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Edited Transcript of CNTB.OQ earnings conference call or presentation 13-Sep-22 8:30pm GMT

·33 min read

Q2 2022 Connect Biopharma Holdings Ltd Earnings Call Sep 13, 2022 (Thomson StreetEvents) -- Edited Transcript of Connect Biopharma Holdings Ltd earnings conference call or presentation Tuesday, September 13, 2022 at 8:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Chin Lee Connect Biopharma Holdings Limited - Chief Medical Officer * Steven Chan Connect Biopharma Holdings Limited - CFO * Zheng Wei Connect Biopharma Holdings Limited - Co-Founder, CEO & Director ================================================================================ Conference Call Participants ================================================================================ * Dingding Shi Jefferies LLC, Research Division - Equity Analyst * Joseph Michael Catanzaro Piper Sandler & Co., Research Division - Director & Senior Biotech Analyst * Louise Alesandra Chen Cantor Fitzgerald & Co., Research Division - Senior Research Analyst & MD * Thomas Jonathan Smith SVB Securities LLC, Research Division - Senior MD of Immunology and Metabolism & Senior Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, and thank you for standing by. Welcome to Connect Biopharma First Half 2022 Financial Results Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker for today, [Ina McGinnis]. You may begin. -------------------------------------------------------------------------------- Unidentified Participant, [2] -------------------------------------------------------------------------------- Thank you, operator. Today's call will be hosted by Connect Co-Founder and CEO, Dr. Zheng Wei; Chief Medical Officer, Dr. Chin Lee; and CFO, Steven Chan. Today's call is being webcast, and the replay will be available on the IR section of the company's website for 12 months. Following our prepared remarks, we'll open up the call to Q&A. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations, and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the safe harbor statement contained in the press release we issued earlier today as well as those contained in Connect Biopharma's registration statement on Form F-1 for a more complete discussion of the risks and uncertainties. Now I'd like to turn the call over to Wei. Wei? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Ina, and good day to all of those joining us today on this call and webcast. I plan to talk about the clinical progress we have made over the last 6 months, starting with our lead clinical candidate, CBP-201. Turning to our trials to treat adult patients with moderate to severe atopic dermatitis, or AD. In the Phase IIb global CBP-201 trial, we reported 16-week data that met the primary and key secondary endpoints of the trial with favorable safety data. Additional analysis demonstrate a potentially competitive therapeutic profile for CBP-201 300 milligram administered every 2 weeks or every 4 weeks. In the ongoing pivotal China-only trial for CBP-201 in AD, we received feedback from China's Center for Drug Evaluation, or CDE, that led us to review the data from the first 255 patients already enrolled in our Stage 1 16-week treatment period, and if positive, review this data in a pre-BLA meeting with the CDE. This is particularly good news as this would potentially accelerate the timeline to BLA submission of CBP-201 in China. As a result, we plan to report the topline data next month, in October, potentially 8 months earlier than originally planned, if positive and having positive results from the stage 2 36-week data readout, we could be in a position to file a new drug application in 2024 and a potential NDA approval in China as early as 2025. It's our goal to use this potentially positive results from this PRC specific trial to start handling discussions. We also plan to enroll our first patient in the company's global CBP-201 Phase III study in moderate to severe AD by the end of 2022. We also see great potential for CBP-201 in the treatment of patients with severe asthma with type 2 inflammation, and anticipate complete full enrollment in the first half of 2023. This is 6 months later than previously anticipated. We will also then plan to report the Phase II topline result of CBP-201 in asthma in the second half of 2023 versus first half of 2023 as previously indicated. Turning to CBP-307. CBP-307 is a proprietary oral drug candidate under development to treat ulcerative colitis, a disease that onsets early in adulthood and lasts a lifetime. Despite the available treatment, UC patients continue to suffer with unmet need, while new ones join the ranks in increasing numbers as the disease grow in incidence and regional prevalence. In May, we reported 12-week topline data in a global Phase II trial in moderate to severe UC. I think it's important to take some time recapping the status of CBP-307, outlining the partner opportunity and why 307 presents a compelling partnering opportunity. CBP-307 has a proven mechanism of action operating within a well-validated disease pathway demonstrated to be clinically effective against UC. Pharmacodynamics and pharmacokinetics show that CBP-307 hits its target and does so rapidly. In addition, CBP-307 has a higher affinity for binding to Sphingosine 1-phosphate receptor 1 or S1P1. The targeted signaling pathway implicated in ulcerative colitis disease cascade than the other 2 drugs in S1P1 modulator class. Biomarker analysis also shows that CBP-307 reduces the level of circulating lymphocytes in the blood. The downstream and desired effect of hitting this target to meaningful disease mitigated levels of less than 800 cells per microliter. This level of lymphocyte reduction is stronger than (inaudible) and the effect on set is faster than that observed for (inaudible). Moreover, CBP-307 significantly reduced the level of (inaudible) patients, a reliable biomarker correlated with UC disease severity. This is why we think CBP-307 will interest partners. CBP-307 demonstrated a statistically significant clinical remission rate at a higher dose. And while this was a secondary endpoint in this trial, clinical remission based on the adapted Mayo score is currently the regulatory endpoint in UC registrational files. And it was the primary endpoint for (inaudible), the only approved drug in this class. Given all of this, any potential CBP-307 partner will be able to enter the UC therapeutic space with a Phase III-ready candidate that has the potential to provide a new and clinically attractive treatment option to patients. With that recap of highlights and a short review of the state of CBP-307, let me now turn the call over to Chin to discuss in more detail our lead candidate, CBP-201. Chin? -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [4] -------------------------------------------------------------------------------- Thanks, Wei. I'm going to talk more about plans for our lead drug candidate, CBP-201 in AD and specifically the trial designs for our planned global Phase III program. And then I'll recap the news we just reported our earliest clinical drug candidate, CBP-174. We've made a lot of progress this year on our CBP-201 AD program. Notably, we had a successful end of Phase II meeting with FDA, and our team has worked diligently on a robust Phase III program, and we are now looking forward to enrolling the first patient into our initial registrational trial before end of this year. The first global Phase III study is part of a larger registrational program comprising 4 controlled clinical trials and a separate open-label extension study for patients with moderate to severe AD. Of the 4 controlled trials, 3 of them will evaluate patients through 52 weeks of treatment. In these trials, patients will receive 300 milligrams of CBP-201 every 2 weeks for the first 16 weeks of treatment. Thereafter, over the remaining 36 weeks, patients who are deemed to be responders will be re-randomized into 1 of 3 groups. Some will remain on the 300-milligram dose given every 2 weeks. Some will step down to 300-milligram dose given every 4 weeks, and others will receive placebo. In 2 of these 52-week studies, we will compare CBP-201 to placebo during the first 16 weeks of each study. The fourth control trial will be 16 weeks in duration, and it's designed to assess the 300-milligram dose of CBP-201 given every 2 weeks as compared to placebo in patients using background topical agents such as corticosteroids. Our Phase III program is designed to clearly show how well our 300-milligram dose given every 2 weeks performs against placebo in the first 16 weeks of treatment. The Phase III data set will also provide evidence on CBP-201's ability to maintain clinical improvement in patients who stepped down to a more convenient treatment regimen of 300-milligram given every 4 weeks for long-term use, which is part of our overarching goal of demonstrating the potential differentiated therapeutic benefits of CBP-201 for patients with AD. Now I would like to turn your attention to our early-stage clinical drug candidate, CBP-174, which is being studied to treat chronic pruritus or itching associated with allergic and inflammatory skin conditions including AD. CBP-174 is a highly selective, perfectly acting H3R antagonist for oral administration. As you likely saw on August 30, we reported topline results from our Phase I trial designed to evaluate safety, tolerability and pharmacokinetics, or PK, in healthy adults. I'm pleased to report that CBP-174 administered orally was observed to be safe and well tolerated across 8 dose escalation cohorts evaluated up to a maximum dose of 16 milligrams or placebo in this randomized, double-blind, placebo-controlled single ascending dose study. There were no serious adverse events and reported adverse events were predominantly mild in severity with no dose-limiting toxicities. The CBP-174 PK profile exhibited rapid absorption with dose proportional increases and exposure followed by linear elimination. This promising first-in-human data represents progress for the development of CBP-174 as a potential novel treatment for pruritus associated with allergic and inflammatory skin conditions, including atopic dermatitis, which affects millions of individuals worldwide. This is our first clinical trial for our third clinical stage drug candidate, and we look forward to continuing to evaluate CBP-174 as we work towards improving the quality of life for patients with debilitating dermatologic diseases. And with that, let me turn the call to Steve to cover the financial report. -------------------------------------------------------------------------------- Steven Chan, Connect Biopharma Holdings Limited - CFO [5] -------------------------------------------------------------------------------- Thanks, Chin. Today, we filed our Form 6-K for the 6 months ended June 30, 2022, which contains detailed financial results and is available on the SEC and Connect websites. I'll cover a few key financial metrics starting with our cash position. For all of my remarks, I'll be comparing the 6 months ended June 30, 2022, to the 6 months ended June 30, 2021, unless specified otherwise. As of June 30, 2022, cash, cash equivalents, short-term and long-term investments were USD 212.9 million or RMB 1,429.1 million compared to RMB 1,706.9 million at December 31, 2021. The decrease was mainly due to R&D and administrative costs associated with our 3 clinical drug programs. Our total cash and investments of USD 212.9 million are expected to fund our operations into at least 2024 based on our current operating plan. R&D expenses increased to USD 50.8 million or RMB 340.8 million from RMB 217.8 million. This increase was driven primarily by higher clinical trial-related expenses, including expenses related to advancing CBP-201 for AD in China, the ongoing global Phase II costs for CBP-201 in asthma, our global Phase II trial cost for CBP-307 in UC as well as higher personnel costs for additional R&D headcount. Administrative expenses totaled USD 10.7 million or RMB 71.8 million compared with RMB 48.0 million in the same period in 2021. Admin expenses rose primarily due to higher personnel costs, stock-based compensation expenses, higher professional services and other costs associated with building out a public company infrastructure and supporting clinical trials. Net loss totaled USD 59.8 million or RMB 401.3 million compared with a net loss of RMB 942.5 million for the 6 months ended June 30, 2021. The net loss in the prior year period was higher due to the recognition of RMB 674.3 million of fair value adjustments on our preferred stock, which were converted to common stock in last year's IPO. With that, I'll turn the call over to the operator for instructions and how to participate in the Q&A portion of today's call. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from the line of Louise Chen with Cantor Fitzgerald. -------------------------------------------------------------------------------- Louise Alesandra Chen, Cantor Fitzgerald & Co., Research Division - Senior Research Analyst & MD [2] -------------------------------------------------------------------------------- Congratulations on all the progress this quarter. So I had a few questions for you. First question I had for you is that atopic dermatitis is a crowded development space. So just curious what you think your differentiation will be here? And then secondly, for CBP-307, do you think we could hear about a partner before the end of the year? Or is this more of a 2023 or -- if you could give us any sort of timing, that will be helpful. And has there been interest by partners in your discussions? And then lastly, what is the opportunity for CBP-201 in asthma? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [3] -------------------------------------------------------------------------------- Essentially -- thank you for the question, I believe that we have 4 questions here. Let me take a crack on the first questions, and then Chin can address the 307 and the timeline for clinical report. And I can probably also after my answer to the first question, some insight on interest of investors and partners on 307 and then, again, maybe back to Chin on asthma potential. So with respect to the opportunity of CBP-201 in the AD space, you are absolutely correct that the AD space treatment has evolved quite a bit now since launch of dupilumab. And it is now becoming a more crowded space. But if you'll look at the market opportunity and the number of patients worldwide that can be -- that can benefit from systemic treatments, the opportunity, obviously, is very large, and that's validated by the performance of drugs like dupilumab in the marketplace. Now when we look at opportunities, obviously, we're looking at this time, we believe that biologics, especially biologics that have significant efficacy and excellent safety profile, is going to continue to be most important and will continue to dominate this space as the market grow. And, obviously, other modalities will have a significant role as well. Now within the IL-4 alpha receptor antibody space represented here by dupilumab, we believe that blocking IL-4 and IL-13 continue to be the most effective way of treating AD as well as other diseases, allergic diseases associated with type 2 inflammation. So if you just look at IL-4Ra antagonist space, obviously, so far dupilumab is the only drug on the market right now. Connect is developing a potentially differentiated antibody as a second to the market in this specific class, right? And as we have communicated in the past, dupilumab is good, it's a wonderful drug. But certainly, in terms of its efficacy, in terms of convenience of use, in terms of dosing frequencies, there are clearly opportunities to improve and allow other molecules to come in. When we look at CBP-201, it's an entirely different molecule with different binding epitope. And our goal here is to have differentiation in perhaps a number of areas, right? So we have potentially the overall efficacy, and we're going to find out in our future studies. And the other is potentially in the long treatment period of maintenance where -- and Q4W may be an opportunity where it's not available for dupilumab. So to kind of circle back to the question, yes, it is a crowded space. And each of this kind of category have their specific utility to address patients' needs, and we believe that CBP-307 does have a great opportunity if our clinical data support a robust efficacy and potentially dosing (inaudible). The -- let me go to the question on CBP-307. We -- as in my opening remarks here, we emphasized that CBP-307, by all the measures that we look at, looked at the totality of our Phase II data, we are quite comfortable that clearly the molecule is working the way it should, especially by the clinical remission rate. And there have been continued interest in CBP-307, and we have been an ongoing discussion. And at this time in point, we don't have anything to update, but we will be happy to do so when we are ready to announce any sort of update on this discussion. Let me ask Chin to address the progress in terms of when our clinical report will come up and also the asthma opportunity for CBP-201. Chin? -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [4] -------------------------------------------------------------------------------- Yes. Thanks, Wei. So I think as you heard on the first part of this call, so for the AD program, so we're well underway for the first study looking forward to getting our first patient in the study before the end of this year. And then we'll continue to make positive steps towards the program as we move the AD indication forward. So we're very excited about that. And then maybe a quick update regarding asthma. So we look forward to getting the results closer to the first half of next year and continue to make progress on that. And I think, Louise, your question around CBP and asthma, certainly, the line of the response that Wei gave on your -- one of your questions around the AD space, I think asthma is not dissimilar. Obviously, there's many treatments for that. But we believe that we've got potentially a molecule that in 201 -- CBP-201, that can be very competitive once we've generated the totality of data for approval across the different indications we are currently pursuing in AD as well as asthma. And I think that in of itself represents opportunity for us with the molecule, not just in AD, but asthma because I think with a molecule like this, we want to pursue indication that will allow us to continue to layer on the different treatment options that physicians will have from CBP-201. -------------------------------------------------------------------------------- Operator [5] -------------------------------------------------------------------------------- Our next question comes from the line of Thomas Smith with SVB Securities. -------------------------------------------------------------------------------- Thomas Jonathan Smith, SVB Securities LLC, Research Division - Senior MD of Immunology and Metabolism & Senior Research Analyst [6] -------------------------------------------------------------------------------- I guess first on CBP-201. Can you give us any additional color on your regulatory interactions with China CDE? And maybe speak to your level of confidence that positive results from the ongoing study could result in an approvable data set? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [7] -------------------------------------------------------------------------------- Thank you, Tom. Thank you for the question. Yes, and I can provide an update here. We did talk about this in our press release. And -- it really is an excellent development for the program, trying to get dropped a proof and make it available to patients in China. As you recall that in our previous discussion, we had planning to enroll more patients in that study in order to satisfy the exposure center. And in our discussion with CDE, based on their reply our questions, it certainly appear to us, and we believe, that the CDE want to see the -- how the data set looks like and because we already have a global Phase IIb trial, and on top of that, we built this China pivotal trial, in terms of the designs and the purpose, it's entirely consistent with the pivotal trial. So -- now we won't be able to provide sort of additional detail, in fact, we -- this is not in-person meeting with the CDE. And so we believe that it will depend on whether or not we hit our endpoint in our pivotal trial in China. And the other thing I should point out is that the ability to very quickly follow up with the pre-BLA meeting, which is what we agreed on with the CDE immediately after the 16-week data, it's a very positive sign. It also allow us to have better understanding of what else is needed, whether on our package to be complete, and that will all depend on the pre-BLA meeting that we're going to schedule as soon as we have our data together. -------------------------------------------------------------------------------- Thomas Jonathan Smith, SVB Securities LLC, Research Division - Senior MD of Immunology and Metabolism & Senior Research Analyst [8] -------------------------------------------------------------------------------- Okay. Got it. That makes sense. And then you mentioned -- it sounded like in the prepared remarks, potentially using the China pivotal data as the start of potential partnering discussions. Can you just talk about what you'd be looking for in terms of partnership? And I guess, latest thoughts on how you're thinking about commercialization in China versus the U.S. versus Europe versus other regions? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [9] -------------------------------------------------------------------------------- Yes. So on the partnership front, I think we indicated also in previous discussions with investors is that we are open to partnering CBP-201, both in regional deals, China specific -- Greater China specific, for example, as well as global deals. Now obviously, our expectation is that the global deal or ex-China deal will take a little bit longer to conduct and to complete. And so that's sort of our objective is that we will have a regional deal first. So just in sort of in terms of the logistics and the realistic timeline for negotiations and partnership discussions, but it -- we will also be interested in ex-China partnership. With respect to commercialization, we certainly are open to working with China pharmaceutical companies -- China-based pharmaceutical companies who may have much more capability in their marketing, especially in immunology space. I think we all come to realize that to be successful in the China market, we do need efficiencies, and building a sales force is not a trivial task. So if the deal is favorable and they allow us to achieve our goal in terms of getting the drug in approved China as well as generating revenue, connect in a the form of royalty, we are completely open to that as well. And as I said at this moment, we are not able to share any specifics on the progress, we will be very happy to discuss when the time comes. And -- Yes. Just to add a little bit related to your question, Tom, is -- yes, the -- now that the pivotal trial data is available rather quickly, much earlier than previously anticipated, and so this certainly will become also part of the discussion in our partnership discussions, and we see this as a very positive sign with another set of data available to us. I hope this helped. -------------------------------------------------------------------------------- Thomas Jonathan Smith, SVB Securities LLC, Research Division - Senior MD of Immunology and Metabolism & Senior Research Analyst [10] -------------------------------------------------------------------------------- Yes. No, that's very helpful. And then just maybe last question. Just -- when can we expect to hear more on your plans and next steps for future studies with CBP-174? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [11] -------------------------------------------------------------------------------- Yes. And we literally just got the data and are able to present, right? So this first study is truly a typical first-in-human study to allow us to get an understanding of the drug characteristics, right, the safety profile, which is the most important part of this evaluation. And by this study so far, we are happy with the safety profile with the dose level that we have achieved. The next step, obviously, require a little bit more kind of deliberation here in terms of how we leverage a next study that will look like -- I think most people think it will look more like a multiple ascending dose, but not just purely a multiple ascending dose in healthy individuals, to be able to think about whether or not we can build certain kind of biomarker or even running the study in patients of, say, skin inflammation. So I -- we're going to have to go back and put our heads together to come up with that plan. So we'll be happy, again, to update when the time comes. -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [12] -------------------------------------------------------------------------------- Yes. And Wei, if I can just add one more point to Tom's good question around CBP-174. The other thing is, Thomas, one of the things that we did in the Phase I single ascending dose study is, we administered the drug using it in a solution. And there may be opportunities for us to think about optimizing the formulation in the next study. And so that's another reason we want to sort of consider some of the details around what that next study will look like in addition to other comments that Wei made that are really excellent points in terms of the things that we want to think through rather than just doing a sort of just a usual typical MAD type of Phase I study. -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [13] -------------------------------------------------------------------------------- Thank you, Tim. That's another excellent point in here. This type of first-in-human study is to find out some information as quickly as possible. The correct way of hosting the drug, as Chin pointed out, is API in solution. Certainly, it's not the format of the formulation we would like to take to the next study. So -- yes, that's a (inaudible) as well. I hope this is helpful. -------------------------------------------------------------------------------- Operator [14] -------------------------------------------------------------------------------- (Operator Instructions) Our next question comes from the line of Kelly Shi with Jefferies. -------------------------------------------------------------------------------- Dingding Shi, Jefferies LLC, Research Division - Equity Analyst [15] -------------------------------------------------------------------------------- Can you hear me fine? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [16] -------------------------------------------------------------------------------- Kenny -- yes, we can hear you. -------------------------------------------------------------------------------- Dingding Shi, Jefferies LLC, Research Division - Equity Analyst [17] -------------------------------------------------------------------------------- Okay. So first of all, could you actually share some color regarding the payback of the end of Phase II meeting with FDA? Do you still plan to enroll more severe AD patients? And how do you implement this strategy into the operation for the global Phase III trial? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [18] -------------------------------------------------------------------------------- Great. Thank you for the questions. And this sounds like a question for Chin. Would you like to take on this question? -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [19] -------------------------------------------------------------------------------- Yes. Great question, Kelly. So as mentioned in the first part of the call, we did have what we believe to be a very successful interaction with FDA. And during that meeting, a lot of time -- most of the discussion was spent on how our Phase III program will look like, and had a lot of discussions around very detailed things, everything from the design of not only the initial treatment, but beyond the primary endpoint in terms of generating more chronic use data in our 52-week study. So that was very informative for us and also had good discussions around the details of who we would take into that chronic long-term study, for example, who -- the definition of responders, even down to the details around -- some of the details around end point and how we would train investigators. So it was a very fruitful conversation around sort of nuts and bolts of our clinical Phase III program. And we did have some other conversations, for example, around patient population about -- for example, including children, younger adolescents. That was something that we know the FDA was favorable in wanting us to pursue. So we got some good feedback on that. And so I think a very fruitful conversation, again, more around the Phase III program. And I would say that the bulk of the conversation was, in fact, going through our different trial designs. I would say about 80% of the call. And then -- in terms of -- you had a question around a sense of getting more severe patients. So this is something that, coming out of our Phase III -- or excuse me, Phase II global study, this is something that is first and foremost in our mind. I should first say that in terms of executing excellence, so far, if the current large trial in China that Wei discussed, that serves as our pivotal trial for potential registration in China, that study, I think, will be a good sort of next step for us to see if we're able to recruit the kind of more severe patients. And so far, based on what we know, that looks to be the case. In terms of replicating that in a Phase III global program, there's going to be inherent challenges there because we'll be going to, obviously, different geographies. But one of the things that we've discussed is trying to balance the operational challenge of trying to enroll patients in a timely fashion versus making sure we get sufficiently active patients at baseline. And one of the things we may do is allow patients who have higher levels of baseline that's been typically required for some subgroup of patients to enroll as part of the entry criteria until we get enough of those more severe patients. But on a whole, we would still allow those patients who have moderate to severe AD as all of the other Phase III trials in the AD space has done. But again, we may have a subgroup that may actually have even a higher level of disease severity so that, overall, we'll have a patient population that will be hopefully more severe than what we had in our Phase II global study. -------------------------------------------------------------------------------- Dingding Shi, Jefferies LLC, Research Division - Equity Analyst [20] -------------------------------------------------------------------------------- I also have a follow-up. So on the clinical trials dugout, it was showing that the nasal polyps trial was terminated. Curious, do you plan to resume the program in the future? And what are your thoughts for 201 in terms of indications beyond AD? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [21] -------------------------------------------------------------------------------- Chin, do you want to go ahead and also take another question? Yes? -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [22] -------------------------------------------------------------------------------- Yes. Absolutely. Yes. So another really good question, Kelly. So we made a very difficult decision to terminate that study and it was -- I think you may be aware, it was not due to any safety issues at all. It was more of an operational issue in terms of enrolling the study during a very challenging period. And I think 2 important factors that weighed in on that study was -- number one, the pandemic that was ongoing at the time as well as the lockdowns in China, but also, secondary, there was also the Ukraine conflict that had an important impact on that study because we had sites in Ukraine that were to start up, and I think people who are experienced in running clinical trials, Ukraine is often a country that serves to enroll a lot of patients in different clinical trials. And so when that conflict beget, it impact their ability to get those sites recruiting patients. So those are 2 key reasons that really impacted our ability to continue to enroll that study. And again, we made a very difficult decision to stop that study. In terms of whether or not we will pursue nasal polyps in the future. maybe I can turn that back to Wei to comment on that. But obviously, I think with dupilumab having shown efficacy there in that indication, I think we know the mechanism should work and our drug would likely work in that indication. So -- let me turn it over to Wei to see if you want to -- if you could answer the question about would we pursue nasal polyps in the future? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [23] -------------------------------------------------------------------------------- Sure, sure. Well, thank you, Kelly, for the question. And thank you, Chin. Yes, so this tie into a kind of a broader question of indications for a drug like CBP-201. And we want to go back to the same thesis of why IL-4Ra antagonists, they're different from IL-13 antibodies for their ability to block a broader disease pathways. And if you look at dupilumab, for example, right now, it looks like it's going to be approved for many, many indications in the type 2 pathway. I think we believe CBP's value is going to be significantly increased with additional indications such as asthma, nasal polyps and other studies, other indications as well because these type 2 diseases are very often -- they are kind of comorbidities, and patients suffer from more than one type of type 2 diseases and, therefore, potentially making this class of drug a lot more attractive, right? So we're seeing that being played out already. So a nasal polyps will one of the indications that either our partner in the future will pursue and perhaps that's both in China and ex-China as well. But again, that's not something we're going to begin running starting in the next few months, right, but that's certainly in the plan in the future. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- (Operator Instructions) Our next question comes from the line of Joe Catanzaro with Piper Sandler. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - Director & Senior Biotech Analyst [25] -------------------------------------------------------------------------------- Just two quick ones for me. Maybe first one following up on the discussion earlier around the potential for partnership opportunities for CBP-201. Just want to confirm that it is your expectation to launch the global Phase III AD program before year-end, irrespective of whether you have any partnership in place by then? And then second question around the October readout and how you're thinking about the extent of disclosure in the topline? Should we expect something similar to last November's Phase IIb topline readout? Or would you expect to include some more details like P values or maybe even absolute efficacy metrics? -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [26] -------------------------------------------------------------------------------- Thank you, Joe, for the question. Let me take a kind of stab at the first question first on the potential partnership. Yes, so with respect to launch of our Phase III global studies and whether or not by the time we would have a global partner. The assumption right now, obviously, is that we will be able to launch our study given our financial operation at the moment, without securing a global partner by the time we launch. We are talking about only a quarter's time, right? So -- but again, with the new data that we have, that we're going to release. We are going to continue our global discussions and hopefully, in the not-too-distant future, we'll be able to have a good partnership to move the program forward. So that's -- so the part of the question. Was there another question on the partnership? -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - Director & Senior Biotech Analyst [27] -------------------------------------------------------------------------------- No, I think that covers it. The second question was on sort of the disclosure level on the October readout. -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [28] -------------------------------------------------------------------------------- Yes. And I would like to turn this to Chin to provide some detail. -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [29] -------------------------------------------------------------------------------- Yes. Thanks, Wei. Thanks for the question, Joe. So for the topline readout -- so I think your question is in terms of level of detail relative to, I think you're referring to that original press release we had for our Phase II global AD trial data. Is that correct? -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - Director & Senior Biotech Analyst [30] -------------------------------------------------------------------------------- Yes. That's right. -------------------------------------------------------------------------------- Chin Lee, Connect Biopharma Holdings Limited - Chief Medical Officer [31] -------------------------------------------------------------------------------- Okay. Great. So in terms of maybe just to give you a little bit of context around what we plan to have for the topline, it's going to obviously be the primary endpoint at week 16, which is the ED75. We'll have some key secondary endpoints, IGA, itch, et cetera, along with very topline safety results. And given that we will have primary and key secondary -- I think one of the things that we took away from the first press release is the desire for external investor community to have that level of granularity you're probably referring to. And so we -- I think at this point, we would look forward to disclosing as much of that information as possible versus something that's more higher level. I don't know if that completely answers your question. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - Director & Senior Biotech Analyst [32] -------------------------------------------------------------------------------- Yes, that does. That's helpful. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- (Operator Instructions) I'm showing no further questions in the queue. I would now like to turn the call back over to Zheng Wei for closing remarks. -------------------------------------------------------------------------------- Zheng Wei, Connect Biopharma Holdings Limited - Co-Founder, CEO & Director [34] -------------------------------------------------------------------------------- Sorry, I just muted myself. Well, thank you, operator. Looking forward, just in the next several months, we have a number of milestones that we anticipate will help advance our goal of developing T cell-driven therapies to treat inflammatory diseases to improve the lives of patients with chronic inflammation. For CBP-201 in AD, we are on track to report topline data from the Stage 1 16-week treatment period of the China-only pivotal trial in October. We plan to initiate a global Phase III trial before the end of 2022. For CBP-201 in asthma, we anticipate completing enrollment in a global Phase II trial in asthma patients with type 2 inflammation in the first half of 2023. We plan to report topline finding in the second half of 2023. Additionally, CBP-307 in UC will complete its Phase II maintenance phase in the second half of 2022. Thank you all for your interest in Connect Biopharma, and I look forward to reporting to you on the progress in the coming weeks and months. -------------------------------------------------------------------------------- Operator [35] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.