Hello, all, and welcome. My name is Fawzi Kawash, and I'm Associate at JPMorgan. It's my pleasure to introduce our speaker for today, Eric Shaff, President and CEO of Seres Therapeutics. With that, I'll hand it over to Eric to get us started. Good morning, everybody, thanks to JPMorgan for inviting us to present today. We're thrilled to be in person with those in the room as well as those joining us on the phone or online. After a couple of years of being virtual, it's terrific to be together. We think it's a great time to connect with you with the opportunity to talk about Seres and in some sense, what we've accomplished in 2022, but more importantly, what we think about in 2023. We think that 2023 will be an incredibly important year for Seres, for the microbiome space and really most importantly for patients. In any new treatment modality, in any new therapeutic modality, there can be hope, there can be the kind of aspiration of treating patients sometime in the future. We feel that we're at that moment now with SER-109 for recurrent C. diff, and we think that the time is now for the microbiome to really help patients and drive this space forward. Pleased to be here to connect and, at the end of the session, certainly will invite my colleagues up to talk about our work together in helping patients through the microbiome. Now, I will be making forward-looking statements in today's presentation, and I would encourage you, as usual, to review our safe harbor statements and risk factors included in our last 10-Q. Now, I always like to start with our mission, which is to transform the lives of patients worldwide with revolutionary microbiome therapeutics. As we look forward in 2023, I think it's important to start with where we started, right? Which is kind of an audacious or surprising notion of a what if question. What if we could use bacteria as therapy, right? There was this proof of maybe crude proof of concept through fecal transplants that you could potentially interdict into the health of a patient's microbiome and have an impact into serious diseases like recurrent C. diff infection. The founders of Seres took it further and they said, "You know, what if you could deliver therapy in a reliably safe and effective way? And what if you could do it under GMP manufactured conditions? What if you could do it under rigorous FDA oversight? Importantly, what if you could put it into oral presentation?" We know that the microbiome is essential to human health and, here we sit today, with our BLA accepted and in process with a PDUFA date of April 26th. This what if question that was considered over 10 years ago, we think is about to come to fruition with SER-109. My goal for today is to cover three important topics. The first is to talk about SER-109 and our intention and what we expect will soon be, we believe will soon be a reality to change the lives of patients broadly with a recurrent C. diff infection. The BLA is submitted, accepted. We have a PDUFA date of April 26th. The FDA has indicated to us that they don't expect us to require an ad com, and we continue the critical work with our partners at Nestlé Health Science to prepare the market for the launch of SER-109. Second is to continue a conversation that we have around our infection modality and the idea that through our platform, we can take learnings, capabilities, insights from SER-109 into adjacencies and infection where we think we can address unmet need. Next, after SER-109 is 155. We announced earlier this week that we had cleared a pre-planned DSMB that allows us to go into the second cohort. We expect to have initial safety and engraftment data for SER-155 early this year. Lastly, to update you on our work in IBD and specifically our 287 and 301 programs, where we're in the process of mining data-rich study results to better frame our path forward in UC as well as our platform. Speaking of platform and pipeline, this is the pipeline. It starts with SER-109 for recurrent C. diff infection. SER-109 is a program that has both breakthrough and orphan designation from the FDA. SER-109 is partnered with Nestlé Health Science globally, including a co-commercialization agreement to bring 109 to patients in the U.S. We continue to be incredibly excited about what we think will be a tipping point for the microbiome space, but also an opportunity to help patients and change the standard of care in recurrent C. diff. SER-155, currently in a 1B study for patients with GVHD and other infections. We talked about the DSMB. We think that 155 is really the next step in infections. Further in the infection space, we've talked about including an R&D event that we had about a year ago. Our actions in pointing our R&D engine into the areas of infections where like with 155, we think we can take capabilities to help patients in other areas, including in AMR, which we think is a growing problem. You've heard us speak about these efforts. I think you will continue to hear us talk about our interest in pursuing the pipeline and progressing the pipeline as we can drive value further for patients for the company. Let's start by digging deeper into 109 and we're excited about the prospect of helping patients with 109 in the launch because we're proud of the journey that has taken us here because we think that 109 will be the tipping point for microbiome therapeutics, but most of all, because we think that the profile of SER-109, the safety and the efficacy that's incumbent upon what we saw in our phase III results, really puts us in a position to change patients' lives for the better. We think that the opportunity to help patients with SER-109 is considerable. Just for background, C. diff is an urgent threat as designated by the CDC. It's estimated that over 20,000 people die each year in the U.S. from C. diff. This is a major healthcare issue. If you think about the nature of the disease, you understand that you're more likely to get C. diff once you've already had C. diff. Once you get into the recurrent patient segment, which is the group that we're looking to help with SER-109. It's an orphan disease, high unmet medical need. It's extremely costly to the system, and there are, we believe, inadequate solutions today for patients in this space. The study results from our phase III program were and are, we believe, remarkable. Approximately 88% sustained clinical response rate for those that were treated with SER-109 versus those with placebo. That's a 27% absolute delta in re-reduction of recurrence, which is a significant effect for these patients. Of course, a significantly greater relative delta. The results were statistically significant in our age stratified groups and a sustained clinical benefit over a significant period of time. The FDA has set for us a statistical bar by which we could potentially qualify for one single pivotal study from an efficacy perspective. As we have mentioned before, we believe we not only met but meaningfully exceeded that bar. In a field where there has been perhaps more speculation, historically than actual data as to how effective, unapproved procedures like FMT can be for patients, we think that these study results really set the bar. Just to support that, notable that our phase II results have been published in two top journals. The New England Journal of Medicine article, which came out roughly this time last year, additional data, including the durability of response published in JAMA, which we put out this past fall. I will say that we are incredibly proud of both of these papers, further, we're active with key stakeholders in Medical Affairs, and we're hearing more and more about the traction that these papers are actually getting with key providers in the field. Now, importantly, SER-109 showed a favorable safety profile in our phase III study. This profile is important compared to the safety profile, and safety concerns from potential contamination and viral transmission that's possible with FMT or FMT-like approaches that just rely on donor screening alone, which is inherently backwards-looking. We think that the differentiated efficacy for SER-109 sets the bar. Beyond that, we also strongly believe that our approach to safety, including our CMC process, which includes important pathogen inactivation and purification steps, is importantly differentiated as well. We think that is important to healthcare providers, we absolutely think that will be important to patients as well. We had, in addition to our ECOSPOR III study, what we call our ECOSPOR IV study. Following the efficacy that was demonstrated in ECOSPOR III, we designed the ECOSPOR IV study to fulfill the safety requirement that was set by the FDA. We announced these results earlier this year. The dimensions of the study were similar to ECOSPOR III, we did modify the program to include 2 First, is the inclusion of first recurrent subjects. We also modified the entry criteria to broaden a little bit. We were thrilled with the ECOSPOR IV results. We believe that the ECOSPOR IV results were confirmatory of the ECOSPOR III results, both in terms of safety and efficacy. As you can see, 91% clinical response, 94% in first recurrence. Of course, ECOSPOR IV was designed first as a safety study. Importantly, the combination of these two phase III studies really allowed us to move forward with the BLA. Where are we? The BLA was submitted at the end of the summer. It was accepted for priority or accelerated review. Critically important, upon the acceptance of the BLA, the FDA notified us that they did not expect that we would need an Ad Com. I can tell you that that was a tremendous win for us and for our team. We had a considerable amount of time that was deployed towards the preparation of that Ad Com and having that time freed up to deploy towards other activities has been great. The PDUFA set for April 26th, we're deep in our preparations for commercialization, which I'll just talk about in a minute. You know, in this journey of the what if question that was asked, you know, 10 years ago, it's incredibly exciting to me that we believe we'll be in a position soon to change patients' lives for the better and potentially change the practice of medicine with SER-109. Let's talk about the commercial opportunity with SER-109. I would mention that we held an investor event at the end of last year, which is available on our website. I encourage you to take a look at it, where we dug pretty deep into our assessment of the recurrent CDI market, as well as our preparations with our partners at Nestlé. We know that once you've had a recurrence of C. diff, you become a marked man or woman, you become a marked person to the risk of further recurrences, which escalates dramatically. Our market research and really every conversation that we've had with a healthcare provider maintains or confirms that the high unmet need exists in preventing recurrence of infection. The ability of SER-109 to meet that need, we believe allows us to potentially fundamentally transform the standard of care for patients. Once we are on the market, we believe that you know, healthcare physicians and providers will have an option that they simply just haven't had historically. Within this opportunity, we think that the profile is unique. The data that I presented is meaningfully differentiated. We think that based on the opportunity, the profile, the unmet need, we have the opportunity to create a significant amount of value for patients. The capabilities that we have been investing in for over a decade, combined with the strengths that we're leveraging from our partners at Nestlé Health Science, we believe put us in a position to really maximize the opportunity after a potential approval. Now, on the heels of the ECOSPOR III trial, we continued building out our marketing, our market access, and our Medical Affairs capabilities at Seres. We're also leveraging and accessing capabilities at our partners at Nestlé Health Science. For example, we deployed their payer field team last spring to begin our pre-approval information exchange with payers. Our market access capabilities across the two companies have extensive experience managing complex products through specialty pharmacies. We'll also be leveraging additional elements of Nestlé's GI Pharma commercial and medical infrastructure, including a highly experienced and tenured sales force of about 150 sales reps, covering more than 85% of GI practices to set up SER-109 for a successful launch. I'll note that we will also be standing up an additional sales team at Nestlé to cover the top volume hospitals, in addition to infectious disease specialists who tend to spend much of their time in hospitals. Between the two companies, we feel we have proven capabilities, and we will continue to work together to bring SER-109 to patients. In summary, from the commercial lens towards things, we will continue to take a very deliberate stepwise approach to gaining our foothold and then broadening that over time. Here on the slide, you can see our activities, both in the shorter and the longer term, that we think will help us focus during a launch period and after, creating broad market and patient access, and a positive experience for those that take SER-109 is critically important, mission critical for us within the space. We are well aware that we have an innovative medicine that really could fundamentally transform care over time for a patient population that is really in desperate need of a better option. We'll start with areas where we're primed for early use, and then we will grow as we continue to launch the product. Now lastly, before I move on, I just wanna note, at least in my opinion, one of the more chronically underappreciated aspects of being successful in a new area really relates to manufacturing. We've been investing in manufacturing really since the company's inception. We recently announced a significant collaboration with Bacthera, which is a global leader in biopharmaceutical product manufacturing, that further increases our long-term commercial product supply. Bacthera is a joint venture between Lonza and Chr. Hansen. They are building a dedicated facility for Seres, in their flagship site in Visp, Switzerland. Following this agreement, combined with our existing relationship with Recipharm, we look forward to partnering with Bacthera to expand upon our existing production capacity, which we expect will be well suited to support our launch and ensure that eligible patients can receive this potential new treatment option going forward. Incredibly excited about the opportunity that we have with SER-109, continuing to make progress through the BLA cycle. Looking forward to the PDUFA of April 26th, after an incredible journey, just excited about changing patients' lives with SER-109. As I mentioned towards the beginning of the presentation, one of the themes that you will also hear from us this year is the idea of harnessing our R&D engine to maximize our opportunity in addressing unmet need. When I say harnessing, what I mean is we know that the microbiome has an extraordinary breadth of potential application. As a company, we also think about focus, right? Focus on not only where we've had success, but where we've had really an incredible data result with SER-109 and an opportunity. The opportunity to explore adjacencies from C. diff or from SER-109, where, as I said before, we bring capabilities and insights and tools, and ultimately a proven mechanism to help patients, we believe, with a higher probability of success. We have been and will continue to be pointing our research engine into areas where we can leverage these factors to help patients and support the company. Just for background, Seres has built really a leading research engine and platform capabilities that allow us to delineate at high resolution the mechanism of action, the PK/PD, what we term are the engraftment of our drugs, and importantly, to learn from our clinical studies and apply those learnings to future development efforts and applications. We feel we've made incredible progress in preclinical models, but the best way of actually testing what works in the human microbiome is in the human microbiome. As an example of this, on the left, we're showing that treatment with SER-109 can lead to a significant onboarding of bacteria in our drug, leading to a restructuring of a patient's GI microbiome. This restructuring is also associated with shifting the functional metabolic landscape of the GI tract. Why is this important? If you look on the right side of the slide, we're also showing that treatment with SER-109 can also reduce the total abundance of other pathogenic bacteria, and notably, other pathogens that are associated with antibiotic resistance. We're building upon the success of SER-109 by constructing candidates to prevent other infections. Our platform allows us at high resolution to deconvolute or disentangle the bacterial landscape and the mechanism of our drugs and apply those learnings into new diseases. Further to that, we think that antimicrobial resistance really is a major healthcare threat, resulting in mortality and significant increases in healthcare costs. With the urgent threat of the pan-pandemic, we've seen really remarkable innovation, of course, in the area of vaccines and therapeutics, while this threat, the AMR threat, continues to accelerate. It has been said that the kind of the silent pandemic, I think it's actually becoming less silent over time, there's been more focus on it, but there actually has been limited innovation to prevent these types of infections. The mechanisms that SER-109 uses to prevent recurrent C. diff infections actually have the promise to prevent a broader spectrum of infections. These are particularly important and relevant and needed in patient populations at greater risk. Think of hospitalized patients, people with suppressed or compromised immune systems, people with chronic diseases that may struggle to fight off infections. Based on our oral formulation, we think we have an advantage of bringing potential therapies to patient populations broadly in areas of need. Let's talk about 155. As I noted in the prior slide, allogeneic stem cell recipients face major risks from infections. They can have highly disrupted microbiomes. Data connects these disruptions to increased mortality due to bloodstream infections and GVHD. We have data that suggests that a decreased presence of commensal bacterial species can be associated with positive outcomes. Leveraging data from our partners, our clinical studies, our preclinical assays, we've designed SER-155 to target multiple disease-relevant pathways, including two of particular importance. One is the direct decolonization of VRE and CRE, and the second is the prevention of translocation of VRE and CRE from the gut that can result in bloodstream infections. We think that leveraging both of these pathways is actually reasonably unique, and we're excited about this early study. As I said before, we had a positive result from a pre-planned DSMB at the end of last year. We expect to release early safety and engraftment data in 2023, early 2023. If you think about infection, we start with SER-109. We've got the phase 1B study for 155 to assess safety and engraftment of the bacteria and also to understand if there are signals of reduced bloodstream infections with GVHD. We think that 155 is just one of many opportunities in infection, as I outlined here on this slide. As I mentioned before, we conducted an R&D day to highlight our strategy. I would encourage you to review the scientific foundation of our excitement in this space, the unmet need in the space, the commercial opportunity, and of course, additional detail in our research efforts. As we think about 2023, we think that Seres is in an incredibly strong position to extend our leadership in microbiome therapeutics. 2022 was a highly progressive, important substantive year for us and for our patients. The BLA was complete. It was submitted. The potential to be the first in class microbiome therapeutic with a considerable opportunity to help patients. We build upon the success of SER-109 with SER-155. The balance sheet is in a strong position, cash of approximately $233 million as of the end of September. I would remind you that we are eligible for $125 million milestone from Nestlé upon the approval and launch of SER-109. I started this presentation by talking about the what if question that was asked so many years ago, and I would say that the team and I continue to ask those questions, right? The big one for us is, what if SER-109 is really just the beginning of this story, right? What if the ability to help patients through microbiome therapeutics starts with C. diff infection, but by no means ends with C. diff infection? I think you will hear from us going forward, progress as we think about the launch of SER-109, proving to the world that microbiome therapeutics are here now and the ability to leverage into other areas, to help patients in need. Again, wanna thank JPMorgan for having us here today. The team and I are thrilled to answer your questions. We've got Dave Ege, our head of manufacturing, Teri, our chief commercial strategy officer, David, our chief financial officer, and Matt, our CSO. Thanks again and happy to take questions. Well, thanks very much, Eric. I'll start us off with a few questions, then we'll go to the floor for any further questions. There'll be a mic going around. Firstly, can you provide a little more detail on the 109 commercial opportunity and also the commercial readiness? Sure. This is an area where there have been inadequate solutions in this space, and it's somewhat ironic that the standard of care for treating patients has been antibiotics. Antibiotics can could be very effective in killing all organisms. Following antibiotic therapy, there is what we call a race to repair. Either a patient will repair or reconstitute their microbiome or C. diff will infiltrate and which can lead to a recurrence. Physicians have to this point been incredibly limited as to what tools they have at their disposal to treat patients. We know that once you're in the recurrent patient segment, the time to recurrence can be very short. If a patient recurs, they know that they're in this fork of the road, and they're going the wrong way. Maybe I can ask Teri to comment further on our preparations in capitalizing on this opportunity and, in serving patients. Sure. Well, you know, to build on the opportunity commentary, Eric, you mentioned the tools that physicians have. I think about tools to do what, right? That, that's where the unmet need lies in the category. It's the tool that they're lacking is the tool to make this infection stay away. They have a tool to make it go away. They don't have a tool to make it stay away. That is the number one unmet need in the category. SER-109 with the results that Eric walked you guys through just now in terms of our efficacy, safety, and oral administration, meets this unmet need in a unique way, in an enormous magnitude. You have the almost 90% efficacy rate and then the durability out through six months. We feel like we really hit the sweet spot of the unmet need in the category. Once approved, we are absolutely an appropriate foundational therapy for all 156,000 cases in the U.S. that we estimate will occur this year. With respect to commercial readiness, we have been getting ready for launch since I joined the company two and a half years ago and even before that. Even on the back of the ECOSPOR III data receipt in 2020, we stood up and scaled our Medical Affairs teams. We put in place an MSL team in the field, medical science liaison team, to call on KOLs and large academic centers. One of the real advantages of our partnerships with Nestlé is that we can leverage capabilities that they have in place that are fully operational today to support their inline products. Proven capabilities. We don't have to build these from scratch. We don't have to hire new people. These people are in place now, including the 150 sales representatives that are calling on gastroenterology offices. I feel like we are absolutely on track and on plan with our launch readiness and, you know, with proven talent on the Nestlé side. Got it. Maybe you can comment further on your manufacturing approach and your supply capacity. Well, let me start by saying, I think I made the comment during the presentation that manufacturing tends to be underappreciated. We've been investing in capabilities for over a decade because they simply didn't exist. When the company was founded and we talked about bringing spores into a manufacturing biopharma network. Usually people wanna get spores as far away from their plants as humanly possible. By necessity, we built, over the period of a decade, a great deal of know-how, which we think is proprietary to Seres and really sets us up for success in the long term. Maybe I can ask David to comment further. Sure. I maybe make two key points. One about the product that's differentiating from others in the field, and that is that our product is highly purified from acute spores, as was highlighted by Eric in the presentation. We have both that and specific inactivation processes in our manufacturing process that ensure the safety and efficacy of our drug. As far as commercial readiness for manufacturing, we have a combination of in-house assets and our manufacturing partners that Eric talked about. These are the same assets, the same staff and capital equipment that we used for Phase 3. We did not have to scale to get to launch. Again, as Eric mentioned, we're growing that through the partnership with Bacthera to meet the upside demand that we see in the coming years. We feel really, really good about where we are for launch in terms of launch supplies and meeting the demand that Teri and the Nestlé team are going after. Great. Maybe switching to SER-155. Can you talk a little bit about what you're thinking about the overall market opportunity there? Sure. Maybe I can ask Teri to comment and maybe Matt as well. Sure. With 155 and our infection protection franchise, because you know, on our final slide, Eric did reference additional candidates that we may be bringing into the clinic. This could be an entire franchise, but this is a franchise that's really built on the success that we've seen with 109. You know, with 109, we've determined and proven that we can go after microbiome restoration with a goal of preventing bacterial bad actors and containing bacterial bad actors in the gut and preventing them from causing damage and causing infection. With 155, the goal in the trial is to prove that we can do that yet again in a medically compromised, highly vulnerable patient population, in this case, stem cell transplant recipients. We estimate there are about 9,000 of these procedures annually in the U.S. This again, is just the next step into our infection protection vertical. There are other medically compromised, highly vulnerable populations that we plan to go after, cirrhosis patients, other patients receiving transplants. This is an interesting way for us to help patients. We think that the approach that we're taking is uniquely, you know, just can uniquely meet the unmet need across many disease states. Maybe my final question, what data do you plan to report with your 155 readout in early 2023? What would you like to see? Yeah. So it's a 1B study. We talked about clearing the DSMB at the end of last year. Maybe I can ask Matt to talk about what we are looking for. You know, as we progress in our clinical studies, of course, there's the clinical results, but there's also the microbiome analysis that we think provides a rich data set that we use across our platform. Maybe Matt can comment further on that. Sure. Seres from its inception has been a data-driven company. As Eric noted, in his presentation, we've been really building a research engine at the company to look at high resolution into how changes in the microbiome impact different microbes and how they interact with human cells and tissues, and we continue to build on that. What we have with 155 and the strong proof of concept coming out of SER-109 is strong knowledge about how bacteria in our drugs can both inhibit and decolonize particular pathogens in the gastrointestinal tract and the mechanisms by which they do that. As well as importantly, we've designed these drugs to be able to look at the epithelial barrier and protect the epithelium and restore epithelial damage, which is often the case in these patients who have a highly disruptive microbiome. As a result of that, we have the potential to bring novel mechanisms to a major public health threat. That, as Teri pointed out earlier and Eric talked about, applies to a very broad swath of patient populations. As example, in allo-HSCT patients, keep in mind, we have about 20% mortality in that patient population due to the onset of bloodstream infections, and we've got a drug that can both decrease the pathogens in the gastrointestinal tract, as well as prevent translocation events into the gut. The data that we will be looking at coming out of cohort one, is looking at pathogen reduction, and incidents of bloodstream infections and of course, the safety profile of the drug, which as Eric noted, based on our Data Safety Monitoring Committee, we had a favorable profile to date Great. Maybe I'll open up to the floor now. Mic's coming around. We have one question over there. I'll try to start. I guess you mentioned, hey, what if we're just scratching the surface? You know, it's an interesting point because there's a lot of interesting, like, you know, kind of pseudoscience, but anecdotal evidence of, you know, dietary interventions that are aimed at sort of restoring the microbiome. There's a lot of anecdotal evidence that it does seem to work and, you know, particularly at a big market of broad autoimmune disease. How do you think about that? I mean, that obviously would be an enormous market. If we look at the biologics that are kinda just, you know, treating not really getting to the root causes as much. It's a big market. It's a very uncharted territory. How do you try to attack studying that and kinda going beyond to that much bigger picture? Yeah, thanks for the question. Let me start, and I'll ask Matt to comment as well. I think I highlighted in the presentation, we think about the breadth of opportunity and focus at the same time. I can tell you that our priority as a team is ensuring that we are maximizing our chances of success with SER-109. We think that the ability to really drive value with 109 earns us the right to think more broadly about the next steps along the path. We are maniacally focused on doing the best job that we can to ensure that we're moving forward with SER-109. At the same time, we are absolutely believers, and there is simply too much evidence to suggest that the role of the microbiome in human health isn't incredibly broad. We believe in metabolic disease and the opportunities, and that we believe in inflammatory disease. We believe in the gut-brain axis. As we think about a smaller company charting a path forward and doing so with the highest probability of success, our intent is to take stepwise progress into additional layers of complexity. Everyone said, "Hey, C. diff is easy." I can tell you, having been there is nothing easy about C. diff. As you know about the path that we've taken with a successful phase II, a disappointing phase III, a disappointing phase II, and then a remarkably successful phase III, this is complicated. At the same time, we are incredibly proud of how we addressed the surprising phase II results, where we took a rigorous, objective, scientific approach in thinking about changes that could enhance our probability of success, and it turned out that we were right. We think that's a model that we can take to other areas of additional complexity in the future. Maybe I can ask Matt to comment further. I mean, I think Eric hit on the key points, but what I'll emphasize is the systematic approach. Seres at its heart is a platform company, and we have been putting in place a reverse translational platform in which we can look at high resolution in human subjects, how and find these key associations that you hear about a lot in literature. That's just the first step. We've also done is built the back-end, non-clinical, preclinical capabilities to actually get to causality and be able to link specific microbes with specific functional pathways and understand that complexity space, and importantly, evaluate what happens when you apply an intervention. Where we're at as a company is very exciting because now we have large clinical datasets that are translationally rich in which we've invested significant money around biomarkers and additional data, and we have the models and assays now to test those hypotheses. I think we're sitting at that sweet spot as a company to actually start to, as Eric said, one, go as rapidly as we can in that infection expansion space, where I think there's clear, very strong proof of concept, as well as move into these other modalities, where we have the tools now to be able to get the insights we need to actually design the drugs. Yeah. A quick question. This is actually moving, looking at 2025 and looking at your pipeline. When you start looking at immunomodulation, versus infectious disease inhibition, preventing proliferation of pathogenic DNA, could you kind of talk through a little bit, the mechanisms of action of actually immunomodulation using microbial consortia and how that has an impact on oncology? Unless that's not how you're thinking about oncology, could you kinda just go through that a little bit? Sure. Matt, do you wanna start? Yeah. If you've got about 2 hours, we could have a nice long conversation. But nonetheless, briefly, it is well known from the literature as well as our own datasets that microbes can actually interact directly with particularly the epithelial barrier in the gastrointestinal tract and have an important impact on multiple inflammatory pathways. Where we are at as a company is we've actually started to learn specifically which immunological pathways are triggered and/or modulated by the microbes. When I say by the microbes, what we do is we actually look at the various metabolites and peptides that are generated by these various different microbes and then how they interact specific with these mechanisms. I'll just give you one example of this. For example, one of the biggest issues in patients who have inflammation is a highly disrupted epithelial barrier, which is highly inflamed and becomes permeable, right? We have data now that support both preclinically and clinically, based on gene transcription data, that we can increase the upregulation of occludin genes in the epithelial barrier. Those of you who don't know what occludin genes are, those are the genes that actually control tight junctions in the epithelial barrier. We are finding these kinds of insights and getting down to those specific mechanisms. We know we can modulate Tregs, we know we can modulate Th17 and do that directly by the microbes. We can actually now have the models to be able to show and show consortia that can do that, as well as design consortia that cannot do that. That becomes a very powerful set of tools, to really unlock what is a complex space. I think a final question. More in the minutiae. Assuming approval, can you just walk through at the payer level in the hospitals, what you're gonna need to accomplish before you can start, you know, getting the drug reimbursed? I know in the hospital setting, I'm not sure if it's mostly outpatient, inpatient, all of those, I won't call them barriers, but. Yeah. things you're gonna have to deal with. Yeah, thanks for the question. Obviously things that we've thought about, worked on, and maybe Terri can comment further. Sure. In the hospital setting, site of care, if you will, the patient segment we're most interested in, excuse me, is the one we're calling hospital to home. It's the vast majority of patients who go into the hospital will actually be discharged in the middle of their vancomycin regimen. We actually last quarter hired a hospital sales team of 20 that we will be deploying this quarter to profile the largest institutions that have the most robust patient volume for recurrent C. diff. In those institutions pre-launch, they'll be mapping the patient pathway, excuse me, understanding what physicians are active in writing prescriptions and mapping these patients. Okay. Sorry. I think that covers the first part of that. I'm the We do believe that this will be largely outpatient. Vancomycin and other antibiotics are very effective in knocking back the infection. The vision is that a patient is released from the hospital with a specialty pharmacy. There's a high touch process by which SER-109 is delivered to their house, as an example. You know, we aren't concerned about the DRG side of things, as an example, if that's the base of the question. Those plans are in process and moving towards finalization with our partners at Nestlé. Well, it looks like we're out of time. Thanks very much, Eric and team. It's a pleasure to have you at JPM. Thank you. Thank you.