Rani Therapeutics Holdings, Inc. (RANI) Earnings Call Transcript & Summary

Welcome to the Rani Therapeutics ProGen Strategic Collaboration Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, June 24, 2024. I would now like to turn the call over to Kiki Patel at Gilmartin Group. Please go ahead.

Thank you, operator. Please turn to Slide 2. During this conference call, Rani will make forward-looking statements that are subject to risks and uncertainties, including statements regarding collaboration between Rani and ProGen, estimated obesity market size, product development and clinical trials, product potential of oral biologics, including RT-114, the regulatory environment, certain business strategies, capital resources or operating performance. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, such as risks related to collaboration with third parties, including the current collaboration with ProGen, risks inherent in the preclinical and clinical development process, the regulatory approval process, the risks and uncertainties in commercialization and gaining market acceptance, the commercial potential of oral biologics, including RT-114, our ability to complete development of RaniPill HC and conduct additional clinical and preclinical studies of RaniPill HC, as well as other risks discussed in the Risk Factors section of Rani'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 the specific risk factors that may cause actual results and timing of events to differ materially from those described in these forward-looking statements. Slide 3. Highlighted here is ProGen's disclaimer. With that, I turn the call over to Slide 4 and Talat Imran, Chief Executive Officer of Rani Therapeutics. Talat?

Thank you, Kiki. I'm delighted to share that, today, Rani Therapeutics has announced a new strategic partnership with ProGen. My name is Talat Imran, and I'm the CEO of Rani Therapeutics. Here's our agenda for our meeting today. Slide 5, please. I would like to introduce Jong-Gyun Kim, CEO of ProGen, who brings over 30 years of expertise in pharmaceutical R&D and strategic drug development across various therapeutic areas. On to Slide 6, please. Both Rani and ProGen have some additional members of our team with us today. Rani's Chief Scientific Officer, Mir Hashim, has been with Rani since our inception and brings over 30 years of scientific expertise. Jesper Hoiland is Rani's Strategic Adviser, advising Rani on our obesity strategy with over 30 years of executive leadership experience at Novo Nordisk, Radius Health and Ascendis. From ProGen, we have Dr. Kyoung-Hwa Son, Chief Development Officer, who oversees all clinical development activities; and Dr. Sae Won Kim, Chief Scientific Officer, in charge of translational research and scientific strategy. Thank you for joining us today, and please turn to Slide 7. At Rani Therapeutics, our mission is to end painful injections for the millions of patients with chronic conditions. We have developed a technology intended to enable the oral administration of any biologic with bioavailability comparable to subcutaneous injection. Rani's pipeline consists of immunology and endocrinology programs. And today, we are very excited to add an obesity program in partnership with ProGen. Rani has completed 3 Phase I studies via our RaniPill platform. The RaniPill HC, which is the high capacity version of our platform intended to be used for the collaboration with ProGen, has the capacity to deliver 200 microliters of liquid drug. Central to our unique value is Rani's strong patent protection with 472 granted patents and pending applications. Now Slide 8. Rani and ProGen, who you will learn more about today, are entering into a strategic partnership for the development and commercialization of an oral version of ProGen's PG-102 program. The program will be known as RT-114 at Rani and RPG-102 at ProGen. The rationale for this strategic partnership is combining a potential best-in-class GLP-1/GLP-2 asset with the convenience and dosing flexibility of the RaniPill. PG-102 has potential advantages in lean body mass preservation, nutrient absorption, reduced GI side effects compared to existing GLP-1 RA agonists and may not need up-titration because of the higher Tmax, which we will share more details on today. We believe that combining this incretin therapy with the RaniPill has the potential to create a strongly differentiated singular product in the obesity market. Now on to Slide 9. The structure of the partnership between ProGen and Rani is a 50-50 co-development, co-commercialization model. Rani and ProGen will share all development-related costs 50-50 as well as potential revenues and losses should the product be approved. Rani will take the lead in developing RT-114, the combined PG-102 and RaniPill program, through Phase I studies. Thereafter, Rani will be responsible for development and commercialization in the U.S., Canada, Europe, including the U.K., and Australia, and ProGen will be responsible for development and commercialization of the product in all other territories in each case in accordance with mutually agreed plans. ProGen is responsible for the manufacturing of the drug substance and Rani is responsible for manufacturing the drug product. Please turn to Slide 10. So let's discuss why the RaniPill could be a game changer in the highly competitive obesity market. Slide 11, please. It is well established that the obesity market is large and growing, with the potential to be north of $100 billion globally by 2030. We believe that as this market gets larger, it will likely segment given the large and heterogeneous patient population that includes overweight patients who are not yet obese, diabetic patients and patients that are severely obese and need to lose significant amounts of weight. For all these patient populations, lean body mass preservation will be critically important. It is also noted that oral therapy could be necessary to fully unlock the market potential of incretin therapies, and it has well established that patients prefer orals over injectable therapies. In fact, Rani conducted research with patients on various injectable regimens and 64% to 88% of the patients surveyed said they would prefer a daily oral therapy over their current injectable regimen. Please turn to Slide 12. We believe that the current slate of oral therapies under development all have significant shortcomings. The small molecule approaches have often shown high rates of discontinuation. Twice-daily danuglipron, a Pfizer compound, for instance, demonstrated discontinuation rates north of 50% across all doses in a Phase II study, which led to the termination of that version of the compound. This approach has also to date been limited to mimicking single GLP-1 agonists, where in the injectable space, there has been a clear shift to a broad mix of multi-agonists. The other category of oral therapies to date are orally available peptides, which include oral amycretin, oral semaglutide and Viking's VK2735 oral program. In each of these cases, the API utilization is or is expected to be from 100 to 300x what would typically be used in a subcutaneous injection. This raises significant cost of goods and supply chain questions given the high demand and critical shortages of the approved drugs. We believe that RaniPill addresses the challenges faced by chemistry-based orally available peptides by having the potential to deliver drug with high bioavailability with dosing size and frequency similar to a subcutaneous injection. We believe this is an advantage unique to the RaniPill. Our target product profile for RT-114 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 2x2 matrix, the oral therapy is required daily or twice-daily dosing with doses in the hundreds of milligrams. While for small molecules this 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 cost of goods dramatically. Of the therapies listed on the chart, RT-114 is the only proposed oral in development that is expected to utilize similar API quantity and dosing frequency as an injectable product. Please turn to Slide 14. Now I will share a little background on Rani Therapeutics and the progress we have made with our disruptive technology. We have made significant strides since Rani's inception more than 10 years ago, and we have extensively tested the RaniPill capsule technology over that period of time. In preclinical studies, the RaniPill has delivered high bioavailability compared to subcutaneous injections for antibodies, peptides and large proteins. We have conducted numerous preclinical safety studies, including a 60-day repeat administration GLP study announced last year where the RaniPill was well tolerated, and there were no treatment-related adverse events. All the dogs remained healthy throughout the study, and in addition, there were no RaniPill-related effects on food consumption during the dosing and recovery period. Clinically, we have completed 3 Phase I studies. And in these studies, the RaniPill has been well tolerated with no serious adverse events reported, and that is with more than 200 pills administered to over 100 patients. Please turn to Slide 16. Here are the results of a research collaboration with an undisclosed partner, where a triagonist was delivered via the Rani route of administration and demonstrated weight loss and lipid reduction comparable to the subcutaneous comparator critically at the exact same dose. Now on to Slide 17. In preclinical studies, drugs delivered through the RaniPill or the RaniPill route of administration have consistently shown high bioavailability comparable to subcutaneous injection. This is true across peptides, antibodies, a large protein in Factor VIII and oligonucleotides. As you can see listed here, we studied the GLP-1 exenatide and the RaniPill delivered 80% bioavailability, which is significantly better than the 1% or less absolute bioavailability shown by oral semaglutide. As I said, Rani has now completed 3 Phase I studies, and in every study, demonstrated high bioavailability. Illustrated here is Rani's recently announced Phase I data for RT-111, the orally delivered ustekinumab biosimilar. As you see, the RaniPill delivered bioavailability comparable to subcutaneous ustekinumab. Please turn to Slide 18. The RaniPill is an oral capsule 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. Once in the small intestines, the higher pH levels break down the enteric coating and outer shell of the RaniPill capsule, which exposes the delivery mechanism to intestinal fluid. The mechanism has a self-inflating balloon that contains 2 reactants separated by a dissolvable valve. Exposure to intestinal fluid dissolves the valve, allowing the reactants to mix creating carbon dioxide gas. This inflates the balloon and creates the pressure needed to inject a dissolvable microneedle which delivers the drug via transenteric injection. The balloon is longer than it is wide, which aligns the microsyringe with the intestinal wall. The intestinal injection is pain-free as it is well established that the intestines have no sharp pain receptors. Once delivered, the drug is quickly absorbed by the highly vascularized intestinal wall, and the balloon then deflates and is safely passed out. Please turn to Slide 19. Now I will turn it over to Jong-Gyun Kim, CEO of ProGen, to provide an overview of PG-102 and the NTIG technology that underpins it. On to Slide 20.

Thank you, Talat. ProGen is a clinical-stage biotech company based in Seoul, Korea. We specialize in developing next-generation long-acting fusion protein for the treatment of metabolic and immune related disease as well as cancer. Our technology utilizes a fusion platform called NTIG, short for Neo Tri-ImmunoGlobulin, that allows the generation of multi-specific fusion protein with longer in vivo persistence compared to conventional IgG-based products. Our lead candidate is PG-102, our Phase I clinical stage asset of bivalent GLP-1 and GLP-2 dual agonist fused to NTIG platform for obesity and type 2 diabetes treatments. And we also utilize NTIG platform technology to develop immunocytokine and bispecific ADCs for autoimmune disease and cancer. Today, we will focus on delivering oral version of PG-102 using RaniPill technology. I believe PG-102's distinctive PK profiles, along with the unique benefits of GLP-1 and GLP-2 combination, have potential to synergize effectively with the RaniPill capture. Please turn to Slide 21. Our leading pipeline program, PG-102 is a bivalent GLP-1 and GLP-2 dual agonist fused to NTIG platform. It is being developed as a biweekly to potentially monthly injectable weight management agents. We have optimized the receptor potency balance to exert GLP-1 favor the agonism [indiscernible] for obesity and type 2 diabetes treatment. GLP-2 activity was dialed down, but sufficient to provide anti-inflammatory effects. We confirmed in our Phase I single ascending dose trial that PG-102 shows a differential PK profile with longer Tmax and higher AUC compared to existing peptide-based GLP-1 receptor agonists, including semaglutide and tirzepatide. Please turn to Slide 22. To elaborate a little bit more on how we came up with PG-102. What we did for the past 6 to 7 years was generate various GLP-1/GLP-2 Fc molecule with different GLP-1/GLP-2 potency ratio. For instance, the far left figure represents low GLP-1 receptor potency, but high GLP-2 receptor potency and far right one indicates high GLP-1 receptor potency, but low GLP-2 receptor potency. Our prototype product having similar GLP-1 and GLP-2 receptor potency was called PG-05, and its potential to treat mice was initially published in Hepatology 2022. What we did further was to try to come up with optimal receptor potency ratio and finally derived the one having about 84 higher GLP-1 receptor potency compared to GLP-2 receptor. This final candidate called PG-102 far outperformed PG-05 in terms of weight management and glycemic control and better safety. The figure on the left shows that PG-102 indeed induced great body weight loss compared to PG-05 in [indiscernible] mouse. Now on to Slide 23. ProGen is currently conducting Phase Ib multiple ascending dose study with PG-102 and presented the results from the Phase Ia single ascending dose at the ADA Conference few days ago. This study was conducted with healthy volunteers who had normal body weight and BMI under 25. What's interesting was, as we increased the dose from 5 milligram, 15 milligram to 30 milligram, there were 0 incidence of GLP-1 associated gastrointestinal side effects, such as nausea, diarrhea and vomiting, which commonly seen with existing GLP-1 receptor agonist. At the highest dose tested, 60 milligram, we observed 30% nausea, 10% vomiting, but 0 diarrhea. Considering the fact that [indiscernible] induced up to 60% nausea and 40% vomiting in its safe trial with healthy volunteers, PG-102 has shown favorable safety profile in humans. Thank you, Talat. I will turn it back to you and to Slide 24 to discuss the rationale and next steps with our partnership. Talat?

Thank you, Jong-Gyun. Next, we would like to share with you some details behind PG-102 and the new program coming out of our partnership, RT-114. Please turn to Slide 25. The distinguishing feature of PG-102 in terms of obesity treatment is its capacity to improve body composition. In a diet-induced obesity mouse model, PG-102 induced greater weight loss than dapiglutide, a peptide-based GLP-1/GLP-2 dual agonist. When compared to tirzepatide under conditions that induced a similar degree of weight loss, PG-102 resulted in a greater reduction in fat mass loss with less lean mass loss, yielding a relative fat versus lean mass loss ratio of 6.4, outperforming the 2.9 ratio for tirzepatide. I also would like to highlight the fact that this relative fat versus lean mass loss ratio of 2.9 for tirzepatide aligns closely with the results from the SURMOUNT-1 Phase III trial of tirzepatide, implying that our preclinical results could correlate well with actual human data. We hope to see these advantages of PG-102 in improving weight loss quality in ProGen's upcoming Phase II trial. Now please turn to Slide 26. ProGen has also demonstrated that PG-102 shows greater glycemic control as compared to approved drugs, semaglutide and tirzepatide, while inducing a similar degree of body weight loss in a db/db diabetic mouse model. This was attributed to better protection of pancreatic beta cells and superior induction of glucose uptake by PG-102. These data were partially disclosed in the EASD Conference last year, and ProGen shared additional data comparing anti-hyperglycemic activity of PG-102 with mono, dual as well as triple agonist in this month's ADA Conference. On to Slide 27. The PK profile of PG-102 differs greatly from existing GLP-1 RAs. As you are aware, dulaglutide, a GLP-1 fused to IgG4 Fc and tirzepatide, a sequenced mix peptide that has an acyl chain for albumin binding in vivo are once-weekly injectables. Compared to these agents, PG-102 shows a delayed time to reach maximal serum concentration. This suggests that PG-102 is released into the system more slowly, allowing patients more time to adapt to the drug's action, thereby potentially improving tolerability. Another feature to note is the higher area under the curve shown by PG-102, which suggests a longer persistence of the drug in the system. Please move to Slide 28. The importance of having a longer Tmax is well demonstrated in the review article by Dr. Michael [ Nock ]. As you can see on the left, most peptide-based albumin binding drugs have a Tmax of 24 hours or less, which is typically when gastrointestinal side effects are observed. Dulaglutide has a Tmax of 48 hours and albiglutide has a Tmax of 96 hours. Notably, Amgen's AMG 133, or maridebart cafraglutide, has a Tmax of about 120 hours. We believe it is established the dulaglutide, albiglutide and AMG 133, or maridebart cafraglutide, are unique agents that do not require up-titration in patients. Given that the Tmax of PG-102 lies in between 72 to 96 hours, we believe that PG-102 will similarly not require up-titration. Let's now turn to Slide 29. As I shared with you, the current orals in development have suboptimal dosing schedules. Given the high bioavailability previously demonstrated with drugs loaded into the RaniPill capsule, our plan with RT-114, the oral version of PG-102, is to develop a once-a-week oral dosing regimen. We believe that this product candidate has the potential to have similar efficacy to a subcutaneous injection while only requiring 1 pill per week or 52 per year. This would require far less API than what is expected with either small molecule or orally available peptide technologies, thus reducing API costs and impacts to the supply chain. Our aim with the RT-114 program is to eliminate the need for painful injections and achieve better tolerability with more frequent, smaller doses than injectable products. There is also a potential to develop RT-114 as a monthly short-course dosing regimen, which we intend to explore in a repeat dose study. Please turn to Slide 30. As you can see from the information presented today, RT-114 is well positioned in the current obesity landscape of on-market products and molecules in development. RT-114 has the potential to be the only oral multi-agonist therapy that can be dosed weekly or less frequently for obesity. Now on to Slide 31. We intend to move rapidly to advance RT-114 into the clinic in early 2025, and then to generate efficacy data in humans by early 2026. Here is the study proposal for the RT-114 Phase I single and multi-ascending dose studies. We intend to test 2 or more doses in the RaniPill capsule in the SAD portion of the Phase I. And in the MAD portion, we plan to bring at least one of those doses forward along with either a monthly or biweekly dose as well. The costs associated with the studies will be split between ProGen and Rani. Slide 32, please. Based on all the information we shared today, we believe that the partnership between ProGen and Rani around PG-102 and the RaniPill capsule has the potential to create an oral product in the obesity space with dosing and efficacy similar to a subcutaneous injection. With less API required compared to orals, we expect competitive COGS at commercial launch. Taking advantage of the potential for lean body mass preservation and reduced adverse events of a GLP-1/GLP-2 dual agonist, we believe RT-114 could create a highly differentiated and desirable product. Finally, please turn to Slide 33. In closing, we are proud of the progress we have made at Rani Therapeutics and the opportunity to advance our technology into the $100 billion obesity market. And I would like to thank everyone at Rani Therapeutics and our partner, ProGen. Overall, we believe that the deal we have announced today provides validation for our RaniPill capsule and emphasizes our commitment to making oral alternatives a reality as we strive to develop RT-114 as a next-generation obesity treatment. With that, I will now open up the call for questions. Operator?

[Operator Instructions] Our first question comes from Mitchell Kapoor with H.C. Wainwright.

Congratulations on the deal. The first one I wanted to ask was about the overall market size for the GLP-1/GLP-2 space. And specifically, with respect to oral positioning versus other competitive molecules, could you just talk about where the best fit for this particular profile would be?

Mitchell, good to hear from you, and thank you for your question. I think the overall market size has been well established through the potential market size by 2030 at about $100 billion -- $75 billion to $100 billion depending on whose report you look at. This particular GLP-1/GLP-2 agonist because of the Fc and the potential to eliminate a dose titration can play in patients who need faster weight loss onset, patients who care about lean body mass preservation and then because of greater glycemic control potential because of the GLP-2 in diabetic obese patients. So we're not arguing that this is going to have 20%, 25% weight loss. But I think based on those criteria, this can be a highly differentiated product against the overall market. I'd like to ask our lead adviser, Jesper Hoiland to add any color on his view of an oral agent in this particular market given his background.

Thanks, Talat. Yes, I do believe that the $100 billion has been established, I even see numbers significantly higher by 2030. But let's stick to the $100 billion by 2030, very realistic. We're going to see a very dynamic picture going forward as far as I'm concerned because there is, as I also said in the opening remarks by Talat, numerous players that will open up the market. Having said that, I do believe that with ProGen molecule, we have a very special position to take in the marketplace, and I certainly believe that we will take a lion's share of the oral segment when coming on to it.

And I guess -- thank you, Jesper. The final thing I would add, Mitchell, is when you look at the current slate of orals, you have the peptide-based approaches that have clear API utilization issues, and I'm not the first person to bring this up. On the small molecule side, it seems like we are trading tolerability for convenience. And so I think at a high level, that's the clear differentiation with the RaniPill and a long-acting drug like PG-102 is the potential to marry good tolerability with good efficacy in an oral format.

Great. And then thinking about following the development of PG-102 and with respect to RT-114, will PG-102 advance separately ahead of this RT-114 combination product? And will we see data from that PG-102 without the RaniPill?

Yes. So ProGen presented their Phase I SAD data at ADA this year -- or this month, I should say, pardon me, and is in their MAD portion of the study, and they plan to run a Phase II as well. I think I'll turn it over to Dr. Sae Won Kim to provide some additional color on ProGen's plans with the injectable version of this drug.

Yes. Thank you, Talat. So as Talat mentioned, ProGen is currently running a Phase Ib multiple ascending dose trial in overweight volunteers. And the current focus for RT-114 is on the obesity, but PG-102 has also shown dramatic efficacy in blood glucose lowering. So basically injectable form of PG-102 is advancing through the obesity as well as type 2 diabetes treatment. And we are currently looking at the way to expand the potential of PG-102 to several types of comorbidities, including the CKDs or CBDs or fatty liver disease. So thank you.

Congrats again on the deal.

Our next question comes from Julian Harrison with BTIG.

Congratulations to getting this deal done. Very timely with ADA this past weekend. I'm curious if there are any PK advantages enabled with the RaniPill that could maybe improve efficacy, tolerability both with PG-102? And then the potential benefits of hitting GLP-2 in addition to GLP-1, I thought there was a great overview there. I'm just wondering if you could talk more about the potential of that differentiated approach and if there have been any learnings from dapiglutide that are relevant?

Julian, thank you for the questions. In terms of improved PK profile with the RaniPill, I think the advantage you get with the RaniPill is that it's oral, and so we can adjust frequency. So I think from the SAD data with PG-102, there's already been a very encouraging profile that's emerged in terms of treatment-related adverse events around nausea, diarrhea and vomiting as Jong-Gyun Kim mentioned. They're looking -- ProGen's looking at doing this on a biweekly or monthly basis. With the pill, we can comfortably dose on a once a week or even twice a week basis if you wanted to smooth out the curve even further. So I think that's the way that we could potentially benefit the PK profile or improve the PK profile with the RaniPill. As far as the advantages of PG-102 versus dapiglutide, I think there was a bit of discussion in the presentation around the bias nature towards GLP-1 versus GLP-2. I think, ProGen, during their development, looked at an equipotent molecule similar to dapiglutide and didn't see the weight loss that was expected or desired, which is why they moved to this biased approach, which at least in the preclinical work continues to show the knock-on benefits, if you will, in terms of lean body mass preservation and better glycemic control from the GLP-2, but you're still getting fairly profound weight loss in those preclinical studies. Sae Won Kim, do you want to add anything to what I've said?

Yes. I guess the main reason of utilizing GLP-1/GLP-2 dual agonism, everyone else says they're utilizing GIP or glucagon. And what's unique about GLP-2, first thing is it has capacity to basically reduce gut permeability that is known to drive low-grade chronic inflammation that causes or drives various type of metabolic disorders, such as CBDs or CKDs. And that is why people like us or [ Zillion Pharma ] is targeting the low-grade inflammation to reduce systemic inflammatory effects. Another thing is unique with the GLP-2 is basically it increases mesenteric blood flow into the intestine to increase nutrient absorption. And this nutritional supply is very important in losing weight because lots of muscle mass is majorly caused by these malnutrition. So what we did is basically controlling relative GLP-1/GLP-2 to potency enough to use their GLP-1's anti-obesity mechanism and add a little bit of GLP-2 sufficient for reducing inflammation as well as providing a right amount of nutritional health and that basically keeps the muscle loss preservation. So this is a major distinction between our product and dapiglutide.

Well, said, Sae Won. And so I think it's hard to compare this given the biased nature of this molecule to dapiglutide for those reasons.

Our next question comes from Brandon Folkes with Rodman & Renshaw.

Congratulations on the acquisition. I want to just focus on the Phase Ia SAD results, obviously, look very good. Just in light of putting this into a RaniPill, can you just elaborate on the dyspepsia adverse events? Just any color on those events and your view and sort of as we move forward in future studies with the RaniPill? And then maybe in the same vein, that one case of constipation, I know it's only one case. Just is that compound related? And is constipation an issue, if we see it more broadly with the RaniPill? Given the dosing is going to be sort of weekly or monthly, it wouldn't seem so, but just I'd love to get your color.

Brandon, thank you for the question. In terms of dyspepsia and constipation, I guess the short answer is that we've seen these -- these are AEs that happen often in clinical studies, and we've seen both of them in our other Phase I studies, and there were no other issues associated with them. The RaniPill performed as expected. Given that we're only giving 1 pill per week, even if a patient is constipated, one would hope and expect they would have a bowel movement or 2 within a week. And so the likelihood of the capsule remnants passing through are fairly high. This is very different in that regard compared to the studies we've run before, where the expectation was that we would be doing QD dosing.

Great. Congratulations on the acquisition.

Our next question comes from John Vandermosten with Zacks.

I thought I'd start with a question on the regulatory process that you anticipate. Will there be any required preclinical work? And then after that, if necessary, will you follow just the regular Phase I, II, III process for developing this and getting in front of the regulatory agencies?

Yes. Thank you, John. In terms of preclinical work, we need to do confirmatory PK studies in awake canines. So we plan on doing that. Now that the deal is announced, we'll get access to the molecule, and we'll be running those studies shortly and then some additional CMC work in order to enable our Phase I study. We're going to mirror what ProGen did largely in their Phase I SAD and MAD or they have done and are doing, I should say, though we're targeting obese subjects in the MAD portion. And then from there, yes, we will do a typical Phase II. We're expecting to do a 12-week study because of the potential to obviate the need for dose titration. I think that 12-week weight loss data will be an important mile marker for this particular compound. And then beyond that, I think this is becoming a well-treaded path, if you will, in terms of doing a Phase IIa, a Phase IIb and a Phase III. We'll see in discussions with the regulators, what else is required for this particular compound and our route of administration, but that's our expectations at this point.

Okay. And ProGen's working with the Korea Drug Development Fund as a partner on PG-102. I think they just announced that recently. Is that something that will help you as well? Will they participate in the process of developing the oral option?

We have not had any conversations with the Korea Drug Development Fund. I would say that the advancement of PG-102 benefits both parties because a lot of the work, and as I should have said this, a lot of the work that's being done with the injectable compound will inform our clinical studies.

Thank you. [Operator Instructions] And there are no further questions. I'd like to turn the call back over to Talat for any closing remarks.

Thank you, everyone, and this ends our conference call.

Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.