Ascentage Pharma Group International H1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 20, 2026

Key Takeaways

  • Positive Sentiment: First-half revenue rose 29.3% year over year to $44.5 million, including $41.6 million in product sales, driven by continued growth of olverembatinib and lisaftoclax in China.
  • Positive Sentiment: The company said enrollment is progressing across nine global registrational trials, with GLORA-2 completed and GLORA-3 nearing completion; it expects several studies, including POLARIS-1, POLARIS-2, and GLORA-4, to finish enrollment by late 2026 or early 2027, potentially supporting up to three NDA filings in the second half of 2027.
  • Positive Sentiment: Management highlighted lisaftoclax’s approved post-BTK CLL/SLL indication, daily dose ramp-up, and potentially favorable safety and drug-interaction profile, while stating that the product has passed initial review for China’s NRDL and is expected to receive coverage, although final pricing remains uncertain.
  • Neutral Sentiment: Cash and equivalents totaled $279.4 million at June 30, and management reaffirmed runway through the end of 2027; however, R&D expenses increased 32% and selling and distribution expenses rose 64.3% as the company funds late-stage trials and builds commercial infrastructure.
  • Negative Sentiment: Ascentage acknowledged substantial future capital needs for global commercialization and remains exposed to competitive and execution risks, including the need for Takeda to exercise its olverembatinib licensing option and continued competition in Bcl-2 and BTK-targeted therapies.
AI Generated. May Contain Errors.
Earnings Conference Call
Ascentage Pharma Group International H1 2026
00:00 / 00:00

Transcript Sections

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Operator

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 Sumedh Neni. You may begin.

Sumedh Neni
Sumedh Neni
Director of Investor Relations and Corporate Strategy at Ascentage Pharma

Thank you, operator, and good morning, everyone. Thank you for joining today. Welcome to Ascentage Pharma's 2026 interim results and business update call. I'm Sumedh 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. These statements involve risks and uncertainties, and actual results may differ materially. For discussion of these risks, please refer to our disclosures. Joining me today are Dr. Dajun Yang, our Chairman and Chief Executive Officer, Dr. Faiçal Miyara, our Chief Business Officer, Mr. Jim Ziegler, our Chief Commercial Officer, Dr. Yifan Zhai, our Chief Medical Officer, and Dr. Veet Misra, our Chief Financial Officer. Yesterday, we issued a press release with our unaudited financial results for the six months ending June 30, 2026.

Sumedh Neni
Sumedh Neni
Director of Investor Relations and Corporate Strategy at Ascentage Pharma

That release and the slide presentation accompanying this call are available in the investor relations section of our website. Turning to our agenda, Dr. Yang will open with a business update, and we will hear briefly from Dr. Miyara and Mr. Ziegler on the business development and commercial priorities behind our global hematology franchise. Dr. Yang will then cover our R&D highlights, and Dr. Misra will review the financials. Dr. Zhai will also join us for part of the Q&A session. We will then open the line for your questions. I'd now like to turn the call over to our CEO, Dr. Dajun Yang. Dr. Yang, you may begin.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you, Sumedh, and thank you all for joining us. The first half of 2026 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. We are currently advancing nine global registrational trials, four of which are cleared by both the FDA and the EMA. The total revenue grew to $44.5 million, up 29% year-over-year, of which were product sales of $41.6 million on a constant exchange rate basis. And we are reaffirming cash runway through the end of 2027. Importantly, and playing a role to achieving our global strategic objectives, we strengthened our leadership with the appointments of Dr. Faiçal as Chief Business Officer and Mr. Jim Ziegler as the Chief Commercial Officer.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Both are with us today and will be sharing preliminary results. Let's just look at the next slide. This slide, we have two approved products and a late-stage pipeline that's highly de-risked. Olverembatinib, our third-generation BCR-ABL inhibitor, has been approved CML-CP in China since 2021. Tens of thousands of patients have been treated today. The longest patient on our drug has been near almost 10 years now. We have real-world long-term safety and efficacy data that really few companies at our stage can point to. We also have global registration trials, including FDA and EMA cleared, that are ongoing. Our plan is to commercialize olverembatinib in the U.S. and the major pharma markets. Lisaftoclax, our selective Bcl-2 inhibitor, is approved as a single agent in post-BTK CLL/SLL. Globally, we are the second selective Bcl-2 inhibitor to reach the market after decades have passed.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

However, in the single-agent post-BTK CLL, we are actually the first to get approved to the market. Lisaftoclax has a unique daily dosing up. We are the only one approved with that label. Enhanced safety and as well as drug-drug interaction observed to date is much reduced compared to other Bcl-2 inhibitors. It also has FDA and EMA-cleared global registration trials, GLORA and GLORA-4. Behind those two, we also have five additional clinical-stage assets all conducting trials in U.S. and China and the rest of world. APG-2449 is a triple kinase inhibitor covering FAK, ALK, ROS1. The MDM2 inhibitor APG-115, and also targeting both Bcl-2 and Bcl-xL APG-1252, and the EED inhibitor APG-5918.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Also the newer one joining this year to the U.S. and China phase I trial is the APG-3288 BTK degrader. In light of our mission to build Ascentage into a leading global hematology/oncology company, we have strengthened our leadership team in the two areas that determine whether franchise reaches patients outside China: global business development and commercialization. I'm really pleased to welcome Dr. Faiçal Miyara as our Chief Business Officer and Mr. Jim Ziegler 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 attracted them to Ascentage. Faiçal, let me turn it over to you.

Faiçal Miyara
Faiçal Miyara
Chief Business Officer at Ascentage Pharma

Thank you, Dr. Yang. My name is Faiçal Miyara. I'm the current Global Chief Business Officer at Ascentage. I have 20+ years in oncology business development, social evaluation, and I also was involved in venture investing across leading pharmaceutical industry. I was in, as you see in the bottom, multiple large pharmas like Lilly, Pfizer, Sanofi, Ipsen, as well as mid-size biotech like Kadmon and IO Biotech. I was also instrumental in the deal or the M&A that happened between Kadmon and Sanofi in 2021 for $1.9 billion. I led multiple global oncology partnering and executed teams at IO Biotech and Ipsen. When I was at Eli Lilly, I advanced ERBITUX and CYRAMZA as a lead oncology product or antibodies, and co-initiated the Pfizer Centers for Therapeutic Innovation. So I'm very, very pleased to join this very, very good team at Ascentage. We'll talk about our pipeline.

Faiçal Miyara
Faiçal Miyara
Chief Business Officer at Ascentage Pharma

It is very, very outstanding. With that, I will leave it to Jim to give you some information on the Chief Commercial Officer.

Jim Ziegler
Jim Ziegler
Chief Commercial Officer at Ascentage Pharma

Thank you, Faiçal, and good morning, everyone. I am also very pleased to join the Ascentage team. I have spent more than 25 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 U.S. and other key markets. I look forward to providing updates on our progress over time. I will now turn the call back to Dajun.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you both. Let us look at the R&D highlights. Our development strategy is the engine for full global commercialization strategy. Two approved hematology asset anchor it, and everything behind them is designed to add to our best-in-class portfolio. Turning first to lisaftoclax, our cornerstone asset. Lisaftoclax was approved in July last year for the treatment of adult patients with CLL/SLL who have previously received at least one set of therapy, including BTK inhibitors. Actually, we conduct the registration trial for the patients who have failed BTK inhibitors. For that indication, we are actually global first one. More importantly, we are running four global registration trials, two of them cleared by FDA and EMA, 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-4.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In the frontline, high-risk MDS evaluates lisaftoclax in combination with azacitidine versus azacitidine alone. This has been cleared by FDA, EMA, China CDE, and also PMDA in close to 20 countries. Let me also highlight a few key differentiation with two other currently on the market, Bcl-2 inhibitors. As you can see, the lisaftoclax was the only one designed with daily dose ramp-up in the beginning, and the only one approved with only three dose strengths and five daily dose ramp-ups planned, and then reached the target dose, 600 mg, and continue. As you can see, the venetoclax was first approved about 10 years ago, has a five-week dose ramp-up. The other one just approved, sonrotoclax, early this year, with the five-week dosing. I mean, the weekly dose ramp-up by the nine dose cohorts, okay?

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Because lisaftoclax started with 1 mg. Initially in the trials, it was nine weeks. I think they combined two into one week. So each week they have do the ramp-up 2x and then total nine dose levels to reach a target dose. I think that is very important for the patients with the CLL/SLL, the convenience and also reduce the time of hospitalization. Let us also look at the summary of favorable safety profiles and the better drug combinability. We try to compare in the same setting, same patient population, but also be clear, this is not a head-to-head comparison. But if we look at the overall, the safety profile in terms of infection and the PK variabilities, lisaftoclax is probably the best one among the three. If we look at the SAE incidence, lisaftoclax also much lower and no drug-related death reported to date.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In the PK variability, I think the other two are strong, the only three or four inhibitors, and we show minimum fluctuation in plasma concentration compared to other two. I think also no dose adjustment required, compared to the other two in terms of DDI issue. I think for the chronic dosing patient, like many hematology malignancies, safety and tolerance and the drug-drug interaction risk are important differentiation. Let us also look at the key data in the U.S. trials. In the MDS, lisaftoclax as decided in frontline produced overall response rate 80% and 50% in relapse R/R MDS patient. More importantly, we have a 40% CR rate. The time to response also very short. Here we also highlight two representative real-world cases in high-risk MDS, since it was launched last year in China.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In the first case, a 71-year-old patient achieved CR after two cycles with a rapid hematological recovery. In the second case, a patient with a poor response and failed venetoclax and then achieved the CRI within just 14 days after switching from venetoclax. These cases provide encouraging indications of clinical activity, including patients previously exposed to venetoclax. Let us also look at the AML case. The overall CR/CRI rate was 72%, with a 61% MRD negative rate. Response was 100% with patients with NPM1 mutation and 83% in the IDH2 mutation. I think it is important all those trials actually with the patient in U.S. and Australia. This is not the clinical data from China. As we previously indicated, in the case of patient who failed the venetoclax, which is truly a medical need globally, we still see a 31.8% overall response rate with no cases of tumor lysis syndrome.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Same target, same pathway, lisaftoclax remains active. I think at least based on the current clinical data of the resistance to Bcl-2 inhibitor, majority are not due to new mutations, but MCL1 upregulation and some also with the Bcl-xL upregulation. So I think that explain partially why the same AML patient failed venetoclax, lisaftoclax can still achieve activity. So I think that those reflects a key differentiation in the downstream resistance profile and represent meaningful clinical opportunity. But of course, more importantly, with the better safety profile and the lower risk of DDI, also provide more opportunity for combination. In our case, combination with olverembatinib would overcome venetoclax resistance in AML. Turning to the second pillar of product strategy, olverembatinib.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I also want to highlight why we believe this can be a best-in-class third-generation BCR-ABL inhibitor to patients with CML in the second line or late settings. This has already been approved and highly de-risked asset with several years of clinical and real-world use in China. We receive a validation from Takeda as they hold exclusive option to license olverembatinib outside Greater China and certain other territories. This was entered with Takeda about two years ago. Globally, the most important study for the CML is the POLARIS-2. Part A enroll chronic phase who has received at least two prior TKI randomized olverembatinib against bosutinib. This is clear by FDA and EMA, and there is also Part B, which evaluate olverembatinib in patients with T315I mutation. As you know, bosutinib does not have activity, so that is the single-arm trial.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

You can see, this is a difficult second-line patient population, which we believe olverembatinib can be most differentiated. Besides the CML, olverembatinib also have a strong activity in Ph-positive ALL. So POLARIS-1 is also important. This is our global phase III study in newly diagnosed Ph-positive ALL. 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 we continue to advance the global study. Let us look at some of the important bridging study, led by Dr. Elias Jabbour at MD Anderson. This actually was conducted four or five years ago. Dr. Elias Jabbour, as you know, is a leading investigator in CML and also Ph-positive ALL. In this particular study, we enroll 62 heavily pre-treated CML-CP patients.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

More than half 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 T315I mutation. I think with this really poor baseline patient population, we achieved the MMR as a single agent, 42.9% in ponatinib-resistant patients, 33% in asciminib-resistant patients, and more importantly, 27% in patients who failed both ponatinib and asciminib. Basically, those are the patients with no other options. But single agent olverembatinib have a pretty good efficacy. I think that this treatment, again, strengths the overall differentiation and the clinical efficacy versus ponatinib and asciminib. Also we have a pretty long-term safety profile. In China, the longest patient have been using olverembatinib almost 10 years, since October 2016.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In this particular patient trial, the longest patient treated in the U.S. is over three years with a manageable safety profile. Let us turn to slide 16. I want to show some more recent data. I think one case is the second-line trial strategy. Olverembatinib demonstrated 47.6% MMR rate as a single agent. More importantly, the new data, just in this year reported, in a prospective controlled data, in the second line or late-line setting, showing a clear benefit from switching to olverembatinib, a type of evidence that remains uncommon in this patient population. I think the differentiation you can see is very dramatic, right? So if they do not switch to the best-in-class potential olverembatinib, the MMR rate remain only 10%. I think that is a huge benefit in terms of for the patients in the late-line CML. Those patients actually have been treated with at least two TKI.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Some of those also with asciminib. Olverembatinib delivered six months MMR rate 54%, and then even higher at 57% in 12 months. Those who did not switch remain only low 20% response. I think, as you can see, this is a huge benefit for patients if they switch to the olverembatinib. Also important safety profile in terms of AEs. Let's turn into slide 17. I think that the benchmark is important because the landmark changed over the last two years. I think in addition to at least two years ago, the only competitive product we consider is the asciminib, but now there is two drug TERN-701 and ELVN-001 in the study in the U.S.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

But first, I think the most important one, we are the only one have long-term evidence, the other program does not yet have as those are still in the phase I or early phase II, and we have six years follow-up for patients who are in the second line, and 10 years for the first line, the phase I trial. We are the only one have controlled the comparative data set. Those are new requirement from FDA in terms of Project Optimus. So you have to run the RCT trial in order to get the NDA approved. Another important differentiation in the CML patient population is really the baseline, right? So you can see the patient treated with olverembatinib are more late-line, heavily pretreated, and also with the mutations.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I think those data clearly demonstrated olverembatinib as the potential drug of choice in the second line of CML after patient who failed the most advanced available TKI. 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 69 blast crisis CML patient who went on transplant, and 26 was treated with olverembatinib, and 43 with first and the second generation TKI. So the olverembatinib group entered transplant in deeper molecular remission. MMR rate 53.8% versus only 16%, and the CMR rate 23 versus 4.7%. The olverembatinib also have more favorable survival outcome, one year overall survival of 89% versus 71%, and the no relapse mortality 11% versus 23%. These are the two separate patient cohorts in a retrospective real world analysis, not a randomized comparison.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

But again, demonstrate important differentiation of olverembatinib in large patient population, on how to treat CML patients. Let's also take a look at the combination strategy. In the patient in the POLARIS-1, with low intensity chemotherapy in front line. I think that the POLARIS-1, three key important differentiation, the data. One, this is front line newly diagnosed Ph-positive ALL. In most cases around the world, chemotherapy is still required because of the aggressiveness nature of the Ph-positive ALL. In the registration trial design, we conduct the Part A, with the low intensity chemo. As you can see, this demonstrate MRD negative CR rate about 63%. This is almost double the ponatinib in the same patient population, the PhALLCON trial, about 34%. Of course, in the trial data, the imatinib only 17%, dasatinib is only about 20%+.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

So this clearly demonstrate, in the registration trial setting, olverembatinib is the best among the current treatment option. We also try to enter the chemo-free registration trial. Currently, we have data from the oral report at the ASCO, by Dr. Elias Jabbour around MD Anderson, demonstrate that if we combine with the blinatumomab, we can achieve 80% MRD negative rate, and a 91% CR/CRI. We also demonstrate importantly in the pediatric R/R Ph-positive ALL patients. Actually, those data have been available, reported first time two years ago. We continue see benefit of safety and overall response. I think very impressively, we achieve 89% overall response rate after cycle two, day 15, and the overall complete response in an oral chemo-free regimen. I think that this combination data is key because this is two orally active agent, chemo-free, in the pediatric ALL setting.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Moving on to the APG-115, another asset in our portfolio, small molecule targeting MDM2-p53. It actually holds six FDA ODD, and two rare pediatric disease designation. This actually has been conducted in our portfolio for a while, as there's no approved product yet globally, targeting the MDM2-p53, as MDM2-p53 is one of the most important tumor suppressor gene. But I think that you do see some recent progress that Ipsen acquired Kartos MDM2 inhibitor, and with actually pretty decent $450 million up front and up to $1.75 billion, including milestones for our phase III program in myelofibrosis. I think that there is a probably potential for the MDM2-p53 inhibitor combined with a JAK inhibitor in that actually trial as an add-on strategy. I think that data is encouraging. We are also currently do that trial with MF patients. So again, this remain wholly owned by us.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In the ASCO, we present encouraging data for APG-115 in combination with the lisaftoclax in the pediatric soft tissue sarcoma patients. Globally, pediatric rhabdomyosarcoma and other soft tissue sarcomas are truly a medical need. In that setting, we demonstrate good combination safety and impressive 23.5% response rate and also 70% disease control rate. I think that those 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. Here's a slide to show you that the cornerstone asset of a Bcl-2 inhibitor lisaftoclax combinability with three other targeted small agent all are already active. I think we all know, as mentioned, that the main reason for Bcl-2 resistance is the upregulation of Mcl-1. So we have demonstrated olverembatinib actually can indirectly down-regulate Mcl-1.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

We not only have preclinical data, but now have clinical data to demonstrate that combination of the olverembatinib with lisaftoclax can show the synergy, more importantly, not just the CML or Ph-positive ALL, but the patient with AML or MDS and the Ph-negative ALL. Especially for those patients who fail the venetoclax in the AML, we have clinical data to demonstrate that in addition to what we showed before in the Ph-positive ALL. Again, with MDM2-p53 inhibitor APG-115, now we have clinical data to demonstrate the safety efficacy, especially in those hard-to-treat soft tissue sarcoma patients. We are 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 all three assets wholly owned by Ascentage.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

In the interest of time, I do not have much data to show, but I can tell you that our BTK degrader, APG-3288, have advanced well in the phase I setting in both the U.S. and China across the B cell malignancies who previously exposed the BTK inhibitors. I think we can stay tuned for the progress for both the oncology and the non-oncology indications with the BTK degrader. I think that is all the highlight of our R&D. Let me turn the call over to our CFO, Dr. Veet Misra, for the review of our financial result. Veet?

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Great. Thank you, Dr. Yang. Good morning, everyone. Turning to our financial results, the first half of 2026 was another period of continued commercial growth and investment behind our global development programs. Total revenue was $44.5 million, compared to $32.6 million in the first half of 2025, representing an increase of $11.9 million or 29.3% on a constant exchange rate basis. Product sales growth has been our main driver, as indicated by $41.6 million 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 OpEx and supporting our, and advancing our global clinical programs. Research and development expenses were $102.8 million, compared to $73.8 million in the first half of 2025, representing an increase of $29 million or 32% on a constant exchange basis.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

As planned, this was our expenditure, to execute on our high priority to advance enrollment in multiple global registration trials. Selling and distribution expenses were $33.4 million, compared with $19.2 million in the first half of 2025, representing an increase of $14.2 million or 64.3% increase. This was driven by marketing and commercial investment behind our products. Administration expenses were $17.5 million, compared to $13.9 million in the same period last year primarily due to RSU expense. Turning to our balance sheet. We are pleased to report cash balances were $279.4 million as of June 30th, 2026, as well as reaffirming our cash guidance runway through 2027, as we have said before. This funds us through multiple key registrational studies ongoing globally.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

To emphasize, we are funding nine registrational programs and are currently taking initial steps to building a commercial organization in the U.S., and remain on target for investments required at the appropriate time to fulfill our global strategic objectives. Thank you. With that, I will turn back the call to Dajun for his closing remarks. Dr. Yang?

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Great. Thank you, Veet. I think that with the overall R&D highlight and the financial update, as you can see our last slide, to show we have seven active products in the clinic, with two of them already landed, approved in China. But more importantly, with these already active target agent, we cover all majority of Heme malignancies, from the CLL/ALL 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. To become a global player in the Heme malignancies globally. I think that's all for the brief update with the key data and the financial results. Thank you all for joining us, and also our team.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I think now we are open for the Q&A.

Operator

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 Cheng with JPMorgan. Please unmute your line and ask your question.

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Hey, guys. Thanks for taking our questions this morning. Faiçal and Jim, welcome to the team. Just to start off, in China, can you talk about how we should think about the NRDL listing for specifically lisaftoclax later this year? Can you talk a little bit about 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? Then we have a couple follow-up. Thank you.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you, Brian. A very good question. Lisaftoclax was approved in China July last year. We are the first domestic Bcl-2 inhibitor approved in China. We are the only one, the first one, approved in terms of post-BTK R/R CLL/SLL patients in the registration trial. That was a tough trial, but we demonstrated good safety efficacy. We clearly show the differentiation versus venetoclax or sonrotoclax in terms of the only approved daily dose turn up with a clear safety profile and a lower risk of DDI. I think if you are looking not just at clinical data, but the NRDL reimbursement, less hospitalization, less risk, and also convenience are all important favorable factors for the NRDL consideration. 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.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

This year, the timeline is actually a little bit ahead of previous timeline. As currently, there are two groups, NRDL experts, officials, and those health economics experts are conducting the meetings, reviews right now. We may call up to a meeting with the experts later this month or early September. Then with the final, we are very confident we will get NRDL coverage for these indications in China. The concern we have or worry is working with the expert is the final price. Of course, venetoclax is already covered for different indication AML in China. It is probably a benchmark. I think we are confident we will have coverage for this indication.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Which is important in China, that NRDL is not just a reimbursement, but the ticket to enter the hospital. Majority of hospital in China rely on the NRDL approval to enter the hospital in terms of a prescription. In case of a CLL/SLL, this is chronic dosing patients. Reimbursement by NRDL means that they can reduce their out-of-pocket payment by the average two third, 60%-70%. In certain regions, the NRDL coverage can up to 90%, so I think that is a huge benefit to the patients in chronic leukemia setting.

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Great. Maybe just also turning into your ongoing clinical studies. Curious if you can talk about what is going on with POLARIS-1 and GLORA trials, specifically how is enrollment looking like, and just any sense of how we should think about the timing of the next data readout, and potential pathway to NDA filing. How should we think about the timing of those milestones?

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I think for those question, maybe we have our CMO, Dr. Zhai, on the call. Maybe Dr. Zhai can give some answer first. Dr. Zhai?

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

Sorry, Brian. Regarding GLORA-4 study, right? Sorry, I thought you addressed somebody else's question. Could you—

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Yeah.

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

—repeat the question?

Brian Cheng
Brian Cheng
Analyst at JPMorgan

No problem. Yeah, no, just curious how the enrollment is going in the global studies like POLARIS-1 and also the GLORA studies for lisaftoclax. How's enrollment going, and do you have a better sense of when we are going to get the final data cut, to file for the NDA?

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

Regarding all those global registrational trials, the team worked very hard and tried to complete their enrollment as soon as possible. It is still under the plan. In particular, the GLORA-4 study perhaps is under the radar and everybody paid particular attention to that global registrational trial. Regarding GLORA-2, GLORA-3, and Dajun actually already announced yesterday we already completed the enrollment. For GLORA-2, I am waiting for the data review to mature. GLORA-3 also very close, and the remaining, we plan to complete the enrollment either by the end of this year or early next year.

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Great. Thank you.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Let me add a few points to what Yifan said. We have said yesterday in the Hong Kong call that we completed the enrollment for the GLORA-2, which is frontline CLL/SLL setting, combination with other setting and with fixed duration. Of course, that one is not with the FDA, because the control arm is the chemo immunotherapy. That is also over 400 patient enrollment demonstrate our capability in the clinical operation. GLORA-3 is the AML combo with azacitidine versus azacitidine alone. We are in the final stage to closing the enrollment. The GLORA-4, obviously, in the high-risk MDS, many people are watching closely. I think there are a few key points also important to share. One is, this is the frontline. The frontline patient with high-risk MDS. In the trial design, similar to the VERONA, the combo with azacitidine, versus azacitidine alone.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

This has been cleared by FDA, EMA, PMDA, and China. Globally, not because venetoclax failed, but also another Bcl-2 inhibitor, venetoclax, is not on the MDS, not on the registration trial. Globally, we are the only phase III registration trial for the high-risk MDS. There is no target drug approved in the high-risk MDS in the last 20 years. This remains globally a mathematical need, and enrollment is doing well because experts around the world in MDS are really enthusiastic, all want to help patients with high-risk MDS. Overall, I think to summarize, we anticipate, as we said before, the enrollment for GLORA-4 and the POLARIS-1, POLARIS-2 could complete by late this year or early next year. The good problem to have, we are looking for potentially three NDA to file the second half of next year.

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Great, and if I can squeeze one more in. Just for the BTK degrader, APG-3288, do you have a sense of what you want to see from the early data cut so that investors can make a good comparison against other BTK degraders? Do you have an internal benchmark of efficacy early on? Thanks for taking our questions today.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Yeah, I think we all know that the BTK as a target is very competitive, very crowded, and there are many inhibitors, covalent, non-covalent on the market, and some are doing very well. But the BTK degrader does have an advantage, at least with some of the current up to even Phase III data. We conducted carefully preclinical data to show our drug APG-3288 versus other two from Nurix or BeiGene that have better selectivity and stronger efficacy. But that, again, is in the preclinical setting. Currently, I think in the phase I, we are moving along very well in terms of dose escalation for safety. But more importantly, first, those are all BTK-exposed patients. Doesn't matter covalent or non-covalent, and we want to show some response in those patient population first, right? That is important. That is the key differentiation for the degrader.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Second, we probably will take some patient population, the indications that currently BTK inhibitor is not very active. Some more so importantly, combination with our Bcl-2 inhibitor. I think one example in that setting may be the DLBCL, because so far the BTK inhibitor has not shown good activity as a single agent in that DLBCL setting. And of course, there are also a lot of data that combined with the Bcl-2 may have better readout in this patient population. Another potential one, but we do not have data to share yet, is in the non-oncology indication. I think that there are many autoimmune indications could be benefited with the BTK degrader.

Brian Cheng
Brian Cheng
Analyst at JPMorgan

Great, thank you, Dajun, and congrats on the progress.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you.

Operator

Your next question will come from the line of Biren Amin with Piper Sandler. Please unmute your line and ask your question.

Biren Amin
Biren Amin
Analyst at Piper Sandler

Yeah. Hi, team. Thanks for taking my questions. Maybe if I could just start with the POLARIS-1 and POLARIS-2 trials. Can you just provide us with an update in terms of when we can expect data from both studies?

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Again, for that question, Yifan, our CMO, can address first.

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

Oh, we just addressed the same question. Let me repeat it. Currently we are very actively enrolling patients and plan to complete the enrollment either by the end of this year or early next year. We plan to submit the NDA next year.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Yeah, I think that they just added a little bit. For the POLARIS-2, the filing NDA is six months MMR rate after the last patient in. We already demonstrated very strong data in the MMR rate for this patient population, and we are confident on that. The key, of course, is finishing enrollment. For the POLARIS-1, the filing of NDA with FDA is the three months MRD negative CR rate. I think, again, the target enrollment is on track. With these six months or three months endpoint for the NDA filing, we are looking for potential filing of those two NDAs second half of next year.

Biren Amin
Biren Amin
Analyst at Piper Sandler

Great, and maybe just follow up on a couple of questions. For olverembatinib, when could we expect to see Takeda make a decision on its option on the license? That is the first question on the global license. Second, as it relates to China specifically, where are you as it relates to achieving access to 2,000 hospitals in China? I think that was a target that was previously set by the company. Maybe a question on the BTK with APG-3288. Could we see first data at ASH this year, and are you planning to evaluate also in the MS setting?

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Maybe I will answer your last question first. The APG-3288 is still ongoing in the phase I trial, U.S., China. I think because this is dose escalation and the cutoff for the ASH already ended, we do not anticipate to present the phase I data this year at ASH. The progress is doing well. Perhaps we can have some to share maybe EHA next year in terms of timing for the phase I data. Again, we are conducting several autoimmune indications demonstrating good preclinical activities. Because the non-oncology trials in the phase I health volunteer, you do need a placebo control, right? That is where we are working with to getting IND filed for the non-oncology indications, including the MS. That data will come from a little bit behind because of making the placebo control.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

We do anticipate the IND to be filed soon with the autoimmune indications. For your first question, I think the Takeda deal, as you know, we entered the global exclusive partnership option agreement two years ago, 2024. That is again exclusive global outside China and some territories. For that, Takeda, back two years ago, paid $100 million upfront and $75 million equity investment. There is also a total up to $1.2 billion aggregate when they exercise the option and a certain milestone payment. Also they tier the royalty rate from 12% to start, up to 19%. I think globally, Takeda is a key player in the CML and ALL, after Novartis, obviously. I think we do believe Takeda is an important and a global partner for commercialization of olverembatinib.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

One of the main reason for the option agreement is obviously they have a competitive product, ponatinib, and the potential antitrust issue. ponatinib patent will expire early next year. I think that is the key component in the option exercises. Also we do work closely since the option agreement signed with the Takeda team. We are actually working closely together to advance all the enrollment and a lot of KOL reaches and planning for the commercialization. With Jim on board, we do looking forward working together ahead of the launch with the Takeda team for the great potential of olverembatinib in the global market. I think you have one more question about the hospital, right? I think currently we are doing well in terms of getting the hospital covered.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I mean, still have a second half of time to report, but we are on the track currently bring the total commercial team about 300, and the goal is to build close to 400 commercial forces in China. I think it is not just the number 400 staff in the commercial team, but more importantly is to cover 80% of the market potential with the two product in China. I think that is where the 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 U.S. and China.

Biren Amin
Biren Amin
Analyst at Piper Sandler

Great. Thank you.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you.

Operator

Your next question will come from the line of Jeet Mukherjee with U.S. Bancorp BTIG. Go ahead with your question.

Jeet Mukherjee
Analyst at U.S. Bancorp BTIG

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-1, 2 and GLORA-4? Then just turning to olverembatinib, 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.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Really great question. First, based on the preclinical data, our drug is probably among all the TKIs or all LSD1 inhibitors, the most potent one against the T315I mutation and also the compound mutation. Because in the BCR-ABL gene, the mutation not just happen in one hotspot. The T315I is considered a gatekeeper mutation, differentiate those in terms of third-generation BCR-ABL inhibitor. On top of that, there is also the more than one mutation, called a compound mutation, in the same cell. Currently, asciminib and also those TERN-701 or ELVN-001 do not have those strong data. So olverembatinib is the most potent one and also most active one against a wide spectrum of mutations, including the compound mutations. That hurts about at least up to 40% of layline CML patients.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Currently, even though asciminib has approved a label with only U.S. to treat the patient with the T315I mutation, they need a five-time dose, and also in U.S., that is 5x the cost, almost a million dollars. I think that in the layline CML, patients with mutations, we do show probably the most potent one. ELVN-001 or TERN-701 now with Merck do not have those data. They are also mostly in the early phase I or II. In the U.S., because the Project Optimus, we have those data four or five years ago with MD Anderson, that we have patient basically unmet medical need. Patient who fail both ponatinib and asciminib are the patient with no other treatment options.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Because of the Project Optimus, FDA do not allow the single agent, single arm period of phase II trials for the registration. That is why we have to conduct the RCT. We have to have the control arm like bosutinib. I think that none of those competitive products have those data or registration trial agreement with the FDA yet. In the real world, the consensus among the CML experts community is you want to give the best BCR-ABL inhibitor to the patient failed after first-line early. You do not want to wait until after four or five line. You want to give the strong one so the CML patient who achieve deeper response, like a MMR, MRD, an active CR, or the MR4 or DMR of 4.5.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Patient who can achieve a deeper response early would be able to achieve TFR, and in certain cases, maybe, drug-free for many years, defined as a clinical cure. I think that is important. That is why we have a second-line data. We have the real world data perspective comparative study to demonstrate that olverembatinib could be the choice of patient who failed the front line. It does not matter is it TKI or asciminib or any other allosteric inhibitor. That is the goal. That is the key differentiation we have been showing, presented with the clinical data.

Jeet Mukherjee
Analyst at U.S. Bancorp BTIG

Thank you. Appreciate it.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you.

Operator

Your next question will come from the line of Gregory Renza with Truist Securities. Please unmute and ask your question.

Gregory Renza
Gregory Renza
Analyst at Truist Securities

Greg, good morning, and thank you, Ascentage team, for taking my question, and congrats on the progress. My question just to start is just on the lisaftoclax. Certainly, when it comes to the commercial trajectory over this year, can you just comment about how that is perhaps changed since sonrotoclax has entered the market? Are these two drugs competing directly, or is lisaftoclax certainly as approved in the post-BTK monotherapy setting, just producing more of a meaningfully different initial patient mix? Maybe just comment a bit on the five-day ramp-up as you have mentioned, how that is perhaps translating to more measurable real-world advantages in China. Thank you.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Great question. Overall, Bcl-2 is a very tough target, right? We have been working on that in the lab for 30 years, clinically for 21 years, advanced three products in the clinic, but only the venetoclax made to the market. Again, we always compare with venetoclax, and that daily dosing up was a key differentiation in the beginning. We are the only one approved to go to the clinical trial and approve the label with the clinical data. I think in the CLL patients, some of the early risk was in the tumor lysis syndrome. That is why venetoclax, and also sonrotoclax went to this weekly dosing up, right? Require hospitalization and close monitoring because of tumor lysis risk.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

But on the other hand, because venetoclax is already on the market, same with sonrotoclax now, the differentiation in the chronic dosing patient, like a CLL, is actually the safety. If the drug tolerate well with less tumor lysis syndrome, less bone marrow toxicity primarily in our case is we have a shorter T1/2 that translate into better safety profile, less neutropenia, thrombocytopenia, and also much less infection. Some of the hematology malignant patients in the clinic presented first is actually the infection, like a high-risk MDS. And then they found out actually the bone marrow is the one has the cancer cells. So the patient with a high risk of infection is important you have lower risk of DDI drug to combine with.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Not just combine with azacitidine, standard care for high-risk MDS right now, but also in some case of marrow disease especially the multiple myeloma, the combination with antifungal drug is essential for those patients. I think the key differentiation, as we alluded to before, is less is more. So they compare even with sonrotoclax now on the market, you see from the label that they even have a higher risk of DDI than venetoclax. Okay? So I think that the differentiation in terms of daily dosing up convenings, better safety profile tolerance, and lower risk of DDI is important for these chronic dosing leukemia patients. I think that those are the ones we remain confident will show the benefit to the patients globally once they reach to the market.

Gregory Renza
Gregory Renza
Analyst at Truist Securities

That's really helpful. Thank you, Dr. Yang. Maybe just a question on the pipeline. You spoke highly of APG-115 and that development flexibility that you have with the program as well as APG-3288, 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 two commercial assets, and which ones you're perhaps most excited about? Thank you.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

To be honest, it's hard to say which one. It's all data-driven. But to your question, we are very happy to see we demonstrate clinical benefit in the pediatric soft tissue tumor setting, combined with, in our case, a Bcl-2 inhibitor. So one of the challenges for the MDM2-p53 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, including the combo with KEYTRUDA in the phase II setting, multiple tumor indications, but we haven't really seen the signal for the registration path before. But currently, we do see now with this combination with the Bcl-2 inhibitor, clinical benefit and the MOA of synthetic lethality.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

On the other hand, even those from the competitive product, the Kartos compound also entered the phase III registration trial with the add-on strategy of a JAK inhibitor in MF. Obviously, it is encouraging to see Ipsen enter the acquisition with potentially USD 1.75 billion. I think there is a potential, maybe at the end of the tunnel, to see that finally MDM2-p53 inhibitor may enter the market or a registration path. For your question, I think among the pipeline, we have five of them right now. Each one of them has a unique different strength differentiation based on the current data. Obviously, the two new ones, the EED inhibitor APG-5918. We will show the data at the ASH this year. We have completed close to 100 patient phase I trial in informal setting. We are very excited to show this data at the upcoming ASH, that is already submitted.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

For the EED inhibitor, there is also potential in prostate cancer in some other settings of a solid tumor. I think there is a lot of potential in the EED. We are the first one in China, globally the second in oncology setting. I think there are a lot of potential in the EED in both Heme and solid tumor. Of course, the BTK degrader APG-3288 is also very exciting in terms of oncology, non-oncology. I think they currently, in addition to the two approved product in China, globally for registration trial, clearly the focus, right? We want to getting the first NDA filed with the FDA in those two product. As you can see on the five clinical stage asset, at least those three I mentioned clearly show the leading advantage globally with clearly clinical data.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

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 a favor is hard to say. It is all data-driven, but I think all these three do have a really exciting data and a path to registration.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Yeah, maybe just to add to that. As it relates to our presence in China, our legacy in China, we are one of the few companies that can de-risk and gain real information about how to tactically prioritize our portfolio and what to take and execute in other countries and globally. So I think that is important to keep in mind about us.

Gregory Renza
Gregory Renza
Analyst at Truist Securities

That's great. Thank you, gentlemen, for all the color, and congratulations again.

Operator

Your next question will come from the line of Mayank Mamtani with B. Riley Securities. Please go ahead with your question.

Mayank Mamtani
Mayank Mamtani
Analyst at B. Riley Securities

Yes, team. Thanks for taking our questions and appreciate the helpful detail. A couple of quick questions on lisaftoclax. I think you were talking about ven-resistant patients development being explored. Could you maybe just touch on how quickly you can generate data there? What does a patient pool look like? On GLORA-4, if you could maybe comment on your expectation for CR rate and TLS, and how maybe the interim OS analysis would be handled in the study if there's anything early built in there. Then I have a follow-up question on POLARIS.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

The first question, I think maybe Yifan can answer.

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

Oh, great question. Yes, based on our preclinical data, we have reported using the lisaftoclax in combination with olverembatinib able to overcome venetoclax resistance, which we have previously reported at the AACR. We also use very preliminary data we submitted to this year ASH, and when the data mature, we have data demonstrated the combo able to overcome the venetoclax resistance. The data is preliminary, but very exciting. We submit the abstract to ASH. That's address your question. We in the process in globally, including in China or outside China in U.S., and we try our best effort try to enroll more venetoclax treatment failed patient population, using different strategy, based on the known resistant mechanism, to target this ven-resistant AML population, either using the combo or our other compound, APG-1252.

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

To address your question, GLORA-4 study, as we mentioned, because this is a double-blind randomized study, we cannot analyze the data early, because the enrollment's still ongoing. But as I mentioned earlier, we plan to complete the enrollment either by the end of this year or early next year. Because based on the current design and the dual primary endpoint, we're able to submit the NDA, and using the CR rate as the primary endpoint. Continue to mature the OS data sometimes next year.

Mayank Mamtani
Mayank Mamtani
Analyst at B. Riley Securities

Thank you. I appreciate the detail. On a similar kind of question on POLARIS-2, on the treatment effect for a 24-week MMR rate, if you could maybe just comment on what you've powered the study for. I was also curious because your MMR rates grow over time, 48-96 weeks. How are you handling crossover from control arm ponatinib there? Do they have option to get your drug, or they're moving on to other trials? What sort of longer term efficacy we can get there?

Yifan Zhai
Yifan Zhai
Chief Medical Officer at Ascentage Pharma

Very good question. Based on the current study design, at the beginning, FDA denied our study design to allow patient crossover from the control arm to the investigation arm. Later on, we tried again to request the FDA finally give the green light, allow those patients who failed from the control arm to crossover to olverembatinib. That will make the study more attractive, number one. Number two, regarding the endpoints. Currently, we use the 24 weeks, at the 24 weeks MMR rate as the primary endpoint. The basic study design is powered enough and double the MMR rate compared to the control arm.

Mayank Mamtani
Mayank Mamtani
Analyst at B. Riley Securities

Okay.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Also, just to add on one, the design of the POLARIS-2, because of the Project Optimus, you have to do the RCT, and you have to have a control arm. But in that particular setting, FDA did agree this is a 2:1 ratio, and also allow the crossover. Remember, the POLARIS-2 also has the arm B, the mutation with T315I mutation patient only that we can do the single arm design with the 48 patients. So I think the total POLARIS-2 is 333 patients and enrolled well, and then the six months MMR rate for the initial filing of the NDA with the FDA.

Mayank Mamtani
Mayank Mamtani
Analyst at B. Riley Securities

Awesome. Thank you. Last one for Veet, if I may just, if you could comment, Veet, on your OpEx trajectory and if you are getting to peak. I know you have a lot of registration studies. Just maybe comment on where we are with the R&D spend, on what you expect to see with the pipeline over the next 12 months. Thanks for taking the question.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Yeah. Great question, Mayank. So, as I said, we reaffirmed our cash runway and we are happy that we have been adhering to our forecasted spending given the scale of our studies, globally, multiple countries. We are at a point now, what we wanted to do for this year was to de-risk the balance sheet in 2025 so that we can execute on enrollment. This year is the year of execution. Enrollment is going well. Dr. Yang and Dr. Zhai would discuss that. So I think, as it relates to the expenses for the studies, given we are at the late stages of enrollment, we are now at the peak as it relates to OpEx spend. So, all that is going as planned and expected.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

We are not only in a position to complete enrollment, but also with the cash we have on hand, but also for the data, as well as our multiple NDA filings. Those are the key expected milestones we have with the cash in our balance sheet.

Mayank Mamtani
Mayank Mamtani
Analyst at B. Riley Securities

Got it. Thank you, Veet.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Of course.

Operator

Your final question will come from the line of Michael King with Rodman & Renshaw, LLC. Please unmute and ask your question.

Michael King
Michael King
Analyst at Rodman & Renshaw

Thanks for taking the question. Congrats on the progress, guys. I wanted to drill down a little bit further on the balance sheet question. If you could talk a little further about capital allocation, because you guys do have a fairly hefty burn rate, and even with the Takeda opt-in, you are going to require a lot of capital. In highly competitive markets, even with differentiated products, you do have entrenched competition. I am just wondering 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.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Yeah. Maybe I can start. Or go ahead, Dr. Yang.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

No, Veet, you go ahead.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

Yeah. In terms of allocation of our total budget to programs, we have not 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. Obviously that is what we wanted to establish. What we have done is with the dual listing, steps we have 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 have allowed ourselves to hopefully deliver on catalysts, gain value, and thereby have less dilutive sources for raising capital going forward. Of course, with Faiçal on board, the optionality as it relates to potential partnerships when it makes sense as well.

Veet Misra
Veet Misra
CFO at Ascentage Pharma

We are not in a pressure for one particular path, which is exactly where we want to be at this point.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

I think I fully agree. Just add one more point, that our current cash runway, as we stated before, consistently can support our R&D plans through the end of 2027. More importantly, with nine registration trial and four global clear by FDA and EMA, majority of this enrollment are already done. That's why you see the first six months, we have R&D expense of more than 30% increase, primarily due to this heavy enrollment. But the good news is that most part of the cost is already at least more than halfway done. Of course, we remain open, flexible for many options for the fundraising, and also partnership, other source of income. On top of our positive continued growth revenue with the two product sales in China. I think we're really unique.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

It's not just because we have legacy and resources in China, but also steady growing revenue income from China and looking forward for the global commercialization and the revenue as well.

Michael King
Michael King
Analyst at Rodman & Renshaw

Well, thanks for taking the questions.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you, Mike.

Operator

That concludes the question and answer portion of today's call. I will now hand the call back to management for closing remarks.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you all for joining us. I think this interim report, again, position us well to be the global player in the Heme malignancies. More importantly, we are advanced well in terms of all the key registration trials with the target to complete them by the end of the year or early next year. More importantly, we are in the position. If you look at some other competitor or the really excellent biotech company this time last year. I told my team and many investors, Ascentage will be a different company by the time next year. We are looking forward to your support and looking forward to working with our team, investors and HCP globally, to make those novel, safe, efficacious drug into the global market to help patients with unmet medical need globally.

Dajun Yang
Dajun Yang
Chairman and CEO at Ascentage Pharma

Thank you all for your attention and support.

Analysts
    • Sumedh Neni
      Director of Investor Relations and Corporate Strategy at Ascentage Pharma
    • Dajun Yang
      Chairman and CEO at Ascentage Pharma
    • Faiçal Miyara
      Chief Business Officer at Ascentage Pharma
    • Jim Ziegler
      Chief Commercial Officer at Ascentage Pharma
    • Veet Misra
      CFO at Ascentage Pharma
    • Brian Cheng
      Analyst at JPMorgan
    • Yifan Zhai
      Chief Medical Officer at Ascentage Pharma
    • Biren Amin
      Analyst at Piper Sandler
    • Jeet Mukherjee
      Analyst at U.S. Bancorp BTIG
    • Gregory Renza
      Analyst at Truist Securities
    • Mayank Mamtani
      Analyst at B. Riley Securities
    • Michael King
      Analyst at Rodman & Renshaw
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