Good morning, everyone, and thank you for coming to another session of H.C. Wainwright's 26th Annual Global Investment Conference. My name is Eduardo Martinez. I am a biotech equity research associate with H.C. Wainwright, and it is my pleasure to introduce Mr. Adam Mendelsohn, Co-Founder and CEO of Vivani Medical. Mr. Mendelsohn, the floor is yours.
Thank you, Eduardo, and good morning to everyone here. It's a pleasure to be presenting at the H.C. Wainwright Conference this morning. As Eduardo said, my name is Adam Mendelsohn. I am a Co-Founder and the CEO of Vivani Medical, and I'm excited to share our story about how we are aiming to make chronic disease treatments easier, more convenient, and potentially more tolerable. Starting with GLP-1 treatments for obesity and diabetes through our miniature subdermal implants that are designed to guarantee adherence and thereby improve real-world patient outcomes. We have a very seasoned and experienced leadership team with decades of successful experience developing drug- device products and drug- device combination products.
I'm not going to spend too much time because of the limited time I have here, but Don Dwyer, our Chief Business Officer, is here in the audience with me, and both he and I will be available at the end for questions or afterwards as questions may arise. As I mentioned at the start, we're developing ultra-long-acting miniature subdermal implants that are designed to address what we believe is the largest challenge associated with chronic disease treatments in the real world today: medication non-adherence.
I'll tell you more about the statistics as we go forward in the slide deck, but about half of patients do not take their medicine as prescribed in the real world, and this has really drastic consequences as far as the medications that have been developed by the industry not achieving their full potential benefit that we believe our technology may help enable them to achieve. In addition, the technology is associated with very steady release profiles that we think may have tolerability benefits for certain drugs, including GLP-1 agonists, where rapid rises in the exposure level can be responsible for the gastrointestinal events that people experience on these therapies. Our lead program, NPM-115, utilizes a miniature, six-month GLP-1 implant, which is under development for chronic weight management in obese or overweight patients.
We also have a program designed to evaluate this product for patients with type 2 diabetes, as well as another program, NPM-139, which incorporates a different GLP-1 molecule, that is also under development for chronic weight management. And while our lead program incorporating exenatide, we have demonstrated six months of levels of pharmacokinetics in animals that we anticipate will be therapeutic in humans. Semaglutide has indications that it may support a once-yearly administration, which we think would be even more preferable to twice yearly. We are well-positioned to advance these programs, as we go forward, and I am excited to share about those plans with you today. Just a recap of the pipeline that I just described. These are programs that have really tremendous market potential.
As we proceed, I think everyone is already aware of the tremendous growth of the GLP-1 class, the tremendous expected continued growth, and where we see ourselves having a place is for the segment of patients that have challenges with adherence, that could really benefit from an option that enables them to not have to worry about taking their medicine on a frequent basis, which, as I mentioned, is one of the largest challenges associated with chronic disease treatments. We also do have a partnership with a small animal health company who is working with us to develop a version of this implant for companion animals that could benefit from this sort of treatment. I'm not going to be discussing that today, but it is something that we do have in our pipeline.
So here is an image of our implant, and I actually have one here. If anyone wants to take a look after the presentation, I can pass it around. It's a titanium reservoir. It has a material which we have developed on one end that controls the release of medicine from a high-concentration reservoir, such that the release is substantially constant over many months. There is a silicone septum at the other end, which facilitates loading of the high-concentration formulation into the reservoir. We intend to place this under the skin in the upper arm, very similar to the contraception implant Nexplanon, which is routinely administered in an outpatient setting, in a primary care setting with very few complications, and very well-adopted. The implant will be loaded into an applicator that you see on the bottom right of the screen.
After some local administration of anesthetic, the loaded implant can be placed under the skin by this tool in a quick, you know, few-minute procedure that can be performed in an outpatient setting by nurse practitioners, physician assistants, or physicians. Now, the technology that underlies this product we call NanoPortal, and when the device is fully assembled with the formulation, the molecules can only leave the reservoir through the inner diameter of titanium oxide nanotubes, which are represented in the gold material that you see on the screen. These are grown electrochemically from a piece of titanium, and as grown, they're vertically oriented and adjacently attached. To give you a sense of scale, if the inner diameter of each of these nanotubes were the size of a golf ball, the length would be about ten stories tall.
Very, very high aspect ratio structures through which the molecules need to transport, and we can define how many of these nanotubes are accessible to the reservoir, which allows us to control the rate of delivery, and we can control the size of these openings, which ultimately allows us to control the profile of the delivery. Now, as grown, the inner diameter of the nanotubes are about thirty nanometers in size. And to give you a sense of scale, a human hair has a width of about one hundred thousand nanometers.
And what we have been able to demonstrate is the ability to control that inner diameter at the nanometer scale through a process called atomic layer deposition, where we start with something that's about 30 nanometers, and we can deposit one atomic layer at a time of titanium oxide to bring that 30-nanometer opening down to zero or anywhere in between with precise control over the average pore size. Now, what happens is when the opening is close enough in size to an individual drug molecule, then the interactions that the molecule has with the walls of the nanotube end up dominating the overall transport kinetics, and above a certain concentration in the reservoir, all of the nanotubes are completely filled with medicine, and as soon as a single molecule leaves, there's a single vacancy, but multiple molecules in the reservoir are competing to fill that single vacancy.
And as long as that dynamic persists, we achieve substantially constant release, even though the concentration in the reservoir is decreasing over that time. And by being able to have millions of openings with sizes that are on the same order as a drug molecule, with a material that is both biostable and biocompatible, which is what this material chemistry enables over what has been tried previously, enables this material to be applied in this way, which we are very excited about. Now, we've shown, both in vitro and in vivo, substantially constant release rates. Here is some data, in vitro with two different doses of a drug over, in the case of the lower dose in this particular experiment, over a six-month duration, showing very constant release rates over time.
But importantly, and we think specifically importantly for the GLP-1 class, the rate of delivery on very short time interval basis is very smooth. On the right, there are individual device release rates with 2.5 hour interval measurements. In the case of exenatide, which has a half-life of 2.4 to 4 hours, this is the relevant time scale to determine what sort of in vivo plasma fluctuations may occur. And what we see is these changes are within the measurement error of our assay, and essentially, you know, non-fluctuating release, which makes sense given that there are no moving parts, that it is a passive delivery mechanism. And this is what excites us about the potential tolerability benefits that we think this type of approach may ultimately show for GLP-1 therapies.
Now, ultimately, this is a platform technology that although we are starting with a couple of molecules in the GLP-1 class, we intend to apply to the latest and greatest molecules that are in development. As I'm sure all of you are aware, we're looking at how we might be able to couple this with the dual, triple agonist, et cetera. But also, even outside of the GLP-1 space, this platform technology, we think, can be applied across a wide range of chronic disease areas where sustained pharmacokinetics and essentially guaranteed medication adherence could be beneficial. But we're staying focused initially on bringing our GLP-1 product into the clinic so we can demonstrate clinical validation of the technology and data that supports what we think could be an exciting product going forward as we proceed.
And it's important to point out that our delivery technology, we think, differentiates from prior attempts at similar types of delivery in the most critical and specific ways, and one that people are familiar with is Intarcia Therapeutics, which developed a six-month exenatide implant that was unable to obtain an approval. But as a result of very public hearings that have occurred between Intarcia and the FDA, we know through public documents that the reason that the FDA believes that Intarcia struggled were because of irregular and uncontrolled release of the drug. When the FDA requested daily in vitro release data from Intarcia, it demonstrated wild fluctuations that occurred, which our delivery technology directly addresses.
We've demonstrated with substantial data that the FDA has reviewed, which led ultimately to their clearance of our IND to study this in patients, that demonstrates very non-fluctuating release rates. So we think we do have a way of differentiating against prior delivery technologies while enabling us to access the same enormous market opportunity, going forward. Now, our lead program, NPM-115, application of exenatide at high doses for chronic weight management. I'll tell you a little bit about... I don't think I need to inform this group about how many people are living with obesity, how large of a problem it is, how the revenues of the products in the space are currently increasing faster than expectations year after year.
One thing I am gonna talk about in the next couple of slides is some data we've generated, which demonstrates the comparability of the molecule exenatide that's in our lead program, with what semaglutide, the drug substance in Ozempic and Wegovy, based on achieving the right dose and maintaining that exposure level over a period of time. We believe that the existing exenatide products have been held back by both dose, higher doses than that which is sufficient for glycemic control, were never evaluated in patients. Also, the products incorporating exenatide required a lot of extra steps and were a larger needle gauge that, when compared with the other weekly GLP-1s, led to much worse adherence rates, and other complications that limited the data that those products were able to establish.
But with a device that continuously replenishes the drug into the bloodstream, the short half-life of exenatide, which was responsible for the more challenging products that were required to be developed, isn't a problem because the drug is continuously being replaced by the device. Now, we've seen a lot of challenges with adherence and persistence with pretty much all chronic disease treatments. But in the case of semaglutide, about one year after initiating treatment, only about 40% of patients remained on therapy. Now, this was touted as a big advance over the prior generation weight loss drugs, which on average had only 13% stay on therapy. But to us, there's still 60% of people that were not receiving therapy a year later.
When people go off of therapy, you know, the weight comes back and a lot of the potential benefits go away. The transient use of GLP-1, we think, might not, may not show the pharmacoeconomic value to payers, and anything we can do to ensure that those benefits are more long-lasting, we think could be very beneficial. Now, there is another study that came out since we prepared this slide that showed after two years, less than a quarter of patients remained on semaglutide therapy. We think there is a very large opportunity to improve upon the real-world outcomes of these treatments that our implant may be able to provide. We have released data from a study in which we evaluated our exenatide implant compared with semaglutide injections in obese high-fat diet-induced obese mice earlier this year.
And what we saw was, comparable weight loss, when we used, and this is really important, super therapeutic doses. We delivered doses that were well above the maximum potential efficacy of either of these compounds. Often, when we see data comparing drugs, a particular dose is administered, and it isn't clear whether that dose would achieve the maximum potential. So we said, "Well, what's gonna happen if we give human doses, not human equivalent doses, but human doses to mice? And what's the maximum potential efficacy that these compounds could possibly provide?" And what we see is that a GLP-1 monotherapy is a GLP-1 monotherapy, and as long as the dose that's necessary for efficacy is achieved and maintained, we get a similar result. After a twenty-eight-day treatment period, with these two treatments, we see about a 20% weight loss.
Now, in this case, we directly controlled the exenatide implant with semaglutide injections in the same study, so we could get a direct comparison. But these results are also consistent with what, you know, semaglutide has shown in other studies as far as the amount of weight loss in this animal model over this period of time. Now, in addition, we didn't continue the semaglutide injection arm beyond 28 days, but we did continue the sham implant and the exenatide implant arm over a period of 12 weeks, and we measured the liver fat content of the animals at the end of the 12-week treatment period. And what we see is about 5% liver fat in the exenatide implant-treated mice and over 30% in the sham implant-treated mice.
And what's important about this is that this is also consistent with what semaglutide and other GLP-1s have shown in similar animal models as far as the ability to reduce liver fat. So just another orthogonal demonstration of the expected comparable efficacy of exenatide versus semaglutide that we have been shown to deliver with a single administration, with very long-lasting, durable effects. And then the third set of data that I think is important to share is this is a study that it was not in an obese animal model, it was in healthy rats, but we compared with a vehicle implant control and our exenatide implant treatment group over a four-month duration. And you can see the vehicle control adjusted weight loss over time.
We did have a recovery group in this study, where we removed the implants after day 112, and we see the weight recovering in the compared to the vehicle implant control, demonstrating that the drug that's delivered through that entire four-month duration remains active. This is consistent with our PK data, in which we are measuring specifically exenatide, but nevertheless, it's good to have a PD demonstration of this effect as well. Here is some PK data from that obese mouse exenatide implant study that I mentioned. On the left, as you can see, the pharmacokinetics are all substantially constant and steady over the duration. On the right half of this slide, this is an N of 17 in vitro release rate study, where we have two 24-hour intervals, one 5-day interval over the entire 12-week duration.
And in this case, every single individual point is plotted. And you can see the mean, the upper and lower 95% prediction interval. And if you look at some of the data that the FDA shared as far as Intarcia's daily in vitro data, it's night and day. Here you see not a single data point that is outside of a, you know, smooth profile going forward, and that makes us excited. And this is part of what the FDA evaluated in providing us with the clearance to begin human testing and we have demonstrated proof of concept of the ability over a six-month duration to achieve levels that we anticipate will be therapeutic in glycemic control at the doses used here.
On the left is our measured plasma concentrations in rats, and on our right is the expected exenatide plasma concentration based on established clearance rate data, in this animal model with this compound. We do anticipate higher doses being necessary for the weight loss effects, and we look forward to evaluating that as we proceed. Now, we are expecting in the fourth quarter of this year to initiate our first in-human trial, which we call LIBERATE-1. In this trial, the primary objective is to confirm that the implant performs in humans in the same way that it has performed in animals. We will be enrolling patients who are overweight or obese so that the PK data will be representative of our target population but are otherwise healthy.
We're gonna titrate patients on semaglutide for eight weeks and then randomize them to continue the next dose of semaglutide, our exenatide implant, or Bydureon, which is the once weekly exenatide that is included, because we ultimately intend the 505(b)(2) pathway and PK comparison to the marketed product, including this compound. We think will be important. Let's see, I only have a little bit of time. This is essentially announcing the expectation of initiating the study in the fourth quarter, and results being available in twenty twenty-five. Probably quarter two or mid-twenty twenty-five is when we expect results will be available.
Now, we also have a program for type 2 diabetes that I'm not going to have time to share more details with you about, and our focus is obesity, so I'm just gonna jump through these slides, but I will mention that there has been patient survey data confirming the likelihood that they would want to adopt a six-month exenatide implant. The patients already on a GLP-1, 56% of them said they would likely or definitely get and use a six-month exenatide implant, but this was in the context of Intarcia's device, but is nevertheless relevant to us if it were FDA approved, recommended by their physician, and covered by insurance.
And also, we have done our own prescriber research, indicating, particularly in the primary care setting, where 90% of patients get their care, that 8.3 out of 10 is the likelihood they would recommend this type of product to their patients, and payers have a strong value incentive for improving adherence also, so with that, I will. I'm already out of time, so I'll leave it with the end slide, and thank you for being here. I'll be around. Don Dwyer, our Chief Business Officer, will be around for any questions, afterwards. Thank you.
Thank you so much, Dr. Mendelsohn. Sorry, I called you Mister earlier.