Ascentage Pharma Group International (HKEX:6855) Q2 2026 Earnings Call

0:00 Testing audio. Hello, everyone. Good morning. 1234567. Testing audio. We cannot hear anyone.

52:24 Hello? Can you hear me? Hello, and welcome to the 2026 interim financial results. We ask that you please hold all questions until the completion of the formal remarks, at which time you will be given instructions for the question and answer session. Also, as a reminder, this conference is being recorded. If you have any objections, please disconnect at this time. With that, I would like to turn the call over to Sumit Neni. You may begin. Thank you, operator, and good morning, everyone. Thank you for joining today. Welcome to Ascentage Pharma's twenty twenty six Interim Results and Business Update Call. I'm Sumit Sunkaraneni, Director of Investor Relations and Corporate Strategy at Ascentage. Please note that today's discussion will include forward looking statements based on our current expectations and assumptions.

53:10 These statements involve risks and uncertainties, and actual results may differ materially. For a discussion of these risks, please refer to our disclosures. Joining me today are Doctor. Dzheng Yang, our Chairman and Chief Executive Officer Doctor. Faisal Miara, our Chief Business Officer Mr. Jim Zeigler, our Chief Commercial Officer Doctor. Yifan Zai, our Chief Medical Officer and Doctor. Veep Misra, our Chief Financial Officer. Yesterday, we issued a press release with our unaudited financial results for the six months ending 06/30/2026. That release and the slide presentation accompanying this call are available in the Investor Relations section of our website. Turning to our agenda, Doctor. Yang will open with a business update, and we will hear briefly from Doctor. Mihara and Mr. Ziegler on the business development and commercial priorities behind our global hematology franchise.

53:56 Doctor. Yang will then cover our R and D highlights, and Doctor. Misra will review the financials. Doctor. Tsai will also join us for part of the Q and A session. We will then open the line for your questions. I'd now like to turn the call over to our CEO, Doctor. Lejune Yang. Doctor. Yang, you may begin. Thank you, Sumit, and thank you all for joining us. The first half of twenty twenty six advanced a single objective, building Ascentage into a leading global, fully integrated hematology oncology company. We are a company that discovers, develops, conducts global clinical trials, and now taking steps to commercialize best in class potential therapies for hematological malignancies worldwide.

54:44 We are currently advancing nine global radio treatment trials, four of which are cleared by both the FDA and EMA. The total revenue grew to 44,500,000, up 29% year over year, of which were product sales of 41,600,000 on a constant exchange rate basis. And we are reaffirming cash runway through the end of twenty twenty seven. Importantly, and playing a role to achieving our global strategic objectives, We strength our leadership with the appointments of doctor Faizo as chief of business officer and mister Jim Zeigler as the chief commercial officer.

55:33 Both are with us today. I'll be sharing preliminary thoughts. So let's just look at the, next slide. So the this slide, we have two approved products and the late stage pipeline that's a highly derisked. Orenbatinib, our third generation BCI ABO inhibitor, have been approved CML CP in China since 2021.

56:19 Tens of thousand patients have been treated today. The longest of patient on our drug have been near almost ten years now. We have a real world long term safety and efficacy data that really feel companies under our stage can point to. We also have a global registration trials, including FDA and EMA clear that's on ongoing. Our plan is to commercialize ormatinib in The United States and the major pharma markets. The Esophil class, our selective b cell two inhibitor is approved as a single agent in post BTK, CLL, SLL. Globally, we are the second selective b cell two inhibitor to reach to the market after decades have passed.

57:08 However, in the single agent post the BTK CLL, we are actually the first to get approved to the market. The suffer costs have a unique daily dose right now. We are the only one approved with that label. Enhanced effort, safety, and as well as a drug drug interaction observed today is much reduced compared to other v shalt two inhibitors. It also has FDA and EMA cleared global registration trials, GLORA and the GLORA four. Behind those two, we also have five additional clinical stage assets or conducting trials in US and China and the rest of world.

57:56 AAPG two four four nine is a triple kinase inhibitor covering FAK, AUK, ROS one. And the m d n two fifty three inhibitor, a p g one one five, and also targeting both b g l two and XL a p g twelve fifty two, and the EED inhibitor five nine one eight, and also the newer one joining this year to The US and the China phase one trial is the APG thirty two eighty eight BTK degrader. In light of our mission to build Ascentage into a leading global hematology oncology company, we have a strength our leadership team in the two areas that determine whether franchise reaches patient outside China, global business development and commercialization.

58:55 I'm really pleased to welcome doctor Faisal Miraya as our chief business officer and mister Jean Zachner as our chief commercial officer. Both bring deep experience directly relevant to the next stage of Ascentage's growth. I would like to give each of them a moment to introduce themselves and share what attract them to Ascentage. Faisal, let me turn it over to you. Thank you, doctor Young. My name is Faisal Miara. I'm the current global chief business officer at Ascentage. I have a twenty years plus in oncology business development, search and evaluation, and then also was involved in venture investing across leading pharmaceutical industry.

59:45 I was in, as you see in the bottom, multiple large pharmas like Lilly, Pfizer, Sanofi, Ipsen, as well as mid sized biotech like Kadman and IO Biotech. I was also instrumental in the deal or the M and A that happened between Kelvin and Sanofi for in 2021 for $1,900,000,000. I led multiple global oncology partner and and executed teams, at IO Biotech and Ipsen. And when I was at at at Eli Lilly, I advanced as a lead oncology product or antibodies and co initiated the Pfizer Center of Therapeutic Innovation. So I'm very, very pleased to join this very, very good team at Ascentage, and then we'll talk about our pipeline. It's very, very outstanding.

1:00:38 And with that, I'll leave it to Jim to give you some information on the chief commercial officer. Thank you, Faso, and good morning, everyone. I am also very pleased to join the Ascentage team. I've spent more than twenty five years building and leading commercial organizations with broad experience in hematology, oncology, and specialty products across both large cap and small cap biopharmaceutical companies. What attracted me to Ascentage is the opportunity to take a deep, late stage hematology oncology portfolio with two already approved products and help translate this clinical foundation into a global commercial organization. My immediate focus is on building the foundation for potential commercialization of our products, including commercial strategy, market access and associated capabilities we will need as our registrational programs advance in The United States and other key markets.

1:01:40 I look forward to providing updates on our progress over time. I'll now turn the call back to Dajun. Thank you both. Let's look at the r, r and d highlights. Our development strategy is the engine for full global commercialization strategy. To approve of hematologic asset anchored and the everything behind them is designed to add to our best in class portfolio. Turning first to the Silver Class, our cornerstone asset. The Silver Class was approved in July last year for the treatment of adult patients with a CLL SL who have previously received at least one certain method including BTK inhibitors.

1:02:34 Actually, we conduct the rejection trial for the patients who have to fail BTK inhibitors. So for that indication, we are actually global first one. But more importantly, are running four global registration trials. Two of them cleared by FDA and EMA. Which of each of them will have a transformative therapy globally. I think the most important one among the four registration trials for the global strategy is the GLORA four. In the frontline high risk MDS, evaluates Lisophila class in combination with azacitidine versus azacitidine alone.

1:03:21 This has been cleared by FDA, EMA, China CDE, and also PMDA in clear in close to, 20 countries. Let me also highlight a few, key differentiation versus two other currently on the market, b cell two inhibitors. As you can see, the result class was the only one designed with daily dose and up in the beginning. And the only one approved was only three dose strengths and five daily dose and ups plan, and then reach the dose of target dose six hundred milligram and continue.

1:04:12 As you can see, the venetoclax was the first approved about ten years ago, has a five week dose ran up. The other one just approved sorandoclast early this year with a five week dosing. I mean, the the daily weekly dose are enough by the line dose cohorts. Okay? Because Sarena class start with a one milligram. Initially, in the trials, it was nine weeks. I think they combine two, into one week. So, each week, they have do the ran up two times and then total nine, dose levels to reach a target dose. I think that's really important, for the patients with a CILSL, the convenience and also reduce the time of hospitalization.

1:05:05 Let's also look at the summary of a favorable safety profiles and the better drug combine ability. We try to compare in the same setting, same patient population, but, also, be clear, this is not a head to head comparison. But even we look at the overall, the safety profile in terms of infection and the PK variabilities, the silver class is probably the best one among the three. If we look at the ASA instance, these are class also much lower and, no drug related deaths reported today. And, in the TK variability, I think that they we you know, the other two are strong, the only, three or four, inhibitors, and we show minimal fluctuation in plasma concentration, compared to other two.

1:06:07 I think that they, in also, the low dose adjustment required, compared to the other two, you know, in terms of, DDI issue. I think, for the chronic dosing patient like many hematology malignancies, safety and tolerance and drug drug interaction risk are important, differentiation. Let's also look at the, key data, in The US trials. Okay? In the MDS, the silver cards with us as a side of the in front line produced overall response rate eighty percent and fifty percent in relapse are, MDS patient.

1:06:58 And more importantly, we have forty percent CR rate. Okay? And the time to response also, really short. Here, we also highlight two, representative real world cases in high risk MDS, since it was launched last year in China. In the first case, a 71 year old patient achieved a CR after two cycles with a rapid hematological recovery. In the second case, a patient was a poor response and failed another class, and then achieved the CRI within just fourteen days after switching from Vanilla class. These cases provide encouraging indications of clinical activity, including patients previously exposed to venetoclax.

1:07:52 Let's also look at the, AML case. The overall CRCI rate was seventy two percent with a sixty one percent MRD negative rate. Response was a hundred percent with patients with MPN one mutation and eighty three percent in the I d h two mutation. I think it is important all those trials actually was a patient in US and Australia. This is not the data, clinical data from China. As we previously indicated, in the case of patient who failed the mandelacast, which is a truly a mathematical lead globally, we still see a thirty one point eight percent overall response rate with no cases of tumor lysis syndrome.

1:08:43 Same target, same pathway, and the Lisovacast remains active. I think at least, you know, based on the current, clinical data of the resistance to, b c l two inhibitor, majority are not due to new mutations, but m c l one upregulation and some also with the b c r x l upregulation. Also, I think that that explained partially, why the same, you know, AML patient failed another class. The several class can still, achieve activity. So I think that those, reflects a key differentiation in the downstream resistant profile and represent meaningful clinical opportunity. But, of course, more importantly, which is the better safety profile and the low lower risk of DDI, also provide more, you know, opportunity for combination.

1:09:39 And in our case, combination with orambutinib would overcome when you look at the resistance in AML. Turning to the second pillar of a product strategy, orbatinib. I also want to highlight why we believe this can be a best in class third generation bciBo inhibitor to patients with CML in the second line or late settings. This has already been approved and highly derisked asset with several years of clinical and a real world use in China. We received a validation from Takeda as the the whole the exclusive option to license ormatinib outside Great China and certain other territories.

1:10:34 This was entered with Takeda about two years ago. Globally, the most important study for the CML is Polaris two. Part a, enroll chronic phase who has achieved at least who has received at least two prior TKI randomized orinvatinib against the vosutinib. This is clear by FDA and EMA. And, there's also part b, which evaluate oenvatinib in patients with t three one five I mutation. As you know, vosutinib doesn't have activity, so that's the single arm trial. Overall, you can see, this is a difficult, second line patient population, which we believe obrutinib can be most differentiated.

1:11:28 Besides the CML, ovaltinib also have a strong activity in pH positive AL. So Polaris one is also important. This is our global phase three study in newly diagnosed PH positive AL. Again, both cleared by FDA, EMA, and CDE, and also with breakthrough therapy designation in China. We have already shown strong part a data at ASH as oral presentation last year, and then we continue to advance the global study. Let's look at some of the the important bridging study led by doctor Ali Jabou at MD Anderson.

1:12:16 This actually were conducted, four, five years ago. And doctor Ali Jabou, as you know, is a leading investigator in CML and also a positive l. In this particular study, we enrolled 62 heavily pretreated, CML CB patients. More than half have achieved at least have received at least four prior TKI. They are, like, fourth or fifth line, and half of them have received the, ponatinib. And a third of them have t c one five mutation. I think it was this is really, you know, poor, baseline, patient population. We achieved the MMR as a single agent, forty two nine percent in ponatinib resistant patients, thirty three percent in Ascentamab resistant patients, and more importantly, twenty seven percent in patients who fell both Ponatinib and Ascentinib.

1:13:18 Basically, those are the patient with any with no other options, but single agent or have a pretty good advocacy. I think that this treatment, again, strengths, you know, the overall differentiation and the clinical efficacy versus, ponatinib and, Ascentage. And, also, we have a pretty long term safety profile. In China, the longest patient have been using ormatinib almost ten years, since October 2016. And in this particular patient trial, the longest patient treated in The US as over three years was a manageable safety profile.

1:14:10 Let's turn to, slide 16. I want to show some, more recent data. I think one case is the second line trial strategy. Over 10 up demonstrated, 47.6 MMR rate as a single agent. More importantly, the new data just last in this year, reported, in a perspective of control data, in the second line or late line setting, showing a clear benefit for switching to o r m batonib, a type of evidence that remains uncommon in this patient population. I think that the differentiation you can see, is very, dramatic.

1:14:57 Right? So if they don't switch to the best in class potential or bartender, the MMR rate remain only ten percent. I think that that's a huge benefit, in terms of for the patients in the late line, CML. Those patient actually, you know, have been treated, with at least two TKI. Some of those also, with Ascentage. All of our data have delivered, six months MMR rate, fifty four percent, and then even higher at fifty seven percent in twelve months. Those who didn't switch remain only low twenty percent response.

1:15:44 I think that, you know, as you can see, this hugely, benefit were for patients if they switch, to the overtender. And also, important, safety profile, in terms of AEs. That's also turning that's turning to slide 17. I think that the benchmark is important, because the NIM market changed, over the last two years. I think in addition to the at least two years ago, the own only competitive product we consider is the Ascentage. But now there is two drug turns seven zero one and eleven o o one in the study in The US. Okay? But first, I think the most important one, we are the only one have a long term evidence that other program doesn't yet have, though as those are still in the phase one or early phase two.

1:16:54 And, we have, you know, six years of follow-up, for patients who are in the second line and, ten years, for the first line, the phase one trial. And, we also have we are the only one have control the comparative dataset. Okay? Those are new requirement from FDA, in terms of a project optimist. So you have to run the RCT trial, in order to, you know, getting the NDA approved. Another important differentiation in the CML patient population is the the really, the baseline. Right? So you can see, the patient treated with oembatinib are more a lay line, you know, heavily pretreated and also with the mutations.

1:17:50 I think that they, those data clearly demonstrated, omartinib as the potential the drug of a choice in the second line of CML, of the patient who failed the most advanced available TKI. And I think I will show you a few more study, in the control, in more details on the next slide. Slide 18 is a real world analysis of a sixty nine blast crisis CML patient who went on transplant, and twenty six was treated with the oimertinib, and forty three was the first and the second generation TKI.

1:18:36 So the oimertinib group entered transplant in deeper molecular remission. MMR rate fifty three point eight percent versus only sixteen percent, and the CMR rate twenty three versus four point seven percent. The over attainable also have more favorable survival outcome. One year over survival of eighty nine percent versus seventy one percent, and the no relapse mortality eleven percent versus twenty three percent. These are the two separate patient cohorts in a retrospective real world analysis, not a randomized comparison. But, again, demonstrate important differentiation of ofatumumab, in large patient population on a hard to treat, CML patients.

1:19:29 Let's also, take a look at the, combination, strategy. In the patient, in the Polaris one in with a low intensity chemotherapy in frontline. I think that the Polaris one, three key, important differentiation, that that that data. One, this is frontline newly diagnosed PH positive AL. In the most cases, around the world, chemotherapy is still required because of the aggressiveness nature of the PH positive AL. In the, registration trial design, we conduct the part a, with the low intensity chemo.

1:20:15 As you can see, this is demonstrate MRD negative CR rate about the sixty three percent. This is almost double the ponatinib in the same patient population, the FALCON trial about thirty four percent. Of course, in the real, in the trial data, they imatinib only seventeen percent, dasatinib is only about twenty plus percent. So this clearly demonstrate in the registration trial study, orinbatinib is the best among the current, treatment option. We also try to enter, the chemo free registration trial. Currently, we have a data from, the oral report at ASCO, by, doctor Ali Jabou, around MD Anderson, demonstrate that if we combine with a brittle, we can achieve eighty percent MRD negative rate and a ninety one percent CR CRI.

1:21:13 We also demonstrate, importantly, in the pediatric RR PH positive l patients. Actually, those data have been available, reported first time two years ago. We continue to see benefit of safety and the oral response. I think very impressively, we achieved eighty nine percent oral response rate after cycle two, day 15, and the oral complete response in an oral chemo free regimen. I think that this combination data, is a key because this is a tool already active agent, chemo free, in the pediatric, AL, setting. Moving on to the a p g one five, another, asset, in our portfolio, small molecule targeting m d n two p p three.

1:22:07 It actually holds the six FDA, ODD and the two, rare pediatric, disease designation. This actually has been, conducted, I mean, in our portfolio for a a while as there's no approved product yet globally, targeting the MDN two p v three, as, you know, p v three is one of the most important tumor suppressor gene. But I think that you do see some, recent progress that Ipsen achieved acquired a CARTOZ MDN two inhibitor and was actually pretty decent, $450,000,000 upfront and up to 1,750,000,000, including milestones for phase three program in myelofibrosis.

1:22:59 I think that there is probably potential, for the m d two p three inhibitor combined with a JAK inhibitor, in that actually trial as an add on strategy. I think that data is encouraging. We're also currently, do that trial, with MS MF patients. So, again, this remain, wholly owned, by us. And, in the ASCO, we present an important data for APG one five in combination with the deservo class in the pediatric soft tissue sarcoma patients. Globally, pediatric rhabdomyosarcoma and other soft tissue sarcomas truly unmet medical need.

1:23:47 In that setting, we demonstrate good combination safety and impressive twenty three point five percent response rate and also seventy percent disease control rate. I think that those are encouraging data in the clinic demonstrate the already active agent, from, Ascentage. I think, in the interest of time, I try to focus on mostly, the key data. And, here's a slide to show you that the cornerstone asset of a b shell two inhibitor, the silver cast, combinability, with, three other targeted small agent all are already active.

1:24:33 I think that they we all know, as I mentioned, that, the major the main reason for b cell two resistance is the upper regulation of Mcl one. So, we have demonstrated overattendive actually can indirectly downregulate m c l one. We not only have preclinical data, but now have a clinical data to demonstrate that combination of the orbatinib with the LisoCAS can show the synergy, more importantly, not just the CML or patient positive AL, but the patient was AML or MDS and the patient negative AL. Especially for those patient who failed the vanilla cards in the AML, we have clinical data to demonstrate that in addition to what we showed before in the PH positive L.

1:25:26 And again, with MDN two p v three inhibitor, a p g one five, now we have a clinical data to demonstrate the safety advocacy, especially in those hard to treat soft tissue, sarcoma, patients. And we're also moving into the DLBCL, AML, and MF. Part of the MOA for this combination is the synthetic lethality. Again, we are the only company worldwide have, know, all three asset wholly owned by Ascentage. In the interest of time, I don't have much, you know, data to show, but I can tell you that our BTK degrader, APG thirty two eighty eight, have, advanced well, in the phase one setting, in both The US and China across the b cell malignancies who previously, exposed the BTK inhibitors.

1:26:27 I think, we can stay tuned, for the progress, for both the oncology and the non oncology indications which is the BTK, degrader. I think that that's all the highlight of our r and d. And, let me turn the call over to our CFO, doctor Wade Misra, and for the review of our financial results. Weed? Great. Thank you, doctor Young. And good morning, everyone. Turning to our financial results, the first half of twenty twenty six was another period of continued commercial growth and investment behind our global development programs.

1:27:13 Total revenue was $44,500,000 compared to $32,600,000 in the first half of twenty twenty five, representing an increase of $11,900,000 or 29.3% on a constant exchange rate basis. Product sales growth has been our main driver, as indicated by $41,600,000 of product sales compromising our total revenues. During the first half, we continued to expand our commercial reach and invest behind both products, while maintaining a disciplined approach to managing operating expenses and supporting our and advancing our global clinical programs.

1:28:01 Research and development expenses were $102,800,000 compared to $73,800,000 in the first half of twenty twenty five, representing an increase of $29,000,000 or 32% on a constant exchange basis. As planned, this was our expenditure and to execute on our high priority to advance enrollment in multiple global registration trials. Selling and distribution expenses were $33,400,000,000 compared with $19,200,000 in the first half of twenty twenty five, representing an increase of 14,200,000 or 64.3% increase. And this was driven by marketing and commercial investment behind our products.

1:28:49 Administration expenses were $17,500,000 compared to $13,900,000 in the same period last year, primarily due to RSU expense. Turning to our balance sheet. We're pleased to report cash balances were $279,400,000 as of 06/30/2026, as well as reaffirming our cash guidance runway through 2027, as we've said before. This funds us through multiple key registrational studies ongoing globally. And to emphasize, we are funding nine registrational programs and are currently taking initial steps to building a commercial organization in The U. S.

1:29:39 And remain on target for investments required at the appropriate time to fulfill our global strategic objectives. Thank you. And with that, I'll turn back the call to Daijun for his closing remarks. Doctor. Young? Great. Thank you, Wei. So I think that they, with the overall r and d highlight and the financial update, As you can see, our last slide, to show we have seven seven active products in the clinic, which two of them already landed, approved in China.

1:30:26 And more importantly, with these, already active target agent, we cover all majority of him malignancies, from the c l l l to the, CML, AML, MDS, and also, with clinical activities in potentially, multiple myeloma and the DLBCL. I think, moving forward, our goal is to focus on the current global registration trials and reach to the NDA stage and build a strong commercialization team, outside China as well and, to become a global player in the hem malignancies, globally.

1:31:14 I think that that's all for the brief update, with the key, data and the financial results. And, thank you all for joining us and also our team. And then, I think that now we are open for the, q and a. Thank you. At this time, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. When it is your turn, you will receive a message on your screen from the host allowing you to talk, and then you will hear your name called. Please accept, unmute your audio, and ask your question. We will wait one moment to allow the queue to form. Our first question will come from the line of Brian Chang with JPMorgan.

1:32:01 Please unmute your line and ask your question. Hey, guys. Thanks for taking our questions this morning. And Faiza and James, welcome to the team. Just to start off, in China, know, can you talk about how we should think about the NRDL listing for specifically lease after class later this year? Can you talk a little bit about, you know, what's the progress that you have been seeing in China, and how should we think about the next updates, related to the NRDL listing? And then we have a couple follow-up. Thank you. Thank you, Brian. Really good question. So the thought class was approved in China July last year.

1:32:48 We are the first, domestic b c r two inhibitor approved, in China. And also, we are the only one, the first one approved in terms of post the BTK, RRCL, SL patients, in the registration trial. That was a tougher trial, but with them as a good safety advocacy. And, we clearly show the differentiation versus another class or certain class in terms of the only approved the daily dose turned up with a clear safety profile and the lower risk of DDI. I think that if you're looking not just a clinical data, but the the NRDL reimbursement, you know, less hospitalization, less risk, and also convenience, all important favorable factors for the NRDL consideration.

1:33:46 I think currently, as update, we have passed the initial review. We are on the final, product list for the NRDL, expert review right now. This year, the timeline is actually a little bit ahead of previous timeline. So currently, they both they they there's two, groups, NRDL, experts, officials, and all those are the health economics, experts are conducting, the meetings, reviews right now. So we may call up to a meeting with the experts later this month or early September. Then they with the final we're really confident we will get a NRDL coverage for these indications in China.

1:34:37 They probably only the the concern we have or worry is working with the expert is the the final price. But, of course, the NARC has already covered for different indication AML in China is probably a benchmark. And but I think we are confident, we'll have a coverage, for this indication, which is important, in China that an RDL is not just a reimbursement, but the the ticket to enter the hospital. Majority of hospital in China rely on the NRDL approval to enter the hospital in terms of prescription. And in case of a CIL or SCL, this is a chronic dosing patients.

1:35:25 Reimbursement by NRDL means that they can reduce their, you know, pay, you know, out of pocket, the payment by the average two third, 70%. In certain regions, the NRDL coverage can up to 90%. So I think that's a huge benefit to the patients in chronic, you know, leukemia setting. Great. Maybe just also turning into, your ongoing clinical studies. Curious if you can, talk about, you know, what's going on with, Polaris one and GLORA trials, specifically how's enrollment looking like? And, you know, just any sense of, how we should think about the timing of the next data readout, and potential pathway to NDA filing. How how should we think about, the timing of milestones?

1:36:19 So I think for those question, maybe, we have our, CMO, doc Dai, on the call. Maybe, doc Dai can, give some answer first. Doctor Dai? Sorry, Brian. So regarding GRAND-four study, right? Sorry. I thought I addressed somebody else's question. So could you please repeat the question? No problem. Yeah. No. Just curious how the enrollment is going in, the global studies like Polaris one and also the GLORA studies, for the sapticlox. You know, how's enrollment going? And do do you do you have a better sense of how you know, when we're gonna get the final data cut, you know, to to file for the NDA?

1:37:09 So regarding all those, global registrational trial, the team worked very hard and and tried to complete their enrollment as soon as possible. So it's still under the plan. In particular, the growth four study perhaps is under the radar, and everybody pay particular attention to that, global registrational trial. Regarding GRAW two, GRAW three, the gene actually already announced yesterday. Already complete the enrollment. For GAR two, I'm waiting for the data review, mature. GAR three also very close, and the remaining, we, plan to complete the enrollment either the end by the end of this year or the early, next year.

1:38:03 K. Thank you. Maybe let me, add a few points to what Yifan said. So, you know, we have, you know, said yesterday in in the Hong Kong call that we complete the enrollment for the GLORA two, which is frontline, CIL as a setting, combination with as a setting and, with a fixed duration. And, of course, that one, is not with the FDA, because of the control arm is the chemo immunotherapy. But that's also over, you know, 400 patient enrollment, demonstrate our, capability in the clinical operation.

1:38:52 And, GLORA three is the AML, combo with the ASR versus the ASR long. We are in the final stage to closing the enrollment. The GLORA four, obviously, in the high risk MDS, many people watching closely. I think there's a few key points also important this year. One is this is the frontline. Okay? The frontline patient with high risk MDS. In the trial design, similar to the Verna, the combo with AZA, versus the AZA alone. And, this has been cleared by FDA, EMA, PMDA, and China. And globally, not because Verona fell, but also, another, v c l two inhibitor, Verona class, is not on the MDS, not on the registration trial.

1:39:44 And, globally, we are the only phase three registration trial for the high risk MDS. There's no target drug approved, in the high risk MDS in the last twenty years. So this has remained globally a mathematical need. And enrollment is doing well because experts around the world, in MDS are really, enthusiastic or want to help patients, with high risk MDS. So, overall, I think to summarize, we anticipate, as we said before, the enrollment for GLORA four and the Polaris one plus two, could complete by late this year or early next year. And the the good problem to have, we're looking for, potentially three NDA to file, the second half of next year.

1:40:36 Right. And if I can squeeze one more in, just for the BTK degrader three two eight eight, do you have a sense of what you wanna see from the early data cut so that, you know, investors can make a good comparison against other BTK degraders? Do you have a benchmark internal benchmark of efficacy early on? And thanks for taking my questions today. Yeah. I think, in all know that the BTK as a target is very competitive, very proud, and there's many inhibitors, covalent, noncovalent on the market, and, some are doing very well. But the BTK degrader do have advantage, at least, with some of the current, up to even phase three data.

1:41:22 So we conduct carefully preclinical data to show our drug, thirty two eighty eight, versus the other two from Newrix or b one, that have more a better, selectivity and a stronger efficacy. But, that's, again, is in the preclinical setting. Currently, I think that in the phase one, we're moving along very well in terms of those escalation for safety. But more importantly, first, those are all BTK exposed patients. Okay? Doesn't matter covalent or non covalent. And, we want to show some response in those patient population first. Right? That's important. That's the key differentiation for the degrader.

1:42:10 Second, though, we probably will take some patient population, the indications that currently BTK inhibitor is not really active. Some more so importantly, combination with our b c l two inhibitor. I think that one example in that setting may be the DLBCL. So because so far the BTK inhibitor hasn't show good activity as a single agent in that DLBCL setting. And, of course, there are also a lot of data to combine with the b c l two, may have, you know, better, readout in this patient population. Another potential one, but we don't have a data to share yet is in the lung oncology indication. I think that there are many, autoimmune indications, could be, benefit with the BTK integrator.

1:43:06 Great. Thank you, Dajun, and congrats on the progress. Thank you. Your next question will come from the line of Byron Amin with Piper Sandler. Please unmute your line and ask your question. Yes. Hi, team. Thanks for taking my questions. Maybe if I could just start, with the POLARIS one and POLARIS two trials. Can you just provide us with an update in terms of when we can expect data from both studies? Again, for that question, Yifan, our CMO, can address first. Oh, we just addressed the same question. Let me repeat that. So currently, we'll very activate enroll patients and and plan to complete the enrollment either by the end of this year or the early next year.

1:43:59 Plan to submit the NDA next year. Yeah. I think that they, just add a little bit. For the Polaris two, the filing NDA is six months MMR rate after the last patient in. So, of of course, we already demonstrate, very strong data, in the MR rate, for the this patient population, and we're confident on that. But the key, of course, is the finished enrollment. And for the Prolaris one, the filing of NDA with FDA is the three months MRD negative CRA. So I think, again, the target enrollment is on track.

1:44:48 And, with these six months or three months, endpoint for the NDA filing, we're looking for potential filing of, those two NDAs, second half of next year. Great. And maybe just follow-up on a couple of questions for overrembatinib. When could we expect to see Takeda make a decision on its option on the license? That's, the first question on the global license. And then second, as it relates to China specifically, where are you as it relates to achieving access to 2,000 hospitals in China? Think that was a target that was previously set by the company. And then maybe, a question on the BTK with APG-three288.

1:45:36 Could we see first data at ASH, this year? And are you planning to evaluate also in the MS setting? Maybe I'll ask answer your last question first. Uh-huh. So the 3288 is still ongoing in the phase one trial, US, China. I think, because this is a dose escalation and the cut off for the ASH already ended. So we don't anticipate to to present the phase one data this year at ASH. But the progress are doing well. Perhaps we can have some to share, maybe next year in terms of timing, for the phase one data.

1:46:22 And, again, we are conducting several autoimmune indications, demonstrate good preclinical, activities. And because of the non oncology trials, in the phase one health volunteer, you do need a placebo control. Right? So that's where, we are working with to getting, IND filed, for the non oncology indications, including the MS. But that data will come from a little bit behind because, making the placebo control. But, we do anticipate, the IND to be filed soon with the autoimmune indications.

1:47:09 And for for your first question, I think that they Takeda a deal, as you know, that we entered the global exclusive partnership option agreement two years ago 2024. And that is, again, exclusive global outside China and some territories. And for that, Takeda, back two years ago, paid a $100,000,000 upfront and 75,000,000 equity investment. And there's also a total up to 1,200,000,000 aggregate when they access the option and a certain milestone payment. And also the tier, the royalty rate from 12% to start up to 19%.

1:47:58 I think, you know, globally, Takeda is a key player, in the CML and the AL, you know, after Novartis, obviously. But I think we do believe Takeda is important and a global partner, for commercialization over in Bartender. And one of the main reason for the option agreement is obviously to have a competitive product, Ponatinib, and the potential antitrust issue. But Ponatinib will pattern will expire early next year. I think that's the key component in the option accesses. And also, we do work closely since the option agreement signed with the targeted team.

1:48:47 So we are actually working closely together to advance all the enrollment and a lot of KOL reaches and planning for the commercialization. With the gene on board, we do looking forward working together ahead of the launch, which is targeted team for the great, you know, potential of bartender in the global market. I think that you have one more question about the hospital. Right? I think that they they currently, we we are doing well in terms of getting the the hospital covered. I think that we we do I mean, still have a second half time to report.

1:49:34 But we are, on the track, currently, bring the total commercial team, about 300. And the goal is to to build up close to 400, commercial forces in China. I think it's not just the number, you know, 400, staff in the commercial, team, but more importantly, is to to cover 80% of a market potential with the product two product in China. I think that that's, where the, you know, 2,000 hospitals number, we try to achieve. We are on the track, to achieve, that, with the, expanding the commercial team and also the leadership, both in US and China.

1:50:22 Great. Thank you. Thank you. Your next question will come from the line of Jeet Mukherjee with U. S. Bancorp BTIG. Go ahead with your question. Great. Thank you for taking the question. Maybe just to dig a little bit further into some of these upcoming readouts, just how should we think about setting expectations for Polaris one, two and GLORA four? And then, you know, just turning to overimbatinib, you highlight some of your competitors on slide 17. But if you could just provide some further detail or perspective on what you see are the biggest differences, for your molecule versus those competitor agents on both efficacy as well as safety. Thank you. Really great question.

1:51:10 But first, based on the preclinical data, our drug is probably among all the TKIs or allostatic inhibitors, the most potent one against the t c one five mutation and also the compound mutation. Because in the b c I ball gene, the mutation, not just happen in one hot spot. The t c one five I is considered a gatekeeper mutation, differentiate those in terms of the third generation, VJIBO inhibitor. But on top of that, there's also the more than one mutation called a compound mutation, in the same cell. Okay? And currently, Ascentage and also those turns or 11 do not have those strong data. So oimertinib, is the most important one and also most active one against wider spectrum of mutations, including the compound mutations.

1:52:13 That hurts hurts about at least up to forty percent of a late line CML patients. So currently, even though Ascentage have approved label, in with only US, to treat the patient with the t three one mutation, but they need a five time dose. Right? Five time dose and also in US, that's a five times the cost, almost a million dollars. So I think that they in the late line CML patients with mutations, we do show the probably the most important one. Okay? And 11 or turns seven zero one now with Merck, do not have those data, and they are also mostly in the early, you know, phase one or two.

1:53:01 And and then in The US because of project optimist, you know, we we have those data four or five years ago with MD Anderson, that we have, you know, patient, basically, unmet medical need. Right? For a patient who fell both ponatinib and Ascentage are the patient with no other treatment options. But because of the project optimist, if they do not allow the single agent, single arm period of phase two trials, you know, for the registration. So that's why we have to conduct the RCT. We have to have the control arm like vosutinib. I think that none of those, you know, competitive product have those data or registration trial agreement with the ADA yet. In the real world, the consensus among the CML experts community is you want to give the best which are able inhibitor to a patient fulfilled after first line early. Right? You don't want to wait on after four or five line. You want to give the strong one. So the CML patient who achieve deeper response, like a MMR, MRD, you you know, an active CR, or the MR four or or DMR four point five. So a patient who can achieve a deeper response early would be able to achieve TFR.

1:54:21 And, in certain cases, maybe, you know, you know, drug free for many years, defined as a clinical cure. I think that that's important. That's why we have a second line data. We have a the real world data perspective, study to demonstrate the omartenib could be the choice of patient who fell the frontline. Doesn't matter is a TKI or Ascentage or any other, you know, allosteric inhibitor. That's the goal. That's the key differentiation we have been showing presented, with a clinical data. Thank you. Appreciate it.

1:55:07 Thank you. Your next question will come from the line of Gregory Renza with Truist Securities. Please unmute and ask your question. Greg, good good morning, and thank you, Ascentage, for taking my question, congrats on the progress. My question, just to start, is just on the sapticlox. Certainly, when it comes to the commercial trajectory over this year, could you just comment about how that's perhaps changed since Sonro has entered the market? Are these two drugs competing directly, or is liseftriqop certainly as approved in the post BTK monotherapy setting just producing more of a meaningfully different initial patient mix?

1:55:54 And maybe just comment a bit on the five day ramp up as you've mentioned, how that's perhaps translating to more measurable real world advantages in in China? Thank you. Okay. Great question. So, overall, Vishal two, is a very tough target. Right? And we have been working on that in the lab for thirty years, clinically for twenty one years, advanced the three product in the clinic, but, only the server cost made to the market. But again, compare we always compare with another class and that daily dose or not, was a key differentiation in the beginning. We're the only one approved to go to the clinical trial and approve the label, with the clinical data.

1:56:46 I think that in the CL, as our patients, some of the early, risk was in the tumor lysis syndrome. That's why, vanilla cast and also cerinocast went to these weekly dose are not right. And require hospitalization and the close monitoring because of tumor lysis risk. But on the other hand, because of the vanilla class already on the market, same with the sorinoclast now, the the differentiation in the chronic dosing patient like a CL is, they actually the safety. Right? Even the drug are tolerated well with the lesser tumor lye syndrome, less bone marrow toxicity, primarily, in our case is we have a shorter t half, that translate into better safety profile, less neutropenia, thrombocytopenia, and also much less infection.

1:57:42 Some of the hematology molecules in patients in the clinic presented the first is actually the infection, like a high risk MDS. Right? And then they find out actually the bone marrow is the one has the cancer cells. Right? So the the patient with a high risk of infection is important. You have a lower risk of DDI drug to combine with. Right? Not just to combine with asascitidine as standard care for high risk MDS right now, but also in some case of marrow, you know, disease, especially the motor myeloma, the combination with, you know, antifungal drug is essential, for those patients. I think the key differentiation as we we alluded to before, is less is more.

1:58:31 So they compare even with the sorinoclass now on the market, you see from their label that they even have a higher risk of DDI than meninoclass. Okay? So I think that the differentiation in terms of daily dose are not committing, better safety profile, tolerance, and lower risk of DDI is important for these chronic dosing, leukemia patients. I think that they those are the one we remain confident. We'll show that, you know, benefit to the patients globally once once they reach it to the market. That that's really helpful. Thank you, doctor Yang. And maybe, just a question on on the pipeline that you spoke highly of, APG one one five and that development flexibility that you have with the program as well as three thousand two eighty eight and certainly the synergy potential there with your portfolio. Can you just comment about how you and the team are thinking about prioritizing your resources to accelerate the programs beyond the the two commercial assets and which ones you're perhaps most excited about? Thank you.

1:59:45 To be honest, it's hard to say which one is all data driven. Right? But to your question, we we we are very happy to see we demonstrate clinical benefit in the pediatric soft tissue tumor setting, combined with, in our case, b cell two inhibitor. Right? So one of the challenge for the MDN two fifty three target, that's why currently no approved product yet, is this negative feedback loop and, also the requirement of a combination. We have tried multiple, you know, including the combo with KEYTRUDA in the phase two setting, multiple tumor indications, but we haven't really see the signal for the rejection pass before.

2:00:34 But currently, we do see now with this combination with the b shelter inhibitor, clinical benefit, and the MOA of a synthetic lethality. On the other hand, even though this is from the competitive product, the CARTOs, you know, CARTOs compound, you know, also enter the phase three registration trial, which is the add on strategy of, you know, a JAK inhibitor in MF. And obviously, it's encouraging to see, Ipsen enter the acquisition, with a potentially 1,750,000,000. I think, there is a potential, maybe, at the end of the tunnel, see the finally, MDN two fifty three inhibitor may enter the market or or registration pass.

2:01:21 For your question, I think, among the pipeline, we have five of them right now. Each one of them have a unique different, strands differentiation based on the current data. Obviously, the two, new one, the EAD inhibitor five nine one eight, we will show the data, at ASH this year. We have completed, you know, close to a 100 patient phase one trial, in informal setting. We are very excited, to show, these data, the upcoming ASH, that's already submitted. And, for the EED, inhibitor, there's also potential, in, you know, prostate cancer in some other settings of a solid tumor.

2:02:07 I think that there's a lot of potential, in the EED. We are the first one in China globally, the second in oncology setting. And I think that there are lot of potential in the ED in both him and solid tumor. And, of course, the BTK degraders 32 ADA is also very exciting in terms of oncology, non oncology. I think that they currently, in addition to the two, you know, approved product in China, globally for registration trial, clearly the focus. Right? We we want to, you know, getting the first I n NDA filed with the FDA, and those two product. But as as you can see, on the five clinical stage asset, these are those three I mentioned, clearly show the leading, advantage globally with clearly clinical data.

2:03:04 I think, those are still early, not reaching the registration trial yet. So I think, we have sufficient resources in terms of budget and the clinical team, to advance those trials. Again, which one is the favor? It's hard to say. It's all data driven, but I think, all these three do have a really exciting data and a path to registration. Yeah. Maybe just to add to that, you know, as it relates to our presence in China, our legacy in China, we have you know, we're one of the few companies that can derisk and gain, you know, real information about how to tactically prioritize our portfolio and what to take and execute in other countries and globally.

2:03:56 So I think that's important to keep in mind about us. That's great. Thank you, gentlemen, for all the color, and congratulations again. Your next question will come from the line of Mayank Namtani with B. Riley Securities. Please go ahead with your question. Yes, team. Thanks for taking our questions, and appreciate the helpful detail. A couple of quick questions on, the Zafclax. I think you were talking about when failure patients, development being explored. Could you maybe just touch on, you know, how quickly you can generate data there? What is the, you know, patient pool look like? And then on, Dora four, if you could maybe comment on your expectation for, you know, CR rate and TLS, and and how maybe the intent and OS analysis would be handled in the study if you, if there's anything early built in there.

2:04:55 And then I have a follow-up question on on Polaris. So the, the the first question, I think, maybe Yifan can answer. Great question. Yes. Based on our preclinical data, we have reported using nisoft class in combination with overamplatin, able to overcome mystic acid resistance, which we have previously reported at the AACR. We also, use very preliminary data we submit to this year, ASH.

2:05:44 And and and when the data mature, will we have data demonstrate the combo able to overcome the, when the cause of resistance? The data is preliminary, but very exciting. We submit the abstract to OSH. So that's just your question. We, in the process, in globally, including in China or outside China in US, and we try our best effort, try to enroll more, when we class treatment failed patient population, using different, strategy, based on the known, resistant mechanism to to target this van resistant AML population, either using the combo or our other, compound, ABG twelve fifty two.

2:06:44 To adjust your question, GARA four study, as we mentioned, because this is a double blind randomized study, We cannot analyze the data early because the enrollment is still ongoing. But but as we I mentioned earlier, we plan to complete enrollment, either by the end of this year or early next year. Because based on the current design and the dual primary inhibitor, we we were able to, submit the NDA, and using the CRA as the primary endpoint and then continue to to mature the OS data and sometimes next year.

2:07:42 Thank you. I appreciate the detail. And then on a similar kind of question on POLARIS two, you know, on the treatment effect for twenty four week MMR rate, if you could maybe just comment on, you you know, what's what you've powered the study for. And I was also curious because your, you know, MMR rates grow over time, you know, forty eight, ninety six weeks. How are you handling, you know, crossover from control amp and up there? Are they do they have option to get the get your drug, or or they're moving on to other other trials? And and what sort of longer term efficacy we can get there? Very good question. So based on the current study design, at the beginning, actually, FDA deny our study design to allow patient crossover from the control arm to the investigation arm. But later on, we we try again to request the FDA finally give the green light, allow those patient fail from the control arm and crossover to overamatinib.

2:08:50 So that will make the study more attractive, number one. Number two, regarding the the endpoints. So currently, we use the twenty four weeks at the twenty four weeks MMR rate as the primary endpoint. So the basic this study design is, the power enough and and double the MMRA compared to control arm. Okay. And, also, just to add a one, the the design of the Polaris two in terms of because of the project optimists.

2:09:36 Right? You have to do the RCT, and, you have to have a control arm. But, in that particular setting, FDA, you know, did agree. This is a two to one ratio. So and also allow the crossover. Okay? And, remember, the Polaris two also have the arm b, the mutation was t three one mutation patient only that we can do the single arm design, with forty eight patients. Okay? So I think that the total Polaris, two is three hundred thirty three patients and, enroll well. And then the six months MMR rate for the initial filing, of the, NDA with the FDA.

2:10:25 Awesome. Thank you. And last one for Veith, if I may, just if you could comment, Veith, on your OpEx trajectory and, you know, if you're getting to, peak since I I know you have a lot of registration studies. Just maybe comment on where we are with the r and d spend on what you expect to see with the pipeline over the next twelve months. Thanks for taking the question. Yeah. Great question, Mayank. So, so as I said, we, we reaffirmed our our cash runway, and, we're, you know, happy that we've been, adhering to our, forecasted forecasted, spending, you know, given the scale of our studies, you know, globally, multiple countries. And, you know, we're at a we're at a point now what we wanted to do for this year was to, you know, de risk the balance sheet in 2025 so that we can, you know, execute on enrollment.

2:11:20 And this year is the year of execution. Enrollment is going well. You know, doctor Young and doctor Zai would discuss that. And so I think as it relates to the expenses for the studies, we're now given we're at the late stages of enrollment, we are now kind of, at the peak as it relates to, OpEx spend. So so all that is going as it as planned and expected. And, we are, not only in a position to, complete enrollment, but also with the cash we have on hand, but also for data, as well as our multiple NDA filings.

2:12:09 So those are the, key, expected milestones, we have with the cash in our balance sheet. Got it. Thank you, It. Of course. Your final question will come from the line of Michael King with Rodman and Renshaw LLC. Please unmute and ask your question. Thanks for taking the question. Congrats on the progress, guys. Maybe I wanted to drill down a little bit further on the balance sheet question. If you could talk a bit about a little further about capital allocation because you guys do have a fairly hefty burn rate. And even with the Takeda opt you know, it's still, you're going to require a lot of capital.

2:12:55 In highly competitive markets, even with differentiated products, you do have entrenched competition. So I'm just wondering, how if you feel any urgency to, do additional partnerships or other, types of arrangements where you could, lay off, some of the capital allocation demands. Yeah. Maybe I can start. Oh, go ahead, Doctor. Young. We you go ahead. Yeah. In terms of, you know, allocation of our total budget to, programs, we haven't given that level of attribution. But, as I stated, we have prioritized so that, we can, align our spend with expected major, milestones and catalysts. So, obviously, that's the that's what we wanted to establish.

2:13:47 What we have done is, you know, with the dual listing, steps we've taken, is allow ourselves, we believe, within, as reasonable as possible, maximal, flexibility and optionality in terms of, various alternatives, to raising capital. Obviously, when it comes to commercialization, that requires expansion capital. And we believe as a company, we've allowed ourselves to, hopefully deliver on catalysts, gain value, and, thereby have less dilutive sources for raising capital going forward. And of course, with Faisal onboard, the optionality, as it relates to potential partnerships, when it makes sense as well. So we are not in a pressure, for one particular path, which is exactly where we want to be at this point.

2:14:52 Yeah. I think, I fully agree. Just to add one, more point that our current cash runway, as we stated before, consistently can support our our r and d plans through the end of twenty twenty seven. More importantly, was, you know, non rejection trial and, for global, cleared by FDA and EMA. Majority of this, enrollment are already done. You know, I see that's why you see the first six months, you know, we have our own expense, you know, more than 30% increase, primarily due to this, you know, heavy enrollment. But the good news is that that that most, you know, part of the, you know, cost is already, at least more than halfway done.

2:15:39 Right? Of course, we remain, open, flexible, for many, you know, options for the, you know, fundraising, and also partnership, other, source of, income. On top of our, you know, you know, positive, continue to grow revenue, with the two product sales in China. I think that we're really unique is not just because we have, you know, legacy and resources in China, but also study the growing revenue income, from China and looking forward, for the global, commercialization and the revenue as well. Well, thanks for taking the questions.

2:16:29 Thank you, Mike. That concludes the question and answer portion of today's call. I will now hand the call back to management for closing remarks. Thank you all for, joining us. I I think, this, interim report again position us well, to be the global player of, you know, in the hem malignancies. And, more importantly, we are advanced, well in terms of all the key registration trials. And then with the target to complete them by the end of the year or early next year. But more importantly, we are in the position.

2:17:14 If you look at some of the competitor or the really excellent biotech company this time last year. Okay? So I told my team and the many investors, Ascentage will be a different company by the time next year. Okay? So we're looking forward to your support and looking forward to working with our team, investors, and the HCP globally to make those novel safer efficacious drug into the global market to help patients with unmet medical need globally. And thank you all for your attention and support.