Assembly Biosciences, Inc.

Good morning, and welcome to the Assembly Biosciences Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session after the prepared remarks. As a reminder, this conference call is being recorded. I would now like to hand the call over to Lauren Glazer, Senior Vice President of Investor Relations and Corporate Affairs for Assembly. Please go ahead.

Thank you, Bridget. Good morning, and thank you for joining us on such short notice. Today's announcement of our strategic collaboration with Beijing is an exciting and significant milestone for assembly. This collaboration provides a strong foundation to accelerate the development in China of our hepatitis B portfolio, which currently consists of three clinical stage core inhibitors, ABI-H0731 and ABI-H2158, which are an ongoing phase two clinical trials, and ABI-H3733, which is in phase one development. The press release and the slides we will refer to during the call are available in the news and events section of our corporate website at www.assemblybio.com. Please note that a replay of today's call and webcast will also be available from our website. In a moment, I will turn the call over to Dr. John McCutcheson, Assembly's Chief Executive Officer and President, who will discuss the important and strategic benefits of our collaboration with Beijing. Then, Tom Russo, Chief Financial Officer, will review the financial terms and economics of this collaboration for Assembly. Finally, John, Tom, and Jason Okazaki, our chief legal and business officer, will be available for the Q&A portion of the call. Before we begin, I want to remind you that we will be making forward-looking statements, such as statements regarding the potential of our collaboration with Beijing, future milestones and royalties that may result from the collaboration, our future research and development plans, the timing of clinical trials, trial results, and therapeutic potential of our development programs, as well as financial estimates and guidance. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, and we caution you not to rely on these statements. We intend any forward-looking statements to be covered by the Private Securities Litigation Reform Act of 1995. They involve certain assumptions, risks, and uncertainties that are beyond our control, and actual results may differ materially from those forward-looking statements. A description of these risks can be found in our latest SEC disclosure documents and press releases. Assembly does not undertake any obligation to update any forward-looking statements made during this call. I'll now hand the call over to Assembly CEO, Dr. John McCutcheson.

Thank you, Lauren, and thanks to everyone who is joining us this morning. During our recent call in early May, we talked about the significant pipeline progress we have made with our Hepatitis B portfolio and our acceleration of activities over the last six months. As a company that is focused on advancing new therapeutic options for patients with hepatitis B, China has always been and is a priority for us. The People's Republic of China has an enormous burden due to this disease. It is home to one-third of the world's population living with chronic hepatitis B infection. Addressing this significant unmet need in China has always been a critical component of our strategy. Today we are thrilled to announce our collaboration with Beijing, a partner that shares our mission and is well positioned to help us achieve it. As we have previously stated, establishing a collaboration in and for China has been one of our top priorities this year also. It was important to us that we identify a partner that shares our commitment to scientific and clinical excellence and has deep expertise and experience in bringing products to patients in China. In Beijing, we are fortunate to have a partner that shares our values, commitment and priorities. Beijing is ideally positioned to deliver on the high expectations we place on addressing the disease burden in China. I'd like to step back and discuss what we were focusing on in the China partnering process and why Beijing is the premier and best choice for our partner. First, we were looking for a company with world-class and well-established operational infrastructure in China, with strong capabilities spanning clinical development, regulatory and commercial. Beijing has over 3,200 employees in China, including approximately 700 professionals in clinical development and around 1,300 in its science-based commercial group. Hepatitis B is a significant unmet need in China, as I've said, and Beijing has an extensive network of investigators and sites that we can additionally leverage for this important liver disease indication. Beijing's network offers the capability to enroll large numbers of patients quickly in clinical trials also. We believe their infrastructure, their network, and experience will accelerate our clinical development efforts and the data generated will support our registration in China and potentially other geographies as well. Beijing's team currently markets five approved therapies in China with plans for more in the future. They are a trusted partner to global biopharmaceutical companies, including Amgen, Bristol-Myers, Seattle Genetics, and others. Its collaboration with Amgen, which just closed in January, is a proof point in the transformative potential of Beijing's unique clinical development capabilities to accelerate global drug development. With that deal, Amgen, widely recognized as an industry leader, has entrusted three commercial products and joint development of a deep pipeline of oncology products to Beijing. Secondly, we were looking for attractive financial terms that reflect the potential value of our hepatitis B product portfolio, which we believe we have achieved. And Tom will go over those details in a few minutes. Finally, we were looking for a partner with good chemistry with assemblies, business philosophy and teams. From our first discussion at the highest level of the companies many months ago, it was clear that we were aligned, both at the executive levels as well as across the working team. We share a view about the importance of treating patients with this disease in China and the need for new treatment options. Through the diligence process also, Beijing showed us that they are clearly a world-class organisation, from the leadership again and from top to bottom across the organisation and in China also. Already we have seen great synergies and alignment between our company's research, development, manufacturing and corporate teams. Together, we share that commitment to executing a critical mission to deliver not only a chronic suppressive therapy, but also a potential finite duration therapy as we drive towards a cure for patients with chronic hepatitis B infection. Now that we've signed the agreement, what are we focused on next? Our key priority is advancing the development of our lead core inhibitor 731. We continue to conduct study 211 our ongoing Phase 2 open-label extension trial. As we have talked about previously, we are beginning to transition patients off combination therapy with 731 and standard of care nuke therapy to then monitor them for sustained virologic response, or SVR. For China specifically, we are in the end of Phase 2 meeting processes with China regulatory authorities. We hope to incorporate data and our learnings from Study 211 into the design of our future Phase 3 programs in China and globally. We believe we could potentially initiate registration studies in China for 731 as early as the first quarter of 2021 next year. We plan to share more details around our Phase 3 plans after we complete discussions with the regulators. So stay tuned for more on this, please. For our next generation, more potent core inhibitor 2158, we have initiated a randomized placebo-controlled phase two trial that will evaluate 2158 with nuke versus placebo with nuke in approximately 80 treatment-naive patients who are e-antigen positive chronic hepatitis B infection without cirrhosis. In phase 1b, 2158 was well-tolerated and demonstrated potent antiviral activity at the 300 milligram dose, the dose we will study in phase two. And for our third core inhibitor, 3733, we are conducting a phase one trial in healthy volunteers. I'll now turn the call over to Tom.