Welcome back, everyone. Next, we have Vivani Medical Inc., trades on the Nasdaq under the symbol VANI, and through leveraging its proprietary NanoPortal platform, develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and potentially to improve tolerance to their medication. Happy to welcome in CEO Adam Mendelsohn. Welcome to the conference, Adam. Nice to see you.
Nice to see you as well. It's nice to be back here, and I look forward to sharing the company's story and how we've made progress since the last time that I was here. Let me start by just reiterating what Ana had mentioned with regards to the focus of the company is to address what we view as one of the largest unmet needs and challenges associated with treating chronic diseases: medication non-adherence. More than 50% of people generally do not take their medicine as prescribed. So the incredible results that are demonstrated in clinical studies do not translate to the real world. We think that we ought to do something about that, and we're developing an option that we think can provide a convenient way for people to make sure that they get the medicine that they need without having to worry about frequent administration.
And also, I'll talk about this in a little bit, by mitigating fluctuations in the drug levels that are associated with each administration, and in particular, when people miss doses, even greater fluctuations, we think we might improve tolerability as well. We're starting off with our platform technology in the GLP-1 space that everyone, I'm sure, is already aware of in obesity and diabetes. And as I advance the slides, I'll look forward to sharing more details with you. Here are our disclaimers. And moving forward, let me just start off by spending a moment talking about the obesity market.
It wasn't that long ago that the GLP-1 medicines at higher doses than had been originally approved for treating type 2 diabetes have transformed the landscape as far as being able to finally achieve really compelling weight loss results with acceptable tolerability compared to some of the older generation weight loss drugs that had been available. I don't think I need to educate this audience on what has happened in this space. It's been truly remarkable. The number of people that are participating, that are receiving the benefits of these treatments, and the revenue that's being generated and the future growth potential is truly remarkable. Right now, there are three FDA-approved GLP-1-based injectable drugs with chronic weight management or obesity indications. Around the corner, we do expect some orals to be available, but as of right now, there are no approved orals.
But what most of the people in this space have been focused on are developing different injectable or oral approaches to treating obesity. There's over 50. There has been a ton of activity in this space, again, because of the large revenue being generated, the large growth potential, et cetera. But we are the only company that is developing an option that could provide very long-lasting treatment with a single administration while simultaneously having the ability to, if necessary, stop treatment by removal of the implant in case someone develops a condition that would be contraindicated for care. There are some longer-lasting injectables in development. So far, these have been associated with pretty poor tolerability. But even in the event that those obstacles are overcome, there would not be a quick way to stop treatment. So we are very excited about the approach that we're pursuing.
Again, we're the only ones with this particular approach. We finished a clinical study earlier this year that was successful, and I'll share more about our development plans as we go forward in a moment. So these are the way that we see the market challenges and the way that our technology is intended to address these challenges. First, the poor medication adherence that I've been talking about is associated with suboptimal outcomes. It should go without saying that if someone doesn't take their drug, they don't get the benefit of the medicine. And this happens to a large extent in this population. In the GLP-1 space specifically, when someone discontinues treatment, then it triggers a kind of cold turkey starvation response that causes people to have massive hunger that results in rapid weight rebound.
In some cases, if someone is on treatment for, say, six months and then they stop cold turkey, the weight is likely to come back. Much of it is likely to come back as fat. They may end up worse off than they were before they even initiated treatment. It's really important to find a way to sustain the treatment or to have lifestyle changes in the interim that enable sustained, durable health outcomes to be achieved. With our implant, we anticipate being able to provide convenient, essentially guaranteed adherence to avoid missed doses, to eliminate the adherence challenges over the duration of the implant, which we anticipate significantly improved real-world outcomes. The next piece is tolerability. The largest complaint of GLP-1 medicines are the gastrointestinal side effects: the nausea, vomiting, diarrhea that are associated with use of these medicines.
Although they're acceptable and much better than the side effects had been with the older generation weight loss drugs, there still is a lot of room to improve, and this is a major key area of development. The reason for the tolerability, or one of the main reasons for the tolerability issues, is when someone experiences a rapid rise in the exposure level of the GLP-1. That is why there are these complex titration schemes that are necessary to take someone who's never been on this therapy up to a high enough dose to get the maximum amount of weight loss. We need to get them there slowly so that their body can get used to the GLP-1 levels and allow them to get there while minimizing tolerability issues.
As you can imagine, if someone misses a dose or two, then they're going to experience a significant rise in exposure quickly that would, even if they miss the dose because of tolerability, by missing the dose when they resume treatment, they're likely to experience more tolerability issues, which kind of initiates a vicious cycle that really can only be prevented if there is 100% adherence and people are maintaining their levels. In addition, even between weekly administrations, there's a fluctuation from people that do take their medicine regularly that we think could be mitigated and potentially tolerability could be improved upon. The stable delivery from our implant, which both will eliminate the week-to-week or administration-to-administration fluctuation and also eliminate missed doses, we think has a real chance to improve the tolerability associated with these treatments.
Third, I'll mention the injectable and the peptide-based GLP-1s appear to be emerging as the most effective option. There are some small molecule oral options in development, but they have not performed as well as the peptides as far as efficacy is concerned. And in the realm of peptide therapy, the cost associated with producing these either because of the low bioavailability of the oral peptide approaches requiring massive amounts of drug to be produced or the devices used to administer the injectables, which right now, if you have an auto injector pen with four doses, that's 13 devices per year. Most of the costs are in the devices. We anticipate one or two implants per year, one or two devices per year to be able to provide peptide and injectable level efficacy at a lower cost of goods.
That could address the access challenges, the cost-effectiveness challenges by enabling greater pricing flexibility with this approach. And lastly, there are populations that we think are not being well served by any treatment that requires frequent administration, that having the ability for an implant to make sure, in these populations, that everyone involved in the care of an individual can be assured they're getting their medicine, we think would be very appreciated and could potentially expand the market beyond the populations that are currently being addressed. So at Vivani Medical, we are focused on enhancing patient outcomes right now in the GLP-1 space via our unique route of administration focused on adherence, tolerability, and convenience. Our technology enables miniature subdermal implants to provide once or twice yearly administration. Our lead program is a semaglutide implant.
Semaglutide is the active ingredient in Ozempic and Wegovy that is being developed for chronic weight management in obese and overweight individuals. Earlier this year, we completed a successful first-in-human study with the technology that demonstrated positive safety and tolerability and encouraging performance in humans, and we've shown with our now lead program, the semaglutide implant, that we can sustain preclinical weight loss of approximately 20% over a seven-month period of time and counting in an ongoing study, which is what gave us the confidence to prioritize the semaglutide implant program, which is anticipated to initiate clinical development in the first half of next year, so with the semaglutide implant for obesity as our lead program, we are also intending to evaluate the semaglutide implant for type 2 diabetes.
The exenatide implant, which was in the clinical study earlier this year, is still in our pipeline and something we're evaluating next steps on, but we are prioritizing the semaglutide implant programs that you see at the top of this slide, and lastly, we do have a partnership with an animal health company because we think that beyond humans, there are opportunities to enable these medicines to become available to our animal friends, cats and dogs, and we're exploring and working with an animal health partner to see how we might be able to make these available to those patients in addition to humans, so let me just quickly talk about our technology, so the implant you can see on the left of this slide, a small implant that would get placed under the skin.
We have a custom tool on the bottom left called an applicator, which helps facilitate the easy insertion of the implant under the skin comfortably. What you see here is appropriate for what we anticipate for a twice yearly implant that would be designed to produce Wegovy-level efficacy. If you look at the middle of this slide, the product consists of a titanium reservoir with a high-concentration drug formulation on the inside, and the key technology around which the company was formed is represented by this gold material here, which represents millions of titanium oxide nanotubes that are vertically oriented and adjacently attached and whose inner diameter is the only path for the drug molecules from the reservoir to exit once the implant is inserted.
It's the ability to control the size of these openings to be close enough in size to individual drug molecules that enables the substantially constant release over many months and how the technology functions. On the right at the bottom, you can see what these nanotubes look like up close by electron microscopy. We can control the inner diameter all the way to zero nanometers, which is what you see on the leftmost image of these three images, or to 30 nanometers, which is what you see on the right, or anywhere in between. We can control this with a process called atomic layer deposition, which allows us to tune the size to accommodate various drug molecules. We've been working primarily with peptides, and that's what most of our optimization has been, but we do think that the technology could be expanded further as we proceed.
What we've been able to demonstrate when we have the right size characteristics of the nanotubes and the right formulation of the drug, which all influence the interactions that the drug has with the nanotubes, that we can achieve substantially constant release. Here's an example of our technology delivering constant release over a six-month period of time in vitro, and this was kind of one of the first examples of the technology's ability to achieve its intended result. We've taken the same GLP-1 implant and put it into animals, and what we've shown on the right are the pharmacokinetics, substantially, really remarkably steady pharmacokinetic profile compared to what would be typically observed with administration.
On the left, you can see the control of the release with 17 different implants over this 12-week duration that we've analyzed, including the 95% confidence interval, and all with daily intervals mixed in, which demonstrates the smoothness of the release on an intra-device basis, which is important to mitigate the fluctuations that could be responsible for tolerability issues. With this same study, we demonstrated reduction in liver fat by 82% compared to the sham implant control over the 12-week duration. This is what GLP-1s have demonstrated preclinically generally, and our implant was able to do that with a single administration. We have also demonstrated durable body weight effects. This is also preclinical, in which we've shown that the ability for a single implant to produce compelling weight loss that is sustained.
Importantly, once the implant was removed in both the sham implant and the active groups, the weight starts to come back as would be expected when treatment discontinues and is a demonstration that the drug that's being delivered during the treatment duration remains active over the entire treatment duration. We, this year, completed a first-in-human study with the technology. This was around the exenatide application of the technology, but this was a study that was primarily designed to assess the safety and tolerability and characterize the pharmacokinetics and the performance of the product in a human. This is the first time this technology has ever been studied in a human, and we were very pleased with the results.
We were able to titrate subjects up to a certain dose on semaglutide and then randomize them to our implant, to the marketed weekly version of the same drug by Bydureon and to continued semaglutide treatment, and what we observed were that we met all the primary study objectives. One important thing for our technology, given the history of other implant technologies, is that we looked specifically at the burst that would happen after administration and whether there was any evidence of dose dumping. There was no clinically meaningful initial burst, and there was no evidence of dose dumping. The implant was well tolerated, and there were no serious adverse events in the study.
The release profile we observed was encouraging and indicated it supported the potential for durable long-term delivery based on the profile that we saw and, at the end of the day, supported further clinical development with the NanoPortal technology. Now, what we had decided to do at the same time that we announced those results was based on the very positive preclinical data being demonstrated with our semaglutide implant, based on semaglutide having a much more robust clinical data package associated with it, already having demonstrated compelling weight loss in humans being associated with products that already sell tens of billions of dollars per year.
We decided, having now demonstrated the feasibility of the technology with semaglutide, to characterize the exenatide study as a great proof of concept of the technology and to prioritize advancing our semaglutide implant program into clinical development, which we expect to do in the very near future. And what we call the semaglutide implant is NPM- 139. What I'll mention about this is that GLP-1 products in general for chronic weight management have generated over $14 billion in sales in 2024, and a staggering 32% compounded annual growth rate is expected in this class until the early 2030s. And I'll reiterate what I've been mentioning earlier. The real-world adherence and persistence with these medicines is very much suboptimal. More than 50% of patients regularly missing doses, more than 50% discontinuing by year one, and 75% discontinued by year two.
And lastly, the initial activities with our semaglutide implant, although focused around obesity, are designed to support additional applications of semaglutide, such as type 2 diabetes, which is in our pipeline as NPM-133, chronic kidney disease and type 2 diabetes, MASH, which semaglutide just became the second drug to have an approval for treating MASH earlier this year, Alzheimer's disease, which Novo is completing a phase III clinical study of semaglutide in Alzheimer's disease. If there's a positive signal there, then the rationale for an implant in that population, we think, is pretty obvious. Alcohol addiction and other indications that are being explored with semaglutide that we're really excited to follow and see how well our implant will be positioned to capitalize and become a good option for those indications in addition to obesity.
Some data behind the persistence and adherence issue. Although semaglutide, you can see on the graph on this right, has better persistence, meaning people continue with therapy, the percentage of people that continue with therapy after six or 12 months from initiation, than the older weight loss drugs here. We're still talking about numbers that are far too low. There's a lot of opportunity to increase these persistence and adherence numbers so that we can maximize the benefit of the treatments for as many people as possible. And the problem when someone discontinues treatment, and this is from one of the phase III studies that led to the approval of Wegovy, the injectable semaglutide for obesity, is as soon as someone discontinues, the weight comes back, and it comes back really fast. And this is just one example of that phenomenon. It's happened. We've seen it ourselves preclinically.
It's something that's very ubiquitously observed. As soon as you stop the treatment, the weight comes back, and it comes back because people feel very, very hungry, so what we've been able to show preclinically with semaglutide that inspired us to prioritize this program going forward is preclinically approximately 20% weight loss being maintained over a seven-month duration in an ongoing study, and our preclinical data all supported the decision to proceed towards initiating and rapidly proceed towards initiating clinical development of the semaglutide implant, which is where we're moving to very soon. Let me quickly provide a little bit of data on how we anticipate this type of an option to be received by the market. This is some patient survey data on the left with regards to a six-month GLP-1 implant. What we see are very compelling numbers.
For those that were already on a GLP-1 therapy, 56%, if you combine likely or definitely, indicated that they would likely or definitely get and use a six-month GLP-1 implant if it were FDA- approved, recommended by their physician, and covered by insurance. We've done our own prescriber research indicating a very high likelihood of prescribing an implant for those of their patients in particular who they already believe are not as well adherent to therapy, which is a very large amount, and there's a really good analog for us, which is Nexplanon, which is a subdermal implant in primary care for contraception that last year generated approximately $1 billion in sales, and all of these pieces, when you put them together, paint, we think, a very promising picture for how our implant, ultimately, if approved, will be received by the market.
We've had a rapid-fire sequence of news events after just last month announcing completion of LIBERATE-1, first-in-human study with the technology, which was successful, at the same time reporting the positive weight loss preclinically with our semaglutide implant. Then, earlier this month, disclosing the proposed clinical program for both a phase I and a phase II study with the semaglutide implant, with the phase II study preparation happening in parallel with conducting the phase I studies. And I'll share those proposed designs with you in just a moment. And then announcing that we anticipate initiating that clinical program in the first half of next year.
Our proposed phase I study, this is really primarily a de-risking study for the phase II, but because of our experience in humans with the LIBERATE-1 study with exenatide and our preclinical data with semaglutide, we are preparing for the phase II study in parallel so we can be ready to initiate shortly after results of the phase I that we want to conduct again as a de-risking event. But we're sufficiently confident that we're preparing the phase II study.
This is a low-dose, 28-day study comparing with the starting dose of Wegovy to confirm that the performance is as we expect it to be so that we can have confidence to move into what our proposed phase II study would be, which is after patients have been titrated on semaglutide treatment to randomize to three different doses of our implant as well as a placebo implant and continued semaglutide treatment with Wegovy over a four- or six-month duration, evaluating the ability for the implant to, one, provide weight loss relative to the placebo control, but then, two, what the weight loss is relative to continued injections of semaglutide at comparable exposure levels. We have a really accomplished and seasoned leadership team with a fantastic Chief Medical Officer, Lisa Porter, endocrinologist. She was at Amylin when the first GLP-1 products were approved by the FDA.
Truc Le, our COO, has decades of experience with drug- device combination products, manufacturing operations, quality, and development. Chief Business Officer, Don Dwyer, our CBO, really capable team to help us succeed in our objectives. We have a facility in Alameda, California, that facilitates GMP manufacturing. This is what we use to produce the materials for the first-in-human study that completed earlier this year, and we anticipate this will support us through early commercial manufacturing, and let me finish with just reiterating that we're the only GLP-1 implant in development for obesity and chronic weight management, convenient one- to twice-yearly dosing expected to address some of the key unmet needs and our unique modality we think could reach underserved and under-addressed populations.
And lastly, for those that are following our filings, it behooves me to mention that we do have a subsidiary Cortigent that we're spinning off to our shareholders. And any shareholders who hold common stock as of October 8th will be eligible to receive a dividend of shares in Cortigent, which is a leading developer of brain implant devices based on precision neurostimulation technology, very different from what we are working on at Vivani. But feel free to learn more at their website or related filings, including a Form 10 filing that you'll be able to find. And I'm also happy to answer questions about that. So with that, let me take the last five minutes and see if there are any questions. And thank everyone for being here with us today.
Perfect. Thank you, Adam. All right. Let's start with a question from Kevin.
He wants you to explain, "The implant is injected in fat cells, or is it in a layer of the dermal/subdermal skin layers?" Since it's so small, if you can explain that.
Sure, so the implant is placed as shallow as possible under the skin, very similarly to how Nexplanon, the contraceptive implant, and Eversense, the implantable glucose sensor, are placed, so it's just under the skin in the subcutaneous space. The shallower it's placed, the less likely it will be to migrate based on the experience of these implants, which makes it easier to remove.
Perfect. Thank you. And are you developing treatments with a variation in the amount of dosing, or are multiple different trials required?
We, at the moment, are initially focused on the dosing that will match the highest approved dosing of the existing products. But we do anticipate that having lower dosing with potentially a smaller implant could be appealing to segments of patients. And so it would not be surprising if we end up with different doses so that we can appeal to different segments and also people that end up choosing different exposure levels based on their needs. But for the first two trials, we will be evaluating the doses to determine which dose is equivalent to the highest approved dose of Wegovy.
Perfect. And Oscar wants you to talk about usable life maintenance.
So again, it's once or twice yearly dosing. So the initial application that we're pursuing is a once every six-month usable life for the implant, if I'm understanding the question correctly. But we do anticipate, based on the data we've been generating preclinically, that this could support once yearly dosing. And that would probably be a follow-on next-generation product that would be for once yearly dosing.
Okay, and can you talk about the size of the device?
Yeah. So the upper end of the size that we're looking at, and depending on the dose that's needed, which we're going to be evaluating in the phase II study, we're going to minimize the size for whatever that dose that's needed. So we won't know the size of the commercial product until we have the results of the phase II study. But the upper end, I can say, is in diameter very similar to the Eversense, the commercial implantable glucose sensor, which is about 3.5 mm diameter. And length is about 30 mm -35 mm. But on the smaller end, it could be much smaller than that. What we put into the first-in-human study with exenatide earlier this year was a 2.2 mm diameter with a 21.5 mm length.
As we optimize for dose and also maximizing payload that we can put into the implant, we know we want to minimize that as much as possible. There have been implants that are even larger than that, 4-mm diameter by 45-mm, that have had very high patient satisfaction associated with them. They're all in the small range. Just to give just some numbers of the range that we're talking about, all we think will be acceptable and comfortable for patients. Those are the range of sizes that may help the person asking the question understand what we're talking about here.
Perfect. Adam, do you have any closing remarks for our viewers today?
Thank you for being with us. I look forward to sharing updates on our journey, which looks like it's happening faster and faster as we proceed, and hope everyone enjoys the rest of the conference.
Perfect. Thank you so much. And congrats on this great progress. We'll see you again soon.
Thank you.
Okay, everyone. We'll be right back.