Brii Biosciences Limited (HKG:2137)
Hong Kong flag Hong Kong · Delayed Price · Currency is HKD
1.380
+0.040 (2.99%)
May 7, 2026, 4:08 PM HKT
← View all transcripts

Earnings Call: H2 2023

Mar 25, 2024

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

Welcome to Brii Biosciences' 2023 full-year Earnings Call. Before we begin, I want to remind everyone that today's discussion may contain forward-looking statements, which involve risks and uncertainties. Actual results may differ materially from those discussed today. These statements reflect our views only as of today and should not be relied upon as of any subsequent date. We disclaim any obligation to update such statements. Joining us today from Brii Biosciences' executive management team are Dr. Zhi Hong, Chairman and Chief Executive Officer; Dr. David Margolis, Chief Medical Officer; Dr. Ellee de Groot, Chief Technology Officer; and Dr. Ankang Li, Chief Strategy and Financial Officer. Dr. Hong will begin with an overview of our strategic priorities and corporate updates, then Dr. Margolis will review our clinical programs, followed by Dr. de Groot with the CMC strategy update on recent business agreements. Finally, Dr. Li will discuss our financial status. We will then open the call for questions with Dr. Qin Zhu, Head of China R&D, joining us. Now over to our CEO, Dr. Hong. Dr. Hong, please go ahead.

Zhi Hong
Chairman and CEO, Brii Biosciences

Well, thank you, Sarah. Good morning and good evening, everyone. Welcome to our full-year 2023 Earnings Call. It is my pleasure to speak to you today and review our investment and the ongoing progress. Since the beginning of 2023, we had prioritized our pipeline and stock for the investment in the COVID antibody therapies that had contributed to our strong cash position at the end of 2023, that is close to CNY 2.7 billion or $376 million. The state of our mission remains very strong. I'd like to start by highlighting some of the strategic moves we made in 2023 and that position us for significant growth opportunity in 2024. I will outline our initiatives going forward, including what to expect for the rest of the year and the year after.

2023 served as a pivotal year for us, marked by the significant expansion of our HBV portfolio and notable clinical progress. Each of these steps brought us closer to our central goal of achieving an optimal functional cure. Our focus remained on HBV as we have concentrated our effort to the clinical and commercial development of our advanced HBV portfolio, and we continue to look to partner our other promising global program for further development to ensure optimized resource utilization and maximize our impact in the field. Over the last 5 years, our vigorous clinical investigation has given us a deeper understanding of what is required to maximally reduce and sustain HBV surface antigen loss. With BRII-179, BRII-835 or elebsiran, and BRII-877 or tobevibart, we have assembled a potent and diverse HBV portfolio.

These assets are advanced along the clinical development process and hold significant potential to impact HBV curative treatment positively. Each has a very different mechanism of action that allows us to address HBV from multiple angles in our pursuit to develop a better cure for the broadest patient population. Through ongoing combination studies as well as strategic partnership, we are working to cement the position of our proprietary therapeutic vaccine, BRII-179, aiming for a substantial improvement in the HBV functional cure rate. Building on the key data readout as well as recent agreement on acquiring intellectual property rights and technology transfer of BRII-179, which Ellee and Ankang will provide more detail in just a few moments, we are poised to initiate multiple late-stage combination studies in 2024.

In November, we presented new data on the phase II studies of BRII-179 plus PEG-IFN-alpha and also BRII-179 plus BRII-835, the siRNA combination, as late breakers at the AASLD conference. Following that, BRII-179 received the Breakthrough Therapy designation from the Center for Drug Evaluation, CDE, of the China NMPA, National Medical Products Administration. We recognize the inherent value of BRII-179 and its potential to amplify the immune response. As such, we extended our global rights to the BRII-179 in July last year and early this year. We took one step further, acquiring BRII-179 outright in February. The technology transfer gave us even more flexibility and control of BRII-179 development, extending our operational reach as part of the transaction. We'll also eliminate all future milestone and royalty payments to VBI, offering a significant upside and economic benefit to our shareholders going forward.

Data for BRII-179 has already shown its ability to induce strong anti-HBV surface antibody and broader B-cell and T-cell response in HBV patients. Two phase II studies are still ongoing and completing with BRII-179. What is most important is that BRII-179 holds the potential to identify immune-responsive HBV patients with the highest chance of achieving a functional cure. We are strategically assessing BRII-179's ability to enhance HBV patients' intrinsic immunity and targeting therapy to those who are most likely to respond. We're sparing others from poorly tolerated regimens. These important breakthroughs have helped us transition our HBV cure program into multiple late-stage combination studies to further investigate and confirm BRII-179's role in enhancing functional cure rate.

The interim results we will be reporting throughout 2024 and 2025 from the current as well as the planned trials, that these are playing key roles in informing our registration strategy in China and around the world. PreHevbri is another HBV 2023 addition to our HBV portfolio that extended our capability into HBV prevention. We have submitted two pre-IND to the CDE for a PreHevbri registration plan in China, and a market authorization application was also filed in Hong Kong. As we continue developing functional cure regimen, which is our focus, the addition of PreHevbri to our portfolio allows us to simultaneously address prevention needs in a susceptible adult population who remain at high risk because they're either not vaccinated or non-responsive to the traditional vaccine or to have vaccine immunity that had waned over time.

Buying down future milestones and royalty payment and acquiring manufacturing capability of PreHevbri may offer us more flexibility of partnership throughout the region. With BRII-179 as well as BRII-835 and then BRII-877, we stand in our strongest position yet to reach our goal of much improved functional cure. As for our next step in HBV, we will initiate multiple combination studies in the second half of 2024 to validate and confirm BRII-179's ability to enhance HBV functional cure rate in combination with other modalities. In addition to new trial initiation, we have multiple data readouts planned for this year.

The first will be an oral late breaker presentation at the APASL 2024 conference at the end of March in Kyoto, Japan, where we will present data on patients meeting NUC discontinuation criteria in our ongoing phase II study of BRII-179 in combination with PEG-IFN-alpha in HBV patients. We will report early top-line results from our ongoing phase II study investigating BRII-835 in combination with PEG-IFN-alpha in the Q4 . This study was fully enrolled at the end of last year and also has the proper control of PEG-IFN-alpha alone. Additionally, our partner, Vir Biotechnology, expects to report data from its MARCH and SOLSTICE studies, which BRII-877 and BRII-835 in the second and the Q4 of this year, and providing more data to inform our registration strategy in China.

Beyond HBV, we will also be looking to partner our promising MDR/XDR antibiotics, HIV program and CNS program for further development. We'll keep you updated on our progress. Our decision to focus on the HBV cure program is a reflection of our confidence in the scientific insight and clinical evidence that we have gained through the clinical investigation in the past five years. In summary, we're confident we're on the right path with our substantial HBV assets. We know what is important to sustain the loss of HBV surface antigen. More importantly, we have developed a strategy to assess HBV patients' intrinsic immunity in reaching patients who may have the best chance of achieving a cure, while sparing others the long and expensive treatment with little hope of cure. These pivotal breakthroughs inform our late-stage clinical combination trial, allowing us to advance with greater clarity and intention. With that overview, I'd like to turn the call to Dr. David Margolis, who will provide more details on our clinical program. David?

David Margolis
CMO, Brii Biosciences

Thank you, Zhi. Hello, everyone. Today, I'd like to update you on our portfolio and, in particular, speak about some of our recent hepatitis B data. Across our HBV portfolio, we are exploring a data-driven HBV functional cure strategy. We believe this is evident in our trial designs and how we are exploring these candidates in various combination regimens with each other, both with and without PEG-IFN-alpha. Our approach includes these three clinical assets. BRII-179 is our therapeutic vaccine, BRII-835 siRNA approach, and BRII-877 monoclonal antibody approach. We have three ongoing phase II combination studies with these candidates, and our partner, Vir, is currently running two phase II trials. Today, I'm going to highlight some of our recent data published at AASLD in November, which helps to elucidate our current strategy.

Starting with our phase II study of BRII-179 plus BRII-835, we presented immunologic data looking at one arm of siRNA alone, alongside two arms where siRNA was combined with nine doses of the therapeutic vaccine. What we found was that a distinct Hep B specific antibody response was inducible in the majority but not all of individuals with chronic hepatitis B, suggesting that these groups of individuals that are able to respond may have a better chance of functional cure, while those that are not responding immunologically may be more resistant to functional cure. It is generally believed that a strong immunologic response is needed to attain functional cure, including components of T-cell and humoral B-cell response. This data generated from this study is important for us to help elucidate what type of immunologic coverage we have in the T and B-cell space.

We are learning more and more about each of these areas as we continue to generate data from our studies. Looking at the left side of this graph, we're looking at T-cell responses by ELISpot with the top row demonstrating cohort A, which is 835 or siRNA alone, and the combination below of B and C where 835 is combined with the therapeutic vaccine. You can see, initially, prior to dosing, minimal ELISpot responses to specific antigens prior to dosing. In the top, over time, you see some evolution of the primary S antigen response when siRNA is used alone. Underneath, when 179 or the therapeutic vaccine is introduced, we see a significant increase in the breadth and strength of the T-cell response, as noted by ELISpot, which increases over time and is notable by its broad spectrum of hepatitis B-specific antigen response.

To the right, we have previously shown some antibody data for shorter-term vaccine dosing. But here, we can see evolution of the antibody response with significant, strong anti-HBs response elicited in some but not all chronic hepatitis B patients. And that evolution of response continues with continued dosing. Similar kinetics were observed in patients receiving 4 or 9 doses of BRII-179 with or without BRII-835. Again, we believe it's important that there are some individuals who are not able to fully elicit a response to BRII-179. We also presented interim data from our randomized, placebo-controlled, and double-blinded phase II study of BRII-179 in combination with PEG-IFN-alpha in patients with chronic hep B infection.

Data shown that BRII-179 add-on therapy to existing PEG-IFN-alpha treatment was generally safe and well tolerated, with adverse events similar to those associated with PEG-IFN-alpha treatment and BRII-179 data that had previously been reported. In this study, at week 36, which is 12 weeks after the end of treatment, the BRII-179 plus PEG-IFN-alpha combination group achieved higher HBsAg loss rate compared to placebo plus PEG-IFN-alpha. The difference in the loss rate was observed at week 24, which was at the end of treatment, and now maintained through week 36. The clinical study also found that the combination group had significantly higher HBsAg seroconversion rates than the placebo PEG-IFN-alpha group at week 24. The addition of BRII-179 induced a robust and functional HBsAg antibody response.

The participants in BRII-179 plus PEG-IFN-alpha group achieved significantly higher HBs antibody response than those in the placebo arm, both at week 24 and at week 36. The titer of this response was significantly associated with HBs surface antigen loss at both week 24 and week 36. When looking specifically at patients who rebounded, four out of five of the patients who rebounded had no detectable antibody response. These data demonstrate that the addition of BRII-179 induced functional immune responses that could improve the rate and duration of HBs surface antigen loss, seroconversion rates, and antibody responses in chronic hep B patients compared to PEG-IFN-alpha alone, thereby increasing the CHB functional cure rate. We are very encouraged by both of these data sets as we proceed with our next steps in developing BRII-179 in China.

What we learned has helped us shape our clinical trials going forward, informing our clinical and regulatory path. Initiating multiple combinations with BRII-179 this year is our next step as we build on these critical insights and demonstrate the versatility of BRII-179 as a treatment option. One approach that we are taking will assess the potential of BRII-179 as a patient enrichment strategy, while the other will be to enhance immunologic control of HBV infection with the simultaneous induction of both a T-cell and B-cell response. Our overarching goal, of course, is to develop HBV assets to achieve best-in-class functional cure in the broadest set of patients.

Now, as we turn to our other programs, in multi-drug and extensively drug-resistant Gram-negative bacterial infections, we maintain global rights to BRII-693, a novel polymyxin, with significantly differentiated safety and efficacy profile to address the most difficult-to-treat S and E bacteria and Pseudomonas infections that are resistant to carbapenem. In HIV, we have BRII-732 as a potential once-oral weekly long-acting combination treatment for HIV. This is a phase II ready asset, as well as BRII-753 as part of a long-acting subcutaneous injection regimen, which could potentially be dosed between monthly and every 6 months. Lastly, in our CNS program, we have 2 ongoing trials that represent this exciting first-of-its-kind treatment for patients with various mental illnesses.

We have begun dosing, in fact, completed dosing in a phase II proof-of-concept study with BRII-296 and postpartum depression in the U.S. and are expecting data readouts in the Q2 . We have also completed dosing in a healthy volunteer study, phase I with BRII-297. It's a long-acting injectable being developed for the treatment of anxiety and depressive disorders. We expect to have a safety, tolerability, and pharmacokinetic data in the second half of this year. Last month, our partners at AN2 Therapeutics voluntarily paused phase III enrollment of their phase II/III epetraborole study for treatment-refractory MAC lung disease, pending further data review. Updates on that data set will be provided as more information becomes available. As Zhi has mentioned, our primary focus remains on hepatitis B. And with that, we are looking to partner each of our other programs for further development.

As we continue to focus on hepatitis B with our three ongoing trials and additional trials planned for initiation this year, more data will be forthcoming from both ourselves and our partners, reinforcing our leadership and pioneering functional cure for hepatitis B. With that, I would like to turn over the call to Dr. Ellee de Groot to address the importance of our new manufacturing capabilities. Ellee?

Ellee de Groot
CTO, Brii Biosciences

Thank you, David. It's a pleasure to speak with you all today and cover our HBV program CMC strategy. As we continue to ramp our clinical trials and enter late-stage development with our HBV program, integrating our R&D capabilities with a global manufacturing strategy becomes an increasingly essential component of our strategic growth. With our most recent acquisition of BRII-179, we also acquired manufacturing control, an important first step in fulfilling this need. The expansion of our manufacturing capabilities ensures that we can produce the necessary supply for our multiple combination trials and future global commercial efforts as we move closer to that stage. Since our announcement in February, we have already started working closely with our partners and biologics manufacturing experts to secure BRII-179 supply and its manufacturing technology.

VBI will continue to supply BRII-179 batches through this transition, which will provide sufficient clinical materials for our upcoming trials. To ensure security of clinical and commercial supply, the manufacturing processes for BRII-179 will be expanded to an additional manufacturing site. Throughout this transition, we will, of course, ensure consistency and compliance with domestic regulatory requirements. Our top priority is to ensure we can readily produce our core BRII-179 candidates. Both the purchase of the Rehovot manufacturing site and the transfer and the manufacturing processes to additional suppliers help accomplish this goal.

As we assume responsibility for the Rehovot manufacturing site, we will also become VBI's commercial supplier for PreHevbrio and PreHevbri. In summary, we are aligning our R&D capabilities with global manufacturing under a strategic staged approach. Our newly acquired manufacturing capabilities provide Brii with additional control and stability for supply chain, quality, and cost efficiency, and will ultimately expand our clinical and commercial manufacturing footprint for our entire HBV portfolio. With that review, I'll now pass the call to Dr. Ankang Li, Chief Strategy and Financial Officer. Ankang?

Ankang Li
Chief Strategy and Financial Officer, Brii Biosciences

Thank you, Ellee. Thank you all for joining today's call. Ellie has summarized what our recent transaction with VBI brings to the company from a manufacturing and drug supply perspective. Before I review our annual financial results, I would like to walk you through the financial aspects of the transaction. The agreement was signed last month. Upon completion of this transaction, we will own all of BRII-179's IP worldwide, eliminating all future royalty and milestone fees to VBI for BRII-179 and PreHevbri. On financial terms, we issued an initial $2.5 million promissory note to VBI, which eliminated all royalty and milestone payments for PreHevbri. This will be followed with a $7.5 million promissory note to acquire all of VBI's IP for BRII-179 upon VBI's completion of certain activities. We are now working to transfer manufacturing technology for BRII-179, which Ellee just discussed.

Once this transfer is completed, we will issue up to an additional 8 million promissory notes to VBI. Subject to certain conditions, we will also assume control of VBI's Rehovot-based manufacturing facilities for BRII-179 and PreHevbri for $10 million in cash later this year. At that time, we also expect to enter an agreement with VBI to become its commercial supplier for PreHevbrio and PreHevbri. Now, on our annual financials. As of December 31st, 2023, our bank deposits and cash and cash equivalents were CNY 2,661.4 million, which is approximately $370 million. Compared with last year's end, which is CNY 2,999.3 million, approximately $417 million. The decrease was primarily due to payouts of daily operations and research and development activities.

Our research and development expenses were CNY 402.7 million, which is $56 million in 2023, representing a decrease of 8.6% compared with CNY 440.6 million or $61 million in 2022. The decrease was primarily due to the decrease in discontinuation of the COVID-19 program. If you take this part out, our research and development expenses were actually higher in 2023. Our other income was CNY 163.7 million or $22.7 million for 2023, representing an increase of 51.7% compared with CNY 107.9 million or $15 million in 2022. The increase was mainly due to the increased bank interest income of CNY 70.8 million or $9.8 million attributable to the rising interest rates on US dollar and Hong Kong dollar time deposits. The increase was partially offset by the decrease in income recognized from PRC government grants.

Our total comprehensive expense for 2023 was CNY 159.7 million or $22 million, representing a decrease of 33% compared with CNY 238.5 million or $33 million for 2022. The decrease was primarily due to the increase in other gain and loss, which was partially offset by the decrease in gain arising from exchange difference on translation from functional currencies to presentation currencies. We expect our current fund to be sufficient to support our development needs as we advance our HBV programs through 2027 and look to partner our other promising candidates. 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.

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

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. We will go first to Roanna with Leerink. Roanna, please go ahead.

Rosa Chen
Equity Research Associate, Leerink Partners

Hi. Good morning, everyone. This is Rosa Chen on for Roanna Ruiz at Leerink Partners. I hope you can hear me.

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

Yes.

Rosa Chen
Equity Research Associate, Leerink Partners

Oh.

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

Yes, we can hear you very well.

Rosa Chen
Equity Research Associate, Leerink Partners

Are you able to hear me? Oh. So I can't hear you guys, unfortunately, but I'm going to ask my question. So, regarding the trial for 179 on top of pegylated interferon, can you share with us the criteria for NUC discontinuation? And separately, will you incorporate NUC discontinuation in the future combo trials of 179 as well?

Zhi Hong
Chairman and CEO, Brii Biosciences

Hey, thank you for the question. I'm going to ask our head of R&D in China, Dr. Qin Zhu, to answer that question. Qin?

Qin Zhu
Head of China R&D, Brii Biosciences

Discontinuation criteria will be HBsAg undetectable, meaning less than 0.05 IU per mL, and also undetectable DNA level. That's the strict criteria. For all the patients doing the follow-up post-treatment from week 36 or 48, anyone met the criteria and also have two consecutive HBsAg undetectable level will meet the criteria into the discontinuation period. We will use the similar discontinuation criteria for the future study as well. Does that answer your question?

Rosa Chen
Equity Research Associate, Leerink Partners

Another one from us. Thinking about the partnership for your non-HBV program, which one would you say is a top priority to find a partner in continued development?

Zhi Hong
Chairman and CEO, Brii Biosciences

Yeah. I'll take a first shot at this and then ask David to comment on that as well. So I think we're clear that where the entire company is focusing on HBV functional cure clearly this is an area that we hope to develop through partnership. And these represent enormous public health implications. So we do believe that we are able to work both with public as well as private partners to work through this. For example, the MDR XDR antibiotics, this is really the best-in-class next-generation polymyxin that we already have the phase I study completed. The exposure, the dose has been selected, and the safety profile has been evaluated and is showing much reduced renal safety concerns as well as some of the neurotoxicity concerns. So this is something that we have discussed with regulators and FDA and EMAs and getting broader feedback online.

And then we're looking to initiate a number of smaller studies, the so-called phase Ib study that will allow us to initiate the global registration studies. So those are the areas where we're looking to various fundings and to bring us together to further develop it. And obviously, we're looking for partners as well. We are in discussion with the partners on that. I can tell you that right now. And with the HIV program, we're obviously looking to partner with an organization that has significant setup for late-stage development as well as commercialization. This is one area that we have been very passionate about. And then both David and I and our CSO, Brian, has worked extensively in this area and created a lot of value in the past. So this is one area we're looking for, a very different treatment options for patients.

As mentioned, that once-weekly oral, which is one of the options that currently does not exist. And the other is looking at even less frequent dosing. For example, once every quarter or as every six months, long-acting injectable therapy. So those are very exciting opportunities. So we're hoping to discuss with potential partners. As you know, this is one area where Gilead as well as GSK ViiV Healthcare is dominating in the space. Lastly, on the CNS program, I think this is one area that there are quite a number of companies, including startups, looking to find new options for CNS diseases. And this is one area that where because our focusing on the HBV cure, and then we decide to work with the partners and let the people who have more experience than us in conducting clinical stage development drive additional value. So those are the current plan. I can't tell you which one is further along, but I think we'll report as soon as we have some more conclusive agreement or discussion on this. And David, do you have anything there?

David Margolis
CMO, Brii Biosciences

No, I think it covered that really well, please. Nothing else.

Zhi Hong
Chairman and CEO, Brii Biosciences

Thank you for the question.

Rosa Chen
Equity Research Associate, Leerink Partners

Thanks for the details. One final one, a financial question. So given the increased manufacturing responsibilities that you're taking on with the new facilities, can you share your outlook for R&D and G&A spend in 2024 and beyond? So that's relative to 2023 as a base.

Zhi Hong
Chairman and CEO, Brii Biosciences

Yeah. I'm going to try to attempt to address this quickly. Then I'm sure Ankang Li has more detailed thinking and Ellee de Groot as well, please chime in. So I think our transaction with VBI was a very careful one where we based our investment as a convertible note based on the deliverables where VBI is working very hard to deliver. And if they deliver all the milestones or essential activities, as we call that, and we will be able to come in to take over the site, I think the burn rate of the site is manageable. It's probably around $15 million annual burn rate. And although that number, probably we still have to look at that more carefully in terms of whether or not we're going to take on the entire facility or maybe part of it.

But that's also predicated on us becoming the commercial supplier for VBI's vaccines in Europe and in the U.S. as well. So I think the net burn is something that we have to really determine once we realize how much supply they're requiring, how much we can supply. So those are the things that we are still in the process of discussing. And there's obviously people as well as we step into this and taking on the manufacturing capabilities. I think we also have to take on the people in Israel, which I have to say that given the current situation, we're quite pleased with the colleagues over in Israel. They have continued to produce clinical supplies of 179 and commercial supplies of PreHevbri, PreHevbri. So those are the things we're looking forward. I think more importantly, I don't want to miss this, there's a strategic component in this.

That is that as a start, as a young company, we have to take control of the manufacturing and supply sooner or later. As we're getting close to starting our late-stage trials and having a clear registration pathway, we have to figure out how to address the manufacturing and the supply and the quality aspect of the work that we are taking on. So these are very, very important strategic decisions as well. So I'll see if Ankang has any additional comment on the financial aspect of this and then Ellee have anything on the people side of it. Thank you.

Ankang Li
Chief Strategy and Financial Officer, Brii Biosciences

Sure. Right now, we are still projecting about $60-$80 million a year total burn rate. And I think the cash burn rate at the manufacturing side is about the size that we mentioned, about somewhere around $15 million. But of course, that's still variable based on how much we are making there. Otherwise, we still see that our cash will be able to support us through 2027. Eddie, do you have anything to add?

Ellee de Groot
CTO, Brii Biosciences

So I think you all have covered it well. I'll just reiterate how important the Rehovot site is to our strategy. We will be relying on that team to help us to do the technical transfer of the BRII-179 manufacturing technology and processes to our additional suppliers. This is really critical for our overall CMC strategy given the importance of this asset to us. And as he mentioned, the team will also then the balance of that work is really doing the commercial manufacturing for the PreHevbri product to which we will be supplying then through a supply agreement to VBI. So the team has those two primary objectives will continue. And it is truly critical to our strategy. And we've gotten just such a strong partnership from that team. They're working really hard despite the things going on in the country. We are just very confident that we'll be able to accomplish our goals.

Zhi Hong
Chairman and CEO, Brii Biosciences

Yeah. For those of us who are doing this for any major product, which we believe 179 is, you need a bit of some redundancy from the manufacturing footprint. Given the geopolitical and the tension and the war ongoing, we believe having this broader footprint is important for us to supply 179 not only to China and also to countries outside China. So I think those are very, very important considerations. But obviously, going forward, we have to adapt our strategy based on the evolution of the pipeline as well as the geopolitical and the war situation in Israel. So those are good questions. I really appreciate that question. And it gave us a chance to give you a full answer on this.

Rosa Chen
Equity Research Associate, Leerink Partners

Okay. Great. Thank you so much, everyone. Thanks for taking your questions. That's it from us.

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

Thank you, Rosa. Thanks, everyone. We got a question here for Zhi. With the acquisition of full global IP rights and manufacturing capabilities for BRII-179, how does this change Brii Bio's strategic flexibility and optionality for this asset? Are there any plans to explore novel external partnerships or combinations that were previously not feasible?

Zhi Hong
Chairman and CEO, Brii Biosciences

Yeah. I mean, I think that's a great question. I think we're obviously taking on this with the intent to drive to success with BRII-179. And as we stated, this will ensure the flexibility and control of the manufacturing and supply and the quality aspect of our investment. I mean, we do have the global right for BRII-179. And not only just on the BRII-179, we also have the PreHevbri, which is a therapeutic vaccine, which is something that we're actively looking for partners in the Asia-Pacific area and the region. So BRII-179, we clearly are having the right conversation to discuss with potential partners to further leverage its very versatile kind of this is a very versatile modality that can not only help us to identify the immune response of patients and also help us to induce the immune response and enhance the functional cure rate.

So I can see multiple partnerships and multiple curative treatments that could potentially be very feasible. And then we are in multiple discussions and also including some of the public agents where we're looking to explore some really novel combinations. And so having this global right, that gave us the flexibility to do so because otherwise, we had to ask our partner for permission to do such a study. So now we can just make those decisions on our own. I think with our strong cash position, we're in a position to explore multiple combinations. But we also have to be mindful about how to design some study quickly to get a product to the market. And that's also something that we're evaluating. So when we look at all this partnership, we have to look at the timeline, the uniqueness of it, and the differentiation of the combination. All of those will become important. But having this asset to ourselves, it gave us a lot of optionalities. Thank you for the question.

Sarah Qiu
Associate Director of Investor Relations, Brii Biosciences

Thank you, Zhi. Okay. This concludes the Q&A session of today's call. Now, I will turn the call back to Dr. Hong for his concluding remarks.

Zhi Hong
Chairman and CEO, Brii Biosciences

Well, thank you, everybody, for joining this call. I know some of you have already joined last night, which we had a call for our investors from China that gave this in Chinese. We appreciate your attention and ongoing support of Brii. I think we have accomplished quite a lot in 2023, and we're ready to apply those important learnings and insights in 2024 and beyond. Company-wide, we are focusing our mission to address the major public health challenges with scientific breakthroughs and critical patient insight. That will not change. Our laser focus on HBV functional cure in 2024 will give us that added direction and clear path forward. Breakthrough data with 179 elevate our combination treatment strategy. Then we're looking forward to further exploring into this already promising and, in my mind, a de-risk asset.

For those of you who probably have not followed us closely, with other programs that we partner with ViiV, the BRII-835, and BRII-877, all of these three programs not only have generated very important efficacy data, the proof of mechanism, and the proof of a cure, also, we have accumulated a large number of patient safety populations. These are very important. These are in the hundreds of patients that have been given to these important assets. So HBV is an area that we know that we must succeed. And then this will allow us to help a large underserved patient population. And the three assets that we have allow us to create the best-in-class combination that we know that not all HBV patients are the same. So we may very likely have to customize our curative treatment regimen towards sub-patient populations.

I think we're learning more and more as we go forward. Clearly, in the last five years, we have learned tremendous amounts of information that we will apply to the next five years. We know that we have the right asset. We have the team. We have the execution. I think these are very, very important for us. HBV functional cure is our focus. More data, more study will become available in the next year or so. This will be very important data readout that will help us to inform our registration strategy in China and around the world. At the same time, we look forward to finding the right partner to strategically develop our other program in HIV, MDR, XDR, and CNS program. With that, I just really want to thank you all again for joining us today. Thank you for supporting us. Thank you for taking the time to understand the program, the pipeline vision that Brii has. Thank you very much.

Powered by