Vivani Medical, Inc. Common Stock (DE) 0 Earnings Call

Welcome back. Next, we have Vivani Medical, Inc. It trades on the Nasdaq under the symbol VANI, and by leveraging its proprietary NanoPortal platform, develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time. Happy to welcome co-founder, CEO, and director, Adam Mendelsohn. Welcome back, Adam. We're looking forward to hearing your update today.

Thank you so much, Anna. It's really a pleasure to be back with everyone. It's been a couple of months since I've last given a presentation. I have a short 10-minute window here. It's been some of the most exciting couple of months in the history of our company, highlighted very recently with an agreement that we announced for Novo Nordisk to evaluate our semaglutide implants. Let me just quickly reintroduce people to what we're working on at Vivani Medical. I'll tell you a bit more about the updates, and if there's time, I'll take some questions.

First, let me just orient everyone into the challenge that we are tackling here at Vivani Medical, that we're really excited about the opportunity for our particular product to address, which is what's happening in the kind of transformational obesity market with GLP-1s that for the first time have enabled highly effective, adequately tolerable means to cause people to lose and maintain significant amounts of weight loss and corresponding long-term health outcome benefits in cardiovascular and other areas as we're learning over time. Among this large space, we remain the only option that promises to provide both very infrequent administration, in our case, once or twice a year, which we expect to offer considerable convenience and we think will be welcomed by a meaningful segment of the patients.

In addition to that, the peace of mind that if treatment did need to stop at any time, with a simple removal of the implant, it could and stop quickly, and this differentiates us versus the longer-acting injectables and gene editing approaches that are among these greater than 50 clinical stage injectable and orals that are being developed. We're unique in our differentiation, and we're very excited about what this can do ultimately to the market. A couple of highlights for where we expect to shine ultimately is by essentially guaranteeing adherence with an implant. We expect to improve on the outcomes that currently, with only less than 50% of people taking medicine as prescribed, there's a lot left on the table that we anticipate our implant to be able to provide better real-world efficacy outcomes.

A stable delivery from our implant we think can help avoid the peaks and troughs that happen right now with weekly administration, particularly when people miss doses, which does happen more often than we'd like to see. We anticipate potentially better tolerability. Lastly, making this option available to a larger segment of patients, particularly caregivers treating someone for whom regularly ensuring that they receive their medicine might not be easy for them to do. Our implant could be a welcome solution to make it easy for everyone involved to maximize the benefit of these treatments. Moving on. At a high level, we're focused right now on this GLP-1 space, improving adherence, tolerability, and convenience. Our focus is with this NanoPortal technology delivering a GLP-1 for 6 or potentially 12 months that we call NPM-139. This is a semaglutide implant.

Semaglutide is the active ingredient in Ozempic and Wegovy. We're about to start a clinical study in August. We're announcing the specific month for the first time today. This comes on the back of a successful study we ran with exenatide a year ago that paved the road for us to continue development. Semaglutide, we think, is a really exciting application of the technology. We have cash into the second half of 2027 and just really excited to be positioned where we are today. One of the updates, in addition to being ready to begin this clinical trial with semaglutide, is that we have started work with some of the next generation incretin molecules. In particular, we have some data I have later in this deck with retatrutide, which is Eli Lilly's triple agonist drug that has caused on the approximately 30% weight loss in clinical trials.

We intend for this technology to be a platform that we could apply to newer molecules as they're developed in this really fast, dynamic industry with SEMA as our lead program, as well as an application of the SEMA implant for type 2 diabetes. Lastly, we continue to make efforts to make this available for cats and dogs, which we see as a growing area that can leverage a lot of the work that we're doing on the human side. Just as a quick reminder, it's a small implant. As you can see on the left, we have a technology that controls the release of the medicine. You can see what that looks like on the bottom right, but I won't go into too much detail here other than this enables substantially constant release over many months at a time.

It's a unique technology that we built in-house, and we're excited to be moving forward. Let me quickly just get to one of the major updates recently, which was that just a week ago, we announced an agreement with Novo Nordisk, in which they will be evaluating our semaglutide implant. This agreement is notable because until now, a mention of a big pharma company having a potential interest in an implant modality for GLP-1s has not happened. To our knowledge, we are the only company that's actively developing such a solution. We've made considerable progress developing the semaglutide implant. We're excited both for what the potential results of our upcoming clinical trial will be, as well as Novo Nordisk's evaluation, which paves the road for obviously what may happen in the future. We're very excited about this development.

Lastly, as a quick reminder, we're addressing the challenge of people discontinuing treatment, which happens far too often. Here we can see semaglutide at 12 months, only 40% remaining on treatment. The consequence of that are the rapid weight rebound that occurs upon discontinuation, as you can see in this data, which came from the Wegovy clinical program. This weight rebound, we anticipate being able to mitigate through our steady blood concentrations that are produced from our technology. This is some preclinical data, including the configuration that we intend to use in our upcoming human trial, demonstrating how our technology's capable of providing gradual, steady release over very extended periods of time. We've also previously disclosed data that goes out to a full year, showing the ability to maintain levels over that entire duration. Overall, we're very excited with what we've been able to accomplish technically.

Another update here is that we are now projecting the 1st dosing of the SLIM-1 clinical trial to happen in August, which is just around the corner. We did receive regulatory approval to begin the study that we announced last month in June. We're rapidly progressing towards initiating the trial, the design of which you can see here. Initially, the idea is to demonstrate translation from our animal models to humans with a low dose and as quickly as we can, which in this case, we've chosen to use a dose of the implant that would match the starting dose of the Wegovy titration sequence around 0.25 milligrams per week for a 4-week duration, which is the duration over which patients initiating Wegovy treatment take a certain dose before they escalate to a higher dose. This should allow us to assess safety, tolerability, pharmacokinetics. We'll measure weight loss. We'll see how that compares to our active control, which would be 0.25 milligrams per week Wegovy treatment.

We anticipate that this could give us the confidence to roll forward into a more efficacy-oriented dose-ranging study, in which patients would be titrated to a maintenance dose of Wegovy before being randomized to 3 different doses of our semaglutide implant, as well as placebo or continued Wegovy treatment for a period of up to approximately 6 months, which is our commercial target product profile. We're excited to be where we are. I'll end here with a snapshot of some ongoing data that our technology is generating with retatrutide.