Okay, I think we will start. Hi, everyone, and a warm welcome to this presentation on the Ethics Committee's approval of clinical strategy in Jodhpur, India. Of course, we, in the company, are very excited to have reached this incredible milestone, and to have been able to share this with you is a great feeling. I believe that one of the most important parts of our trials is the fact that they're being conducted at All India Institute of Medical Sciences, AIIMS, an incredible institution which has 20 operational university hospitals all over India. Not only does this provide a credibility, having chosen to pursue our trials, but they're rather unique, given their large exposure to patients.
As you can see here, the fact that they were created by the government as an institution for national importance and having international recognition, it's a major factor why ChemoTech approached them. The India- Sweden Healthcare Innovation Centre have been an instrumental part of us providing a unique passage to decision-makers and researchers at AIIMS. Here, we are the technology partner in their Center of Excellence for Head and Neck Cancer Treatment. Given that the innovation center is the result of a bilateral agreement between the Swedish and Indian healthcare ministries, funded by AstraZeneca mainly, and administered by Business Sweden, it ensures a roadmap of moving forward. The center has about 25 startups working there, all with technologies of interest for the global healthcare system. ChemoTech is actually one of the most successful cases in this project.
Today, you'll hear more about the giant step that ChemoTech has taken in the world of cancer treatment, and I'm glad to welcome Suhail Mufti, our Chief Medical Officer, who will share more about the importance of the ethics committee's approval and clinical strategy. So Suhail, I leave it over for you.
I am not sure that Suhail has been able to connect, unfortunately. We have a little bit of a technical issue here. We excuse ourselves for this mishap.
Shall we move over to the market side instead in the meantime, or?
Yeah, let's...
We're giving a second, maybe. Well, while we wait, I might as well share a little bit about the innovation center, which is an incredible institutional venture or initiative that's come along. It is quite rare in India, actually, and right now, having something which is going on all around the country, is that the government is setting up these centers of excellence in various, in this case, medical colleges. And it is this one is the biggest and most successful one. And why it's important also, because in India, given that this is our largest market for human care, it is a very, very large potential, I would say, for anyone coming in, in these initiatives.
The Center of Excellence are a government-sponsored in the sense that they set up the structure and help out to attract everyone. Now I see that we have Suhail, so I will hand it over to you now. Thank you. Welcome back.
Hi, good morning to everybody. So, this is-
So... Sorry.
Yeah.
Right.
So an exciting year to start with at ChemoTech. We have our clinical trial amendment, the protocol which was running at AIIMS Jodhpur for the last close to one year now, and we have done a landmark amendment in the protocol, which is to include Tumour Specific Electroporation into earlier paradigms, into curative paradigms, in head and neck cancer. So I have highlighted for you here the two inclusion criteria which have been amended, and this is for the first time ever that electroporation has reached to the level that it can, in combination with other therapies in head and neck cancer, be given at an earlier and an earlier paradigm, I would say, in head and neck cancer. So we are here including patients who do have a recurrence, but are still curable and are eligible for radiation.
That means they've not received either radiation in the first line, or they haven't received the full dose of radiation. And we are interposing Tumour Specific Electroporation to do the immune sensitization and increase the efficacy of radiotherapy, and ultimately increase the chances of complete cure in head and neck cancer, which is locally advanced. The other major inclusion is highlighting the immune potential of TSE, and there we are giving it to those patients who are eligible for targeted therapies or even immunotherapy, and thereby immunomodulating the tumor and increasing the chances of the efficacy of checkpoint inhibitors. ... The endpoints are very specific and very direct, and will give us very clean data. Our objective response rate is going to be the major endpoint, the primary endpoint, which is at two weeks of giving TSE.
And then patients may receive other treatments, but we do receive clean data, not only the basis of clinical outcomes, but also on the basis of the biomarkers which we are using. You know, biomarkers are the most important surrogate endpoints, which highlight the areas where the biology of the diseases and where the targets are, and where the therapy is hitting the targets. So what we are doing here is, we are doing a battery of immunological biomarkers, which include the immunohistochemistry-based biomarkers and flow cytometry-based biomarkers like CD34. We're using these are the tumor-infiltrating lymphocytes by which we will be confirming that the tumor has been converted from a cold or a barren tumor to a hot tumor. We will be out with this data very soon, and of course, this trial is an AIIMS internal trial.
It's an Investigator-Initiated Trial, but we do collaborate with them very closely on an academic front. From a scientific standpoint, we do have a discussion with them, what the outcomes of the biomarkers are. So stay tuned, we'll be coming up with some good academic news for you. Now, this is for you. This is a very busy slide. I'm sorry for that, but this is to highlight that there are three columns you'll see in this flowchart, and the trial used to be only in the palliative care setting, as you see on the left, here, that only those patients who had unresectable, loco-regionally advanced, and in a palliative care setting, the trial used to go.
All, most of the trials in electroporation, be it irreversible electroporation or static reversible electroporation, most of the research has happened on the palliative care setting and has been restricted with outcomes. What ChemoTech has done with Tumour Specific Electroporation, and in itself, the technology of Tumour Specific E lectroporation has, I would say, found space in the earlier curative lines, and that's where we are taking it into those patients who are still eligible for radiation. We give TSE before that, or those patients who are eligible for chemotherapy, immunotherapy, or even targeted therapy, we're giving TSE before that to increase the chances of complete cures.
Now, again, I would like to highlight the accrual rate, that is, the enrollment rate in this clinical trial is going to be, you would say, dependent on the busy hospital schedules of the doctors in the AIIMS busy center, which is a very, very high-volume center as far as the oncology setup there is concerned. So it's their internal trial, so we are dependent on them to get the right information regarding the accrual rate. Of course, they're doing their best. The researchers there have reached to this level and have taken electroporation to the next level. Next slide, please. Yeah, so coming to what are the outcomes of this clinical trial?
On one side, it's going to give a landmark treatment modality available for oncologists, the surgeon, the medical oncologist, and the surgical oncologist working for head and neck cancer, be it in India, South Asia, where head and neck cancer is very, very... You would say the prevalence is high, and even in the West, with other types of head and neck cancers, like the HPV-positive ones. So it has given one more modality of high efficacy to use for, and has, this trial has found the positioning of electroporation per se and Tumour Specific Electroporation in particular. Now, the outcomes of this trial would be that other solid tumors would also benefit. Of course, breast cancer. I would highlight one area, triple-negative breast cancer.
That's very, very, that's a very, an area of need in breast cancer, even though, breast cancer may have multiple modalities of treatment, but triple-negative breast cancer, we don't have much, and they are barren tumors again. So there, in those locally advanced cancers, TSE will definitely find a role, and we need to do more studies. Then in neoadjuvant, that means before the surgery, reducing the cytoreduction of the tumor, reducing the size of the tumor so that other drugs work well, where radiation has been used at the moment, chemoradiation with a lot of side effects. That's where TSE, again, will find its positioning. Also, in those tumors with difficult to resect, say, in pancreatic tumors, those retroperitoneal sarcomas, they are the areas where in adjuvant setting, also TSE will find a role.
As I highlighted, we are a radio sensitizer, so TSE will find a role or a positioning also in any type of a solid tumor, where we don't want to give a lot of radiation, like the head and neck cancer. Additional clinical trials would be required, as is obvious, that once we increase as any pharma or biotech, everybody tries to increase the life cycle of a drug or a biologic, increasing the, I beg your pardon?
...
Okay, so, increasing the indications, we will need more clinical trials. As we go into breast, we go into neoadjuvant settings, we will need more clinical trials. Now, highlighting here that we have treated hundreds of patients with TSE with differing responses, and this is where the data actually hints towards other indications and not restricted towards head and neck cancer. We already treated, apart from head and neck squamous cell carcinoma, we treated breast cancers. But these are late-stage cases, and since we are moving in head and neck also to earlier stages or earlier curative lines, other solid tumors may also benefit in due course from in the earlier curative lines of treatment.
We've treated breast, we've treated rectal tumors, we've treated squamous cell carcinoma of the vaginal wall, cervical, soft tissue sarcomas, all types of histologies, all major histologies have been exposed to TSE. And you'll find this data in a published article from our Chennai hospital, where we published our first article. So this data is available. I would request you to go through it and see the entire gamut of tumors which have been exposed to Tumour Specific Electroporation. Do we have another slide? Yes, even though it's more of tumor biology, but I would like to highlight here that Tumour Specific Electroporation does immune modulation by the release of new antigens, which may be ATP, which may be damage-associated molecular patterns, like calreticulin.
And all this is basic biology, but what happens ultimately is there is an increase in tumor-infiltrating lymphocytes. If you just find out more about tumor-infiltrating lymphocytes, they are required for killing the tumor. The body should start killing the tumor itself, and that's why the... And that's the whole story around immunotherapy at the moment in cancer research. TSE does promote immunomodulation for increasing the tumor-infiltrating lymphocytes in the tumor, thereby increasing the chances of the tumor getting killed by the T lymphocytes of the body itself. More in literature and more in our deeper scientific discussions, everybody is welcome for those discussions.
If you have any questions, please feel free to get in touch with us regarding the basic biology of tumors, solid tumors, and how at the biological level Tumour Specific electroporation does a good thing of boosting other type of therapies, like immunotherapy. So, we can go ahead.
All right. Thank you so much, Suhail-
Mm-hmm.
for, for that. We have question, possibility for everybody to ask questions later. But let us, finish off, with the impact that this, the changes in the protocol in the ongoing trial might have in the longer and shorter run for the company. Obviously, our company is, established to, not only treating, patients, we also obviously want to ensure that we have a profitable and growing, company and business. And changing the addressable market in such a way of being, in the past, positioned in the palliative lines of therapy, and now becomes a more earlier-stage potential, and that we have one of the lead- most leading institutes in the world when it comes to, cancer and, healthcare protocols, is aston...
It's an astounding milestone, and I know how hard the medical and clinical team has worked towards this target and to this milestone. So I'm very, very happy for your achievement. So yes, for ChemoTech, as a commercial company, being able to address a market that also includes curable, curable patients at an earlier stage, makes the potential market much, much bigger. In a country like India, where 50%, around that, are very late stage, it might not be as big of an impact. It is a big impact, but not as big impact as this would be the day when we have enough clinical data and feel that we are strong enough for the company to enter into the European market.
Then, being in a therapy line where we actually can have a potential to cure patients will dramatically grow our potential. Only in India, the head and neck cancer market is, for a company like ChemoTech, worth over EUR 160 million per year, only on sold treatment kits. So yes, the Indian market is of significant size for us, and that's also why the Indian market is the number one priority in our Human Care division. An approval like we got now from AIIMS for this trial also have a potential to increase our credibility in the short run when we are now doing marketing and business development towards different parts of the private sector in India. But also-...
When our product and therapy is being registered and part of the public database, where the public healthcare system will be able to acquire or asking for requirements of TSE devices into their hospitals. So having this kind of trial ongoing will obviously improve our potential in the public sector as well. As you all know, we have a long-term strategy, not only to be a successful treatment in India. Our target has always been Asia and Southeast Asia as a whole, and even the Middle East and African countries.
Having an ongoing trial with an institute like AIIMS and, if we, as we believe it will be, a successful trial, it also have an incredible impact on our chances to establish new relationship with distributors in other countries, as well as having an easier launch of the technology and implementation in the local countries outside India. We're getting the question when we can or when we are able to launch the product in the European market. From a regulation perspective, we are already able to perform treatments in the European market, and that is an effect of this CE mark.
But from being certified to having institutes and doctors using the therapy in an earlier stage or even in palliative stage takes sometimes quite a long time, and takes a lot of resources for us. We have since almost we started the company always had the strategy to invest the shareholders' money into markets where we believe that we could give you the best return. India, with enormous amount of patients, a great need of new technologies, and a slight more innovative and open-minded healthcare system, have always been our focus. But as we now getting earlier and earlier in the patient sickness, the European market will automatically be of more and more of interest.
So, we really hope that we will come to that stage within a couple of years, that we could have clinical results that not only, not only giving us opportunities to create further new trials in the European market, but also that we can start the commercial, our commercial route in EU and Scandinavia. So, with that-
Mm
... it's, we ending our presentation for the update of the trial. I know that, a lot of shareholders have different questions that they would like to ask us, and we therefore open up for you to write the questions in the chat group for us.
Yeah, given that we have our board member, Rolf Ehrnström, with us, he should be there. It'd be good also to hear from you, Rolf, if you could share a few comments.
Hello, Rolf Ehrnström here. Yeah, I'm very excited about the event we have come to now with this amendment to the prospectus. And, as I've been very much involved in clinical studies in many of the different cancer areas, I see this as a great potential, not only for India, really for the whole world. And, having discussions with clinicians, everyone excited about the technology, but they want to have more proofs before they really embark on this. So this is very crucial for us to be able to also initiate studies across the globe and have this technology being evaluated in more, the Asian environment. But, I'm very happy for this, and I really look forward to a successful future for the company.
Mm
... in the treatment and handling of cancer, care.
Thank you, Rolf, and given that you are a medical expert on the board as well, so we really appreciate all your input, both in the work and here as well. Thank you. Mohan, do you want to go over to, answer some of the questions?
Yes, I can. So we have a few questions here. None of them I've seen so far relates to the actual news that we're presenting today. But let us go through some of them anyway. So, one question that I got is about the 15 units that were scheduled to be installed on a commercial program in India, in the fourth quarter 2023. We have, when I'll say it like that, this, when we do not reach our targets, it's absolutely of highest importance for the company to investigate the reason for these, and we don't take it with ease when we do not deliver.
We are in a program to in India to really accelerate the commercialization, and sometimes, you know, in the beginning, a lot of these processes hit certain situations where it's a little bit unforeseen in the beginning, and we sometimes have to amend and change ways in the contract or in the negotiations. Anyhow, our target is still to reach these 15 in the first quarter, and we will absolutely update the market. I would say half, half time through the quarter, so you will have a good idea of where we are in these commercial discussions and negotiations. I also have a question regarding the number of IQ waves that AIIMS is today in operational.
The contract we had with AIIMS was to install two units with AIIMS in Jodhpur, where the innovation center is located. One is for the trial, and one unit is earmarked for the university for educational programs and for commercial use. And we will update the market once AIIMS have reached this level. As we have, as you perhaps know in the Animal Care division, we have the same situation with our veterinary college in London, that recently had an ongoing educational seminar for TSE on treatment of horses. So in the same way, when we have reached a situation where AIIMS are starting academic programs using the second device, we will inform everybody that that milestone has been reached. We're also getting questions about the financing.
The company's financing is always something that is an ongoing project for a company like ours, and we will inform the market when we have news of different kinds of financing programs in parallel to the regulations that we have to follow. So, we will let you know when and if we have new investment programs in place that we are going to activate. And then we have another question, which is the frequency of the IQwave. This is a very technical question, and I'm not sure if, Suhail, can you answer that?
Uh, that-
The frequency of TSE.
Right, the frequency of TSE, if I understand the question correctly, is how many times you want to know how many times we have to go for TSE sessions for the different solid tumors. On average, less than two is too less. It has to be more than two, but we've seen in head and neck cancer that sometimes we go for four or five sessions as well. So, until the tumor is shrunk to a marginal level to a large extent, that even the surgery can remove it, or we can just have a good, you would say, life for the patient in the palliative care setting.
But in the curative lines now, I think, now we will have to give it at least twice, 2-3x , to have a good, appreciable decrease, in the size of the tumor, and which we have seen in our, current study as well, that two to three sessions gives a very good response. Now, again, there is... I'm sorry I'm taking more time, but I want to give an elaborate, answer to this question because it's a question which comes frequently from, from multiple sides and has financial implications also. So now it's almost standardized that two to three sessions are a minimum to be given for any type of a tumor, whether it's a deep-seated tumor, superficial tumor, or any type of tumor we are, using.
But the upper limit is we can go to the extent of a complete CR. I would also highlight the Ukrainian study, which we saw for the Ukrainian patients for squamous cell carcinoma of the inguinal region. With just three sessions of Tumour Specific Electroporation, the tumor had completely vanished, and the patient had avoided surgery completely, which she didn't want to have, which was the first line of treatment as per the NCCN Guidelines at the moment. So that's, again, a lot of information for us, that at least two to three sessions does a good amount of immune modulation and tumor kill.
... Thank you, Suhail. We have another question regarding that relates to the clinical side of TSE. Someone is asking: Do you see that cancer cells are the same overall, meaning that a soft tissue sarcoma in human would that be the same kind of cell phenomena as any other living species? Or is it, are the cells very oriented to humans or species-specific?
Brilliant question, and I think very, very important for electroporation. So far, say, the NICE Guidelines and the ESOPE Guidelines, they have considered one size fits all, and that's not correct, and this is, we are telling this with data. Everybody in the electroporation space, be it irreversible or static reversible electroporation, everybody has considered all the histomorphologies as one when it comes to electrochemotherapy. It's not the case. We have data that the squamous cell carcinomas, the adenocarcinomas, they respond differently and require a different mode, requires different sessions. So, everything is different, just like any other therapy. In cancer, you cannot have one, one size fits all.
So, we are collecting data, we are accruing data for different histomorphologies, and that type of data would be data mined, and we will be coming up with, specific data and publications that what is the cure rate in squamous cell carcinoma, adenocarcinoma, sarcomas in general. Now, I think the ESOPE Guidelines have missed it. It was that time, but now we have to realize that we have to take every patient, every histomorphology differently.
All right, thank you. Thank you so much for that. We also had a question here regarding the cyclone in South India and the impact it had on our commercial operations last year. Tamil Nadu, which is in the south of India, is the center of ChemoTech, I would say, clinical and commercial operations, and have been for the last four years. Even, even before the pandemic, that's where we had the center. And, yes, the cyclone was a huge catastrophe for the people there, our staff, and, obviously, also, since we could not. The roads were not open, the hospitals were not open, we could not continue the negotiations with the clients there.
So yes, it has a tremendous impact on the overall infrastructure in that region and put us back quite a few weeks. So that was the impact of the cyclone. All right, let's see if we have one more that we could take here. Someone's asking how many IQwaves we need in the market to become profitable. I don't think it's a secret for anyone out there, the burn rate of the company or the total cost that we have to operate the company. It's today about SEK 1.6 million a month, and for every IQwave that's out in the market, it generates revenues from used kits.
It's very hard for us to predict exactly how many kits every single device would be, would be used. But we have a little bit of a framework of where and when we are offering the device, based on consumable kits alone. And these devices should bring us an income or revenue on about minimum SEK 350,000 per year. That means that 10 devices would then give a little bit more than SEK 3 million , and 20, a little bit more than SEK 6 million a year. So with that kind of mathematical example, I think it's clear for all of you approximately how many devices we would need to install on usability alone. Obviously, we have also clients that are in favor of acquiring the machine.
For example, in India, the public healthcare is not eligible to acquire devices only based on consumable goods. They have to own the devices. So in that situation, the cash flow of the company will be positively impacted by a one-time purchasing revenue, as well as later on, generating revenues from these sold treatment kits. I think that was the last question we have time for today. I hope all of you thought that it was worthwhile connecting and listening to our presentation today. Robin, do you have a last word?
Robin, you seem to be muted.
I was very excited to start talking, so I was muted. No, I think it. I was just saying that I think it'd be good if everyone follow our social media, of course, where we share information, and you can always see the thing that's coming up there as well. And also, if you're interested, send questions in to the company, if you have anything specific, and we'll do our utmost to respond to them, obviously. The focus now, of course, has been on this, and we're very much looking forward to the next step here. There is no putting your foot off the gas, so it's now full on as much as we can with the financial situation we have.
As Mohan said, it's an ongoing, ongoing situation there, and we're very happy to see what's going on as well in the vetIQure side in U.S. So please follow us, and keep engaged. Thank you.