Q2 2022 Connect Biopharma Holdings Ltd Earnings Call
Good day, and thank you for standing by. And to connect by formal first half 2022 financial results conference call.
At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session.
To ask the question during the session, you will need to press star 1 1 on your telephone.
I would now like to hand the conference over to your speaker for today. Ina McGinnis, you may begin.
Thank you, operator. Today's call will be hosted by Connect co-founder and CEO , Dr. Zhen Wei, Chief Medical Officer, Dr. Chin Lee, and CFO , Stephen 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 tech biopharmas registration statement on form F1 for more complete discussion of uncertainties. Now I'd like to turn the call over to Wei. Wei?
Thank you, Ina, and good day to all of those joining up today on this call and webcast.
I plan to talk about the clinical progress we have made over the last six months, starting with our lead clinical candidate, CDP-201. I am going to talk about the clinical progress we have made over the last six months, starting
Tune into our trials to treat adult patients with moderate to severe atopic dermatitis, or AD.
In the Phase IIB global CVP201 trial, we reported 16-week data that met the primary and key secondary endpoints of the trial with favorable safety data.
Additional analysis demonstrates a potentially competitive therapeutic profile for CVP201 300 mg administered every 2 weeks or every 4 weeks.
In the ongoing pivotal China-only trial for CVP201 in AD,
We received feedback from China Center for Drug Evaluation or CTE that led us to review the data from the first 265 patients already enrolled in our Stage 1 16-week treatment period and if positive, review this data in a pre-BLA meeting with the CTE.
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 this top-line data next month, in October .
potentially eight months earlier than originally planned, if positive, and tag in positive results from the state to 36-week data results.
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 result from this PRC specific trial to start handling discussions.
We also plan to enroll our first patients in the company's global CVP201 Phase 3 study in moderate to severe AD by the end of 2022.
We also see great potential for CVP201 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 six months later than previously anticipated.
We would also then plan to report the Phase II top-line results of CPP201 in asthma in the second half of 2023 versus first half of 2023 as previously indicated.
Turning to CVP 307.
CVP307 is a proprietary oral drug candidate under development between ulcerative colitis.
a disease that onset early in adulthood and last a lifetime.
Despite the available treatment, UC patients continue to suffer with unmet needs.
while neurons join the ranks in increasing numbers as the disease grows in incidence and regional prevalence.
In May, we reported 12-week top-line data in a global Facebook trial in moderate to severe UC.
I think it's important to spend some time recapping the status of CBP 307.
outlining the partner opportunity, and why 307 presents a compelling partnering opportunity.
CBP307 has a proven mechanism of action operating within a well-validated disease pathway demonstrated to be clinically effective against UOC.
Pharmacodynamics and pharmacokinetics show that CBP307 hits its target and dies so rapidly.
In addition,
GBP0.7 has a higher affinity for binding to spinosin 1-phosphate receptor 1, or S1P1, the targeted stymoline pathway implicated in ulcerative colitis disease cascade.
Then the other two drugs in S1P1 Modulator class.
Biomarker analysis also shows that CVP307 reduces the level of circulating lymphocytes in the blood.
The downstream and desired effect of hitting this target
Two meaningful diseases mitigate the levels of less than 800 cells per microliter.
This level of linsoff cell reduction is stronger than atruss mode and the effect onset is faster than that observed for ozonimo.
Moreover.
CBP307 significantly reduced the level of fecal carpal technically patient
A reliable biomarker correlated with UC disease severity.
This is why we think CBP 307 will interest partners.
CCP307 demonstrated a statistically significant clinical re-immission rate at a higher dose.
And while this was a secondary endpoint in this trial,
Clinical remission based on the adaptive male score is currently the regulatory endpoint in UC registration of files.
And it was the primary endpoint for Denimal, the only approved drug in this class.
Given all of this,
Any potential CBP307 partner would be able to enter the UC therapeutic space with a phase three ready candidate that has the potential to provide a new and clinically attractive treatment option to patients.
With that recap of our highlights and a short review of the state of CDP-307.
Let me now send a call over to Qin to discuss in more detail our lead candidate, CDP-201.
Okay.
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 our recap, the news we just reported, our earliest clinical drug candidate, CBP174.
We've made a lot of progress this year on our CBP 201 AD program.
Notably, we had a successful interface to meeting with FDA, and our team has worked diligently on a robust phase 3 program.
And we are now looking forward to enrolling the first patient into our initial registration trial before end of this year.
The first global phase 3 study is part of a larger registration program comprising four controlled clinical trials.
and a separate open label extension study for patients with moderate to severe AD.
Of the four controlled trials, three 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 one of three groups.
Some will remain on the 300 milligram dose given every two weeks. Some will step down to 300 milligram dose given every four weeks, and others will receive placebo. A
In two of these 52-week studies, we will compare CBP201 to placebo during the first 16 weeks of each study. We will compare CBP201 to placebo during the first 16 weeks of each study.
The fourth controlled trial will be 16 weeks in duration and it's designed to assess the 300 milligram dose of CBP201 given every two weeks as compared to placebo in patients using background topical agents such as corticosteroids.
Our phase three program is designed to clearly show how well our 300 milligram dose, given every two weeks, performs against placebo in the first 16 weeks of treatment.
The Phase III data set will also provide evidence on CBP201's ability to maintain clinical improvement in patients who step down to a more convenient treatment regimen of 300 milligrams given every four weeks for long-term use.
which is part of our overarching goal of demonstrating the potential differentiated therapeutic benefits of CDP 201 for patients with AD.
Now I would like to turn your attention to our early stage clinical drug candidate, CBP174, which is being studied to treat chronic pruritus or itching associated with allergic and inflammatory skin conditions, including AD. CBP174 is a highly selective, peripherally acting H3R antagonist for oral administration.
As you likely saw on August 30th, we reported top line results from our phase 1 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 will tolerate it across eight dose escalation cohorts, evaluated up to a maximum dose of 16 milligrams or placebo in this randomized double-blind placebo-controlled single-hanging dose study.
There were no serious adverse events and reported adverse events were predominantly mild in severity with no dose limiting toxicity.
The CBP174PK profile exhibited rapid absorption with dose proportional increases in exposure, followed by linear elimination.
This promising first in human data represents progress for the development of CBP174 as a potential novel treatment for pruritus associated with allergic and inflammatory skin conditions, including atopic dermatitis, which affects millions of individuals worldwide. leads to long term change mark
This is our first clinical trial for our third clinical stage drug candidate, and we look forward to continuing to evaluate CBP174 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.
Thanks, Jim.
Today we filed our Form 6K for the six months ended June 30th, 2022, which contains detailed financial results and is available on the SEC Internet website.
I'll cover a few key financial metrics starting with our cash position.
For all of my remarks, I'll be comparing the six months ended June 30, 2022 to the six months ended June 30, 2021 unless specified otherwise.
As of June 30, 2022,
Cash, cash equivalents, short-term and long-term investments were 212.9 million US dollars.
or R&D 1429.1 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 three clinical drug programs.
Our total cash and investments of 212.9 million US dollars.
are expected to fund our operations into at least 2024 based on our current operating plan.
R&D expenses increased to $50.8 million U.S. dollars or R&D $340.8 million.
from RMB $217.8 million.
This increase was driven primarily by higher clinical trial related expenses.
including expenses related to advancing CBP201 for AD in China, the ongoing global phase 2 costs for CBP201 in asthma,
Our global Phase 2 trial calls for CPP 307 in UC.
as well as higher personnel costs for additional R&D headcount.
Administrative expenses totaled $10.7 million.
or RMB 71.8 million compared with RMB 48.0 million in the same period in 2021.
and inexpensive rose primarily due to higher personnel costs.
start base compensation expenses.
higher professional services, and other costs associated with building out a public company infrastructure and supporting clinical trials.
Net loss totaled $59.8 million US dollars or RMB 401.3 million compared with a net loss of RMB 942.5 million for the six 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 on how to participate in the Q&A portion of today's call.
Operator for instructions on how to participate in the Q&A portion of today's call. Operator.
Thank you.
As a reminder to ask the question, you will need to press star 1 1 on your telephone.
That's star 11 to ask the question.
Please stand by while we compile the Q&A roster.
Oh, first question.
One moment.
Our first question comes from the line of Louise Chen with Cata Fitzgerald. Your line is open.
Hi, thank you for taking my questions, and also congratulations on all the progress this quarter. So I had a few questions for you. First question I have for you is that a topic differentiately 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...
or if you could give us any sort of timing that would be helpful, and has there been interest by partners in your discussions? And then lastly, what is the opportunity for CBP-201 in asthma? Thank you. Thank you.
Thank you, Louise.
Thank you for the questions. I believe that we have.
Four questions here.
Let me take a crack on the first question and then Ching 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 the interest of investors and partners on Bill 7.
And then again, maybe back to a chin on asthma potential.
So with respect to the opportunity of CVP201 in the AD space.
You are absolutely correct that the AV space treatment has evolved quite a bit now since the launch of the tequila mask.
and it is now becoming a more crowded space.
But if you look at the market opportunity and the number of patients worldwide that can benefit from systemic treatments, the opportunity obviously is very large and that is validated by the performance of drug-like torpedo mapping on the marketplace.
Now, when we look at opportunities, obviously, we're looking at this pie. 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. So, thank you very much.
Now within the IL-4, our IL-4 receptor antibody space, represented here by Dupilomet, we believe that blocking IL-4 and IL-13 continue to be the most effective way of treating AD, as well as other allergic diseases associated with type 2 inflammation.
So if you just look at the alpha-alpha antagonist space.
Obviously so far, 2-Pilomat 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. Okay, and 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 CVP201, it's an entirely different molecule with different binding epitopes. Our goal here is to have differentiation in perhaps a number of areas. The most logical way is at risk ofcia.com.
potentially the overall efficacy. And we're gonna find out that 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 or through PIVAMET. So to kind of circle back to the question, yes, it is a crowded space. And each of this kind of category have that specific.
utility to address patient's needs. And we believe that CDP-607 does have a good opportunity if our community data support a robust efficacy and pertends to these causing differences.
Let me go to the question on CPP 307. In my opening remark in here, we emphasized that CPP 307, by all the measures that we looked at, look at the totality of our phase two data, we are quite comfortable that clearly the molecule is working the way it should.
Especially we emphasize the clinical admission rate.
and there have been continual interest in CBP 307 and we have ongoing discussions. And at this time point, we don't have anything to update, but we will be happy to do so when we're ready to announce any sort of update on the discussion.
Let me ask Tim to address the progress in terms of when our clinical report will come up and also the asthma opportunity.
or CBP201. See?
Yeah, thanks, Way. So I think as you heard on the first part of this call, so for the...
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 1st, half of next year and continue to make progress on that. And I think your question around CDP and asthma certainly in the line of the response that way 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, CDP-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. I think that in and of itself represents opportunities for us with the molecule, not just in AD, but as asthma. Because I think with a molecule like this, we want to pursue indications that...
will allow us to continue to layer on the different treatment options that physicians will have from CDP-201.
Thank you.
Thank you.
Please stand by for our next question.
Our next question comes from the line of Thomas Smith with SBB security. Your line is open.
Hey guys, good afternoon. Thanks for taking the questions. I guess first on CBT-201, can you give us any additional color on your regulatory interactions with China CBE and maybe speak to your level of confidence that positive results from the ongoing study could result in an approvable data set? Yes, I think so indeed.
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 to try to get drug approved and make it available to patients in China.
As you recall, in our previous discussion, we had a planning to enroll a…
more patients in their study in order to satisfy the exposures. And in our discussion with CDE, based on their reply to our questions, it certainly appeared to us and we believe that
the CDE want to see how the data set look like and because we already have a global base for these file and on top of that we build this China pivotal trial. In terms of the designs and the purpose it's entirely consistent with a pivotal trial. So now we won't be able to provide sort of additional sort of additional detail.
In fact, this is not an in-person meeting with the CDE. And so we believe that it will depend on whether or not we hit our end point in our pivotal trial in China. And the other thing I should point out is that the ability to very quickly follow up with a pre-BRA meeting, which is what we have agreed on with the CDE, immediately after the 16-week data is a very positive sign.
It also allows us to have a better understanding of what else is needed, whether or not our package will be complete. And that will all depend on the pre-VLA meeting that we're going to schedule as soon as we have our data together.
Okay, got it. That makes sense. And then…
You mentioned, it sounded like in the prepared remarks, potentially using the China pivotal data as a start of potential partnering discussions.
Can you just talk about what you'd be looking for in terms of partnership and I guess you know latest thoughts on how you're thinking about commercialization in China versus the US versus Europe versus other Regents.
Uh, yeah.
So on the partnership front, I think we indicated also in previous discussion with investors is that we are open to partnering CVP 201 both in regional deal, China specific, greater China specific for example, as well as global deal.
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 reasonable deal first. So just in terms of the logistics and the realistic timeline for negotiations and partnership discussion. But it will also be interesting external partnership.
With respect to commercialization, we certainly are open to.
working with China pharmaceutical companies, China-based pharmaceutical companies, or 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 the cell force is not a trivial task. So if the deal is favorable and they allow us to achieve our goal in getting the drug.
Approving China as well as generating revenue connecting 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.
Just to add a little bit related to your question Tom, now that the PIPF-12 data is available rather quickly, much earlier than previously anticipated, and so this will become also part of the partnership discussion and we see this as a very positive sign.
with another set of data available to us. I hope this helps.
Yeah, no, that's very helpful. Thanks. And then just.
Maybe last question. Just when can we expect to hear more on your plans and next steps for future studies with CDP 174?
Yes, and we literally just got the data and were able to present. So this first study is truly a typical birth in human study to allow us to get an understanding of the drug characteristics, the safety profile, which is the most important part of this evaluation. Bye.
So by this study so far, we're 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, you know, 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, you know, to be able to think about whether or not we can be almost
in the phase one single-way thinning dose study is we administer the drug using it in a solution. There may be opportunities for us to think about optimizing the formulation in the next study. That's another reason we want to consider some of the details around what that next study will look like in addition to all the comments that Wade made that are really excellent points in terms of.
So the things that we want to think through rather than just doing a sort of just a usual typical MAD type of phase one study.
Thank you, Chin. That's another excellent point in here. This type of first in human study is to find out some information as clearly as possible. The current way of dosing the drug, as Chin pointed out, is API in solution. Certainly, it's not the format or the formulation we would like to take to the next study. So, yes, that's almost there.
well.
I hope this is helpful.
Got it. That makes sense. Yeah, I know. Thanks for taking the questions guys. Appreciate it.
Thank you.
Please stand by for our next question.
Our next question comes from the line of Kelly Shy with Jeffrey. Your line is open.
Thank you for taking my questions. Can you hear me fine?
Hi, I'm Kenny.
Yes, we can hear you. Okay, thank you. So first of all, can you hear me fine?
Hi, I'm Kenny.
Yes, we can hear you. Okay, thank you. So, first of all, could you actually share some color regarding the feedback of the end-of-phase two meeting with FDA? Do you still plan to enroll most severe AD patients, and how do you implement this strategy into the operation for the global phase three trial?
Great, thank you for the questions and this sounds like a question for Chin. Would you like to take on this question?
Yeah, 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 would look like, and had a lot of discussions around very detailed things, everything from biinky cuphauv Dark
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
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.
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 the—some of the details around the endpoint and how we would train investigators. So it was a very fruitful conversation around.
nuts and bolts of our clinical phase three program.
And we did have some other conversations, for example, around the patient population about, for example, including children, younger adolescents. That was something that, you 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 sense of getting more severe patients. So this is something that coming out of our phase three, excuse me, phase two global study, this is something that is first and foremost in our mind. I should first say that in terms of executing.
So far, it's the current large trial in China that we discussed that serves as our pivotal trial for potential registration in China. Thank you again.
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 3 global program. There's going to be inherent challenges there. Because we'll be going to obviously different geographies, but 1 of the things that we discussed is trying to balance the operational challenge of trying to enroll patients in a timely fashion versus making sure we.
still allow those patients who have moderate, severe
as all of the other phase three trials in the AD space has done. But again, we 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 pop.
hopefully more severe than what we had in our phase two global study.
Thank you for the color. I also have follow up. So on the clinicaltrials.gov, 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 Tool 1 in terms of the indications beyond AD?
follow up. So, on the clinicaltrials.gov, it was showing that the nasopollus trial was terminated. Curious, do you plan to resume the program in the future, and what are your thoughts for tool one in terms of indications beyond AD? Thanks.
I want to go ahead and also take on that. Yeah, absolutely. Yeah, so another really good question, Kelly. So we made a very difficult decision to...
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 two 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.
It 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
experience 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 began, it impacted their ability to get those sites recruiting patients. So those are two key reasons that really impacted our ability to continue to enroll that study. And again, we made a very difficult decision to stop that. Thank you.
study. In terms of whether or not we will pursue nasal polyp in the future.
Maybe I can turn that back to Wade to comment on that. But obviously, I think with the building that hasn't 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 get an answer to the question about would we pursue nasal polyp in the future.
Sure, sure, but thank you Kelly for the question and thank you, Chin. Yeah, so this ties into a kind of a broader question of the indications for a drug like CBP201 and I know we want to go back to the same kind of thesis of why alpha are alpha antagonists. I'm going to proceed then. Alright fine.
They're different from IL-13 antibodies but for their ability to block the broader disease pathways. And if you look at two kilometre, for example, right now it looks like it's going to be approved for many, many occasions in the type two pathway. I think we believe CBP's value is going to be.
significantly increase 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. So we're seeing that being played out already.
So a nasal polyp will be one of the indications that either us or our partner in the future will pursue and perhaps both in China and next China as well. But again, there's not something we are you know, we're going to begin running this starting in the next few months, right, but definitely
in the future.
Thank you very much.
Thank you.
Please stand by for our next question.
Our next question comes from the line of Joe Cantizar with Piper Sandler. Your line is open.
Thanks for the update. Thanks for squeezing my questions in here. Just two quick ones for me. Maybe first one following up on the discussion earlier around the potential for partnership opportunities for CBP 201. I 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 top line. Should we expect something similar to last November's Phase 2B top line readout or would you expect to include some more details like p-values or maybe even absolute efficacy metrics? Thanks.
Thank you, Giao, for the question.
I'll take a step at the first question first on the potential partnership.
Yeah, so with respect to launch of phase three 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 that in the not too distant future we'll be able to have a good partnership to move the program forward. So that's for the part of the question. Was it another question on the partnership?
No, I think that covers it. The second question was on the disclosure level on the October readout. I would like to turn this to Ching to provide some detail.
Thanks, Wei. Thanks for the question, Joe. So for the top line 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.
ADE trial data, is that correct?
Yep, that's right. Okay, great. So, in terms of maybe just give you a little bit of context around what we plan to have for the top line, it's going to obviously be the primary endpoint at week 16, which is the EZ75. We'll have some key secondary endpoint, IGA, itch, etc., along with very top line safety different results.
And given that we will have the primary and key secondary, I think one of the things that we took away from
the first press release is the desire for
the external industrial community to have that level of granularity you're you you're probably 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.
So I don't know if that completely answers your question.
Thanks for taking my questions.
Yeah, that's that's that's helpful. Thanks for taking my question. Okay, great
Thank you. As a reminder, ladies and gentlemen, that's star 11 to ask the question.
I'm showing no further questions in the queue. I would now like to turn the call back over to Zenway for closing remarks.
I would now like to turn the call back over to then wait for closing remarks. Sorry. I just muted myself. I think 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 CBP201 in ID
We are on track to report top-line data from the Stage 1 16-week treatment period of the China-only digital trial in October .
We plan to initiate a global phase III trial before the end of 2022.
For CVP201 in asthma, we anticipate completing enrollment in a global phase two trial in asthma patients with type 2 inflammation in the first half of 2023.
We plan to report top-line findings in the second half of 2023. Additionally, CDP 307 in UC will complete a 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.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
The conference will begin shortly. To raise your hand during Q&A, you can dial star 11. you
you
I.