My name is Matthew Keller. I'm a VP in the equity research department. It's now my pleasure to introduce our next presenting company. With us today we have Seres Therapeutics, presenting for the company is President Matthew Henn. Matt, welcome. Thanks, Matt. Good afternoon, everyone. I'm Matt, as he said, I'm the President and Chief Scientific Officer of Seres, my colleagues, Marella Thorell, who's our Chief Financial Officer, and Kelly Brady, who's our Chief Operating Officer, probably will be joining us momentarily when they come from the next prior meeting. Let me just start by saying thanks to Matt and the whole H.C. Wainwright team for giving us the opportunity to touch base about our technology. I will be making forward-looking statements today, anything I talk about that's not a historical fact is forward-looking. Seres as a company has been really focused for over a decade trying to tap the therapeutic potential of microbes that live on and in the human body. Really, over the past 25 so years or so of research, we have really learned a tremendous amount about how vital microbes are to our general health and to disease. Seres has had a track record of success. We pioneered a totally novel drug technology, which is consortia of bacteria and using bacteria as drugs. We've had numerous successes, including the commercialization of VOWST, which was the first drug to be orally formulated that is a consortia of bacteria and go all the way to commercialization and licensure with the FDA. This drug achieved an 88% sustained clinical response for preventing recurrence of C. difficile, a therapy, a disease for which prior there really weren't solutions. We've continued to innovate as a company over the years, to date, we've achieved two breakthrough therapy designations, one for VOWST and one for our SER-155 program, which I'll talk about in just a minute. We are well-positioned, we feel now, to really truly deliver shareholder value as we move forward, because we have a phase II-ready asset, the SER-155 program, and we are on the cusp of reading out an immune-related enterocolitis program in the coming weeks. The company has built a platform that all of this is anchored on. This platform is our MbTx platform, which really goes from discovery all the way through to manufacturing, where manufacturing is at the level where it has delivered a commercialized product. As well, this includes a front end where we've now integrated large amounts of clinical and preclinical data sets, both of our owns and externally, and can now mine that data using both machine learning originally, but now more recently, we've rolled out a generative AI capability into this system to do drug optimization as well as to think about how we are designing clinical trials in the future to deliver success. What is our drug technology? Our technology is live biotherapeutics. These are drugs that are actual consortia of bacteria, and so there are multiple strains of bacteria that are orally formulated for delivery. As I've said, we've had successes here and focused the company really on a couple of different biological areas. One is the ability to decolonize and prevent the colonization of harmful bacteria in the gastrointestinal tract, and the second is really on epithelial barrier biology and the ability to maintain that barrier, which is vital to the health of an individual. Overall, our drugs to date have been well-tolerated. We've been in numerous different patient populations. In all those patient populations, including highly immunocompromised patients, we have had a placebo-like safety profile. I'll talk a little bit more about that in just a second. It obviously affords us the opportunity to think about this drug technology very broadly, as well as in combination therapy without adding additional toxicities. A little bit briefly about the epithelial barrier, 'cause some of you may not be as familiar with that. The epithelial barrier is a very important part of your gastrointestinal tract, and it gets compromised by various different insults. Chemotherapy is one example. When these compromises happen to the barrier, you lead to a situation where, one, bacteria that are in your gastrointestinal tract can translocate or move from the gut into the bloodstream, causing bloodstream infections, which is particularly harmful. As well, of course, you have the movement of various different inflammatory compounds and molecules, which create all kinds of downstream cascades. The key point I want you to learn here is that the barrier is tied to numerous diseases that span inflammatory and autoimmune diseases, as well as infection and even metabolic diseases. We have a technology we feel is uniquely positioned to target this upstream cause of many of these different diseases. Our pipeline is really centered on diseases associated with oncology patients, that can actually lead to mortality and the discontinuation of cancer therapies, as well as various inflammatory diseases. Our SER-155 program is now our lead asset since VOWST is now commercialized. SER-155 the program targets bloodstream infections in hematologic stem cell transplant patients, or you might hear me refer to this as allo-HSCT. Notably, this program is phase II-ready, and it following compelling phase Ib data. Importantly, we have an upcoming readout for an investigator-sponsored study in immune-related enterocolitis, which I'll talk about in just a little bit more in a second, and that readout is actually pending within weeks. These, both of these programs combined really represent multi-billion dollar opportunities addressing diseases in high-risk patients that are very costly to the healthcare system. In addition, we have early-stage programs where we are conducting IND-enabling studies, and those span various other infections, including antimicrobial-resistant infections and a program in inflammatory bowel disease. Seres' strategy is really focused to advance these novel biotherapeutics and address these unmet medical needs. Our priorities in the near term are first to partner our phase II-ready SER-155 program and achieve the program's interim study and interim analysis. Why is it important to get to this interim analysis? Again, we've been engaged with the agency. This drug, again, has breakthrough therapy designation, this interim analysis will enable key discussions with the FDA on potential paths forward for expedited development of this drug, as well as planning for indication expansion into other indications that we believe this drug is suitable. Secondly, we are focused on achieving clinical proof of concept for the immune checkpoint inhibitor-related enterocolitis program. Again, this is an investigator-sponsored study, coming with data soon. Positive data here would support the potential to treat one of the most significant immune-related adverse events experienced by the approximately 500,000 patients on ICI therapies worldwide. And lastly, we are looking to position our early-stage programs, in particular our IBD program, for clinical development. Let me transition to talking about our SER-155 allo-HSCT program. Sorry, jumped ahead. My apologies. That's what I just talked to you guys about. My apologies. Let me transition now to talking about our HSCT program specifically, again, a drug that's phase II-ready and has breakthrough therapy designation. Allo-HSCT patients are severely immunocompromised patients due to conditioning and treatment regimens. The patients have a high risk of bloodstream infections, and infections are the leading cause of death in these patients in the first 100 days, where most of the infections occur within 30 days post the conditioning regimen. Through day 100, infections account for about 7.5% of the mortality rate. The primary cause of these bloodstream infections in these patients is the movement of bacteria from the gastrointestinal tract through a compromised barrier into the bloodstream. As I've talked about before, this is an area that we've been very focused. I will note in this patient population, there has been an uptake of a procedure called post-transplant cyclophosphamide. In the case of this has been brought into this patient population rapidly to address acute graft versus host disease. There's actually been an unintended consequence of this new regimen in this patient population, where it's actually significantly increasing bloodstream infections. Where a recent study showed that it's increased these bloodstream infections from around 15% or so up to close to 45%-50%. Okay, based on our market research, and engagement with various KOLs, globally, I will simply say that bloodstream infections are rated as one of the most significant unmet medical needs in this patient population, and there's highly demand for a solution to this particular problem. Let me let you know that this program right now, as I've already noted, has breakthrough therapy. I'll talk a little bit about the efficacy in just a minute, and some of the key translational data that we have generated on this particular program to date. The data. Basically here, what you're looking at on the, on the left, you can see that in a phase Ib study, we saw a placebo-controlled study. We saw 77% reduction, relative risk reduction in bloodstream infections compared to placebo. Notably here, we also saw a trend towards reduction in febrile neutropenia. Moving to the, to the middle, this was associated as well with lower antibiotic use, which is important because antimicrobial resistance is a particular problem in this patient population. As well, we saw a significant reduction in hospital utilization. This middle panel is particularly important 'cause when you think about the data that's out there, a hematopoietic stem cell transplant patient that gets an infection will typically be derailed from their treatment and on average cost the hospital system about $242,000. We are addressing a very high cost challenge here. Lastly, on the far right, when something we were excited about coming out of this phase Ib study was the clinical translation data. Here what you're looking at is that we actually were able to clinically translate on the ability to actually protect the epithelial barrier, and this is the first clinical translation of this and as an anchor for us moving forward in multiple different disease areas. This program is, as I said, phase II ready, we have alignment with the FDA on the phase II study design, we also have all the clinical infrastructure in place as well as key manufacturing steps advanced. We believe this study with compelling safety and efficacy data would enable a discussion with the agency on potential expedited paths forward for approval. Additionally, we anticipate that data coming from this interim analysis will enable key decisions around indication expansion into both auto-HSCT as well as blood cancers. This is a sizable population to be targeting from this, given the cost to the healthcare system, and we believe there's a meaningful commercial opportunity in auto-HSCT in its own right. There are 40,000 allo-HSCTs performed annually with, as I noted earlier, with infections typically driving about $250K in higher cost of care. Further, we believe there's meaningful expansion of opportunities, as I noted, into autologous HSCT as well as these other bloodstream blood cancers, and the underlying mechanisms in these patients is similar. Let me transition quickly to our irAEs program. Again, this is a program that's an investigator-sponsored study being conducted in collaboration with Memorial Sloan Kettering with the readout coming in several weeks. What is irAEs? First, immune-related adverse events are occur in approximately 50% of the 500,000 patients receiving ICIs globally, and irAEs can be observed in up to 50% of these patients with rates varying based on cancer drug and treatment regimen. Moderate to severe irEC occurs in 25% of these patients, and it accounts for approximately 1/3 of deaths due to fatal immune-related adverse events. The challenge here with irEC is it takes patients off their cancer therapy. They typically have to stop ICI treatment, and the only treatment that exists to date for this is corticosteroids, which are immunosuppressive. Obviously, you don't want to put a cancer patient who's trying to get an immune therapy on an immunosuppressive because it can have an impact on disease. What we're seeking to do here is to prevent diarrhea and severe forms of it, as well as delay the onset or the use of immunosuppressive drugs. This is a barrier associated disease that's linked to similar etiology that I talked about before. One, basically, where we're trying to prevent the translocation of inflammatory stimuli and cytokine-based inflammation, as well as actually modulate T-cell populations to be more to drive immune homeostasis. Okay. Basically, the study that is on the cusp of reading out is a 15-subject open label study. We will be, of course, evaluating safety and tolerability, and we'll also assess the efficacy of SER-155 in patients with moderate to severe irEC. We'll be looking for resolution of diarrhea, which is the core symptom of severe diarrhea, which is this core symptom of irEC, as well as the avoidance of immunosuppressive drugs. In addition, we'll be looking at the drug's pharmacokinetics, both PK and PD coming out of this study as well. Notably, we anticipate that the results from this study will provide an additional independent validation of our ability to target and observe clinical translation of the epithelial barrier, which of course will give us confidence in many other diseases that we're considering moving into. It will also support and provide the key data to enable phase II study design, at, and position this program for partnership as well. As I noted, we have programs in inflammatory bowel disease. I'm not gonna have the time to talk about that today. I will point you all to our corporate deck and our website where you can see data from this program. Most importantly, recent advances through support from the Crohn's & Colitis Foundation, where we've had strong support over the past couple years to move this program forward because they see it as addressing a critical unmet need in the space. Additionally, we recently received a Poster of Distinction award for this program at the Digestive Disease Week conference, which is probably one of the major GI conferences globally. Just to recap and close up here, but before we open it up to some questions, Sorry, I gotta click ahead 'cause we don't have time for that. Whoop, sorry. There we go. Just to kind of wrap it up, you know, we are operationally focused on executing our I&I programs, and particularly the irEC program, as I said, with the readout coming, as well as moving our IBD program towards the clinic. We are pushing strongly to get a partnership for our SER-155 allo-HSCT program, which, as I said, is phase II-ready, and we will initiate that study once we secure funding. Lastly, we are continuing to progress securing and aggregating capital from various different sources that include partners as well as other avenues, and be happy to talk to all of you about that further. Thank you. Marella and Kelly are now here in person over there in the corner. Yes. We're gonna open it up for Q&A. Let me get the microphone. Is it working okay? Can you hear me now? All right, perfect. Would you guys like to come up? Can you talk about how Nestlé has done commercializing VOWST? You know, what's their price point, the size of their sales force, and how do their scripts look versus the other microbiome-based therapeutic the FDA approved? Yeah. Sure. As a rule of thumb, we don't speak on behalf of Nestlé and their commercialization of our drug 'cause at this point, they wholly own that product. Would you like to add anything, Marella? Yeah. We sold VOWST to Nestlé our remaining interest in it about two year. Thank you. No, no, I understand that. Okay. I just want to understand the ca-- you know, from a ca-. Yeah How's anybody been commercializing in this category? Yeah, sure. So- Sure Nestlé does have a sales force that is dedicated to VOWST as well as their other GI products. They don't disclose publicly sales of VOWST. We're not able to do that either. IMS data? Yeah. Yeah. The challenge with IMS data is how C. difficile is treated, so that data, unfortunately, is not very accurate. Any other questions from the audience? If not, I have a couple follow-ups, if you don't mind. Kind of related to that question that the gentleman just asked. You know, how has the success of VOWST at least back in the day, live biotherapeutics were very much more nascent, right? You've obviously come a long way last couple of years. We talked about VOWST. You know, how has that changed both, I guess, the perceptions around the technologies and your interactions with... Sure ...you know, partners, interested, you know, other parties as well? I think it's a great question. Thanks. Thanks, Matt. Look, I think the commercialization of VOWST has been a critical step for this field. It is the first approval and commercialization of a drug. It is commercially launched. It is being sold. It is being used. Unfortunately, we just can't comment on or have all the details on its trajectory. Basically, what I think is most important here really is that I think there's been a lot of cycles in the microbiome space and the ability to drug that. I think what VOWST really does is actually demonstrates that you can have a viable product in this space. That you can achieve regulatory licensure, et cetera. I think what the field has needed is really unpacking the core biology and the underlying mechanisms to demonstrate that we actually do understand what these drugs are doing. We do understand the mechanisms which they have. That's where Seres has been focused as a company moving forward, is actually doing that hard work to understand drug pharmacokinetics, pharmacodynamics, and the mechanisms. We only had a chance to touch on it lightly here. We have a deep set of data as well as publications that support we understand that mechanism. I think those are the data that are now enabling more meaningful discussions with potential partners around these particular programs. Add anything? You know, that's actually a perfect segue. For the sake of time, one additional follow-up question. You know, I think one of the big topics both this conference and the nation, probably a lot of these rooms, is AI, right? Yeah. You mentioned it briefly, but you have a platform that incorporates AI technology, right? The MbTx platform. Yep. I was wondering how our audience investors, others should think about that platform, that technology a s it propels your pipeline now, and I guess potentially. Sure in the future as well. It's a great question. Yeah, you know, I've been involved on the front end of technologies, genomic technologies, computational tools for over three decades. There's been numerous cycles. AI, and particularly generative AI, is undoubtedly an incredibly powerful technology, it is a tool. And that tool is only as good as the data that goes into it, and then the deployment of that data to essentially ask critical questions. At Seres, we've been establishing and setting up a platform that's been generating the type of data and the high-quality data that's needed to go into generative AI models to produce meaningful insights. We've rolled out an agentic AI system recently over our over our underlying preclinical and clinical databases, and I'd say it is actually truly starting to improve both how we can target and identify pathways that are targetable with our drugs, as well as is actually giving us pretty interesting insights in how to think about patient populations and how to stratify across our clinical trials. We are right now using it as a tool to continue to refine our mechanistic understandings of our drugs and where there might be potentials beyond our current program. I think it's a very powerful tool. We'll start to see a lot of great progress with. Yeah, definitely excited to see what comes next. Excuse me. I think we have to leave it there for now for the sake of time. One big Matt, Seres, and the entire team again for the presentation. Thank you again. Thanks. Yeah.