PCI Biotech Holding ASA

OSE:PCIB

Earnings Call Transcript

[Per Walday, Chief Executive Officer]

Good morning, and welcome to PCI Biotech Fourth Quarter and Preliminary Full Year 2021 Presentation. My name is Per Walday. I'm the CEO of PCI Biotech. And I have with me also Ronny Skuggedal, who is the CFO of PCI Biotech. Note that on this slide, we have details surrounding a Q&A session that will come live after the presentation. So please use these details if you want to call in and ask questions. This is a live presentation but also webcast presentation. But to ask questions, you can either put them through the webcast or call in and ask them directly. Please also pay attention to this important notice and disclaimer.And with that, I will start the presentation. What we'll go through today is the highlights of 2021 and then an operational review where we will go through all the different programs. Then we will look at key financials and an outlook of the future before moving over to the question-and-answer session. So let's start then with the highlights of 2021. And I need, unfortunately, to start with the fimaCHEM program that we had to close the recruitment into earlier in 2021. It was due to a competitor product that reported positive results. And these results will -- are expected to quickly change the standard of care for this patient population that we are including in our RELEASE study. And we, therefore, think that this is going to be very challenging to complete and potentially inadequate for approval.Approximately 30% of the 41 enrolled patients into this will continue to receive solid treatments for up to 6 months. This is because we had quite good recruitment towards the end of this study. And we will not treat them more than during this treatment period. And therefore, this enables a swift wind down of the study and this trial. And then what we are going to do is to collect the efficacy results and safety, of course, also, and see where this data can be utilized for anything of value going forward. So that's also an important part of closing down the study.Our lead program now is the vaccination technology, fimaVACC. This program is progressing towards an initiation of a Phase II clinical proof-of-concept study. And we have product definition and overall study design clarified after comprehensive consultation with external experts. We are aiming to complete this during the spring, and we'll come with more details about this at a later stage. Importantly also, in last year, we had a U.S. patent granted for the fimaVACC in combination with immune checkpoint inhibitors, which is where we plan to use our fimaVACC technology. So this is an important patent for the -- this program going forward.The second program that we are -- continue to develop is fimaNAc. And this has now gone into a more focused internal development. So we have a plan that we initiated based on strategic research and the collaborations that we have done. And we are targeting applications that are specifically suited for the PCI technology to develop those further for potential collaborations with partners. We had some very encouraging data from collaborations that we, for the first time, presented in -- at the U.K.-based 12th Annual RNA Therapeutics Virtual Conference in January 2021. This data has also later we presented at other places, most recently now in the fourth quarter at a conference in Berlin.We have also used this data to establish further collaborations within the fimaNAc. And there are 2 new collaborations that have been established, one with OliX Pharmaceuticals, which is a South Korean company working on RNAi, this interference RNAi Therapeutics, which is one of the technologies or products that our technology can efficiently deliver to the intracellular compartment where it's needed to be delivered for this application. And also, earlier this year, we entered into a preclinical development -- or preclinical research collaboration with another South Korean company called MDimune who are also developing an innovative drug delivery technology for modifying cellular and disease processes. And we will look at synergies between these 2 technologies.On the corporate side, in last year, we significantly strengthened the organization. We hired 3 highly skilled individuals, an experienced clinical operational leader and 2 key employees within clinical science and business development, which are focusing on our fimaVACC and fimaNAc program. So these were the highlights for 2021.Now I will go through the different programs. Just have a look at the pipeline first. We have now 2 different programs, one in clinical development, which is the fimaVACC program that we are developing further. It's approaching Phase II after a successful Phase I. And now the fimaNAc program, where we have several collaborations also established with other companies, which is developed in nucleic acid therapeutics delivery. And this is a preclinical program.So with this, I will go into the more program-based operational review, and I will start with the fimaCHEM program. So we had a pivotal study or we still have a pivotal study, but recruitment has closed to this, which was called RELEASE. We closed this because of data that came out at the conference, ASCO GI Conference in the U.S. in January. It was presented on the 21st of January, late in the evening. And these data presented that -- demonstrated that a combination of a specific checkpoint inhibitor with gemcitabine and cisplatin, so which is the standard of care today, combination of these 2 drugs with a checkpoint inhibitor provide a significant survival benefit in this patient population.This is really good news for the patients because there's nothing new that has been developed for these patients for the last 10 to 12 years. But unfortunately, for us, this means that the standard of care is expected to rapidly change. And when that change, it makes a RELEASE study not feasible to perform. And since we had recruitment for maybe 1.5 year going forward, and the standard of care is expected to change rapidly, it makes it unfeasible to continue to perform the RELEASE study to, complete RELEASE study. What we saw in this presentation is that the specific subgroup that we are targeting with our technology have quite good results within this TOPAZ-1 study that was presented. So it is expected to rapidly change for that specific population.I would like to stress, and we informed about this, I think, on the 24th of January. And I would like to stress again that there is nothing of signals from within the study that has made us made this decision. This decision is based on the data that came with this comparator in January at the ASCO conference. We had an IDMC review of safety of actually a safety of doing 2 fimaCHEM treatments with our technology in December, and there were no additional safety signals and a recommendation from our independent data monitoring committee was that we could just continue with 2 treatments. So there are nothing other than the specific results that makes it very difficult, very challenging to complete this study.As I said, such a change in the standard of care will render this trial very challenging to complete and also potentially inadequate for approval. And it will also significantly diminish the market opportunity that we had for the -- for our treatment approach in this patient population. So what we now will focus on is a swift and cost-efficient closing process of this trial. And this is work in process with the CRO. All the details have not yet been elucidated in this process. And there are a number of different decisions that needs to be taken. So we don't have currently a precise time line or a precise budget for how much it will cost to close this study. We have an ethical responsibility for the patients that have signed informed consent and gone into the study. So we will give them the treatment that they were promised when they entered into the study. We'll follow them until treatment is completed, but then close the study as swiftly as possible and as cost efficient as possible.To this aim, we are able to close almost 60% of the sites immediately. And we will then follow the other patients sites with patients in them to monitor efficacy and collect this and ensure that we can close them as quickly as possible. We will take these results afterwards, and they will be available later this year. We had quite a lot of recruitment towards the end of the year. So we are still waiting a lot of the efficacy results to come in. So we don't have anything to report right now. But when we have these data, we will come back to the market and talk about what this data are and if there is any potential value that we can take out of this data. So that is the fimaCHEM program, which is then being winded down and not continued to be developed in the way that it was.And now fimaVACC is our lead program. And this is where we're leveraging the PCI platform within immunotherapy. And it is immunotherapy that made us or forced us to close down the RELEASE study. And immunotherapy is really now the new standard and a new way of treating cancer patients. So this rather works together with immunotherapy, this fimaVACC technology. And we have some really compelling preclinical results with unique mode of action for this technology. We have particularly strong CD8 T-cell immune responses. And for vaccination, what you need is cytotoxic T-cells if you want to kill cells in the body because these are the cytotoxic, which means that they are able to kill cells -- excuse me, that can recognize cells that are infected or that are diseased and take them out with specific T-cells.This data that we have from preclinical has also been successfully translated into humans. We have done a Phase I study in healthy volunteers, and the results from that study was published. So we have a publication with full insight to all the data in that study. Some very nice data on the increase of responders that we see with our technology compared to a state-of-the-art adjuvant technology. It is also a versatile vaccination platform that can potentially be used in several different modalities. What we have done preclinically and translated into humans is with protein and peptide-based vaccines.And as I mentioned, last year, we had a patent granted in the U.S. for combination with immune checkpoint inhibitors. And this is very important for this technology, which means that we have protection for this combination, which is where we want to take the technology for a long period forward in time. It covers the important foreseen development combinations that we have for this technology.So since this now is our main program, I will go a bit more into detail and just sort of rewind a bit and talk a bit about the preclinical results and the clinical translation. And then as much as I can say today about our plans going forward, which are still being developed together with a group of expert clinicians. So as mentioned, we have some really compelling preclinical results. We have seen that intradermal vaccination with our fimaVACC technology induces strong anti-tumor response. These are TC-1 tumors that has been inoculated in animals. And if you don't, on the left-hand, untreated, this is how these tumors grow, what you can see is growth of the tumor in size if they're not treated. And these are aggressively growing tumors and no of these -- none of these animals survive beyond day 30.Now if we do the same inoculation of tumors to these animals, but then do an intradermal into the skin vaccination of -- with fimaVACC and antigens that are relevant for these TC-1 tumors that can make the immune system potentially recognize the cells and start combating these cancer cells. You can see that had a dramatic effect. It started to grow. The vaccination just wiped out the tumors and the mice became tumor free. And they were immune to a new challenge because after this, we then try to put in a new tumor of the same type into the animals, and they are not being established when you do that afterwards, which means that now the immune system of this mice recognizes these tumors and are not allowing them to grow in the body. And this is exactly what you want to achieve with therapeutic vaccination and with immune checkpoint inhibitors with immunotherapy in cancer.It is a versatile vaccination platform. And earlier this year in January, we also published some positive results from preclinical studies on BCG vaccination towards tuberculosis. It was performed in collaboration with the University of Zurich and ETH Zurich and were accepted for publication in Frontiers in Immunology, which is an high-impact immunology journal. And what we show in this article is that when you do vaccination with fimaVACC with BCG, you get an enhanced cross-presentation of -- [ aghast ] inflammation and cross-presentation of these proteins, which then stimulates strong CD4 and CD8 T-cell responses in mice.And you can see that on the figure on the right-hand side up here, how this both CD4 and the cytotoxic, not least those CD8 cells increased dramatically in these mice. These are very important responses because you need to attack cells because bacteria are hiding inside cells in this disease, in tuberculosis. And generally, the results support our understanding and the mechanism of action and the potential that we see for this technology. Although infection is not our focus area, we're looking for therapeutic vaccination. This data validates the technology.Now we took this from the preclinical setting and into the clinical setting by doing a Phase I study in healthy volunteers. In healthy volunteers, we then used specific antigens against HPV, and HPV is a virus that often induce cancer in patients. And then we measured in those healthy volunteers, the amount of T-cells, how many of them developed T-cells against these specific proteins or antigens that we were -- or peptides and antigens that we were vaccinating with. And what you can see on the right-hand side here is a panel with -- at the top, the number of responders we saw in the different dose groups, and there was one control group with a state-of-the-art adjuvant that was used together with this peptide, with this vaccine. And then we added fimaVACC in different doses on top of that.And you can see that we had an increase -- 8x increase in the number of responders, those who develop significant T-cell response. We also saw T-cell responses that were much more robust and that is what you see on the lower panel here on the right-hand side, whether in the control, we didn't see much at all, while they were quite much more robust in 2 different dose levels where we tested this. So in summary, we see a substantial increase in the number of responders with the T-cells, which are the response you really need for the HBV E7 peptides. We also saw enhanced responses, not more -- just more responders, but also enhanced responses and more robust CD8 T-cell responses, which are important.And looking at those CD8 T-cells, we also looked at the functionality. And so there was also better functionality, more markers that these reacted on in, as you can see on the right -- 2 right-hand side bars here. So these are quite good results from a healthy volunteer study, and it validates what we have seen in the preclinical setting and our mode of actual understanding of our mode of action. So what we want to do now is to take these, harness this what we can achieve with this technology in patients.So we are now progressing towards initiation of a Phase II clinical proof-of-concept study in patients. We will start small and build upon the results. The study here is done in cancer patients, and the goal is, of course, to demonstrate that we can do -- see anti-tumor activity. And the patient population, we will aim this for is recurrent and metastatic head and neck cancer patient, which we have as a perceived high likelihood of response and there's clearly a high unmet medical need in this patient population.What we do here is we combine different therapeutic approaches and that we do to achieve maximal immune response, maximum immunotherapy effect. So what we want to do is to convert what is called cold tumors, tumors that the immune system cannot see to become hot tumors, tumors that the immune system starts to recognize and can start to come back. And we are working closely, as I said, with international experts in the fields of this specific disease and specifically immunotherapy.So as I said, we want to harness the power of our technology to address unmet medical needs. And the entry indication for this is HPV negative metastatic and recurrent head and neck squamous cell carcinoma. And this is a population that today are treated by immune checkpoint inhibitors. But a majority of these progress quite quickly on these immune checkpoint inhibitors or are not sensitive to these immune check inhibitors. Even though we go straight into this population, if we can show benefit here that we can convert cold to hot, there is ample opportunity to expand this to other indications as well.As I said, a high unmet medical need. A majority of these patients do not respond to immune checkpoint inhibitor therapy. Those who respond have a great benefit of it. So it's -- if you can convert nonresponders to responders, that is very important. So there is really a high morbidity with these patients. And normally, they have survival less than 1 year. So it's really a high unmet medical need for those who are nonresponders. Now the ICI treatments, they are designed to target the immune system to sort of put up some checkpoints to make it possible for the immune system to attack tumors. But the immune system needs to be awake. It needs to be able to recognize the tumor. It needs to be able to have the soldiers that can invade and start to combat this tumor.And one of the mechanisms to -- this doesn't work, it's because you don't have that immune system that are awake and T-cells that are produced against the tumor. And this is what we can do with fimaVACC. These tumors are not referred as cold tumors and what we want to do is to convert them to hot by activating the immune system so that the checkpoint inhibition actually has recently opened -- the checkpoint inhibition opened the gates, so to speak, to the tumor. And with fimaVACC, we think we can provide the soldiers that have entered through this gates and infiltrate the tumor and start combating it.We have, as I've shown you some really compelling preclinical and clinical data that shows enhanced T-cell induction and that is what we need for this to work. And we've seen strong, as you see in anti-tumor -- strong anti-tumor responses in animals when we use this fimaVACC technology and use intradermal and intratumoral, which we'll also look into whether we can do in this setting vaccination with local illumination. And what we want to do is enhance the T-cell immune activation. And if we can achieve that, we can trigger a response to immune checkpoint inhibitors in those patients who don't do it. And that opens up a vast and ample opportunity to look into other indications. So we've chosen what we think is the best indications, entry indications for this, but there is ample opportunity to expand afterwards.So the status for this is that the ongoing activities are focusing on preparation of the study protocol, CMC, which is CMC is to really produce the product and the components that are needed. And this is a peptide-based vaccine. So it constitutes several peptides that are the most promising as tumor-associated peptides to target this tumor with and validated in other clinical studies as well. And then also operational activities that needs to be done in order to start a study. As mentioned several times, we have a forum of clinical investigators that has been established, and they are supporting the preparations and will be supporting and take part in the conduct of the study.And we will come back with more information when all the key aspects of this study have been discussed and endorsed by the clinical expert group. So we want to make sure that we have all the clinical experts on the same page before we go out and inform you about what it is exactly in more detailed level that we are going to do and talk more about how long time it will take and the budget for such a study.Then I'm going to talk a bit about fimaNAc program, which is a preclinical program. And this program is really working on helping nucleic acid therapeutics get into cells. Nucleic acid therapeutics is a really large emerging area of treatment, a treatment class or actually several different classes of nucleic acid therapeutics with different mode of actions, but they are a class of product, so to speak. And they have in common that they are quite large molecules. They need to get into cells to work, and they are often charged and they have a problem in getting into cells. And what we have with our technology is an intracellular delivery technology.So this is where we're focusing this on nucleic acid therapeutics to develop applications that can deliver nucleic acids in 2 cells. We have some compelling preclinical results, really strong data for a range of nucleic acid therapeutics. It addresses the major hurdle for this class of drugs. There are applications that -- where this works quite nicely today, and we have the COVID-19 vaccines, for example, which have shown the -- some of the power of this technology, especially and for specific prophylactic vaccination. But in many applications, intracellular delivery remains a major obstacle. As we have seen with the collaborations we have with companies who have these kind of drugs who are interested to look into other ways and better ways of delivering their drugs into cells.So what we have done so far with this technology until last year, it was more of an opportunistic collaborative approach. We have this technology and anyone who thought they could use it could go into a collaboration with us. What we are now doing after a strategic review of this and what is needed to be successful on the business development front is to develop more targeted applications that are suited specifically for the strength of our platform. So we more -- to more towards a turnkey solution that can be used in specific applications where there is a need.And the initial focus on this will be on, of course, easy illuminable clinical conditions, where we also have supporting preclinical results. And one obvious area for this is a large area with a number of different diseases, skin applications. The biggest organ of the body, the skin. We've shown that in preclinical experiments that we can substantially enhance the delivery and transfection. And we also have the advantage with our technology of an excellent spatial specificity. It means you don't get leakage. If you give this locally, it leads to a much less extent than many other technologies to other parts of the body, and therefore, reduces the risk of side effects induced by the -- you have effects of these nucleic acid therapeutics where you don't want to have them. So you can really spatially focus it on where you want the effect to happen.And you can see on the right-hand side here, the example of when we have delivered this mRNA without fimaNAc and mRNA with fimaNAc. We can see that, that really increases the enzymatic luciferase activity, which is the enzyme that the mRNA we've used here produces. So if the mRNA comes into the cell and it produces the protein and then we measure how much of that protein is in and how active is that protein in the cells. Excuse me.As mentioned, we have encouraging collaborative data on enhanced delivery of mRNA for various medical applications that were presented. The first at the U.K.-based 12th Annual RNA Therapeutics Virtual Conference and later complemented with more data and presented at other conferences, and now most recently in the fourth quarter in Berlin. And this data really suggests that it provides an appealing intracellular delivery solution for certain applications within this emerging class. It's not a one size fits all application, but we are developing now further targeted applications, which we think are most suited for our technology.And these results have really helped boost the interest in the technology. And we have, as I mentioned, 2 collaborations that recently have been initiated with both of them actually with South Korean companies. South Korea is quite an active area in biotech and in emerging technologies.And just to summarize the research collaborations. We have several of these, 6 for the time being. Generally, they offer valuable scientific knowhow, encouraging results and intellectual property, as you have seen from data that we have presented before and also from new patents that have come out of this. As I said, currently, 6 collaborations. They span across different classes of drugs and therapeutic applications. Some of them are within the fimaVACC program. Some of them are within the fimaNAc program.The most recently established collaboration is with MDimune, which is a South Korean company, as I mentioned, that are developing innovative drug delivery technologies. And we are looking at how we can combine our technologies to really make a bigger difference as strong synergy for targeting and delivering drugs into cells. And we continue to pursue new and value-adding collaborative opportunities within this program. But as I said, now focusing on specific applications. So we will be seeking more towards business development opportunities in specific applications that we are also internally developing further.So that was the end of the operational review. Now we are moving over to a section where we'll go through the key financials, the outlook, and then we will have a Q&A session afterwards. And I remind you that you can send in through the webcast console questions. We will also take questions from the audience here. If there is any questions -- are any questions. And there is also this phone facility that we will open to see whether there are any callers with questions.Now with this, I want to leave the stage here for a few moments and let Ronny Skuggedal, the CFO, talk a little bit about the finance, the key financials.

[Ronny Skuggedal, Chief Financial Officer]

Yes. Thank you, Per. Key financials and the key financial figure here is cash, and we have NOK 116 million of cash in the bank at year-end. This cash position is estimated to give the company a financial runway well into 2023. And regarding the RELEASE wind-down costs, the closed process is under a review -- as peer reviewed under the operational review earlier. And the current cost base of RELEASE will be reduced over time. But as Per said earlier today, the Q4 was the best quarter recruitment wise, and these patients need to be followed up with treatments for up to 6 months. So the costs will be reduced over time.But of course, there is also a benefits on the cost-saving area by our ability to close down 60% of the sites immediately. But we need to come back to the exact figures because there are still just weeks since the decision was made. So this is currently under review. Regarding potential capital need for the next clinical phase of fimaVACC. And again, as Per said earlier under the operational review, this is under evaluation and needs to be finally discussed with this international expert group.Other financial figures to note here is maybe the other income public grants. For 2022, we have this standard SkatteFUNN tax scheme with an estimated value for the full year of up to NOK 4.8 million. And the net financial results are fluctuating between -- both between quarters and between years. And this is mainly a result of exchange rate effects on cash deposits in euros. And from a pure accounting perspective, the decision to close RELEASE is a non-adjusting after reporting date event, meaning that no items in the balance sheet are impacted by this decision. But in Q1 2022, the carrying amount of laser devices that have been acquired for the RELEASE study and were tailored for the RELEASE study of carrying amount of NOK 5.8 million will be fully depreciated in Q1. But this has no cash flow effect. It's pure accounting depreciation.Then I think I leave the outlook for you.

[Per Walday, Chief Executive Officer]

Thank you, Ronny. So with regard to the outlook, our lead program now is fimaVACC. This is progressing towards initiation of a Phase II clinical proof-of-concept study. And our aim here is to improve the response to immune checkpoint inhibitors. The new promising class of treatment that is really taking the front stage -- has really taken the front stage in cancer treatment, but still has a lot of patients who are not responding due to different reasons. And one of those reasons being not have sufficient T-cell responses in the body. And we want to combine this then with our fimaVACC technology in recurrent metastatic head and neck cancer patients.We have established a very good clinical expert group that supports this clinical development. We will discuss this in a forum with them in the near future. And this will be when we sort of can home in on all the details and have a full understanding of what this program looks like. This is really a versatile technology that can be used both with protein and peptides and also potentially with nucleic acid therapeutics for vaccination. And it is available for partnering and licensing as a technology today. And we have some collaborations in this area.fimaNAc. What we are doing here is to refine the technology internally. So we are putting some effort in making this to a more of a targeted technology is to -- that we develop applications that are most suited for our -- the fimaNAc technology. So what we're doing is we are taking some more internal development into this to home in and focus on specific applications where we think we have the best chance of success. And with this, pursuing collaborations and out-licensing opportunities.And then fimaCHEM. Unfortunately, we had to close recruitment into the RELEASE study. And I would like to thank all contributors to that external contributors and our investigators, the investors and everyone, the patients not least, that have been treated in the study and contributed to the progress of the study. We are focusing on a swift and cost-effective closing of this study now. And we'll come back to what this means and also revert back when we have compiled and analyzed the results for a valuation of potential value in this small randomized study.So with this, I think we are done with the presentation. And I think we should start by asking whether there are any questions in the audience here first.

[Per Walday, Chief Executive Officer]

And it doesn't seem to be any questions in the audience.

[Ronny Skuggedal, Chief Financial Officer]

Webcast.

[Per Walday, Chief Executive Officer]

And then the -- what I'm hearing here is that we're going to take some questions from the webcast first, from the webcast console before we go into the calling. So Ronny?

[Ronny Skuggedal, Chief Financial Officer]

Yes. First, some questions regarding RELEASE. When do you foresee the results of the 41 patients to be released? And can you say anything about the number of patients treated with fimaCHEM versus standard of care?

[Per Walday, Chief Executive Officer]

I could have said something about it if I had the details in front of me, but I don't have the details in front of me so I can't say. I know that we have had more discontinuation, as we've talked about in the control arm. So there are more patients that have received treatment than in the control arm. But exact ratio here, I don't have that in my head. So we'll need to come back to that. When it comes to when the results will be available, we are -- we haven't -- most -- many of these patients haven't had their first imaging yet and it's radiographic results we're talking about. So we need to have their first imaging first, and they should follow their treatment period. So my guess is that we will not have results on this until earliest maybe before the summer, but more likely in the second half of the year because some of these treatments go all the way to July, August before they finish. But it depends a little bit on the process. We are closing this with now, which we are negotiating with the CRO at the time.

[Ronny Skuggedal, Chief Financial Officer]

It's fair to say that it was a 1:1 randomization. So it's approximately 20…

[Per Walday, Chief Executive Officer]

It is approximately -- it was a 1:1 randomization. There has been slightly high discontinuation in 1 arm than in the other. Controlled patients had some tendency, more tendency to discontinue, but there was a 1:1 randomization, yes. So it's not far from 1:1.

[Ronny Skuggedal, Chief Financial Officer]

Good. Then we move over to fimaVACC. When do you foresee to be able to dose the first patient in the study?

[Per Walday, Chief Executive Officer]

I think we need to come back to that. And we will revert to that after we had this clinical core group expert meeting, which will happen later in the spring. And that really -- we also need to home in specifically with a selection of the CRO and get the feedback from the CRO with all the processes before we can come back with the data. And I don't want to guide this until I have some certainty around what is -- what the answer is.

[Ronny Skuggedal, Chief Financial Officer]

And a follow-up question here is, they understand that the study will be combined with the CPI. How will you get access to this CPI?

[Per Walday, Chief Executive Officer]

So we are looking at whether there is possibilities of getting some kind of a supply agreement for this. If not, the first part of this study, as I said, we are going to start small and then build on those results. The first start -- first part of that study is something that we could potentially finance ourselves, but that remains to be seen. We can't conclude on that yet.

[Ronny Skuggedal, Chief Financial Officer]

Can you say a little bit more about the market size for the head and neck indication? And if the target population is suitable for a potential orphan drug designation opportunity?

[Per Walday, Chief Executive Officer]

So that's 2 different -- very different questions in a way. There is -- we are homing in on a specific patient population where we think we have the highest likelihood of showing effect with a small patient number because that is what will get us to some results that we can build this on with least investment and least time. So that specific target population that we are homing in for just a proof of concept in the clinical patients is not a very large population. I don't have the number of patients in my head, but it's not going to be a very large population. If you expand this then, when we see this anti-tumor effect, we can expand within that study to a broader head and neck cancer population. And then it goes beyond what would be an orphan population.Now you can't just sort of reduce eligibility criteria and say that this is now the number of patients here because of the eligibility criteria is less than the level needed for getting an orphan designation, and therefore, it should be an open product. Orphan products are defined in that there needs to be a disease that this treatment can treat only those patients. So it's -- those regulations are not -- you can't just say that all the people with blue eyes and red hair is going to be treated. And therefore, that's an orphan population. It needs to be a criteria for the disease that is really defined by the disease or by the target that you are going for.

[Ronny Skuggedal, Chief Financial Officer]

Good. And then Donald Duck here wants to know some more details about which peptides we are using and what's the logic behind HPV negative patient population.

[Per Walday, Chief Executive Officer]

What peptides we are going to use or what peptides we have used in the HPV? Or the relevance of the HPV negative -- okay, now I understand the question I think that Donald asked. Yes. So the peptides we are using are not HPV peptides. That is really the question we are going for. So HPV positive head and neck cancer is a really crowded area. And this is an area where head and neck has been induced by the specific papillomavirus. And that were the -- I think the confusion here is that we use some of these peptides to do the Phase I study in healthy volunteers because those are peptides that are relevant to test this for in that setting.But what we're going for now is HPV negative, which has a worse outcome, different disease and is not such a crowded area as the HPV positive. So the peptides here are peptides that are associated with the tumor cells that you see in HPV negative. So we are not including any HPV peptides into this peptide mix. I think this is the -- probably the question.

[Ronny Skuggedal, Chief Financial Officer]

Good. And how is the fimaVACC plan received by this expert investigator forum? And do they look on the exceptional results we already have in head and neck with fimaCHEM?

[Per Walday, Chief Executive Officer]

So again, 2 different questions. So the first question, the results we have and that we presented to them is primarily the fimaVACC results, not the fimaCHEM results, which was the previous head and neck study. So the fimaVACC results, they are really impressed. Specifically, the results that I showed you here with aggressively growing tumor and just intradermal vaccination with fimaVACC completely eradicates these, and you can no longer inoculate and have these tumors growing in the months. These are data that they are really impressed by, and they are -- it's a very good group of people. It's really key opinion leaders and international experts that are in this group.And it would be very interesting to get them together in a forum and discuss the best way forward for us in the concept that we are developing. They have not been exposed to our head and neck results that we have from the previous study. That was a completely different study, where we tried to ablate the tumor by using a number of optic fibers and have a PCI effect across the whole tumor. Now we are working on waking up the immune system, so it starts to recognize the tumor. So it's 2 very different approaches to the disease. So those are not really relevant and has not been discussed with this expert group.

[Ronny Skuggedal, Chief Financial Officer]

Then we will move over to fimaNAc. Can you say any more or give any more granularity on the progress of the different collaborations? What's first in line and so on?

[Per Walday, Chief Executive Officer]

So I can't give very much on this. Of course, we have 2 collaboration that was recently started, the one with MDimune. That is now going into its experimental phase. So it is moving nicely forward and really interesting potential synergies that we're looking for here. The OliX collaboration, which is the most -- the next most recent, so to speak, is progressing really well as well. A lot of experiments have been done. I can't talk about these experiments. These are confidential information between the 2 companies, so we can't sort of go out with data on this. But that continues. And we're looking at whether it's potential to expand that into other areas as well. We don't know really yet whether we will do that, but that's a potential that we already discussed in the press release when we established it. It was mentioned by their CEO. So that's something that we are also discussing for the time being.We have a collaboration with eTheRNA that was started a long time ago, but then they had a number of management changes and changes of strategy and it had a pause for a period. It was sort of still not terminated collaboration, but it was really waken up again a couple of years ago. We're starting theoretical discussions and moving into a very good phase of experiments that was done last year. And we'll see when we can come back with any results out of this experiment. We also have a nice experiment on collaboration ongoing with Immunicum with a completely new approach to treating cancer cells, which we will continue this year and see whether we can get something further out of that. It was announced, I think that we moved into the next stage sometime in the autumn last year. So there's a lot of activity here in many of these different collaborations.

[Ronny Skuggedal, Chief Financial Officer]

Exciting. Well, and the last question here about fimaNAc. Regarding this skin application, is this able to heal diabetic wounds?

[Per Walday, Chief Executive Officer]

So it will be fantastic if it could heal diabetic wounds. But that depends on the target you deliver. So wound healing is absolutely an exciting area that we will be looking into. But there are a number of different applications for skin. But our technology, remember, is an enabling technology. What we do is we deliver this nucleic acid therapeutics efficiently into the cells so they can start producing factors that could modify the disease. And that is the major hurdle for many of these nucleic acid therapeutics. And for wound healing, it's easily accessible for illumination and so on. So it's absolutely as any skin application actually, a reasonable place to look but we need to have -- we need to develop the application and show that we can deliver these drugs efficiently into the right cells, in the right diseases, and then we can start looking for targets and companies to collaborate with.

[Ronny Skuggedal, Chief Financial Officer]

Very good. Then I think we can ask a moderator to open the lines for potential questions from the telephone conference facility.

[Operator]

[Operator Instructions] The first question will be from Adam Karlsson from ABG.

[Adam Karlsson, Research Analyst]

First of all, I know you're reluctant to commit to a time line for these Phase II studies over the fimaNAc, but I was wondering if you can give an idea of what specific activities that remain before you could get the Phase II study underway?

[Per Walday, Chief Executive Officer]

Yes. Thanks for that question, Adam. So as I said, we are in the CMC development pace right now and protocol establishment. And I also mentioned that we are homing in on which CRO to use for this study. So with this, of course, we need GMP production of the peptides that we have selected to go into this product. And that is, as you know, a process that takes time. That process has been initiated. So this is ongoing activities. But there are several months of activities in getting all of that CMC part done. In addition to this, of course, selecting the right [ serial ] to do the study. That's also an ongoing process. And then really defining all the details in the study design and develop the protocol. And that is something that also has been started. So these are the activities that are ongoing for that study.

[Adam Karlsson, Research Analyst]

Great. And I apologize if it's already been mentioned, but the actual peptides that are going into the vaccine, that you're intending to use. The vaccine itself then is -- are we to understand that it is internally developed? This is not a vaccine that you're getting in from some kind of collaboration with an external party?

[Per Walday, Chief Executive Officer]

That is true. This is an internally developed combination of specific tumor-associated peptides that rank among the 10% best for treatment of these tumors. So it's a mix of peptides to be able to target the most relevant different tumor-associated antigens.

[Adam Karlsson, Research Analyst]

Great. And maybe just a final question, if I could on cash and costs. I was wondering if you could give an indication on the -- where perhaps a more precise indication of the costs associated with fulfilling the RELEASE study obligations and closing that study down. And then separately, how far towards initiating the Phase II study with fimaVACC you expect your current cash position to take you? And is it fair to assume it wouldn't be possible to start that study prior to raising additional funding?

[Ronny Skuggedal, Chief Financial Officer]

So do you want me to answer that question? Okay. So I think it's too -- we are in the process right now. This is a global -- big global study, and we are swiftly closing down as many sites as we can. But we are in the process of closing this down, and it is a negotiation also with the CRO and all the details need to be put in place for this, termination. So it is -- we are not at this stage able to guide on this. And I don't want to do it until we have a more firm grip on what it really looks like and how swiftly we can do this and how cost efficient it can be done. So we will need to come back to that, unfortunately. We say that this -- the cash will -- so what we communicate is that it will take us well into 2023. And I know that you are so well versed within this area. So you understand that this fimaVACC study will not have been completed in that time period. But I think that's the only thing I can tell you right now.

[Adam Karlsson, Research Analyst]

Okay. No, that's helpful. But not to labor the point then, but that would imply that you feel you could initiate a Phase II study with the funding that you have, even though that funding wouldn't necessarily take you through to readout? Or is it fair to assume that you'd want to have funding in place for the entirety of the study before it came underway?

[Ronny Skuggedal, Chief Financial Officer]

So I think, as I said, it's a bit too early to say this until we know the exact cost of closing down the RELEASE. It may be that it would be possible to initiate, maybe not. It's too early to say. So I don't want to guide on this at the current stage. So I hope to come back to this at the next quarterly presentation and provide more details on where we are because then we have hopefully had our forum discussion with the clinical experts, and we know much more about the RELEASE wind-down costs, and we will have much more granularity at that stage on where we're going, is what we're hoping.

[Operator]

[Operator Instructions] As there are no more questions, I will now hand it back to the speakers for any closing remarks.

[Per Walday, Chief Executive Officer]

Okay. Thank you, and thanks to everyone listening in to this. I hope we will be able to come back soon again with you with some more granularity. I understand that there's a lot of wish out there to know more about the cost of closing down the study and the time lines to go forward with fimaVACC and so on. But I ask you to please understand that we don't want to go out with guesses on this. We really want to have the details in place and understand, and nothing is sort of fixed on this until everything is fixed of it. So we'll come back as soon as we can with more details about these things. And thank you so much for listening in and for your attention today. Goodbye.