Brii Biosciences Limited

Good day, ladies and gentlemen, and thank you for standing by. And welcome to BRIE Biosciences Limited 2021 Annual Results and Business Update Conference Call. At this time, all participants are in 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 GreenBowl's 2021 Annual Results and Business Update Conference Call. Our annual results announcements can be found on the Investor Relations section of our company website. Joining me today on the call from GreenBowl's senior management team are Dr. Z. Hong, our co-founder, chairman, and the chief executive officer, Mr. Rogers Luo, our president and general manager of Greater China, Dr. Lee Yin, our chief medical officer, and Dr. Ang Kong Lee, our chief financial and strategy officer. Dr. Hong will provide a high-level overview of our key programs, company strategy, and future development plan, followed by Mr. Law, who will summarize further details about our HPV and COVID-19 programs, and our overarching prioritizations of R&D and commercial efforts in China. Dr. Yan will provide updates on central neuroscience programs as a priority for the UIC. Dr. Li will then provide a brief summary of our full financial results and corporate strategy, including business development plan. After the management team's presentation, we will open the Q&A session to take questions. Before we start, we would like to remind you that for 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 undertake any obligation to update this forward-looking information accepted as required by law. Now I turn the call over to Dr. Hong, our co-founder, chairman, and CEO. Dr. Hong, please go ahead.

Thank you, Chris. Thank you all for joining us, and welcome to our 2021 financial year results and the business update call. It has not been long since our last call. We are very pleased to update you with our latest progress. Less than four years ago, we launched the company with a mission to be the best public health-inspired biotech, tackling some of the world's greatest public health challenges with breakthrough innovation and insight. We have done just that. Almost all our programs aim to address huge disease burden and stigma from diseases of HIV or HIV infection to mental illnesses. But these goals cannot be accomplished by one organization alone. Partnership with investors, governments, and societies are needed to truly deliver much needed support and innovation to those who need it. We made significant progress in 2021 to bring us closer to reaching these goals and look forward to further advancing our mission in 2022. Early in 2021, we completed a Series C financing, moved our HPV functional acute program into combination studies in the APEX countries or region. Together with our partner, Viewer Biotechnology, we are currently testing four different combination of HPV therapeutics with the support of our investors and partners and the promise of transformational therapeutic options, we completed our IPO listing on the Hong Kong Stock Exchange in July 2021, raising nearly 2.8 billion Hong Kong dollars. As we continue to move our COVID-19 antibody combination therapy from the clinic to regulatory submission, and the world has faced resurgence in COVID-19 with the Delta and Omicron variants, and revealing the critical and urgent need for safe and effective therapeutic options. As of December 2021, we are honored to be the first company in China to successfully develop and gain biologic license application of BLA approval from China's NNPA. followed the COVID-19 treatment. In less than 20 months, we were able to move amibarumab, aromalusivumab, which is the COVID-19 antibody combination therapy, successfully from the laboratory through clinical trial to gain the regulatory approval. Just last week, National Health Commission of China added our neutralizing molecule antibody combination to AIDS COVID-19 Diagnosis and Treatment Guidelines, the ninth edition, marking a critical breakthrough in COVID-19 therapeutic drugs in China. Our Emergency Use Authorization, EUA, remains under active review by US FDA and is pending on satisfactory completion of FDA's inspection of the manufacturing site at our contract environment manufacturing company CDMO. Today we're working closely with governments and local authorities and our shared goal of delivering our important COVID-19 therapy to patients in need in China and around the world. The ongoing COVID-19 surges in Hong Kong, Shanghai and other cities throughout China reaffirm our belief that the combination of public health tools such as effective treatment masking, border access control, and broader access to vaccines will all be needed to end the pandemic. Apart from COVID-19, our overarching business strategy is set on our long-term goals to address increasingly prevalent infectious disease and the same as diseases. First among this, and perhaps most important for China, is chronic hepatitis B, or HPV infection, where we are the leader in the race to identify a functional cure. Searching for a cure of HPV will be the top priority of our China team, which has led to clinical investigation of our phase two clinical stage asset in various combination. Postpartum depression is another example how we are leading the industry in searching for a truly transformational therapy for women who suffer from these terrible mental illness, who unfortunately lack support or understanding or empathy from those around them. The current standard of care is simply inadequate. Awareness of the disease is insufficient, further exacerbated by the gaps in our healthcare system and the lack of treatment options. Our US team is leading the effort in launching our clinical trial in women who are either diagnosed with PPD or at high risk of developing PPD. 2022 will be an exciting year for our CNS programs with RAID 296, which is the single treatment option moving to the clinical trial in the U.S. for both treatment and prevention of postpartum depression. GRADE 297, a new chemical entity, will enter phase one study in the U.S., expanding our R&D effort in central nerve system diseases. I would also like to touch upon our endeavor for new HIV treatment. Gave some background on the activities surrounding islazovir, also known as EFDA. First and foremost, While the FDA, U.S. FDA, has put a hold on all trials related to isletrovir or EFDA since December 2021, due to the observation of decline in CD4 cell count in some subject, there were no safety concerns, nor any decrease in CD4 cell count in our phase one study of 3732. which is the pro-drug office, or also known as the FDA. The clinical hold by US FDA on Brie 732 was a decision made out of abundance of caution by both Brie and the agency. The last multiple rising dose cohort had not yet been dosed at the time, and it is no longer needed, which means our phase one study has completed. The data will be presented at a future scientific conference in the second half of 2022. And based on the published data and information disclosed by Merck, the safety finding of CD4 cell count decrease is both dose and time dependent. And we believe based on our phase one study, we can define or select a safe dose of ray 732. And then that will be efficacious. As such, we will meet with FDA and discuss our plan to investigate and to further develop Brie732 with the aim of lifting the clinical hold in the second half of 2022. We hope to proceed with the development of our once weekly oral combination of Brie732 and Brie778 as soon as we can. For our multi-drug and extensively drug-resistant MDR, XDR, gram-negative antibiotics. We are working in collaboration with our partners, QPACS, where we own the license right for the development and the commercial activities in Greater China. Right now, QPACS is progressing Brie 636, Brie 672, and Brie 693 in parallel with the goal to moving all three assets to pivotal studies in the near future. By design, BRII will consider participation in these trials by joining and conducting the phase three studies in China, where there will be a critical need for this important hospital antibiotics. Leveraging the data from early US studies and participating in late stage trials in our licensing territory is part of our strategy to bring these critical medicines to market quickly without incurring significant early trial costs and risk. The last program I would like to highlight is BRI-65A, Ipatroboroli, which we license from AM2 Therapeutics for the treatment of refractory non-trabucculosis micro bacteria and also known as ANTM infections. This is life-threatening lung diseases, often affecting many patients in U.S., Japan, and China. NT Therapeutics, which is based in the U.S., already filed for their S1 prospectus and IPO registration in March 2022. Brie 658 is a novel, completely novel antibiotics product. has a potent and a broad spectrum activity against mycobacteria and many other bacteria pathogens. AN2 is developing a petrol borole as a once daily orally administered treatment for patients with NTM with the initial focus on treatment refractory mycobacterium avium complex, also known as MAC, which is a very severe lung disease. into an expected to initiate the registration phase two, three study in the first half of this year, 2022. And the U.S. FDA has granted AN2, the orphan drug, qualified infectious disease product, and FAST-TRACK designation for apetroboroli in treatment refractory, NTM, MAC, lung disease. Our aforementioned achievement are also gaining traction in the capital markets with our addition to eight pension indexes and the Hong Kong Connect Exchange in the fourth quarter of 2021, which raises our visibility and added to our higher liquidity. We're also honored to have received more than 10 awards from prestigious media and financial industry outlet that highlights our accomplishment in 2021. Being a very small and a young BALTAC, we are pleased to be recognized for our mission to tackle the world's greatest challenges in public health. In 2022, we strive to do more. With our forthcoming inaugural ESG report, we will highlight our convictions around our corporate social responsibilities and especially those that further integrated our values across each aspect of our company while advancing public health at a global scale. Our momentum and success in 2021 have pushed us to the next stage in commercialization and manufacturing. This has significant implication in our longer-term business strategy and planning. which may accelerate our growth and expand our business opportunities. Our pipeline is very unique and strong, aimed to change the way how patients are cared for. At the same time, eliminate social stigma rooted deeply in many communities facing public health inequities. Lastly, we see a remarkable opportunity to tap into patients' insights while creating our medicines. Following our patient-centric values, we are embarking a new investment into patient advocacy to establish relationship, share knowledge, ultimately guide us in our clinical development and to better serve our patients in need of innovative medicines. So with that, I would like to turn the call over to Mr. Luo and our president and general manager of the Greater China, who will provide additional details on our ongoing focus in HPV clinical development, as well as COVID-19 antibiotic commercialization in China. Rajesh, please go ahead.