Q2 2026 Ascletis Pharma Inc Earnings Call
Speaker #1: Good evening and good morning, depending on where you are right now. Thank you very much for dialing in today, and to Ascletis One Health, to DUNS 26, English earnings call.
John Yao: Good evening and good morning, depending on where you are right now. Thank you very much for dialing in today and to Ascletis' H1 2026 English earning call. This is John Yao from Citi Healthcare. Today, I am very honored to invite Dr. Wu Jinzhi Jason, the CEO and also Chairman of Ascletis, and of course, also our old friend, Mr. John P. Gargiulo, the Chief Business Officer of Ascletis. I believe, beyond the results, of course, both of the management will share with us the latest updates to the trials and the latest development of the company. To avoid further delay, I will pass the time to Dr. Wu, please. Thank you.
John Yao: Good evening and good morning, depending on where you are right now. Thank you very much for dialing in today and to Ascletis' H1 2026 English Earning Call. This is John Yao from Citi Healthcare. Today, I am very honored to invite Dr. Wu Jinzi Jason, the CEO and also Chairman of Ascletis, and of course, also our old friend, Mr. John Gargiulo, the Chief Business Officer of Ascletis. I believe, beyond the results, of course, both of the management will share with us the latest updates to the trials and the latest development of the company. To avoid further delay, I will pass the time to Dr. Wu, please. Thank you.
Speaker #1: This is John from City Healthcare. Today, I'm very honored to invite Dr. Wu Jing Jason, the CEO and also Chairman of Ascletis, and of course, also our old friend, Mr. John Gargiolo, the Chief Business Officer of Ascletis.
Speaker #1: So I believe, beyond the results, of course, both of the management will share with us the latest updates to the trials and the latest developments of the company.
Speaker #1: To avoid further delay, I'll pass the time to Dr. Wu, please. Thank you.
Speaker #2: Well, good morning, good afternoon, good evening, wherever you are. Thank you, John Young, for hosting us. Thank you, city team, for hosting us. My name is Jingzi Jason Wu.
Jinzhi Jason Wu: Well, good morning, good afternoon, good evening, where you are. Thank you, John Yao, for hosting us. Thank you, Citi team, for hosting us. My name is Jinzhi Jason Wu. I am together with our Chief Business Officer, John P. Gargiulo. I am very happy to update you and share some exciting R&D progress. Let me start from finance point. As we say in our mid-year interim reports, financially, we are very strong. The last half year, from beginning to 30 June, we increased R&D expense significantly because we invest in metabolic disease portfolio a lot, and also consistent with the progress we made in metabolic disease area, including oral small molecules, ultra long-acting injectable peptides, and oral peptides. More investment, more progress. Financially, our position is very strong.
Jinzi Jason Wu: Well, good morning, good afternoon, good evening, where you are. Thank you, John Yao, for hosting us. Thank you, Citi team, for hosting us. My name is Jinzi Jason Wu. I am together with our Chief Business Officer, John Gargiulo. I am very happy to update you and share some exciting R&D progress. Let me start from finance point. As we say in our mid-year interim reports, financially, we are very strong. The last half year, from beginning to 30 June, we increased R&D expense significantly because we invest in metabolic disease portfolio a lot, and also consistent with the progress we made in metabolic disease area, including oral small molecules, ultra long-acting injectable peptides, and oral peptides. More investment, more progress. Financially, our position is very strong.
Speaker #2: I'm here together with our Chief Business Officer, John Gargiolo. I'm very happy to update you and share some exciting R&D progress. Let me start from the finance point.
Speaker #2: As we said in our mid-year interim reports, financially we are very strong. In the last half year, from the beginning of the year to June 30th, we increased R&D expenses significantly because we invested in the metabolic disease portfolio.
Speaker #2: A lot. And also consistent with the progress we made in the metabolic disease area, including autosomal molecules, non-actin injectable peptides, and oral peptides. So more investment, more progress.
Speaker #2: Financially, our position is very strong. As we say in our interim reports, we have sufficient cash on hand to support our operations into 2029.
Jinzhi Jason Wu: As we say in our interim report, we have sufficient cash on hand to support our operations into 2029 and including AACR3 global phase III program. As we mentioned, we expect to have top-line data of AACR3 phase III global program, top-line data from that phase III global program in Q3 2028. We expect to file a new drug application to FDA by end of 2028 and file to EMA, MAA early 2029. This cash will support us in terms of operation beyond that. Financially, we are very strong. Another thing I want share with you the good news. You will hear the announcement from us and from Hong Kong Stock Exchange. We are accepted into Hong Kong Stock Connect.
Jinzi Jason Wu: As we say in our interim report, we have sufficient cash on hand to support our operations into 2029 and including AACR3 global phase III program. As we mentioned, we expect to have top-line data of AACR3 phase III global program, top-line data from that phase III global program in Q3 2028. We expect to file a new drug application to FDA by end of 2028 and file to EMA, MAA early 2029. This cash will support us in terms of operation beyond that. Financially, we are very strong. Another thing I want share with you the good news. You will hear the announcement from us and from Hong Kong Stock Exchange. We are accepted into Hong Kong Stock Connect.
Speaker #2: And including AC30, global Phase Three program. So, as we mentioned, we expect to have pipeline data of the AC30 Phase Three global program.
Speaker #2: Pipeline data from phase three global program in third quarter 2028. We expect to file new drug application to FDA by end of 2028. And file to EMA MAA early 2029.
Speaker #2: So this cash will support us in terms of operations beyond that. So financially, we are very strong. Another thing I want to share with you—the good news—is that you will hear the announcement from us and from the Hong Kong Stock Exchange.
Speaker #2: So we are accepted into Hong Kong Stock Connect. That's very important, because every six months Hong Kong Stock Exchange does very strict and comprehensive selections, selecting a really small number of listed companies into this Hong Kong Stock Connect.
Jinzhi Jason Wu: That is very important because every 6 months, Hong Kong Stock Exchange does very strict and comprehensive selections, select a really small number of listed company into this Hong Kong Stock Connect. We are one of this half year, and this is very important in terms of improvement of liquidity and have broader investor bases for our stock. That is exciting news in terms of liquidity and a broader investor base in terms of joining, accepting by Hong Kong Stock Exchange into Stock Connect. That is very exciting news for us, for our shareholders. Beyond finance and update, I want to focus this talk on the R&D progress in our metabolic disease portfolio. If you allow me, let me just show you quickly in terms of our progress.
Jinzi Jason Wu: That is very important because every six months, Hong Kong Stock Exchange does very strict and comprehensive selections, select a really small number of listed company into this Hong Kong Stock Connect. We are one of this half year, and this is very important in terms of improvement of liquidity and have broader investor bases for our stock. That is exciting news in terms of liquidity and a broader investor base in terms of joining, accepting by Hong Kong Stock Exchange into Stock Connect. That is very exciting news for us, for our shareholders. Beyond finance and update, I want to focus this talk on the R&D progress in our metabolic disease portfolio. If you allow me, let me just show you quickly in terms of our progress.
Speaker #2: And we are one of these this half year. This is very important in terms of improvement of liquidity and having a broader investor base for our stock.
Speaker #2: So that's exciting news. In terms of liquidity and the broader investor base, joining or being accepted by the Hong Kong Stock Exchange into Stock Connect is significant.
Speaker #2: So that's very exciting news for us, for our shareholders. So beyond the finance update, I want to focus this talk on the R&D progress in our metabolic disease portfolio.
Speaker #2: So if you allow me, let me just show you quickly, in terms of our progress. As you know, we focus on discovery, clinical development, TMP manufacturing, of metabolic disease, and all the clinical studies conducted in the US and globally.
Jinzhi Jason Wu: As you know, we focus on discovery, clinical development, GMP manufacturing of metabolic disease, and all the clinical studies conducted in the US and globally. Again, as I mentioned, we have sufficient cash on hand to support our operation into 2029. 2026 is a busy year. We start one phase I for ASC30 global. Sorry. We start one phase III for ASC30 global phase III program, and we are started and also starting 10 phase I program for our small molecule peptides injection once a month, once a quarter, and oral peptide. All these 12 programs, 5 in small molecules and 5 in once monthly to once quarterly injection peptides and 2 in oral peptides, all discovered based on our three underlying platform technology, namely AISBDD, ULAP, and POTENT. We address a huge market, as everybody know.
Jinzi Jason Wu: As you know, we focus on discovery, clinical development, GMP manufacturing of metabolic disease, and all the clinical studies conducted in the US and globally. Again, as I mentioned, we have sufficient cash on hand to support our operation into 2029. 2026 is a busy year. We start one phase I for ASC30 global. Sorry. We start one phase III for ASC30 global phase III program, and we are started and also starting 10 phase I program for our small molecule peptides injection once a month, once a quarter, and oral peptide. All these 12 programs, 5 in small molecules and five in once monthly to once quarterly injection peptides and two in oral peptides, all discovered based on our three underlying platform technology, namely AISBDD, ULAP, and POTENT. We address a huge market, as everybody know.
Speaker #2: And again, as I mentioned, we have sufficient cash on hand to support our operation into 2029. So 2026 is a busy year. We start one Phase III for AC30 global—sorry, we start one Phase III for the AC30 global Phase III program.
Speaker #2: And we have started and are also starting 10 Phase One programs for our small molecule peptides: injection once a month, once a quarter, and oral peptide.
Speaker #2: So, all these 12 programs—five in small molecules, five in once-injection peptides, and two in oral peptides—were all discovered based on our three underlying platform technologies.
Speaker #2: Namely, AI, SPDD, and ULAB, and POTENS. So, we address a huge market, as everyone knows. Let me go into more detail on our pipeline.
Jinzhi Jason Wu: Let me go into more detail on our pipeline. First, let me focus on our small molecule pipeline in metabolic disease. Most exciting program, most advanced is ASC30, once-daily oral small molecule agonist targets the GLP-1. We made announcement a while ago, we initiate a global phase III for ASC30, to enroll about 4,600 people in US, in European countries. Two days ago, we made announcement, we successfully dosed first patients in our ASC30 phase III program. Top-line data of ASC30 phase III study expected Q3 2028. Now we expect to file FDA NDA filing expect end of 2028. And filing to MAA to EMA early 2029. If everything approved, this will make ASC30 potentially second small molecule approved in US, European market after Ozempic. We also made significant progress in our small molecule program against the targets beyond GLP-1.
Jinzi Jason Wu: Let me go into more detail on our pipeline. First, let me focus on our small molecule pipeline in metabolic disease. Most exciting program, most advanced is ASC30, once-daily oral small molecule agonist targets the GLP-1. We made announcement a while ago, we initiate a global phase III for ASC30, to enroll about 4,600 people in US, in European countries. Two days ago, we made announcement, we successfully dosed first patients in our ASC30 phase III program. Top-line data of ASC30 phase III study expected Q3 2028. Now we expect to file FDA NDA filing expect end of 2028. And filing to MAA to EMA early 2029. If everything approved, this will make ASC30 potentially second small molecule approved in US, European market after Ozempic. We also made significant progress in our small molecule program against the targets beyond GLP-1.
Speaker #2: Okay. First, let me focus on our small molecule pipeline. In metabolic disease, our most exciting and most advanced program is AC30, a once-daily oral small molecule agonist. The target is GLP-1.
Speaker #2: We made announcement a while ago we initiate a global phase three for AC30 to enroll about 4,600 people in US in European countries. And two days ago we made announcement we successfully dose first patients in our AC30 phase three program.
Speaker #2: So, top line data of AC30 Phase 3 study expected third quarter 2028. Now we expect to file FDA NDA filing, expect end of 2028, and filing to MAA to EMA early 2029.
Speaker #2: So if everything is approved, this will make AC30 potentially the second small molecule approved in the US and European markets, after all four. We also made significant progress in our small molecule program against targets beyond GLP-1.
Speaker #2: So one of the exciting targets is AMBA. AMBA, everybody knows, is one of the most exciting targets in the area of obesity. Maybe it's the most exciting target in the area of obesity.
Jinzhi Jason Wu: One of the exciting target is Amylin. Amylin, everybody knows, is one of the most exciting target in the area of obesity, maybe is the most exciting target in the area of obesity. ASC39, which is once daily oral small molecule agonist, against amylin receptor. However, this is a SARA, Selective Amylin Receptor Agonist. Now we believe, ASC39 is the first in class, potentially oral small molecule SARA with eloralintide-like selectivity and efficacy. FDA IND filing expected this quarter, this year, Q3 this year. As you know, eloralintide, which is once weekly injectable peptide, demonstrate very good efficacy. After 48-week treatment, the weight loss is 20%. Since our ASC39 have same selectivity, same potency, efficacy like eloralintide, we expect monotherapy of ASC39 will show similar weight loss, around 20%, in clinical trials.
Jinzi Jason Wu: One of the exciting target is Amylin. Amylin, everybody knows, is one of the most exciting target in the area of obesity, maybe is the most exciting target in the area of obesity. ASC39, which is once daily oral small molecule agonist, against amylin receptor. However, this is a SARA, Selective Amylin Receptor Agonist. Now we believe, ASC39 is the first in class, potentially oral small molecule SARA with eloralintide-like selectivity and efficacy. FDA IND filing expected this quarter, this year, Q3 this year. As you know, eloralintide, which is once weekly injectable peptide, demonstrate very good efficacy. After 48-week treatment, the weight loss is 20%. Since our ASC39 have same selectivity, same potency, efficacy like eloralintide, we expect monotherapy of ASC39 will show similar weight loss, around 20%, in clinical trials.
Speaker #2: So AC39, which is a once-daily oral small molecule agonist, is active against the receptor. However, this is a SARA—selective amine receptor agonist. So we believe AC39 is potentially the first-in-class oral small molecule SARA, with selectivity and efficacy already demonstrated.
Speaker #2: FDA defining expected this quarter, this year—third quarter this year. And, as you know, it already tied, which is a once-weekly injectable peptide, demonstrated very good efficacy. After 48-week treatment, the weight loss is 20%.
Speaker #2: So since our AC39 has the same selectivity, same potency, and efficacy—it's already tied—we expect monotherapy of AC39 will show similar weight loss, around 20% in clinical trials.
Speaker #2: So we definitely want to share that data with you once we get there. We also have a third small molecule, which is AC48, and we believe that's the first-in-class GIP receptor agonist. AC48 is an agonist, not an antagonist.
Jinzhi Jason Wu: We definitely want to share that data with you once we get there. We also have a third small molecule, which is ASC48. Now we believe that's the first in class GIP receptor agonist. This is agonist. ASC48 is agonist, not antagonist. As you know, tirzepatide made a record sales for the first 6 months 2026. I believe something around $27 billion. The fixed-dose combination of ASC30_48, namely our research code is ASC30_48FDC. We believe this oral small molecule, one pill, once daily, GLP, GIP oral agonist will demonstrate similar efficacy tolerability like tirzepatide. This is really, truly first-in-class opportunities. FDA IND filing expect in Q4 this year. We also have is a triple, fixed-dose combination, all oral small molecule, namely ASC30_48_39FDC. This target is a GLP-1, GIP, and Amylin cell.
Jinzi Jason Wu: We definitely want to share that data with you once we get there. We also have a third small molecule, which is ASC48. Now we believe that's the first in class GIP receptor agonist. This is agonist. ASC48 is agonist, not antagonist. As you know, tirzepatide made a record sales for the first 6 months 2026. I believe something around $27 billion. The fixed-dose combination of ASC30_48, namely our research code is ASC30_48FDC. We believe this oral small molecule, one pill, once daily, GLP, GIP oral agonist will demonstrate similar efficacy tolerability like tirzepatide. This is really, truly first-in-class opportunities. FDA IND filing expect in Q4 this year. We also have is a triple, fixed-dose combination, all oral small molecule, namely ASC30_48_39FDC. This target is a GLP-1, GIP, and Amylin cell.
Speaker #2: So as you know tazeptide made a record sales for the first six months 2026. I believe something around 27 billion dollars. So the fixed dose combination of AC30 48 namely our research code is AC30 underscore 48 FDC.
Speaker #2: We believe this oral small molecule, one-pill, once-daily GLP-GIP oral agonist will demonstrate similar efficacy and tolerability as tazeptide. So this is really, truly first in class.
Speaker #2: Opportunities. So FDI I defining expect in the fourth quarter this year. And we also have is a triple six dose combination. All oral small molecule namely AC30 underscore 48 underscore 39 FDC so this target is GLP-1 GIP and amine SARA.
Speaker #2: And so this is also truly a first-in-class, once-daily, one-pill, triple agonist. And it showed better activity than dual agonists in preclinical models.
Jinzhi Jason Wu: And so this also truly first-in-class, one pill, once daily triple agonist, show better activity than dual agonist in a preclinical model. FDA IND filing, expect Q4 this year. Of course, we have another combination which is ASC30 and ASC39 FDC combination. Also potential first in class, FDA defining expect Q3 this year. So, in addition to small molecule monotherapy and fixed-dose combination therapies, we do have a once-a-month peptide, an oral peptide. Let me start with once-a-month peptide. So we have initiated three once-a-month to once-a-quarter ultralong-acting injectable peptides phase I study in US. Number one is ASC36-I, which is a once-a-month to once-a-quarter subcu peptides. So we initiated a phase I study. The preclinical study is really good, as we demonstrate here. Now we also initiated phase I study for once-monthly subcutaneous peptide agonist, ASC35, which is a dual agonist, GLP-1, GIP.
Jinzi Jason Wu: And so this also truly first-in-class, one pill, once daily triple agonist, show better activity than dual agonist in a preclinical model. FDA IND filing, expect Q4 this year. Of course, we have another combination which is ASC30 and ASC39 FDC combination. Also potential first in class, FDA defining expect Q3 this year. So, in addition to small molecule monotherapy and fixed-dose combination therapies, we do have a once-a-month peptide, an oral peptide. Let me start with once-a-month peptide. So we have initiated three once-a-month to once-a-quarter ultralong-acting injectable peptides phase I study in US. Number one is ASC36-I, which is a once-a-month to once-a-quarter subcu peptides. So we initiated a phase I study. The preclinical study is really good, as we demonstrate here. Now we also initiated phase I study for once-monthly subcutaneous peptide agonist, ASC35, which is a dual agonist, GLP-1, GIP.
Speaker #2: And the FDA finding I define, expect fourth quarter this year. And of course, we have another combination, which is AC30 and AC39 FDC combination, also potential first in class. FDI defining, expect the third quarter this year.
Speaker #2: Okay. So, in addition to small molecule monotherapy and fixed-dose combination therapies, we do have once-a-month peptide and oral peptide options. Let me start with the once-a-month peptide.
Speaker #2: So, we have initiated three once-a-month to once-a-quarter ultra-long-acting injectable peptides Phase One studies in the US. Number one is AC36I.
Speaker #2: Which is a once-a-month to once-a-quarter subcu peptide. So we initiated a Phase 1 study. The preclinical study is really good, as we demonstrate here.
Speaker #2: Now we also initiate a Phase One study for once-monthly subcu 10-year peptide agonist AC35, which is a dual agonist—GLP-1/GIP. Its half-life, without preparatory formulation, is six-fold longer than tazeptide.
Jinzhi Jason Wu: The half-life with our proprietary formulation is sixfold longer than tirzepatide. So this is our second phase I. And in this phase I, we do have head-to-head comparison with once-weekly tirzepatide. So once-monthly ASC35 versus once-weekly tirzepatide head-to-head. So we are expecting that data soon. Now we also have a fixed-dose combination, two injectables, ASC36_ASC35 fixed-dose, FDC. So that's the Amylin, GLP, and GIP. As you know, Eli Lilly and Company's tirzepatide and zouxantan combination, which is two injection a week, eight injection a month, demonstrate great weight loss at week 32, 29% weight loss. But however, two injections a week, eight injection a month. Our ASC36, 35 fixed-dose combination is one injection a month. So beyond this, we do have our triple G, ASC37-I, once-a-month subcu injection, triple peptide agonist. And we also have ASC36, ASC37, fixed-dose combination quad, which is Amylin, GLP-1, GIP, and GCG.
Jinzi Jason Wu: The half-life with our proprietary formulation is sixfold longer than tirzepatide. So this is our second phase I. And in this phase I, we do have head-to-head comparison with once-weekly tirzepatide. So once-monthly ASC35 versus once-weekly tirzepatide head-to-head. So we are expecting that data soon. Now we also have a fixed-dose combination, two injectables, ASC36_ASC35 fixed-dose, FDC. So that's the Amylin, GLP, and GIP. As you know, Eli Lilly and Company's tirzepatide and zouxantan combination, which is two injection a week, eight injection a month, demonstrate great weight loss at week 32, 29% weight loss. But however, two injections a week, eight injection a month. Our ASC36, 35 fixed-dose combination is one injection a month. So beyond this, we do have our triple G, ASC37-I, once-a-month subcu injection, triple peptide agonist. And we also have ASC36, ASC37, fixed-dose combination quad, which is Amylin, GLP-1, GIP, and GCG.
Speaker #2: So this is our second phase one and in this phase one we do have a head to head comparison with once weekly tazeptide. So once monthly AC35 versus once weekly tazeptide head to head.
Speaker #2: So we are expecting a data soon. Now we also have a fixed dose combination two injectables AC36 underscore AC35 fixed dose FDC. So that's the amine GLP and GIP as you know Lilly's tazeptide and it already tied combination which is two injection a week eight week eight injection months demonstrate great weight loss at a week 32 29% weight loss.
Speaker #2: But however, eight to two injections a week, eight injections a month. Our AC36/35 fixed-dose combination is one injection a month. So, beyond this, we do have our triple D AC37I, once-a-month subcu injection, triple peptide agonist. And we also have AC36/AC37, six-dose combination quad, which is amine, GLP-1, GIP, and GCG in. Beyond that, we do have two oral peptides, and for oral peptides, our goal is to have a 10 to 25 milligram oral dose per day.
Jinzhi Jason Wu: Beyond that, we do have two oral peptides. And oral peptide, our goal is have 10 to 25 milligram oral dose per day. So that's very critical. So we do have ASC36 oral, the Amylin receptor, and also have triple G, ASC37 oral, to have IND submission for both, expected in this quarter this year. So as you can see, we are one of very few biotech companies who have both small molecules against all the validated targets, GLP, GIP, Amylin. And we also have once-a-month, once-a-quarter injectable peptides against all these targets, GLP, GIP, Amylin. Now we also have oral peptide against Amylin, GLP, GIP, and GCG. So this is very comprehensive. So, this is a quick summary about our competitive edge in terms of our small molecule portfolio against other small molecules.
Jinzi Jason Wu: Beyond that, we do have two oral peptides. And oral peptide, our goal is have 10 to 25 milligram oral dose per day. So that's very critical. So we do have ASC36 oral, the Amylin receptor, and also have triple G, ASC37 oral, to have IND submission for both, expected in this quarter this year. So as you can see, we are one of very few biotech companies who have both small molecules against all the validated targets, GLP, GIP, Amylin. And we also have once-a-month, once-a-quarter injectable peptides against all these targets, GLP, GIP, Amylin. Now we also have oral peptide against Amylin, GLP, GIP, and GCG. So this is very comprehensive. So, this is a quick summary about our competitive edge in terms of our small molecule portfolio against other small molecules.
Speaker #2: So that's very critical. So we do have AC36 oral, the amine receptor, and also have triple D AC3037 oral. The IND submission for both is expected in this quarter, this year.
Speaker #2: So as you can see, we are one of very, very few biotech companies who have both small molecules against all the validated targets: GLP, GIP, and amine.
Speaker #2: And we also have once-a-month and once-a-quarter injectable peptides against all these targets: GLP, GIP, and amylin. Now, we also have an oral peptide against amylin, GLP, GIP, and GCG.
Speaker #2: So, this is very comprehensive. This is a quick summary of our competitive edge in terms of our small molecule portfolio compared to other small molecules.
Speaker #2: So as you can see compared to all four clip on. Based on our phase phase two data we expect better GI tolerability versus all four clip on and model predict which we could get a 15% weight loss at a week 72 versus 11.5% for all four clip on.
Jinzhi Jason Wu: So as you can see, compared to orforglipron, based on our phase II data, we expect better GI tolerability versus orforglipron, and the model predict we could get a 15% weight loss at week 72 versus 11.5% for orforglipron. And as I mentioned, we dosed the first patient in the ASC30 global phase III program. This program is expected to enroll 4,600 people in U.S., Europe, and top-line data expected in Q3 2028. So, and we have a few fixed-dose combination, ASC30, 48, GLP, GIP, and triple combinations, small molecule, all oral, one pill once a day combination. We expect to deliver very strong weight loss with good tolerability, as no one has right now. We are definitely first in class. So for our ASC39, we have SARA, other company like ACCG, is data. So, for our peptide portfolio, we also have a very strong competitive edge.
Jinzi Jason Wu: So as you can see, compared to orforglipron, based on our phase II data, we expect better GI tolerability versus orforglipron, and the model predict we could get a 15% weight loss at week 72 versus 11.5% for orforglipron. And as I mentioned, we dosed the first patient in the ASC30 global phase III program. This program is expected to enroll 4,600 people in U.S., Europe, and top-line data expected in Q3 2028. So, and we have a few fixed-dose combination, ASC30, 48, GLP, GIP, and triple combinations, small molecule, all oral, one pill once a day combination. We expect to deliver very strong weight loss with good tolerability, as no one has right now. We are definitely first in class. So for our ASC39, we have SARA, other company like ACCG, is data. So, for our peptide portfolio, we also have a very strong competitive edge.
Speaker #2: And as I mentioned, we dosed the first patient in the AC30 global Phase 3 program. This program is expected to enroll 4,600 people in the US and Europe, and top-line data is expected in the third quarter of 2028.
Speaker #2: So and we have a few fixed dose combination AC30 48 GLP GIP and triple combination small molecule all oral once once one pill once a day combination we expect the deliver very strong weight loss a good tolerability at no one has right now.
Speaker #2: We are definitely first in class. So, for our AC39, we have Sarah; other companies like ACCG, this DAC. So for our peptide portfolio, we also have a very strong competitive edge.
Speaker #2: AC35 is a once-a-month GLP-GIP, versus Tizepatide from Lilly, which is once weekly. As I mentioned in the study design, in the Phase 1 study we initiated in the US, there is a head-to-head comparison between AC35, which is a once-a-month injectable peptide, versus Tizepatide, a once-weekly injection.
Jinzhi Jason Wu: ASC35 is a once a month GLP GIP versus tirzepatide, Lilly, is a once weekly. As I mentioned in the study design, in the phase I study we initiate in U.S., there is a head-to-head comparison between ASC35, which is a once a month injectable peptide, versus tirzepatide, once weekly injection. We really exciting looking for that data. As I mentioned, another strong data from Lilly, which is eloralintide plus tirzepatide, demonstrate 29% weight loss at the week 32. However, it is two injections a week, a injection a month. Our ASC36_35FDC, Amylin GLP-1, GIP, is one injection per month. One injection per month versus Lilly's a injection per month. This is a huge deal for us, and this one we already initiate phase I in U.S. We also have Amylin injectable peptides, and I want bring your attention to oral.
Jinzi Jason Wu: ASC35 is a once a month GLP GIP versus tirzepatide, Lilly, is a once weekly. As I mentioned in the study design, in the phase I study we initiate in U.S., there is a head-to-head comparison between ASC35, which is a once a month injectable peptide, versus tirzepatide, once weekly injection. We really exciting looking for that data. As I mentioned, another strong data from Lilly, which is eloralintide plus tirzepatide, demonstrate 29% weight loss at the week 32. However, it is two injections a week, a injection a month. Our ASC36_35FDC, Amylin GLP-1, GIP, is one injection per month. One injection per month versus Lilly's a injection per month. This is a huge deal for us, and this one we already initiate phase I in U.S. We also have Amylin injectable peptides, and I want bring your attention to oral.
Speaker #2: We are really, really excited, looking forward to that data. As I mentioned, there is also strong data from Lilly, which is already tied, plus tazeptide, demonstrating 29% weight loss at week 32.
Speaker #2: But however, it's two injections a week, eight injections a month. Our AC36 35 fixed-dose combination amine GLP-1 GIP is one injection per month.
Speaker #2: One injection per month versus Lilly's eight injections per month. So this is a huge deal for us. And with this one, we have already initiated Phase One in the US.
Speaker #2: So, we also have amine injectable peptides, and I want to bring your attention to oral. So, we have two oral peptides with our technology platform called PROTON for oral peptide delivery, and we have AC36, an oral peptide amine. And extremely important, our model predicts a 10 milligram oral dose per day.
Jinzhi Jason Wu: We have two oral peptides with our technology platform called POTENT for oral peptide delivery. We have ASC36 oral peptide Amylin, and extremely important, our model predict 10 milligram oral dose per day. That is huge because as oral peptide, if you go beyond 25 milligram, the cost goods will be significant. Right now for ASC36 oral, which is oral Amylin peptide, our model predict 10 milligram oral dose per day. Now we do have ASC37 oral, which is triple G oral, predict dose is 25 milligram oral dose per day. Both of them are very attractive oral peptide clinical candidates. One is going to phase I very soon. In summary, we are very happy to share with you, we are financially strong. We can support operations into 2029.
Jinzi Jason Wu: We have two oral peptides with our technology platform called POTENT for oral peptide delivery. We have ASC36 oral peptide Amylin, and extremely important, our model predict 10 milligram oral dose per day. That is huge because as oral peptide, if you go beyond 25 milligram, the cost goods will be significant. Right now for ASC36 oral, which is oral Amylin peptide, our model predict 10 milligram oral dose per day. Now we do have ASC37 oral, which is triple G oral, predict dose is 25 milligram oral dose per day. Both of them are very attractive oral peptide clinical candidates. One is going to phase I very soon. In summary, we are very happy to share with you, we are financially strong. We can support operations into 2029.
Speaker #2: That's a huge concern because as an oral peptide, if you go beyond 25 milligrams, the cost of goods will be significant. So right now for AC36 oral, which is an oral amino peptide, our model predicts a 10 milligram oral dose per day.
Speaker #2: Now we do have AC37 oral, which is Triple D oral. Predicted dose is 25 milligrams oral dose per day. So both of them are very attractive oral peptide clinical candidates.
Speaker #2: One is going to phase one very soon. So, in summary, we're very happy to share with you that we are financially strong. We can support operations into 2029.
Speaker #2: We just get accepted by Hong Kong stock change into stock connect which will increase our liquidity broaden our share of shareholder basis and we we are the only we are one of maybe only maybe one of very few companies have strong small molecule portfolio and peptide portfolio.
Jinzhi Jason Wu: We just get accepted by Hong Kong Stock Exchange into Stock Connect, which will increase our liquidity, broaden our shareholder basis. We are maybe only, maybe one of very few companies have strong small molecule portfolio and peptide portfolio. Most exciting thing is ASC30 phase III program already dosed first patients. I stop here. I hand over to John.
Jinzi Jason Wu: We just get accepted by Hong Kong Stock Exchange into Stock Connect, which will increase our liquidity, broaden our shareholder basis. We are maybe only, maybe one of very few companies have strong small molecule portfolio and peptide portfolio. Most exciting thing is ASC30 phase III program already dosed first patients. I stop here. I hand over to John.
Speaker #2: And the most exciting thing is the AC30 Phase 3 program has already dosed its first patients. So I'll stop here and hand over to Jeff.
Speaker #1: Thank you, Dr. Wu. You mean me, right? Because Jeff—
John Yao: Thank you, Dr. Wu. You mean me, right? Because John-
John Yao: Thank you, Dr. Wu. You mean me, right? Because John-
Speaker #2: Yeah Jeff Jeff from city.
Jinzhi Jason Wu: John from Citi, John Yao.
Jinzi Jason Wu: John from Citi, John Yao.
Speaker #1: Okay. Okay. Yes. I I just want to make sure. Well thank you very much for the for the presentation. Then operator why why don't we just announce the the the Q&A rules so that investors knows how to submit the question then I can ask on behalf.
John Yao: Well, thank you very much for the presentation. Operator, why don't we just announce the Q&A rules so that investors know how to submit a question that I can ask on behalf?
John Yao: Well, thank you very much for the presentation. Operator, why don't we just announce the Q&A rules so that investors know how to submit a question that I can ask on behalf?
Speaker #2: Yes, thank you. Attendees can submit questions through the Q&A box beside the webcast. Thank you.
Operator: Thank you. Attendees can submit questions through the Q&A box beside the webcast. Thank you.
Operator: Thank you. Attendees can submit questions through the Q&A box beside the webcast. Thank you.
Speaker #1: No, yeah, thank you. Then, before we wait for the next question, maybe I can come with the first question, which is actually a hot topic among some of the investors that we talked to.
John Yao: Thank you. Before we wait for the next question, maybe I can come with the first question, which is actually a hot topic among some of the investors that we talked to. According to the public information, it seems like there was a hearing that happened very recently, likely yesterday, on the IP, the patent matter between Ascletis and also CSPC on the small molecule. According to Dr. Wu and also John, could you guys add some color to that, and what is your latest update to that event, please? Thank you.
John Yao: Thank you. Before we wait for the next question, maybe I can come with the first question, which is actually a hot topic among some of the investors that we talked to. According to the public information, it seems like there was a hearing that happened very recently, likely yesterday, on the IP, the patent matter between Ascletis and also CSPC on the small molecule. According to Dr. Wu and also John, could you guys add some color to that, and what is your latest update to that event, please? Thank you.
Speaker #1: According to the public information it seems like there was a hearing that happened very recently likely yesterday on on the IP the patent matter between the Ascletis and also CSPC on on a small molecule.
Speaker #1: So yeah and then according to but it shouldn't be according to me but according to to to to Dr. Wu and also John could you guys add some color to that and what is your latest update to to that event please?
Speaker #1: Thank you.
Speaker #2: So Jeff, thank you for the question. So yesterday, August 31 US time, there was a hearing for our post-grant review, called PGR, versus CSPC Country Pro.
Jinzhi Jason Wu: So John, thank you for the question. Yesterday, 31 August, US time, has a court hearing for our Post-Grant Review, called PGR, versus CSPC, Conjupro. This is one of procedure steps expected many months ago, all in public information. Number two, we were told, we heard the court hearing is very positive for Ascletis. We are very excited, very happy with it. The court hearing, we heard, is very positive for Ascletis. Number three, we always believe our patent position for ASC30 and related compounds, GLP-1, small molecule, is very, very strong. Our ASC30 and related compound demonstrate very significant advantage over any prior art. We do not believe CSPC and Conjupro have any meaningful ground. We believe we have very strong patent folio. We have very strong position. Reflected by positive court hearing yesterday, 31 August. Thank you.
Jinzi Jason Wu: So John, thank you for the question. Yesterday, 31 August, US time, has a court hearing for our Post-Grant Review, called PGR, versus CSPC, Conjupro. This is one of procedure steps expected many months ago, all in public information. Number two, we were told, we heard the court hearing is very positive for Ascletis. We are very excited, very happy with it. The court hearing, we heard, is very positive for Ascletis. Number three, we always believe our patent position for ASC30 and related compounds, GLP-1, small molecule, is very, very strong. Our ASC30 and related compound demonstrate very significant advantage over any prior art. We do not believe CSPC and Conjupro have any meaningful ground. We believe we have very strong patent folio. We have very strong position. Reflected by positive court hearing yesterday, 31 August. Thank you.
Speaker #2: Okay, so this is one of the prestigious steps expected many months ago, all in public information. Number two, we were told and we heard the core hearing is very positive for Ascletis.
Speaker #2: So, we are very excited, very happy with it. The court hearing we heard is very positive for Ascletis. Number three, we always believe our patent position for ASC30 and related compounds—GLP-1 small molecule—is very, very strong.
Speaker #2: Our AC30 and the related compound demonstrate a very significant advantage over any prior, so we don't believe CSPC and Country Pro have any meaningful grounds.
Speaker #2: So, we believe we have a very, very strong patent portfolio. We have a very, very strong position, as reflected by the positive core hearing yesterday, August 31st.
Speaker #2: Thank you.
Speaker #1: Thank you. Thank you for answering the question, Dr. Wu. We actually have a question that was submitted. I just want to ask on behalf of the investor—I'm not sure if the question is for you, Dr. Wu, or for John.
John Yao: Thank you. Thank you for answering the question, Dr. Wu. We actually get a question submitted through, I just want to ask on behalf of the investor. I am not sure if the question is for you, Dr. Wu, or for John. The question is quite simple. Since we are starting the phase III trial of ASC30 in the US, the investor wants to know, and the investor knows that we are still open to BDs or other types of collaboration or even M&As going forward. The investor wants to know, is there going to be a golden time, like how much percent into the phase III, let us say, with enough data that we can probably sort of seal the deal or such thing does not exist, in terms of the timing of this kind of collaboration of BD related to the phase III? Yeah.
John Yao: Thank you. Thank you for answering the question, Dr. Wu. We actually get a question submitted through, I just want to ask on behalf of the investor. I am not sure if the question is for you, Dr. Wu, or for John. The question is quite simple. Since we are starting the phase III trial of ASC30 in the US, the investor wants to know, and the investor knows that we are still open to BDs or other types of collaboration or even M&As going forward. The investor wants to know, is there going to be a golden time, like how much percent into the phase III, let us say, with enough data that we can probably sort of seal the deal or such thing does not exist, in terms of the timing of this kind of collaboration of BD related to the phase III? Yeah.
Speaker #1: The question is is quite simple is like since we're starting the phase three trial of AC30 in the US the investor wants to know and and the investor knows that we're still open to BDs or other types of collaboration or even M&As going forward.
Speaker #1: The investor wants to know is there going to be a a golden time like like how much percent like into the phase three that's like with with enough data that we can probably sort of like seal the deal or or or such thing doesn't exist in terms of the timing of this kind of collaboration of BD related to the phase three.
Speaker #1: Yeah.
Speaker #2: Let me say one thing I hand over to Jeff answer that question. So golden time we have best financial advisor. So we we believe we going to advise on the golden time.
Jinzhi Jason Wu: Let me say one thing and I hand over to John answer that question. Golden time, we have the best financial advisors. We believe they are going to advise on the golden time. We leave to them. John, you want to add some more colors on that?
Jinzi Jason Wu: Let me say one thing and I hand over to John answer that question. Golden time, we have the best financial advisors. We believe they are going to advise on the golden time. We leave to them. John, you want to add some more colors on that?
Speaker #2: So, we'll leave it to them. Jeff, do you want to add some more color on that, or do you want me to?
John P. Gargiulo: Yeah. As Jinzhi said, we have some of the best financial advisors, and we see constant interest in our portfolio from strategics, not just ASC30, but all of our long-acting peptides and our oral small molecules. We are very actively engaged in business development discussions across the whole portfolio. We still have people expressing interest in ASC30. We are still talking to people about that. I am not sure if there is any one moment in time that is the golden time, but I will say that we are constantly in discussion with companies, and those are very active across the whole portfolio for BD.
John Gargiulo: Yeah. As Jinzi said, we have some of the best financial advisors, and we see constant interest in our portfolio from strategics, not just ASC30, but all of our long-acting peptides and our oral small molecules. We are very actively engaged in business development discussions across the whole portfolio. We still have people expressing interest in ASC30. We are still talking to people about that. I am not sure if there is any one moment in time that is the golden time, but I will say that we are constantly in discussion with companies, and those are very active across the whole portfolio for BD.
Speaker #1: Yeah. Still still is Gen Z. As Gen Z said we had some you know some of the best financial advisors and we see constant interest in our portfolio from strategics not just AC30 but all of our long-acting peptides and our all small molecules so we are very actively engaged in business development discussions across the whole portfolio we still have people expressing interest in AC30 we're still talking to people about that so I'm not sure if there's any one moment in time that's the golden time but I will say that we are constantly in discussion with companies and those are very active across the whole portfolio.
Speaker #1: For BD. Got it. Got it. Understood. Okay. Then let's see if there are more questions online. I think those are probably the two questions I wanted to know about the most.
John Yao: Got it. Understood. Okay, then let's see if there are more questions online. I think probably those are the two questions people want to know the most. Okay, then I understand that the call was scheduled for 30 minutes anyways, and then we already have two questions answered. If there are no further questions submitted online, then I will just pass the time again to Dr. Wu and John for the closing, please. Thank you.
John Yao: Got it. Understood. Okay, then let's see if there are more questions online. I think probably those are the two questions people want to know the most. Okay, then I understand that the call was scheduled for 30 minutes anyways, and then we already have two questions answered. If there are no further questions submitted online, then I will just pass the time again to Dr. Wu and John for the closing, please. Thank you.
Speaker #1: Okay. I understand that the call is scheduled for 30 minutes anyway, and we already have two questions answered. If there are no further questions submitted online, then I will just pass the time again to Dr. Wu and John for the closing, please.
Speaker #1: Thank you.
Speaker #2: Thank you, John, again. Let me just say this briefly for closing: we are financially strong. We have sufficient cash on hand to support our operations into 2029.
Jinzhi Jason Wu: Thank you, John, again. Let me just say this briefly for closing. We are financially strong. We have sufficient cash on hand, support our operations into 2029, which we can finish phase III and finish a lot of clinical trials. We recently accepted into Hong Kong Stock Connect, which is a huge deal for us in terms of liquidity and broaden shareholder basis. Our portfolio, as we said, is very competitive, comprehensive. We are maybe one of very few companies which has both small molecules against all targets, validate targets, GLP, GIP, Amylin, and we have a once a month, once a quarter injectable peptides and oral peptides. Very comprehensive. Most important, we have money to support all these product clinical programs. Thank you, John.
Jinzi Jason Wu: Thank you, John, again. Let me just say this briefly for closing. We are financially strong. We have sufficient cash on hand, support our operations into 2029, which we can finish phase III and finish a lot of clinical trials. We recently accepted into Hong Kong Stock Connect, which is a huge deal for us in terms of liquidity and broaden shareholder basis. Our portfolio, as we said, is very competitive, comprehensive. We are maybe one of very few companies which has both small molecules against all targets, validate targets, GLP, GIP, Amylin, and we have a once a month, once a quarter injectable peptides and oral peptides. Very comprehensive. Most important, we have money to support all these product clinical programs. Thank you, John.
Speaker #2: Which means we can finish Phase Three and complete a lot of clinical trials. And we were recently accepted into Hong Kong Stock Connect, which is a huge deal for us in terms of liquidity and broadening our shareholder base.
Speaker #2: Then our portfolio, as we say, is very competitive and comprehensive. We are maybe one of very few companies which has both small molecules against all targets, validated targets, CLP, GIP, M&A, and we have a once-a-month, once-a-quarter injectable peptides and oral peptides. Very comprehensive.
Speaker #2: And most importantly, we have money to support all these protein clinical programs. Thank you, Jeff.
Speaker #1: Thank you. Great. Well, thank you very much for dialing in, and thank you, Dr. Wu and John, for your time. With that, let's conclude today's call.
John Yao: Thank you. Great. Well, thank you very much for dialing in, and thank you, Dr. Wu and John for the time. Then let's conclude today's call. Thank you. Good night. Good evening.
John Yao: Thank you. Great. Well, thank you very much for dialing in, and thank you, Dr. Wu and John for the time. Then let's conclude today's call. Thank you. Good night. Good evening.
Speaker #1: Thank you. Good evening. Good night.
Jinzhi Jason Wu: Bye-bye.
Jinzi Jason Wu: Bye-bye.
