Seres Therapeutics Q2 2025 Earnings Report

Seres Therapeutics EPS Results

• Actual EPS: -$2.27
• Consensus EPS: -$2.72
• Beat/Miss: Beat by +$0.45
• One Year Ago EPS: N/A

Seres Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $11.75 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Seres Therapeutics Announcement Details

• Quarter: Q2 2025
• Date: 8/6/2025
• Time: Before Market Opens
• Conference Call Date: Wednesday, August 6, 2025
• Conference Call Time: 8:30AM ET

Seres Therapeutics (NASDAQ:MCRB), a microbiome therapeutics company, develop microbiome therapeutics to treat the modulation of the colonic microbiome. It develops a novel class of biological drugs that are designed to treat by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. The company's lead product candidate is VOWST, an oral microbiome therapeutic that has completed Phase III clinical trial for the treatment of recurrent Clostridioides difficile infection. Its product pipeline also includes SER-155, an investigational oral fermented microbiome therapeutic which is in Phase 1b clinical trials for the treatment of gastrointestinal infections, bacteremia, and graft versus host disease in immunocompromised patients including patients receiving allogeneic hematopoietic stem cell transplantation. In addition, the company engages in the development of SER-287 which is in Phase 2b and SER-301 that is in Phase 1b to treat ulcerative colitis. Further, it has license Agreement with NHSc Rx License GmbH for the therapeutic products based on the microbiome technology, which includes VOWST product candidate, which is developed for the treatment of CDI and recurrent CDI; and collaboration license agreement with Société des Produits Nestlé S.A. (Nestlé) for the development and commercialization of certain product candidates for the treatment and management of CDI and inflammatory bowel disease including UC and Crohn's disease. The company was formerly known as Seres Health, Inc. and changed its name to Seres Therapeutics, Inc. in May 2015. Seres Therapeutics, Inc. was incorporated in 2010 and is headquartered in Cambridge, Massachusetts.

Seres Therapeutics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: The Phase Ib study of SER-155 showed a 77% relative risk reduction in bloodstream infections with a number needed to treat of three and a placebo-like safety profile in allogeneic HSCT patients.
• Positive Sentiment: Seres submitted a Phase II protocol for SER-155 to the FDA under its breakthrough therapy designation, aiming to enroll about 248 allo HSCT patients with an adaptive design and expected interim results within 12 months.
• Negative Sentiment: The company recorded a net loss of $19.9 million in Q2 2025 and is actively pursuing partnerships, in-licensing, or mergers to secure additional capital while evaluating cost reduction measures to extend its cash runway.
• Neutral Sentiment: Seres reported $45.4 million in cash as of June 30, 2025, including a $25 million installment from Nestlé, and expects current resources to fund operations into 2026.
• Neutral Sentiment: The company highlighted new biomarker and mechanistic data across its live biotherapeutics pipeline, including IBD patient stratification findings and an investigator-sponsored study of SER-155 for immunotherapy-related enterocolitis.

Presentation

[Operator]

Good morning, and welcome to the Seres Therapeutics Second Quarter twenty twenty five Results and Business Update Call. At this time, all participants are in a listen only mode. A question and answer session will follow the prepared remarks. Please note this call is being recorded. I would now like to turn the conference over to Doctor. Carlo Tanzi of Investor Relations. Please go ahead.

[Carlo Tanzi, Principal & Founder at Kendall Investor Relations]

Thank you, and good morning. Our press release with the company's second quarter twenty twenty five financial results and business updates became available at 7AM 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 valve 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.

[Carlo Tanzi, Principal & Founder at Kendall Investor Relations]

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 Morella Thorel, Co CEO and CFO and Matthew Penn, Chief Scientific Officer. Additional members of the management team, Tom DeRosier, Co CEO and Chief Legal Officer Teri Young, Chief Commercial and Strategy Officer and Dennis Walling, M.

[Carlo Tanzi, Principal & Founder at Kendall Investor Relations]

D, Senior Medical Senior Vice President of Clinical Development will also be available during the Q and A portion of the call. And with that, I'll pass the call on to Morello.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

Thank you, Carlo, and good morning, everyone. Today, we'll share recent business highlights, progress on SER-one 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 two 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 populations.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

We have advanced preparation of SER-one hundred fifty five for the next stage of development. As a reminder, our previously completed SER-one hundred fifty five Phase Ib study provided highly promising results that supported continued development. The study showed that SER-one hundred fifty five administration resulted in a seventy seven percent 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 three to prevent one bloodstream infection. This represents a compelling outcome for this high risk patient population in need of better options. SER-one hundred fifty five was generally well tolerated in the study consistent with the placebo like safety profile we've seen historically across our live biotherapeutic product platform.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

The clinical results generated to date underscore the potential of CR-one hundred fifty five 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 CR-one hundred fifty five 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 two forty eight participants undergoing Allo HSCT and with the primary endpoint of prevention of bloodstream infections.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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 twelve 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 two study would represent a very meaningful value inflection point for the company and could support advancing to a single registrational study for approval of CR-one hundred fifty five in allo HSCT.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

In conjunction with the development of the study protocol, we have continued to progress operational preparations for the study, including commencing study startup activities with our CRO and advancing the manufacture of clinical supply. We are optimistic about the prospects for SER-one 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 CR-one 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.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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.

[Matthew Henn, EVP & Chief Scientific Officer at Seres Therapeutics]

Thanks, Mirella. I'd like to review some of our recently presented data from our SER-one hundred fifty five and additional biotherapeutic programs. At the May ASCO meeting, we presented new exploratory biomarker data from the SER-one 155 Phase 1b study. These biomarker data provided evidence of the potential of SER-one hundred fifty five to promote immune reconstitution following allo HSCT through the modulation of homeostatic cytokines and peripheral T cell expansion. The results highlight the potential of role of SER-one hundred fifty five in promoting peripheral T cell recovery and immune reconstitution to support favorable outcomes post allo HSCT.

[Matthew Henn, EVP & Chief Scientific Officer at Seres Therapeutics]

Based on the SER-one hundred fifty five clinical results to date, as well as our other mechanistic data, we believe that SER-one hundred fifty five 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 of 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 of reality for gut related inflammatory and immune diseases and suggest that sizable patient subpopulations well suited for this approach may be identified.

[Matthew Henn, EVP & Chief Scientific Officer at Seres Therapeutics]

In conjunction with the partnership opportunities that Morella mentioned, we are exploring potential R and 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-one hundred fifty five 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 thirty five percent to fifty percent of patients undergoing this cancer treatment.

[Matthew Henn, EVP & Chief Scientific Officer at Seres Therapeutics]

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 known from our preclinical studies and clinical pharmacology data to be positively impacted by SER-one 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 Merle.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

Thank you, Matt. I'll now turn to second quarter financial results. As a reminder, Seres has classified all historical operating results for the Voust 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 $19,900,000 in Q2 twenty twenty five as compared to $26,200,000 in the 2024. Research and development expenses for this quarter were $12,900,000 compared to $15,800,000 in the 2024, reflecting lower costs related to the completion of the SER-one 155 Phase 1b study, lower personnel expenses and a decrease in platform investments.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

General and administrative expenses were $10,300,000 in the quarter compared to $13,100,000 in Q2 twenty twenty four, driven primarily by lower personnel and related expenses including IT related. In July, we received the 25,000,000 installment payment due from Nestle as expected. As of 06/30/2025, we had cash and cash equivalents of $45,400,000 Based upon our current cash balance, the $25,000,000 payment received, voused transaction related obligations and current operating plans, we expect to be able to fund operations into the 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 Schaff for his significant contributions to the company over the past decade.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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 Rossello, an Executive Partner at Flagship Pioneering, who will be joining our Board as Paul Biondi, also of Flagship, transitions off. We thank Paul for his service on the Board. To summarize, we are making good progress advancing SER-one 155 to enable readiness for the Phase II study.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

We are also progressing our efforts to secure capital and resources to enable the continued development of CR-one 155 that could capture substantial therapeutic and commercial opportunities. Operator, you may now open the call for questions.

[Operator]

Your first question comes from the line of Joseph Thome with T. D. Cowen. Please go ahead. Your line is now open.

[Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen]

Hi, there. Good morning and thank you for taking my questions. 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?

[Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen]

What would be the ideal structure for the team, and the investor base, in your opinion? And then second, I saw on the corporate deck that you highlighted encouraging feedback from European physicians on SER-one 155. I guess is there plans to include the EU in the Phase II? And do you believe that the EMA would accept the trial design that you've been going back and forth on with the FDA? Thank you.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

Great. Good morning, Joe, and 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-one 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.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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.

[Thomas DesRosier, Co-President, Co-Ceo , Chief Legal Officer & Secretary at Seres Therapeutics]

Yes, sure. Thanks, Marella. Hey, Joe. As you recall for months, we've been talking about our one hundred fifty five partnership process and that continues. We are having discussions with companies about somewhat simple partnership process with one hundred fifty five.

[Thomas DesRosier, Co-President, Co-Ceo , Chief Legal Officer & Secretary at Seres Therapeutics]

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.

[Thomas DesRosier, Co-President, Co-Ceo , Chief Legal Officer & Secretary at Seres Therapeutics]

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 McCarray 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 Morella said the market is tough out there, no guarantees, but we're going to continue to work hard on our BD process.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

Thanks Tom. And your second question regarding EU feedback. Yes, we've had robust interaction with EU KOLs. These two studies will be a global study including European countries. Importantly, the design of the Phase two study is very robust.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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.

[Dennis Walling, SVP - Clinical Development at Seres Therapeutics]

Yes, thank you, Morella. 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 US based KOLs that is bloodstream infections in this alloHSCT 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-one 155 with such a novel approach to a problem that has not been solved yet.

[Matthew Henn, EVP & Chief Scientific Officer at Seres Therapeutics]

Perfect. Thank you so much.

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

Thank you, Joe.

[Operator]

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

[Marella Thorell, Co-CEO, Co-President & CFO at Seres Therapeutics]

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

[Operator]

That concludes today's call. Ladies and gentlemen, thank you all for joining. You may now everyone, have a great day.

Participants

Executives

• Marella Thorell, Co-CEO, Co-President & CFO
• Matthew Henn, EVP & Chief Scientific Officer
• Thomas DesRosier, Co-President, Co-Ceo , Chief Legal Officer & Secretary
• Dennis Walling, SVP - Clinical Development

Analysts

• Carlo Tanzi, Principal & Founder at Kendall Investor Relations
• Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen