Finch Therapeutics Group, Inc.

Good morning and welcome to the Finch Therapeutics Corporate Update conference call. At this time, all participants are on a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star followed by 1 on your touchtone telephone. If anyone has difficulty hearing the conference call, please press star 0 for operator assistance. I would now like to turn the conference call over to Stephen Jasper of Gilmartin Group. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining today's call. As a reminder, this call is being recorded, and the replay will be available later today on the Investors & News section of the Finch Therapeutics website at www.finchtherapeutics.com. This morning, Finch issued a press release providing a corporate update as well as financial results for the first quarter of 2022. You may access the release under the Investors & News section of the Finch website. On today's call, I'll be joined by Dr. Mark Smith, Chief Executive Officer of Finch, and Dr. Howard Franklin, our newly appointed Interim Chief Medical Officer. Dr. Smith and Dr. Franklin will be providing updates regarding Finch's development programs and other business highlights. Joe Battiglio, Chief Business and Legal Officer, and Mark Blaustein, Chief Operating Officer and Principal Financial Officer, will be available for the question and answer session following today's remarks. Before we begin, I'd like to remind everyone that various remarks made about companies' future expectations, plans, and prospects constitute forward-looking statements. We will discuss Finch's expectations regarding its clinical development programs, platform, and runway. These forward-looking views are subject to risks and uncertainties, and our actual results could differ materially from the views expressed today. These risks and uncertainties include those described in the earnings release we furnished to the SEC on Form 8K, our annual report on Form 10K, and our other filings with the SEC. These forward-looking statements speak only as of today's date, and we undertake no obligation to update or revise any of these statements. I'll now turn the call over to Finch's CEO, Dr. Mark Smith. Mark.

Thank you, Steven, and thank you to everyone for joining the call this morning. Following the resolution of the clinical hold on our IND for CP101, we are excited to take this opportunity to provide updates on our development programs. On today's call, we will briefly review our strategy here at Finch and then discuss the next steps for our CP101 program in recurrent C. difficile infection, or CDI, and the next steps for our FIN211 program in autism spectrum disorder, or ASD, At the conclusion of our prepared remarks, we'll open up the floor to questions where I will be joined by Howard, Joe, and Mark from our executive team. Moving down to slide four, before I dive into the updates, I thought it would be helpful to remind everyone about the platform that we're building here at Finch and share broader context on how we think about this new modality. The microbiome consists of a community of tens of trillions of bacteria that live on and inside of us. and are responsible for many aspects of human health, ranging from modulation of our immune system to shaping our metabolism and even the production of key neurotransmitters. What is fascinating to me is that while we're all born with roughly 20,000 genes that we get from our parents, we have nearly 20 million that we get from our microbiome. We see the microbiome as a new organ system that comprises the majority of our genetic repertoire, and at Finch, We're focused on developing tools to engineer the microbiome to transform human health. Moving to slide five, our human first discovery platform is designed to enable capital efficient data generation to support our development programs. Our approach starts with clinical proof of concept data. There are more than 300 registered clinical trials right now exploring microbiota transplantation across a number of academic centers around the world. This research spans a diverse range of therapeutic areas, And we've established strong partnerships with many of the largest providers of microbiota transplantation in the world that enable us to use clinical data to evaluate new opportunities for engineering the microbiome before we make significant investments in a new program. As the field continues to mature and our collaborators generate ever more clinical data, we feel this approach which is the first stage of our human-first discovery process, will continue to differentiate Finch and provide us with capital-efficient entry points into new therapeutic areas. We believe having proof-of-concept clinical data before we initiate development is a key advantage to our approach, and we see it as a necessary but not sufficient step before we initiate a new program. The second element that we look for is having mechanistic insights, To gain these, we mine clinical data to identify the specific microbes and metabolic pathways that are driving the promising outcomes we see in early proof-of-concept studies. Once we have met both of these criteria with clinical data and mechanistic insights in hand, that's when we deploy our product development platform, which I will review in more detail on slide 6. Our product development platform is designed to enable us to tailor our products based on what we learn from the clinical data and our mechanistic insights, providing everything from full microbial ecosystems down to individual microbes. With our complete consortia product candidates, we have the ability to deliver entire intact microbial communities derived from rigorously screened healthy human donors. On the other end of the spectrum, our targeted consortia product candidates deliver individual organisms grown in pure culture from master cell banks. And then we have a third approach, our enriched consortia product strategy, which combines the first two approaches. For enriched consortia products, we use a complete consortia scaffold and then add individual strains that hit specific pathways of interest on top of that scaffold. All of these product candidates are orally administered And because we are able to deliver full communities, we can let the biology guide our development, rather than being limited by our technology to delivering narrow subsets of the microbiome. We believe that our ability to tap large clinical datasets, mine them for mechanistic insights, and then translate them into differentiated products uniquely positions Finch to lead the next chapter of this field as we look to build on our promising clinical data in CDI and bring this emerging modality into the many conditions that are closely linked to the microbiome. Slide seven shows how we are executing against our strategy to first demonstrate the power of our platform in CDI and then extend into new areas of significant unmet need that are linked to the microbiome through interventional clinical data. Our lead program in CDI is in phase three development And Howard will share more on the data we have generated to date and our plans for this program going forward in just a few moments. We also have a partnership with Takeda focused on inflammatory bowel diseases. We have handed off development responsibility for TAC524, the first product candidate to emerge from this collaboration with Takeda, and we are leading discovery efforts in FIN525 for Crohn's disease. Separately, we are also developing FIN211 for autism. focusing initially on the roughly one-third of autistic children that have significant GI symptoms. We see this as a transformational opportunity, and I'll provide additional detail on our plans for this program after Howard wraps up his discussion of CDI. Today, all of the programs we have prioritized for development target gastrointestinal effects as a component of their target product profile, a logical starting point given the physical proximity for our GI-targeted therapies and one which we hope to build on over time. I'll now turn it over to Howard to share more about our exciting work developing CP101 in recurrent CDI.