Afternoon, everyone. My name is Brandon Folkes. I'm one of the equity research analysts here at H.C. Wainwright. Next up, we have a fireside chat discussion with Rani Therapeutics, and joining me from Rani is Talat Imran, CEO. Talat, thanks very much for joining me. Brandon, thank you for having us, and thank you to H.C. Wainwright as well for giving us this opportunity. Fantastic. Always a pleasure to have you and talk about the story. Really exciting. Maybe just to start us off, can you share more about Rani Therapeutics and your innovative technology, the RaniPill? Absolutely. Rani Therapeutics is a clinical stage biotech, and we've developed a platform technology for the oral administration of virtually any biologic. Are you guys hearing that boom as well? Is that? No. Okay. Any biologic with bioavailability that's comparable to a subcutaneous injection. This is a really big claim. It's been called the Holy Grail of drug delivery before. Prior to us, the best performing technologies like SNAC, which is used in oral semaglutide, can deliver bioavailability sub 1%, and that only for small peptides. We can deliver monoclonal antibodies, large proteins, and we do this with what we call the RaniPill. It looks like a pill, but it is essentially a swallowable auto-injector. It's a mechanical device that survives the acidic environment of the stomach, gets to the small intestines. There's a self-inflating balloon in it that opens up, aligns, and then delivers an injection pain-free through the gut wall. There are no sharp pain receptors in the gut, so this is a pain-free injection. The drug is delivered, and it's because of this, it's essentially a sub-Q injection by other means. You can think of it that way. We can deliver HUMIRA, dupilumab. It doesn't matter what you put into the RaniPill. And in every case, in our preclinical studies, we've shown equivalent to superior bioavailability. Fantastic. Late last year, Rani announced multi-target, a billion-dollar potential partnership with Chugai. Can you just share some of the additional details around what this collaboration means for Rani and how this informs future opportunities with Chugai, but also other pharmaceutical partners? I guess in a word I would use to describe it is validation. What we are doing is incredibly novel. When people see it the first time, we hear science fiction quite a bit, right? Maybe Brandon, when you saw it for the first time as well. Even in describing it, a self-inflating balloon and an automated injector, a robotic pill, however you put it. They did two years of diligence on us. They tested two of their molecules in the RaniPill, came on site, looked at our manufacturing and automation, looked at our quality processes, and got comfortable enough because focus initially was on a rare disease target, which is what the license portion of the license and option agreement is for with Chugai and Roche. After looking at what we do, they added five option agreements for another $900 million in potential payments to the company. Those cover broadly high-value immunology targets. I think that helped catalyze the concurrent PIPE that we did with H.C. Wainwright last year, a $60 million PIPE that brought in Samsara and RA Capital and some other investors. I think that has been the critical value inflection driver for us. Obviously, we have generated a ton of data pre-clinically and clinically before. But in combination now with validation from a big pharma company, it set up, I think, the next chapter of the company. Fantastic. What are some of the milestones we should be looking out for that could potentially validate the additional opportunities with Chugai? With Chugai. And have them expand the partnership. There's not a ton I can say on that because it's their programs, but there are development milestones pertaining to manufacturing miles development that we have to do for our aseptic manufacturing process and for our assembly of the device. Beyond that, they will take the program into the clinic, and there will be additional milestones that come out of that. We expect probably at least one milestone to hit next year. Fantastic. And you do have multiple different models of value creating levers here from the RaniPill. You've got an internally controlled program, RT-114. You've got the large partnership with Chugai, and then also the earlier stage collaboration with PegBio. How do you think about the optimal mix of the models, where it makes sense to retain economics, where it makes sense for you to go forward alone, and where does it make sense to have some of these larger partnerships? Sure. There are different paths of getting there, but ultimately, we're a partnering business. We have this platform technology, and we can either partner out the technology itself as we did with Chugai, or we can partner out products. With products like RT-114, the goal is to get through proof of concept, proof of principle, show efficacy, weight loss, whatever it is for that particular drug, and then ultimately find a partner because it's better to get a large pharma company to pay for late-stage clinical development and for commercialization and have us spend our money on developing the next ones. Specifically, where do we bifurcate? I think the Chugai programs are a good example. Rare disease is an area where you need deep expertise to run clinical studies. They take a long time, which means you're going to burn a lot of capital. Chugai's already been a market leader in that space. They are the market leader, I should say, in the category we did the deal on. They know how to run those studies, they know how to commercialize it, and it's better for us to enable someone else with our technology. There are areas like in immunology, I think, where we can run the early-stage studies if we find the right program to bring in, get to POC, and then there's a wide range of companies, of big pharma that distribute and commercialize in those therapeutic areas. Fantastic. In that partnering model where it's a very large partner who's taking on a lot of, if not all of the work, are there any limitations internally on Rani resources or how you view in terms of the optimal number of partnerships, so how many you may want to execute in that model? That's a good question, and I think it's going to be our primary focus going forward is on scaling up our manufacturing. This is a significant internal investment for the company as we stand. We can already comfortably run multiple phase I studies in any given year, additionally, more than one phase II. We are rolling out our first fully automated manufacturing line. That line will do 1,500 pills per day, and I think there's an important point to bring up about this, but that covers virtually all of rare disease. Any rare disease program, we could get to peak commercial scale with that, and run any phase III study as well. We are also going to be scaling up from there to 10,000 pills per day, which will cover peak commercialization for immunology. I think that we're not limited right now. We're not rate limited with our manufacturing abilities or capabilities in order to run the studies that are in front of us, both internally and from adding even additional partners. Part of the reason for that, and I didn't touch on this earlier, is that the programs that we're looking at are weekly, monthly, and quarterly dosing. So we're taking advantage of the fact that most biologics have a long half-life and can be delivered infrequently, putting that into our pill, and so that really provides us some leverage on the manufacturing side. So take STELARA RT-111. We've modeled that it would only take 12 pills per year to replicate the PK curve of injectable STELARA. So you don't need a lot to reach a lot of patients. Fantastic. I want to focus on RT-114, your lead BC program now. You reported strong phase I-A data in July. In that data you showed 150% or at least 150% bioavailability compared to subcutaneous dosing. Can you just share the details around that bioavailability reported, any additional analyses you may have done, any feedback you've had from that, and anticipated next steps? Well, as you said, we were very surprised by the results to show greater than 150% relative bioavailability to the sub-Q. For anyone who's followed the space of oral biotherapeutics, struggle to get sub 1%, and that's for small peptides. This was an Fc fusion protein, so an antibody fragment, and we're still showing greater than 1.5x the sub-Q. You see it in the peak, you see it in the overall exposure, and where you don't see it though is in the AEs. There were higher AEs than the matched sub-Q dose in our study. But when you compare it back to the ProGen sub-Q data, it actually looks like the same or lower AE, so that was encouraging to see. Given that ProGen showed nonlinearity in their sub-Q phase I, and we had such a higher exposure rate that you can't really compare to their sub-Q, we've added an additional cohort in an extension that will be testing a 24 mg dose, in order to see what the relationship is between doses in the RaniPill. I do want to talk about that additional cohort, but I do want to just come back to that bioavailability. Yeah, absolutely. That appeared to be very validating in terms of bioavailability across many molecules, right? How have you seen the response to that RT-114, in particular bioavailability data, change interest in the company's partnering activities, or the perception of unlocking the full value of Chugai because we had that validation? Well, Chugai was obviously very happy to see the data, but we have, call it half a dozen other pharma partnership discussions going on, and it's just further validation. We've shown with STELARA 84% relative bioavailability, with teriparatide 400% relative bioavailability. That one's an outlier, but what you see consistently is that we're getting similar or better than the sub-Q in almost every case. I think this allows for easy modeling of what the dosing's going to be with a specific drug, and it also doing an infrequent dose with a pill, being able to have some confidence in that makes the commercial rationale even stronger as well in some of these discussions. Fantastic. I want to come back to that RT-114 and that expansion dose. In that 24 mg expansion cohort, what specifically are you looking to learn that will inform the next stage of development? Yeah. Since the oral PK was different than the sub-Q PK, we want to see what the Cmax relationship is. If anybody's familiar with incretins, there's a Cmax mediated AE relationship there, right? This is why the small molecules, you have peaks and troughs every day. They tend to have higher AE rates or more frequent at a minimum. I think we want to see what the relationship is, that goes to the Cmax, and then what are the relative AEs by increasing the exposure. Because ultimately we have to select the right doses for our induction phase, which is what we're testing over the two-month period with RT-114 and the 1B. Sounds good. When we think about that one phase I-B, what do you consider a successful data set in phase I-B? There's been such a focus on initially in the obesity space, just the magnitude of absolute weight loss. The whole category is somewhat shifting, and it is shifting quite rapidly into be more than just ultimate weight loss, right, in terms of tolerability, muscle preservation. Can you just help us think about what does a successful phase I-B look like for 114? I am not going to point out any particular program, but if you followed the incretin space, these 30 or 60-day studies, they tend to jack up the dose, show significant weight loss, and then go back and run a phase II that is 12 weeks, 24 week, where now they test titration, and get very similar weight loss over those much elongated periods of time. What ProGen did from their phase I to their phase II, and it is part of the reason we chose this drug, was this is an Fc fusion protein. It has a longer time to Tmax, incredibly good tolerability, and this is what you are getting at, Brandon. If we can replicate that with a weekly administration of a pill, we think that is a highly differentiated product. We are not trying to blow the doors out and be tirzepatide or Wegovy in terms of weight loss over this period of time, but it should be competitive with a really attractive AE profile. If you can do that, then I think it informs what would happen in a 12 or a 24-week study because, like ProGen, we would very likely use the exact same titration schedule in our longer studies. All right. Fantastic. I do want to touch on the other value driver- right, PegBio. That potentially gives Rani several additional obesity and metabolic shots and goals here. What was your motivation behind that partnership? Well, from the moment we did the ProGen RT-114 deal, we said that we look at this $100 billion potential market as heterogeneous. There is going to be the morbidly obese, which make up maybe 4% of the population. BMIs over 40, they are candidates for Roux-en-Y, and that is what you are competing with. There are elderly women where muscle loss and bone loss are going to be the biggest issue for them. There are diabetic obese that everyone knows about, and then the healthy fat or people who are trying to get ready for a wedding. I mean, we know that is how it is being used. These are all different patient populations, and there is going to be different drugs for them. There is no one size fits all. With RT-114, I am going to get to the ProGen thing, the goal was, or to PegBio, pardon me. The goal was to find the most tolerable oral so that you do not have this axis of, okay, well, we have made it into a pill, but it is now less tolerable than the current injectable incretins on market. We are very excited about that program. PegBio is dedicated to, this is a Chinese company that has an approved GLP-1, and they have a very broad pipeline of incretins that they are developing. These are GLP-1, like a Wegovy type of drug, penta-agonists, drugs for MASH. They have mazdutide-like assets that are going to be once a month to once every two month injections, siRNAs. We have this platform technology that is unique, singular, but we do not design or discover drugs on our own. Having partners in our constellation, if you will, like PegBio is really, really helpful. We're going to be able to evaluate drugs that fit some of those other patient populations. Then if we find a partner or if we decide collectively that it makes sense to invest, then we'll advance those programs. Okay. Just to drill down on that, how do you make the decision to invest capital in RT-114, the PegBio assets, and together, how do you take a portfolio approach to obesity with partners involved? With partners involved. You mean the partners that we get the drugs from or the downstream partners? No, with PegBio, right, and with some of these decisions you talked about, right, where you will decide which molecules to take forward. Right. Just how do you make that decision in terms of to develop certain other PegBio opportunities alongside 114? Right. It goes back to complementary mechanisms or complementary patient populations. As I mentioned with the RT-114 program, it's highly tolerable. It's not going to be a 20 or a 25 or a 30% weight loss drug. It won't. But PegBio is developing a penta-agonist, as an example. That could be a very interesting drug for us to put into the RaniPill. Now, how do we decide whether to fund this ourselves or to partner out? I think there are certain areas like obesity and immunology where we can credibly run the clinical studies without becoming dedicated and focused in that space, at least through a phase II study. Whereas if you're in hemophilia or certain rare diseases, you need KOLs, you need a whole ecosystem of experts from the clinical side and from the investigator side to make those studies work. I think that's one place we bifurcate. I will say part of this is also having not just the technology to go and speak to large pharma that's in the metabolic space, but also having drugs, drug products, and combinations of those drugs with the RaniPill that we can advance forward. So it's maybe not either/or as well, I would say. Fantastic. We touched on earlier your ability to bring in additional partnerships and sort of the capacity there. But how do we think about scalability as your external partnerships grow, but also your internal opportunities grow as well? What does the company need to do differently maybe from your answer in the partnership— Sure. —as you scale. Well, I think we're doing the right things right now. We're scaling our manufacturing to our needs, so we're not getting out over our skis and spending too much money on it. At this point in our conversations with large pharma, it isn't anymore, is our drug going to work? Many of them are not even requiring feasibility studies. It isn't, is it going to work in the clinic? Are we going to get the efficacy? That's very rarely where the conversation is. It's, are you going to meet our peak commercial manufacturing requirements? This is where we're investing. I think we're making very good progress on that. The next step after we've developed the core automation is going to be tech transfer. We will enable injection molding of parts, automation replication, and then aseptic manufacturing and device assembly to third parties that can service the industry writ large. Fantastic. Rani has made tremendous progress over the last 12 to 18 months, right? Sort of really moved the company forward. When we are sitting here next year, 2027, and we are having this discussion, if you execute on the goals ahead of you between now and then, what does the company look like? I think we will start with manufacturing since we just talked about it. We will have completed deployment and qualification and validation of our first fully automated manufacturing line. That will be in our facility in Fremont, California, where we manufacture the RaniPill. We will have made progress towards the milestones with Chugai. Our RT-114 program will have gotten the phase I-B efficacy data, first efficacy data in the clinic. We have done it four times at this point pre-clinically, so this will be replicating what we have already done. Then I think as a cherry on top, if we had one more partnership by then, that would be a pretty good year and a half. I don't doubt it after this year. But maybe just to close out, to execute against those goals, can you just give us an update on the cash position? Absolutely. We reported at the end of Q2 $53 million on our balance sheet. That gives us runway into the end of next year, end of 2027, not inclusive of any milestones from Chugai. So those will help give us runway even further. So we are well capitalized to meet the objectives that we have set out for ourselves, both the 1a readout, the extension readout this year, and the 1b in the H1 of next year. And we raised another $20 million opportunistically earlier this year, brought in some great investors in that to add to an already broadening institutional base. So I think our ability to go raise more money if we hit our spots is going to be. It's never easy, but it should be straightforward. Fantastic. Well, Talat, congratulations on all the progress so far. Thank you so much. I look forward to seeing those milestones. Thank you for your support, Brandon.