
The processes are very different, et cetera. I don't dare to give a specific date for the first sales, and I think the reason for this is that when we commit to something, we want to make sure that we can deliver. I think this is what we have done so far. We have been delivering on what we have promised, and I don't want to depart from that attitude. I have been told that I am too conservative, maybe, but I think it's better to do it like this. What we can say is the process is going well. The different steps, the number of hospitals that we have in these different steps of the process is going well.
For sure, we will see sales rolling in this year. I don't want to give a specific month or date now. Just be confident that the process is being followed, and that if the process is being followed, it's a matter of time that the sales will come.
Again, I encourage you to send your questions, put them into the chat room. Let me take also one that came in before, and a tricky one that does not sort of. It's not specific to 2cureX. I think we all have seen that the market is pretty depressed at the moment. We've had a couple of shareholders who said, I mean, "How can you comfort us of that 2cureX is the right investment?" This is a tricky one, Fernando, but I don't know whether you dare to comment on that one.
Well, I mean, first, we know that it is probably one of the most challenging moments in the last years worldwide in terms of the capital markets. We are sympathetic with the investors that are suffering from this. From our side, we think that the best way that we can support and help our shareholders is by actually focusing in the development of the business. There is not much we can do in terms of the share price itself. We are fully committed to delivering on our plan. We are fully committed to delivering on the promise of 2cureX as an investment, as a business, as a tool for oncologists.
We are sure that if we stay within our plan, and we deliver according to our plan, at one point, and hopefully sooner than later, the share price and the real value of the company will converge again. That's all we can do at this point.
Now, we promised you that this would take 30 minutes, and again, I apologize that we had a couple of minutes cut out. It was without our involvement, so we didn't know what happened. If you have a last question, we can have it. If not, I will ask Fernando to close this webcast. Okay.
You-
Me? Okay. I apologize. I mean, the net really gives us challenges this morning. There is actually a number of questions, so let me take it here. The first is, "Has any of the IGNITE agreements been transferred to a commercial client?"
Well, I would say not a commercial client, because all the customers that are involved in the IGNITE programs are by definition potential commercial clients. The question is whether the IGNITE agreements have already transitioned into a commercial contract. The answer is not yet.
There's a question here that relates to our goals for 2022. "Why do you not have sales as a goal this year?" That's literally the same, and I guess you have.
Yes. We have modeled, obviously, the business, and there are a number of variables in this modeling, and these variables go from number of hospitals to number of samples per hospital to percentage of patients who are eligible for IndiTreat to number of other things. There are a lot of variables in the model. Many of these variables have not yet been validated in real life. We are starting to see now which parts of our assumptions were right or not, et cetera. We will not provide a sales guidance until we are sure that what we are saying is solid and is founded on solid ground.
This is the reason why we have not yet provided the end goal, which is the sales. We are there to provide the intermediate steps, number of countries, number of hospitals, et cetera. We first need to validate our model before we can say whether the sales is going to be X or Y. As soon as I mean as we are rolling and in the coming months we will get real-life information about the different things, that's I think the moment when we can issue a sales guidance.
Yeah, this is obviously very important for our shareholder, as it is for us. The next question is so exactly the same. When can we expect next sales and increase in operating income? I think you have answered that one.
I think we have.
Let me take the next that relates to our IGNITE program. Now, we have been in contact with a number of oncologists in the IGNITE program, and want to hear what are the feedbacks from these oncologists.
The feedback, as I mentioned before, but I want to emphasize it, the feedback is very positive. We have not found anyone who told us this is useless or this is a product that I wouldn't use. From this perspective, very positive, and most of them are actually saying that they would like to try it in the context of the IGNITE program. What we have to realize anyway is that we are offering them a tool, let's say, that changes the way how they make decisions. Today, they have been making decisions without this tool for quite a long time, and also the guidelines don't require this tool.
Although they see the value and they want to try it, and then eventually after trying it, using it takes time, and that's what we are seeing. It takes time for them to get started with it because it's a new thing. I mean, any time that we are coming up with a new technology, with something that is disruptive, especially in the diagnostics, but in general in medical devices, it's. Okay, now I have stopped seeing, but I hope that it's still going on. Every time that we have introduced a new technology, we have seen that it takes time. It's never immediate. But again, the feedback is very positive.
That's why we are very encouraged, and that's why we keep saying that we think that the goals that we have for 2022 we will fulfill because we are not seeing any pushback. Actually, yeah, what we are is encouraged to continue with the direction that we have taken.
To the last question, and that is sort of which countries have hospital that have enrolled in the IGNITE program?
I don't think we have disclosed that, and I don't know if that can be considered privileged or not.
Yeah. I think that.
Maybe if we want to answer to that, we should do it in a public way probably. We can. We will. When we show a new update about the progress of the IGNITE program, we can include that information in the update.
Yeah. With that, this has been a little bit of a technical challenge, I have to say, and again, apologize for that. We are so busy in developing the company, so but thank you very much. Fernando, do you have a concluding remark?
No, just thanking the shareholders who participated, encouraging you to participate again next quarter, emphasizing that we think we have had a very good first quarter. It has been an extremely busy beginning of the year, and that we look forward to updating you again in August with the occasion of the Q2 report. Thank you.