Brii Biosciences Limited (2137) Earnings Call Transcript & Summary

Good day, everyone. Thank you for standing by. Please be advised that today's call is being recorded. This is Sarah Qiu, Associate Director of Investor Relations. Welcome to Brii Bio's First Half of 2023 Earnings Call. Our interim results announcement can be found on the Investor Relations section of our company website. Before we start, I would like to remind everyone that today's call may contain forward-looking statements, which involve several risks and uncertainties. Actual results and outcomes may differ materially from those mentioned in today's announcements and this discussion. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. Joining us today on the call from Brii Bio's executive management team are Dr. Zhi Hong, Chairman and Chief Executive Officer; Dr. David Margolis, Chief Medical Officer; Dr. Susannah Cantrell, Chief Business Officer; and Dr. Ankang Li, Chief Strategy and Financial Officer. On today's call, Dr. Hong will first provide an overview of our strategic priorities and business developments, followed by Dr. Margolis, who will review our clinical programs in China and in the U.S. Dr. Cantrell will provide an update on our recent business transactions. And Dr. Li will then go over our financial status. Following these prepared remarks, we will open the call for questions, at which time we will be joined by Dr. Ellee de Groot, Chief Technology Officer; Dr. Aleks Skuban, CNS TA Head; Dr. Qing Zhu, Head of China R&D; and Mr. Rico Liang, General Manager of Greater China. With that, I will now turn the call over to CEO, Dr. Hong. Dr. Hong, please go ahead.

Thank you, Sarah. Good morning. Good evening. Welcome, everyone, to join our call today. It's my pleasure to speak to you and review our ongoing progress. The significant development we have made with our clinical program and licensing agreement in the first half of the year have brought us to a very exciting time with near-term commercial prospects. Today, I would like to review some of the advancements that we have made across our business and discuss our strategic goals and outlook for the remainder of the year. First and foremost, we have expanded our leadership in chronic HBV infection. As our robust HBV portfolio progresses into late-stage trials, we have extended our goal of finding a cure to also eliminating the viral infections through the best-in-class vaccination in susceptible and high-risk populations. Adding the clinically differentiated 3-antigen PreHevbri to our portfolio, we can now holistically address the WHO goals in eliminating viral hepatitis B from prevention to cure. And specifically, WHO called for 90% reduction of new infection and 90% treatment of eligible patients and 65% reduction in mortality related to chronic hepatitis B. We can't succeed in this unless we have a highly effective vaccine and also much improved cure against chronic hepatitis B. As we have discussed in the past, HBV is a condition that affects millions of people worldwide. Over 800,000 people die of complication from chronic HBV each year. China in particular is the epicenter for HBV infection with the world's greatest prevalence of infection. The APAC country regions also have more than, together, 150 million people infected with chronic HBV, many of whom remain undiagnosed. While China and many other Asia Pacific country or region have adopted national HBV immunization programs for newborns, this is not sufficient to protect the massive adult population in the region who remain unvaccinated or undervaccinated, therefore susceptible to HBV transmission and diseases, specifically in those with comorbidities. Given the disease prevalence and high transmission rate, HBV awareness and investment in prevention has been mounting on a global scale. Last year, U.S. CDC updated its recommendation to include universal hepatitis B vaccination for all adults. China has also adopted more proactive approaches to HBV infection reduction, with key industry opinion leaders calling for expanded and universal domestic HBV vaccination coverage. The introduction of PreHevbri to markets in APAC answers this call. PreHevbri is a clinically differentiated adult prophylactic HBV vaccine that has already been approved for commercial use in multiple major European countries and North American markets. It is the only commercially available 3-antigen HBV vaccine for adults and has proven to be a much more effective adult HBV vaccine than the current available options in the APAC regions, eliciting strong and long-lasting anti-HBV surface antigen antibody responses and superior seroprotection compared to the Engerix-B, which is the current vaccine available in the region. It has also shown to be particularly effective in underprotected adult population with robust immunogenicity in key high-risk subgroups. Its superior immunologic potency and safety profile position PreHevbri to become the world's leading clinical solution in adult HBV vaccination. As VBI and its affiliates work to disperse PreHevbri worldwide, our licensed territories including a sizable addressable market of unvaccinated adults, including more than 200 million in China and additional 300 million in other Asia Pacific regions. We are actively engaged the regulatory authorities to introduce the vaccine in APAC countries, prioritizing regions that may not require additional clinical data or local data. A market authorization application has been filed in Hong Kong, and we are also exploring fast track approval in other countries or regions. Our parallel effort in China includes working diligently with CDE in preparation for clinical work in order to gain approval of PreHevbri in China as soon as we can. Our overarching goal with PreHevbri is to broaden vaccine usage across the APAC markets. PreHevbri complements our portfolio of HBV candidate aimed at finding a functional cure. We continue to progress these curative treatment candidates and explore multiple novel combination in late-stage global trials in partnership with Vir. Last month, we secured global rights of BRII-179 from VBI, which also present us with promising near-term partnership and revenue opportunities. We have made exciting progress this year in HBV, and I encourage you to join us virtually at our upcoming HBV R&D Day, the second such event we have sponsored, and for a closer look at our HBV portfolio this Thursday on August 24. Our second leading program centers on mental health where we are focused on alleviating the impact of anxiety and depressive disorders for a considerably underserved global population. We have made continuing development progress in the U.S. with our internally discovered candidate, BRII-296 and BRII-297. In the third quarter of 2023, we plan to initiate our Phase II proof-of-concept trial with BRII-296 in postpartum depression or PPD patients in the U.S. Early this year, we also began dosing in a first-in-human Phase I trial with BRII-297, a NCE we are developing. And both BRII-296 and 297 represent very exciting first-of-its-kind treatment options for patients with various mental illnesses. Our patient-centric approach have strengthened our relationship with patients and their caregivers and patient advocacy group. During the first half of 2023, we continue to foster partnership in key mental health advocacy group in the U.S. and similarly, actually, the advocacy group in China. We have sponsored the 2023 Maternal Mental Health Forum, the fifth annual Black Maternal Mental Health Week, 2023 Climb Out of Darkness event and the Mind the Gap strategic action plan by Postpartum Support International at the 36th Annual PSI Conference. This activity and industry acknowledgment have furthered our commitment to ensuring patients' voices be heard and understood and through the discovery, development process and R&D through to commercialization. With our HIV program, we continue to explore partnership opportunities for BRII-732 as part of the potential oral once-weekly long-acting combination treatment option for HIV patients as well as for BRII-753 as part of a long-acting subcutaneous injection with the potential to dose once -- from monthly to every 6 months. Turning to our work in multidrug and extensively drug-resistant or MDR/XDR gram-negative bacterial infections. We have taken a more dedicated approach to advancing BRII-693 by obtaining the global development and commercialization right for this candidate. BRII-693 has a significantly differentiated safety and efficacy profile to address the most difficult-to-treat Acinetobacter baumannii and the Pseudomonas aeruginosa infections resistant to carbapenem. This is now our primary candidate in MDR/XDR gram-negative bacterial infection indications. In summary, our accomplishments in the first half of the year have advanced our clinical development and near-term commercialization opportunities and long-term growth foundations. Our top priorities are to further our work in our core HBV and CNS program. On the second -- for the second half of the year, we expect 2 HBV data readouts from our ongoing Phase II trials, along with initiating the Phase I study for BRII-877 in China following the IND approval from CDE of China's NMPA this month. Simultaneously, we are moving the commercialization of PreHevbri in APAC markets forward. We will also continue to advance our clinical program in MDD -- PPD and MDD and other anxiety disorders. With that overview, I would like to turn the call over to Dr. David Margolis, who will provide more details on our clinical program in China and the United States. As a reminder, Dr. Margolis has recently been appointed as our Chief Medical Officer. As a licensed infectious disease specialist and a seasoned drug developer, his skill set is ideally suited to lead our successful advancement through the late-stage clinical trials towards commercialization. David, please go ahead.

Thank you, Zhi, and hello, everyone. We are making exciting advancements across our pipeline of more than 10 differentiated therapeutic candidates, addressing infectious diseases and the central nervous system. Our primary focus remains on our 2 lead clinical programs where we are developing our assets to address HBV disease from prevention to cure in China and in the U.S., and we are building a potential first-of-its-kind treatment for PPD and MDD. Our advanced portfolio of HBV assets offers different mechanisms of action from directly turning off all HBV viral transcripts by siRNA to neutralizing antibody against hep B surface antigen and the therapeutic vaccine to spur HBV-specific antibody and T-cell responses. BRII-835 is an anti-HBV RNA siRNA targeting all HBV RNA transcripts with extensive clinical data from close to 400 human subjects. It was designed based on Alnylam's siRNA platform, the only one that has been validated through multiple commercial launches. BRII-877 is a very potent broadly neutralizing antibody that was shown to reduce HB surface antigen by 1 log with a low 6-milligram subcu dose in patients. It has a safety population of over 240 subjects. BRII-179 has been investigated in 3 Phase Ib and Phase II studies with a safety population of more than 180 patients. It has been shown to induce strong anti-HBs antibody response and broad T-cell responses in HBV-infected patients. Together, they are individually best in class and, in combination, enable broad HBV treatment paradigms to succeed in achieving higher functional cure rates. Our decision to invest further in BRII-179 was a data-driven one based on our own findings as well as data evolving in the HBV cure space. BRII-179 is a recombinant 3-antigen Pre-S1, Pre-S2 and S in virus-like particles, which has been specifically formulated for use in chronic HBV patients as a therapeutic vaccine. The data we have seen so far provides us with evidence that BRII-179 is able to induce a specific hepatitis B antibody and T-cell response in the setting of chronic HBV infection. As a reminder, we have 2 ongoing combination trials exploring functional cure regimens for HBV with BRII-179. The first is a Phase II study of 179 in combination with BRII-835, an siRNA. We presented interim findings of this trial at the APASL conference in February, showing that when BRII-179 is combined with BRII-835 and dosed for a longer duration of time, more prominent response in more individuals was seen in both antibody and T cell space. In fact, the majority of individuals were able to generate a hep B specific antibody response. And in the majority of those individuals, the response -- anti-HBs antibody titers were greater than 100 mIU per mL. Additional data from this Phase II combination study are expected later this year, and additional combination studies are expected to commence in the second half of 2023. The second HBV trial under our purview is also in Phase II. Here, we're evaluating BRII-179 plus pegylated interferon alpha. Last December, we completed enrollment in this study, and we expect to report top line results in the second half of this year. Based on scientific insights, BRII-179 could potentially enhance patients' natural humoral immunity for curative treatments, with ongoing efforts to investigate its role as a primer to elicit stronger antibody response in enriching patients for curative treatments such as BRII-835 plus peg interferon alpha alongside other combinations addressing a wide range of HBV patients. Brii Bio is strategically preparing for multiple combination studies, with the earliest to start in the second half of 2023 to investigate the potential value of BRII-179 in combination regimens for increasing the rates of functional cure. We are also very encouraged by the results presented earlier this year by Vir at EASL 2023 for BRII-835 and BRII-877. As you previously heard on our last call, data from Phase II clinical trials with BRII-835 plus pegylated interferon alpha showed that robust anti-HBs antibody responses at the end of treatment were associated with sustained HBs antigen loss 24 weeks posttreatment, pointing to the important role of patients' humoral immunity in achieving sustained immune control of HBV. Building upon this critical insight, we initiated a randomized and active-controlled BRII-835 plus pegylated interferon alpha Phase II study following regulatory approvals from multiple regulatory authorities in APAC, including NMPA in Mainland China. We intend to include patients in the study who were previously exposed to BRII-179 in a different study and who had documented anti-HB surface antigen responses because we believe that BRII-179 has the unique ability to distinguish patients who have significant intrinsic humoral immunity versus those who do not. In addition, as I just mentioned, the first of several studies to investigate the potential of BRII-179 in enriching patients with strong intrinsic anti-HB surface antigen responses for curative treatment will start in the second half of 2023. Our strategic partner, Vir, continues to advance studies and generate encouraging data for BRII-835 and BRII-877, for which we hold Greater rights in China. We expect additional combination studies with BRII-835 to begin as early as this year and initial data from Part B of the MARCH trial to evaluate BRII-835 and 877 with or without pegylated interferon to be available later this year. Vir also presented a poster at EASL that highlighted the single dose pharmacokinetics of BRII-877 from a Phase I clinical trial in patients with chronic HBV infection, with data supporting continued evaluation of BRII-877. On the heels of these data, we have perceived ourselves IND approval of BRII-877 from CDE of NMPA in China, and we expect to initiate a Phase I clinical trial before the end of this year. These promising results endorse the continued development of these assets in our HBV portfolio to achieve best-in-class functional cure in broad HBV patient populations. With our acquisition of global rights to BRII-179, we now believe we have all the tools we need to evaluate the primary strategy of functional cure, which is the potent reduction of surface antigen while at the same time promoting an immune response, which can help to maintain HB surface antigen seroclearance over time. Our next step with these important candidates will be to leverage these data to develop BRII-179 in China. Next slide. Moving on to our CNS program. In the U.S., we are primarily focused on our postpartum depression and major depressive disorder disease programs. BRII-296 is our novel long-acting single-injection therapeutic candidate under development for the treatment of PPD and MDD. Following agreement with U.S. FDA, we will start a Phase II study evaluating BRII-296 in PPD in the third quarter of 2023. We are also working to expand the clinical indications of BRII-296 with plans to initiate additional studies in the U.S. in 2024. In June of 2023, we announced that we began patient dosing first-in-human Phase I clinical trial in Australia for BRII-297, which we are developing as a long-acting injectable treatment for various anxiety and depressive disorders. The current study underway aims to evaluate the safety, tolerability and pharmacokinetics of BRII-297 in healthy volunteers. With a primary focus on HBV and CNS, as discussed, in HIV, we continue to seek development partnership for BRII-753 and BRII-732. Both of these compounds demonstrate considerable promise to serve as a key component of long-acting HIV treatment regimens that will offer a more discrete and convenient option for patients living with HIV and potentially as monotherapy treatments for pre-exposure prophylaxis. In the second quarter of 2023, we initiated patient dosing in a Phase I study to investigate a lower oral dose of once-weekly BRII-732. This comes after the successful lifting of the U.S. FDA's previous clinical hold on studies involving islatravir. We're also making progress in tackling MDR/XDR gram-negative bacterial infections with a dedicated focus on BRII-693, for which we secured global rights in June. BRII-693 is a novel polymyxin with highly differentiated safety and efficacy profile showing great promise toward addressing the most difficult-to-treat carbapenem-resistant infections, Acinetobacter baumannii and Pseudomonas aeruginosa. Phase I studies, which included an ethnic Chinese cohort, demonstrated the improved safety profile of BRII-693 with existing antibiotics in the polymyxin class. Our pre-IND was submitted to the NMPA in April, and we are actively working to progress BRII-693's development. For treatment-resistant mycobacterial avium complex or MAC lung disease, our partner, AN2, is actively conducting a pivotal Phase II/III trial for once-daily epetraborole. With over 90 active clinical sites across the U.S., Japan, South Korea and Australia, Phase II enrollment and commencing Phase III in September is anticipated. The accelerated enrollment pace and strategic clinical protocol modifications have propelled AN2 towards initiating Phase III next month, right after completing Phase II enrollment. Top line data for each trial leg is expected approximately 9 months after enrollment is completed in each portion of the trial. Once the Phase II data becomes available, we plan to leverage this work to progress clinical trials within China. Our achievements thus far position us for continued R&D growth and commercialization across our China and U.S. programs. Our ongoing efforts in HBV in China and CNS in the U.S. as well as our integrated licensing strategy supports effective resource allocations and gives us the bandwidth to move on strategic licensing acquisitions and support our leadership in these areas. With that, I would now like to turn over the call to Dr. Susannah Cantrell to address our recent acquisitions. Susannah?

Thank you, David. We have recently completed 3 successful transactions, 2 that advance our position in HBV and 1 that advances our MDR/XDR gram-negative bacterial infections program. I'd like to begin by reviewing our new licensing arrangement with VBI Vaccines for HBV. First, we acquired exclusive rights to develop and commercialize the PreHevbri vaccine in Greater China and other Asian countries, including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. We secured this license from VBI with upfront payments of USD 15 million, which included $5 million ring fence for manufacturing and supply, as well as a $3 million equity investment by Brii Bio contingent on near-term milestone achievements. VBI is also eligible to receive additional payments based on achievement of regulatory and commercial milestones as well as royalties. PreHevbri has already been approved for commercial use in the United States, Canada, European Union, European Economic Area, the United Kingdom and Israel, paving the way for us to introduce this vaccine in APAC markets. PreHevbri greatly accelerates our near-term revenue opportunities and complements our robust HBV portfolio in which we can now address disease prevention as well as continue to develop curative treatment candidates such as BRII-179 to address cure. We also extended our development and commercialization license of BRII-179 from VBI, building on our existing rights in Greater China to exclusive global rights. As we look to find a best-in-class HBV functional cure, we believe our increased investment in BRII-179 will afford us more leverage to capitalize on our work in the HBV field while reinforcing our leadership in pursuing a functional cure for HBV. Our third transaction involved a novel lipopeptide BRII-693, previously known as QPX9003, for MDR/XDR gram-negative bacterial infections. BRII-693 was previously under a license agreement from Qpex that gave us development and commercialization rights in Greater China. Based on BRII-693's unique microbial and clinical profile, we decided to prioritize this candidate's global development and acquired exclusive global rights to BRII-693 from Qpex in June. As part of this strategic move and in association with Qpex acquisition of Shionogi, we returned the Greater China rights of beta-lactamase inhibitor QPX7728-based products to Qpex for an upfront cash consideration of approximately USD 24 million. This empowers us to focus on propelling BRII-693 polymyxin against multidrug-resistant infections. Beyond the immediate impact, this deal yields substantial long-term benefits. We've freed around USD 60 million from future milestone payments and R&D budgets through the termination of BRII-636, BRII-672 and gained the capacity to cover over 5x the global populations without future economic sharing with Qpex. All rights to BRII-693 have fully transferred to Brii Bio, and the development plan is proceeding as planned, starting with our IND application in China. With that review, I'd now pass the call to Dr. Ankang Li, Chief Strategy and Financial Officer. Ankang?

Thank you, Susannah, and thank you all for joining today's call. As a reminder, the financial figures I will be reviewing today are in RMB unless otherwise noted. For the first half of 2023, our revenues increased by CNY 0.6 million from 0 in the first half of 2022. The increase was mainly due to commercialization of the long-acting amubarvimab/romlusevimab combination therapy in China for the treatment of COVID-19. Our other income was CNY 85.9 million for the first half of 2023, representing an increase of 124.9% compared with CNY 38.2 million for the first half of 2022. The increase was mainly due to the increased bank interest income of CNY 36.1 million attributable to the additional placement of time deposits with original maturity over 3 months as well as the increased income recognized from PRC government grants of CNY 11.6 million. Our total comprehensive expense for the first half of 2023 was CNY 104.0 million, representing a decrease of 52.2% compared with CNY 217.7 million for the first half of 2022. The decrease was primarily due to the increase in other income and decrease in the research and development expenses. Our research and development expenses were CNY 202.2 million for the first half of 2023, representing a decrease of 21.8% compared with CNY 258.5 million for the first half of 2022. The decrease was primarily due to the reduced third-party contracting fees for COVID-19 programs after the company decided to terminate these programs. Administrative expenses for the first 6 months of 2023 were CNY 102.8 million, representing an increase of 7.6% compared with CNY 95.5 million for the first 6 months of 2022. The increase was primarily attributable to the increase in employee head counts and computer software fees. As of June 30, 2023, our bank and cash balance, including restricted bank deposits and time deposits, was CNY 2,740.9 million compared with CNY 2,999.3 million at the end of 2022. The decrease was primarily due to payout of daily operations and third-party contracting cost. As we advance our existing programs and expand our pipeline through both in-house discovery and external partnership, and enhanced financial support from recent transactions, we expect our current funds to support our development needs through 2026. We look forward to delivering continued shareholder value as we advance innovative therapies with the goal of broadening choice and access to patients. This concludes our prepared remarks. We will now open the call to your questions. Sarah, please go ahead. Thank you.

Okay. Thank you, Ankang. We will now open the line to Q&A. [Operator Instructions]

And Sarah, for some of the investors who prefer to ask questions in Chinese, that's completely fine. We can also answer them in Chinese.

Yes, of course. Okay. So for the first question, we will go first to David Guo with UBS.

Can you hear me?

Yes.

I'm David from UBS. I just saw that there's a new Phase II cohort that is going to be initiated to further the BRII-835 plus PEG interferon alpha versus PEG interferon alpha. May I ask about more details about the design of these clinical trials as I also noticed that company plans to include some of the previously dosed BRII-179 patients into it? Any details about the cohorts and the details of the design, basically neutral?

Thank you, David, for the questions. Yes, indeed, and this is a study that it's an extension of the study of Vir's presentation at last year's AASLD, where they present in a single cohort study of BRII-835 plus PEG interferon. So we are seeing some exciting data with the 30% end-of-treatment loss of surface antigen and then which 16% maintained -- sustained seroclearances from that study. The issue with that particular study is that it is a single-arm study. There's not a comparison -- comparator studies with PEG interferon for the reasons of, I mentioned this before, IRB approval because you can't have a very broad surface antigen level and then prescribe PEG interferon because it's not known to actually be effective at all when the surface antigen level is higher than 1,500. So for that reason, they couldn't conduct the PEG interferon control study. So what we're doing in this study is that we're able to actually initiate a PEG interferon controlled study. In this case, we actually compare the combination of siRNA plus PEG interferon with PEG interferon alone. So in this study, we actually expanded the surface antigen level from 100 international unit to 3,000. And we're very pleased that we're able to actually get the study agreed by various regulatory jurisdiction, and then we begin to dose patients as of yesterday. You mentioned about the previous exposure of 179. Indeed, we have done Phase Ib and Phase II studies. And we obviously conduct these trials mainly in APAC country and regions. So we're able to bring those patients back and then -- because those patients, we have -- normally have their treatment in response to the 179. We also know the antibody response. So with the antibody response, this allows us to analyze how that's going to contribute to the cure rate. Because as David mentioned earlier, we believe 179 offers us a tool to investigate and to assess the intrinsic antibody immunity, which we all know is very critical for the sustained clearance of surface antigen or functional cure. So this is really the study design, and then we're very eager to get all of these things started and hopefully quickly enroll those patients, and we'll be able to look at some results next year. Thank you for the questions.

May I follow up? That's the -- so will the pre-exposed BRII-179 patients form an individual cohort? And how many patients are they available for this study so far as you dose 180 patients? Are they all available? Or like what is the number of that?

We have to look at some of these patients. Some of the patients has been finished treatment for a long time, and we want to make sure that we can trace them back. And we think there's about 90 patients where we have our record. So we're looking forward to bring some of them back. And so hopefully -- we can't really promise to give you any number that we -- the preliminary survey with the site and the patient, it looks like everybody is very enthusiastic about this study. So we're hoping to bring a significant proportion of that patient -- those patients back.

Okay. And are they all going to be assigned to the BRII-835 cohort or the control cohort?

They will be assigned to the combination studies.

Thank you, David. Thank you, Zhi. We will go next to Nik Gasic with Leerink.

This is Nik Gasic on for Roanna Ruiz. Maybe first off, maybe just to follow up on the new HBV trial that you're conducting. Do you anticipate any enrollment challenges for the pegylated interferon control arm in this new Phase II? And I guess how long do you think it would take to fully complete this study and read out data? And then I have a quick follow-up on 296 in PPD.

Yes. So the quick answer is we aim to finish enrollment by the end of this year.

Got it. And then also on PPD, could you give us a sense of what the Phase II trial design could look like and maybe what you're hoping to see in terms of efficacy and safety to support advancement into a larger Phase III program?

Well, thank you, Nik, for the question. I mean you probably have seen a lot of news recently where I think FDA over the last couple of years has become really, really conservative when it comes to clinical trials. I think we have a pretty significant interaction with FDA in the last 9 months, and really looking at this patient population where not only are you treating the mother and also the newborns, right? So -- and FDA are really concerned about the safety monitoring plans. So this is really -- there's no question about the biology. There's no question about potential efficacy and effect of the drug. It's really think about, how can we conduct a study with the utmost care for both the mother and the infant? So that's really where we spend a lot of time talking to each other. So I think the study is smaller than we originally anticipated because I think we want to make sure that this is a study that we can quickly assess the safety and tolerability profile as well as the patient acceptability for this very new first-of-its-kind injection therapy. So those are the primary goal of getting the study launched. So it's smaller than the previous study we anticipated, but this should allow us to gain those tolerability, safety profile as well as a chance for us to assess whether or not there is some efficacy signal. As you know, this type of trial are pretty challenging to conduct with all the CNS diseases, as you know. This is one area that we're -- unlike COVID program is moving a lot more faster, I think this is where we all hope this can move along much faster and given the massive mental health issues around the globe. And so we're continuing to engage the advocacy group, and you know that this is one area we're very passionate about, and we talk about this at great lengths. So we think the community understand what we're trying to do. And hopefully, this is going to help us to rally the enrollment and try to get the study done very quickly. And then we're going to move on to investigate the potential for other depression -- depressive disorders such as MDD.

Very helpful. Are you able to share what the efficacy endpoint or endpoints could be for this Phase II?

Yes. So I think it's mainly the HAMD-17 reduction, the scorings the company use. And then we obviously have other -- there's other scales that we can talk about. Aleks, our TA Head, is on the line. He can add to that. But we are actually looking at multiple endpoint and time point in terms of early response, the day 15 and day 30 and day 45 because we believe with this extended-release profile, we can improve the tolerability profile on one hand. On the other hand, we can extend the benefit of the drug because we don't have to worry about adherence issues related to this patient population. And we believe that we can detect some -- the durability of the treatment. Perhaps that's where we can focus our attention on. Aleks, I don't know whether you have anything to add to this. It's relatively a straightforward topic or question.

Absolutely. Thank you, Zhi, and thank you really for the question. I would just like to add that this is the first time that an LAI of brexanolone and almost any compound has been administered in mood disorders. So in PPD population, as Zhi has mentioned, we focus on safety, efficacy and pharmacokinetics. The primary endpoint is changed from baseline -- sorry, the primary endpoint is obviously safety and PK endpoints. The efficacy endpoint is measured at days 3, 8, 15 and also 45. So we are looking both at the early onset. The main endpoint that we are looking at is day 8, but we are also looking at durability of effect in this population. So as Zhi mentioned, this is a straightforward study. This is a study that has been fully agreed with FDA, and the study that we are really, really excited about because this is the first time that PPD patients will have a treatment that is easily administered and that assures complete adherence and that we will have a very clear readout for both efficacy and safety and being able to assess further development.

Thank you, Zhi, Aleks and Nik. We will go next to Yizheng Yang with CICC.

Dr. Hong, this is CICC. This is Yizheng Yang. I guess, Dr. Hong, one question. What's your marketing plan of HBV prevalency to vacancy?

Yes. So I think we're, as we speak, actively working on this, and our Greater China GM, Rico Liang, is leading the team. Obviously, before any commercial alliance, we have to really engage the regulatory authorities. So a lot of the effort is really geared towards engaging the various jurisdictions, regulatory jurisdictions. I mean make no mistake, I mean this is not something we intend to commercialize ourselves. So we're looking at partnership opportunity as well in APAC region. So those are the -- we haven't really have a fully embedded commercial strategy, but rest assured, we're -- over the next 6 months, we're making progress, and this is shared with you. I don't know whether or not, Rico, you have anything additional to share. But I think at the high level, this is where we are. Yes. Rico, do you have anything to add?

Yes, I agree with you. And great, no, I can just hopefully introduce with everybody -- introduce the prevention market. You can attend the R&D day tomorrow, and provide -- we'll talk about the emergency use for the vaccine -- prevention vaccine in China. Yes.

Thank you, Yizheng. Thank you, Zhi and Rico. Let's wait for any more questions. We actually have received a question here regarding any specific business development plan for Brii Bio.

Well, thank you for the question. Obviously, we'll always be on the lookout to look at some business development opportunities. We have -- we look at a lot of companies. And I think the 2 -- the 3 transactions that Susannah just highlighted on was maybe a great example in terms of how we leverage the capital market condition and distress that our peers and our partner are going through, and then we're able to use this and then to create opportunity for us with the very favorable term to us. I think this is something we're going to continue to look at it. I just want to remind everybody that we're -- even though we conducted the 3 transactions, we're actually cash-positive. We're able to leverage our equity investment in Qpex, which give us a strong return on investment and then allow us to redeploy the capital to complete the 2 transactions with VBI. So at the at the end of the 3 transactions, we're actually cash-positive. So I think it's the same thing that you would wish us to do as investors, to be very frugal about deploying our capital in terms -- making business development transaction. We're clearly looking at this very carefully in terms of what are the new opportunity. At the same time, we also now have increased optionality for partnership. This include both the transaction with VBI as well as Qpex. We have global rights of 179 and global rights of 693 and Asia Pacific right for PreHevbri. All of this will increase our opportunity to partner with others and increase our near-term partnership revenue or income. So this is something we're obviously actively pursuing. So now if there is any great opportunity, which we are looking at many, and then we certainly will perhaps let you know once we consummate the business transaction. So this is clear challenging time, and this is also a time with a lot of opportunities for us.

Okay. Thank you, Zhi. Okay. This concludes the Q&A portion of today's call. Now I will turn the call back to Zhi for some final remarks. Zhi, please go ahead.

Well, thank you, everybody, for joining, and I'm very pleased to have this opportunity to report to you our midyear results as well as the update our executive team was able to put together for you. I really appreciate your attention, your support of Brii in the past. And I think as a company, our mission has never changed. We are a company that focus on major public health challenges with critical scientific -- with scientific breakthrough and critical patient insight. And we're obviously focused on infectious diseases and the mental health conditions. And all of this have the hallmark of huge patient population and significant social stigma and very limited treatment options. So this is an area where it's going to affect all of us, our society, our company, our investors and our partners. I think this is one area that is so broad that I think it's all -- we can all relate one way or the other to a lot of things that we're working on. So I do appreciate your support, and I expect continued support from you. And we're very excited about the HBV program that we're able to progress. And I think one other thing highlighted by David already, we're not just having 3 assets for HBV cure. We actually have 3 best-in-class assets. This will allow us to create multiple best-in-class combinations. I think sometimes people are just mistaken that if you have a piece of siRNA, then you have a program or if you have a neutralizing antibody, then you have a drug or if you have something else, then you have an asset. That's entirely wrong. I think we should be very mindful about making sure that every single asset we're working on, we have full understanding of those assets mechanistically, scientifically and clinically and making sure they actually on its own is the best-in-class asset that we have. So as David mentioned, that we do have -- we show that we have all the tools we need, and then we just really need to move on to execute on the multiple studies with the aim to provide definitive answers in the near term. And that's what we're trying to focus on. On the CNS, we continue to progress in U.S. I think this is one area that we have such profound, potentially transformational assets. So we will not give up, and we will continue to work with the advocacy group and the regulatory authorities. I think through our interaction with FDA, we have already got a good understanding of what their expectations are. And then -- and this is very, very important. As Aleks mentioned earlier on that, this is the first time for treatment of depression and anxiety disorder where you have potentially a single treatment option. Can you imagine this, where people be on chronic treatment with antidepressive for a very, very long time? It's taking them months in order to receive the clinical benefit, and they don't know how to get off. I think this is a total transformation in our mind that we're going to continue to push ahead for developing this. It's very exciting that we're finally getting to patient studies, and this is what provide us the efficacy data. So with that, I want to thank you all for joining. And I'm very pleased with all the progress we made in the first half of the year, and I'm looking forward to a successful execution in the second half of the year and also reporting some ongoing studies. As David mentioned, we have 2 Phase II study readout that we will share with you as soon as we can, and we're also presenting at the scientific conferences as well. So thank you very much. Have a good day. Have a good evening in U.S. And thank you very much.

Thank you, everyone, for joining. Goodbye.