Good day, everyone. Thank you for, thank you for standing by. Please be advised that today's call is being recorded. This is Sarah Cho, associate director of investor relations. Welcome to Brii Biosciences' 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. 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 Biosciences' 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 US. Dr. Cantrell will provide an update on our recent business transactions, 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 Eleanor de Groot, Chief Technology Officer, Dr. Alex Suban, CNS 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 joining our call today. It is 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 advancement 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 infection through the vaccine crush vaccination in susceptible and high-risk populations.
Adding the clinically differentiated three-antigen PreHevbri to our portfolio, we can now holistically address the WHO calls in eliminating viral Hepatitis B from prevention to cure, specifically, WHO call 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 the 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 or regions also have more than, together, 150 million people infected with chronic HBV, many of whom remain undiagnosed. 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 under-vaccinated, therefore susceptible to HBV transmission and diseases, specifically those with comorbidities. Given the disease prevalence and high transmission rate, HBV awareness investment in prevention has been mounting on a global scale. Last year, US CDC updated its recommendation to include universal hepatitis B vaccination for all adults. China has also adopt a 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 three-antigen HBV vaccine for adults. 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. We are also exploring fast-track approval in other countries or regions. Our parallel efforts 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 aim, 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 the 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, for a closer look at our HBV portfolio, this Thursday, on August 24th. 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 US 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 US. Early this year, we also began dosing in a first time-in-human phase I trials with BRII-297, a NCE we are developing. Both BRII-296 and BRII-297 represent a very exciting first-of-its-kind treatment options for patient 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 continued to foster partnership in key mental health advocacy group in the US and similarly, the HBV advocacy group in China.
We have sponsored a 2023 Maternal Mental Health Forum, the 5th 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 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 six months.
Turning to our work in multi-drug 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 commercialization right of 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, the resistance to carbapenem. This is now our primary candidate in MDR, XDR Gram-negative bacterial infection indications. In summary, our accomplishment in the first half of the year has advanced our clinical development and near-term commercialization opportunities and our long-term growth foundations. Our top priorities are to further our work in our core HBV and the CNS program.
On the second, and for the second half of the year, we expect 2 HBV data readout from our ongoing Phase 2 trials, along with initiating the Phase 1 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 PPD and MDD, and other anxiety disorders. With that overview, I'd 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 advancements 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 two lead clinical programs, where we are developing our assets to address HBV disease from prevention to cure in China and in the US, 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 a 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 subQ 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, PreS1, PreS2, 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 an HBV-specific antibody response, and in a majority of those individuals, the response in 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 alfa.
Last December, we completed enrollment in this study. 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 pegylated interferon alfa, alongside other combinations addressing a wide range of HBV patients. BriivBio 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 Biotechnology 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 alfa showed that robust anti-HBs antibody responses at the end of treatment were associated with sustained HBs antigen loss 24 weeks post-treatment, pointing to the important role of a patient's humoral immunity in in achieving sustained immune control of HBV. Building upon this critical insight, we initiated a randomized and active controlled BRII-835 plus pegylated interferon alfa 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-HBs 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 received ourselves IND approval of BRII-877 from the 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 HBV 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 the 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 discreet 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 once-weekly BRII-732. This comes after the successful lifting of the U.S. FDA's previous clinical hold on studies involving this last year. We are 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 profiles, showing great promise towards 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. We're 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 US programs. Our ongoing efforts in HBV in China and CNS in the US, 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, we have recently completed three successful transactions, two that advance our position in HBV and one 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 $15 million, which included $5 million ringfence 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 BBI, 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 QPX-9003, 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, in association with Qpex acquisition of Shionogi, we returned the Greater China rights of beta-lactamase inhibitor QPX-7728-based products to Qpex for an upfront cash consideration of approximately $24 million. This empowers us to focus on propelling BRII-693 polymyxin against multi-drug-resistant infections. Beyond the immediate impact, this deal yields substantial long-term benefits.
We've freed around $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 five times 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, Susanna, 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 RMB 0.6 million from nil 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 RMB 85.9 million for the first half of 2023, representing an increase of 124.9%, compared with RMB 38.2 million for the first half of 2022.
The increase was mainly due to the increased bank interest income of $36.1 million, attributable to the additional placement of time deposits with original maturity over three months, as well as the increased income recognized from PRC government grants of $11.6 million. Our total comprehensive expense for the first half of 2023 was $104.0 million, representing a decrease of 52.2% compared with $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 $202.2 million for the first half of 2023, representing a decrease of 21.8% compared with $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 six months of 2023 were $102.8 million, representing an increase of 7.6% compared with $95.5 million for the first six months of 2022. The increase was primarily attributable to the increase in employee headcounts and computer software fees.
As of June 30, 2023, our bank and cash balance, including restricted bank deposits and time deposits, was RMB 2,740.9 million, compared with RMB 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.
Thank you, Ankang. We will now open the line to Q&A. If you have questions, please click Raise Hand in the webinar controls, and we will prompt you to unmute yourself.
Sarah, for some investors, if they prefer to ask questions in Chinese, that's completely fine. We can also answer them in Chinese.
Yes, of course. Okay, for the first question, we will go first to David Guo with UBS. David, please go ahead.
Hi, thanks. Can you hear me?
Yep.
Okay, great. Thank you. I'm David from UBS. I just saw that there's a new phase 2 cohort that is going to be initiated to, for the, the BRII-835 plus peg interferon alfa versus peg interferon alfa. 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, the BRII-179 patients into it. Any details about the cohorts and the details of the design of this clinical trial? Thank you.
Great. Thank you, David, for the questions. Yes, indeed, This is a study that, it's an extension of the study of years presentation at last year's AASLD, where they present, in a single cohort study of, BRII-835 plus peg interferon. We have seen some, exciting data with the 30% end of treatment, loss of surface antigen, and then which, you know, 16% maintain, sustained serum clearances, 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 the 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, is higher than 1,500. For that reason, they couldn't conduct the, the, the, the, the peg interferon control study. What, what we're doing is this, in this study, is that we're able to actually initiate a peg interferon controlled study. In this case, we actually the combination of siRNA plus peg interferon with peg interferon alone.
In this study, we actually extended the surface antigen level from 100 international unit to 3,000, and we're very pleased that we're able to actually get this study agreed by various regulatory jurisdiction, and then we begin to dose patient as of yesterday. You mentioned about the previous exposure of 179. Indeed, we have done, you know, phase 1B and phase II studies, and we obviously conducted trials mainly in APAC country region, so we're able to bring those patients back. Because those patients we had normally have their treatment in response to the 179, we also know their antibody response.
With the antibody response, this allows us to analyze how that's going to contribute to the cure rate. Because as David said, mentioned earlier, we believe BRII-179 offers us a tool to investigate, to assess the intrinsic antibody immunity, which we all know is very critical for the sustained clearance of surface antigen or functional cure. This is really the study design, and then we're very eager to get all of this thing started and hopefully quickly enroll those patients, and we'll be able to looking at some results next year. Thank you for the questions.
Thanks, Dr. Hong. Matt, follow-up, that's the... Were the pre-exposed BRII-179 patients from 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 what is the number of them? Thank you.
We, we, we have to look at some of these patients. Some of the patient has been finished treatment for a long time, and we want to make sure that we can trace them back. Then we think, there's, there's, there's about 90 patient we're, have on record, so we're looking forward to bring some of them back. Hopefully. We can't really promise to give you any number that we, we, the, the, preliminary survey with the site and the patient, it, it, it looks like everybody's very enthusiastic about this study. We're hoping to bring a significant proportion of that patient, those patients back.
Okay, are they all going to be assigned to the to the BRII-877 , sorry, BRII-835 cohort or, or the control cohort?
They will be assigned to the combination studies.
Okay. Thank you very much.
Sure.
Thank you, David. Thank you, Xie. We will go next to Nik Gasic with Leerink. Nick, please go ahead.
Hi, everyone. Good morning. This is Nik Gasic on for Roanna Ruiz. Thanks for taking our questions. Maybe first off, maybe just a follow-up on, on the new HBV trial that you're conducting. Do you anticipate any, any enrollment challenges for the pegylated interferon control arm in this new phase II? I guess, how long do you think it would take to fully complete the study and, and, and read out data? Then I have a quick follow-up on two nine six and PPD. Thank you.
Yeah, the, the quick answer is we aim to finish the enrollment by the end of this year.
Got it. Thank you. Then also on, on PPD, could you, could you give us a sense of, of what the phase two trial design could look like? Maybe what you're hoping to see in terms of efficacy a- and safety, you know, to support advancement into a, into a larger phase III program.
Well, thank you, Nick, 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, you know, pretty significant interaction with FDA in the last nine months, and really looking at this patient population, where not only are you treating the mother and also the newborns, right? FDA really concerned about the safety monitoring plans. This is really... there's no question about the biology. There's no question about, you know, 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.
That's really where we spent a lot of time talking to each other. 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 tolerability profile, as well as the patient acceptability for this very new, first-of-its-kind injection therapy. Those are the primary goal of getting the study launched. It's a, it's a, 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, are pretty challenging to conduct with all the rare disease, as, as you know.
This is one area that we're unlike, you know, COVID program is moving a lot more faster. I think this is where we all hope this can move along much faster. You know, given the, given the massive mental health issues around the globe, we're continuing to engage the advocacy group. And you know that this is one area we're very passionate about, and then we talk about this, you know, at great lengths. 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. We're going to move on to investigate the potential for other depression, depressive disorders such as MDD.
Very helpful. Thank you. Are you able to share what the efficacy endpoint or endpoints could be for this phase II?
Yeah. I think it's mainly the HAMD 17 reduction, the score, and it's the commonly used. Then when obviously, there's other scales that we can talk about. Alex, our TA head, is on the line, he can add to that. We actually looking at multiple endpoint, time point in terms of the early response, you know, you know, 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. We believe that we can detect some, the durability of the treatment.
Perhaps that's where we can focus our attention on. Alex, I don't know whether you have anything to add to this. It's relatively straightforward presentation.
Absolutely. Thank, thank you, Zhi, and thank you really for the question. I, 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. 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. 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, of effect in this population. As, as Zhi mentioned, this is a straightforward study.
This is a study that has been fully agreed with FDA and a study that we are really, really excited we 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, Alex.
Very helpful. Thank you. Thank you very much.
Thank you, Zhi, Alex, and Nick. We will go next to Yizheng Yang with CICC. Yizhen, please go ahead.
Hi, Dr. Hong. This is CICC, this is Yizheng Yang. I just have one question. What's your marketing plan of HBV prevention vaccine? Thank you, sir.
Yeah. I think we're, we're, as we speak, actually working on this in our Greater China GM, and Rico Liang is, is leading the team. Obviously, you know, before any commercial lines, we have to really engage the regulatory authority. You know, a lot of the effort is really geared towards engaging the various jurisdictions, regulatory jurisdictions. I mean, make no mistake, and this is not something we intend to commercialize ourselves, so we're looking at partnership opportunity as well in APAC region. Those are the... We haven't really have a fully vetted, you know, commercial strategy, but rest assured, we're over the next six months, we're making progress and just share with you.
I, I don't know whether or not, Rico, you have anything additional to share, but I think at the, at the high level, this is where we are.
Okay. It's clear. Thank you.
Yeah. Rico, you have anything to add?
No, no. Yeah, I agree with you, and probably, you know, I can just, probably introduce to everybody if interested in the prevention market, you can attend an R&D day tomorrow, and Professor Zhuang Hui will talk about the emergency use for the vaccine, prevention vaccine in China. Yeah.
Yeah. Thank you.
Okay. Thank you. Thank you.
Thank you, Yizhen. 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 Rebile.
Well, thank you for the question. You know, obviously, we always be on the lookout to look at some business development opportunities. We have looked at a lot of companies, and I think the two, the three transaction that Susannah just highlighted on was, was a, maybe a great example in terms of how we leverage the capital market condition and, and the stress that, that our peers and our partner are going through, and then we're able to, you know, use this and then to create opportunity for us, with, with the, you know, very favorable term to us. I think this is something we're gonna continue to look at it. I just wanna remind everybody that even though we conducted three transaction, we're actually cash positive.
We're able to leverage our equity investment in Qpex, which give us a, a strong return on investment and then allow us to redeploy the capital to complete the 2 transaction with VBI. At the, at the, at the end of this 3 transaction, we're actually cash positive. I think it's the same thing that you would, you would wish us to do as investors, to be very, you know, frugal about deploying our capitals in terms, you know, 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 is what, This include both the transaction with VBI as well as Qpex.
Now we have global rights of BRII-179 and global rights of BRII-693, and Asia Pacific right for PreHevbri. All of this will increase our opportunity to partner with others and then increase our near-term partnership revenue or income. This is something we're obviously actively pursuing. There, if there is any, you know, great opportunity, which we're looking at many, and then we'll certainly will perhaps let you know once we consummate the business transaction. This is a clear, a challenging time, and it's 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 mid-year results, as well as, you know, the update on that, our executive team was able to put together for you. I really appreciate your attention, your, your, your, your support of Brii in the past, and I, I think as a company, our mission has never changed. We are a, a company, that focused on major public health challenges with critical scientific, with with scientific breakthrough and then, and then critical patient insight. We're obviously focused on infectious diseases, and the mental health, conditions, and all of this, have the hallmark of huge patient population and a significant social stigma and very limited treatment options.
This is the area that where it's gonna 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 we can all relate it, one way or the other, to a lot of things that we're working on. I do appreciate your, your support, and then I expect continuous support from you. We're very excited about actually the program that we're able to progress, and I think one of the things that highlighted by David already, we're not just having three assets for HPV cure. We actually have three best-in-class assets. This will allow us to create multiple best-in-class combinations.
I think sometimes people just mistaken that if you have a piece of mRNA, 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 a full understanding of those asset mechanistically, scientifically, and clinically, and making sure they actually, on its own, is the best-in-class asset that we have. As David mentioned, that we do have-- we feel that we have all the tools we need, and then we just really need to move on to execute on, on, on the multiple studies that, with aim to, to provide definitive answers in the near term. That's, what we're trying to focus on.
On the same as we continue to progress in, in U.S., I think this is one area that we have such a profound, potentially transformational asset, 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. This is very, very important, as Alex mentioned early on, that this is the first time for, you know, for, for treatment of depression and anxiety disorder, where you have a potentially a single treatment option. How can you imagine this, where people be on chronic treatment with antidepressant for a very, very long time?
It's taking them months in order to receive the clinical benefit, and then they don't know how to get off. I think this is a, this is a total transformation in my-- in our mind, that we're gonna continue to push ahead for developing this. It's very exciting that we finally get into patient studies, and this is, will provide us the efficacy data. With that, I wanna 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 on some ongoing studies.
As, as David mentioned, we have two phase two study readout that we will share with you as soon as we can, and we'll also, also present it at the scientific conferences as well. Thank you very much. Have a good day, have a good evening in US, and, and thank you very much again.
Thank you, everyone, for joining. Goodbye.