Welcome to the Rani Fourth Quarter and Full Year 2024 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, Rani will hold a Q&A session. To ensure that we have ample time to address everyone's questions during the Q&A session, we would ask for a limit of one question and one follow-up question per person. [Operator Instructions]. As a reminder, this call is being recorded today March 31, 2025. I would now like to turn the conference over to Kiki Patel at Gilmartin Group. Please go ahead.

Thank you, Operator. Please turn to Slide 2. Joining us on the call today from Rani Therapeutics are Chief Executive Officer, Talat Imran; and Chief Financial Officer, Svai Sanford. During this conference call, management will make forward-looking statements that are subject to risks, uncertainties and assumptions such as but not limited to, those discussed in the Risk Factors section of the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K and quarterly reports on Form 10-Q, which identify specific Risk Factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These statements may include without limitation statements regarding product development and clinical trials, product potential, market sizes, platform progress, platform potential, certain business strategies, capital resources, financing plans or operating performance. Actual results and the timing of events could differ materially from those projected in such forward-looking statements. With that, I turn the call over to Slide 3, and introduce to you Talat Imran, Chief Executive Officer of Rani Therapeutics. Talat?

Thank you, Kiki. Good afternoon, everyone, and thank you for joining our earnings call for the fourth quarter and full year of 2024. Rani Therapeutics is a clinical stage biotech company that has developed a platform technology for the oral administration of biologics with proven bioavailability comparable to a subcutaneous injection. Our RaniPill technology is currently being evaluated across several high value indications including the obesity and immunology spaces. I will start the call by providing a brief overview of our RaniPill capsule technology platform and highlight the important advancements that Rani has achieved in its pipeline over the past year. Then I will share how we are leveraging the RaniPill technology to develop the next-generation of obesity therapies including our RT-114 and semaglutide programs. And then finally Svai Sanford, our CFO, will provide an update on our financial results for the fourth quarter and full year 2024. So let's begin. Please turn to Slide 5. At Rani Therapeutics, our mission is to end painful injections for the millions of patients living with chronic conditions. With this mission in mind, we have made significant strides since Rani's inception more than 10 years ago. The RaniPill capsule, which has been extensively tested and clinically validated, represents a breakthrough in oral biologics with its ability to match injectable bioavailability across multiple indications. The RaniPill technology consists of an innovative robotic pill with a proprietary enteric coating that makes it easy to swallow and allows it to pass-through the acidic environment of the stomach. Previous attempts at delivering biologics orally have struggled to pass-through the stomach and as a result have been unsuccessful. Once in the small intestines, the higher pH level breaks down the enteric coating and outer shell of the RaniPill capsule, which exposes the delivery mechanism to intestinal fluid. In…

Thank you, Talat. Good afternoon, everyone, and thank you for joining the call. Earlier today, we issued a press release and filed our Form 10-K with the Securities and Exchange Commission, which contain our financial results for the full year ending December 31, 2024. I will briefly share some key financial highlights on this call. You can also find additional information in our Form 10-K for the year ended December 31, 2024. Turning to our balance sheet. Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $27.6 million, compared to $48.5 million as of December 31, 2023. We expect the cash, cash equivalents, and marketable securities to be sufficient to fund our operations into the third quarter of 2025 without additional funding. For our operating results for the fourth quarter and year ended December 31, 2024, for the fourth quarter and full year 2024, we earned contract revenue of approximately $1 million related to a research evaluation service testing a prospective partner's drug in the RaniPill. We have performed this service from time to time and have demonstrated successful deliveries of several drugs using the RaniPill. There was no contract revenue for the same period in 2023. Research and development expenses for the fourth quarter and full year 2024 were $6.8 million and $26.7 million, respectively, compared to $7.6 million and $39.6 million for the same period in 2023, respectively. The R&D expenses for the full year 2024 decreased by $12.9 million, compared to the prior year due to our cost containment measures. General and administrative expenses for the fourth quarter and full year 2024 were $5.5 million and $23.9 million respectively, compared to $5.8 million and $26.5 million for the same period in 2023, respectively. The G&A expenses for the full year 2024 decreased by $2.5…

Thank you, Svai. Please turn to Slide 14. In conclusion, we take immense pride in the substantial advancements made at Rani Therapeutics and the remarkable opportunity we have to leverage our technology across a diverse array of product candidates within the obesity sector. We believe the preclinical data we have generated with RT-114 and RT-116 provide validation of the potential for the RaniPill oral delivery platform in the obesity space. We look forward to bringing RT-114 into the clinic in mid-2025. We are confident that the RaniPill platform possesses the transformative potential to redefine the treatment paradigm for injectable large molecule therapeutics by converting them into accessible oral treatments. I would like to convey my sincere appreciation to our stakeholders for their unwavering support of Rani and commitment to our vision of making oral biologics a reality. With that, I will now open the call up for questions. Operator?

[Operator Instructions]. Our first question comes from Annabel Samimy with Stifel. Your line is open.

Hi guys, thanks for taking my question. So a few here. So first on the oral semaglutide that's in development, are you developing this individually or are you using it as a validation tool for the other incretins that you can investigate the dual GLP-1/GLP-2. So I just want to understand the rationale of doing of developing a GLP-1 when I guess by the time you could even potentially get on the market, there's going to be a number of oral GLP-1s, whether it's daily or weekly. I just want to understand the rationale of doing that. Given your capital constraints, what are the costs to conduct the next Phase 1 trial? Could you do that with the capital that you have? And I guess, there's no real update on the other programs. So are those put aside for RT-114 prioritization? Thanks.

Hi Annabel, thank you for the questions. I'll take the last one first. We are -- our primary focus is on RT-114 for this year because of the capital constraints that you alluded to. We are still excited about those programs, the immunology programs in particular. And as more capital becomes available, we can advance those in the clinic. And I think on the RT-114 front that sort of alludes to your other question around RT-116, the semaglutide program. That is a discovery program. We are not planning to run a clinical study for that program at this time. We did do it, as you said, to validate the delivery of an incretin and be able to show PD effect as well, which we were able to do both of those successfully in that study, 107% bioavailability relative to SubQ and equivalent weight loss in those canines. In terms of development, our primary focus is RT-114. As I said, it is a GLP-1/GLP-2 a novel mechanism. The obesity data that ProGen put out last week for their clinical study is very promising. The only additional comment I'd make on RT-116, the semaglutide program is, you are correct that by the time you would be able to bring that onto the market in the U.S. there will be many other incretins that are better suited RT-114 potentially included in that list for patients. Having said that, it is -- the semaglutide molecule is less than 40 amino acids. The composition of matter in many jurisdictions goes off patent next year. And so there is a potential to develop it in an accelerated fashion for those markets thinking of places like the GCC, the Middle East, Brazil and the like, where you can command a decent price and there's very large obese populations. And in that scenario, but we're not committing to it right now, there's a potential to launch that kind of product much sooner than you would with a novel NCE or NME.

Okay. If I can ask one more follow-up.

Please.

I guess, do you have the capital to conduct the Phase 1 trials? I guess, that was one question that you missed answering. But secondly, can you tell us what would the expected cost of goods sold would be on a product like this in light of potential small molecules that might be out? Would you potentially have cost advantages or any kind of flexibility in terms of your cost of goods here? Because it seems like this would be possibly difficult to manufacture, but maybe I'm wrong on that point.

Yes. So apologize. When you asked about the Phase 1, I thought you were referring to the RT-116 Phase 1. And as I said, we don't have plans to move that into the clinic at this point. The RT-114 Phase 1, if that's what you were referring to, yes, we do have that in the budget as it's currently constituted. In terms of cost of goods, we look at this as compared to the biologics because you're right, it's very cheap to make small molecules and to claim even just the API of a biologic to be competitive in pricing with a small molecule wouldn't be fair or justified. Having said that, the small molecules have their own issues, which are around tolerability. So what we're targeting here is developing a weekly oral with RT-114 that will be competitive on a cost of goods perspective with the injectables. We have invested in our manufacturing, automation, and scale and we're confident we'll be able to achieve a COGS target that, that will make the product competitive even as the price comes down in the market overall.

Thank you. Our next question comes from Andreas Argyrides with Oppenheimer. Your line is open.

Thank you. Hi everyone, this is Eka on for Andreas today. Thanks for taking our questions. I want to ask on the variability that you mentioned compared to PG-102 subcutaneous injection, RT-114 had less variability in comparable weight loss. Can you talk about different reasons behind this in your opinion? And how do you see this translating into patients? And then I have one follow-up.

Sure. So Eka, thank you for the question. The transenteric route, we have tested 19 molecules now and several of them are larger proteins like monoclonal antibodies. And we've observed that it is a more efficient route than subcutaneous. It's where we evolved to take up nutrients. And so you see rapid onset and as you alluded to less variability than you see with subcutaneous. Typically, that's what we've observed in our preclinical studies and RT-114 is in line with those prior findings. Now what do we expect in the clinical study? I think the clinical study will tell us, but if it tracks the way that, that, that prior work has, like our STELLARA biosimilar as an example that we tested, we're pretty excited about being able to show perhaps less variability in humans as well.

Got it. Thank you. That's helpful. And for the Phase 1 study for RT-114, can you talk about the patients that you envision enrolling in the study and then what subsequent studies you plan to conduct? Thank you.

Sure. Absolutely. So the Phase 1 is going to be a single ascending dose and then a multi-ascending dose. We're considering running a two-month MAD study in obese patients. So patients with a BMI above 30, these will be non-diabetics to start with. And we're going to be looking at the tolerability of repeat dose and the overall weight loss. In terms of subsequent studies after that, our expectation, we'll have to review the data, but most likely would be to do a Phase 2a 12 weeks study with a larger patient population and test perhaps two doses in the RaniPill versus a placebo.

Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open.

Hi, thank you for taking my questions. I'm curious how much tolerability will guide early clinical development of RT-114 and how much flexibility you expect to have in dosing to optimize tolerability.

Hey, Julian, and thank you for the question. You bring up a great point. Tolerability is really the key here. This is where we see the potential differentiation. If we look at the PG-102 clinical data, they showed excellent tolerability in their Phase 1 repeat dose study. And that was with a very rapid titration to maximum dose. What we'll be looking at in our study is to match those results or come as close as possible. And in terms of flexibility, the beauty of an oral formulation is you can always take another pill. If one pill has greater tolerability issues, for instance, we could split it into two doses and bring the peak down, bring the trough up, and potentially improve tolerability if that's necessary. So not only the vector that every injectable uses of titrating over a greater period of time, we can also spread out the dose. Just one anecdote on that. I was reading about the compounded semaglutide that, that a number of patients are on in the U.S. and some of these patients, because of tolerability issues have started splitting their dose, and taking a couple of injections a week, which you can do with a needle and syringe or a vial and syringe, I should say. And so we have that same flexibility built in to the fact that we have an oral formulation.

Thank you. Our next question comes from Mitchell Kapoor with H.C. Wainwright. Your line is open.

Hey everyone thanks for taking the questions. First one is I wanted to ask about the higher peak concentration of 114 that you show versus subcutaneous and just kind of the implications for that, I think we've seen with the RaniPill formulated drugs that they can get to this higher peak concentration initially. Is there something that we should be thinking about in terms of the implications there and what that means?

So we didn't see a statistic -- hey, Mitchell, by the way, good to talk to you. We didn't see a statistical difference between the nausea or vomiting and the canines. I think in the clinical study we will look at titration schedules because there is a higher peak and as you're alluding to, there is a correlation across studies with higher peaks and incidence of nausea and vomiting. I think this is something that can -- first, we'll have to see if that's an issue because the route of administration is different. And then, secondly, if there is, we can always just titrate a little bit slower given how quick the titration was with PG-102 in their injectable study or split it into two pills and that that will bring the nausea and vomiting potentially under control. What was interesting, we didn't do this with the RaniPill but in the subcutaneous we -- when we were doing dose findings so that we could select the right dose for the RaniPill. For the RT-114 preclinical study, we tested lower doses of PG-102 subcutaneous. And if you go down half a dose or by half, I should say there were no AES whatsoever. So I think that would be potentially a really successful approach if there is some issue with the peak.

Okay. Perfect. Very helpful. And then on the BD front, can you just talk about any interest you're receiving or kind of the types of interest or anything that may have changed since the last time you updated the Street on that front? And then just the priorities you have for developing the RaniPill as a platform and trying to get this across many indications versus just the product that we're currently focused on.

Sure. So thank you for asking that. And partnering is still a primary focus for us as a company. We've done the development work we have in part to prove out the platform, I think with PG-102 that partnership with ProGen was to bring a really novel and potentially best-in-class GLP-1/GLP-2 in to the market. So that was a BD deal that we did last year. As you heard from Svai, we can't disclose the partner but we have been doing some research collaboration with a large pharma company. And then beyond that, there's a tremendous amount of interest in the RaniPill and that interest is in obesity, in immunology and in rare disease. And there's multiple potential partners in both of those -- in all of those categories, I should say.

Great. Thank you very much, Talat and Svai.

Thank you. Thank you, Mitchell.

Thank you. [Operator Instructions]. Our next question comes from Michael Okunewitch with Maxim Group. Your line is open.

Hi, this is Chad on for Michael. Thanks for taking the questions. We were just wondering how does ProGen's PG-102 weight loss and speed of titration compare to Zealand's GLP-1/GLP-2.

Yes. Good question, Chad. It's hard to compare across studies. I will caveat that. The -- in their Phase 1 multi dose there, meaning Zealand's, I think they showed similar, maybe slightly lower weight loss if my recollection serves me. But then it was the little bit more muted in the repeat dose study or the longer-term repeat dose study that they ran. And then they tested higher doses which led to better weight loss. What we saw in the preclinical or what ProGen saw in their preclinical DIO work with both the Zealand's peptide, they got a research grade version of that of dapiglutide versus the FC fusion protein version of the GLP-1 and GLP-2 ProGen's drug was that PG-102 had much more sustained weight loss over time. And the dapiglutide product at those doses plateaued, which is what we ended up seeing in the clinical studies from Zealand, the sort of intermediate repeat dose study. So it's hard to draw a conclusion from that. But what I would say is that the looking at the preclinical data and the clinical data we now have from ProGen, we're very excited about this program. And then the final part that you alluded to as well was the titration. This is something that is incredibly attractive about this drug. It is an FC fusion protein, not a peptide. And so similar to MariTide from Amgen, which requires no titration, they were able to get to a maximum dose within a month and that bodes well for patients potentially.

Great. Thanks for taking the question, Talat.

Thank you.

Thank you. Our next question comes from Xinwei An with Canaccord Genuity. Your line is open.

Hey, congrats on the progress and thank you for taking my questions. I have two regarding the 114 program. The first one is, do you plan to conduct any additional animal studies before you go into the clinics? And then, how confident you are that we will see the human data mimicking what we have seen so far? Thank you.

Hi, Xinwei. So, on the first question, that's easy. No, we don't plan to do any more preclinical work in order to get into the clinic. On the second one, it's hard to speculate. What I will say is we have -- this will be our fourth Phase 1 study and we have shown very good bioavailability in those prior studies. And with the preclinical data that we put out showing similar weight loss and similar PK as compared to the SubQ, we have a lot of confidence going into it, but the clinical study will ultimately tell the story.

Thank you. Our next question comes from John Vandermosten with Zacks. Your line is now open.

Thank you, and hello, Talat and Svai. So regarding PG-102, do we expect to see the standard Phase 1, Phase 2 and pivotal studies before that goes in front of the regulatory agencies, or is there some twist to that at all?

Hi, John. So you're asking about the subcutaneous version of…

Right.

Yes.

Exactly. Yes. What ProGen is going to do?

Got it, got it. Yes. So I just want to make sure I was catching that right. So what they have said publicly and what I can speak to is they have completed their Phase 1, right? They put out the data last week. They are in a Phase 2a and they plan on filing an IND, I believe, for their SubQ in the U.S. in I want to say it's the next year. We can come back to you on the exact public guidance that they've given. But they do plan to move that forward. And that's one of the attractive things about the RT-114 program is we get to, as we do with biosimilars though this is a novel molecule, we get to sort of tread in their wake. We can look at the doses that they have tested, we can observe the titration schedules and any improvements, challenges that they have, and we can apply those which should make our clinical studies faster and more efficient.

Okay. And then I guess, you'll be trailing behind them by just a certain fixed margin, I guess, in terms of timing. So as soon as they complete their pivotal studies then and submit, you would submit following that or how would that look when we get.

Yes, another good question. That that is very likely the case since the molecule is the same. We could get some advantages from them having submitted already. Again, time will tell as we go through development, which one gets prioritized more by ProGen as well. I think the differentiation, speaking from Rani's perspective of RT-114 is tremendous as compared to an injectable GLP-1/GLP-2 against the backdrop of the broader market. They'll have to make that determination. But it does confer some advantages if they do submit to the Rani ProGen partnership.

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Talat Imran for closing remarks.

Thank you, Operator. This concludes our fourth quarter and full year 2024 financial results and corporate update conference call. Thank you again everyone for joining us this afternoon.

This concludes today's conference call. Thank you for participating. You may now disconnect.