Rani Therapeutics Holdings, Inc.

Welcome to the Ronnie 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, Ronnie 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. To ask a question at that time, please press star followed by 11 on your touchtone phone. If anyone has difficulty hearing the conference call, please press star zero for operator assistance. As a reminder, this call is being recorded today, March 31st, 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, our Chief Executive Officer, Talat Imran and Chief Financial Officer, Svay 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 reports 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 three and introduce to you Talat Imran, Chief Executive Officer of Ronnie 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. Ronnie 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 Ronnie Pill 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 Ronnie Pill capsule technology platform and highlight the important advancements that Ronnie has achieved in its pipeline over the past year. Then I will share how we are leveraging the Ronnie Pill technology to develop the next generation of obesity therapies, including our RT-114 and semaglutide programs. And then finally, Savai 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 five. At Ronnie 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 Ronnie's inception more than 10 years ago. The Ronnie Pill 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 Ronnie Pill 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 Ronnie Pill capsule which exposes the delivery mechanism to intestinal fluid. In the small intestine, a self-inflating balloon creates the pressure needed to inject the dissolvable microneedle and deliver the drug via a transenteric painless injection. Once delivered, the drug is quickly absorbed by the vascular system and the device deflates and is safely passed out. Our platform technology is intended to enable the oral administration of any biologic with bioavailability comparable to a subcutaneous injection, resulting in a potential for broad application across multiple indications. Our Ronnie Pill technology is currently being evaluated in several high-value indications across the immunology and obesity spaces. Furthermore, Ronnie has a robust patent portfolio with over 450 granted patents and pending applications. Please turn to slide six. Today, our platform technology stands as a proven success, demonstrating consistency across a wide range of preclinical and clinical trials. In preclinical studies, the Ronnie Pill has delivered high bioavailability compared to subcutaneous injection for 19 molecules, including antibodies, peptides, and large proteins. In addition, we have conducted a 60-day repeat administration GLP study where the Ronnie Pill was well-tolerated and there were no serious adverse events. Clinically, we have completed three phase one studies. And in these studies, the Ronnie pill has been well tolerated with no serious adverse events reported with more than 200 pills administered to 146 subjects. Overall, we believe the Ronnie pill addresses the challenges faced by chemistry-based oral delivery by having the potential to deliver drug with high bioavailability and dosing size and frequency similar to a subcutaneous injection. We believe this represents a distinct advantage that positions Ronnie programs for future success. Now on to slide seven. Moving on to our pipeline, we are proud of all that we have accomplished in 2024 and thus far in 2025, especially the advancements we have made in our pipeline focus in the obesity space. a market projected to reach $100 billion by 2030, where oral alternatives could redefine the treatment paradigm. To date, RONI has successfully evaluated four incretin-based molecules in preclinical studies. These studies underscore the potential of the RONI pill platform to enable the oral delivery of a diverse range of obesity treatments, including both single and triagonous incretin therapies, as well as semaglutide and RT-114. We are confident that the significant advancements made in our pipeline over the past year position us to further expand our obesity portfolio and realize the transformative potential of Ronnie Pill technology. As a reminder, in June of 2024, Ronnie announced that it entered into a definitive agreement for the co-development and commercialization of RT-114 with Progen Co Limited, a South Korean clinical stage biotech company developing next-generation, long-acting, multi-specific fusion protein therapeutics. RT-114 combines Progen's FC fusion protein conjugated GLP-1, GLP-2 dual agonist, PG-102, with the RONI pill. The rationale behind this strategic partnership is to combine a potential best-in-class GLP-1, GLP-2 asset with the convenience and dosing flexibility of the RONI pill to create a strongly differentiated singular product in the obesity market. Ronnie shared a preclinical update on RT-114 last week, and Progen presented data on PG-102 at the Asian Association for the Study of Diabetes Conference. I will review the results and next steps for our RT-114 program later on in the call. Beyond RT-114, One of the most significant advancements in our pipeline over the past year is the introduction of RT-116, an orally administered version of semaglutide. Semaglutide selectively binds to and activates the GLP-1 receptor, mimicking its natural activity. GLP-1 is an incretin hormone, an enterogastrone, that plays a crucial role in regulating appetite and food intake by stimulating insulin secretion, inhibiting glucagon secretion, and delaying gastric emptying. Last month, we shared encouraging preclinical data demonstrating the successful delivery of semaglutide via the RONI pill, and I will provide an overview of those results shortly. Overall, we are encouraged by the progress we have made with our obesity program, especially in the light of the tolerability challenges that limit the efficacy of first-generation and cretin-based therapies, thus highlighting the need for more tolerable options. While our current focus is on the obesity space, we have additional assets in development in our pipeline in immunology and endocrinology. Overall, we are open to additional opportunities to partner with pharmaceutical companies using our drug agnostic platform to advance oral biologics for patients. Now I will review the data we shared this quarter on RT114 and RT116 as we leverage the Ronnie Pill technology to develop the next generation of obesity therapies. Please turn to slide nine. In February 2025, Ronnie announced preclinical data demonstrating the successful oral delivery of semaglutide, or RT-116, via the Ronnie pill. On this slide, purple represents RT-116, and the teal green represents subcutaneously delivered semaglutide. As you can see looking at the pharmacokinetic curve on the left, RT116 achieved comparable pharmacokinetics to subcutaneous administration. As for pharmacodynamics, both groups saw comparable weight loss, which appeared to be driven by decreased food intake. Weight loss coincided with rises in plasma drug levels, thus indicating there is a pharmacodynamic effect to treatment. Both groups saw comparable decreases in serum triglycerides and cholesterol. As for biologic activity, the relative bioavailability of orally administered semaglutide versus subcutaneous administration was 107%. Furthermore, RT116 was well tolerated with no serious adverse events reported. Overall, we are pleased with this data. semaglutide is available exclusively as a subcutaneous injection for the treatment of obesity, marketed in the U.S. under the brand name Wigovi by Novo Nordisk. While Rebelsis offers an oral version of semaglutide approved for improving glycemic control in adults with type 2 diabetes, it requires daily administration at a significantly higher dose than its subcutaneous counterpart. In contrast, The target product profile of semaglutide in the Ronnie Pill capsule would be a once-weekly oral administration of semaglutide therapy at a dose similar to the injectable, which we believe may be more convenient for patients and could lead to improved adherence. Please turn to slide 10, where I will share the exciting preclinical results of our RT114 data released last week. Ronnie released preclinical data evaluating a head-to-head comparison of orally administered PG-102, Progen's GLP-1, GLP-2 molecule delivered via the Ronnie pill capsule, otherwise known as RT-114, compared to PG-102 delivered subcutaneously in 16 healthy canines. As you can see when looking at the pharmacokinetic curve for both treatments, RT-114 yielded a higher CMAX and earlier TMAX with a relative bioavailability of 111% compared to PG102 delivered subcutaneously. Furthermore, these data confirm bioequivalence of RT114 to subcutaneously delivered PG102. The Ronipil capsule was well tolerated with no changes in drug-related safety profile compared to subcutaneous delivery. On the bar graph on the right-hand side, you will see the pharmacodynamics of RT114 measured by body weight. Both groups demonstrated an average peak weight loss of 6.7%. However, there was more variability in results with subcutaneous dosing. Please turn to slide 11. Overall, we believe that Rani has the opportunity to create a truly differentiated product profile with RT-114, combining the potential advantages of PG-102 with the convenience of oral delivery. Progen recently announced preliminary results of the repeat dose portion of its phase one clinical study. In the trial, subcutaneous PG102 demonstrated weight loss in obese subjects with an average reduction of 4.8% and up to 8.7% following five weeks of dosing. Subcutaneous PG102 demonstrated tolerability while reaching the target dose of 80 milligrams within one month. Even with rapid dose escalation, there were no treatment discontinuations, illustrating a potentially significant tolerability benefit of this molecule. Furthermore, PG102 has demonstrated improved body composition, fat versus lean mass loss, compared to terzepatide and dapaglutide in a diet-induced obese mouse model. We believe this preservation of lean body mass could serve as a key differentiator for PG102 particularly due to the recent FDA guidance emphasizing the critical importance of body composition in the development of obesity treatments. As a result, we believe that RT-114 has several potential key advantages in the competitive landscape. First and foremost, we believe RT-114 has the potential to demonstrate comparable weight loss, a better tolerability profile, and greater preservation of lean muscle mass compared to currently approved products. Also, a shorter titration schedule may facilitate a quicker onset of effect. This could address the significant challenge with current GLP-1 treatment options, where many patients discontinue therapy before achieving clinically meaningful weight loss. And finally, the currently available oral therapies and those in clinical development for the treatment of obesity required daily dosing. In contrast, our target product profile for RT-114 is for less frequent and potentially weekly oral dosing. Looking ahead, we intend to move rapidly to advance RT-114 into the clinic in mid-2025. Overall, we believe that RT-114 has the potential to be a highly differentiated and desirable product in the obesity market due to its potential to have a favorable safety profile and to preserve lean body mass as an oral therapy. Please turn to slide 12. Our target product profile for RT114 and RT116 is to be differentiated and competitive when compared with both subcutaneous and oral formulations of incretin therapies. Illustrated on this chart are approved obesity products and certain molecules in development. On the x-axis is the frequency of administration, and the y-axis is the maximum API dose per week. As you can see in this two-by-two matrix, the oral therapies require daily or twice-daily dosing with doses in the hundreds of milligrams. While for small molecules, this dose does not dramatically increase the cost of goods, for the orally available peptides, it has the potential to burden the supply chain and potentially increase COGS dramatically. Of the therapies listed on the chart, RT-114 and RT-116 are the only proposed orals in development that are expected to utilize similar API quantity and dosing frequency as an injectable product. Now I would like to pass the call over to slide 13 and to Savai Sanford, our Chief Financial Officer, to review our financial results.

Thank you, Talad. Good afternoon, everyone, and thank you for joining the call. Earlier today, we issued a press release and filed a 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 total $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 Ronnie pill. We have performed this service from time to time and have demonstrated successful deliveries of several drugs using the Ronnie pill. 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. Their 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 million compared to the prior year due to our cost containment measures. In the fourth quarter and full year 2024, we recorded an impairment loss of $3.7 million related to certain manufacturing property and equipment, which were previously reported as construction and progress assets. We consider a number of factors required by GAAP to assess whether the value of the property equipment is recoverable. After a thorough assessment, it was determined that the carrying value of the property and equipment has exceeded the fair value. And therefore, it was written down to the salvage value. There were no such impairment losses in the comparable periods last year. Net loss for the fourth quarter and full year 2024 was 15.7 million and 56.6 million, respectively, compared to net losses of 14.1 million and 67.9 million for the same period in 2023, respectively. The net losses for the fourth quarter and full year 2024 include non-cash impairment loss of 3.7 million and stock-based compensation expense of $4 million and $16 million, respectively, compared to non-cash stock-based compensation expense of $4.5 million and $19 million for the fourth quarter and full year 2023, respectively. That concludes the financial section, and I will return the call back to Talad for closing comments. Talad?

Thank you, Suvai. please turn to slide 14. In conclusion, we take immense pride in the substantial advancements made at Ronnie 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 RT114 and RT116 provide validation of the potential for the Ronnie Pill 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 Ronnie Pill 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 Ronnie and commitment to our vision of making oral biologics a reality. With that, I will now open the call up for questions. Operator?

As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Please stand by while we compile the Q&A roster. Our first question comes from Annabelle Samimi with Stiefel.

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 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 one 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 114 prioritization? Thanks.

Hi, Annabelle. 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 sub-Q 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, the semiglutide 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, though 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 I trials? I guess that was one question that you missed answering. But secondly, can you tell us what would be the expected cost of goods sold would be on a product like this? You know, 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.

Yeah, so apologize. When you asked about the phase one, I thought you were referring to the RT-116 phase one. And as I said, we don't have plans to move that into the clinic at this point. The RT-114 phase one, 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 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 will make the product competitive, even as the price comes down in the market overall.

Thank you.

Yeah, absolutely.

Thank you. Our next question comes from Andreas Argerides 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, Ika, thank you for the question. The transenteric route, we have tested 19 molecules now, and several of them are, you know, 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 RT114 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 prior work has, like our Stelaro 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 one 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. Sure, absolutely. So the phase one 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, you know, we'll have to review the data, but most likely would be to do a phase 2a 12-week study with a larger patient population and test perhaps two doses in the RONI pill versus a placebo.

Thank you.

Thank you. 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 one 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 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.

Very helpful. Thank you.

Yeah. Thank you, Julian.

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

Hey, everyone. Thanks for taking the questions. First one is I wanted to ask about the IRP concentration of 114 that you show versus subcutaneous and just kind of the implications for that. I think we've seen you know, with the Ronnie pill formulated drugs that they can get to this higher peak concentration initially. Is there something that we should be thinking about in terms of, you know, 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 in 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 incidents 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 will bring the nausea and vomiting potentially under control. What was interesting, we didn't do this with the Rani pill, but in the subcutaneous, when we were doing dose findings so that we could select the right dose for the Rani pill 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 Ronnie Pill 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 platform to the market. So that was a BDE deal that we did last year. As you heard from Savai, we can't dispose 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 Rani pill. 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 Fai.

Thank you. Thank you, Mitchell.

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. Again, that is star 1-1 to ask a question. Our next question comes from Michael Akunowich with Maxim Group. Your line is open.

Hi, this is Chad Ong from Michael. Thanks for taking the questions. We're just wondering, how does Progen's PG-102 weight loss and speed of titration compare to Zeeland's GLP-1, GLP-2?

Yeah, good question, Chad. It's hard to compare across studies. I will caveat that. In their phase one multidose there, meaning Zeeland's, I think they showed similar, maybe slightly lower weight loss, if my recollection serves me. But then it was a 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 Zeeland peptide, they got a research-grade version of that of dapaglutide versus the FC-fusion protein version of the GLP-1, GLP-2 Progen's drug. was that PG-102 had much more sustained weight loss over time, and the dapaglutide 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 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 questions, Bob. Thank you.

Thank you. Our next question comes from Shen Wei On 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.

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 this will be our fourth phase one study, and we have shown very good bioavailability in those prior studies. And with the preclinical data that we've put out showing similar weight loss and similar PK as compared to the sub-Q, we have a lot of confidence going into it. But, you know, the clinical study will ultimately tell the story.

Thank you.

Our next question comes from John Vannermussen with ZACS. Your line is open.

Thank you, and hello, Talat and Savai. So regarding PG-102, do we expect to see the standard Phase I, Phase II, 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 PG-102?

Yeah, exactly. Yeah, what ProGen's going to do.

Got it, got it. Yeah, 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 one, 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 sub-Q in the U.S. 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 and submit, you would submit following that? Or how would that look?

Yeah, another good question. 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 Ronnie'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 Ronnie ProGen partnership. Okay. Thanks, Talat. Yeah, absolutely.

Thank you. I'm showing no further questions at this time. Oh, now I'd like to turn it back to Talat Amaran. 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.