Okay. Good afternoon, everyone, and thanks for joining this last presentation of the day. Rani Therapeutics. Rani is developing a special Rani pill, which is essentially taking injectable biologics and turning them into orals. So, very interesting technology. And we've got Svai Sanford here, CFO of Rani, as well as Kate McKinley, Chief Business Officer. So thank you for joining us. And maybe before we start, you can just give us a five-10 minute quick overview of where you stand, and we'll go into questions. Perfect. It's great to see you, Annabel, and we're looking forward to the discussion today. Rani Therapeutics is a clinical-stage biotherapeutics company whose mission is to end the issue that continues to plague biologics, and that is delivery via painful injection. We do that through our proprietary technology called the RaniPill. The RaniPill is a capsule that is intended to replace subcu and IV injection. We've been able to do that now multiple times over. We have completed 15 preclinical studies and three studies in the clinic where we've been able to test the bioavailability and found that the RaniPill delivery demonstrates bioavailability consistent to both subcu and IV, regardless of the molecule that has been tested. So we also have very strong, as you can imagine, patent protection because of this innovative proprietary technology with close to 500 filed and pending patent applications. Okay, so you've taken a very interesting approach to trying to get these injectables into oral form. You're not taking a pharmacological approach, but more of a, I guess, swallowable device. So maybe you can describe that and tell us, sort of, take us through the regulatory process there of having this kind of drug-device combo? Yeah, it is in. I don't know if my mic's working. Yep, there it is. Okay. So it is indeed a drug-device combination with the drug as the primary mode of action. So therefore, the development path will follow the drug development path. And so we would expect, depending on the drug, the FDA division that will be reviewing this would be CDER, but the safety and the safety profile of the device will be reviewed by CDRH. Okay. We would expect the two branches of the agency to work together to review our application from the drug arm and the device arm. Maybe you just want to describe what this pill is because it is strangely a device and a pill. It's essentially an autoinjector, right? So the pill is the size of a large vitamin capsule or fish oil. If you've taken one of those, you've taken a similar size to the RaniPill. It has the proprietary special enteric coating on it where it will not dissolve in the stomach. It could sit in the stomach for hours. In our clinical studies, we've had pills sitting in the stomach for as long as eight to 10 hours. It won't dissolve. But everything that you eat, it empties out of your stomach. It goes into your small intestines. When it gets to the small intestine, your pH level rises. It's above six or above, and that's when the pill, the other side of the capsule, will dissolve. And when it dissolves, it exposes the mechanism of delivery to the stomach fluid. If you've taken Alka-Seltzer, when you drop Alka-Seltzer in water, it fizzles. It creates gas, so the same chemical is in the RaniPill, and that's the power source for the balloon. The pill contains a balloon, and when the balloon activates and this Alka-Seltzer reaction happens, it provides a power source and inflates the balloon. That balloon power is strong enough to create the injection. So the drug is delivered through the small intestine, and it gets absorbed just like a subcu injection would. And we have proved it over and over again, whether it's in preclinical studies or in our three phase one studies, we have the ability to deliver the same amount of drug very consistently as a subcu. So that's the big advantage of the RaniPill. You don't have to overdose. You don't have to do multiple full API to get similar drug absorption to a subcu. We can provide the same amount of a subcu injection and get the same bioavailability level. Okay. So that's, I guess, an important point. The bioavailability is very high with these pills because usually when you go from injectable to oral, you lose bioavailability, especially with what people know as Rybelsus (s emaglutide), lost a lot of bioavailability. Have you tested it in? We saw the bioavailability numbers for osteoporosis, which actually were something in the order of 300%, I think. So does it depend on the actual compound that you're using, or are you potentially needing to lower doses? Can you use less of a dose with this specific technology? I think it is molecule specific, to your point, so as I said, we've tested now 15 molecules in preclinical, three in the clinic, one of them being the parathyroid for osteoporosis, another being octreotide, and then the ustekinumab biosimilar for Stelara, and in most cases, we can match the dosing exact or very close to the self-injectable dosing. For the parathyroid program, that phase one results taught us that that would be one where we would look at a different dosing scheme if we move forward with that program. Okay. Great. And then maybe just big picture again, can you talk about the analogs that we should think about when moving from an injectable to an oral, what that does for the opportunity, the market? Does it expand? Does it stay the same? So how are we thinking about what this formulation could do? There's a lot of actually really great examples out there. I think one thing we know from the research that's available is that patients really have an aversion to needles and a very strong preference towards oral delivery. A couple of examples in the real world, you mentioned Rybelsus. Darzalex is another one to look at. Both were orals that were introduced into an injectable market, and both are inferior products, yet they quickly gained share over the injectable when they launched. You also look at migraine with the introduction of CGRP. When those orals were introduced, they now have 50% of the utilization, and the market has grown 300%. We're seeing this growth in sales, but also overall market growth opportunity. Then finally, we like the Otezla example at Rani because we do have a psoriasis program as well. Otezla is a multi-billion-dollar brand, actually has 25% of the psoriasis market share, but as an oral, is actually quite inferior, less efficacious compared to the injectables that are out there. Still, patients and even physicians prefer that oral option. Okay. So now you have actually two types of RaniPill. You have RaniPill Go, and then you have the RaniPill. HC. HC, high capacity. I was trying to remember that. So can you tell us where you are with each of these and which products you expect to, or which ones you expect to take forward? Yes. The RaniPill technology really is a platform with two different payload capacities. The RaniPill Go has a payload capacity of three mg, and the RaniPill HC has a payload capacity to deliver 200 microliters of aqueous liquid solution. The HC delivers liquid. The Go delivers solid drug. Really, when you look, all of the components between the two are exactly the same, which is why we look at it as really a platform versus two separate products. The only difference of the components is that the HC is delivering that liquid drug. The manufacturing processes stay almost the same as well. Why we're particularly excited about the HC is with this expanded payload capacity, we now have the ability to carry over 90 drug candidates and also enable a flexible dosing scheme. So what you'll see going forward is the majority of our programs will no longer be a daily pill with the HC. They'll move to a weekly and maybe even less frequent dosing scheme. All right. Great. So maybe we can go into some of your priority programs. And I think that's shifted around a little bit over time, but you have the most recent one, which I think is what you're most excited about. That's 114, if I remember the number correctly. GLP-1/ GLP-2. So maybe you can talk about that program. Obviously, we all know that the development landscape in obesity is deep and maybe broad. We're not sure yet. But this is a GLP-2, which has not been studied that readily yet. So maybe you can talk about that level of differentiation that you could bring. Absolutely. So RT-114 is a program that we announced in June. This is a partnership between Rani and ProGen for their PG-102, which is GLP-1/ GLP-2. The terms of the partnership are a 50/50 co-development, co-commercialization agreement. Rani has the rights in U.S., Europe, U.K., Australia. ProGen has rest of world. And the strategic rationale behind this program is a potential best-in-class GLP-1/ GLP-2 combined with the Rani route of delivery, which, of course, is oral, as well as enables a dosing flexibility. So we do get a lot of questions around why this compound, why GLP-2. And it's interesting because ProGen developed the molecule themselves, spent a lot of time perfecting the ratio of the GLP-1 to GLP-2. And what we see is an 80-fold higher GLP-1 receptivity to the GLP-2. What you see in terms of how some of their early clinical data looks, as well as their preclinical, is definitely potential tolerability improvements, certainly really strong weight loss, but also the potential to improve lean body mass composition, which really will be kind of the future of where we see, from our perspective, the obesity landscape advancing. Okay. Sorry, maybe you want to add something. No, just to that point that Kate just made in terms of you want to lose weight, but what type of weight do you want to lose, right? And part of the attraction with this PG-102 is that in the DIO mouse model, it indicates a significant muscle preservation, like six times better than what's out there. So that you're losing the fat, you're not losing the muscle mass. And hopefully, that's what we're going to be proving to be the key differentiator. Are there any other GLP-2s that have been validated in humans? Zealand, I think, just put out their phase I study. That's the only one that we are aware of in terms of the combination of GLP-1/ GLP-2. So GLP-2 on its own is not a weight loss drug. I think that's another point of why we're not seeing so much in development. It's great for glycemic control, potentially nutrient absorption, and it does appear to have some of these tolerability properties. GLP-1 and GLP-2, the best known is Zealand's product. And they have been starting to put out some early data. In the preclinical data, PG-102 outperforms both in weight loss and in body composition. Okay. You mentioned that you had the right ratio between GLP-1 and GLP-2. Are you delivering less GLP-1 because of the synergy with the GLP-2? How are you dealing with the tolerability aspect of it? Is it Cmax, or how do you just address [crosstalk] that? There is still more GLP-1 than GLP-2 in the ratio. What's interesting, though, you bring up tolerability. So we're excited at Rani because the subcu program, ProGen continues to keep moving that forward. So we have the opportunity to really observe their results, and that helps inform our clinical development plan. So ProGen has now released their phase Ia data, and they tested four dosing schemes. And the common GI side effects that we're seeing so much with tolerability, there were none in the first three doses and only like 30% in the highest dosing scheme. So we're already seeing a tolerability benefit potentially with PG-102. Were they able to measure the lean muscle mass in that four weeks? It was not powered for that yet. So obviously, that'll come. Okay. Great. Yeah. And I would add that we picked this PG-102 as our first program on the Rani pill in obesity. It doesn't stop us from doing other combinations, whether it's triagonist, single agonist, or other dual agonist, as long as it's not a GLP-1/ GLP-2 specific. That's the only exclusion we have in terms of doing other obesity programs. And Rani has been looking at the obesity space for quite some time. We just didn't jump into this market because it's so hot today. We were testing GLP alone for diabetes years ago. And then in the recent month, we also tested a triagonist with an undisclosed partner that we got a drug from. And there's potential collaboration there too. Can't get into the detail, but there are potential other combinations that we could do within the obesity space with the Rani pill. What type is it for daily administration as well, or do you expect to extend that? As Kate had said earlier, and I want Kate to expand on this, she's much closer to the program than I am. With the RaniPill HC, it's very unlikely we're going to do daily dosing because for one, it's convenient for patients and for the doctors to prescribe it, but for two, it's manufacturing capacity. If we don't have to make 365 pills for one single patient, we do weekly, it'll be 52 pills. It's a lot less burden on the manufacturing, but if you would like to add to that. No, I think that answered it. Absolutely. Yeah. The HC is why we have focused our efforts so much onto it. We have essentially migrated significantly from the RaniPill Go, which is the solid formulation. The solid formulation, because of the payload capacity, it wasn't ideal. It was what we started with, as you know. You've followed us for quite some time. The HC really gives you that scalability and flexibility. You can dose as little as one milligram, but you can also go up to 40 milligrams depending on the drug concentration per pill. So, fractionating the dose from if you think of Humira dosing 40 milligrams every two weeks, we can fractionate it so that it actually delivers a much smaller dose, but still get enough drug concentration to be within the therapeutic window all the time so that not at the end of the four weeks or two weeks in the case of Humira or four weeks in the case of Stelara, patient may actually be out of the therapeutic windows. I'm going to actually get to those drugs in a minute. But just to go back to the GLP-1/ 2 drug, what level of milligrams do you anticipate requiring for that pill? Because obviously, supply and capacity constraints, not just your technology, but the actual API is in high demand. Yeah. I'll let Kate elaborate on this, but I would say that that's the biggest advantage of the RaniPill is you don't have to overdose on the API like some of the oral attempts right now where they put 100x the amount of API into the oral formulations. With the RaniPill, you take the equivalent of the subcu from a payload perspective, and that's all you need. So you don't have to overload the drug. Yeah. So we're going to watch ProGen's development, as I said. Looking at their early data, you may not need to move up to that 60 mg. You may be fine at the 30, but I think we'll obviously work through the development, doing the preclinical work right now, move into the clinic to see. But to Svai's point, regardless of what dosing scheme we end up with, it will be comparable to the injectables. When you look at the landscape of all the orals in development, there's a lot of issues in obesity, one of which is the significant amount of API, hundreds times over, that have to be utilized in those small molecule products. We don't have to do that in the Rani pill. Yeah. Okay. So it looks like HC is the ideal pill for you to move forward. You mentioned that. Which other compound are you using with the HC? It's the Humira, or was it? All of our future development will likely be on HC. All of the future development is going to. Right. And then just to finish up the thought on the potential dosage for RT-114, it's likely going to be between 30 and 60. And we've already seen the early clinical data that they were well tolerated, even at the 60 level of drug. So we have the benefit of learning from the subcu too because ProGen will continue to study their subcu with the same drug, and we'll be able to benefit from the dose finding from those studies as well. What's the expectation to be able to move into phase I? Early next year. We are doing the preclinical preparations, and we'll do the live swallow study where we use the canine model. So the preclinical study will be done hopefully soon, and then we'll move quickly into phase I. That has always been our original plan. Okay. Great. So just moving on to the next programs that you have targeted for the HC pill, maybe you can discuss those for me. Kate, you can maybe speak to 111. Our next priority program is RT-111. This is the RaniPill delivered, Stelara biosimilar, ustekinumab. We've now completed our phase I study, really successful study. All of the patients tolerated the RaniPill delivery, no serious adverse events, and we demonstrated 84% bioavailability via the RaniPill route compared to the subcu. What we're working on right now is looking at potential dosing schemes for the phase II and spent a lot of time on that and really think we have come up with a proposed dosing scheme that is really quite innovative. Likely would be 12 mg per RaniPill. For the loading dose, it would be a daily pill for one month. And then that would be when a patient was new to therapy or experiencing a flare. Now they've stabilized and moved into maintenance therapy, which would be three pills at the beginning of the month. So ultimately, over time, the patient would only experience 36 pills on an annual basis. But what this allows us to do is enable a dosing scheme that we believe could create a more efficacious product because based on our modeling, those patients' serum concentration levels remain within the therapeutic range, which is not what happens to Svai's point in the current Stelara and the future biosimilars. The patients do experience going in and out of therapeutic range during that month of their course of therapy. So we are really excited about this program. Stelara alone is poised to be a $10 billion product this year. So we see significant value with this program. What's your partnership situation with this right now? I think you had Celltrion was maybe going to be looking at an option, maybe not. I can speak to that. We have a supply arrangement with Celltrion. In that supply agreement, they ask for first right for negotiation once we finish the phase I, and we have given them that opportunity. We continue to speak with Celltrion on a regular basis in terms of their interest in putting, whether it's this program, Humira, or other potential products on the RaniPill. They're very much interested in working with us on the RaniPill, whether the first program will be ustekinumab, Humira, or another product. We don't know yet. That ongoing discussion is happening on a weekly basis. In some cases on a daily basis. Would these be programs that you would expect to, I guess, launch as biosimilars or new to enter the market? Their two products are biosimilar. I believe, Kate, if you can speak to it, they've already got approval for Humira in Europe and in the US. With the Ustekinumab, I think they just submitted for approval for the US. So their subcu strategy is absolutely biosimilar. I think we have to look at could we enable a biobetter strategy, potentially deliver better efficacy with the dosing scheme that I described. So I would say some of that does remain to be seen depending on what strategy we take with the development. Okay. And you mentioned Humira also. Is that moving forward at all or? So Humira is our RT-105 on our pipeline. Because of the cash runway that we have, we've been very judicious about what program we spend on. The highest priority program now is 114. So the Humira program is on the back burner. But whether it's Celltrion or another partner, once we've established the terms for the potential collaborations, we will move forward with those programs, hopefully funded by the partner, if not all of it, a shared cost of it. Yeah. I guess just curious about your strategy in terms of development. I think there was a time where you were doing proprietary development, then you moved over to a little bit more of a service model. Now you have a 50/50 partnership with ProGen. So you're back in the development game. So what is your pathway going forward, and do you have the capital to be able to pursue a more development pathway? Yeah. From the outside looking in, I think it would seem to suggest we're changing our strategy, but it hasn't really changed, right? In the early days, we had to move the device technology forward. So we were testing on programs that we can get our hands on the drug. Like if you go back to PTH or Octreotide, it's the early days of validating the RaniPill platform. We were doing our internal program. But the ultimate goal for us was always to partner with pharma companies that have much bigger, higher resources to put more drug on the RaniPill. Because we have validated the platform significantly with numerous preclinical studies, three phase one studies, and we have proven we don't get those questions any longer with the RaniPill work because we have demonstrated over and over again that we can deliver the drug absorption very consistently from drug to drug. The partnership model was always in the longer-term strategy. Here we are, because we've validated the platform. We are getting a lot of interest. Kate was brought on a little bit over a year ago to lead that business development effort, and she's been very busy in talking with multiple companies on putting their drug on the RaniPill, not just the one on our pipeline, but additional molecules. And so how is that activity? I mean, should we expect a certain pace of partnerships going forward, or is this just one-offs that we should think about? Very busy, very active. I think the expanded capacity and being drug agnostic and therapeutic agnostic enables a lot of interest. But the interesting point is that that spans multiple stages of development. So we have companies evaluating Rani's technology for NCEs, for on-market products, those big brands looking for loss of exclusivity strategies, and then the biosimilars, as we've been talking about. Is there an opportunity to create a bio-better or get a competitive edge upon launch? So various companies in various stages of development that you should be hearing more about in the coming months. Okay. And then manufacturing of the RaniPill is obviously that was one of the biggest CapEx expenditures for you. So can you talk about where you are in terms of manufacturing, the capacity, how you can scale up, and what stage you're at right now? At this time, all of our manufacturing is done in-house, from needle injection molding to making the actual RaniPill that would actually be used in clinical studies are all done in-house. We have enough capacity today to support multiple phase I and phase II studies. In terms of the significant investment that you're referring to for phase III and for potential commercial launch, that would be heavy spending. But with the strategy that we have in partnering with pharma partners, we hope that a lot of that cost will be borne by the potential partner that comes with the program. So they would be investing in the scale-up. That's right. How easy is it to scale up? We would have to say the manufacturing process itself is well validated in-house. We are now talking to one of the largest contract manufacturing companies. I'm not allowed to disclose their name at this point, but they are interested in partnering with us to do the tech transfer to be able to make the RaniPill for whoever the commercial drug partner will be. Okay. I guess last. It's doable. It's doable. It's very much doable. Okay. And the less than one second cash position runway, all of that fun stuff. Right. So we had an opportunity to raise an additional $20 million in the last few months. What it does is give us a little bit more breathing room. We have a cash runway that extends into Q3 of 2025. Okay. Great. Well, thank you. Thank you for having us. Appreciate the time. Appreciate it. This is