Back, everyone. Next, we have Vivani Medical. It 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. Please welcome its CEO, Adam Mendelsohn. Nice to see you today, Adam. Welcome to the conference.
Good to see you as well. I'm happy to be here.
Okay, the floor is yours. Call me back when you're ready for questions.
Okay. Fantastic. It is a pleasure to be back here at the Emerging Growth Conference, and I look forward to sharing some really exciting updates with regards to what our company has been doing so far this year, and also providing overview of what Vivani Medical is working on. Before I get to the slides, I will just start by mentioning, as Anna mentioned, we are developing miniature implants that can be placed under the skin and provide steady delivery of chronic disease medications. We are focused initially on the GLP-1 class, which everyone is now familiar with because of the blockbuster success of products like Ozempic and Wegovy and Mounjaro and Zepbound.
With over a billion people living with obesity and these highly effective treatments available for allowing people to lose and maintain that weight loss for extended periods of time, what we're focused on is how we can help make sure that people can maximize the benefits of these treatments by removing the human element that gets in the way of real-world health outcomes, with only about half of people regularly taking the doses as recommended. This has both efficacy as well as tolerability consequences that I'll talk about in the deck. We are very excited about the prospects for our implant to potentially improve significantly on both of these elements in the blockbuster GLP-1 class. A couple of disclaimers here on this slide. I'll move to slide three here.
We do have an outstanding team with decades of experience developing drug-device combination products, including the world's first inhaled insulin product, as well as being involved in the approval of the first GLP-1 products that were ever marketed and commercialized. We are prepared with the capabilities and experience of our team to continue to execute on our plans, ultimately towards success. Let me just, before I get into more of the detailed slides, you know, who are we, what are we doing? We are a clinical stage company. We started our first clinical trial at the end of last year. It rapidly enrolled, and we've implanted a number of people who have all tolerated the implant procedure well. This is part of a portfolio of ultra-long-acting drug implants that are designed to address, as I mentioned at the beginning, the challenge of medication adherence.
I'll show some data a little bit later. Potentially, we think by eliminating missed doses and providing steady exposure levels, reducing some of the side effects, which represent the largest complaint associated with this class of treatment. Our lead program is NPM-115, which is an exenatide implant that's currently in our clinical study, which we've branded LIBERATE-1 . We are also prioritizing the development of NPM-139, which is our semaglutide implant, for which just yesterday we announced some very positive preclinical weight loss data. Semaglutide is the drug which is in the drug products Ozempic and Wegovy. Exenatide is also a GLP-1 agonist that was in the first commercialized GLP-1 products, Byetta and Bydureon. These products are being developed for obesity treatment, chronic weight management, and are being designed for once or twice yearly dosing. NPM-115, twice yearly dosing.
NPM-139, we think, has the potential for once yearly dosing. We also have in our pipeline NPM-119, which is being developed for type 2 diabetes. The first indications of GLP-1 agonists were for the treatment of type 2 diabetes, and then they've expanded to treat obesity more recently, and that's where a lot of the market excitement has been. These are still highly effective treatments for type 2 diabetes, and we want to make the product available as widely as we can. During this year, we anticipate possibly multiple, potentially transformative milestones, including the results of our first clinical study, which is currently ongoing, continued development of our pipeline programs.
With the cash that we had, $18.5 million at the end of last year and an $8.25 million financing that we just announced this morning, we have runway into the second quarter of 2026, plenty of runway to be able to meet many of our near-term milestones and continue developing the programs. As I mentioned, NPM-115 is in a phase I clinical study, and I'll tell you more about that as we proceed. NPM-119 has had a study cleared by, with an IND that's cleared by the FDA. Our strategy is to prioritize the obesity and weight management application of the technology, which is NPM-115, and then as we proceed in development, incorporate the evaluation of the, on the treatment of type 2 diabetes in addition as part of the NPM-119 development program.
NPM-139, the semaglutide implant, we just showed some very positive weight loss data in a preclinical study, and that has now moved from the feasibility stage into the preclinical stage, and we're advancing that ultimately towards clinical development, and we're very excited about that. We have a partnership with an animal health company to develop a version of these GLP-1 products to treat companion felines who have diabetes and obesity, and we're excited about making this technology as widely applicable, including to our animal friends as well. Let me tell you about the product and the technology. This is the first of its kind technology to now be in a clinical study based on a nanoporous membrane consisting of titanium oxide nanotubes that control the release of medicine from a high-concentration reservoir constructed of titanium.
When fully assembled, the only path for drug molecules is to go through the nanotubes, which ultimately results in very steady and substantially constant release of the molecules. The implant is placed just under the skin for the first clinical study. It's going in the inside of the upper arm, which is a similar location as both the contraception implant NEXPLANON as well as the implantable glucose sensor Eversense, both commercial products administered in an outpatient setting with few complications. The product that we're evaluating in the first clinical study is, you can see on the top right, very small, about the width of a dime. And we have a custom applicator tool that facilitates the insertion of the implant to make sure that it's placed shallow, which is ultimately important, and to facilitate the ease of the procedure for the healthcare practitioner.
The technology is based on, as I mentioned in the last slide, this array of titanium oxide nanotubes represented in the gold-colored material that you see on this, on the right half of this slide. When the membrane is welded, the titanium portion of the membrane is welded to the titanium reservoir, then the high-concentration drug formulation has to go through these very high aspect ratio nanostructures to ultimately become available. To give you a sense of scale, these nanotubes, which are vertically oriented and adjacently attached, if the opening was the size of a golf ball, the length would be about 10 stories tall. You have a very narrow path that the drugs have to traverse in order to be able to become available. There are millions of these openings.
What we've shown is that when as grown, the nanotubes have an opening that's about 30 nm in size. 100,000 nm would be the width of a human hair. These are very, very small openings. We can precisely tune the size of this opening at the nanometer scale using a process called atomic layer deposition, where we take on the top right, you can see an electron micrograph of what the material looks like as grown initially by growing its anodization process, kind of like chrome plating a rim that goes on a tire. We can deposit one layer of pure titanium oxide along the entire length of all the nanotubes to bring that 30 nm all the way to zero nm or anywhere in between with extreme precision over the average pore size.
Titanium oxide is both biocompatible and biostable, which enables it to ultimately be applied to this particular application. Now, when this happens, above a certain concentration in the reservoir, the rate of delivery can't be any faster because the nanotube, that long narrow structure, ultimately constrains the transport of the molecules, and standard concentration gradient-based diffusion breaks down, and you end up with substantially constant release, as we've shown here on this next slide with a couple of different doses. On the top, on the left, you see a three-month substantially constant dose, and on the bottom, you see six months of constant delivery, even as the concentration is decreasing in the reservoir. That really is the fundamental technological development that this nanostructure was able to provide, without moving parts or electronics, to be able to achieve a passive, constant rate delivery of drugs.
Now, on the right half of this slide, we think particularly important for GLP-1 agonists and possibly other drugs as well, is even at very short time intervals, the change in delivery rate is very small. It's very minimally or almost non-fluctuating, which is what you would expect based on how the physics of this kind of system would work. It's passive. Once it's in the body, it's just this material that's constraining the motion of the drugs. What that enables is the absence of fluctuations in exposure, which can be responsible both for, in the case of GLP-1s, when the exposure level goes low, then people get hungry, and they eat more. They experience something called hunger rebound. When the exposure comes up quickly, they can get the side effects, the gastrointestinal effects.
The technology is really, we think, perfectly suited to the delivery of GLP-1 agonists, and to the extent this is important for other drugs, we're also excited about its possibility. Although most of the rest of the presentation is going to focus on our lead products, it is a platform technology that we expect to ultimately apply widely across multiple disease areas as we proceed. The opportunity in the GLP-1 class for type 2 diabetes and obesity, and many of the other indications that are being explored with great promise, is too enticing and exciting that that's where we've decided to keep our focus for the time being. One, there was a, we aren't the first company to think about applying a long-term implant to the GLP-1 class.
There was a company which at the time was developing a product with a lot of excitement around it that ultimately met its demise because of what the FDA indicated in a hearing, were fluctuating release profiles associated with the delivery technology, which is why the graph that I showed you earlier demonstrating very steady delivery associated with this different delivery technology is critical and addresses the fundamental reason why this other company's product on the left did not get approved. We believe it enables us a good chance to obtain regulatory approval and test the commercial hypothesis, which both they and us think is extremely attractive. Moving on, our lead program, NPM-115, is exenatide for chronic weight management. There are actually almost a billion people living with obesity now. That figure is a little bit outdated.
With the opportunity for a six-month product to have a beneficial impact by guaranteeing medication adherence and steady drug levels, we think it can be a very attractive alternative to needing to take lifelong weekly injections or pills, which are in development, and for a meaningful segment of the population, be the choice that they ultimately select when we get through the approval process. Now, I've mentioned poor medication adherence. There's also persistence, which is people discontinuing their treatments. Here is some data showing with semaglutide, which is the drug in Ozempic and Wegovy, after one year, only about 40% of people are still on therapy. Actually, more recent data has shown after two years, only about a quarter of people are still on therapy.
The problem when people discontinue is that they increase their food consumption and they gain the weight back, which we believe an implant can provide an attractive option that can help keep the weight off and provide a more convenient long-term maintenance solution for people that are seeking long-term maintenance of the weight that they've lost on these therapies. Here is a little bit of data demonstrating what's happened in a clinical study with semaglutide that when discontinuation occurred, the weight came back quickly. That's what you see on the left of this slide and on the right.
What we've shown ourselves, and this is consistent with others, is when we removed an exenatide implant in an animal study and measured food consumption, these mice ate 50% more food than the control mice ever had eaten, which is consistent with this hunger rebound response being ultimately responsible for the challenges associated with discontinuing treatment. Now, with our exenatide implant, we've shown comparable weight loss, 20% compared to a sham implant control with injections of semaglutide. Our weight loss curve is extremely smooth, which is what you would expect from a product that delivers very steady doses of the medication. We've also shown a significant reduction in liver fat in obese mice after 12 weeks of treatment with a single administration of our exenatide implant. The GLP-1s are showing promise in fatty liver disease and MASH, as well as obesity and type 2 diabetes.
We've also shown very durable weight loss. This is a study in which we've, for a four-month duration, we had an implant. This was in rats, and the weight loss was significant and maintained over the entire four-month duration. In a recovery group on the right half, you can see when we removed the implants, the weight came back, as you would expect, which is why consistent with the need for consistent and sustained medication delivery. We have shown the ability to deliver this compound for a six-month duration, which is the target commercial product profile for the exenatide implant and the initial version of the semaglutide implant. Now, our first clinical study, which is ongoing right now, rapidly enrolled in just four weeks, 24 subjects across two sites. This is very fast enrollment.
We were very pleasantly surprised with how much interest there was from people to participate in our study. Most of the subjects have gone through the titration period with 0.25 mg semaglutide and 0.5 mg semaglutide before being randomized to receive either our exenatide implant, the once-weekly marketed exenatide Bydureon, or continued semaglutide treatment. We've had several subjects that have been implanted, all of whom have tolerated the insertion procedure well. I very much look forward to sharing results when they are available as we proceed with the study. I do expect to have the top-line data around the middle of this year. On this slide, you can see the history of how we got to this point. Last year, we announced some very compelling preclinical weight loss data, which led us to shift our strategy from diabetes to focus on obesity.
We are in the middle of our first clinical study and very excited about those prospects. Now, I am going to talk a little bit about the diabetes application, which is NPM-119. I will not spend too much time, and I'll make sure there's time for questions afterwards. The adherence rate of diabetes products, and adherence is defined as how consistently people are taking their medicine, are only around 50%, which, as described before, can have significant consequences, not just in terms of efficacy, but also intolerability when people resume treatment after they've allowed their drug exposure levels to go down.
The opportunity in diabetes, we think, remains worth discussing for a number of reasons, including patient research, which was conducted with a six-month GLP-1 implant, in which 56% of patients who had been asked whether they would likely or definitely get and use such an implant, who had already been on GLP-1 treatment, if it were approved by the FDA, recommended by their physician, and covered by insurance, said that they would.
This is a very large proportion of the population and motivates us in particular because the number of people that were on a GLP-1 before, as opposed to never been on a GLP-1, who suggested that they would use an implant was greater, which motivates us to initially target the maintenance phase of treatment where people who already know that they like and can adequately tolerate the drug, who are willing to commit to six months or a year at a time. The opportunity there, we think, is truly tremendous. Lastly, I'll quickly mention the program for which we had a data update yesterday morning, which is NPM-139, which is the application of this technology to semaglutide, which, between Ozempic and Wegovy generated $25 billion in sales last year.
We think the opportunity to present an implant that can make sure for once or twice yearly administration, the semaglutide treatment can be provided is really tremendous. We showed over a 91-day period, nearly 20% weight loss by day 14. That was maintained through the 91-day treatment period after a single administration of the implant. We have shown six months of therapeutic levels with the semaglutide implant as well. We are looking forward to extending the duration of demonstrated weight loss and ultimately advancing this program into human studies. With that, I will just wrap up with reminding everyone we are a clinical-stage biopharma company developing a portfolio of miniature ultra-long-acting drug implants addressing what we think are the largest reasons for poor real-world health outcomes for chronic diseases, mainly medication adherence. We have our lead program in a clinical study now.
We're very excited about how that is going, how quickly it was enrolled. Expect to have top-line data in the middle of this year. We will be advancing our semaglutide implant, NPM-139, on the heels of some positive data that was announced yesterday. We're really, really excited about what the rest of this year can bring for us as we advance our pipeline of implantable GLP-1 products. With that, I'll take any questions that the audience may have.
Great. Adam, thank you so much. We do have some questions. First of all, Yana says, "Congratulations on the first trial. Can you give a little bit more details, specifically size, duration, and what you are expecting?
Yes. Let me go to that trial. This trial is primarily designed to determine how the performance of the implant will translate from the animal studies that we've conducted into humans. We've designed for it to have a nine-week treatment duration. There are eight subjects that were enrolled that intended to go into each of the treatment groups, which includes the exenatide implant treatment group, the NPM-115 treatment group, the Bydureon treatment group, and the semaglutide treatment group. We're primarily assessing safety, tolerability, and characterizing what the pharmacokinetics are of our implant in these subjects over this period of time.
Because we expect that the dose that's going to be delivered will have some effect, we are measuring weight, and we are comparing the results with the marketed once-weekly exenatide and continued semaglutide treatment so that we will be able to understand, based on the exposure levels that are measured in the implant group, what kind of weight effects are observed relative to continued semaglutide treatment. We'll be able to assess any tolerability differences compared to semaglutide. We think that after the first administration, the fluctuations that happen with each dose of semaglutide could lead to more side effects that we think might not be as present in the implant, which will provide a steady delivery over that duration.
We are also going to be comparing the pharmacokinetics to the Bydureon group, ultimately as part of what we anticipate being a 505(b)(2) approval pathway to reference the safety data that Bydureon has already established, which should make for a much leaner and more efficient approval pathway than would be the case for a kind of a new chemical entity. That is why we have Bydureon in this group. Just to be clear, what we do not expect is to have demonstrated maximum potential weight loss with our implant at this dose.
We will follow this study with a second study that will be dose-ranging, where we intend to evaluate higher doses of NPM-115 that we would anticipate to ultimately demonstrate the maximum weight loss capability to identify the dose that would ultimately be the most effective. After that second study, to design a third potentially registrational trial to evaluate that dose and generate the data that could ultimately support an approval.
Mark asks, "Is the delivery through the reservoir proprietary technology? And if so, how is it protected?
Yeah, great question. The nanotube layer itself, just the composition of the nanotubes, a titanium oxide nanotube directly attached to a titanium substrate, that's the subject of a patent which is issued in the U.S. and in multiple countries. That was really how the company got its initial start. There is also another patent on the deposition using atomic layer deposition to tune the size of the nanotubes, which is also in a U.S. patent that is issued.
There are many patents on the formulation of the drug that maintains its stability within the device that came later that further push out the expiration of the patents, and even more that are in prosecution. What I will say is, I mean, all of our patents are mentioned in the 10-K. We will be shortly filing our next 10-K with a refresh of the patent landscape. You can take a look at that for more details. It is very well protected out into the 2030s, with some that could provide protection into the 2040s.
Vicki asks, "What other applications can this technology be used for? Can it be licensed?
Yeah, I think it can be used for really any application for which the drug molecule is adequately potent such that a clinically meaningful duration can fit into an acceptably sized device where the drug can be made to be adequately stable, so that it can stay active over the duration of treatment, and for which steady levels in the bloodstream are effective. There are a number of possible applications outside of GLP-1s. Each new drug molecule does carry new technical risk in formulation development.
The formulation development work also typically would lead to new intellectual property, but b ecause of how exciting the GLP-1 indications are and us already having demonstrated and reduced the technical risk of creating formulations that allow the technology to work with those drugs, that is where we are focused now. As we ex pand, we will look to licensing opportunities, partnership opportunities to maximize the potential applicability of the technology.
Last question from Ari, "Will patients in the clinical study be placed on a full-service obesity management program, or will their diet and exercise program be at their own discretion?
Yeah. The recommendations to the subjects in the study are no different from anyone that is beginning GLP-1 treatment. There is no additional diet and exercise counseling associated with this study. It is a controlled study with different groups with subjects who are all receiving the same recommendations. One thing I should caution is that it's also a small study with only eight subjects in each arm. It's not powered for us to really demonstrate with statistical significance differences between the groups. Again, it's primarily designed for us to characterize how well the technology is working in humans. The second study, once we confirm the performance of the technology, will be designed with enough power to make those kinds of comparisons. We will consider including diet and exercise counseling to maximize the weight loss effects that will happen with studies that are designed to demonstrate maximum weight loss.
Sure. Fascinating time to be in this industry, for sure.
Yes. It's definitely a rapidly changing but exciting time.
Yes, it is. All right, Adam, thank you for this thorough presentation. We'll send you the rest of the questions so you can answer on your own. Please come back to the conference in the near future with some more updates.
Okay. Thank you, Anna. Thanks, everyone.
All right, everyone. We'll be right back.