Good day and thank you for standing by. Welcome to the Seres Therapeutics Third Quarter Earnings Conference Call. At this time, all participants are in a listen -only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today. Dr. Carlo Tanzi, Investor Relations, please go ahead.

Thank you and good morning. Our press release with the company's Third Quarter 2021 financial results and a business update became available at 7 AM Eastern Time this morning and can be found on the Investors and News sections of the company's website. I would like to remind you that we will be making forward-looking statements relating to the timing, enrollment, and results of our clinical studies. The anticipated safety profile of our products, regulatory approval, the success of our agreement with the health science, the anticipated market for [Indiscernible] 109, and the promise and potential impact of any of our microbiome therapeutics. Actual results may differ materially. Additionally, these statements are subject to certain risks and uncertainties which are discussed under the Risk Factor section of our recent SEC filings. Any forward-looking statements made on today's call represent our views as of today only. We may update these statements in the future but we disclaim any obligation to do so. On today's call with prepared remarks, I am joined by our President and Chief Executive Officer, Eric Shaff, doctor Lisa von Moltke, our Chief Medical Officer. David Arkowitz, our Chief Financial Officer. And Matt Matthew Henn, our Chief Scientific Officer. During the Q&A portion of the call, we will also be joined by Dr. Terri Young, our Chief Commercial and Strategy Officer, and Dr. David Arkowitz, our Chief Technology Officer. And with that, I'll pass the call to Eric.

Thank you, Carlo and good morning, everyone. The last several months have been a productive period for Seres where we have meaningfully advanced our microbiome therapeutic pipeline. Our key recent highlight include the completion of enrollment in our open-label SER-109 study. The [Indiscernible] advancement of this program towards the BLA filing for recurrent [Indiscernible] infection and actions we have taken to prepare for a successful product launch. We believe that SER-109 has the potential to become the first ever FDA approved microbiome therapeutic therapeutic. And important milestone for this emerging class of medicines. We have also continued to perform microbiome data analysis following. And our 87 Phase 2b clinical results in [Indiscernible] colitis announced earlier this summer. Our expectation is to communicate those results before the end of this year. To remind you of the development progress of SER-109, during the summer of 2020, we announced successful phase 3 study results in patients with multiply recurrent C difficile infection. These efficacy data surpassed statistical thresholds that had been communicated to us by the FDA. And as a result, we expect the data of this study to provide the efficacy data in support of a BLA filing. The FDA had also communicated that our BLA filing should include a safety database of at least 300 subjects dosed at the Phase III dose and with a 24-week follow-up. Following the Phase III results, we enrolled an open-label study to gather the required safety David, to support this filing. Notably, and following discussion with the FDA, are CAR-109 open-label study also includes patients with a first recurrence of C-difficile. section and expanded patient group compared to the Phase III study population, which included patients with multiply recurrent CDI. In September. We were pleased to have achieved target enrollment with our open-label study of…

Thanks, Eric. Our SER-109 Phase three study was a data rich trial. And since obtaining the initial top-line results in July of 2020, we have presented various datasets at a number of prominent conferences that are well attended by leading infectious diseases physicians, and gastroenterologists. Last month, we presented at both ID Week and at the American College of Gastroenterology Annual Meeting. In total, we presented 8 posters and 1 oral presentation. In addition, at ID Week, we sponsored a talk led by Dr. Paul [Indiscernible] a leading academic expert in the CDI field on the disease, pathogenesis and the potential role for microbiome therapeutics. At the meeting, we presented data from our lead SER-109 program, as well as on our earlier stage, SER-155 program. I would like to highlight some of the key results recently presented. Data from an exploratory analysis presented at the ACG Meeting in a late breaker poster session, demonstrated that SER-109 reduced the risk of recurrent CDI compared to placebo, including in-patients with significant risk factors for recurrence. This includes those taking acid-reducing medications such as proton pump inhibitors and H2 blockers representing approximately 40% of our patients in our Phase 3 study. Importantly, SER-109 showed broad efficacy in the Phase 3 study, including in the these patients known to be at higher risk of recurrence. As expected, given the demographics of CDI, more than half of the study population in our Phase 3 study had at least one co-morbidity, including diabetes, cardiac disease, and malignancy. It was reassuring to see that SER-109 results in high levels of efficacy, including in the higher-risk patient groups. At ID Week, in a late-breaker oral presentation, we presented results showing that SER-109 reduces the abundance of antimicrobial resistance genes. In the GI tract in patients with recurrent CDI.…

Thank you, Lisa and good morning. I'll begin with SER-155. SER-155 is an orally dose rationally designed, cultivated microbiome therapeutic candidate designed to decrease the instance of gastrointestinal infections, bacteremia, and graft versus host disease in immunocompromised patients, receiving allogeneic stem cell transplantation. SER-155 is designed to prevent both bacterial bloodstream infections, particularly those that harbor antibiotic resistant genes, as well as to modulate post immunity to reduce the onset of graft versus host disease. Prior published studies by our collaborators at Memorial Sloan Kettering Cancer Center, indicate that HSCT patients with a disrupted low diversity microbiome are at substantially increased risk for bacterial infection including antibiotic-resistant infection and poor clinical outcomes. At the recent ID Week Conference, in an oral presentation, we highlighted preclinical data showing that SER-155 can decolonize patient isolated antibiotic-resistant pathogen including vancomycin -resistant enterococci and carbapenem -resistant Enterobacteriaceae, such as Enterococcus faecium and Klebsiella pneumonia, which are notable escape pathogens. The continued emergence of antibiotic resistant bacterial infection is a top global health priority identified as such by both the World Health Organization and centers for disease control with significant clinical implications, particularly in immuno -compromised patients. Prior studies published by our collaborators at MSK indicate that HSCT patients with the disruptive low diversity microbiome on a substantially increased risk of bacterial infections, including antibiotic resistant, resistant infections and poor clinical outcomes. Based on these observations, in our clinical programs and our preclinical data supporting SER -155 mechanisms of action. We believe SER-155 has the potential to reduce the risk of infection in individuals with compromised immune systems. IND for SER-155 was cleared by the FDA and we are in the late stages of prepping the dose our first patient in the SER-155 Phase 1b study in collaboration with MSK and the University of Chicago.…

Thank you, Matt, and good morning. The details of our quarterly financials are included in this morning's press release. So I won't reiterate them here. Series ended the third quarter of 2021 with approximately $353 million in cash, cash equivalents and marketable securities. The September 30, 2021 cash balance includes the upfront fee of $175 million that Seres received in July following the SER-109 co-commercialization agreement announced on July 1, 2021, Nestle Health Science. I would just remind you all of the deal terms and exchange for CO-109 commercialization rights in North America. Nestle Health Science provides series with an upfront payment of a $175 million series will also receive an additional 125 million upon FDA approval of SER-109 SG and a $10 million payment upon Canadian regulatory approval. Furthermore, the agreement includes meaningful sales milestones, which if achieved, total up to 225 million. In summary, the aggregate value of the potential approval and sales milestones totals $360 million upon commercialization of SER-109. Series will be entitled to an amount equal to 50% of commercial profits. We're very pleased with the collaboration, which is financially attractive for series and provide series with bulk near-term value and substantial longer-term value. We continue to work very closely with EMEA, that division within Nastle responsible for this effort in preparing for the launch of SER-109. And as part of the agreement series is funding all prelaunch commercialization and medical affairs expenses up until launch. As I've mentioned, once SER-109 is commercialized, the profits will be split 50-50. Immune has developed a highly effective pharmaceutical business, including a sizable GI, sales force and top-notch marketing team. And we believe that their commercial capabilities will help ensure a successful launch as well as provide meaningful efficiencies related to SER-109 commercialization. Want to point out that…

Thanks, David. I will conclude our remarks by recapping the progress we have made across our microbiome therapeutic pipeline and key important milestones that we are looking forward to during the remainder of this year and into 2022. This include our achievement of over 300 subjects enrolled in our CAR-109 open-label study, and our preparations for [Indiscernible] filing in the middle of next year. Continued progress executed on CAR-109, commercial readiness, working closely with Nestle, including an expanded market. The efforts the initiation SER-109 of expanded access program. The expansion of our longer-term commercial supply capabilities and capacity, including our recent collaboration with Taxera. Completion of our CO-287 study data analysis, and continued progress with SER-155 and SER-301 earlier stage programs. Our organization continues to strengthen our microbiome research platform and preclinical efforts. In the coming year, we expect to advance our microbiome therapeutic candidates forward. We plan to focus on areas such infectious disease where we have clear clinical and mechanistic data demonstrating the utility of our approach. Seres is supported by a strong scientific foundation and solid balance sheet. We believe that our company is well-positioned to continue to lead the microbiome therapeutic field, and we look forward to executing on our mission in seeking to improve the lives of patients. With that operator. We'll now open the call up to questions.

As a reminder, [Operator Instructions], please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Thome of Cowen and Company. Your line is open.

Good morning. Congrats on the progress and thank you for taking our questions. Maybe the first one in the commercial manufacturing agreement, press releases, this could be the first ever live bio-therapeutic product commercially produced. I guess, is there anything from an FDA perspective that they are pointing to specifically that you would need to clarify. given that this could be groundbreaking here and maybe how you're responding to them or getting data ready. And then second question, just on the potential for re-treatment, in patients that maybe re-elapsed after SER-109 treatment, is it possible to go back in with another course? Mechanistically with this makes sense? Thank you

Joe good morning and thanks for the two questions. On the first from a manufacturing perspective, maybe I'll start and I'll ask David to comment as a reminder that [Indiscernible] is not up on online yet. It will take some time to complete the facility and bringing them online. We're taking into our commercial launch the same process that we took into our Phase 3 study. So we're continuing to work through the elements of the BLA. We feel good about where we are. But following the positive Phase III results in the summer of 2020, we pivoted pretty quickly to investing in and continuing to prepare both the capabilities and the capacity to launch the product and in fact that included in subsets hiring Dave, who brings just exactly the right experience of being able to move quickly and bring a key product up to scale. Maybe I'll ask Dave to comment further and then we'll take your second question in terms of retreatment.

Sure. Thanks, Eric. And so, Joe, you're asking about questions from the FDA. And so, I'd emphasize that because of our breakthrough designation, we've been in ongoing, almost continuous interaction with the FDA. So we have a really good dialogue with them and understanding what their expectations are and addressing those things as we prepare the [Indiscernible] itself. And as Eric said, just to re-emphasize the point that our current supply chain is our launch supply chain. The new investment is not required for BLA filing or launch. There's no change to that timeline as it relates to manufacturing. The same supply chain that we have was used for Phase 3, same scale, same facilities, same equipment and same staff. So that's what I could share with you this morning.

And Joe, maybe we can take your second question in terms of the potential for retreatment. And here I'll ask Lisa the comment, but just to start just a couple of comments. One is that I think the question on retreatment is an important one. We've gotten to know these patients incredibly well and what I think hasn't come to light as much as it could have, just fear and emotional burden of the idea of a recurrence rate. Once you get hit by [Indiscernible] just not knowing whether you're likely to recur again or not. And one of the reasons that we were still gratified by our faces. Results was certainly the efficacy that we saw in that study. -- And medically, no reason that we know of why you couldn't retreat. But, one of the -- the elements of the Phase II results was that, there weren't that many patients on that actually recurred, right? So maybe I can ask Lisa to comment further on that.

Eric, exactly right. There's no medical reason not to retreat and in fact, we did have a few patients in the O-12 study that did recur, rolled over into the open label and received retreatment and did well. But as Eric said, we had so few people in the active arm recurring to begin with, that, it's just not large numbers.

And super helpful. Thanks again.

Sure

Thanks the question, Joe

Your next question comes from the line of Ted Tenthoff of Piper Sandler. Your line is open.

Great. Thank you very much. And just with respect to preparation for the BLA, since this is a new class, is there anything you meet -- kind of picking up on the last? The restructuring that would be required since it is a microbiome therapy. Thanks.

Ted, Thanks for the questions. I would say as Dave mentioned before him, we think we have a pretty good sense of what the FDA is looking for. This is a new [Indiscernible] modality but we're not starting fresh in terms of our discussions with the FDA, right? We've been in discussions with the FDA around release facts around our approach. Obviously, they had communicated to us the bar that they were looking for in terms of what would qualify from an efficacy perspective for one single pivotal study. Not only that we meet that, but significantly surpassed that. We've ever had the discussion around safety and the idea that they were looking for density 100 patients on the Phase 3 dose, which we of course also executed as well. So it's a breakthrough doesn't beta program. We continue to be in contact with them, we think we have a pretty good sense of what they've asked for and we're providing it. So, that's the best that we could say at this point. We'll continue the dialogue with them and progress and align with the BLA.

And as you say, the quality and the clear signal both from safety and efficacy really can be helpful. Awesome. Thanks. Looking forward to continued updates on pipeline. Thanks.

Thanks, Ted, thanks for the question.

Your next question comes from the line of Chris Shibutani of Goldman Sachs. Your line is open.

Hi, this is CJ on [Indiscernible] Chris this morning. Thanks for taking the question. Congratulations on the quarter. Can you help us think a little longer-term about the potential competitive commercial landscape for therapeutic approaches to recurrent c dip? In particular, I don't think we've discussed this as much previously, but Pfizer has a vaccine and we're, it's Phase 3 data could come in the near-term. How do you see therapeutics and the potential vaccine fitting into the overall clinical management are momentary? Thank you.

Yes, CJ. Thanks for the question. Let me take the first part of it and then maybe I can ask Terri to comment on more specifically vaccines or maybe ultimate approaches. We are working this disease a long time and what we know is what's needed in the space, which is something which is we think oral, highly efficacious, G&P manufactured and incorporates the right safety dimensions that you look for. And that's what we we have with some 109. The idea of having a limited number of capsules. We think is highly, attractive for patients. -- We think that the safety. Dimension of not just relying on donor screening and hoping that you capture pathogens that might be transferred. We know that our CMC processes set up for additional steps that support patient safety. Most importantly, we think we have an efficacy profile which is represents a step function increase in how you treat these patients with the 8%. So we feel very strongly about where we are and we're highly focused. We're certainly aware of the competitive landscape, but we're our focus really is first and foremost is just getting to the BLA and trying to get to the end of the regulatory finish line [Indiscernible] stride to patients, but maybe I can ask Terri, our Head of Commercial to comment further and maybe capture the vaccine question.

Sure, Eric. I'll go straight to the vaccine and just point out a couple of facts about them. Number 1, they are operating or aiming to operate quite fire upstream from the market for recurrent CDI infection. So, they are actually going for patients who are at risk of a primary CDI infection. So for example, patients who were going in for surgery, who were essentially going to be exposed to the healthcare system and may encounter [Indiscernible] dispose for someone in set forth in addition to administration of broad spectrum antibiotics. So far extreme from us, we haven't seen Phase III data from them yet, so we don't really have a feel for their efficacy levels. And I think for me, the most relevant piece of information is really around uptake. What kind of uptake could you expect from a vaccine like this Given uptake levels that we're seeing for COVID, vaccines that have probably the best advertising campaign known demand for vaccine and we're still not seeing many cases broad uptake despite mandates and so on so forth? So, that's what I would say about the vaccine. And with respect to competitors that may come along and in the recurrent c, that space, I would just close by echoing what Eric said that we are very happy with our drug's profile in the clear path to approval that we have with our Phase three data, serving as a single pivotal due to surpassing the FDA bar for efficacy and with good direction on the necessary safety database, and we really look forward to bringing this product to patients as soon as we can. Thank you for the question.

Great Thank you.

Our next question comes from the line of Mark Breidenbach of Oppenheimer. Your line is open.

Good morning and thanks for taking the questions. Just a couple for me. First, I'm wondering if we should be interpreting the agreement with Bacthera as an indication of any forward regulatory progress with the EMA and a step towards future European product launch, or will back there up primarily be manufacturing drug products for the North American market. Also, I'm wondering if you can give us any numbers around manufacturing capacity within without the addition [Indiscernible] in terms of drug supply per patient per year. And finally, one last one for me. Maybe you can give us a progress report on the enrollment of the CEREC area. One study. And if we can reasonably expect to see any results from that trial in 2022. Thank you.

Mark. Good morning and thanks for the -- I think it's 3 questions. Let me take a stab at them, but the team can help me if I miss something. So the first -- I think we'd prefer not to parse out signaling I think for us is that, we think this is going to be a major global drug, right? And because of that, we're looking to ensure that we've got the right -- the right commitment, the right capacity to supply this drug globally that includes future regulatory work and includes future commercial work. But ultimately Bacthera with Lonza and Christian Hansen, it's just the state-of-the-art operation that we think industrializes our ability to fulfill our commitment to patients to get this drug to them as quickly and as robustly as possible. I think that's the answer to the first we haven't provided specificity in terms of numbers except to maybe I'll reiterate what Dave said earlier, which is we feel very good about where we are from a launch perspective. I think this is this is more forward-looking in terms of our ability to supply globally. And then in the last question, Mark in terms of [Indiscernible] having provided guidance, I can reiterate what I've said before him, which is that we've made progress. But at the same time we're not so far along in this 1b study where if there are learnings from our analyses that we could apply, we have the ability to do that. I think on the last one, it's really more of a stay tuned.

Okay, got it. Thanks for taking the questions and congrats on the progress.

Thanks for the questions, Mark.

Your next question comes from the line of John Newman of Canaccord. Your line is open. -- >[Operator]

Hi, guys. Good morning. Thanks for taking my question. Just curious if you could talk a little bit about what type of data you might be able to share from the microbiome analysis that you mentioned for later this year, just kind of curious as to what you’re hoping to learn from that analysis that can help inform future studies. Thanks

John, good morning and thanks for the question. And let me start with the status and then maybe Matt can comment a little bit more specifically on the types of analysis that will run. But -- As we've said, we're not finished with the analysis It is in process, for us it's important to not piecemeal data out, but rather give us a sense of the total picture before providing our analyses, conclusions, and potentially next steps. We've debated quite a bit about what we share and when. I think that we -- our intent is to share a more full picture when we have it. And I would say that we're certainly getting closer to that. But maybe Matt, you can comment on the types of analysis and maybe some visibility as to how that informs our platform moving forward.

Good morning, John. Yes. So our 287 Phase two trial was designed to capture a rich dataset around drug activity and pharmacology. And that was done that course, understand what the drug is doing and also enable our reverse translational discovery efforts more broadly. So we're generating [Indiscernible] microbiome data, metabolomic datasets, transcriptional datasets, other functional data as well, which allow us to then look at specifically how the microbiome changed, what happened functionally. Did we or did we not elicit the changes in the metabolic landscape that we would have expected based on our aggregate knowledge across both our pre -clinical work, as well as our Phase 1b study, where we did see meaningful changes that were associated with bulks treatment and clinical outcome. And of course, we're looking more broadly as well to say, we're, IBD relevant inflammatory pathways modulating as we might have expected them to be. And then also we're trying to understand is there any evidence of patient subpopulations that might be more amenable to treatment versus not. So these are the kinds of things we're looking at and digging into. And I will just close by saying, we've got a large, rigorously collected interventional microbiome dataset. This kind of dataset don't exist out there generally speaking and so I think we've got a lot of work ahead of us, but there's much to learn here in terms of how we think about how microbes are interacting with each other [Indiscernible] cells and tissues in the [Indiscernible] I think that has broad applicability across our portfolio.

Thank you.

Thanks for the question, John.

Your next question comes from the line of Vernon Bernardino of H.C. Wainwright. Your line is open. -- >[Operator]

Hi, Eric and team. Thanks for taking my question. Just have a question as far as the Bacthera agreement capabilities and so on. Part of the announcement says that your leverage loans is captured, Joe encapsulation technology. Are there any considerations as far as what would need to be done regarding any differences between the capsule study use now and perhaps our stability testing for CO-109 one saw that they [Indiscernible] up in manufacturing CO-109.

Good morning and thanks for the question.

Good morning.

Let me start let me start and I'll last Dave to comment. So again, I don't think that I've taken the bacteria question yet, but I'm thrilled with this relationship. They really do provide for us a professional industrialization of manufacturing the drug going forward and we're thrilled that they take the best of the 2 companies that really came together to form Bacthera. There's aspects to what we're doing, which we think are best in our hands. There's aspects of what they're doing, which we think that they can provide and sure unique value with us. And from that perspective, we think it's really a win-win in terms of a partnership. but maybe Dave can comment more specifically on the question in regards to the capsules.

Thanks, Eric. And good morning and thanks for the question. I'll just briefly echo what Eric said having worked for 27 years in bio-pharmaceutical manufacturing and biologic and vaccines I'm really, enthused about this partnership with Bacthera are for meeting future expansion of supply at Lonza and Christian Hansen have a long history and the site is top-notch as as Eric said, specifically to your question, this is being highlighted by a [Indiscernible] for their own purposes to highlight it. We've actually used those capsules throughout. Capsugel was acquired by Lonza at some point in time, but those particular capsules that we use had been part of the SER-109 program from early on and we are indeed using Phase III so there is in fact no change with respect to that particular aspect?

Perfect. That's exactly what I was asking. Thanks for taking my question and congrats on the progress.

Thanks for the question, [Indiscernible]

There are no further audio questions at this time. I will now turn the call over to management, for closing remarks. -- >[Operator]

Thank you, Operator. I want to thank everybody for joining our call today and for your continued interest in series. We look forward to keeping you up-to-date on our progress. With that, we will conclude have a great day and thanks again.

This concludes today's conference call. Thank you for participating. You may now disconnect.