Conference Transcript - VANI 2026-06-04

Jonah Sherl, Analyst — Conference Host, Jefferies Investment Banking

Hello, good morning, everyone, and welcome to the Jefferies Global Health Care Conference in New York. My name is Jonah Sherl with the Jefferies Investment Banking Healthcare Team, and it is my pleasure to introduce Adam Mendelson, CEO of Vivani Medical. Thank you.

Adam Mendelsohn, CEO

Thank you for the introduction. It's a pleasure to be here, and I look forward to sharing the story of Vivani Medical, where we are working on long-term drug implants to help with adherence in chronic diseases, initially starting with the GLP-1 class of drugs that has transformed obesity and type 2 diabetes treatment. So let me start by just painting the landscape of what the obesity market looks like today. As everyone knows these drugs really have had a transformative impact finally allowing people to have highly efficacious weight loss in an adequately tolerable manner. There are three approved FDA injectables today for weight loss that are GLP-1 based, two orals, and a ton of development of clinical stage candidates, almost all of which are in either two buckets, longer-acting injectables that have better efficacy and potentially better tolerability, or easier to take oral products that avoid the need for injection. But there isn't anyone else that is developing an approach to delivering GLP-1 that enables both very infrequent administration once or twice a year, like our implant is aiming to do, with the peace of mind that if treatment did need to be discontinued, that it could at any time simply by removing the implant. This product promises to address several of the key unmet needs in this space. First, let me just mention that, and this is true not just of GLP-1s, but of drugs in general, of chronic disease drugs in general, people are not very good about following the instructions from their physician regarding taking their medicine as prescribed. In fact, fewer than 50 percent of people actually regularly take their medicine on time in the way that they're supposed to. And this leads to loss of efficacy for any drug, but in particular for GLP-1s, when the exposure level is quickly decreased, it leads to a pretty quick rebound in weight, eliminating the benefits that people had experienced initially while they were on the drug. In addition, the biggest complaint of GLP-1-based drugs today are the tolerability issues, the gastrointestinal side effects that people experience while they're on treatment. The reason for these tolerability issues is when the drug exposure level increases quickly, then the stomach mobility slows down, people experience nausea, some experience vomiting. And it's very important for the GLP-1 levels to maintain a steady rate for the duration of treatment. When more than 50% of people miss their doses, then not only are they missing out on the weight effects that they could benefit from, but they also are allowing the drug levels to get low enough that when they resume treatment, they experience another rapid rise, which exacerbates the tolerability cycle. A product like an implant that eliminates missed doses promises not only to improve the health outcomes but also to enable a more tolerable treatment and lastly there are segments of patients for whom the existing products on the market or in development we believe are not adequate to be able to enable these patients to receive GLP-1 based treatments think people with severe autism or dementia where we believe that an implant that will make it easy for everyone involved in the care of a patient to have confidence that that patient's going to get their medicine would be adopted. So at Bavani we are focused right now on enhancing outcomes specifically in the GLP-1 space by addressing adherence tolerability and convenience but this is based on a platform technology which we call nano portal that we intend to apply as broadly as possible across chronic disease areas in addition to obesity. Our lead program, NPM 139, is a semaglutide implant designed for twice a yearly administration for chronic weight management. We have taken the technology into a clinical study last year, a study called Liberate One. This was with a different molecule called Xenatide, but the results were successful and paved the road for us to continue development with technology, which is now focused on semaglutide, and we have shown in a preclinical study the ability to maintain more than 20% weight loss after a single administration of the implant for a full year. We have cash into the middle of 2027, and we anticipate starting the clinical program for our semaglutide implant in the middle of this year. So our pipeline includes as our lead NPM 139, which is the semaglutide implant for chronic weight management. And just this morning, we refreshed our corporate deck for this talk and adding more visibility to the fact that the technology is not going to be a one-trick pony for a single molecule. Not only have we gotten it to work with exenatide and now with semaglutide, but we're also showing encouraging results with next-generation incretins, and one of which is ritatritide, in which there will be some PK data fresh as of this morning that's included later on in this deck, ritatritide being the triple-agonist drug that Eli Lilly has recently presented some very compelling weight loss data with just a couple of weeks ago. And lastly, we do have a partnership with an animal health company to develop a version of these implants for cats and dogs. This is a growing segment as far as the revenues that are being generated in treating these animals. People are considering pets as part of their family. It's not our main focus, which is on the human side, but it leverages the work and development that we have already performed on the human side in as many additional areas as possible. So the product, as you can see on the left, is a titanium reservoir. That's my hand holding it up. Now, we have a custom applicator that is used to facilitate easy insertion in a primary care setting. The concept is that if a patient is going to see their physician for routine monitoring anyways, they would tack on an extra 10 minutes to that visit, they would receive an implant, the physician could charge for that procedure, and everyone involved in the care of that patient could have confidence that the medicine will be provided until the next appointment six months or potentially 12 months later. The implant consists of a titanium reservoir that includes a very high concentration drug formulation and a material at one end of the reservoir that controls the release of the medicine so that it stays substantially constant even after many months have passed. This material is what the company was built on. It consists of an array of millions of titanium oxide nanotubes whose inner diameter is the only path for the drug molecules to leave once the product is fully assembled. And if you look on the bottom right, you can see what the nanotubes look like close up by electron microscopy. We can engineer them to have openings as large as 30 nanometers or all the way down to zero nanometers or anywhere in between so that we can achieve desirable profiles for a wide range of molecules. And when the conditions are set just right, we can achieve, as you can see here, here are some in vitro data showing six months of very steady release. This data is with Exenatide and really formed the foundation of why this technology has undergone the development that it has and why we are very excited about what we can do with it going forward. Some additional data here with Exenatide in vitro on the left with a larger number of devices showing the consistency between the devices and some data in mice on the right showing the pharmacokinetics remaining steady after, in this case, a three-month duration. In this, we have some weight data in rats showing after a single administration that a significant amount, more than 20% of weight loss can be maintained over a sham implant control. And on the right, we show that once the implants are removed, some of the weight does come back, which is what one would expect with GLP-1 treatment, and is a demonstration that the product is delivering active drug throughout the entire time that it has been implanted. And lastly, we've also shown with exenatide in diet-induced obese mice the ability to significantly reduce liver fat, in this case by 82 percent, over a 12-week duration, which is consistent with what one would expect from GLP-1 monotherapies in this animal model. Now, the first clinical study that we ran last year ended up proving the concept and paving the road for continued development with our technology as we go forward. This was a primarily safety and PK study looking at the exenotide implant in obese and overweight, but otherwise healthy subjects. We titrated the subjects and we were able to, on semaglutide, and then randomized them to an exenitide implant by durian, which is the once weekly exenitide product, as well as semaglutide injections. And the results of this study really gave us everything that we wanted to see from a safety, from a performance perspective that paved the road for continued development. We were looking for some key technical attributes like a clinically meaningful burst, which did not occur. There was no evidence of dose dumping. These are challenges that other companies with implants have experienced in the past. The implant was well tolerated, there were no serious adverse events, and the performance was encouraging, all of which paved the road for continued development of the product. But what happened was we both got the technology to work with semiglutide, which is a much more established molecule in the chronic weight management space, and the company that was marketing the Xenotide products, AstraZeneca discontinued those two products, so we made the decision last year to switch and pivot and focus on semiglutide as our go-forward program, which is what we are doing right now, but it's all supported by the successful first clinical study that we did with Xenotide, and we benefit from that experience. So right now, we are focused on NPM139, which is our semiglutide implant in chronic weight management we branded the clinical program slim or semaglutide ultra long acting implant in obesity and the first study slim one is scheduled to start in the middle of this year now there are many obvious reasons why this has become our priority program and our lead program it's probably not news to no one the amount of revenue that's being generated in GLP ones in this sector but But the adherence and the persistence data, which really become the significant motivators behind what we're doing and delivering this with an implant, are really severe. More than 50 percent of patients regularly miss doses. You know, 75 percent of patients have discontinued treatment by year one. These are real big problems. And semaglutide has been approved, not just for type 2 diabetes and obesity, but also for MASH, second drug to be approved in MASH, with really promising results and a number of other indications that are being pursued right now. Here is just a snapshot of what the data looks like in persistence. After a year, only 40% of patients are still taking semaglutide who are on it. And this is better than what had been the case with older generation weight loss drugs. But there still is a significant room for improvement. treatment, and that's where we think an implant that would make it difficult to stop treatment as opposed to difficult to continue treatment may be able to have a very positive effect. And the consequences of someone stopping their treatment can be clear by looking at this is the step one trial from the Novo Nordisk Wegovi clinical program in which after 68 weeks of treatment, when discontinued, you can see how quickly the weight comes back. And this has consistently been demonstrated across really all of the incretins, is once discontinuation happens, there's a weight rebound effect. And the health outcomes that really support long-term safety, as well as pharmacoeconomic benefits, are really only realized when people are on these treatments for a long enough period of time, that the cardiovascular and the renal and the other outcome data that's valuable can be realized. If someone goes on a GLP-1, loses 20% of their weight, and six months later goes off and the weight comes back, that's just kind of wasted treatment, wasted expense, and we think that someone should do something about that, and we think the implant has an opportunity to do just that. So here is some of our preclinical pharmacokinetic data demonstrating our implant's ability to deliver steady and sustained levels of semaglutide in rats. We look forward to seeing how this translates into humans later this year. And we're very encouraged by the attractive profile that we've been able to demonstrate as far as the startup release and the sustained levels over extended periods of time. And this data was generated after we had already done a considerable amount of work optimizing the PK profile so that it would be expected to translate into humans with favorable outcomes. This is on the back of some data that we did before we optimized the PK profile, which I'm showing here, showing not as attractive of an initial startup, however, this data demonstrated that the implant was capable of continuing to provide steady levels out to a full year. After the implants were removed after a year, the plasma levels precipitously declined, and the weight loss that was achieved initially was maintained over that entire year of treatment. And so we anticipate, once we have more data and more time with the improvements we've done to optimize the PK profile, that the early parts of the profile that you saw on the previous slide will ultimately translate to six months and, we think, even a year of very attractive, continuous release after a single administration. A couple of items on the market adoption piece that I think are relevant to point out. Here is some information on how patients who have been surveyed with regards to their views on a GLP-1 implant relative to other products answered the question whether they would get and use a six-month GLP-1 implant if it were approved by the FDA, recommended by their physician, and covered by insurance. And a couple of interesting insights from this data. One, the percentages of people that said they would likely or definitely get an implant were remarkably high. But those that were currently on a GLP-1 showed a higher percentage than those that were naive to treatment. And this supports our initial strategy of positioning the implant in the maintenance phase of treatment. Someone has been titrated. They know that they like their GLP-1. We think perhaps they could be titrated on any of the newer drugs in development, and with the GLP-1 monotherapy in the maintenance phase, possibly maintain that weight and have an option where they don't have to continue to administer themselves for, you know, another six months or potentially a year. Another point on this slide is that a great analog for us, we think, is in the contraception space. This is an area where therapy is routinely available in easy-to-take, daily, inexpensive orals, and yet 10.4% of women on contraception choose to have a small procedure in a primary care setting, either an IUD or an implant, to avoid the need to take daily, inexpensive, easy-to-take orals. Now, if translated into the incretin space, a high single-digit percent adoption would obviously justify a very compelling business opportunity for our product. And we think that this analog provides some good justification for that potentially being And lastly, the implant in contraception called Nexplanon generated nearly a billion dollars in sales last year. This is a very successful product, even in a highly generic drug space of contraception. So where we are right now, we did our Xenotide clinical study showing the technology, doing what we wanted it to do and safe and good procedures last year, and we are about to initiate our clinical study with semaglutide in the middle of this year. That study is intended primarily to look at the translation of our attractive animal data into humans? Is the technology going to deliver in a human in the way that we've shown in animals? We'll be looking at safety and pharmacokinetics. We will be measuring weight. The idea is to take a naive sub-patient and enroll them both with a low-dose version of our implant and compare that with the starting Wigovi dose for a 28-day period. No need for titration given the dose that we're going to use, and this should give us enough information for us to have confidence that we could roll into a phase two study with higher doses for longer durations, supported by some of the experience that we expect to gain in humans shortly. We anticipate this data to be available in the fourth quarter of this year. On the back of this, if successful, we would intend to roll this into a phase two dose finding study that's designed consistent with our intended positioning as a maintenance phase implant where patients would be titrated up to higher doses and then they would be randomized at the three different doses of the implant to placebo and to continued treatment with with the injectable and this we anticipate could allow us to identify the dose that we would want to take forward into a subsequent potentially pivotal study thereafter. And lastly, just released this morning, some PK data showing our technology being capable of being applied now not just to exenatide and semaglutide, but to ritatritide. This is the compound that Eli Lilly is developing as a triple agonist with really compelling weight loss having been presented recently upwards of 30 percent and really this is intended to demonstrate that this is not a one-trick pony we believe that a six-month or a once yearly SEMA GLP-1 monotherapy implant remains highly differentiated and will be competitive in spite of all of the developments in this space but it would be even more attractive to deliver some of the newer molecules which our technology is capable of doing and we intend to apply to these as they are developed, as we go forward, continually making better and better products as everything matures. We have an incredible, experienced team focused on this product. I've been running this company for a number of years after having finished a PhD in bioengineering and spent time working in drug delivery prior to the PhD. but everyone around me in leadership positions has done this a number of times successfully. Our Chief Business Officer, Don Dwyer, who's here with us today, we met when he was at AstraZeneca, and when we were a private company, they ended up making an investment in our company when they were looking at the Xenatide franchise. When he told me he was retiring from AstraZeneca, I told him he was too young to retire, and he's been our Chief Business Officer ever since. Lisa Porter, our Chief Medical Officer, she was VP of Medical Development at Amelin, which developed the first GLP-1 products, oversaw the Bidurian Clinical Program, extensive deep experience in the Incretin GLP-1 space, leading our clinical and regulatory efforts. Truk Lee, our COO, has decades of experience in drug-device combination products. He was an Executive VP at Nectar when Exubera was approved, which had five manufacturing sites inspected simultaneously with no 483s. We have very deep operations, quality manufacturing, development experience to support successful execution of our plans as we go forward. Anthony Baldor, our CFO, who's here, tremendous background. So I'm gratified to be surrounded by people with such successful experience developing similar products. And we do have our own manufacturing facility. The processes that we use to manufacture our implants are customized, specialized. We've spent years developing them. We do have an extensive patent portfolio protecting our products, but we also have considerable trade secrets and manufacturing know-how that would be challenging for others to develop on their own. Our own clean room, we've used this facility to manufacture clinical materials successfully before, and it has the capacity to allow us to achieve early commercial scale as we continue to develop our processes and move forward. And lastly, I'll end on reiterating that we are the only GLP-1 implant in development for obesity and chronic weight management. This positions us to have a truly differentiated and unique offering in an otherwise extremely crowded space, addressing what we believe are some of the primary market challenges of adherence, tolerability, and convenience, and our unique modality we anticipate could reach currently underserved segments of the market that would welcome an approach like ours that eliminates the human behavior element from the equation on how well people are able to continue to receive the medicine that they're prescribed. And with that, I thank everyone for being here today. It's been a pleasure. And maybe there's a couple minutes for questions. No questions. People can have five minutes before the next presentation. Thank you so much for being here.