With very short time intervals tested. We've tested as short as 2.5-hour intervals between time points, which is relevant given the 2.44-hour half-life that the drug we're delivering ultimately has, and we see essentially no fluctuation. We've done a lot of in vitro and in vivo tests, you know, many of which were necessary to obtain clearance by the FDA for our IND, and it's very consistent. Delivery, we can define the rate of delivery by the number of nanotubes that are accessible from the reservoir to outside the body. We can control the profile of the delivery through control of various formulation parameters, as well as the size of the nanotubes, which we can control very precisely at the kind of angstrom level.
Yeah, we're very optimistic about the control of the delivery and how that directly addresses the challenges this other company you mentioned faced, enabling us, we believe, to address the same gigantic market opportunity that they were trying to address, but with an approach that we think gives us a path to obtaining an approval.
Right. For your product 115 , you're developing exenatide, which is a GLP-1. Can you talk a little bit about what the rationale for developing exenatide was, as opposed to, let's say, developing semaglutide or tirzepatide, which are like the more known compounds?
Yeah. So exenatide is the drug that was in the very first approved GLP-1 products, Byetta and Bydureon, and those products were approved for treating Type 2 diabetes. They were shown to be safe, but as it turns out, exenatide is also very potent. It does not have a long half-life like semaglutide and tirzepatide can enable weekly administrations without any modification. Exenatide had to be formulated in a very complex PLGA microsphere, a formulation that required multiple steps by the patient in order to ultimately work in a once-weekly injection, but when the drug is being consistently replenished by our device, having a long half-life in circulation is not as important.
The higher potency will enable a smaller implant size for a given treatment duration, and our analysis of the available data is consistent with exenatide having similar potential efficacy as other GLP-1 monotherapies like semaglutide, and in fact, earlier this year, before we announced a strategic focus on the weight loss applications of our lead program, we disclosed some data in animals that showed comparable weight loss effects between semaglutide injections and our exenatide implant, and more recently, we disclosed very significant liver fat reduction at twelve weeks of treatment with our exenatide implant that's consistent with what semaglutide injections have demonstrated in other studies. Now, we are also developing a semaglutide implant in a pipeline program that we call NPM-139.
Part of the reason for that is not just because semaglutide is a drug associated with products that sell, you know, tens of billions of dollars, but also because we have seen indications that a semaglutide implant may enable once-yearly administration, whereas with our exenatide implants, you know, what we've shown is six months, and we don't expect to be able to exceed six months in duration. And then another factor, of course, has been for much of the development of our company, intellectual property is something that we have to keep in mind. Exenatide, the patents associated with exenatide have already expired. We have access to that compound. And with similar expected efficacy to semaglutide, which has been transformational in the marketplace, we are very excited about its path while we also apply the technology to semaglutide.
Underlying all of these products is a platform drug delivery technology that we are going to be consistently looking for the latest and greatest molecules to apply it to as we proceed, you know, including early work to look into dual and triple agonists, but other types of compounds as the company matures and continues to develop.
Thank you. That was helpful. So it obviously stands to reason a one-time, six-month implant significantly improves or should improve compliance, right? You don't have to worry about it on a daily or weekly basis from a patient or a physician perspective. But I guess based on all of your conversations with KOLs and physicians, where do you think this could ultimately be placed or be in terms of the treatment paradigm?
Yeah. So I think that's a very good question. It has been reported on more recently than kind of 10 years ago, but the challenge and the prevalence of medication non-adherence is truly significant. It's about 50% of patients. Depending on the study and depending on the drug, it can be plus or minus 10%. But most people don't take their medicine as prescribed, and they don't get the benefits of that medicine.
So we did some of our own prescriber research a number of years ago, in which in the primary care setting specifically, which is where most of these patients receive their care, it was already believed by these physicians that those of their patients that were not getting the health benefits that they should be getting based on what the clinical trial results would indicate. It's likely because of non-adherence. In the treatment paradigm, the way that we see it when we discussed with these physicians, was that for those patients that you know should be getting benefits from therapy that they're not. Those are a segment of patients for whom the physician might recommend a product that will give the physician more assurance that the patient is actually going to receive their care.
In addition, we hear lots of stories between patients and their caregivers regarding making sure that that patient is taking the medicine that their physician prescribes. The caregiver makes sure that the patient goes to see their physician, but in between appointments, it's not always assured that the patient's gonna take their medicine. So having a physician-administered implant that after doctor's appointment would give everyone in the ecosystem of a patient's care confidence that that patient's going to get their medicine in between their doctor appointments, we think will be relevant to a meaningful portion of the patient population.
Not just based on those who prefer the convenience of not having to worry about taking their daily or weekly injections, although we think there's gonna be a component that will be attracted to that element, but also in improving the real-world health outcomes associated with these treatments, and it is pretty well reported that the results that are achieved in clinical trials do not translate to the real world, and a lot of the reason for that lack of translation is non-adherence, so that's what we're trying to address. We wanna add another option for physicians and their patients to be able to select from, so for those patients whose circumstances justify a very long-term implant, which we think can be a meaningful portion, this will be available for them to select.
On the implant itself, could you talk a little bit about how easy it is, or the process of actually administering the implant into a patient, and sort of how much training might be required for physician offices? Like, how easy is this to do at your typical PCP office?
Yeah. So the implant and the procedures are very similar to that which already occurs on a routine basis for contraception implant use with a product called Nexplanon, which is routinely administered in an outpatient setting. The training requirement for that product is three hours of training, although the physicians we've spoken to, many of them want more training so that they can be more comfortable with administering these kinds of products.
But nurse practitioners, physicians' assistants, and physicians are capable of performing these procedures, and they can be done in just a few minutes time. So we, you know, anticipate a very, you know, reasonable amount of training that will get, you know, the people administering the product comfortable doing so, but nothing that's overly burdensome. And for the patient experience, it's not gonna be that much extra time for them to have this administered, to make sure that they get their treatment.
Vivani is obviously at a very exciting juncture. You're about to initiate your Phase I studies. For the audience, could you talk a little bit about the design of the Phase I study and what you're sort of looking to evaluate?
Yeah. So this first study is primarily designed for us to demonstrate that the performance of our device technology that we've seen in animals translates to humans. Now, we're doing that with exenatide. We're doing that as part of a study that's going to evaluate the impacts of both weight changes and tolerability in patients who are obese or overweight. These patients are going to be titrated initially on semaglutide injections for an eight-week period, where they're at point two five milligrams per week for the first four weeks, point five milligrams per week for the next four weeks. And then, when they would go to their one milligram dose, they're gonna be randomized to either the one milligram semaglutide dose, our implant, or the once-weekly exenatide Bydureon.
And they're gonna be on that treatment initially for this first study for a nine-week period of time, which will be sufficient for us to determine the translation of the animals to the humans. But the reason for the two active comparators is so that, one, we can contextualize any, the tolerability that we see from our implant versus one milligram semaglutide, which we anticipate will have similar activity in the patients. We're looking for signals that the lack of fluctuations in the exposure of the GLP-1 with our implant compared to semaglutide, how that might ultimately manifest in terms of tolerability. But we're also comparing with Bydureon because that ultimately we intend to utilize as part of a 505(b)(2) approval strategy, and we have a very robust PK sampling plan. And our...
The scientific bridge that we intend to build to help us reference some of the safety data that's been generated involves demonstrating the day-to-day fluctuations in pharmacokinetics between our implant and the product that's already proven to be safe, as well as an assessment of the tolerability profile over the duration of treatment. So we're gonna get a lot of really useful and informative data from this initial study that will help, we think, de-risk a lot of the future clinical development.
But after this study, for the chronic weight management application of the program, we would be doing a dose-finding study, looking at even higher doses than are gonna be evaluated in this initial study, that we expect to have ultimately comparable effects as semaglutide injections, like the preclinical work we've already demonstrated suggests, to identify the dose that we would then subsequently do a pivotal study aimed at ultimate approval. So it's a very important foundational study for the technology, clinical validation of our NanoPortal, you know, delivery technology, but in addition, supporting the subsequent clinical development of the NPM-115 program towards an obesity implant.
But the other thing I should mention is that it's also gonna be foundational information for any other indication that we might pursue with a GLP-1 implant, you know, such as diabetes, which is still in our pipeline, as well as, as we pay attention to all of the other data that's being generated with GLP-1 in areas outside of obesity and diabetes. We're following those very closely, because an implant could have an important place in the event that other indications ultimately prove safe and effective in the GLP-1 universe.
Right. When do you expect to initiate the study, and when can we see initial data? Can we see anything from like... I mean, it's actually like an open label study, because one, you're getting implanted. Can we see any interim data at some point?
Yeah. So we received regulatory approval to begin the study just a little while ago, and we provided guidance that we expect to initiate in the fourth quarter, and that's still the case. So we're looking very soon in the coming weeks to initiate the study. And as far as when we're gonna see some interim data, the rough timeframe when we think the full data set could be ready would be the middle of 2025, and we are gonna be looking at kind of the data because it's open label. So figure, you know, maybe sometime in between the beginning of the year and the middle of the year, there could be an interim read that we'll provide, and we'll as we see something compelling and informative, we'll look for opportunities to disseminate that information.
Yeah, just kind of on that point, so you brought this up in the beginning. It's commonly known that a lot of the GLP therapies, whether injectable or oral, are heavily associated with the GI AEs. Do you think there's a potential that I think you commented on this a little bit. Is there a potential to ameliorate some of that when you have, like, consistent release of tirzepatide or GLP-1s in a patient, as opposed to that patient's getting, like, bolus GLP-1s here and there on dosing every week?
I mean, it's a great question, and we think that there may be. It's something that we're going to be looking for very closely, but I wanna make two points on that. One, there is an inherent fluctuation that happens even when someone takes their medicine as prescribed. Let's say it's a weekly injection. The exposure level does decrease before they take their next injection, and then it does come back up.
but what's even more pronounced is in the event that someone is not well adherent to their medicine and they miss a dose or two or three, and then they resume at the same dose level that they had been taking, that's when there's an opportunity for the exposure level to go down to much lower levels and then very quickly rise as they resume therapy, which is what we know happens in the real world with a lot of people.
And that's where we think there could be a much more pronounced potential improvement in tolerability when the implant will not only, we believe, ensure a more steady level, you know, on a kind of week-to-week basis or intra, within a week basis, but also just mitigate the opportunities for someone to have much more wild fluctuations because they aren't regularly taking their medicine as prescribed.
And that's kind of the real promise is providing that assurance on adherence could also improve tolerability. There is ample evidence that it's these, and in some cases, these are the FDA's own words, market increases in exposure level of a GLP-1 being responsible for the gastrointestinal side effects. This is why all of the GLP-1s have to be titrated slowly, so that someone can get used to those higher exposure levels over time, and where we see a potential opportunity for our implant to make the patient experience a little bit better from the tolerability angle. But that remains to be observed based on what we actually see in the clinical studies.
Gotcha. So obviously, GLP-1 as a whole is a very, very hot space. And I understand that Vivani is obviously early in development, but have you seen any partnering or business development interest from other organizations at this point? I feel like it's hard to go unnoticed at this point.
Yeah, I mean, what I can say is that we, of course, are talking to some pharma companies, and there has been some interest. I can't get into it more than that, but it is a hot space. I think we have heard some public statements from some of the pharma company leadership around the desire for longer-acting treatments for better tolerability. Improved muscle retention is also something that people are focused on in this area, but we fit some of the desires for how this drug class could be ultimately improved on, and we're excited by what we think the future can bring as we generate some clinical data in the near future.
Got it. And it does look like we're coming up on time. Could you comment on what Vivani's current cash situation and runway is?
Yeah, so at the end of the last quarter, we had about $25 million in cash. We announced that we expect that to get us into the second half of next year. That's still very much true. So we have the cash to get, you know, through this first clinical study as we expect. We are cognizant of opportunities that we may have to extend our runway, you know, as we go forward. But right now, we have no debt and cash until, you know, sometime later next year.
Got it. So yeah, we're basically up on time. Adam, is there any final takeaways or messages you wanna leave with the audience? I mean, you are right now in probably the most attractive pharma space there is, or the most well-known anyway.
Yeah. Yeah, I mean, I think, you know, we're really excited by the position that we have right now, because we believe the largest opportunity to improve the real-world impact of this revolutionary drug class is to make sure that people get these medicines that have been developed, that have been recommended to them. And if we can improve that, we think that their health, that the pharmacoeconomic value of people being adherent and having fewer unnecessary doctors and hospitalization visits can be very compelling to all of the stakeholders that are involved in an individual's care. And yeah, we're just excited that we're finally moving into this clinical stage, and you know, we think the future is very bright.
Yeah, I mean, it's always an interesting time every time a GLP-1 company reads out data. Those are, like, 20-50% stock movements, or that's what we've been seeing for a lot of these companies, so to the audience, thanks a lot for joining us, not just for this chat, but for this entire conference. I know it's been a lot. Obviously, this is a very interesting company.
If you wanna have a one-on-one or a follow-up with Adam and Vivani, feel free to reach out to your Maxim sales representative, and we'll see what we could do. Adam, thanks a lot for your time. It's always a pleasure talking to you, and I feel like we could probably talk for, like, another hour about this kind of stuff. I'm sure the audience might actually wanna listen to this one. But once again, thanks a lot for your time, and have a good evening, everybody.
Thank you, Naz. Thanks, everyone.