Greetings, and welcome to the Sernova and Evotec conference call. At this time all participants are in a listen-only mode. A brief question- and- answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dr. Philip Toleikis. Thank you, Philip. You may begin.
Thank you very much. Welcome everyone in North America, and good morning, and welcome everyone in Germany and in the rest of Europe, and good afternoon. This is going to be a discussion about the partnership and licensing option agreement for iPSC-based beta cell replacement therapy for insulin-dependent diabetes. As CEO of Sernova, I am extremely excited to have been working with the team at Evotec, and we see this as a transformational agreement between Sernova and Evotec, moving both companies forward. Next slide, please.
Please be aware and read the Sernova forward-looking statements. Also please be aware of the Evotec forward-looking statements. With respect to the partnership highlights and terms, Sernova has acquired an option for an exclusive global license to Evotec's induced pluripotent stem cell iPSC-based human beta cells for use with its Cell Pouch system to treat insulin-dependent diabetes.
This provides Sernova access to an unlimited supply of insulin-producing islet cells, and that removes the major obstacle that we previously had to commercialization of the Cell Pouch technologies, given the current supply constraints of human donor islets that we're currently working on in our clinical trial. Evotec is making a EUR 20 million, CAD 27 million equity investment in Sernova. EUR 15 million or CAD 20 million was priced at CAD 1.57 per share on the closing of May 16, 2022. EUR 5 million and CAD 7 million will be funded by August 31st, 2022 at CAD 2.50 per share or earlier if the five-day VWAP hits CAD 2.50. This equates to an approximately 6% equity position in Sernova by Evotec.
Preclinical development programs will be co-developed by Evotec and Sernova until IND. Evotec will be responsible for manufacturing cells through commercialization processes. We are anticipating that we'll be filing an IND in early 2024. Here, Sernova has the right to exercise its option for an exclusive global license upon IND filing. Sernova will owe an undisclosed milestone payment upon license option exercise and also upon first patient dose. Evotec has an option for joint funding of clinical development with profit-sharing participation upon commercialization of the products. We believe this is a very strong strategic fit to advance potential functional cure for diabetes.
With respect to the Cell Pouch system, I just want to make a few points. First of all, the Cell Pouch is an implantable medical device into which we put immune-protected therapeutic cells. This provides a highly vascularized environment for cells to be placed in. We have created a device that provides a natural tissue environment, and this prevents the formation of fibrosis that other groups have found with medical devices. Our cells have been shown in multiple preclinical studies and in our human phase I/II clinical study at the University of Chicago, to survive for long periods of time.
The reason is that we believe we've created an organ-like environment for the therapeutic cells, where the cells are actually sitting in a tissue matrix and highly vascularized. Sernova has strong patent portfolio and IP around the therapeutic cells as well as stem cell-derived technologies and the device and combination thereof. These are global patents. The device itself is scalable and also retrievable. We also have embarked on a phase I/II clinical trial at the University of Chicago, for which we have shown in a number of patients insulin independence long term. We have one patient who is now insulin independent for over two years and a second patient who has been insulin independent for approximately eight months at this point in time.
This technology is de-risked, and it is proven to work in patients. In terms of the iBeta cells, this is an iPSC-based islet-like clusters mimicking human islet cells. It includes insulin-producing beta cells, but more importantly, also hormone-producing cell types such as glucagon and somatostatin-producing cells. Long-term function has been demonstrated in rodent models of diabetes, and we have also worked with Evotec with respect to combining cells in Cell Pouch previously shown in the gold standard models of type 1 diabetes that we're able to provide long-term insulin independence. Again, this program is de-risked. Evotec also has capability to scale the cells up, which is an important part for our clinical trials going forward.
Our goal is creating an off-the-shelf iPSC-based beta cell replacement therapy as a potential functional cure for insulin-dependent diabetes. What I'm really excited about here is that we have already shown that we can provide a functional cure with the Cell Pouch and the human donor islets in a number of patients. Again, combining these two technologies, we believe will be very, very significant for the industry, and we see this as a relatively de-risk program already since we have been working together.
Next slide. I just want to talk a little bit about the platform approach that Sernova has. Here what we've developed is what we call an integrated regenerative medicine solution for treatment of chronic diseases. It's not only type 1 diabetes, but also a multiple set of other diseases that we're working on. With respect to the Cell Pouch itself, it is very unique in the field. Our goal here is to create a device that allows tissue to grow into the device around removable plugs.
Importantly, the way that we believe that we prevent fibrosis is by having that device heal within the tissues of the body, and then that allows us to form these highly vascularized tissue chambers into which we put the therapeutic cells. We again have demonstrated long-term that our cells are surviving, that they become highly vascularized, and that they produce all of the regulatory hormones to control type 1 diabetes, and that these hormones get into the bloodstream.
This is measured by consistent fasting and non-fasting C-peptide that we find in the bloodstream, not only in our preclinical models, but also in our patients. With respect to immune protection, we've got to protect these cells from immune attack, and we believe that developing a immune-protected device is not the way to go. We like to separate the immune protection from the device itself. We have licensed in what we call a conformal coating technology from the University of Miami that we're now working on and combining with Cell Pouch.
The way this works is that it is a type of shrink wrap polymer cross-link coating that surrounds the cells that then go into the device chambers themselves. We believe that that will protect those cells from immune system attack. With respect to the therapeutic cells, as everyone knows, our first product that we have been working on is with human donor islets within the Cell Pouch. The reason this is because we wanted to work with the actual real thing that is in your own body that we know works and controls blood sugar levels.
Now, in a very exciting way, we have been working with Evotec in terms of their advanced iPSC-based islet-like clusters, which have also been proven to regulate blood sugar levels. Importantly, what this is doing for the combined technologies is allowing us to not only just treat with donor islets, but we can expand our population to the millions of people that have type 1 diabetes. This completely changes the ability of Sernova to commercialize its products and to treat millions of patients with type 1 diabetes.
With respect to our technologies, we have always said that we have a biologically compatible delivery system. We first implant the Cell Pouch deep under the skin of the patient, and we allow the tissue to develop for approximately 30 days. We can go in and place the therapeutic cells into the device that has become already fully vascularized. Essentially, we're placing these cells into a vascularized natural organ-like tissue environment. Those cells can then engraft, and then they can start to produce their product into the bloodstream.
Just one point about the Cell Pouch itself. We manufacture the Cell Pouch under GMP conditions in a facility in the United States, and we make these in multiple sizes, and we can make as many of these as required. They meet the regulatory specifications for North America and also for Europe. This product is GMP manufactured. I'd like to now introduce Dr. Cord Dohrmann, Chief Scientific Officer of Evotec.
Thank you, Philip, and good morning and good afternoon to everybody on the call. Let me start by echoing Philip's introduction and sentiments to the collaboration. At Evotec, we are extremely excited about this collaboration with Sernova. Both companies really complement each other perfectly. With Sernova's expertise, experience, and clinical validation in developing medical devices that are suited for the transplantation of human beta cells. We are convinced that they are the perfect match to Evotec's expertise and experience in the production and manufacturing of iPSC-based human beta cells.
The combination is clearly unique and bears all the hallmarks of a best-in-class, off-the-shelf beta cell replacement therapy. Let me move on to page 10. Induced pluripotent stem cells belong clearly to the most important innovation of the last 20 years. The technology was originally pioneered by Shinya Yamanaka in Japan and allows to directly generate pluripotent stem cells from adult cells that can be taken from the blood, skin or other tissues from adult humans.
The fact that iPSCs can be propagated indefinitely means that they provide an unlimited supply and source, while they can be coaxed to be differentiated in almost any cell type of the body. For almost 10 years now, Evotec has been investing into the industrialization optimization of the induced pluripotent stem cell technology. Evotec has systematically developed proprietary, highly robust and scalable differentiation protocols for a large number of cell types. We are using these iPSCs, derived cells for drug screening purposes, but in particular also for cell therapeutic purposes.
We have structured already a number of successful partnerships, especially when it comes to drug screening in this field, and are very excited about this partnership with Sernova in the field of diabetes. Sernova's Cell Pouch technology is not only unique, but comes highly validated in the field of diabetes with the highly successful transplantation of the device into human using human donor islets. Similarly, Evotec's iPSC-based human beta cells come highly validated through extensive profilin g in diabetic animal models and extensive quality control, down to the single cell sequencing resolution even.
Now we can move forward to the next page. This shows essentially how we are deriving human beta cells from iPSC-derived induced pluripotent stem cells, essentially following the natural path of differentiation. What we're ending up with are really not just isolated beta cells, but islet-like clusters that contain, to a very significant extent, insulin-producing beta cells, but many other hormone-producing cell types, such as alpha cells that are producing glucagon or, delta cells that are producing somatostatin, which are very important to maintain proper blood glucose levels in human patients. Next slide.
Page 12 gives you an idea what these iPSC-based human beta cells or islets look like. These are shown on the left-hand page of the slide. These islets contain optimal composition of insulin-producing cells and other hormone-producing cells, and they undergo usually the highest standards of quality control and are therefore of pharmaceutical quality. These iPSC-based human islets have undergone extensive functional testing in vitro and in vivo.
On the right-hand side, you can see such an experiment where these iPSC-based beta cells have been transplanted into diabetic animals, and blood glucose has been monitored for more than a full year. What you can see here is essentially that at the beginning, shortly after the transplantation, the animals are highly diabetic for the first few weeks. This is due to the fact that, the transplanted islets need to be vascularized and connected to the bloodstream, essentially.
Once this happens, the blood glucose is extremely tightly controlled and this very tight control of blood glucose levels is maintained for the whole extent of the in- vivo experiment here, all the way up to a year. What's also important is that in terms of the blood glucose control, these iPSC-based human beta cells are equipotent to primary human islets, which were also transplanted in these experiments in parallel. We have a highly physiological regulation with no hypoglycemic events that can be observed here.
The next page shows that Evotec has developed a platform here, which is essentially an end-to-end platform that allows us to develop our own proprietary protocols to develop iPSCs cell lines from adult humans, develop appropriate protocols for differentiation, and an extensive quality control array of assays that allow us to monitor the quality of the finalized highly differentiated cell types, but also the expansion of these cells and the upscaling of the manufacturing of these cells all the way up to GMP production. Once again, this is essentially an end-to-end solution from the very beginning of developing these protocols to implementing them into industrial scale manufacturing. Next page.
This page just gives you an idea that at Evotec we are not only interested in the field of diabetes when it comes to cell therapeutic approaches, but we are also developing iPSC-based cell therapies for a number of other indications, potentially for the antitumor cell therapy, but also in the area of immune modulation. However, our most advanced product is currently or are currently the iPSC-based human beta cells, which we're extremely proud to now develop together with Sernova and Sernova Cell Pouch in the field of insulin-dependent diabetes. With this, I'd like to thank you for your attention and hand back to Philip.
I'd like to provide some highlights of the Sernova-Evotec licensing transaction. I would also like to thank Dr. Cord Dohrmann for this excellent presentation with respect to Evotec and combined with Sernova. First of all, we're gonna be combining Evotec's iPSC technology with Sernova's Cell Pouch system. We believe that this will immediately put Sernova at the forefront of this field to find a functional cure insulin-dependent diabetes. The iBeta and Cell Pouch system, we believe will equal the best in class beta cell therapy for insulin-dependent diabetes. Supply of the iBeta cells will remove the limitations of using human donor islets that we currently have.
Cost sharing arrangement will be done for development from Evotec and Sernova up to the IND stage. Then again, Evotec has an option for joint funding of clinical development with profit sharing participation upon commercialization. Sernova now has an unlimited supply of highly ethical iPSC-based beta cells, which can then be transplanted into patients using the Sernova Cell Pouch system. We believe, again, this is a transformational approach for our company. Finally, Evotec equity investment of CAD 27 million is occurring, and Evotec and Sernova are becoming strategic partners in this regenerative medicine cell therapy.
Again, with respect to all of the work, all of the processes that Dr. Dohrmann was talking about, we also have the potential to expand our relationship beyond diabetes itself. I'd like to thank everyone for listening to this presentation, and I would like to invite the operator to now open it up for any questions that may come in.
Thank you. We will now be conducting a question- and- answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment please while we pull for questions. Thank you. Our first question is from Doug Loe with Leede Jones Gable . Please proceed with your question.
Yeah, thanks operator, and good morning, gentlemen. Congratulations on the transaction. Several places we could take the dialogue this morning, I think. Maybe I'll start with this. Dr. Dohrmann, in your own commentary, you indicated, you know, several details on, you know, manufacturing scale up and quality control that'll be relevant before you submit your IND in a couple of years. Just wondering, if there are any specifics with regard to any form of preclinical testing that will be required specifically on any large animal or non-human primate data that you might have to amass prior to IND and over, you know, over what timeframe that those studies might transpire and any details you could provide there would be helpful.
I would say that at this point in time, we do believe that the vast majority of experimentation in the preclinical setting has been essentially completed. With this transaction, we now essentially complete the potential product, you know, combining Sernova's Cell Pouch technology with our IP, iPSC-derived human beta cells. There will be a few more experiments to complete with the combination of this product, but overall, as Philip indicated, we have already been working together here for some time now and feel that this is all basically ready to go now into formal product development.
Thank you very much for that. Then, second of all, this kind of leads into from one of Philip's last comments in his introductory remarks about expandability of the alliance. You already have a solid pipeline in oncology and immune modulation, which is obviously positive. Just wondered if you had any existing data with regard to your ability to be relevant in hemophilia A or thyroid disorders already, i.e., your ability to differentiate stem cells into Factor VIII or thyroxine-producing cell lines. Any insight there would be helpful.
Yeah, I'm happy to comment on that. Essentially, we don't currently have any sort of programs in these areas that are. Nevertheless, we do believe that these are interesting areas for the future of Evotec. We do believe that at Evotec, with our very extensive platform and experience in developing protocols for certain cell types that these are areas that we can easily move into and potentially generate further synergies between the two companies. You know, we, Philip , and I discuss these opportunities. Before we get into those, we currently want to focus in particular on our common opportunity here in the diabetes space, because this is of course the one of the largest cell therapeutic opportunities that exists in the industry.
Great feedback there as well. Thank you. Philip, just a question for you. You mentioned the conformal coating technology that you acquired from the University of Miami without providing too much supplemental detail thereafter. If you maybe just on that, I'll leave it there. Any updates on how that technology is performing in any of your preclinical work? Any aspirations for incorporating it into future phase 1 studies at the University of Chicago? If you have any existing insights into how that technology works with Evotec-derived islet-like clusters, that would be helpful as well. I'll leave it there. Thanks.
Yeah. Thank you very much. We do have a significant collaboration with the University of Miami right now, combining conformal coating with islets in Cell Pouch. We have, in preliminary studies, been able to show that, first of all, the kinetics of insulin and glucose, with the conformal coating in the Cell Pouch is, working very, very well. That's one of the important considerations for any kind of a coating-type technology. In terms of stem cell, Evotec stem cell work with the conformal coating, that's definitely something that we're going to be working on, that we plan to be working on. That combination of stem technologies plus the conformal coating does work. We're just gonna be combining this and continuing on with Cell Pouch.
Now, in terms of potential conformal coating of islets, human donor islets or the stem cell-derived technologies, this is both of these are things that we're going to be working on an immediate basis. The goal here is to get these into clinic and to eliminate the need for the anti-rejection medications that everyone is now using.
Great feedback. Thanks, Philip. Congratulations again.
Thank you.
Thank you. Our next question is from Peter Welford with Jefferies. Please proceed with your question.
Hi. Thanks for taking my question. It's Peter at Jefferies. Just a quick question on really, I think, directed at Evotec. Just with regards to the production of the iPSCs, do you have already internally the sufficient capacity to be able to make iPSCs for these Cell Pouch at the clinical stage? And at what stage do you need to look for further capacity? And related to that, do you plan on potentially building yourself the scalability, or alternatively, do you plan on, I guess, buying a facility, o r do you envisage contracting out to a third party the capacity to be able to produce sufficient iPSCs? Thank you.
Yes, happy to address this. At this point in time, we feel extremely confident that we will be able to manufacture and what is required for the clinical development of this combination product. When it comes to further upscaling, I can only say that we are very confident that we will have everything necessary in place once you know further upscaling is needed.
As we anticipate that the development into the clinic will still take a couple of years at this point in time, we will be you know really well prepared essentially to then provide further upscaling, whatever is needed. This, it's basically a strategic component for us in the field of cell therapy. We will not only need these kind of upscaling capabilities for this diabetes project, but also in other areas.
That's great. Thank you.
Mm-hmm.
Thank you. Our next question comes from Paul Stewardson with iA Capital Markets. Please proceed with your question.
Good morning or afternoon, as the case may be, and congratulations on the partnership. Question for Philip. In terms of, you know, the strategy for Sernova, from the global pharma partnerships that obviously this one has come out of sort of that was how you were talking about these iPSC cells. Does this partnership conclude those research agreements or are there still opportunities for working with the other companies that you were working with for the other programs for thyroid or hemophilia?
Yes. With respect to that, we do have other pharmaceutical relationships, but this is more around other disease indications that we're working on outside of diabetes. For diabetes, our partnership is gonna be focused with Evotec and the iPSC cells because we believe that that is the ultimate solution for patients with diabetes. We're gonna be focused on that, but we do have our other partnerships that we're continuing to work on.
Okay. Yes, understood. Just to follow up, in terms of, you know, the things that brought Evotec to the front. Obviously, it looks like they really have the best validation of the program. There was a lot of data and definitely appreciated the slides in the presentation as well. Can you talk about in terms of other than, you know, being farthest along, what kind of differentiating factors are there for the specific Evotec iPSCs versus, you know, what else is out there in the sector? Other than sort of the amount of progress, which is obviously differentiated, is there differentiation at the biological level at all that you can talk about?
Yeah, a couple of things there. There's a number of components that we put together. As you know, the Cell Pouch has already been proven in clinic. We already have a strong U.S. IND with all of our supporting preclinical studies, et cetera. In terms of the Evotec iPSC cells, this is not something that has just arisen recently.
Evotec has been working on this for many, many years and optimizing, and we see Evotec's quality systems as the best in the world. Really controlling the cells in the same way that we would control a pharmaceutical product is what the goal has been, and this is what Evotec has been focusing on. The other part about this is that it's really the teams and the quality of the teams on both sides working together, and we found that the Evotec teams were and combined with Sernova, just blended together really well. Dr. Dohrmann, do you have any other comments that you might wanna bring up about that?
No, I can only echo this. Essentially, we're gonna continue to strive to produce the highest quality iPSC-derived beta cells. In this case, it's really, as we indicated, really human islets with the optimal composition of various hormone-producing cell types. We have invested heavily into really making sure that the cells are highly mature in terms of functionality, that they have the perfect composition, and that the protocols, in particular, are scalable for the long term. This is actually where a lot of people will struggle in the future.
We try to think this all the way through, not just sort of from coming from sort of a laboratory bench to a first initial clinical trial, but basically to think it all the way through to ultimately serve a huge potential market of insulin-dependent diabetic patients. Here, as you can imagine, that especially in such a combination product, it involves a medical device plus stem cell-derived cells. This is very complex and the eventual cost of goods are gonna be an extremely important component, as will be the ease of use of such a device. Here, once again, it is no accident for us either that we are working here with Sernova.
Evotec has tested a large number of potential devices in the field, and the Sernova medical device Cell Pouch clearly came out on top. We feel this is really, in many ways, a match made in heaven in this regard. We feel that Sernova is currently the absolute leader when it comes to the Cell Pouch technology, providing a retrievable device that allows really perfect vascularization of the transplant and with the potential of going forward of providing even immune protection via a microencapsulation technology.
Once again, we are convinced that the combination of Sernova and Evotec is really the best possible combination currently out there. I'm convinced that on the Evotec side that regarding the iPSC derived human beta cells, but also other cell types, that Evotec is clearly leading. I think some of our track records here in the industry with really big deals also with BMS and others in the field attest to this.
That's great to hear. Really, really helpful color. Thank you so much, both of you.
Yep, you're welcome.
Thank you. Our next question comes from Stefan Quenneville with Echelon Wealth Partners. Please proceed with your question.
Hi, guys, and thanks for taking my question. Congratulations on the deal. You know, given the recent FDA hold that's been put on Vertex's program, can Evotec characterize its interactions with regulators, you know, particularly the FDA, regarding its stem cell program and manufacturing in general, and obviously specifically on their, the beta cell program?
Philip, do you wanna go ahead to try and take this first, or should I give it a shot?
Yeah. I'll just about that. I can't really say too much about what's happening with respect to that program. But I can say that with respect to the relationship between Sernova and Evotec and the products that we are developing together, by putting the cells directly into the Cell Pouch, then it allows those cells to be contained in a local organ-like environment. Again, our device is set up so that the cells are actually sitting in that tissue matrix and don't leave the device. They stay in that location. And also we know that the combination of cells in the Cell Pouch work, they become fully vascularized.
We have been consistently seeing C-peptide in the bloodstream and also seeing clinical benefit with the combination within our clinical trial right now. We have also had consistent safety of the cells and also the device long term in our patients. We're very confident from that perspective. Then also you know Dr. Dohrmann can probably talk about the cells in terms of the consistency and the safety, and again that approach of having a tight pharmaceutical like product going into the Cell Pouch, which I think is very important from the safety perspective. Dr. Dohrmann, you may want to add anything else further on that one, please.
No, I think, Philip, you summarized that quite nicely. You know, especially I think the various features of the Cell Pouch in combination that we are working here with essentially a fully differentiated iPSC-based human beta cells or islets is a new combination, and we feel this addresses most likely many of the potential concerns of regulators in the field.
Mm-hmm.
Great. My next question is sort of, you know, you have mentioned your hopes to file your IND in early 2024. What are the key rate limiting steps to get that done?
I can answer that question. Right now, we are working on combining again the most recent cells from Evotec in Cell Pouch clinical studies for optimization and dosing, et cetera. Then we will start the formal pre-clinical safety and efficacy studies. It's important to remember that Sernova already has a very, very significant documentation with respect to our Cell Pouch safety and efficacy and with respect to our IND in the U.S. Really, it's going to be adding the manufacturing processes for the cells, the CMC section, and then just combining those in the formal safety pre-clinical studies that will enable us to move into the IND phase in our first clinical study together.
Great. My final question is sort of, well, we'll see what you can sort of disclose on this. You know, you talked about the cost of goods, you know, as being an important differentiator over time in terms of getting this out to a large number of people. Do you guys have an aspirational sort of cost of goods at scale once you get, you know, processes, you know, to the level you want to do it, you know, at some, you know, future commercialization date that you're targeting? Is there a kind of number you're trying to get to in terms of, you know, making this broadly accessible?
From my perspective, I think that's something that we're still in discussions with the Evotec team. These cells are very, very cost effective to produce, which hasn't been an issue with a number of other cell producers. Dr. Dohrmann, you may wanna comment on any other comments that you might have around that.
No, I don't have anything to add to that. Once again, the only comment is here that we basically developed the protocols keeping especially cost of goods in mind, for the future, the ease of larger scale manufacturing and the components you need for that. We also firmly believe that there will be further improvements possible. At this point in time, I would say no, we don't have a clear number in mind, but I think we are very well aware of the fact that this will be a factor in our addressing this early on.
Okay. That's all for me. Again, congrats from the other guys.
Thank you.
Thank you. Our next question is from Natalia Webster with RBC. Please proceed with your question.
Hi there. Just checking you can hear me okay.
Yeah. Yes.
Perfect. Thanks for taking my question. My question's on the immune protection technology to protect non-modified beta cells. I was wondering what exactly the process and timeline to validate this will be, and if there's a plan B for dealing with an immune response if this doesn't work.
Yeah. Thank you for that question. As I had mentioned before, we're working with the University of Miami on a technology that is called conformal coating. This is something that is developed over a 12-year period, and it's been proven to be able to provide immune protection in cells, and now it combines that technology with cells in the Cell Pouch study.
As we move forward, it'll take approximately a year, and then we're hoping to from that perspective and, you know, start to move things into the clinic. We have already shown again that, you know, importantly, the kinetics of insulin and glucose moving across that membrane is normal, which is what you need to have good control of blood sugar levels.
We're working on optimization of the conformal coating with the cells and dosing, et cetera, in our collaboration right now. Honestly, this is, you know, the immune protection without the anti-rejection medications is something extremely important to patients. This is something that we're focusing on completing as quickly as we possibly can to get this into clinic.
Okay. That's great. Thank you for your answer.
Thank you. Our next question is from Christian Ehmann with Warburg Research. Please proceed with your question.
Thank you, and hello everyone on what looks like a very good partnership. My question goes a little bit into the same direction as my colleagues before. Do you have any early stage data on the durability of the activity of the cell? Do you know how long they are active in this implant? If not, if it does not prolong very much, how would you be able to then reload, if you will, the implant if need be? Thanks.
Yeah. The exciting thing here is that we do have data with the human donor islets and in our clinical trial. Currently ,our longest standing patient has been insulin-independent with the combination therapy for 25 months at this point in time. We know that Cell Pouch is very, very durable in terms of you know, long lasting production of insulin into the bloodstream.
You know, important for medical devices, we are not seeing the fibrotic reactions that others have seen in this field. With respect to the cells, and I can just briefly mention something that we've shown, we have already seen from Dr. Dohrmann's data, which I think in preclinical studies is the longest standing preclinical study that I've seen in this field.
We're seeing consistent insulin independence in the preclinical models for a year, at this point in time. I see the combination of our technology as having the potential to be long lasting in the patients. Proven by the fact that Sernova already has data for two years, in this first individual patient. The other point that you had made is if the patient does need to get new cells, very importantly, our Cell Pouch is retrievable.
We believe by putting the device deep under the skin rather than in the intraperitoneal cavity, it's a very, very safe environment, and the device is retrievable. If necessary, we can put new devices in after whatever number of years we need, and then we can reload those devices with new therapeutic cells. The fact that we're using this unlimited iPSC cell technology enables us to be able to have a consistent product that can go into patients at any point in time.
Thank you very much. Very helpful.
Thank you. There are no further questions at this time. I would like to turn the floor back over to Dr. Philip Toleikis for any closing comments.
I'd like to thank everyone for coming to the conference call today, and I would especially like to thank Dr. Dohrmann. We are very, very excited to be working with the Evotec team, and we obviously have already established a fantastic relationship with them, not only on the development side, but also on the business side and management teams. We just want to thank everybody for this. The most important thing that I want to do is just have everyone sit and imagine for a moment of what this collaboration could look like in the long term.
I am sure that everyone out there knows people who have diabetes and the suffering that they do on a daily basis. When I look at our patient that has been insulin independent for two years now, it is being able to provide a functional cure to patients and have them be able to come back to being, just feeling normal again. There's nothing better in the world that can happen with that. I am really excited, not only from the business side and the science side, but also from the patient side, to be working together with Evotec to create this functional cure.
Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.