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spk04: Hello, ladies and gentlemen, thank you for standing by and welcome to ZEILabs first quarter 2024 Financial Results Conference call. At this time, all participants are in listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiao, Senior Vice President of Investor Relations. Please go ahead.
spk16: Thank you, operator. Good morning.
spk13: Good evening and welcome to ZEILabs first quarter 2024 earnings call. Today's call will be led by Dr. Samantha Du, ZEILabs founder, CEO and chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer. Dr. Rafael Amado, President and Head of Global Oncology Research and Development. Dr. Harold Reinhart, President and Head of Global Development Neuroscience, Autoimmune and Infectious Diseases. And Dr. Yajing Chen, Chief Financial Officer. Jonathan Wang, Business Officer will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we'll be making certain forward looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause our actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filing. We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on May 8th, 2024 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.
spk03: Thank you, Christine. And good morning and good evening to all who are joining us today. I'm excited to be here to share with you the results from our first quarter. But before I do so, I want to start with a few opening comments. We started Xilab with a vision to build a truly innovative and integrated biopharmacompanies focused on bringing innovative medicines to address the unmet medical needs for patients in China and around the world. We have spent the past few years building our infrastructure capabilities and pipeline to get us where we are today. We're entering a period of robust growth driven by a late-stage pipeline of first and no-binding class products. We're also advancing our global pipeline, where we have three in the clinic today. And we expect to add new China and global assets each year through both internal discovery and business development. This year, we expect three new product approvals, which follows the launch of Vivgard late last year. Over the next two to three years, we have the opportunity to launch multiple potential blockbuster products, and many of those assets are expected to contribute significantly to our revenue way beyond 2028. As we scale our business, we'll continue to expand our operational efficiency and improve our productivity. Our first quarter results demonstrate our progress across each of these areas, strong commercial execution, increasing productivity, and pipeline progress. We expect 2024 to be a strong year for Xilab, and we are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and achieving profitability by the end of 2025. With a strong balance sheet and a cash position of over $750 million, Xilab is in a very good position. And with that, I'll pass the call to Josh. Josh?
spk10: Thank you, Samantha, and thank you everyone for joining the call today. We had a good start to the year with robust revenue growth and continued advancements in our key clinical programs. Our total revenues grew 39% year over year to reach $87.1 million. Our commercial performance was driven by strong execution with the launch of Vivgard and uptake across our existing portfolio. Zajulla continues to maintain its leadership position in the PARP inhibitor class for ovarian cancer. Key drivers of growth for Zajulla remain increasing new patient penetration in first-line ovarian cancer and extending the duration of treatment for patients in the maintenance settings. Kinloch and Nuzaira also showed solid growth, benefiting from their NRDL listings in 2023. Together, these three products collectively grew 24% year over year. Optune showed a recovery from slowdowns in the second half of last year, growing 49% sequentially from the fourth quarter. Now looking at Vivgard. The launch is off to an excellent start. In the first quarter alone, we estimate that nearly 2,700 new patients were treated with Vivgard. Driving this strong initial uptake is our team's ability to execute on several important launch initiatives. First, Vivgard's NRDL inclusion became effective on January 1st, which significantly enhances patient access. Since its inclusion, Vivgard has been steadily added to hospital formularies, and we are making great progress in line with our expectations. Second, our targeted outreach to physicians has been very successful. We've engaged our top 1,000 hospitals, which account for 80% of the eligible patient population. Our highly specialized sales team of 150 reps is well equipped to not only support the launch in GMG, but also upcoming launches of the subcutaneous formulation for this indication later this year, and then for CIDP in 2025. Third, we are seeing high adoption from physicians. Nearly 900 health care professionals have now prescribed Vivgard, and this number continues to climb. Feedback from physicians and patients continues to be positive, and we are focused on providing these key stakeholders with -in-class support. We are tracking well to exceed $70 million in sales of Vivgard this year. Our late stage pipeline also continues to advance nicely. We anticipate several approvals this year. Repotrectinib in ROS1-positive non-small cell lung cancer, where we have seen a significant improvement in PFS versus current standard of care with CNS benefit. Saldor, the first pathogen targeted therapy addressing ABC infections, and the subcube formulation of Vivgard for GMG, which provides additional dosing flexibility for patients. Each of these opportunities has the potential to offer significant benefit to patients, and we look forward to launching these products in the second half of 2024. Looking ahead to next year, we have the potential to launch subcube Vivgard in CIDP, followed by Tivdac, CARXT, and Bemaratuzumab. Many of these potential blockbuster assets are relatively de-risked given their positive pivotal data or compelling proof of concept results, positioning us well for future growth. Now moving on to the cost and investment side of the business. In 2024, we expect to maintain R&D expense at a similar level versus 2023, while modestly increasing sales and marketing expense. As we enter this next phase of significant revenue growth, we remain focused on efficient operations. And this includes enhancing commercial efficiency, optimizing resource allocation, and increasing productivity throughout the entire organization. We will continue to execute financial discipline and cost management, and we expect significant operating leverage as our revenue growth meaningfully outpaces that of our operating expenses. This allows us to prepare for the next phase of growth for Xilab as we drive both revenues and profitability. I'm also pleased to announce that recently Andrew Zhu joined as our Chief Commercial Officer in Greater China. Andrew has more than 20 years of experience in marketing and sales management for innovative drug therapies and a proven track record of driving top-line growth and managing large teams and product portfolios with significant revenue and competitive markets. He brings rich experience in building innovative business models and resource integration, which will help us further enhance our commercial operations and drive sales and profit growth across Greater China. Overall, we continue to make great progress towards each of our three corporate objectives, which are to drive revenue growth, achieve profitability, and expand our global pipeline. We are on track to reach profitability by the end of 2025, and with a cash position of over $750 million, we expect to be able to fund our operations and business development deals through profitability. And with that, I will now pass the call over to Raphael to discuss the great progress within our oncology pipeline.
spk09: Thank you, Josh. Let me begin by highlighting some of the key progress updates in our oncology pipeline since our last earnings call along with our next steps. Starting with street potractiveness, our NDA was accepted by China NNPA with priority review status for Rosfran positive non-small cell lung cancer in both TKI-naïf and TKI-pretreated patients, and we are expecting approval in the next few months. In China, Rosfran rearrangements occur in 2 to 3 percent of patients with advanced non-small cell lung cancer. There is a significant unmet need for these patients given the limited durability of clinical benefits due to the emergence of resistance to approved first generation therapies. Treatment with street potractiveness, a next generation Rosfran and N-tract inhibitor, has been shown to result in high response rates with promising durability in patients with Rosfran positive non-small cell lung cancer, including in those with intracranial disease and in the post-first line treatment settings, which may address the limitations of first generation TKI. Specifically, we've seen a duration of response of 34.1 months and 14.8 months in TKI-naïf and TKI-pretreated patients respectively. With these results, we believe street potractiveness has the potential to become a new standard of care options for patients with Rosfran positive non-small cell lung cancer, including those whose tumors have developed mutations, conferring resistance to previous treatment with Rosfran inhibitor therapy. Next, our tumor-treating field franchise. This March, our partner, NovoCure, announced that the Phase III METSYS clinical trial met its primary endpoint in patients with brain metastasis from non-small cell lung cancer. Patients treated with CT-fields and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone, with a statistically significant p-value of 0.016. CT-field therapy was well tolerated and was associated with sustained quality of life and neurocognitive function. Results from the METSYS study will be presented at a late breaking abstract at this year's American Society of Clinical Oncology annual meeting. We also expect another pivotal readout from CT-fields in first line, locally advanced creatic cancer, by the end of this year. We continue to make great progress with the Marituzumab in collaboration with Amgen and are accruing to Fortitude 101 and 102 studies. These studies are evaluating a doublet and triplet combination respectively in first line STFR2b positive gastric cancer with overall survival as the primary endpoint. In addition to our late stage partner programs, we have optimized our global development capabilities and are making excellent progress with our internal global programs, three of which we have disclosed and are in clinical studies. Zl1310 is our DLL3 targeted homogeneous GAR8-ADC with high affinity and specificity for DLL3. It utilizes a topoisomerase 1 inhibitor payload and has shown promising preclinical data which we presented at the European Lung Cancer Congress in Prague. The program is advancing through a global phase one study in the United States and China for relapse and retractory small cell lung cancer after progression on platinum based therapy and we expect to expand its geographic footprint as the trial progresses. This study will also include patients treated with a combination of our DLL3-ADC and a checkpoint inhibitor. Depending on the totality of the data, we could potentially see early clinical results at the end of 2024 or early 2025. Our discovery efforts are moving at a brick space and we are progressing internally discovered product candidates. In addition, we continue to assess external opportunities across multiple modalities in focused areas of cancer biology with the goal of introducing new products in development this year as we continue to execute on our global development objective of generating at least one global IND per year. I am excited about the great progress we're making in oncology with our existing and future products. I look forward to the approval and filing of noble and best in class oncology drugs and to augment and execute on our regional and global pipeline. And now I will turn the floor to Dr. Harold Reinhart to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas.
spk11: Thank you, Rafael. Our neuroscience autoimmune and infectious diseases or NSAID franchise has also made significant progress advancing our pipeline. Starting with RISCARD or FGAR-TIGIMOD, beyond what Josh shared about the progress of GMG, our supplemental biologics license application for the sub-q formulation of RISCARD in CIDP was submitted to the National Medical Products Administration in China in April. There are approximately 50,000 patients diagnosed with CIDP in China, and today only a small fraction are able to achieve remission with available care. The majority of patients remain symptomatic and the disease can have a debilitating impact on quality of life. Existing treatment options are limited and quite problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy. In China, the situation is worsened due to the persistent shortage of IVIG therapy. As mentioned, we expect the approval of -q-VISCARD and GMG this year, which will provide patients with a second-dosing option in addition to IV. We already know that FGAR-TIGIMOD has great potential across multiple additional indications. Therefore, we will continue working with our partner, Argenics, on indication expansion. We expect to join Argenics in the registration study of FGAR-TIGIMOD in thyroid eye disease, or TED, in Greater China in the second half of this year. Moving to CAR-XT. This is a -in-class antipsychotic combining a centrally acting muscarinic agonist called Xenomalin with a peripheral antagonist called Trospium, which we are developing with our partner, Corona, or now BMS, for patients with acute schizophrenia. In April 2024, BMS presented new interim long-term data from the Phase III emergent program at the annual congress of the Schizophrenia International Research Society, or SIRS. CAR-XT demonstrated statistical and clinically meaningful improvement in PAN's score and a differentiated safety profile with continued lack of weight gain, metabolic dysfunction, and extra-paramidol symptoms over a 52-week period of treatment. We expect to complete enrollment in the Registrational Bridging Study in mainland China this year, the results of which would support our NDA filing for the treatment of schizophrenia in adults in early 2025. We have yet another substantial opportunity for CAR-XT as a treatment for Alzheimer's disease with psychosis, or ADP for short. There are approximately 8 million people with Alzheimer's disease in China, and about 45% of these patients display psychotic symptoms, and there are no approved treatments for these patients. We will participate in the Phase III, ADAPT II, and ADAPT III clinical trials in ADP in Greater China starting in mid-2024. Regarding our infectious diseases portfolio, sulbactam durulobactam, or Suldur, is a treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by Acetoglutobacter barmonii. Our NDA submission is under priority review with the NMPA, with potential approval later this year. In China, there are 300,000 cases of Acetoglutobacter infections annually, with the majority of strains being carbapenem-resistant. Patients have limited treatment options, and the mortality rate is around 43% even with the best available therapy and care. Last but not least, CL1102, our IL-17 tumor body for the topical treatment of chronic plaque psoriasis, is in the final stages of preparation for a Global Phase II dose-finding trial, and we intend to initiate the study in the second quarter of 2024. So, we are looking forward to providing updates at our next earnings call. And now, Yajing will give an overview of our financial results. Yajing?
spk02: Thank you, Harold. Now, I will discuss our first quarter of 2024 financial results compared to the $7.1 million compared to $62.8 million for the same period in 2023, representing -over-year growth of 39% or 43% on a constant currency basis. Our revenue growth was primarily driven by increased sales volume, including from the launch of Viscard and a decreased sales rebate to distributors, resulting from price reduction in connection with NRDO listings for certain products. Now, looking at each individual product, the G-MAT product sales were $45.5 million, an increase of 7% -over-year from $42.7 million for the same period in 2023, driven by increased hospital sales in first-line ovarian cancer and increased duration of treatment. Viscard's net product sales were $13.2 million for the first quarter of 2024, following the launch in China in September 2023 and its first listings on the NRDO with pricing that took effect on January 1, 2024. Our revenue growth was driven by expanding physician and patient adoption, as well as increased patient access, as Viscard is added to hospital formula rates. Optune net product sales was $12.5 million for the first quarter of 2024. There was a sequential increase of 49% from the fourth quarter of 2023, with continued recovery expected throughout 2024. ChinLoc grew 367% -over-year to $6.1 million, and the NeuZira increased 81% to $9.9 million for the first quarter of 2024. The growth was supported by the inclusion of ChinLoc and the IV formulation of NeuZira in the NRDO in the first quarter of 2023, as well as the inclusion of the oral formulation of NeuZira in the first quarter of 2024. Turning now to our expenses, research and development expenses were $54.6 million in the first quarter of 2024, compared to $48.5 million for the same period in 2023. This increase was primarily driven by clinical trial expenses, partially offset by a decrease in milestone fees for our licensed products. Selling general and administrative expenses grew to $69.2 million from $62.5 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and HEPCOM growth associated with the Vivgar launch. Both R&D and S&J expenses significantly declined as a percentage of revenue in the first quarter of 2024, compared to the same period in 2023. And as Jeff stated previously, we expect this trend to continue as a result of growing revenues and ongoing cost and efficiency initiatives. Zylab reported a net loss of $53.5 million in the first quarter of 2024, or a loss per ordinary share attributable to common shareholders of $0.05, compared to a net loss of $49.1 million for the same period in 2023, or a loss per ordinary share of $0.05. We are in a strong financial position, ending the quarter with cash and cash equivalents, current restricted cash, and short-term investments of $750.8 million, compared to $806.5 million as of December 31, 2023. Based on our operating plan and our anticipated revenue growth, we expect to be able to fund our business through profitability, which we expect to achieve by the end of 2025. And with that, I would now like to turn the call back over to the operator to open up lines for
spk16: questions. Operator. Thank you. We
spk04: would now like to open the line for questions. If you do have questions at this time, please press star 1 and 1 on your telephone and wait for your name to be announced. To cancel the questions, please press star 1 and 1 again. Once again, please press star 1 and 1 for any questions or comments. Thank you. We are now going to proceed with our first question. The questions come from the line of Anupam Rama from JP Morgan. Please ask a question. Your line is open.
spk06: Hey, guys. Thanks so much for taking the question. For Viscard, you noted the hospital formulary listings are sort of tracking in line with your expectations post-NRDL. Can you help quantify that a little bit in terms of the number of key hospitals you're on formulary currently and the timeframe in which you would expect kind of to finish the process? Thanks so much.
spk10: Hey, good morning. Anupam. It's Josh. Thanks for the question. We have 1,000 hospitals that we're targeting for key accounts and that we're targeting for NRDL pull through on the listing. You know, based on historical experience, it takes about a year to pull the listings all the way down to the local hospitals. Our goal has been to, through the first half of this year, get at least two-thirds of those 1,000 hospitals to get the listing. And I'd say, you know, we're mid-May. We're well on our way to that goal.
spk16: Thanks. Next question, operator. Sure.
spk04: We are now going to proceed with the next question. The questions come from the line of Louise Chen from Canter. Please ask your question. Your line is opened.
spk15: Hi. Congratulations on the progress this quarter and thanks for taking my questions here. So I had a few for you. First question I had is if you can provide any more color on CAR XT's regulatory status and then any thoughts on this opportunity in light of the changing market landscape?
spk10: Harold, why don't you take the regulatory piece and then I can comment on the commercial opportunity?
spk11: Yeah, thanks for the question. The regulatory update is that we are currently executing a bridging study. This was a study discussed and designed with the agency. We are almost in the final stages of completing that study on time and hope to be able to finish it this year, as mentioned before. So the regulatory status is that we will have a dossier eventually with good results from our bridging study plus the dossier that was presented by Corona last year to the FDA and which contains the large emergence studies as a backup. In addition, we have obviously the case study which we execute in China just in order to complete the bridging program. Thank you.
spk10: Thanks, Harold. Hi, Luis. It's Josh. I think on the commercial opportunity, we're quite excited. As we've, I think, mentioned before, we see somewhere in the range of 8 million patients with schizophrenia in China. I think there's a strong emphasis on improving the care of patients with severe mental illness across China, as you know, with the CAR XT drug based on the global data that we already have all seen. There's strong efficacy performance and really good profile of the drug from a safety perspective. So we think this is going to be an important option for treating patients. We're excited to get through the regulatory process, as Harold mentioned, and begin to get this to patients as quickly as possible. So we're quite excited. Thanks.
spk15: Can I just squeeze in one more question here? So on Vivgard, just curious for the sales ramp, I don't know if you give quarterly guidance, but second, third, fourth quarters, something sort of a steady growth or would it be more back-end weighted? How should we think about modeling that? Thank you.
spk10: Thanks, Luis. I think, you know, first, we're really pleased with the first quarter performance. I think we're off to a good start. As you know, we said earlier in the year that just based on what we were seeing as a function of the NRDL listing, we were comfortable, confident with sales potential for the product in 2024 of greater than $70 million. We think we're well on track for that with the first quarter performance. And yeah, I think in general, we'd expect to see sequential growth through the quarters. Certainly, we see more in Q4 than Q3 and so on. But not back-end loaded in terms of the sort of growth. I think we expect this to be pretty steady. We're seeing that in the patient initiations. I think when we look at the first quarter, we had fewer patient initiations in February, but that was a function of Chinese New Year and the healthcare utilization that always happens in that month. So I think if we look at where we were in March, we continue to see steady acquisition of new patients and would expect that to through the year. So we're looking forward to quarter over quarter continued growth. I think as I say, we're comfortable with a greater than $70 million sales number. We're not going to give specific quarterly guidance, but getting off to a really good and exciting start.
spk04: Thank you. Thank you. We are now going to proceed with our next question. The questions come from the line of Michael Yee from Jeffries. Please ask your question. Your line is open.
spk14: Hey, good morning. Good afternoon. Thank you. We had two questions. One was on VivGuard. I know you commented about your confidence on the year. I think that you mentioned 2,700 patients. And if you multiply that out times the price and maybe some compliance rate, I think it would imply that you're already at a $70 million run rate. So could you comment on my math and whether there's anything I need to consider there like compliance, or you just think that you are already on that run rate and that's why you could beat that number. Talk to that a bit. And then the second question is on BD. I know you made some comments about business development and you've got the team there. Can you maybe just prioritize the one or two things you would like to do? Is that a U.S. pipeline deal? Is that a commercial deal? Would you do a commercial deal, for example? Maybe just talk a little bit about that so we have some expectations. Thank you.
spk10: Thanks, Mike. It's Josh. I'll do the VivGuard question and then ask Jonathan and maybe Rafael to comment on the business development piece. I think on VivGuard, as I mentioned, we're with the 2,700 patients in Q1 and continued hospital listing and good uptake from physicians and adoption. I think we are on the $70 million or greater trend. I think as it relates to the math and thinking about how the patients that are getting VivGuard now play out through the year, I think it's a little bit early to see what we should assume for each patient who starts and of course any patient who starts later in the year is not going to necessarily benefit from the full number of cycles. As you know, in the markets where we've launched the, where Argenics has launched, the cycles have averaged about five per year. We have no reason to believe that won't be the case in China, but it's still very early. Most patients are just coming online now, as you mentioned. I think we'll have more to see and talk about as we get into Q2 and Q3, but for now, I think your math is fine. We are on the trend and that's why we're saying we're quite confident that we're headed that way. Thanks for the question there. Jonathan, maybe you can start on the business development piece.
spk05: Hi, Mike. Thanks for the questions. On BD, I think there are two primary areas that we're focusing on. One is to continue to do what we always do, which is late stage regional deals, China, Asia deals for de-risked assets, especially if they're synergistic with our portfolio. But sometimes, you know, when things like FGIR and CAR XT come, we could potentially expand beyond our therapeutic area of focus. And then also, we're, you know, spending a lot of time on assets that may broaden or accelerate our global ambitions. These tend to be a bit more earlier stage, so maybe less de-risked, but, you know, we have a very strong scientific team. We have done deals in the past, even for regional rights where the asset was still very early stage, such as BEMA, Solder, to name some examples. So we want to continue to leverage that scientific expertise and bring assets that may give us potential global rights and fulfill those ambitions. Thank you.
spk04: Thank you. Thank you. We are now going to proceed with our next question. And the questions come from the line of Lin Haizhao from Goldman Sachs. Please ask your question.
spk07: Thanks for taking my question. I'm Lin Haizhao from GIZ. I have two questions on non-small cell lung cancers. The first one is about allogracid. I recall that previous plan was to file the NDA this year. It does not seem to appear in the OneQ Company of Materials. And just wondering if there's any change of plans for allogracid and if there is what would be the potential next steps for these assets. And the second question for Optium understood that a novel cure has completed the day 100 meeting with FDA without indication for advisory panel. Can you share a bit more on Zylabs visibility of China approval in the second line of non-small cell lung cancer for Optium and will Zylab wait for the FDA approval before filing the MAA in China? Thanks. Thanks.
spk10: Rafael, why don't you go ahead and address both of those please?
spk09: Sure. Thanks for the question. So another aggressive, as you know, there's single data that led to the approval of allogracid in the United States and DMS recently announced the results of the CRYSTAL-12 trial. They announced just top line data which was that primary endpoint was met. Primary endpoint was progression free survival and it was statistically and clinically meaningful. And we are evaluating further data. DMS has announced that they are still evaluating the rest of the data and they expect to present this in Congress in the future. And of course we need to await that evaluation as we make a decision on formulating a plan going forward. So we are essentially expecting further data as DMS looks at the totality of the data set. So that's the update on allogracid. With regards to DTFields, you are right, they filed in December. They had the 100-day meeting which they stated as a very productive meeting. They don't expect an advisory committee. And they've also filed in Europe and they're expecting CE marking as well. And there are negotiations as well in Japan. So fully sort of a global approach here to their submission. And we're working very closely with them. We expect to actually submit ourselves an China this year based on those results. So no change in the plan with regards to our expectation to be able to file lunar this year for second line non-small salon gasset.
spk07: It's just to clarify, for the China filing, we are not necessarily have to wait for the FDA approval, right?
spk09: Not necessarily. We don't have to wait for the approval.
spk07: Got it. Thanks.
spk04: Thank you. We are now going to proceed with our next question. The questions come from the line of Yegal Nuczomowicz from City Group. Please ask your question.
spk12: Hi. Thanks. Another Vivgard question. What are you hearing in the marketplace in China with regard to physicians and patients that are interested in waiting for the sub-Q version before prescribing or do you not see that as an impediment? And then once the sub-Q is launched, do you expect an acceleration in the launch or just a continued linear momentum? And then also, can you talk a little bit about the market for CIDP in China? What is the current standard of care there? Thank you.
spk10: Thanks, Yegal. It's Josh. I'll start and then Harold, maybe you can comment a little bit on standard of care for CIDP currently and how Vivgard will fit. I think in terms of the IV versus sub-Q, right now patients do go to these thousand hospitals that I mentioned which cover the vast majority of patients with GMG. They go to the hospital for treatment. So right now the IV formulation is fine. I don't think there's a wait for sub-Q. And as I think we've mentioned in other settings, we're targeting patients initially who are not doing well either on standard of care or in sort of a flare or rescue episode. So they'd be coming into the hospitals for treatment anyway. And of course, the sub-Q version still will require a physician administration. So I don't think we see that as a barrier today. Certainly we are excited about the opportunity for sub-Q as it provides another dosing option and it's an important formulation for all of the future indications. But I don't think as it relates to GMG, we would expect to see some new inflection point with that approval. We're quite excited about the patient capture and opportunities that we're seeing today and are looking forward to CIDP. And Harold, maybe you could give a few comments there.
spk11: Yeah, thank you. The question was about CIDP and the current standard of care treatment. And currently there is no approved treatment for CIDP anywhere in the world. So the study that was done by Agenix and us in China is really a landmark study in a way that it, first of all, brings a larger patient number into a study situation which you can make some kind of conclusions about treatment. The current treatment everywhere in the world is that these patients get steroids initially and if they progress, and many of them do progress, they end up getting IVIG. There's nothing really in between that has shown to be of benefit to patients. And as I said at some other meeting, the disease is really rather progressive and much more severe than GMBRA, which is a shorter version of this neurologic disease. So we do believe that this guard will have a significant role to play here in CIDP. This is a totally unmet medical need situation and will have a major impact on the treatment modality and the treatment paradigms. Thank you.
spk12: Okay. And then just to follow up, it sounds like based on your comments, Josh, with the dynamics with IV versus sub-Q, that similar dynamics would apply for CIDP. Is that fair?
spk10: Well, CIDP will be approved in the sub-Q version. That's how it was submitted. So I think by the time we get to CIDP, that'll be the formulation for that indication. Okay. So there's no IV for
spk12: the CIDP.
spk16: Okay. Thank
spk12: you.
spk16: We are now going to proceed with our next
spk04: question. And the questions come from the line of Jonathan Chang from Learing Partners. Please ask your question.
spk01: Hi, guys. Thanks for taking my questions. First question on ZL1310, your DLL3ADC. Can you help set expectations for the potential dose escalation data expected end of 24 or early 25? What types of patients are being enrolled in the study? How many may have seen a prior DLL3 targeting agent? And how much duration data are you hoping to have? And then second question, zooming out. How are you thinking about expanding on your global portfolio over time? What are the considerations here beyond the business development comments that you made earlier? Thank you.
spk10: Raphael, why don't you start and I can close out with any final comments on this question. Thanks, Jonathan.
spk09: Yeah, Jonathan. Thanks for the question. So yeah, Samantha mentioned before we have three products that are global, that are in the clinic at the moment. And one of them is ZL1310, our DLL3ADC, which utilizes team-building technology that has a bystander effect. So we see the promise based on preclinical results and have initiated a trial that started in the United States and expanded to China. And we're going to continue to expand the global footprint and try to accelerate dose escalation. I can say that we're proceeding well through dose escalation at the moment. And as we move forward, we will also, as I mentioned in the previous remarks, also combine it with checkpoint inhibitors. And in terms of the patient population, they're all platinum exposed, obviously. And we also are going to enroll some patients that have been exposed to bispecifics as well against DLL3. So those will be studied as well based on biology that sort of informed us that DLL3 remains expressive in patients that progress after bispecifics. So we will have, I think, a wealth of data in the platinum progressors in combination with ADDESO, as a single agent, in DLL3-naive patients as well as pre-exposed patients. In terms of how much data we will have, as you know, this is a phase one study and it depends on when we will achieve DLTs and when we will achieve a dose that we can then commence the expansion of that dose and understand the full potential of the drug. So we've guided towards the end of 2024 and potentially early 2025, at least with the initial data. So that's our expectation and we're very pleased with the way that this program is progressing at the moment. And then with regards to your broader question, Jonathan made some comments about business development. Perhaps I can just complement that with the fact that we are making what I believe is really good progress in discovery. We're focused on certain areas of cancer biology where we have expertise. We're nominating candidates and our goal is to have internal INDs coming from a laboratory, at least one a year. And I'm very pleased, at least, with the progress that we're making at the moment. So thanks for the question.
spk10: Great. I think that covers it. So maybe next question, please, operator.
spk04: Sure. We're now going to take our last question. And the questions come from the line of Jacqueline from Morgan Stanley. Please ask a question.
spk08: Hi, good morning and thanks for taking my question. I have a quick one on the VipGuard and also I think another one touching on the other pipeline. So for VipGuard, I think the other analyst brought up earlier in terms of patient profile. So I was wondering, so we have 2,700 new patients that were dosed over the first quarter. What are we seeing in terms of their treatment profile prior, like the breakdown between patients that were completely treatment-naïve compared to those that were refractory to the conventional immunotherapy and also I think those that are refractory to say C5, which is probably low in China anyway. So in terms of their prior treatment profile in that, and I think also wondering about in terms of the relative expectation in terms of opportunities that we'll compare from the indication expansions for VipGuard. So with CIDP coming and I think also TD later on, how can you have a qualitative comparison as far as China market for these new indications coming out versus GMG? Thank you.
spk10: Great. Thanks, Jack. I'll start. It's Josh and then Harold can provide some more detail and color on the question. I think first as it relates to the patient profiles for the initial launch here, we are targeting as part of the broader 170,000 GMG patients who could benefit from VipGuard, we're targeting initially those who haven't responded well to current treatment and as I say could be in a some type of rescue or flare situation. So I would say without getting into too much detail, the majority of the patients are patients who are not naive to treatment, they've been treated before. And the goal here of course is to get physicians to get comfortable using the product to have a good initial experience. And we know from real world experience, patients who are exposed to VipGuard, who haven't responded well to other treatments or otherwise are going to show a good response and we're seeing that. Of course we'll expand the emphasis over time, but I think initially that's the majority of patients are those who have already been under care and under some kind of pharmacological treatment for GMG. I think as it relates to just market opportunity, then Harold can provide some more comments. I think with all of the programs that we're participating in with Argenics, we're similarly excited about the commercial opportunity in China for this next wave of indications. So you can tell by our participation that we're seeing very good need for VipGuard as a treatment option for many of these devastating diseases, including thyroid eye disease. And we're excited about the opportunity over time. But Harold, anything that you'd like to add to that, please do.
spk11: Yeah, very little to add here. Thank you so much for the question. In essence, the labeling expansion to other indications is something we coordinate obviously with Argenics and there is a regular interaction there as to what is a reasonable next step to take. TED is one of the things that we have announced is definitely coming to us and we will start those programs fairly soon. There is discussion about other indications and we've already committed to doing a myopathy, myositis study, and this includes dermatomyositis, polymyositis patients, for which we believe F-CHI is a good option. But there are more indications like that, that could also be entertained and you just heard from Bristol Myers in the recent press release, they had good results in their Sjogren's phase two study. The list is long, we will be selective clearly, but for most of those indications, the frequency of the disease in China is just what you have everywhere else and so we will engage in an appropriate fashion wherever it makes sense for us in the overall list of autoimmune diseases that could be tackled with F-CHI. Thank you.
spk10: Awesome. Thanks, Harold. I think if there are no other questions, we can turn it back to Samantha.
spk04: I am showing no further questions at this time, so I'll turn back the call to Zainab, CEO, Samantha for closing remarks. Thank you.
spk03: Yes, thank you, operator. I want to thank everyone for taking your time to join us on this call today. We appreciate your support and look forward to updating you again after the second quarter of 2024. Operator, you may now disconnect this call.
spk04: Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you and have a great day.
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