Rani Therapeutics Holdings, Inc. (RANI) October 20, 2026 Conference Transcript

all right great I know we're all coming off lunch and the panel here so I hope everyone can get settled down now I'm excited to welcome the team from Ronnie we have Talat Imran CEO here joining us Kate McKinley and then Nick Myasis okay our special guest in a way I didn't expect him to come so thank you guys for making the trip and joining us here so let's get into it actually why don't we do this for anyone new to the story what act what actually happens after a patient swallows a Ronnie pill well first of all let's just do this maybe give us a quick overview of what Ronnie does how it's differentiated from a lot of the companies out here what I guess would be the call it the holy grail of what everyone's trying to do in terms of taking a biologic and putting it into a pill this is why we're excited about what you guys are working on so just give us a quick intro and then we'll jump into some of the questions absolutely first Andreas thank you for giving us the opportunity to be here and have this conversation so Ryan Therapeutics is a clinical stage biotech and I promise you at a minimum you will not hear this story again today or any other day what we've developed is a platform technology for the oral

administration of virtually any biologic with bioavailability that is equivalent to a subcutaneous injection doesn't matter if you deliver a monoclonal antibody a protein a peptide and oligo we've done all of those and they're all equivalent and as Andrea said that's been called the holy grail of drug delivery the state-of-the-art before us was permeation enhancers that really are only geared towards delivering small peptides and even there you get sub 1% bioavailability, incredibly high variability and food effect. The reason we've been able to work make it work is we are working with the anatomy and physiology of the gut as opposed to against it. What we've developed is essentially a swallowable auto injector. It looks like a pill, patient swallows it and when it gets to the small intestines there's a reaction, an Alka-Seltzer reaction that occurs that inflates and aligns a balloon. There's a microsyringe inside of the balloon that delivers the drug through an injection pain-free because there's no sharp pain receptors in the gut, and the needle itself that does this dissolves, so we don't even leave a sharp in the body. The balloon deflates and is excreted out, and I can see people's faces. It sounds like science fiction. It is very real. We've been through four clinical studies, a repeat dose study, 250 pills, over 250 pills, orally administered, showing incredibly high bioavailability, whether it's a peptide or an antibody. Any, any. We've delivered Stelara in a pill in humans. We've done factor VIII, which is a 300 kilodalton molecule. Yeah, and literally anything there's no limitation yeah we'll take questions sure so there's a balloon that inflates and aligns and it provides apposition so we don't have a picture of it but it has a hump at the back that provides our back force and then the needle comes out very quickly and the drug is delivered into the intestinal wall pain-free comes out in less than a second and then the needle dissolves about 30 seconds later very intuitive and very cool if you guys want to watch the video on the website, and the story's even cooler, right?

Because you said Alka-Seltzer, right? I think that, you know, the founder or the creator or the inventor saw the Alka-Seltzer dissolving, right? And he figured out how you can configure it.

Well, he had spicy Indian food one night, and he had an upset stomach, and he'd been working on this for about a year and a half, but it had springs and levers, and it was really a complicated mechanical device. and when he dropped the Alka-Seltzer in water to calm his stomach, he said, okay, this is going to be it.

Yeah, it's cool. It's why we're excited about it. So, I mean, I guess we've been talking about it. So what actually happens after a patient swallows the Ronnie pill and why does that solve the problem that has defeated biologics for decades, oral biologics for decades?

Well, I'll just take the last part of that because I think I answered most of it. The permeation enhancers are trying to fight evolution. The gut evolved to break down biologic material, so you don't absorb a virus through your gut, and it's to absorb nutrition, so it'll destroy any biologic you put in. We are bypassing that completely with an injection, whereas the permeation enhancers are trying to get infinitesimally small amounts of small peptides across the wall of the gut. It doesn't work very well. As I said, we have solved this problem at this point.

Well, okay, you answered my next question, so we're going to move on to that. let's get into 114 and obesity in July you reported that RT 114 the Ronnie pill delivering progens GLP 1 GLP 2 dual agonist PG 102 achieved bioavailability bioavailability greater than 150 percent of a match 12 mix subcutaneous dose and 30 healthy volunteers with a similar half-life and no device related adverse events why would oral delivery beat subcutaneous and how variable was exposure from patient to patient.

So Kate McKinley is our chief business officer. She led that deal. I'm going to have her talk through it.

Great. Thanks, Andreas, and thank you for having us today. So first, we'll step back and talk a little bit about the partnership that Ronnie has with Progen, which is a company based in South Korea. Ronnie and Progen have a strategic partnership for the oral delivery of Progen's PG-102 via the Ronnie pill. And the strategic imperative behind this partnership is to take the potential best-in-class GLP-1, GLP-2 in obesity and put in the best-in-class oral delivery. And there's some properties that are really unique to PG-102 and got our team very excited to enter into this partnership. The first is it appears that they've demonstrated preservation of lean body mass, which we know is really significant in this obesity space. There's also potential benefits around nutrient absorption and a much more tolerable AE profile. So to your point, Andreas, we've reported out data from our phase one study, and in that study, we were able to demonstrate a PK of greater than 150% PG-102 delivered via the RONI pill compared to the sub-Q. Notably, this was at the exact same dose, which we know is very unique with oral delivery and obesity, and there were no AEs related to the RONI pill. So Rani and Progen were obviously very pleased at these results because what we've seen at these other attempts at oral delivery of biotherapeutics is they tend to deliver less than 1% bioavailability. So what we're seeing here is a really efficient route of delivery via the Rani pill, and notably, we didn't see the impact to AEs. We did not see the AE differentiation between the two arms. They were very consistent with what we've seen in this class, mild to moderate and transient GIs. And we saw no variability between the two arms or from patient to patient. So we're really excited to continue to advance this first program that we have in obesity with the Ronnie pill.

I was just going to say real quick, that was an FC fusion protein, 70 kilodalton. So it wasn't even a small peptide that we showed that with.

Awesome. And maybe a follow-up for you, Kate. The expansion cohort adds 15 volunteers. So what are you specifically trying to learn before Phase 1B?

So great question. So we did announce that we intend to expand our 1A to better characterize this oral to sub-Q PK relationship. So these 15 healthy volunteers will now take two doses, each of the 12-mig PG-102 delivered via the Ronnie pill for a total of 24 migs. And depending on what we see with these PK results, we may be able to actually achieve higher serum concentrations at lower-than-expected dosing. So ultimately, the goal is to inform the dosing for the 1B.

Okay, great. and we're going to say there's a question so we may do that we do it right now yeah completely agree we agree okay all right i love it literally the best drug is going to be the best drug ever fyi okay I love it enthusiasm from the audience we don't get that as opposed to the silence that we get so I appreciate you this is awesome let us continue at least okay your name okay we got we're gonna give reference to now you got to give credit to you all right well we I'll remember your face and I'll remember the moment. The phase 1b repeat dose study in obesity is slated to start by the end of the year with data in 2027. In a market where Lily's oral or a fog lick upon whatever an oral semaglutide oral already offer a pill what is the case for an orally delivered injectable class peptide and what does PG-102's GLP2 component add?

So great question, and we've been particularly excited as we've seen these oral launches, because it demonstrates what we know, what the thought leaders say, and that is that despite a challenging side effect profile, which we are seeing with these orals on the market, as well as the other orals in development, patients will still select and oral every time it's offered. And so our goal is obviously to move forward, generate weight loss data, but this is not necessarily a retactortide. That's a different program. We think we'll have really competitive weight loss, but have a much more tolerable AE profile consistent with what Progen has demonstrated in their sub-Q, a drug that patients can actually stay on, but in a weekly pill. And we know the challenges with the small molecules are these really significant AE profiles. They're a much more frequent dosing scheme than what we're proposing with RT114. And of course, with the oral peptides in development, they're putting significant amount of API from dose to dose, 100 to 300 times the patients are ingesting daily, sometimes twice a day. So it brings in questions around cost of goods, supply chain. With RT114, 14, this is the only proposed oral in development that matches the sub-Q dosing at a weekly pill, competitive weight loss, and a very tolerable AE profile.

So if I give just a couple bullet points on this, we're talking about titration within a month. That's what ProGen has been able to show as opposed to four months. An AE profile where even at the top dose, you're getting half the rates of nausea and vomiting of any of the other incretins. and then now the cherry on top which we don't have data for and progen doesn't yet but they will in their phase two and beyond a lean body mass preservation that looks twice as good as trisepatide so this is it's not retatratide you're not going to get 28 weight loss but this is a drug that you know if half of patients are dropping off within the first 20 weeks which is what the data shows uh this is for those patients do you want to put a bar for the weight lost number?

No, we're not going to hold you. Not yet. Not yet. Okay. Maybe quickly, and I guess maybe for Nick, because we're not going to forget you, I guess. But who owns the what in the pro-gen collaboration? How is the economic split? Oh, that's a K question? Okay, sorry.

So it is a 50-50 cost share. So it's a co-co deal. We jointly own IP, and the markets are split.

Pro-gen owns generally asia and us are ronnie owns the major markets us europe uk australia canada 50 50 cost share and future revenue split okay great um i apologize maybe i have a question a finance question for you right now um shoe guy licensed the ronnie pill for a rare disease antibody and development for hemophilia 10 million up front up to 18 million in tech transfer and 57 development in milestones, 100 million in sales milestones and single-digital royalties, with options on up to five more targets for a headline of one point, I'm rounding it up, one billion, what is the next milestone and what would trigger Shugai to exercise more options? Is that a next question?

It's okay, I'm not a my cog, you just happen to be picking the Kate question. So we are really pleased, so thank you for bringing this up because both Shugai and Ronnie are very pleased at how our partnership has begun this past year. And Chugai has been very validating for the Ronnie Pill platform, obviously generated a lot of interest from investors. We had a concurrent financing as part of that deal announcement. And they did a significant amount of diligence over a two-year period, digging into our manufacturing processes, all our quality controls, a lot of work testing two of their molecules in the Ronnie pill and then got so comfortable that the deal expanded to now these additional targets. So while we can't guide to the exact timing of the additional targets because it is a two guys option, what I will tell you is a couple of those early milestones are tied to Ronnie advancing our platform and our manufacturing processes. We're moving along very well and do anticipate to be able to report out on at least one in 2027 um and then along with uh the program going very well and chugai has been quite vocal um around their confidence in ronnie in a very long-term partnership um and do intend to option off those option on those future partnerships okay great a quick i'm going to do a quick uh follow-on um And in July, you added the PEG-Bio collaboration on obesity and metabolic molecules.

Is the strategy to own obesity assets or to be the delivery partner for many?

That's a great question. So, Ronnie's strategy in obesity is to have numerous programs in our pipeline with diverse drugs. So, the gentleman brought up retatratide. There's nothing about our current obesity program that says we couldn't also have a retatratide program. Ronnie doesn't develop drugs. We don't design drugs. What we do is deliver drugs very efficiently across modalities. So this PEG Bio Partnership is a perfect fit. They're based in China. They have an on-market GLP in China and numerous different molecules in development. They have a couple pentagonists that are really interesting, some triagonist, a meritide-like drug siRNAs. So Ronnie will have the opportunity to test lots of different drugs, then generate the data to go out and find partners, or potentially reinvest and further those programs ourselves.

Okay. I'm going to have one for it's a lot, and then one for you, Nick, I think. I've whiffed twice on that.

So skeptics raise three issues, whether bioavailability above subcutaneous will hold up in larger repeat dose studies, the cost of goods for an ingestible device versus a peptide pen or a small molecule pill and that earlier ronnie programs never advanced past early clinical studies all right so in terms of whether we're at 150 160 or 100 percent bioavailability honestly who cares we're talking about delivering a monoclonal antibody with equivalent bioavailability or superior i'd be happy with any of those it'll just get modeled into the dosing so i don't think that's a really big deal um number two was cost of goods uh we are the the input materials are plastic sugar and alka seltzer there's de minimis costs right and that was by design we didn't put electronics we didn't put any of those things in there so so the cost of goods is really just a factor of amortizing the scale of our manufacturing over the number of pills you make. And so let's take our Stellara program that we've shown 84% relative bioavailability for. We've modeled that it's 12 pills per year to recreate the Stellara PK curve, 12 pills per year, three pills every quarter. So whether it's 10 bucks a pill, 15 bucks a pill, or five bucks a pill, who cares, right? Again, it falls into that category. And when you talk about obesity volumes, that's going to come down to low single digits per pill. And we're talking about weekly administration in most cases, so $100, $200 of COGS. It's not going to make a difference, right? Why did we discontinue our early programs? We do get this question a lot, and I'm going to be candid here. We put out great data to crickets from investors for a while, and it's because what we're doing, and you guys got to hear this, sounds like science fiction, and so people look at it and say, this is great. Why isn't anybody coming and licensing your platform i'm not trying to say it in a negative sense because we just did a 1.1 billion dollar deal a year ago that took time it took time yeah and it was two years of diligence from true guy the partnership expanded over that period of time but after that we raised the pipe with really great institutional investors brought in a sovereign fund this year uh raising capital has not been as difficult and i think that'll be able to support the programs that we have yeah that's for sure you've been you've been pushing through for a long time so Kudos to get to where you guys are today, truly.

I think this is for you, Nick. It's on me. I'm missing whiffing here. All right, so you ended June with $53 million in cash and securities after the $20 million registered direct led by a sovereign wealth fund, as you just looked at, and you guided runway at least through 27. Last October, after the $60 million pipe and a Shugai deal, the guide was into 28.

What changed and how do you fund phase one and beyond without repeated dilution i guess yeah yeah so that's this is my question so you're right um in october uh when we did the deal in october of 25 we guided runway into into 28 um we did update guidance in in march um to uh getting into q4 of 2027 so what changed there um just investment in the platform and we'd also retired some debt after you know doing that 60 million dollar raise um so now uh you know fast forward to we do the 20 million raise in may and our update our updated guidance now is through 2027 so what changed from there is one we extended the runway now we're getting into 2027 the other piece that changed is when i came on board i'm three months now on the cfo role um looked at you know what we were including in our runway and decided to be a bit more conservative so in the prior guidance we had one of the milestones from true guy that that Kate had mentioned nothing changed there we're you know fully you know confident in those milestones but me being a little more conservative decided to use cash on hand to guide our runway so if and when you know we do get a shoe guy milestone they'll be upside and hopefully extend our runway from there okay and maybe I'll just add one thing real quick to

this are our actual clinical studies are incredibly efficient because these are drugs that are known so they're not really single ascending dose in most cases they're single dose right because we know what the target is 114 notwithstanding where we got significantly higher bioavailability and we're doing one more dose and even in that case uh half of the the cost is borne by our partner and for the chew guy programs they cover 100 of the costs so we can do a number of programs and as these options get exercised there'll be a stream of upfronts and milestones that will help support the company fantastic so the next milestone that we can look for is some data from the phase 1b in 27 yes you're welcome to

we got one more minute so go ahead and see you I'm done with my questions Thank you.

No. So with . They get lots of people.

ADAs? Do you still have that? We are going to be testing that this year. We'll have a little bit of data, I think. There is a possibility of that. I don't want to guide to it until we have the data.

It probably doesn't matter anyway. Those are non. They don't matter. Just give a little rest.

Oh, so if you're talking about ISRs, we get none we've never seen one at all yeah so this is something that large pharma companies actually are pretty interested in talking to us with their mab's that have isr we're a public company ticker ronnie r-a-n-i our fourth phase fourth phase one we've shown 400 relative bioavailability with you get the same look i had when i when i cover this company years ago yeah everybody turn them away thank you everybody all right anyway everybody

thank you thank you for the questions from the audience guys appreciate it we're going to start our next panel in a second that was awesome