Good day, everyone, and thank you for standing by. Welcome to Brii's H1 of 2022 earnings conference call. Our interim results announcement can be found on the investor relations section of our company website. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. Please be advised that today's conference is recorded. This is Chris Fang, director of investor relations of the company. Joining us today on the call, Brii Biosciences' executive management team are Dr. Zhi Hong, chairman and CEO, Mr. Rogers Luo, president and general manager of Greater China, Dr. Li Yan, Chief Medical Officer, Dr. Susannah Cantrell, our newly appointed Chief Business Officer, and Dr. Ankang Li, Chief Financial and Strategy Officer. Dr. Hong will first provide an overview covering our strategic pipeline and organizational development, followed by Mr. Luo, who will provide an update on our recently commercialized COVID-19 therapy and our priorities in China. Dr. Yan will then review overall R&D structure and our U.S. priorities. Dr. Cantrell will review our business development strategy. Dr. Li will then go over our financial status, after which we will open the call to take your questions. Before we start, we would like to remind you that today's discussion may contain forward-looking statements which involve several risks and uncertainties. Actual results and outcomes may differ materially from those mentioned in today's announcement and this discussion. In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. With that, I will now turn the call over to Dr. Hong. Hong, please go ahead. Thank you, Chris. Good morning, good evening, good day. Welcome, everyone, to joining our call today. I'm pleased with our interim results and the progress we have made towards our near and long-term goals across our pipeline development, as well as organizational expansion. Since Brii's inception in 2018, we have been on a mission to tackle the biggest public health challenges of our time through breakthrough innovation and insight driven by the fundamental patient insight. At Brii, we firmly believe that disease and scientific innovation have no borders, and our international teams in China and the U.S. are committed to do and adapt by collaborating in ways that maximize our collaborative strength in various areas of expertise in both key markets, as well as other areas around the world. While our U.S. and China team currently have separate therapeutic area of focus, we are united in our operations around our capabilities and our shared vision to deliver world-class medicine to our patients. We just recently celebrate the company's fourth year anniversary. We are proud that our unique global approach has produced a robust and dynamic pipeline of promising therapeutic candidates, as well as a number of other recent and remarkable company achievement. First and foremost, we have reached the commercial stage of growth as an organization with our COVID-19 program, as well as expanded the depths and the breadths of our senior executive leadership team with three key personnel appointments. To that end, I'd like to welcome Dr. Susannah Cantrell as our Chief Business Officer, Dr. Eleanor de Groot as our Chief Technology Officer, and Dr. Aleksandar Skuban as our CNS disease therapeutic area head. As accomplished global leaders, their collected decades of diverse experience in their respective functional areas will serve Brii well into the future. With these new additions to our leadership team, we are well-positioned to leverage each of our senior executives' unique leadership skills and industry experience to extensively execute across our broad therapeutic development strategy. Together, we are working to deliver a positive impact to patients, public health, and society as we invest in medicines that have the potential to make a profound difference in many people's life. Please refer to our recent announcement and our company website for further information about our growing corporate executive team and their roles and responsibilities. Now, let's turn to our recent pipeline development. Our team achieved commercialization of our long-acting Amubarvimab, Romlusevimab COVID-19 combination antibody therapy in China only after 27 months following the initial discovery. We'll carry forward the experience from our COVID-19 program to extend, advance our other public health inspired clinical programs. Our goal is to bring proven and meaningful long-term therapeutic solutions to patients and to the healthcare community. With our commercial effort underway, we have returned our focus to our primary program, working to develop a functional cure for HBV. Most recently, in July, we strengthened our core HBV portfolio by exercising our option to in-license another therapeutic candidate from our partner, Brii Biotechnology. BRII-877, also called VIR-3434, is a potent and broadly neutralizing monoclonal antibody against HBV, showing great potential from the multiple ongoing clinical studies. Together with our current assets, our portfolio of HBV therapeutic candidates is the most advanced worldwide, and we're poised to deliver the search for a functional cure for HBV. Along with Brii and VVI, we have multiple ongoing phase 2 combination therapies, with the new data expected in the Q1 of this year or early next year. Another core project spearheaded by our China team is our multi-drug resistance and extensive drug resistance gram-negative infection program, where we see an increasing need for viable solution around the world, especially in China, especially during COVID, as demonstrated by the sales data, recently approved antibiotics in China. As our partner diligently advances their clinical program in the U.S., we are working closely with them to track and inform strategic development of our in-licensed therapeutic candidates for continued development in China. Currently, our partner, Qpex Biopharma, is moving the development timeline along as expected, with two pivotal studies planned to begin in 2023. We plan to submit IND application to China and NMPA in due course. Moving on to our global self-development programs. Firstly, in our CNS disease therapeutic area, with a focus on mental health, we continue to build our team of industry leaders across the business and execute on our strategy to progress BRII-296 for the treatment and prevention of postpartum depression. As well as BRII-297 for the treatment of various anxiety and depression disorders. Our newly joined CNS disease therapeutic area head, Doctor Aleksandar Skuban, who we introduced at the top of the call, brings important expertise in this phase that will enable us to continue to lay a strong foundation for ongoing development as well as expanding further indications to maximize the value of BRII-296 and BRII-297. In addition, we continue to invest in establishing meaningful patient advocacy and engagement initiatives as part of our strategic approach to incorporate fundamental patient experience and insight into every step of our clinical development. Starting with our PPD program, we have sponsored a number of mental health care events this year, rolled out our people strategy by participating in community efforts to raise awareness of maternal mental health. Our employees are inspired to join the Postpartum Support International in their local chapter of Climb Out of the Darkness annual event, which provide firsthand testimony of patients' need, and that will help to drive awareness of society's stigma associated with postpartum depression. Our HIV program with BRII-732 remains on hold out of abundance of caution as the U.S. FDA further investigate Islatravir, of which BRII-732 is a proprietary product. We have received initial response from FDA providing specific guidance on requirement to lift the clinical hold. We are working closely with the agency to align our understanding of the safety signal identified in the Islatravir related studies. Our aim is to lift the clinical hold as soon as we can in 2022 and proceed with the development of our once-weekly oral combination of BRII-732 and BRII-778. With that overview, I would like to turn the call over to Mr. Luo to provide an update on our operations in China and its COVID-19 antibody commercialization effort. Rogers, please go ahead. Thank you, Dr. Zhi Hong, and hello everyone. Thank you for joining us today. As we just discussed, our China team is strategically focused on our HBV functional cure program. This is the area where we see the most opportunities to contribute significantly and immediate therapeutic impact for patients in the region. In addition, as mentioned, we recently launched our long-acting antibody combination therapy for COVID-19 in China. Our current primary goal in China are twofold. Firstly, our key goal with our operations in China has been the commercial launch of our anti-COVID-19 program. It has been an honor to be the first company in China to provide a domestically originated treatment option for COVID-19 after successfully kicking off the first dispatch and those prescription in July. Our therapy is one of the very few neutralizing antibodies that still remains the neutralizing activity against all current variants of concern. During the recent epidemic in China, of which the BA.2 and BA.4 and BA.5 are the dominant variants, subvariants. Our antibodies have been increasingly delivered to the patients in need. We expect that this product may have potential to play a greater role in anti-epidemic efforts and contribute to the national anti-epidemic policy. With that said, after three years of experiencing outbreaks of COVID-19 and its resurgence, we now know that vaccines alone are not enough to prevent infection, especially in infections in patients who have compromised immunity. Therapeutic pre-exposure prophylaxis and post-exposure prophylaxis, especially with antibody treatment, have been shown to be effective for protecting vulnerable patients and healthcare providers. With the support of Chinese government, hospitals, and investigators, our ongoing work is gearing towards real-world experience of our long-acting Amubarvimab and Romlusevimab. This combination in PrEP and PEP. The other key focus of our China team is HBV development. We aim to be the first company to find a functional cure for HBV. Part of our unique approach to advance our clinical development and achieve rapid commercialization is to leverage potential combination treatments utilizing our robust portfolio of promising HBV assets. Currently, we have two ongoing combination trials in China. BRII-179, the therapeutic vaccine, and on top of Pegylated interferon alpha plus NRTI therapy, and BRII-179 and BRII-835 in combination. For our BRII-835 and BRII-179 combination, we have completed patient enrollments and expect to report interim top-line data by the end of the year, and submit an IND application to the CDE for a pivotal study in 2023 if positive data is achieved. For our ongoing combination studies with BRII-179 with Pegylated alpha plus NRTI therapy, we continue to enroll patients in the first part of this phase 2a and 2b study, and anticipate that all patients will be enrolled by end of the year, with interim top-line results expected in the Q2 of next year. With our newest asset addition to HBV treatment, BRII-877, VIR-3434, two trials led by VIR are on the way and new data were presented at the annual EASL International Liver Conference in June. Leveraging VIR's findings in the U.S., we have the ability to move swiftly in China to later stages of clinical development and ideally push through the regulatory process in an accelerated amount of time. Working tandem with our partner companies in U.S. and our Brii colleagues, we have a clear path to future commercial opportunities in China, while we simultaneously advance our U.S. portfolio. Here to discuss a little bit more on our overarching R&D capabilities and other medical indications we are addressing, is Dr. Li Yan. Please go ahead. Thank you, Rogers. Good morning, good evening, everyone. As you can see, we are developing a world-class R&D enterprise. Our cross-border organic operations are one of our competitive advantages that uniquely position us for accelerated commercialization opportunities. With our presence in both geographies, U.S. and China, we utilize our respective strengths to expedite discovery, development, and the delivery of innovative medicines that have the potential to transform the care for millions of patients around the world. We plan to further extend this unique capability of our R&D organization in 2022. With our planned expansion of our HBV and CNS pipeline, we are considering establishing additional laboratories that serve our international goals, such as advancing our U.S. capabilities. We will continue to keep you posted on that front as those discussions and decisions unfold. As we continue to grow our company, we are investing in our people and a pool of talented R&D professionals who has supported the successful recruitment of additional key leaders. We have built our product candidate pipeline by leveraging our in-house R&D capabilities, external collaborations, and support from our strong scientific advisory board and veteran investors. Additionally, we have R&D collaborations with global pharmaceutical and biotech companies, leading CROs, CMOs, CDMOs, as well as research institutions and other strategic partners. With our plans to expand our R&D efforts in CNS indications, particularly in depressive disorders, we've made some critical new hires, particularly Dr. Aleksandar Skuban, who will lead our entire CNS development effort. We're pleased to welcome Dr. Skuban, who has more than 20 years of experience in global pharmaceutical R&D, as we ramp up the development of our clinical assets for postpartum depression, as well as other depressive disorders. Mental illness and depression, in particular, are among the most common CNS disorders in the world, having increased over the last several decades, due in part to an aging population. According to a recent WHO report, anxiety and depressive disorders increased during the COVID-19 pandemic by 25%, resulting in more than 300 million people impacted by significant depressive disorders. Postpartum depression is our primary area of focus at present, and it is currently lack of effective or convenient treatment options. It's one of the most common psychiatric conditions that impact new mothers after giving birth. With BRII-296 and BRII-297, we are looking to significantly improve the current standard of care with a rapid onset and a sustained reduction in depressive signs and symptoms for these new mothers, as well as to provide improved adherence, convenience via single treatment in an outpatient setting, versus requiring patients to be admitted to a hospital setting to receive the treatment. Patients would not have to repeat the therapy, hospitalization would not be required, nor would patients need to be responsible for remembering taking daily doses. More importantly, BRII-296 has negligible exposure to breastfed infants, making it a potentially safe and unique antidepressant option for mothers who wish to continue to breastfeed their infants, which are the majority of the mothers. During the H1 of 2022, we completed the necessary early development work, including formulation development, short-term toxicity studies with BRII-297. We have submitted the IND to the U.S. FDA, and we plan to initiate first time in human study for this exciting asset in the Q4 of this year. With that, I'm going to turn over the call to Dr. Susannah Cantrell, our new chief business officer, to discuss our upcoming business objectives. Susanna? Thank you, Li Yan, and good day, everyone. I'm pleased to be speaking with all of you on behalf of Brii Biosciences. One of the reasons I was drawn to Brii was the impressive progress the company has made establishing a core development pipeline in such a short period of time, along with the patient-centric culture and the fact that we are set at such a pivotal stage of growth. I'm thrilled to bring my experience of leading international teams to the table as we work to translate promising science into meaningful solutions for patients that are facing the burden of significant infectious diseases and CNS diseases around the world. In addition to our in-house R&D capabilities, we simultaneously work with other industry leaders through collaborative licensing agreements. We currently hold the development and commercialization rights to a number of partner assets in Greater China. As we build our core business in Greater China, we are also seeking global partnerships with industry in order to accelerate bringing world-class medicines to broader patient populations. This approach allows us rapidly turning promising science into therapeutic avenues and highlight the strengths and capabilities of each organization. Enacting this strategic vision carries with it a great deal of planning to drive long-term pipeline expansion and commercial growth. We are dedicated to meeting these goals with respective strengths that are aligned with our major markets, China and the U.S. I'd now like to turn the call over to our Chief Financial and Strategy Officer, Dr. Ankang Li. Ankang, please go ahead. Thank you, Susannah. We are all excited to have you and other new executives on the team. Welcome, everyone who has joined us on today's call. As a reminder, financial figures I will be reviewing today are in RMB, unless otherwise noted. For the H1 of 2022, our income was RMB 38.2 million, representing a decrease of 17.4% compared with the RMB 46.3 million in the H1 of 2021. The decrease was mainly due to the decrease in income recognized from PRC government grants by RMB 17.8 million. This decrease was partially offset by the increase in bank interest income of RMB 9.7 million, attributable to the increased bank and cash balances after our initial public offering on Hong Kong Exchanges and Clearing. Our total comprehensive expense for the H1 of the year were RMB 217.7 million, representing a decrease of 92.5% compared with the RMB 2.9 billion for the H1 of 2021. The decrease was primarily due to the decrease in fair value loss on financial liabilities at FVTPL. Our research and development expenses were RMB 258.5 million in the H1 of this year, representing an increase of 64% compared with the counterparts last year. This increase was primarily due to the increase in third-party contracting fees, as well as employee costs for our continuous development in clinical trials. Administrative expenses for the H1 of this year were RMB 95.5 million, representing an increase of 40.4% compared with the RMB 66.8 million for the H1 of 2021. The increase was primarily due to the increase in the employee headcount as well as increase in stock-based compensation expense for employees. We established a streamlined commercial team to better support the launch and distribution of our Amubarvimab and Romlusevimab combination therapy. As a result, we started to incur selling and marketing expenses, which primarily consist of employee-related costs and pre-launch activities. As of June 30, 2022, our bank and cash balance, including restricted bank deposit and time deposit, was RMB 3.2 billion, compared with RMB 3.3 billion at end of 2021. The decrease was primarily attributable to payout of daily operations and third-party contracting costs. As we continue to advance our existing programs and expand our pipelines through both in-house discovery and external partnerships, our current funds should be able to support us into 2025. We look forward to delivering continuous shareholder value as we advance innovative therapies for significant unmet medical needs and large public health burdens from a patient-centric vantage point. This concludes our prepared remarks. We will now open the call to your questions. Chris, back to you. Thank you. Yeah. Thank you, Ankang and all the presenters. Now we will open the line to take your questions during the Q&A session. All the participants, if you have any questions, please click Raise Hand in the webinar controls, and we will prompt you to unmute yourself. The first question is coming from Chen Chen from UBS. Please go ahead, and operator, please unmute her. Well, thank you. Thanks for taking my questions. I have one question about HBV functional cure. I noticed that we got two siRNA-based combination therapies. Right now, both at phase 2 trials in China. Can the management please give us more color on the endpoint for these two trials? Say, whether it's something like the percentage of patients whose hepatitis B surface antigen decreased to what level, and it lasts for how long. Also, may I ask, like, what is the rationale behind these two trials? Which one do you think has a higher chance of success? Thank you. Thank you, Chen Chen, for the question. Let me try to answer these questions. I think there's a number of questions in there. I just wanna make sure that we are currently conducting two combination study. One is a combination of siRNA plus our therapeutic vaccine, 179. The other one is actually our therapeutic vaccine 179 plus Pegylated interferon. This is on top of this is a highly selected patient that once they become partially responding to the ongoing Pegylated interferon that we'll be adding to our therapeutic vaccine 179. You are correct that we're investigating other siRNA combination because our partner, Brii Biotechnology, is also conducting several combination studies. This includes the combination of siRNA with pegylated interferon and the combination study of siRNA plus the neutralizing antibody BRII-877. Then there's one more combination they are looking at, that is the triple combination, i.e., the pegylated interferon plus siRNA plus neutralizing antibody. All of this will poise to deliver top-line data towards the end of this year or early next year. We're very excited to look at which one is gonna give us the top-line data that we want. With regard to the primary endpoint, we're obviously looking at clearance of surface antigen, and more than that, we're looking for a sustained clearance of surface antigen. This could include some maximum suppression or maximum reduction of surface antigens. We do believe, with the combination of siRNA and BRII-877 neutralizing antibody, as the data we have seen so far, it has the potential to, you know, achieve the maximum reduction of surface antigen in the broadest patient population, given the mechanism of action of the two asset. The primary endpoint, we'll be looking at the maximum reduction of surface antigen, the clearance of surface antigen, and the durability of that and surface antigen reduction. Thank you. Yeah, that's very clear. Thank you. Okay, thank you, Chen. Operator, let's just move to the next question from Sean at Morgan Stanley. Please go ahead. Thank you very much for taking my question. Congratulations on your progress in the clinical front and also the hiring of key executives. I have just a couple questions. One is about your HBV program. Chen asked about these two clinical trials and your clinical endpoint. I would say like, do you have any kind of sense like which amount of functional cure may be actually considered as kind of, adequate of approval, 20%, 30%? This is something people have been talking about for quite a while. Also, now that you have exercised your option to in-license VIR-3434 another kind of siRNA, do you have any kind of, are you thinking about reprioritize? Or like you are just gonna do combo amongst the whole, your three assets. How do you prioritize those kind of programs, and when do we expect to see some results that will kind of point the way forward? That's the question about HBV. Another question is about your neutralizing antibody cocktails. They are launched, and hopefully you can do well. As you may know, AstraZeneca's neutralizing antibodies approved in Hainan. That is for preventative kind of. It's just like a vaccine may be better for the people who have immune compromised systems. In China, I think you are doing some clinical trials on that front as well. Can you report a bit of your progress within that product category? Thank you. Well, thank you, Sean. Let me try to answer your first question, then I'm gonna defer to Rogers to answer the second question with regard to COVID, the purported AstraZeneca PrEP in Hainan and our plans in China for that. With regard to the HBV functional cure, I think there is industry consensus that if we can achieve a functional cure of 20%-30%, that would be great. I think, as you know, the current functional cure rate is about 5%-7%, sometimes people report 9%, mostly involving pegylated interferons. That's the current standard of care. I think double that or triple that will be a significant advance. You are correct. We have multiple programs that we think, you know, if we can, we are conducting five combination studies that will give us more information in terms of how we can combine them in such a way that we can achieve even higher functional cure. Obviously, there's a lot to be learned once we finish those combination studies. I think in the next 12 months, we'll learn a lot about all these different combinations and how to further improve them. I think that's really what I can say on the HBV functional cure front. Now I'm gonna ask Rogers to comment on the effort on COVID. Rogers? Thank you for the good question. As you just mentioned, AstraZeneca has a COVID-19 neutralizing antibody in Boao Lecheng, actually, Boao Lecheng free trade zone for the PrEP indication, but that's only limited in the small area. People have to travel to Boao Lecheng to get their injection. I think that clearly demonstrate there's a unmet medical need for PrEP and PEP in China because, as you just mentioned, for those people, you know, with compromised immunity, they want to have this neutralizing antibody for prevention. We are actually generating some data. We're working with Professor Zhong Nanshan. There's a small trial that's in planning and ongoing. We're trying to generate some data, but that's not full indication. We also plan to do some real-life study to gain experience for those. For that population, and that's number two. Number three is actually we are actively discussing with the CDE to see how we're going to you know moving forward to fulfill the unmet need in China for the prevention. That's basically what we are doing now. May I ask a follow-up question to Dr. Hong? Yeah. For your HBV functional cure, it appears VIR-3434 is additive to BRII-835. Do you plan to do a quartet regimen with VIR-3434 plus BRII-835, and with BRII-179 plus interferon for the last mile clearance? Maybe if you have those four together, you could get an even higher kind of functional cure. Or that's just like the people have been doing with TP. You have multiple things just Mm-hmm. You have lots of things working together. I'm just kinda curious with this. Yeah. Hey, Sean, I think that's correct. I mean, directionally speaking, obviously, you know, with the HBV patient population is quite heterogeneous and diverse, and their underlying functional immunity may be different. So we do anticipate that multiple modality will be needed. I think two is probably the minimum, as you just said, and then we're looking to the new data as we will be informed in the next 12 months to decide whether or not, you know, how we're gonna combine more therapeutic modality. Will they be combined at the same time or will they be combined at a different time? I think all of those will be informed in the current study. We're laying that out. I think if you ask me, are we gonna throw the kitchen sink at the patient or not? I think we need to be careful about safety, making sure that we don't do this and inadvertently create safety issues for the patients. I think we just need to be a little bit more thoughtful in terms of how we're gonna combine it. I think the question, if your question is are we looking to combine more therapeutic modality to achieve a higher functional cure rate? The answer is yes. Really the devil is in the detail in terms of how we're gonna combine them. Are we gonna combine and use them simultaneously? Are we gonna combine them in a staged fashion? Very good questions and more to come, more to learn, and I'm very much hopeful that we can share more information as we go. Okay, thank you. Yeah. Okay, thank you, Sean, Zhi and Rogers. Next question is from Roanna. Roanna, please go ahead. Operator, can you just unmute Roanna? Thank you. Hello. Can you hear me now? Yep. Yeah, great. Okay, great. Hi, so two quick questions, one on the COVID program. I'm just curious, how's the commercial launch going with your antibody regimen in China? And I was curious, specifically, how many total cities or provinces have you shipped courses to so far? And what's that growth or demand gonna look like going into the end of this year? And my second question on the HIV program, I noticed you mentioned you got an initial response from the FDA about the clinical hold and addressing some questions from them. Curious if you could share some additional information about that or how you're thinking about responding to the FDA, et cetera. Well, thank you very much, Roanna. I'm gonna ask Rogers Luo to answer the first question with regard to the active commercial activity of COVID antibody in China. Then I'm gonna ask David Margolis to answer the question related to HIV. Rogers Luo? Yeah, thank you for the question. Since we commercially launched the product in early July, it's already more than one month passed. We supplied several thousand doses to all places where there is a small outbreak of a small pandemic, cities and provinces. That's the first situation. Basically, regarding what our projection for the rest of the year, I would say it very much depends on whether we'll still apply the zero-COVID policy. That's number one. Number two, you know, how this variant will evolving. It's hard to predict how many costs will be for the sales in the rest of the year. Yeah. I would add that we are talking to the government regarding how we're gonna, you know, manufacture more antibodies and how we can determine on the stockpile, the purchase. I think all of these are in active discussion, and we can't really share any information until those materialize. We're working actively in this discussion with the governments. David? Yeah, thanks, Zhi, thanks for the question on our HIV portfolio. As you know, 372 is a prodrug of FDA, and in parallel with the global clinical hold that was placed on the program, 3732 was also placed on FDA clinical hold. As you mentioned, we have been engaging with the FDA on a strategy to lower the overall exposure of EFdA in a way that continues to allow us to dose once weekly. Our recent engagement was specifically around that point and also around the number of steps that we need to take pre-clinically to continue to evaluate the hold. We received a number of really robust and specific assertions from the FDA about the work that we've done, and they gave us feedback on our proposed strategy. We feel like we continue to be in a good place working closely with the FDA to execute on that strategy. Fundamentally, it's just gonna be a requirement that we establish that the exposures we propose will be safe with respect to CD4 signal in patients and also produce additional non-clinical or pre-clinical work to help support that assertion. We're on track to continue to generate that data, and the recent FDA feedback was very helpful to us to give us specifics on how to go about doing that. Thank you. David? Great. Thank you. Thank you, Roanna and David Margolis. Next question is from Roy, Dr. Roy from JMP Securities. Please, operator, unmute him. Thank you. for taking this question. I had a couple. On the BRII-179 plus BRII-835 phase 2 trial, I was looking at ClinicalTrials.gov, and it looks like the trial also has a triple combination cohort, including PEG and adefovir. It's actually a quad combo to include the new. Is that correct? Will you present data on that cohort this year as well? Do the patients, when they come off therapy, do they come off all therapies simultaneously? I had a question on the COVID antibodies. Yes, your understanding is correct with regard to Brii’s combination study. Okay, great. Do you have any sense when the FDA might approve the EUA? And can you share any recent feedback from the agency regarding the application? Thanks. Okay. For the EUA question, I'm gonna ask David to answer what is our current status with U.S. discussion at the FDA. David? Thanks. All I can really confirm is that we remain under emergency authorization review. The FDA's been focused on ensuring that they do all of the necessary inspections and oversight, the manufacturing status. Some of the timeline there has been limited due to access to travel. Fundamentally, we continue to answer questions the FDA poses, and we remain actively under review. I can't speak definitively to FDA's timeline. Great. Thank you. Okay. Thank you, Roy. Our next question is please, David from UBS. Please, operator, unmute him. Thank you. Thank you for the opportunity and many congratulations for the progress. I actually have a question that's on HBV that we see a trend that's using kind of using RNA drugs to reduce the antigen titer and has several pathways later on to achieve functional cure. That includes like vaccine like interferon some use of PD-1 PD-L1 to stimulate the immune response. May I ask any comments from the different pathways on the second step? Are we have any advantage on these parts? Thanks a lot. Yeah. I mean, that's a good question. I think when we started Brii 4 years ago, we kind of focused on, you know, two major pathways. You know, one is to, you know, reduce the immunosuppressive HBV product, specifically the surface antigen. There are many scientific reports have suggested, as well as some clinical data suggests that, you know, having large amount of circulating surface antigen has not been very helpful, and it kept the the host from recovery or restoring their immune responses against the virus. That's probably one of the ways the virus uses to persist itself in the host. The second pathway is trying to, you know, restore and induce strong B cell as well as T cell response. I think you correctly noted that where people, you know, using the RNA interference as a way, whether or not it has RNA or antisense to do the first part, and then people looking at therapeutic vaccine or the Vir's neutralizing antibody in the case of BRII's antibody to induce T-cell response. There are other people trying checkpoint modulators, TLRs, innate immunity agonists, multiple ways in trying to strengthen and induce the higher immune response. We think all of this approach are currently still at play. I think there's a number of program, as you know, that has been terminated due to the lack of clinical evidences we've seen in the past with the capsid inhibitor, with other approaches. I think more and more we see the approach gearing towards the direction that we are hoping. Would that be enough? You know, probably not, and we're still thinking about what else can we do. The one thing that we wanna do as a company is to really focus on hepatitis B functional cure as a matter of public health, and then we will continue to invest in this area where, along broadly on two pathways, i.e., remove the immunosuppression on one hand, on the other hand, safely induce the immune response. Thank you for your. Okay. Very clear. Thank you very much. Yeah. Right. Okay. Thank you, David and Zhi. Next question is from Everbright Securities. Yes, Al, please go ahead. Operator, please unmute him. Thank you. Hi. Thank you for taking my questions. First, I would like to ask, what's the current progress of our COVID antibody, like, for filing the NDA overseas other than the U.S.? My second question is, so for the GSK's ASO drug, I think it's like, 28% response rate or cure rate. I would like to know, what's the reason for it doesn't work on the rest of the population, and does it mean, say like for siRNA, it only can works on like 20%-30% and for the rest of the population, we still need to find another way to cure them? Thank you. Thank you very much. I'm gonna ask David to comment on the global effort on COVID. David, maybe you can give a brief discussion on that, and then I'll do that at the GSK program. Yeah. You know, certainly as we've met the pandemic with our COVID program, we've wanted to make sure that our antibodies were available anywhere that they might be useful. That's involved engaging a number of agencies really around the world over the last 12-18 months. We have been in conversations. We don't have active applications right now with other agencies, so we're focused on discussing with them whether or not, given the evolution of variants and their own evolution of therapeutics, there may continue to be opportunities. Our commercial presence, manufacturing presence, has been focused on meeting the China market. As we explore other potential market opportunities, we need to also make sure it matches with our manufacturing capacity. I'd say we step cautiously in engaging with other agencies to make sure we meet the unmet medical need and also have the manufacturing capacity ready for them, although those conversations continue. I will say in the APAC region there has been interest, and we continue to explore possibilities of expanding within APAC in terms of commercial use. Just to add on that question, I think, among many countries around the world, I think the U.S. FDA EUA is the most recognizable mechanism for approval. With the delay, in the inspection of our CDMO, I think this, you know, a lot of this engagement are also be on hold, because people want to see what will be the outcome of this, the EUA approval. That's where that is. With regard to the GSK antisense oligonucleotide candidate, I think, you know, this is a program that I actually created, so I know this very well, and this was created in 2009, in a collaboration with Ionis. I think it's very interesting. I think why we only see 30% functional, it actually is not the functional cure rate, it's like the surface antigen clearance. There are multiple hypotheses. One is the target site, and it's obviously targeting the DR2 site. That's the site that there may be question whether or not during the integration of the HBV genome into the human chromosome, whether or not that site is lost or not. I think that's one question people have some consideration to say if the site is lost in the integrated copy of the surface antigen open reading frame then, and that surface antigen will not be cleared because it's the target site, the antisense target site is lost. I think the other thing, it could be simply just because the overwhelming amount of the HBsAg being produced and may not have the capacity to just stoichiometrically clear them. Also GSK seem to think there may be additional mechanism of action at play, which they propose a potential TLR mechanism. It's not clear whether or not in those patients, what percentage of patients will have a functional TLR immune activity within the liver and of that particular patient. I think all of that you can hypothesize, but the reality is that we see a 30% and staged clearance of surface antigen. GSK continue to follow them, I think many of them have rebounded. Clearly the goal of the functional cure is not to have a staged clearance of surface antigen. We're looking for a sustained clearance of surface antigen. That's the current status. I'm sorry I can't answer all the questions because I just don't know, even though this has been a brainchild of mine since 2009. Okay, thank you. Just a quick follow-up. So if it's like a overwhelming engineering, could we just simply raise the dose? Also another question is like, 'cause I know the GSK's ASO has been like 3 years, so why it's so slow for them to finish the clinical trial? Like if you know. Thank you. Right. They're all good questions. I'm afraid I can't say much other than what you just stated and observed. I think it is taking time to develop these therapeutic options. I think that's really all that is. I don't think I can offer any insight 'cause I've left the company for more than four and a half years now. Okay, thank you so much. Yeah. Okay, thank you, Sir. Zhi due to the time limit, I will give the last question to Wang Bing from CICC, and then our CEO, Zhi going to have the closing remark. Wang Bing, please go ahead. Thank you. Thank you. Thanks for taking my question. I have a question about our BD strategy. Since we now have a new CBO, so could you? Should we expect more BD deals coming? Thanks. The short answer is yes. Obviously, there's you know, we're very happy and excited to have Dr. Cantrell, who joined us, really helping us to conduct both inbound as well outbound partnership opportunities. I don't know if Susannah, do you wanna add any further comment to that? Susannah? No, I agree that the short answer is yes, and I think you heard in the beginning of the call when we discussed the CNS indications into just depressive disorders alone, there's been a tremendous increase. With the program we have, there's certainly ability to address a large patient population there as we expand beyond PPD. There are many other indications that we could look at other modalities and MOAs, and we will certainly pull together a strategy and do the proper search and evaluation to bolster up our internal pipeline. Short answer is yes. Okay. Well, thank you. Yeah. Thank you. Thank you very much. I think, based on Chris's guidance, that I think it's time for me just to provide some closing remarks. First off, I wanna thank you all for joining the call. As a company, we're very proud of what we have done to develop the COVID therapeutics. I really wanna thank my entire company, my partners and our employees and their families. I can't tell you how much effort the entire staff of Brii has devoted into this area. This is something that we feel very proud of ourself. Second, I wanna make sure that it's becoming clear that we're obviously learning a lot about HDV, and then being a leader in this area, we clearly have a lot of insight in terms of what we're seeing coming from the different combinations, and this is the area we absolutely want to win, and we're gonna double down and invest and focus in this because it's a huge public health issues in China. We see a big, big opportunity for us in HBV functional cure. I think we're also very excited for the CNS program. For the first time, now we're moving into a clinical trial in a target patient population. We're very excited be able to, you know, develop our very proprietary formulation and then finish our phase one study and have the dose selected and moving forward to the target patient population. There's no question that we're at the very beginning of the company inception, that we did not know anything about COVID. But what COVID have taught us is something very important, not only in terms of the infectious diseases, also at the same time we're seeing a very silent and paralyzed huge mental health issues and I would say a separate pandemic. We're very lucky to be a company to be able to be in that position to help address those pandemics. I think that's something that's very, very important. I wanna thank you all. I know many of you have really spent a lot of time following us and understanding our strategy. I wanna thank all our investors who are supporting Brii. What a wonderful company that has stepped up to the challenge during this very difficult time of our life. I just wanna thank you all for supporting us, and I look forward to your continued support to Brii. Thank you. Thank you, Zhi and operator, and, thanks for your participation. I will close the line now. Thank you for joining. Have a good day.