All right, great. I know we're all coming off lunch and that panel here, so hopefully everyone can get settled down now. I'm excited to welcome the team from Rani. We have Talat Imran, CEO here joining us.
Kate McKinley.
Kate McKinley, and then Nic?
Maestas.
Maestas. 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. Let's get into it, actually. Why don't we do this? For anyone new to the story, what actually happens after a patient swallows a RaniPill? Well, first of all, let's just do this. Maybe give us a quick overview of what Rani 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. 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. Rani 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. It doesn't matter if you deliver a monoclonal antibody, a protein, a peptide, an oligo. We've done all of those, and they're all equivalent. As Andreas 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. Even there, you get sub 1% bioavailability, incredibly high variability, and food effect.
The reason we've been able to 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. A 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. 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. 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.
Over 250 pills orally administered, showing incredibly high bioavailability, whether it's a peptide or an antibody.
Any?
We've delivered STELARA in a pill in humans. We've done factor VIII, which is a 300 kilodalton molecule. Literally anything. There's no limitation. We'll take questions. Sure.
You mentioned needle. How do you compact?
There's a balloon that inflates and aligns, and it provides apposition. We don't have a picture of it, but it has a hump at the back that provides sort of back force, and then the needle comes out very quickly, and the drug is delivered into the intestinal wall, pain free. It 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.
Yeah.
On the website. The story's even cooler, right? Because you said Alka-Seltzer. I think that the founder or the creator or the-
Correct.
Inventor saw the Alka-Seltzer dissolving, right? He figured how you can configure it so it-
Well, he had spicy Indian food one night, and he had an upset stomach. He had 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. 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. I guess we've been talking about it. What actually happens after a patient swallows the RaniPill, 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 to the-
Sorry.
Let's get into RT-114 and obesity. In July, you reported that RT-114, the RaniPill delivering ProGen's GLP-1/GLP-2 dual agonist PG-102, achieved bioavailability greater than 150% of a matched 12 mg subcutaneous dose in 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?
Kate McKinley is our Chief Business Officer. She led that deal. I'm going to have her talk through it.
Great. Thanks, Andreas.
Yeah. Thanks, Kate.
Thank you for having us today. First, we'll step back and talk a little bit about the partnership that Rani has with ProGen, which is a company based in South Korea. Rani and ProGen have a strategic partnership for the oral delivery of ProGen's PG-102 via the RaniPill. 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. There are 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.
To your point, Andreas, we reported out data from our phase I study, and in that study, we were able to demonstrate a PK of greater than 150% PG-102 delivered via the RaniPill compared to the sub-Q. Notably, this was at the exact same dose, which we know is very unique with oral delivery in obesity, and there were no AEs related to the RaniPill. 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. What we're seeing here is a really efficient route of delivery via the RaniPill, 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. We're really excited to continue to advance this first program that we have in obesity with the RaniPill.
All right, Kate, I'm going to Oh, do you want to go ahead?
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. Maybe a follow-up for you, Kate. The expansion cohort adds 15 volunteers. What are you specifically trying to learn before phase I-B?
Great question. We did announce that we intend to expand our 1A to better characterize this oral to sub-Q PK relationship. These 15 healthy volunteers will now take two doses, each of the 12 mg, PG-102 delivered via the RaniPill for a total of 24 mg. Depending on what we see with these PK results, we may be able to actually achieve higher serum concentrations at lower than expected dosing. Ultimately, the goal is to inform the dosing for the 1B.
Okay, great. We're going to segue.
There's a question.
What are you calling best in class? Why don't you do an actual experiment with
We may do that.
Just do it right now.
Yeah. I completely agree.
We agree.
Good.
Okay. All right. I love it.
It's fantastic. Literally, it's the best drug. It's going to be the best drug ever. FYI, everyone here, retatrutide, best drug ever.
Okay. I love it. Enthusiasm from the audience. We don't get that, as opposed to the silence that we get, so we appreciate you.
Yeah, this is awesome.
Let us continue, at least.
You heard it here first.
Okay. Your name?
Desmond.
Oh, okay. Who are we going to give reference to now?
Yeah.
We got to give credit to you.
I can't think of my last name. I'm nobody.
All right. I'll remember your face, and I'll remember the moment.
In the future, that's okay.
The phase-
Everybody will tell you exactly the same thing. It's literally the best drug ever.
Okay.
You've seen the data.
Okay. The phase I-B repeat dose study in obesity is slated to start by the end of the year with data in 2027. In a market where Lilly's oral or semaglutide oral already offer a pill, what is the case for an orally delivered injectable class peptide, and what does PG-102's GLP-2 component add?
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 an oral every time it's offered. Our goal is obviously to move forward, generate weight loss data. But this is not necessarily a retatrutide. 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 much more frequent dosing scheme than what we're proposing with RT-114. 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. It brings in questions around cost of goods, supply chain. With RT-114, 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.
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. Then now the cherry on top, which we don't have data for, and ProGen doesn't yet, but they will in their phase II and beyond, lean body mass preservation that looks twice as good as tirzepatide. This is not retatrutide. You're not going to get 28% weight loss. But this is a drug that if half of patients are dropping off within the first 20 weeks, which is what the data shows, this is for those patients.
Do you want to put a bar for the weight loss number or you don't want to hold. No, we're not going to hold you.
Not yet.
Not yet. Okay. Maybe quickly, and I guess maybe for Nic, because we're not going to forget you, I guess, but who owns what in the ProGen collaboration? How is the economic split? Oh, that's a Kate question? Okay, sorry.
It is a 50/50 cost share.
Okay.
It's a co-co deal. We jointly own IP, and the markets are split. ProGen owns generally Asia and Rani owns the major markets, U.S., Europe, U.K., Australia, Canada. 50/50 cost share and future revenue split.
Okay, great. I apologize, Nic. Maybe I have a finance question for you right now. Chugai licensed the RaniPill for a rare disease antibody in development for hemophilia, $10 million upfront, up to $18 million in tech transfer, and $57 million in development milestones, $100 million in sales milestones, and single-digit royalties with options on up to five more targets for a headline of, I'm rounding up, $1 billion. What is the next milestone, and what would trigger Chugai to exercise more options? Is that a Nic question?
It's okay. I'm not a mic hog.
It's a Kate question.
I just happen to be picking the Kate.
I'm just trying to include everybody on here.
The Kate question. We are really pleased, so thank you for bringing this up because both Chugai and Rani are very pleased at how our partnership has begun this past year. Chugai has been very validating for the RaniPill 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 2-year period, digging into our manufacturing processes, all our quality controls, a lot of work testing two of their molecules in the RaniPill, and then got so comfortable that the deal expanded to now these additional targets. While we cannot guide to the exact timing of-
Okay.
The additional targets because it is Chugai's option, what I will tell you is a couple of those early milestones are tied to Rani advancing our platform and our manufacturing processes. We are moving along very well and do anticipate to be able to report out on at least one in 2027. Along with the program going very well, Chugai has been quite vocal around their confidence in Rani in a very long-term partnership, and do intend to option on those future partnerships.
Okay, great. I am going to do a quick follow-on. In July, you added the PegBio collaboration on obesity and metabolic molecules. Is the strategy to own obesity assets or to be the delivery partner for many?
That is a great question. Rani's strategy in obesity is to have numerous programs in our pipeline with diverse drugs. The gentleman brought up retatrutide. There is nothing about our current obesity program that says we could not also have a retatrutide program. Rani does not develop drugs. We do not design drugs. What we do is deliver drugs very efficiently across modalities. This PegBio partnership is a perfect fit. They are based in China. They have an on-market GLP in China, and numerous different molecules in development. They have a couple penta-agonists that are really interesting, some triagonist, a MariTide-like drug, siRNAs. Rani 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 Talat, and then one for you, Nic, I think. I swift twice on that. 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 Rani programs never advanced past early clinical studies.
All right.
As you were.
In terms of whether we're at 150, 160, or 100% 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. I don't think that's a really big deal. Number two was cost of goods.
The input materials are plastic, sugar, and Alka-Seltzer. There's de minimis costs. That was by design. We didn't put electronics, we didn't put any of those things in there. So the cost of goods is really just a factor of amortizing the scale of our manufacturing over the number of pills you make. Let's take our STELARA program that we've shown 84% relative bioavailability for. We've modeled that it's 12 pills per year to recreate the STELARA PK curve. 12 pills per year, three pills every quarter. So whether it's $10 a pill, $15 a pill, or $5 a pill, who cares?
Yeah.
Right. Again, it falls into that category. 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. 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. It's because what we're doing, and you guys got to hear this, sounds like science fiction. 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 deal a year ago.
That took time.
It took time.
Yeah.
It was two years of diligence from Chugai. 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. Raising capital has not been as difficult, and I think that'll be able to support the programs that we have.
Yeah. No, that's for sure. You've been pushing through for a long time.
Yeah.
So kudos to get to where you guys are today, truly. I think this is for you, Nic.
I got it.
It is on me. I am missing Wiffin here. All right. 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 alluded to, and you guided runway at least through 2027. Last October, after the $60 million PIPE and a Chugai deal, the guide was into 2028. What changed, and how do you fund phase I and beyond without repeated dilution, I guess?
Yeah. This is my question.
That is your area.
Yeah. You're right. In October, when we did the deal in October of 2025, we guided runway into 2028. We did update guidance in March, to getting into Q4 of 2027. What changed there? Just investment in the platform, and we'd also retired some debt after doing that $60 million raise. Now, fast forward to we do the $20 million raise in May, and our updated guidance now is through 2027. 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, looked at what we were including in our runway and decided to be a bit more conservative. In the prior guidance, we had one of the milestones from Chugai that Kate had mentioned. Nothing changed there.
We're fully confident in those milestones. But me, being a little more conservative, decided to use cash on hand to guide our runway. If and when we do get a Chugai milestone, that'll be upside, and hopefully extend our runway from there.
Okay.
Maybe I'll just add one thing real quick to this. 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. Because we know what the target is. RT-114 notwithstanding, where we got significantly higher bioavailability, and we're doing one more dose. Even in that case, half of the cost is borne by our partner. For the Chugai programs, they cover 100% of the cost. We can do a number of programs, and as these options get exercised, there'll be a stream of upfronts and milestones that'll help support the company.
Fantastic. The next milestone that we can look for is some data from the phase I-B in 2027.
Mm-hmm. Yes.
You are welcome to. We got one more minute, so go ahead. It is you. I am done with my questions.
That early? This is a no-brainer, ever. Technically.
Thank you.
It's really well articulated. But technically, do you still have the antibody response to the GIP when [trospium] is added in attach and they're not binding? Do you understand what I'm asking?
No.
Okay. So with trospium, on the GIP, they get lots, percent of people.
ADAs?
Yes. Do you still have that?
We are going to be testing that this year. We'll have a little bit of data, I think.
Presumably because you're doing it not with skin, through the gut, you probably will have less.
There is a possibility of that. I don't want to guide to it till we have the data.
The sad truth is it probably doesn't matter anyway because those are non. They don't matter anyway. Just a little rational.
Oh. If you're talking about ISRs?
Yeah.
We get none. We've never seen one at all.
You almost ever see none.
Yeah. This is something that large pharma companies actually are pretty interested in talking to us with their mAbs that have ISRs.
Are you a public or private company?
We're a public company.
Why? What?
Ticker RANI, R-A-N-I.
It's our fourth phase I study.
The fourth phase I. We've shown 400% relative bioavailability with-
You get the same look I had when I covered this company years ago.
Yep.
Everybody turn them away.
Sorry. I'm a stupid Albert Einstein looking at finance. Fine.
Thank you, everybody.
All right. Anyway, everybody, thank you. Thank you for the questions from the audience. Guys, I appreciate it. We're going to start our next panel in a second. That was awesome.