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spk00: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today. Dr. Carlo Tanzi, Investor Relations. Please go ahead.
spk11: 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 a.m. Eastern time this morning and can be found on the Investors & News section of the company's website. I'd like to remind you that we'll 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 SEER-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 factors 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 just claim any obligation to do so. On today's call, with prepared remarks, I'm joined by our President and Chief Executive Officer, Eric Schaaf, Dr. Lisa Von Mulkey, our Chief Medical Officer, David Arkowitz, our Chief Financial Officer, and Matthew Henn, our Chief Scientific Officer. During the Q&A portion of the call, we will also be joined by Dr. Terry Young, our Chief Commercial and Strategy Officer, and Dr. David Agee, our Chief Technology Officer. And with that, I'll pass the call to Eric.
spk08: Thank you, Carlo, and good morning, everyone. The last several months have been a productive period for CERES, where we have meaningfully advanced our microbiome therapeutic pipeline. Our key recent highlights include the completion of enrollment in our open-label SIR-109 study, the continued advancement of this program towards a BLA filing for recurrent pseudothelial infection, and actions we have taken to prepare for a successful product launch. We believe that SIR-109 has the potential to become the first-ever FDA-approved microbiome therapeutic, an important milestone for this emerging class of medicines. We have also continued to perform microbiome data analysis following our SIR-287 Phase IIb clinical results in ulcerative 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 SIR-109, during the summer of 2020, we announced successful Phase III 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 data to support this filing. Notably, in following discussion with the FDA, our SIR-109 open-label study also includes patients with a first recurrence of C. difficile infection, an expanded patient group compared to the Phase III study population, which included patients with multiple recurrent CVI. In September, we were pleased to have achieved target enrollment with our open-label study of CR109 in patients with recurrent CDI. We were highly encouraged with the pace of that study's enrollment and believe that the accelerating rate of enrollment that we observed reflects an increasing level of interest about CR109 within the physician community. There is clearly demand for a new approach to treating our current CDI, and we believe that the physician community is eager to see SIR 109 become commercially available. Recently, we initiated a SIR 109 expanded access program at multiple sites across the United States. This important program is designed to enable adults, with recurrency difficile infection to obtain access to 0109 prior to a potential FDA product approval. We continue to remain on track with our plan to begin a rolling submission of the BLA for 0109 in the first half of next year and finalize the submission, including the required six-month data set from the ongoing safety study in mid-2022. Looking forward, Our top corporate priorities are to prepare for a high-quality CR109 BLA filing, and alongside Nestle Health Science, our commercial partner, we are working to ensure that we are well-positioned for a successful CR109 product launch. The approval and launch of CR109 would represent a landmark event for the field, and our organization continues to prepare for all aspects of a successful commercial launch. We believe that SIR-109 represents a substantial commercial opportunity for CERES. The cost of a patient with a recurrence of CDI has been estimated to result in approximately $34,000 in annual direct healthcare expenses. The recurrent CDI population includes approximately 170,000 cases in the U.S., and we believe we have the opportunity to address this entire patient group. These patients do not have attractive treatment choices today. Some of these patients are currently being provided regimens and procedures that are not FDA approved, including fecal microbiota transplantation and extended courses of antibiotics. All of these approaches have important limitations, and based on our discussions with healthcare practitioners, there is an eagerness for new, safe, effective, and FDA approved treatment options. We believe that SIR-109 could provide a transformational new therapeutic option for recurrent CDI, and we are working with urgency to bring our therapeutic forward to the market as quickly as possible. We recently announced the collaboration with Bactera, a global leader in biopharmaceutical product manufacturing that further increases our longer-term commercial product supply. Following this agreement, BACTERA is establishing a dedicated facility for commercial manufacturing in its new microbiome center of excellence, a manufacturing site dedicated to the production of live biotherapeutic products located in Switzerland. We look forward to partnering with BACTERA to expand upon our existing production capacity to meet demand growth beyond the initial phase of launch and and help ensure eligible patients can receive this potential new treatment option. Following our SIR 109 phase three study results, one of our key initiatives has been to educate the medical community about our investigational therapeutic and our clinical data. I'd like to now pass the call to Lisa to review several important SIR 109 data sets that we have presented at recent medical meetings. These data reinforce the remarkably strong SIR 109 clinical profile and provide notable findings regarding the potential application of our microbiome therapeutics and new indications.
spk06: Thanks, Eric. Our SIR 109 Phase III study was a data-rich trial, and since obtaining the initial top-line results in July of 2020, we have presented various data sets at a number of prominent conferences that are well attended by leading infectious disease physicians and gastroenterologists. Last month, we presented at both ID Week and at the American College of Gastroenterology Annual Meeting. In total, we presented eight posters and one oral presentation. In addition, at ID Week, we sponsored a talk led by Dr. Paul Feuerstadt, 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 SEER 109 program as well as on our earlier stage SEER 155 program. I'd 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 SIR-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 III study. Importantly, SIR-109 showed broad efficacy in the Phase III study, including in 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 III study had at least one comorbidity, including diabetes, cardiac disease, and malignancy. It was reassuring to see that CR109 results in high levels of efficacy, including in these higher-risk patient groups. At ID Week, in a late breaker oral presentation, we presented results showing that SEER-109 reduces the abundance of antimicrobial resistance genes in the GI tract in patients with recurrent CDI. This is an important finding given the public health concerns regarding escalating rates of antimicrobial resistance and the associated negative outcomes for patients. We were pleased to see the impact of our therapeutic approach on this component of the antibiotic resistance paradigm. We believe that our data support a potential role for microbiome therapeutics in the decolonization of bacteria that harbor antibiotic resistance genes. Our novel therapeutic modality has the potential to become an important approach to reduce the transmission of antimicrobial resistance. We also presented an exploratory analysis derived from our Phase III data, which demonstrated that SEER-109 administration was associated with an improved overall mental health score compared to baseline, regardless of clinical outcome. In another poster, we have highlighted the rigor of our SEER-109 manufacturing processes, including methods employed to reduce the risk of transmission of emerging and undetected infections. we believe that our approach has important potential safety advantages as compared to the use of untreated donor stool. Overall, the data we presented further validate the strength of our SEER-109 product profile, and we believe it provides further support for the potential of this investigational therapeutic to transform the management of patients with recurrent C. difficile infection. In addition, Our presentations have meaningfully increased the awareness of SEER-109 among the medical community, as well as in the potential utility of microbiome therapeutics as a new class of medicines. I'll now pass the call to Matt to discuss our earlier stage pipeline program.
spk02: Thank you, Lisa, and good morning. I'll begin with SEER-155. SEER-155 is an orally dosed, rationally designed, cultivated microbiome therapeutic candidate designed to decrease the incidence of gastrointestinal infections, bacteremia, and graft-versus-host disease in immunocompromised patients receiving allogeneic hematic stem cell transplantation. SEER-155 is designed to prevent both bacterial bloodstream infections, particularly those that harbor antibiotic-resistant genes, as well as to modulate host 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 infections, including antibiotic-resistant infections and poor clinical outcomes. At the recent ID Week conference, in an oral presentation, we highlighted preclinical data showing that SIR-155 can decolonize patient-isolated antibiotic-resistant pathogens including vancomycin-resistant enterococci and carbapenem-resistant enterobacteriaceae, such as enterococcus cesium and Klebsiella pneumoniae, which are notable escape pathogens. The continued emergence of antibiotic-resistant bacterial infections 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 immunocompromised patients. Prior studies published by our collaborators at MSK indicate that HHCT patients with a disrupted low-diversity microbiome are at a substantially increased risk of bacterial infections, including antibiotic-resistant infections and poor clinical outcomes. Based on these observations in our clinical programs, and our preclinical data supporting CER155 mechanisms of action, we believe CER155 has the potential to reduce the risk of infection in individuals with compromised immune systems. Our IND for CER155 was cleared by the FDA, and we are in the late stages of prepping to dose our first patient in the CER155 Phase 1b study in collaboration with MSK and the University of Chicago. The Phase 1B study is a two-part trial, including an open-label and placebo-controlled portion, and the overall study is designed to enroll approximately 70 participants. A first part of the study aims to primarily assess safety in SIR-155 in Grafman, and the second part of the study will also evaluate the incidence of bloodstream infections, gastrointestinal infections, and the incidence of acute graft-versus-host disease. We look forward to providing further updates soon on the progress of this important study. Now moving on to our ulcerative colitis efforts. We continue to analyze data from our SEER-287 Phase II study conducted in patients with mild to moderate ulcerative colitis. We're in the process of obtaining and analyzing microbiome results, as well as metabolomic and other functional data from that study. We expect these data to provide us with a much deeper understanding of that study's unexpected clinical outcome, and these results will form our decisions regarding next steps for 287, as well as any potential modifications to our ongoing SEER-301 Phase 1b study. We intend to communicate and update on our initial assessment findings before the end of the year. As a reminder, SEER-301 is a next-generation, orally dosed, rationally designed, cultivated microbiome therapeutic candidate for the treatment of ulcerative colitis. The composition of CR301 is designed to optimize drug species engraftment and the pharmacological properties that our clinical and non-clinical research have identified as potentially important drivers of a treatment effect. Research indicates that individuals with ulcerative colitis can have a gastrointestinal microbiome that differs from those of healthy individuals, and further, that bacteria found in the gastrointestinal microbiome and the metabolites they produce are associated with modulation of many of the immune pathways that have been associated with ulcerative colitis and IBD more broadly. Unlike CR287, a donor-derived product candidate, CR301 is comprised of a targeted set of bacteria selected to optimize the reduction of pro-inflammatory activity, improve epithelial barrier integrity, and modulate multiple UC-relevant immune pathways to suppress inflammation. We continue to enroll our SEER 301 Phase 1B study in adults with mild to moderate ulcerative colitis. As we had previously done several years ago with our SEER 109 program, we are performing an in-depth, rigorous scientific analysis of all available ulcerative colitis study results. Based on the findings from our SEER 287 assessment, we intend to make a thoughtful determination regarding next steps for our UC franchise, and we maintain the opportunity to modify the SEER 301 study if warranted. With that, I'll now turn the call to David to provide an overview of our financials.
spk04: 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. Ceres 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 Ceres received in July following the SEER-109 co-commercialization agreement announced on July 1, 2021, in Nestle Health Science. I would just remind you all of the deal terms. In exchange for SEER-109 co-commercialization rights in North America, Nestle Health Science provides CERES with an upfront payment of $175 million. CERES will also receive an additional $125 million upon FDA approval of SEER-109 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 SEER-109, CERES will be entitled to an amount equal to 50% of commercial profits. We're very pleased with the collaboration, which is financially attractive for CERES, and provide CERES with both near-term value and substantial longer-term value. We continue to work very closely with AMUNE, the division within NSLI responsible for this effort, in preparing for the launch of CERES-109. And as part of the agreement, CERES is funding all pre-launch commercialization and medical affairs expenses up until launch. As I've mentioned, once CERES-109 is commercialized, the profits will be split 50-50. Amune 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 SEER 109 commercialization. I want to point out that our third quarter income statement reflects collaboration revenue of approximately $127 million. which is primarily from the accounting of the $175 million upfront fee from Nestle. As a result of this revenue recognition, Ceres has generated a profit for the quarter. There are additional accounting implications related to the co-commercialization agreement included in our financial statements for the third quarter, and these are further outlined in our 10Q. With respect to our operating expenses and efforts over the near term, We continue to be focused on a number of critical SEER 109 related activities, which include filing the BLA submission, ramping up manufacturing operations for commercial supply, and in conjunction with AMUN, accelerating our prelaunch commercialization efforts. In addition, we continue to invest to advance and expand our pipeline and further build and enhance our platforms and capabilities. As a result of these high-priority and value-generating activities, we expect our expenses to increase in the coming quarters. In summary, we believe the company is well-resourced to prepare for SEER 109 commercialization, drive our ongoing development programs, while also deploying resources to continue to advance our research platforms where we believe we have differentiated proprietary and sustainable advantages. With that, I will pass the call back to Eric.
spk08: 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. These include our achievement of over 300 subjects enrolled in our SEER-109 Open Label Study and our preparations for a BLA filing in the middle of next year. Continued progress executed on SIR 109 commercial readiness, working closely with Nestle, including expanded market education efforts. The initiation of a SIR 109 expanded access program, the expansion of our longer-term commercial supply capabilities and capacity, including our recent collaboration with Baxera, completion of our SEER 287 study data analysis, and continued progress with our SEER 155 and SEER 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 in areas such as infectious disease, where we have clear clinical and mechanistic data demonstrating the utility of our approach. CERES 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 our mission in seeking to improve the lives of patients. With that, operator, we'll now open the call up to questions.
spk00: As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Tomey of Calvin and Company. Your line is open.
spk13: Hello, good morning. Congrats on the progress and thank you for taking our question. Maybe the first one, in the commercial manufacturing agreement, press releases that this could be the first ever live biotherapeutic 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 kind of 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 relapse after CR109 treatment, is it possible to go back in with another course mechanistically, would this make sense? Great. Thank you.
spk08: Yeah, Joe, good morning, and thanks for the two questions. On the first, from a manufacturing perspective, maybe I'll start and I'll ask Dave Eggie to comment. You know, as a reminder, Vaxera is not up or online yet. It will take some time to complete the facility and bring them online. We're taking into our commercial launch the same process, that we took into our Phase 3 study. So, you know, we're continuing to work through the elements of the BLA. We feel good about where we are. But following the positive Phase 3 results in the summer of 2020, you know, 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 some sense, hiring Dave, who brings, you know, just exactly the right experience of BLA be able to move quickly and bring a key product up to scale. So maybe I'll ask Dave to comment further, and then we'll take your second question in terms of retreatment.
spk05: Sure. Thanks, Eric. And so, Joe, you were asking about, you know, questions from the FDA, and so I had emphasized that because of our breakthrough designation, we've been in, you know, ongoing, you know, almost continuous interaction with the FDA. So we have a really good dialogue with them in understanding the you know, what their expectations are and addressing those things as we prepare the BLA itself. And, you know, as Eric said, just to reemphasize the point that our current supply chain is our launch supply chain. The new investment is not required for BLA filing or launch, so there's no change to that timeline as it relates to manufacturing. The same supply chain that we have was used for Phase III, same scale, same facilities, same equipment, and same staff. So that's what I could share with you this morning.
spk08: And, Joe, maybe we can take your second question in terms of the potential for retreatment. And here I'll ask Lisa to comment. But just to start, just a couple of comments. One is that, you know, I think the question on retreatment is an important one. We've gotten to know these patients incredibly well, right? And what I think hasn't – come to light as much as it could. It's just the fear and emotional burden of the idea of a recurrence, right? Once you get hit by antibiotics, just not knowing whether you're likely to recur again or not. And one of the reasons that we were so gratified by our face-to-face results was certainly the efficacy that we saw in that study and the You know, there's medically no reason that we know of why you couldn't retreat, but one of the elements of the phased results was that, you know, there weren't that many patients in the active on that actually recurred, right? So maybe I can ask Lisa to comment further on that.
spk06: Yeah, no, Eric's exactly right. There's no medical reason not to retreat. And, in fact, we did have a few patients in the 012 study that did recur and 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, you know, it's just not large numbers.
spk13: That's great and super helpful. Thanks again.
spk00: Sure.
spk13: Thanks for the question, Jeff.
spk00: Your next question comes from the line of Ted Tantoff of Piper Sandler. Your line is open.
spk07: Great, thank you very much. And just with respect to preparation for the BLA, since this is a new class, is there anything unique, kind of picking up on the last question about going beyond manufacturing, that would be required since it is a microbiome therapy? Thanks.
spk08: Yeah, Ted, thanks for the question. You know, look, I would say, as Dave mentioned beforehand, we think we have a pretty good sense of what the FDA is looking for. This is a new therapeutic. It is a new modality. But we're not starting fresh in terms of our discussions with the FDA, right? And we've been in discussions with the FDA around release specs, around our approach. Obviously, you know, 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 do we meet that, but we significantly surpass that. We then had the discussion around safety and the idea that they were looking for these 300 patients on the Phase III dose, which we, of course, also executed as well. You know, it's a breakthrough designated 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, you know, that's the best that we could say at this point. We'll continue the dialogue with them and progress down the line with the BLA.
spk07: And as you say, I mean, the quality and, you know, clear signals both from safety and efficacy are really going to be helpful. Awesome. Thanks. Looking forward to it. continued updates on the pipeline. Thanks.
spk08: Thanks, Ted. Thanks for the question.
spk00: Your next question comes from the line of Chris Shibutani of Goldman Sachs. Your line is open.
spk03: Hi, this is CJ on for 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. diff In particular, I don't think we've discussed this as much previously, but Pfizer has a vaccine, and where phase three data could come in the near term. How do you see therapeutics and a potential vaccine fitting into the overall clinical management armamentarium? Thank you.
spk08: Yes, CJ, thanks for the question. Let me take the first part of it, and then maybe I can ask Terry to comment on more specifically vaccines or maybe alternate approaches. You know, look, we've been working this disease for a long time, right? And what we know is what's needed in this space, which is something which is, we think, oral, highly efficacious, GMP manufactured, and, you know, incorporates the right safety dimensions that you look for. That's what we think we have with CIRM 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 process is set up for additional steps that support patient safety. Most importantly, we think we have an efficacy profile, which represents a step function increase in how you treat these patients, you know, with the 88%. So, you know, we feel very strongly about where we are, and we're highly focused. You know, we're certainly aware of the competitive landscape. But where 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 so we can get this drug to patients. But maybe I can ask Terry, our head of commercial, to comment further and maybe capture the vaccine question.
spk01: Sure, Eric. I mean, I'll go straight to the vaccine and just point out a couple of facts about them. Number one, they are operating or aiming to operate quite far upstream in from the market for recurrent C. diff infections. So they're actually going for patients who are at risk of a primary C. diff infection. So, for example, patients who are going in for surgery who are essentially going to be exposed to the healthcare system and may encounter C. diff spores and so on and so forth in addition to administration of broad spectrum antibiotics. So far upstream from us, we haven't seen Phase III data from them yet, so we don't really have a feel for their efficacy levels. I think for me, the most, I think, relevant piece of information is really around uptake. What kind of uptake could you expect from a vaccine like this, you know, given uptake levels that we're seeing for COVID vaccines that have probably the best advertising campaign known to man for a vaccine? And, you know, we're still not seeing, in many cases, broad uptake, despite mandates and so on and so forth. So that's what I would say about the vaccine. And You know, with respect to competitors that may come along in the recurrent C. diff space, I would just close by echoing what Eric said, that we are very happy with our drugs profile and the clear path to approval that we have with our Phase III data serving as a single pivotal due to surpassing the FDA's bar for efficacy and with clear 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.
spk00: Your next question comes from the line of Mark Brabenback of Oppenheimer. Your line is open.
spk10: Hey, good morning, and thanks for taking the questions. Just a couple from me. First, I'm wondering if we should be interpreting the agreement with BACFERA as an indication of any forward regulatory progress with the EMA and a step toward future European product launches. or will Bactera primarily be manufacturing drug products for the North American market? Also, I'm wondering if you can give us any numbers around manufacturing capacity with and without the addition of Bactera in terms of drug supply per patient per year. And finally, one last one from me. maybe you can give us a progress report on the enrollment of the SARA 301 study and if we can reasonably expect to see any results from that trial in 2022. Thank you.
spk08: Mark, good morning, and thanks for the – I think it's three questions. Let me take a stab at them, but the team can help me if I miss something. So, you know, on the first, I think we'd prefer not to kind of parse out signaling this or signaling that. I think for us is that we think this is going to be a – a major global drug, right? And because of that, we're looking to ensure that we've got the right commitment, the right capacity to supply this drug globally. That includes future regulatory work. It includes future commercial work. But ultimately, you know, Vaxera 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. So I think that's the answer to the first. We haven't provided specificity in terms of numbers, except 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 more forward-looking in terms of our ability to supply globally. And then on the last question, Mark, in terms of 301, having provided guidance, you know, I can reiterate what I've said beforehand, which is that, you know, 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. So, you know, I think on the last one it's really more of a stay-tuned approach.
spk10: Okay, got it. Thanks for taking the questions, and congrats on the progress.
spk08: Thanks for the questions, Mark.
spk00: Your next question comes from the line of John Newman of Canaccord. Your line is open.
spk09: 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've 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.
spk08: Yeah, 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 analyses that we'll run. But, you know, as we've said, we're not finished with the analysis. It is in process. I think for us it's important to not piecemeal data out but rather get a sense of the total picture. before providing our analyses' conclusions and potentially next steps. So, you know, we've debated quite a bit about, you know, what we share and when. I think that 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 analyses and maybe some visibility as to how that informs our platform going forward.
spk02: Sure. Morning, John. Yeah, so our 287 phase two trial was designed to capture a rich data set around drug activity and pharmacology. And that was done to, of course, understand what the drug is doing and also enable our reverse translational discovery efforts more broadly. So we're generating metagenomic microbiome data, metabolomic data sets, transcriptional data sets, 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 preclinical work as well as our phase 1B study where we did see meaningful changes that were associated with both treatment and clinical outcomes. And of course, we're looking more broadly as well to say, were IBD-relevant inflammatory pathways modulated 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 really I'll just close by saying this is a large, rigorously collected interventional microbiome data set. These kinds of data sets 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 I love those human cells and tissues in the GI. I think that has broad applicability across our portfolio.
spk10: Okay, great. Thank you. Thanks for the question, John.
spk00: Your next question comes from the line of Bernon Bernardino of HC Wainwright. Your line is open.
spk12: Hi, Eric and team. Thanks for taking my questions. Just have a question as far as the Bactera agreement capabilities and so on. Part of the announcement says that you'll leverage lunges capsule gel encapsulation technology. Are there any considerations as far as what would need to be done regarding any differences between the capsules that are used now and perhaps the stability testing? for SARE-109 once Bacteria is up and manufacturing SARE-109.
spk08: Yeah, Vernon, good morning, and thanks for the question. Good morning. Let me start, and I'll ask Dave to comment. So, you know, again, I don't think that I have 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 kind of take the best of it. of the two companies that really came together to form Baxera. So there's aspects of 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 share 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 around your question in regards to the capsules.
spk05: Yeah, thanks, Eric and Vernon. Good morning, and thanks for the question. Yeah, I'll just briefly echo what Eric said. Having, you know, worked for 20-some years in, you know, biopharmaceutical manufacturing and biologics and vaccines, I'm really, really enthused about this partnership, you know, with Bacteria for meeting future expansion of supply. It's, you know, Lonza and Christian Hansen have a long history, and the VISP site is top-notch, as Eric said. Specifically to your question, this is being highlighted by Vectera and Lonza, you know, for their own purposes to highlight it. We've actually used those capsules throughout. So CapsaGel was acquired by Lonza at some point in time, but those particular capsules that we use have been part of the CR109 program from early on and were indeed used in Phase 3. So there's, in fact, no change with respect to that particular aspect.
spk12: Perfect. That's exactly what I was asking. Thanks for taking my question, and congrats on the progress.
spk08: Thanks for the question, Bernard.
spk00: There are no further audio questions at this time. I will now turn the call over to management for closing remarks.
spk08: So thank you, operator. I want to thank everybody for joining our call today and for your continued interest in CERES. We look forward to keeping you up to date on our progress. With that, we will conclude. Have a great day, and thanks again.
spk00: This concludes today's conference call. Thank you for participating. You may now disconnect.
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