Ascentage Pharma Group International

Good day, everyone, and welcome to Ascentage Farmers 2025 Annual Results Earnings Call. At this time, all participants are in a listen-only mode. After management's prepared remarks, we will open the call for questions. As a reminder, today's call is being recorded. Thank you for joining us. I will now turn the call over to Yuli Shen, Senior Director of Investor Relations for the Safe Harbour Statement Yuli, please go ahead.

Thank you, operator. 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 full discussion of these risks, please refer to our filings and disclosures. On today's call, I am joined by Dr. Da Junyang, Chairman and CEO, who will provide an overview of recent developments and 2025 annual performance, as well as Dr. Veet Misra, CFO, who will go through the financial highlights. The presentation will then be followed by a Q&A session. During this Q&A session, the team will be joined by Dr. Yifan Zhai, Chief Medical Officer, Dr. Xiaomeng Wang, co-founder, chief scientific advisor. Dr. Qu Chao Si, head of commercial. I will now turn the call over to Dr. Yang.

Thank you. Good morning. I'm Daojin Yang, chairman and CEO of the company. Today, I'm very happy to present our 2025 four-year financial results and the corporate update. I will have the following agenda, business update, R&D highlights, financial results, and Q&A session. First, on the business update, 2025 was a breakout year for Ascentage. First, we have achieved excellent total revenue, over 90% of growth, and total $82.1 million. Our year-end cash balance is about 353.2 million cash runways through 2027. I think in 2025, we are the first zero-listed biopharmaceutical company on Nasdaq following our Hong Kong Stock Exchange listing in 2019. We successfully raised approximately 322 $6 billion through IPO and a follow-on offering. It's the first time we have a dual commercial product. Based on that, we established a fully functional, large-scale, and fast-growing commercial team, currently close to 300 staff. We are on the path to be a premium global commercial hematology oncology company. We also achieved many major R&D achieved milestones. These are the following examples. First, the SOVA approval as a global first single-agent BCR2 inhibitor after BTK treatment in CLL and SLL. Gloral-4 phase III registration of trial received clearance globally, including FDA, EMA, and CDE. This is a truly unique opportunity as we are the global phase III registration trial in high-risk MDS, the only one in that phase III registration trial stage. Polaris 1, for the PH positive AIL, the phase III registration trial also received clearance globally, including FDA, EMA, and CDE. Part 1 data also reported at ASH demonstrated a strong 64% MRD negative CR rate in the first-line pH-positive AIL. Over-empatient have granted a breakthrough designation for the first-line treatment of pH-positive AIL by CDE. We are also really proud to have FDA and CDE IND clearance for our novel BDK degrader, APG3288. Both the server class and our martinib entered 2025 Cisco guidance. Multiple oral presentations at ASCO and ASH 2025. We continue to lead in the global innovation for many of our products, including multiple presentations at ASH, AACR, ASCO, IHA, and other conferences, and also we publish many peer-reviewed top journals. I think here's our summary of world-class innovative, highly de-risked, and super late-stage pipeline. Here are the list of seven novel compounds. The first two, Orvambactinib, as a novel third generation BCL-ABO inhibitor, and Lisovacast as the novel BCL-2 select inhibitor. Both have been marketed in China, and also entered four global registration trials, cleared by FDA EMA. In total, we actually have nine registration trial for multiple indications. We also have several novel, potentially first-in-class compound targeting, such as FAK ALK ROS1 triple kinase, and MDN2 PV3, the dual PCR2 XL, and the PRC2 third generation, like the EED inhibitor. And more importantly, we have newly cleared phase one novel BDK degrader, ABG3288. All of these are running the trials in U.S. and China and in multiple countries. Many focus on hematology oncology, but also have potential and also in the clinical stage testing indications such as anemia. So we have build a really large commercial scale in China with a dual product approved, especially for our BCR2 slash inhibitor. The subclass was ahead of our schedule last year. And with the two commercial product, we have built over 270 by the year end commercial team, covered 1,500 hospitals, and more than 800 DDP pharmacies. I think our dual engine strategy will go well as you can see our last year commercial revenue. I think that's a transition for our percentage from being rely on the investment, investors and also BD income to the last year 100% cells of the commercial stage of product. I think that that's a really important transition for a company to be able to self-sustain with our own revenue to support our own R&D program. If you look at just our botany alone, we have a strong cell following full NRDL listing covering CML with or without mutation. So if you look at the total cell, reaching $62.2 million, that represents 81% year-over-year growth. And it will continue to cover more hospitals, DTV Pharmacy, and also a broader reach to the Tier 1 hospitals. And with the full NRDR coverage, and also translating into very long DOT that will support or sustain the growth as the patient continues to use our drug over a long time. If we look at the Resolver class, first, this July approval was ahead of schedule, and we built a very fast and full-functional commercial team dedicated to the Resolver class. So the streamline go-to-market strategy using the national commercial infrastructure really helped us to rapidly expand the sales force and the hospital coverage. So just the first five months, we have reached more than 10 million US dollar sales. This is, I think, is among top at least in the hematology oncology product cells in the first couple months in China. And then let's go to the R&D highlight. First, let's look at our NISTOPO class is actively advancing its global phase three registration of trials. First, our approval as a single agent, For CLSL, after BDK inhibitor is really represented the first label for the BCR2-select inhibitor. As you know, Venetocast was approved 2016, and continually, the only single agent was limited to the 70P-DELETE CL and SL. The other CLSL is all combination with the CD20 antibodies. Our Glora 2 and Glora 3 also received FDA EMA and CDE clearance. And more importantly, I think that the Glora 4 is the first-line high-risk MDS in combination with the AZA or without the AZA cytodine control arm. Both received the FDA EMA and the CDE clearance will continue pushing forward all these important global phase three registration trial. I want to share a few important clinical data with you. First, with the single agent approval, based on the CC201 registration study, those patients actually have much poor baseline characteristics. First, the CD actually give us a very high bar about four or five years ago required all these CRS patients have to fail both the BDK and the CD20 antibody-based therapy. Many of them have a high-risk, complex cryotype, and also many have multiple mutations. So we achieved a really good efficacy as a single agent and demonstrate a favorable safety profile. If you look at other key data in the AML and the MDS, actually this is primarily US and Australia data with the leading PI from the US and this actually has presented both at ASCO and ASH. If you look at our ORR as a combination with the AZA, in the naive, newly diagnosed AML patient, we achieved the ORR 83%. And more importantly, in some cases, about 22 patients who have failed the class, we also achieved 32% ORR. In the MDS, we have a In the newly diagnosed, 80%, and in the second line, RRMDS, we have 50% ORR. I think based on those excellent data and many other clinical data, FDA gives us clearance to conduct global phase 3 registration trial as the first line for the high-risk patients. MDS, and this has been cleared by FDA, EMA, and CDE, actually among close to 20 countries regulatory agencies. So we are actively enrolling patients in U.S., Europe, China, and throughout the world. So if successfully carried out, the SOVA can become the first VCR2 inhibitor for the treatment of first-line high-risk MDS. This is really a global and mathematical need. Actually, there's no target therapy approved in the last 20 years. And current therapy have much poor efficacy. And five years survival rate for high risk patients is only about 16% to 24%. We are also really proud of these global efforts, leading by Dr. from MD Anderson and Dr. from Peking University People's Hospital, and many, many excellent experts and PIs for MDS around the world. Based on the public information, we want to highlight few key difference of our drug versus another class or surrender class. If we look at, based on the same, similar registration trial study, Again, this is not a head-to-head comparison, but a very similar patient population, including those in China. So if you look at the SAE incidence, it's much higher for venetoclasts or serendoclasts. And the infection rate is also significantly higher. So that's consistent with clinical observation that the serendoclasts have a better safety profile, better tolerance, and more importantly, we have a better drug compatibility. CLSL patients often are elderly and immunocompromised with frequent infections. Commonly used antifungal drugs are strong 3A4 inhibitors, but does not affect our Resveratrol class PK. So if you look at the PK variability in combination with some strong 3A4 inhibitors, I think that the impact for esophagitis is minimal. For other two drugs, either about eight times or 11 times need to be at the adjusted dose if they're combining those. That will strongly affect clinical combination studies. And also, if you look at the PGP or BCRP sub-trades or inhibitors, the subclasses are probably the ones that have minimal risk in those combination studies. No need to adjust those with many BDK inhibitors. I think that those are a very unique advantage for the subclass as the BCR2 selector inhibitor. I also want to highlight a few important progress made and a summary here for Oren Bartendip. Oren Bartendip is approved with full coverage by NRDL. We see excellent commercial coverage and revenue growth last year. Globally, we are conducting Polaris 2 for the CML, and this single agent study RCT also received FDA, EMA, CDE, and the PMDA clearance. So we are actively pursuing advancing the global enrollment. Polarization I is very important. This is the first time we got a clearance last year for the first-line pH positive ALL. And this is also cleared by FDA EMA and the CDC in China with a breakthrough designation. Part one of this trial, the same trial design data was presented at ASH. And you can see the data from next couple of slides. First, in the Part A of the phase III registration trial, in combination with low-intensity chemo as the first line, we have achieved 64% MRD-negative CR rate. This is almost double the same patient population for the pronatolib, which only have 34.4% MRD-negative CR rate. But this actually is among all the BCR-ABL inhibitors the best one. So we actually almost double the current best PCR-able inhibitor for the same patient population, and also demonstrate really well safety profile. Another data is looking at the potential second-line treatment for the CML-CP patients. This is all, again, presented at ASH last year. We can achieve more than 70% CCYR rate, more than 40% MMR rate, and also have a really durable sustained response. Another important is in the blast crisis of the CML. I think we demonstrate in more than 64 patients with blast phase. and also some serious cytogenetic abnormalities and complex karyotypes. Those patients did very well and also sustained remission with improved survival and much reduced non-relapse fatalities. Another potential treatment is really for the combination with our own . And in this case, it's actually in the pediatric patient population. That is a first-line regimen in the pH-positive L, demonstrate really excellent efficacy and the safety profile. I think that this would be really important for some of the patients to receive the chemo-free and the two already active agents with a long-term benefit. Orvartinib as a multiple kinase inhibitor also demonstrates clinical benefit for some rare hematological malignancies, such as this very hard-to-treat myelo-lymphoid neoplasm with FGFR rearrangement. And these actually take a while to recruit those patients, but most of them achieve an excellent response clinically. And then we continue to push our pipeline. In the interest of time, we only show one example as our novel BDK degrader, APG3288. This actually we receive almost the same time clearance by FDA and the CDE. And based on the preclinical data, I think we also did a comparison with B1 or Neurix BDK degrader, demonstrate good selectivity and potency. And we'll push forward this compound in US and China for multiple indications. I think that in summary, the subclass as a very safe and potent BCR2-select inhibitor. Some refer BCR2 inhibitor as a small molecule of KD1. That really means it has multiple indications and also opportunity for multiple combinations. But I think more importantly, we are probably globally the only company that has not just the BCR2-select inhibitor, but also Oren Bartendorf, representing the best third-generation B-cell elbow inhibitor, and the MDN2-PV3 inhibitor, and also the novel new BTK protein degrader. As you can see, each one of these is a single agent or in combination, have potential to treat multiple B-cell malignancies among many hematological malignancies. Lastly, I think I will turn the financial result to our CFO, Wei. Wei, let's go to the slide number 28. Thank you, Doug, again.