Zai Lab Limited

Hello ladies and gentlemen, thank you for standing by and welcome to Xilabs second quarter 2026 financial results conference call. At this time all participants are in listen only mode. Later we'll conduct a question and answer session and instructions will follow at a time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou Senior Vice President of the Investor Relations. Please go ahead, ma'am.

Thank you, operator. Hello and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Scilabs founder, CEO, and chairperson. She will be joined by Dr. Rafael Amado, President and Head of Global Research and Development, and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer, and Dr. Yuzhe Wang, Our operating partner will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SDC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. please refer to our earnings release furnished with the SEC on August 6th, 2026 for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

Thanks, Christine. Good morning and good evening, everyone. Thank you for joining us today. That lab has reached the important inflection point in its evolution from original business into a global biopharmaceutical company. We built this company by bringing first-of-best-in-class medicine to patients in China. Today, we are developing our own innovative medicine for patients worldwide with our first U.S. regulatory submission expected next year. The transformation reflects the R&D capabilities we have built We're conducting global multiple center registritional oncology trials, advancing additional clinical programs across oncology and immunology, and advancing our clinical pipeline into INDs this year. So see, our potential first and best-in-class DL3 ADC demonstrates what XyLab is capable of. We advance it. from IMD to Global Pivotal Trials in less than two years, reflecting the speed and efficiency of the integrated development organization we have built. By the end of this year, we expect to have three registrational programs in small cell lung cancer and neuroendocrine carcinoma. We're also evaluating ZOSI in combination with T-cell engagers through collaborations with Amjin and Borenger-Ying Gehan. Our second major global opportunity is GL1503, a potential first-in-class long-acting IL-31 bispecific for atopic dermatitis. We believe it has the potential to bring together multiple attributes in a single asset, robust skin clearance, Rapid and durable yeast reduction and longer dosing interval. Later this year, we'll report the program's first human data. At the same time, we continue to strengthen our commercial business. This quarter, we sharpened our focus behind our highest priority brands. Night product revenue grew 11% versus previous quarter. and the business remain commercially profitable. We're setting a strong foundation and expect a return to meaningful year-on-year growth in 2027, followed by the potential for our first U.S. product launch in 2028. SciLife's evolution into a global biopharmaceutical company is well underway. with a growing portfolio of globally developed differentiated medicines and a profitable commercial business. We're confident in the path ahead and the long-term value we can create for shareholders and patients. With that, let me turn the call over to Rafael to further discuss our pipeline in greater detail. Thank you.

Thank you, Samantha. Let me walk you through the pipeline and what to expect this year. Starting with Zosie, our DLL-3 targeted ADC. Small cell lung cancer is one of the most difficult diseases in oncology, and Zosie has demonstrated what we believe is a potential best-in-class ADC profile. In patients who have failed frontline multiple lines of treatment, we're seeing strong responses, including high responses and control of brain metastases. That efficacy with a favorable safety profile positions SOSI as a backbone for future combination regimens across lines of therapy. This program is moving fast. A global registration phase three in second line plus small cell lung cancer is expected to complete enrollment in the first half of 2027 with a US accelerated approval submission expected to follow later that year and approval anticipated in 2028. At ESMO in October, we will present combination data evaluating SOCI plus PD-L1 with or without chemo in first-line small cell lung cancer or during maintenance. Today's standard of care of IO plus chemo delivers a 60 to 70 percent response rate, median PFS of about five months, and grade three or higher treatment-related adverse events around 60 percent. NCCN guidelines recommend four cycles applied on base chemotherapy. A chemo-sparing regimen could offer better tolerability, allow longer treatment duration compared to systemic chemotherapy, and improve control of brain metastasis. This is the basis of our phase three combination strategy with immunotherapy, which we have discussed with regulators. We anticipate initiating the trial in the coming months. And in extrapulmonary neuroendocrine carcinomas, where there is no established standard of care in the second line and beyond, closely demonstrated a confirmed ORR of 38.2%, which is well above the roughly 18% seen with currently used regimens. We're engaging with regulators on a potential approval pathway using extended single-arm data from our ongoing second-line trial with a subsequent approval pathway in first line. So, three registrational programs underway by year-end. We're also collaborating with Amgen and Boehringer Ingelheim to combine ZOZI with T cell engagers. A global phase 1B study with Amgen is already enrolling, including a cohort of untreated small cell lung cancer patients on a triple combination of ZOZI, IMDELTRA, and INFINSI. And the global phase 1B2 study with Boehringer Ingelheim in neuroendocrine carcinoma is expected to initiate it in the coming months. Beyond SOSI, our next wave of global assets is advancing quickly. DL1503 is a long-acting humanized IgG1 by specific antibody targeting both interleukin-13 and interleukin-31 receptor alpha. It includes YTE amino acid modifications in the SCV gene that extend serum half-life and support less frequent dosing. Through blocking both pathways at once, ZL1503 is designed to break the each scratch inflammation cycle with rapid, durable efficacy and less frequent dosing in moderate to severe atopic dermatitis. ZL1503 is in the clinic now with first in human data and healthy volunteers to be presented in the second half of this year. This dataset will include pharmacokinetic data following single-dose administration and pharmacodynamic data including inhibition of AD-related biomarkers such as PSTAT6, TARC, and CCL26, a cytokine that recruits eosinophils during type 2 inflammation. We will also have an initial read on safety and immunogenicity, including assessment of anti-drug antibodies. We're also currently enrolling patients with AD in the multiple ascending dose portion of the trial, and we will share this data at a major medical conference next year. We believe CL1503 with a potentially differentiated profile can address unmet medical needs in one of the largest markets in immunology globally, and we are moving this program forward rapidly. Beyond its lead syndication, CL1503 has the potential to expand into additional IL-13 and IL-31 mediated diseases, creating a broader development opportunity over time. We look forward to sharing updates as the program advances. I would highlight just two more programs. CL6201, our internally discovered LRRC15 targeting ADC. We are actively enrolling patients in the global phase one study and expect to complete enrollment in the dose escalation portion with initial data expected in the first half of next year. By year end, we expect to submit an IND for ZL1311, a next generation T cell engager targeting musin 17, a promising target for gastrointestinal cancer. In summary, we have the infrastructure and capacity to advance multiple global programs at different stages of development simultaneously at speed and efficiency and across geographies, while also advancing a regional pipeline. We have significant data emerging throughout the year on our most advanced products, and I look forward to sharing it with you in the coming months. And with that, I'll hand it over to Yajing.

Thank you, Rafael. As Samantha and Rafael described, Xilab is entering the next phase of its evolution. From a financial perspective, our objective is straightforward. Build on our commercially profitable business while investing with discipline behind the innovation that will drive our next stage of growth. In the second quarter, net product revenue grew 11% sequentially to $105.8 million. and the business remained commercially profitable. The doula was steady, ViviGuard volumes grew double digits sequentially, the doula demand remained strong despite supply constraints and Cox's launch is off to an excellent start. In the second half of the year, we expect to further stabilize product sales while laying the foundation for a return to a meaningful growth in 2027. Cox T is expected to be a key driver of that growth. That's the first new mechanism of action for schizophrenia in decades. With efficacy across positive and negative symptoms, no box warning, and inclusion in national treatment guidelines, we believe Cox T is well positioned to address a significant unmet need. Early physician interest in the positive patient experiences are encouraging. and we are building good momentum ahead of potential NRDO inclusion in 2027. For the ViviGuard franchise, we intend to seek NRDO inclusion for ViviGuard Hytrulo and are preparing for a gradual transition from IV to sub-Q. As a result, reported revenue in the second half may not fully reflect underlying demand due to timing of NRDO related commercial dynamics. Looking ahead to 2027, we are confident in a return to meaningful growth supported by new product launches, potential unideal product inclusion, and continued demand growth across our key brands. Beyond 2027, we expect our internally developed pipeline to become an increasingly important contributor to both revenue and margins. On expenses, We remain disciplined, prioritizing our highest value programs while improving productivity through streamlining the organization and the use of AI across clinical development, regulatory, commercial, and corporate functions. As a result, we expect operating expenses to remain broadly stable through the remainder of the year. We ended the quarter with $717.5 million in cash, providing the financial flexibility to continue investing in the highest value opportunities. Pulling this together, we have a commercially profitable business, disciplined capital allocation, and a global innovative pipeline that will increasingly shape the company's future growth and drive substantial value for patients and shareholders alike. With that, I will open it up for questions.

Thank you. We will now begin the question and answer session. To ask a question, please press star 11 on your telephone and write for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. We will now take our first question from the line of Anupam Rama from JP Morgan. Please ask your question.

Hey, guys. Thanks so much for taking the question. Just looking to ESMO, can you walk us through what you're looking for in the first line small cell study of Zosi plus IO plus or minus chemo? Like what's going to be the size and scope of that data set and how are you defining a win scenario?

Thank you, Anupam. This is Christine. Rafael, could you take that question, please?

Sure. So, at ESMO, we expect to present about 60 patients' worth of data. This will include doublet and triplet, but most patients will be in the doublet with a checkpoint inhibitor at the highest dose of 1.6 milligrams per kilogram. We have been monitoring that data and we think we'll be fairly mature by the time of ESMO with a medium follow up between eight or nine months. So we will be able to report on a meaningful data set by then. In terms of what to look for, I think the benchmark with the checkpoint inhibitor studies have shown responses in the 60 to 70% with chemotherapy. and a progression-free survival of about five months. So there's still room for improvement in the about 80% response rate or so and a 50% increase in medium PFS would be, I think, clinically meaningful. So those are sort of the parameters that we're looking for. We're obviously at the same time that we're preparing this data set moving forward with operationalizing the study. And it's going to be a chemo sparing study, not because we saw any DLTs with the triplet, but because we think it's more convenient and we will be able to give higher dose intensity of SOC than chemotherapy does.

Thanks so much for taking our question.

Thank you. We will now take our next question. And the next question comes from Michael E. from UBS. Please ask your question, Michael.

Good morning, guys. Thanks for taking our questions. This is Kyle Yang for Michael. Two for us. The first one, on the higher level, the company previously guided toward profitability by end of 2025. So how should we think about that, and at what point do you think investors can start to revisit the profitability goal? The second question is on IL-13, IL-31. The atopic dermatitis landscape is getting increasingly competitive, and we recently saw additional investor interest in the space, including a new IPO this week that also has an IL-13, IL-31. So how should we think about the differentiation of your asset versus your competitors? Thank you.

Thank you, Kyle. Yajing, can you please take the one on profitability? And Rafael, the question on the 1503 differentiation, please.

All right, thanks for the question. So I'm really looking at the profitability through the lens of our capital allocation. So we already have a commercially profitable business today. Our local manufacturing is on track for Zabdura and Coxy that will continue to improve our profitability. However, at the same time, we have multiple global competitive programs that we believe have the potential to create substantially greater long-term value. So right now our responsibility is to invest where the returns justify it. We do maintain a very high bar for every investment decision. So in summary, we are kind of growing in revenue with our potential global approval in 2028, which will improve margin drive operating efficiencies across organization at the same time. So believe those factors adding together will naturally need to the profitability over time and continue to improve the profitability over time as well.

Yeah, this is Rafael. I'm just making a few comments about 1503. So the drug, as you know, is designed to have three highly desirable attributes. The first one was robust Clearance, and I think this is through Th2 suppression, but by breaking the cycle of itching, scratching, and inflammation that we see. I think by inhibiting the receptor, the R31 receptor, we should see a brisk reduction in pruritus. We also have a molecule that is YTE modified, so the extended dosing interval that's going to be are tested in the current study that is ongoing both in healthy volunteers and MADs, but we expect they will be superior to the standards at the moment with its every one month and DUPI every two weeks. So we expect to go beyond that. and there are a few agents that actually have these three simultaneous attributes. Some of them are preclinical, some of them are targeting the ligand, some of them are targeting the receptor. We believe that targeting IL-13 ligand and targeting 31 receptor, the YTE modification will result in both better reported outcomes with regards to pruritus, which is really morbid in these patients, but also improvement in inflammation. And also, this is an underpenetrated market where there isn't really a winner takes all, if you will. So I think any improvement in quality of life, dose extension, and more importantly, inflammation and patient symptoms will allow for these drugs to have a role in atopic dermatitis. So we're also moving very fast with the phase one study. And we expect to, as we've guided before, present healthy volunteers data this year. And then next year, the MAD data in atopic dermatitis. So we are a bit ahead of some of the competitors. Thank you.

Thank you. We will now take our next question from Lee Wachsik from Canto. Please go ahead, Lee. Your line is open.

Hey, guys. Thank you very much for taking our questions. I have one pipeline and one commercial question. For 1503, the bispecific antibody, just wondering what is the potential dosing profile that you're looking for? and how would the SET data later this year inform you on the drug profile and early trends on ADA from the MAC cohort? And the second question is on the commercial side, just at a high level, how do you envision the China business to evolve in the coming quarters? What are the metrics that are most important to you?

Thank you, Lee. Rafael, can you take the question on the dosing profile for 1503 and how the upcoming data will inform on the profile and on ADA? And then you, Drew, if you can address the commercial question.

Yeah, so in the Healthy Volunteers data, it's a single IV injection, and we have six cohorts. We're testing four doses. They're single injections, and the patients are being followed long-term. This will inform us mostly on tolerability and PK, including half-life, and then the biomarkers that I mentioned in the prepared remarks, including immunogenicity of anti-drug antibodies. The MAD has two cohorts with two doses, also IV, and it's a larger cohort. I think to hone into the dose, we will need to do a bit more experimentation. There's a equivalency study that will compare the IV to the subcu and then we will do more dose experimentation with the subcutaneous dose. We expect that there will be a short induction course followed by a longer maintenance dosing, but it's premature to speculate on the actual dose. So on the question about antibody drug conjugates, obviously we're looking at this and we will be reporting on this. Suffice it to say that the study continues.

Okay. Hi, Lee. And hi, everybody. This is Ito here and I'm speaking in China right now. Can you hear me okay? Good signal?

Yes.

Okay, very good. Great, great, great. Okay, so commercial. So first of all, I just want to say, you know, three months in a row, I look at that commercial, it's not just a China business only, right? If you look at our three-year horizon, we have the potential to launch our first U.S. assets or global assets. Very exciting. That is Zosie. But that said, being said, the near term, absolutely our focus should be focusing on our regional business, which is primarily our China business. So my view is this. We actually have a pretty sizable business, but with a diverse mix. Some are CSO products, some are. promoted by ourselves. So from my perspective, it's very important going forward to be very focused. Focused on three key brands, that is Returns Agila to Growth and Continued Growth on the Volume Growth Underlying Demand on FGAR and also Launch Excellence for CarXT. For Execution Fraud, we must go back to the basics. We have to be very good at, I call it brilliant at the basics. really drive the metrics. So you asked me about what are some of the potential KPIs. So it's all about underlying demand. So for example, for each of these brands, the new patient style will be critically important. We like to see the signal continue. For those who flatten, we want to return to growth. And for those who have been growing, we want to continue to grow or potentially accelerate. We have seen these signals, right? And that will lead to I think in the next couple of quarters, a consolidation or solidification of our stabilized insurance revenue and eventually turning into a very meaningful growth in 2027. Okay, so that is So in the second, in the upcoming quarter, I look for is, you know, as you see the second quarter, we actually delivered at 11% sequential quota over quota growth. So in the upcoming quarter, we, I see quite confidently we can solidify that. And then really in the meantime, really improving our underlying demand and setting ourself up for a very good next year. and during this period, we also will focus on a couple of NRDL, right, negotiations. We want to make sure we win and we win at a good price.

Thank you, Yujun. Next question, operator.

Thank you. Our next question comes from the line of Igor Notromovic from Citi. Please ask your question, Igor. Your line is open.

Hi, this is Caroline Anfiagal. Thanks for taking our question. We're wondering, as your MUC17 T-cell engager approaches the clinic, what aspects of the preclinical profile give you the greatest confidence that can overcome historical challenges associated with T-cell engagers in solid tumors? Thanks.

Rafael, if you can take this one on MUC17 T-cell.

Sure, yes. This is... Max 17 T cell engager. It's an interesting target. It's in GI tumors, more prominently in gastric, pancreas, and other tumors of the GI tract. It is engineered to be biparotopic, so it targets more than one epitope. So hopefully the ability will be higher. But the CD3 is silenced We believe that hopefully in the clinic will ameliorate cytokine release syndrome, which is really the Achilles heel of these products in that they need to be given in the hospital because of the emergence of CRS. So a lot of the innovation in this field, as you probably know, is directed to increasing efficacy but also decreasing the potential toxicity related to CRS so that eventually one day these products can be given in the community. We can say that perclinically, as we prepare to the IND, the product looks really to have great properties compared to other potential products in this target, including competitors. So we're pretty excited about it and we're moving forward with the goal of having this IND out by the year's end.

Thank you. Thank you. We will now take our next question from Dinah Gray Bolsch from Levering Partners. Please ask your question, Dana. Your line is open.

Hi. Thank you for the question. I wonder if you can talk about the combination of your DL3 ADC with the DL3 targeted T-cell engager and sort of mechanistically and biologically why that has value or differentiation relative to combining a DL3 T-cell engager with a B7H3 ADC.

Thank you, Dana. It's great to have you on the call. Rafael, can you address the question on the combo of Zosie plus TCE and why it may have value in differentiation versus a B7H3 combo?

Yeah, I mean, the more simplistic reason is that the mechanisms of action are orthogonal. They are very different. One is a cytotoxic that can debulk tumors, particularly small cell lung cancer that can present with a high volume disease. and then allow T cells to eliminate residual disease and maintain immune surveillance. As the ADC kills these tumor cells, it liberates other antigens that are neoantigens and the T cells, even though they're directed to DLL3, can respond to these neoantigens, particularly when they're combined with PD-1. So this is a combination which is really targeted to bring in cytotoxicity as well as IL into the tumor. In the case of SOCI and in DELTRA, for instance, the epitopes are different. both drugs can actually bind in the same cell. And it's known that the density of receptors are required for ADCs and TCEs are different. ADCs combine even if there are lower receptors because there's also a bystander effect that can affect cells that have low DL03 expression. So this is something obviously that still needs to be proven. We're doing the studies and the studies are aim to look at tolerability. The good news is that there aren't really overlapping toxicities except for potentially mild suppression. And with regards to whether DLL3 is the best target because it's the same target, there's a B7H3 study that Amgen was conducting. It is on pause at the moment within Delta as well. V7H3 is not a tumor-specific target. It's present in normal tissue, including the lung epithelium. So there's a potential for more toxicity. And in small cell lung cancer patients, lung toxicity can be problematic because of the incidence of ILD with ADCs. So we think that having a safer target that is more tumor specific is probably a better option. So we're looking forward to seeing the results of these combinations. Amgen obviously has data with B7A3, but that hasn't been released. And we look forward to looking at the dual DLF3 dual mechanism approach and hopefully we'll have that data early next year.

Thank you. As a reminder, before we move to our next question, please press star 1 1 if you wish to ask a question now. We will now take our next question from the line of Ling Hai Chou from Goldman Sachs. Please ask your question, Ling Hai. Your line is open.

Thanks for taking my question. This is Ling Han from Goldman. Just a follow-up question on the ZOSI and DL3-TCE combinations. We've seen that both Amgen and BI have initiated Phase 1-2 trials, including different cohorts for both the late line and first line. And for the RP2D in first slide triplet exploration, wondering if the RP2D will still remain as 1.6 MIG or there will be a dose titration to a different dose level. And for the two phase 1, 2 trials, what might be the expected time that we will see some data? Thanks.

Thank you, Linghai. Rafael, could you address a question on the RP2D dose for the SOSI plus T cell engagers study?

Yes. So the two immunotherapies, the PD-L1 as well as the T cell engager, will be used as standard doses. There may be some accommodation to be able to dose every three weeks just because SOSI is dosed every three weeks. With regards to Celsius, we're only exploring two doses and moving very fast. We're exploring 1.2 and 1.6 milligrams per kilogram. We don't have any reason to think that 1.6 won't be well tolerated, so we hope that that will be the dose that we go on to expand. So that's as much as we can say. The study is ongoing. The Amgen-1 is ongoing and accruing well. and he's got a cohort of patients that are untreated, which I think is probably the most exciting cohort. As you know, the response rate with T cell engages is relatively modest. It's in the 30 to 40%, whereas the response rate with ADCs is very high. So, you know, you combine also differential response rate, and others. So, again, mechanistically this makes a lot of sense. And in terms of the doses, well, we hope that we won't have to modify our target dose that we have chosen across the development plan for SOCI, which is 1.6 months per kid.

And when will we see the data results from the trial?

Well, the trial is being operationalized by Amgen, so even though we obviously work very closely with them, It will be probably a joint decision, but they will take the lead as to when those results will be presented. My sense is that it will be next year, but I can't tell you exactly when it will happen. I would probably guide towards the second half of the year. That's very helpful. Thank you.

Thank you. I am showing no further questions. I'll now turn the conference back to Dr. Samantha Du for her closing comments.

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the third quarter of 2026. Operator, you may now disconnect this call.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect your lines.