MCRB

Good day, everyone, and thank you for standing by. My name is RG, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2025 Seres Therapeutics Results and Business Updates. [Operator Instructions] Thank you. I would now like to turn the call over to Dr. Carlo Tanzi of Investor Relations. Please go ahead.

Thank you, and good morning. Today, before market opened, we issued a press release with our third quarter 2025 financial results and business updates available on the Investors and News section of our website. We've also posted an updated corporate presentation. Before we begin, I'd like to remind everyone that we will be making forward-looking statements, including statements around the results of our current or planned clinical trials, studies and data readouts, our product candidates and their potential benefits, development plans and potential commercial opportunities, interactions with and feedback from the FDA, our ability to secure an R&D or other partnership and/or generate or obtain additional capital, financing or other resources, our planned strategic focus and operating plans, cost reduction actions and anticipated benefits and cash runway, the timing of any of the foregoing and other statements which are not historical facts. Actual results may differ materially due to various risks and uncertainties and other important factors described under Risk Factors in our recent SEC filings. We undertake no obligation to update these statements, except as required by law. On today's call with prepared remarks are Marella Thorell, our Co-Chief Executive Officer and Chief Financial Officer; and Dr. Matthew Henn, our Chief Scientific Officer. Additional members of the management team, including Tom DesRosier, Co-CEO and Chief Legal Officer; Terri Young, Chief Commercial and Strategy Officer; and Dr. Dennis Walling, SVP of Clinical Development, will be available during the Q&A portion of the call. And with that, I'll turn the call over to Marella.

Thank you, Carlo, and good morning, everyone. We made good progress during the quarter. Our immediate priority remains advancing SER-155, our lead investigational, oral, live biotherapeutic for the prevention of bloodstream infections, or BSIs, in adults undergoing allo-HSCT into a Phase II study. We believe that results in this study, if positive, could represent a very meaningful value creation event for the company. SER-155 represents a first-in-class mechanistically differentiated approach to address infections, including bloodstream and antimicrobial resistant infections, which are among the causes of mortality in medically compromised patients. In the Phase Ib study, treatment with SER-155 led to an impressive 77% relative risk reduction in bacterial bloodstream infections, along with decreased antibiotic exposure and febrile neutropenia. The therapy is designed to decolonize gastrointestinal pathogens, improve epithelial barrier integrity and restore immune balance, addressing root causes to prevent BSIs and therefore, reduce antibiotic use, antimicrobial resistance and often severe or fatal outcomes. Based on our analysis of the commercial opportunity, we believe that SER-155 could transform how allo-HSCT patients are managed and result in meaningfully improved patient outcomes. In September, we obtained further constructive feedback from the FDA on the SER-155 allo-HSCT program, which has received Breakthrough Therapy designation Phase II protocol. Based on the feedback received, we are pleased to have alignment on multiple key study parameters, including study size, dosing regimen, primary efficacy endpoint and the interim analysis plan. We do not believe there are any gating items to commencing the study from a protocol standpoint and are incorporating FDA feedback into the protocol. Notably, given the planned study design and our experience in this therapeutic area, we expect to be able to efficiently generate Phase II data in allo-HSCT patients, and we estimate that we will obtain meaningful placebo-controlled clinical results from a planned interim analysis within 12 months of study initiation with commencement being funding dependent. Beyond the initial allo-HSCT indication, we see significant expansion potential across other medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T therapy recipients and other medically compromised patients such as those in the ICU who face similar infection risks and unmet needs. Collectively, these represent a multibillion-dollar commercial opportunity in patients facing high unmet need and where there has been limited therapeutic innovation. As Matt will discuss, we also have an ongoing investigator-sponsored study at Memorial Sloan Kettering Cancer Center, evaluating SER-155 in an indication beyond infection that is of high interest, and we look forward to obtaining initial clinical results in early 2026 that may highlight the potential of SER-155 in immune-related negative clinical outcomes. While we advance SER-155 Phase II study start-up activities, we continue our efforts to seek capital in order to initiate the study and support our broader portfolio of product candidates with applications in inflammatory diseases. Advancing SER-155 is our top priority, and we continue to strive to obtain the resources needed to move the program forward. During the quarter, we also implemented targeted cost reduction measures, including a workforce reduction of approximately 25% to extend our cash runway and focus resources on core development priorities. We believe that the cost reduction actions, the resultant operating runway extension will provide us with additional opportunities to advance our strategic priorities. With that, I'll turn it over to Matt.

Thank you, Marella. Seres continues to execute its R&D strategy with efficiency and discipline with a focus on expanding the reach of SER-155 and building on key clinical insights to advance our broader biotherapeutic pipeline. Our recent successes in clinical translation and leveraging external collaborations as well as securing non-dilutive funding allows us to evaluate important new opportunities for SER-155 in additional patient populations. We are thrilled to have recently announced that Seres has received a non-dilutive award from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator or CARB-X, of up to $3.6 million. This award represents the second CARB-X grant to Seres and will support the development of an oral liquid formulation of SER-155, which is intended to expand future access to this biotherapeutic in medically vulnerable patients who cannot easily swallow capsules, including patients in intensive care units and some pediatric and elderly patients. Furthermore, we believe that this CARB-X award underscores the global recognition of the potential of our biotherapeutic approach to address antimicrobial resistance, a major global public health issue and a top strategic priority for CARB-X. Additionally, at the recent IDWeek conference, Seres presented new post-hoc analyses from our SER-155 Phase Ib study in allo-HSCT, which provided deeper insights into bloodstream infection patterns, antimicrobial resistance and clinical outcomes across treatment groups. These data further support SER-155's differentiated mechanism and its potential to reduce serious infections in patients with limited therapeutic options. Also notably, our collaboration with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial initiated by a clinician evaluating SER-155 in patients with immune checkpoint inhibitor-related enterocolitis, or irEC, continues to progress, and the study is currently enrolling subjects. irEC is among the most frequent and severe immune-related adverse events in recipients of immune checkpoint inhibitor therapy and can be observed in up to 50% of patients with rates varying based on cancer drug and treatment regimen. Immune checkpoint inhibitors can cause a wide range of immune-related adverse events with links to T cell biology and epithelial barrier inflammation, biological functions shown in our preclinical studies and clinical pharmacology data to be positively impacted by SER-155. irEC can be a serious condition characterized by diarrhea, abdominal pain, cramping, dehydration and blood in the stool and may progress to more serious complications such as bowel perforation, toxic megacolon or death. Management of irEC includes corticosteroids and other immune-suppressive drugs and can require withholding immune checkpoint treatment. We expect data will be available from this study early next year. We also continue to explore potential R&D partnerships to advance the development of our investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease. These represent large patient populations with a continued need for new mechanisms of action, in particular, therapies that can target epithelial barrier-driven inflammation and that are not immunosuppressive. Clinical and preclinical data generated through support from the Crohn's & Colitis Foundation support the potential use of our biotherapeutics to address these unmet medical needs and provide a new approach to treat these conditions, either as a monotherapy or combination therapy. We continue to advance our novel biotherapeutics using highly focused data-driven approach and look forward to continuing collaboration with our clinical and academic partners to bring important new therapies to patients in need.

Thank you, Matt. I'll now turn to the third quarter financial results. As a reminder, Seres has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statement of operations for the comparative periods presented, and there was no ongoing activity in this quarter related to the discontinued operations. Seres reported net income from continuing operations of $8.2 million in Q3 2025 as compared to a net loss from continuing operations of $51 million in the third quarter of 2024. The results this quarter are comprised of a $22.5 million loss from operations, offset by a $27.2 million gain on the sale of VOWST, resulting primarily from the $25 million installment payment received as expected from Nestlé during the third quarter. R&D expenses for this quarter were $12.6 million compared to $16.5 million in the third quarter of 2024, reflecting lower personnel and related costs, a decrease in platform investments and a reduction in clinical expenses resulting from the completion of the SER-155 Phase Ib study. G&A expenses were $9.5 million in the quarter compared to $12.7 million in Q3 2024, driven primarily by lower personnel and related expenses, including IT-related expenses. As of September 30, 2025, Seres had $47.6 million in cash and cash equivalents. Based on the company's current cash position, remaining VOWST transaction-related obligations and current operating plans, we expect to fund operations through the second quarter of 2026. To summarize, we are disciplined in managing our expenses and continue to work towards securing additional capital to support development activities. In early 2026, we expect to obtain additional SER-155 clinical results, which could highlight therapeutic opportunities in a new patient population. We have also made progress advancing SER-155 preparation activities to conduct a robust Phase II study, commencement of which is funding dependent. Based on the design of the Phase II study and the scope of the opportunity, we believe that positive study results, if achieved, could lead to tremendous value creation. Operator, you may now open the call for questions. Thank you.

[Operator Instructions] Your first question comes from the line of John Newman of Canaccord.

You have some really interesting commentary on this IST at Sloan Kettering for immune checkpoint-related enterocolitis. I wonder if you could just talk to us a little bit more about anything you can tell us regarding the study design and also how you view the commercial opportunity there?

Sure. John, thank you for the question. We're very excited about the study as well. MSK initiated this study, and we're pleased to be looking at one of what could be potentially many different applications for SER-155. As you know, there is a significant unmet need in this patient population, and so we're eager for the results as well. To elaborate a little bit more on the design of the study, I'd like to turn it over to Dennis, and he can share a little bit about the significant impact to patients who are on ICI of the irEC side effect. Dennis?

Yes. Thank you, Marella. irEC is one of the most frequent and severe immune-related adverse events that patients experience in immune checkpoint inhibitor therapy. Up to 60% of patients with rates varying depending on the cancer treatment and regimen used can experience irEC. irEC can be a very serious condition, as Matt previously described, characterized by symptoms, including diarrhea and abdominal pain, cramping, dehydration, blood in the stool and can progress to more serious complications such as bowel perforation, toxic megacolon or even death. And the patients who experience irEC are treated with corticosteroids and other immunosuppressive drugs and also have to withhold their immune checkpoint inhibitor therapy. So the impact of this condition is significant and affects a significant number of patients undergoing this type of treatment. So this is the importance of why the study was originally designed and set up by the collaborator at MSK. The study is a small Phase I open-label study. The readout from this study is expected to occur in early 2026 and will be comprised primarily of safety data, drug pharmacology data and diarrhea symptom response data, following these patients through approximately 6 weeks on the study for those who have received SER-155 for irEC. Our hope is that we could see an impact on the diarrhea symptoms. And certainly, patients who would have improvement in the diarrhea symptoms without needing additional immunosuppressive therapy medications would be a very meaningful finding. So that type of a clinical outcome paired with the safety data and the drug pharmacology mechanistic data would be extraordinarily useful for us to help us plan and inform for any future development -- clinical development opportunities in this new indication.

John, I just want to spend a minute to ask Terri to comment on the second aspect of your question regarding the commercial opportunity.

Thanks, Marella. John, thanks again for the question. As Dennis outlined, and this is a very common side effect of a very commonly used class of medications across many tumor types in oncology, perhaps best evidenced by KEYTRUDA net sales last year of almost $30 billion and growing at 18% versus 2023. So these are highly used agents growing, will continue to grow, particularly as biosimilars become available in the class. In terms of the patient impact, just double-clicking a little bit on what Dennis said, it's not uncommon for patients to have to either pause or discontinue their cancer treatment altogether to go down this detour of addressing the enterocolitis. It frequently drives them into the hospital. It's also a key limitation on physicians' choice of using combination therapies, which may be highly effective for treating the different tumors they're trying to address. But there's this nervousness or anxiety about using combination therapy or even increasing the dose to address the cancer. So we feel like we have a big problem here and a very nice solution to address it. We're very eager to get the data.

Your next question comes from the line of Joseph Thome of TD Cowen.

Maybe just a couple on the potential partnership deals. Can you talk a little bit about how much capital you would need to get to that initial SER-155 data within the 12 months of study initiation? And then I guess, secondly, anything that you can do to kind of convey confidence that you'll be able to achieve something within the next 6 months within your targeted cash runway? And then maybe last, if you're able to comment, there obviously was a report during the quarter that Nestlé made a takeout offer. Are you able to comment on if that was authentic and maybe why that wasn't an appropriate choice at that time?

Great. Joe, thank you for the question. So first of all, just to talk a little bit about the design of the Phase II study. Importantly, that interim analysis 12 months after the study start will allow us a capital-efficient and timely recovery of data, and we are pleased to get feedback from the FDA that they were in alignment with that approach. As to the specific capital needs, we haven't guided on that other than to say that the timing of that and the way that we've designed the study, we do feel that we'll get meaningful safety and efficacy data given the patient count in this study at that IA point. We continue to make obtaining a partnership or another source of capital as our highest priority for SER-155, our lead candidate. So we are continuing to have interactions and looking at a variety of different sources from which that capital could be obtained. So while we can't comment on any specifics as to status, it remains our most important priority. With respect to your last question, we just make it a practice not to comment on rumors, Joe, so I can't comment specifically on that.

That ends our Q&A session, and we appreciate your participation. I will now turn the call back over to the management for closing remarks. Please go ahead.

Thank you. Thanks, everyone, for joining us this morning, and have a great day.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Good morning, and welcome to the Seres Therapeutics Second Quarter 2025 Results and Business Update Call. [Operator Instructions] Please note, this call is being recorded. I would now like to turn the conference over to Dr. Carlo Tanzi, of Investor Relations. Please go ahead.

Thank you, and good morning. Our press release with the company's second quarter 2025 financial results and business updates became available at 7:00 a.m. Eastern Time this morning and can be found on the Investors and News section of the company's website. The company has also posted an updated corporate presentation to the website. I'd like to remind you that we'll be making forward-looking statements, including statements about the timing and results of our clinical studies and data readouts, future product candidates, clinical development plans and commercial opportunities, communications with feedback from or submissions to the FDA, operating plans and our future cash runway, future obligations related to the VOWST sale, our ability to secure a business development deal, partnerships and/or generate or obtain additional capital or financing, our planned strategic focus, anticipated timing of any of the foregoing and other statements, which are not historical fact. 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 disclaim any obligation to do so. On today's call, with prepared remarks, I'm joined by Marella Thorell, Co-CEO and CFO; and Matthew Henn, Chief Scientific Officer. Additional members of the management team, including Tom DesRosier, Co-CEO and Chief Legal Officer; Terri Young, Chief Commercial and Strategy Officer; and Dennis Wally MD, Senior Medical -- Senior Vice President of Clinical Development, will also be available during the Q&A portion of the call. And with that, I'll pass the call on to Marella.

Thank you, Carlo, and good morning, everyone. Today, we'll share recent business highlights, progress on SER-155 development activities and an update on our efforts to obtain additional resources to enable continued advancement of our programs. Seres has continued making meaningful progress toward our mission of bringing novel live biotherapeutic products to patients in need. Our efforts and results to date have clearly demonstrated both the therapeutic power of this modality with highly compelling clinical data sets and 2 breakthrough therapy designations achieved and Seres capabilities to successfully obtain FDA approval. Looking ahead, we are optimistic about the promise of our live biotherapeutics to provide transformative clinical benefits to patients including for serious infections and inflammatory diseases that affect a large patient population. We have advanced preparation of SER-155 for the next stage of development. As a reminder, our previously completed SER-155 Phase Ib study provided highly promising results that supported continued development. The study showed that SER-155 administration resulted in a 77% relative risk reduction in bloodstream infections compared to placebo in patients undergoing allogeneic hematopoietic stem cell transplant or allo-HSCT, resulting in a number needed to treat of 3 to prevent 1 bloodstream infection. This represents a compelling outcome for this high-risk patient population in need of better options. SER-155 was generally well tolerated in the study, consistent with the placebo-like safety profile we've seen historically across our live biotherapeutic product platform. The clinical results generated to date underscore the potential of SER-155 to redefine the standard of care for allo-HSCT recipients and many other vulnerable patient groups at risk of bloodstream infections. Guided by our constructive FDA feedback, we submitted a Phase II protocol to the FDA. we are pleased with the productive interactions we've had with the FDA to date, which have been facilitated by SER-155 having breakthrough therapy designation. The FDA has remained highly engaged and has indicated that they will provide further feedback on the protocol in the near future, which we expect will support finalizing the study design. The proposed Phase II study is designed to be a well-powered, placebo- controlled study with an enrollment goal of approximately 248 participants undergoing allo-HSCT and with the primary endpoint of prevention of bloodstream infections. The study employs an adaptive design with an interim data analysis once approximately half of the enrolled participants have reached the primary endpoint. Based on our operational plans and anticipated enrollment, we believe we could obtain interim results within 12 months of study initiation, thereby rapidly informing next steps in allo-HSCT development, including potential engagement with the FDA on the design of a registrational study. Those data could also support the pursuit of additional clinical development opportunities targeting adjacent patient populations at elevated risk of bloodstream infections such as patients undergoing autologous-HSCT. We believe these indications as well as additional target populations that we have discussed in the past represent multiple substantial commercial opportunities for Seres. If successful, we expect that the results from the planned Phase II study would represent a very meaningful value inflection point for the company and could support advancing to a single registrational study for approval of SER-155 in allo-HSCT. In conjunction with the development of the study protocol, we have continued to progress operational preparations for the study, including commencing study start-up activities with our CRO and advancing the manufacture of clinical supply. We are optimistic about the prospects for SER-155 and our broader pipeline. We are also mindful of the capital and resources required to effectively advance these programs as well as the continued challenging biotech environment. Our immediate top corporate priority is to obtain capital to enable our promising development candidates, starting with SER-155 to progress to meaningful clinical milestones. The types of transactions we are evaluating include partnerships, out-licensing deals, mergers, and other types of structures with counterparties who could provide capital and other resources and which aim to leverage Seres' expertise and track record in successfully bringing a live biotherapeutic product to the market. We are in active discussions with multiple parties aiming to secure a deal. In conjunction with these efforts, we also continue to evaluate potential cost reduction actions to extend our cash runway. With that, I'll turn the call over to Matt to discuss recent scientific progress.

Thanks, Marella. I'd like to review some of our recently presented data from our SER-155 and additional biotherapeutic programs. At the May ASCO meeting, we presented new exploratory biomarker data from the SER-155 Phase Ib study. These biomarker data provided evidence of the potential of SER-155 to promote immune reconstitution following allo-HSCT through the modulation of homeostatic cytokines and peripheral T-cell expansion. The results highlight the potential role of SER-155 in promoting peripheral T-cell recovery and immune reconstitution to support favorable outcomes post allo-HSCT. Based on the SER-155 clinical results to date as well as our other mechanistic data, we believe that SER-155 could provide benefit to a range of patient populations at risk of bloodstream infections and other conditions. I'd like to also provide an overview of our recent activities focused on the development of our live biotherapeutics for the treatment of inflammatory and immune diseases. In May, we presented data at the Digestive Disease Week conference that reported the identification of biomarkers that can identify patients with microbiome driven disease and that can predict response to both existing IBD therapeutics and live biotherapeutic interventions. We were pleased to see that our poster entitled Candidate Biomarkers of Microbiome Disruption for Patient Selection or Stratification in Clinical Trials of microbiome therapies in ulcerative colitis, received a poster Distinction Award in the Microbiome and Microbial Therapy subgroup. We believe that the findings presented support the potential of live biotherapeutics as a novel treatment modality for gut-related inflammatory and immune diseases and suggest that sizable patient subpopulations well-suited for this approach may be identifiable. In conjunction with the partnership opportunities that Marella mentioned, we are exploring potential R&D partnerships to advance our development of our investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease. These conditions impact large patient populations and biotherapeutics could provide a therapeutic approach that is highly differentiated from other drugs that are currently in use or in development with opportunities for both monotherapy and combination therapy. Additionally, the company is collaborating on an investigator-sponsored trial with Memorial Sloan Kettering Cancer Center to evaluate the use of SER-155 for immunotherapy-related enterocolitis, also referred to as IREC. Seres is providing investigational product for the study. IREC is among the most frequent and severe immune-related adverse events and recipients of immune checkpoint inhibitor therapy and is observed in 35% to 50% of patients undergoing this cancer treatment. Immune checkpoint inhibitors can cause a wide range of immune-related adverse events linked to T-cell biology and epithelial barrier inflammation, biological functions known from our preclinical studies and clinical pharmacology data to be positively impacted by SER-155. Positive data from this study would provide further support for the expansion into additional indications likely well suited for our biotherapeutic approach. With that, I'll turn the call back to Marella.

Thank you, Matt. I'll now turn to second quarter financial results. As a reminder, Seres has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statements of operations for the comparative periods presented, and there was no activity in this quarter related to discontinued operations. Seres reported a net loss from continuing operations of $19.9 million in Q2 2025, as compared to $26.2 million in the second quarter of 2024. Research and development expenses for this quarter were $12.9 million compared to $15.8 million in the second quarter of 2024, reflecting lower costs related to the completion of the SER-155 Phase Ib study, lower personnel expenses, and a decrease in platform investments. General and administrative expenses were $10.3 million in the quarter compared to $13.1 million in Q2 2024, driven primarily by lower personnel and related expenses including IT related. In July, we received the $25 million installment payment due from Nestlé as expected. As of June 30, 2025, we had cash and cash equivalents of $45.4 million. Based upon our current cash balance, the $25 million payment received, VOWST transaction-related obligations and current operating plans, we expect to be able to fund operations into the first quarter of 2026. We have implemented and continue to evaluate potential cost reduction actions to extend our cash runway. As I conclude, Tom, I, and the entire Seres team would like to take a moment to acknowledge and thank Eric Shaff for his significant contributions to the company over the past decade. During Eric's tenure, Seres led the maturation of the biotherapeutic field and successfully delivered the first ever FDA-approved oral microbiome therapy to patients. We are pleased to continue benefiting from Eric's perspective as he remains a member of the Seres Board. We also welcome Rob Rosiello, an executive partner at Flagship Pioneering, who will be joining our Board and Paul Biondi also a flagship, transitions off. We thank Paul for his service on the Board. To summarize, we are making good progress advancing SER-155 to enable readiness for the Phase II study. We are also progressing our efforts to secure capital and resources to enable the continued development of SER-155 that could capture substantial therapeutic and commercial opportunities. Operator, you may now open the call for questions.

[Operator Instructions] Your first question comes from the line of Joseph Thome with TD Cowen.

Maybe the first one, just on the potential deals. You obviously indicated a various amount of options with different structures here. I guess how will you decide the best structure for Seres when finishing up a deal, a potential deal going forward? What would be the ideal structure for the team and the investor base in your opinion? And then second, I saw in the corporate deck that you highlighted encouraging feedback from European physicians on SER-155. I guess is there plans to include the EU in the Phase II? And do you believe that the [indiscernible] would accept the trial design that you've been going back and forth on with the FDA.

Great. Good morning, Joe, thank you for your questions. First, with respect to the structure of a BD deal, yes, we are exploring a number of different structures, and there are many types that could make sense for the company. In the first instance, we're looking for an opportunity that provides capital to meaningfully advance our SER-155 program. There also are various capabilities that counterparties bring that would be helpful and additive to our resources and experience, for example, experience conducting a global study. There are also structures, we mentioned mergers as a potential where we could also leverage or the counterparty could leverage the expertise and success that Seres has had getting a product approved through the FDA in the microbiome field. But I'll also offer my co-CEO, Tom, to provide his thoughts.

Yes, sure. Thanks, Marella. Joe, as you recall, for months, we've been talking about our 155 partnership process and that continues. We are having discussions with companies about a somewhat simple partnership process with 155, but interestingly, during that process, a banker called us and suggested that maybe as the leader in the space with all the success we've had with FDA that maybe we would be interested in leading a roll-up of the microbiome company space. That seemed to us to be a bit too complex, but it did get us thinking that perhaps a merger with a live biotherapeutic company with clinical stage assets and a new different set of investors might be an interesting thing to explore, particularly a company who needs our expertise in clinical and regulatory manufacturing. So we actually reached out to a few. And coincidentally or maybe not coincidentally, one reached out to us, and we continue to be in multiple discussions on such a merger. Of course, your question, what would be best for us, we are certainly looking for substantial financial support for what we're doing. And in any such of a merger process, we would need to have it be financeable. But we're optimistic, given the activity that we have going now, we're optimistic that we'll have a deal to decide whether to do and maybe multiple deals to pick from. I'd also say it's been really interesting to hear Commissioner McCari talk about the importance of microbiome, healthy microbiome in the health of the population. And we're excited that FDA is so excited about the microbiome opportunity. So we remain optimistic. As Marella said, the market is tough out there, no guarantees, but we're going to continue to work hard on our BD process.

Thanks, Tom. And your second question regarding EU feedback, yes, we had robust interaction with EU KOLs. Phase II study will be a global study, including European countries. Importantly, the design of the Phase II study is very robust. It's well powered. And so we are excited about the potential receptivity of EMEA, whom we will engage at the appropriate time regarding the study design. But I'll ask Dennis if he has any further comments to add.

Yes. Thank you, Marella. I would like to add that we did have a number of engagement conversations with KOLs in the EU. And we heard the same message that we have heard from our U.S.-based KOLs that is bloodstream infections in this allo-HSCT population are still a major problem and a major unmet need. And every one of them was absolutely excited to be able to participate in a study looking at SER-155 with such a novel approach to a problem that has not been solved yet.

That concludes our Q&A session. I will now turn the call back over to the management for closing remarks.

Thank you very much for joining the call today, and have a great day.

That concludes today's call, ladies and gentlemen. Thank you all for joining. You may now disconnect. Everyone, have a great day.