Brii Biosciences Limited

Ladies and gentlemen, thank you for standing by and welcome to BRIE Biosciences Limited 2021 Interim Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. It is now my pleasure to turn the call over to Ms. Chris Fang, Director of Investor Relations. Please go ahead, Chris.

Thank you, operator. Welcome to BreVal 2021 Interim Financial Results and Business Update Conference Call. Our interim results announcement can be found on the Investor Relations section of our company website. Joining me today on the call from CompanySide Senior Management Team are Dr. Z. Hong, our co-founder, chairman, and chief executive officer Dr. Li Yan, who is our chief medical officer, and Dr. An Kang Li, our chief financial officer. Dr. Hong will provide us a high-level overview of our company strategy, market, and future development plan, and Dr. Yan will walk us through some of the key programs on the development, including our infectious disease and central nervous system programs. Dr. Li will then provide a brief summary of the financial results of the six months ending June 30, 2021, before we turn the call back over to the operator to take your questions. During the Q&A session, our Executive Director, President, and General Manager of Great China, Mr. Rogers Law, and our Senior VP, Dr. Zhu Qing, and VP, Head of Infectious Disease David Magones will join us to share more details. Before we start, we would like to remind you that today's discussion may contain forward-looking statements, which involve a number of risks and uncertainties. Actual results and outcomes may differ materially from those mentioned in today's announcement and this discussion. The company does not take any obligation to update this forward-looking statement except as required by law. Now, I will turn the call to Dr. Holmes, our co-founder, chairman, and CEO. Dr. Holmes, please go ahead.

Thank you, Chris. Thank you all for joining us. It is my pleasure to welcome you all to our first Financial Results and Business Update conference call. As we report our results for the first half of 2021, I would like to highlight what a landmark year it has been for us already. As a company dedicated to public health and focusing on infectious disease and central nerve system diseases, we have made great strides in progressing our clinical programs. In July, we successfully completed our IPO on the Hong Kong Stock Exchange. We are a biotech company with operations in China and the United States. and are committed to advancing therapies against significant infectious diseases such as HPV, HIV, multi-drug resistance, and extensive drug resistance from negative infections, and other illness such as CNS diseases, all of which have significant public health burdens in China and worldwide. We are achieving this vision with the business model that combines internal discovery as well as in licensing and partnership. With our listing on the Hong Kong Stock Exchange, we raised approximately 2.78 billion Hong Kong dollars in gross proceeds. And our IPO ushers a new era for our company as we leverage our in-house research and R&D expertise in licensing and collaboration capabilities to solve significant and medical needs. Our goal is to bring health benefits to those who are deeply impacted by these diseases and to societies in China and around the world. And I'm very thankful to our exceptional management team and devoted employees and their commitment and hard work. Our investors and the new public shareholders for their ongoing support and faith in our ability to make positive impact to society. With our IPO, while our IPO marks a huge milestone for us, I would like to take this moment to highlight several runs of financing prior to our IPO. Since our inception in 2017, we have raised a total over 400 million US dollars. We believe this is a testament to how our mission resonates with investors and public and how we have grown from zero to one and one to many in just a few years, successfully building a robust pipeline of innovative product candidates focusing on impression diseases and CNS diseases. Our business model, which combines internal discovery and in-licensing, has allowed us to develop a rich pipeline of more than 10 innovative clinical stage candidates in a relatively short period of time, making us ideally suited to address those life-threatening diseases. As we move forward, we'll continue to build on this business model and creating more pipeline opportunities. With the infectious disease representing the third largest therapeutic area in the global therapeutic market and posing a massive threat to public health due to their contagious nature, we believe our role as a strong and emerging player in this industry is pivotal. And we are fully committed to finding better treatment, prevention, and cure. So far, we have completed one, we are completing one phase three studies and conducting several ongoing phase two trials as well as many phase one studies. I would like to highlight just a few of our product candidates. Unlike the current standard of care of muke therapies or Pagolida interferon therapies that rarely achieve cure for HPV infection, our most advanced clinical candidate, Brie179 and Brie835, have the potential to be the first functional cure treatment for HPV, allowing patients to live a normal life without indefinite treatment. In China alone, the HPV cure market is projected to grow significantly from $15.9 billion from just $1.6 billion in 2019 to $15.9 billion in 2034. Our focus in the next 12 to 18 months is to generate data supporting the use of our combination of Brie 179 and Brie A35 in patients with XQD infection, giving us a significant lead to address this growing market opportunity. And most recently, we have received a clearance in August from NPA to initiate yet another combination study in Phase II with Brie 179 and Paglete Interfund. the study will start in China. Following the emergence of COVID-19 pandemic in early 2020, there have been significant difficulties of business across the globe and the people from all walks of life. We are fortunate to have been able to step up to the everyday challenges of the pandemic with minimum disruption to our operations while also keeping our employees safe. We also remain on track to deliver various key product milestones in 2021, prioritizing our work on COVID-19. The ongoing pandemic has once again underscored the pressing need for R&D investment in public health arena. We have moved quickly for the antibody treatment of COVID-19, potentially the first approved neutralizing antibody treatment in the greater China area. a cocktail of two human non-competing neutralizing antibodies, Brie-196, Brie-198, which were developed with our partners at Tsinghua University and Shenzhen Serb People's Hospital. This antibody therapy has the potential to be a SARS-CoV-2 antibody therapy with broader coverage of emerging variants and long-lasting treatment benefit for up to 3.6 months. With the resurgence of COVID-19 cases in July and the discovery of the Delta variant in large Chinese cities, BriBio rapidly initiated a phase three study in China to investigate our antibody treatment in patients with the COVID-19 Delta variant. We were also able to quickly complete enrollment of a global phase three study of our 3-196 and 198 cocktail therapy in the US government-sponsored NIH NIAID ACTIV-2 master protocol trials with over 100 clinical sites participating from various countries. This will also be the first pivotal study completed by the ACTIV-2 team, giving us significant lead time compared to other programs or assets in the ACTIV-2 trials. The interim data has shown that our combination therapy have a statistically significant reduction of 78% in the rate of hospitalization and deaths. With more data forthcoming from all 846 study participants expected in the third quarter, we'll be looking to submit emergency use authorization application to gain approval from the United States FDA and for emergency treatment in the United States by the end of the year. Since May of this year, we have been working with the government agency and hospitals in China to provide our antibody to COVID-19 patients on a compassionate use and emergency use basis. So far, close to 400 patients in China have been treated with our antibody cocktail, providing significant use experience to Chinese patients and physicians. We are also developing a novel treatment options for people living with HIV. Our oral therapy treatment regimen offers a once weekly single tablet regimen and greatly, potentially greatly simplify compliance, one of the significant HIV treatment issues. The current standard of care requires patients take medication every single day for the rest of their life, making it very challenging to keep up. We hope our once weekly oral therapy regimen have the potential to improve the quality of life of HIV patients by eliminating the daily reminders of their illness associated with the daily treatment. 3778 and then 3732 would offer a more discreet and non-invasive way for patients who are taking their medications, potentially improving HIV treatment adherence and in turn minimizing the emergence of resistance We currently have two phase one trial ongoing in our initial target market of the United States, the major global HIV drug market. Our second therapeutic area focuses on innovative therapies to address CNS diseases. CNS diseases also represent a major and growing disease category, including psychiatric and neurologic disorders that negatively impact the structure or function of the central nerve systems. often with debilitating results. Depression, for example, is one of the most common and serious medical conditions affecting an estimated 264 million people globally and across a wide range of depressive disorders. Postpartum depression, or PPD, and major depressive disorder, or MDD, are two of the more serious and severe forms of depression. This is where we're currently focusing our effort with Brie 296, undergoing phase one study in U.S. We are excited to see what the future holds for us as a company. We are encouraged by our clinical advancement. Brie Bioscience's deep commitment to developing therapy that combat infectious diseases and other illness representing a significant public health threat and very large disease burden. and requires a focus on transformative approaches with potential curative and preventive therapies instead of incremental improvements over the standard of care. These approaches require robust R&D expertise and deep knowledge and insight of infectious diseases, both of which we have. And we plan to expand and grow from strength to strength. Our highly experienced and competent in-house R&D team and strong scientific advisory board comprising world-leading scientists and physicians, industry expert and diverse board of directors, and our extensive R&D collaborations with pharmaceutical and biotech companies, research institutions, and our strategic capability partners. All of this positioned us well to bring new therapies to China and US market And we expect to continue to invest heavily in R&D as we push the boundary of modern medicines. In terms of business development, over the years, we have partnered and collaborated with several global pharmaceutical companies for various therapies. The combination of in-housing and in-licensing and then collaboration and supplementing with our internal R&D capabilities has served us really well. We will proceed with this strategy path, strategic path, as long as it benefits our development capability and our company. In the long run, we will look to leverage our internal R&D insight and expertise to expand our innovative pipeline. We expect the rest of 2021 to be an exciting time. Our priorities for the remainder of the years will be first to complete the enrollment of 179 and 835 for the functional cure combination therapies for HPV in the ongoing phase two study in the Asia-Pacific countries and regions. Second, to analyze the food data sets and food sets of results from the completed trial of the three 196 and 198 antibody cocktail therapies and submit regulatory files with the goal to secure clearance of near-term emergency use authorization for the COVID-19 in the U.S. and, similarly, emergency use in China. Third, progress our program in HIV and CNS disease area. We are heavily focused on securing near-term stockpile and commercialization of our COVID-19 antibodies as a matter of public health priority and progressing our core program in HPV. Now, with this overview, let me now turn the call over to Dr. Yen, our chief medical officer, who will review the status of our key development program with you in greater detail. Dr. Yen, please go ahead.