Q2 2025 Seres Therapeutics Inc Earnings Call

Good morning and welcome to the series therapeutic. Second quarter, 2025 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 Dr. Carlo 10 of investor relations, please go ahead.

Thank you and good morning. Our press release for the company's second quarter, 2025 Financial results and business updates became available at 7 a.m. eastern time this morning and can be found on the investors and new section of the company's website. The company is also posted an updated corporate presentation to the website. I'd like to remind you that we will 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.

And with that, I'll pass the call on to Mela.

Thank you, Carla, and good morning everyone. Today, we'll share recent business. Highlights progress on Sierra, 155 development activities and an update on our efforts to obtain additional resources to enable continued advancement of our programs.

Series has continued making meaningful progress toward our mission of bringing novel live biotherapy 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 series capabilities to successfully obtain FDA approval, looking ahead. We are optimistic about the promise of our live bio Therapeutics to provide transformative clinical benefits to patients including for serious infections and inflammatory diseases that affect a large patient populations.

We have advanced preparation of CR 155 for the next stage of development. As a reminder, our previously completed CR 155 Phase 1B study provided highly promising results that supported continued development. The study showed that CR 155 administration resulted in a 77% relative risk reduction in bloodstream infections.

Compared to Placebo, in patients undergoing allergenic.

This represents a compelling outcome for this. High-risk patient population in need of better options.

CR 155 was generally, well, tolerated in the study consisted with the placebo, like safety profile. We've seen historically across our live bio, therapeutic product platform.

the clinical results generated to date underscore the potential of CR, 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 2 protocol to the FDA. We are pleased with the productive interactions we've had with the FDA to date, which have been facilitated by cr15, having breakthrough therapy, designation

The FDA has remained highly engaged and has indicated that they will provide further forward feedback on the protocol in the near future, which we expect will support finalizing, the study design.

The proposed Phase 2 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 lohs development, including potential engagement with the FDA on the design of the 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 series.

If successful, we expect that the results from the planned Phase 2 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, 155, and Allo, HSCT.

In conjunction.

We are optimistic about the process, prospects for Sierra 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 Sierra 155.

To progress to meaningful clinical milestones.

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 series expertise and track records. In successfully, bringing a live bio therapeutic product to the market

We are an active discussion 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 Mella.

I'd like to review some of our recently presented data from our seir, 155, an additional bio therapeutic programs. At the May ASCO meeting we presented new exploratory, biomarker data, from The Seer 155, phase 1B study.

These biomarker data provided evidence of the potential of Sir. 155, to promote immune, reconstitution following allo, hsct through the modulation of homeostatic Saito and peripheral T-cell expansion.

The results highlight the potential of role of 0155 and promoting peripheral T Cell recovery and immune reconstitution to support, favorable outcomes post, Allo hsct,

Based on the S15 clinical results to date, as well as our other mechanistic data, we believe that SEIR 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. Bio Therapeutics 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 and 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 bio Therapeutics as a novel treatment, note validity for gut related, inflammatory, and immune diseases, and suggests that sizable patient. Subpopulations. Well, suited for this approach may be identifiable.

In conjunction with the partnership opportunities that Mela mentioned, we are exploring potential. R&D Partnerships to advance our development of our investigational live bio Therapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease,

These conditions impact, large, patient, populations and bio Therapeutics 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 the Memorial Sloan Kettering Cancer Center to evaluate the use of seir, 155 for immunotherapy related, entropy also referred to as irec.

Series is providing investigational product for the study.

I wreck 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 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 Sir 1 155.

Positive data from this study would provide further support for the expansion into additional indications. Likely, well suited for our bio therapeutic approach with that, I'll turn the call back tomorrow.

Has classified all historical operating results for the vast 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.

Series 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 CR. 155 phase 1B 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 Nestle as expected as of June 30th 2025. We had cash and cash equivalents of 45.4 million.

based upon our current cash balance, the 25 million payment received

Vast transaction related obligations and current operating plans. We expect to be able to fund operations in 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 Series team would like to take a moment to acknowledge and thank Eric schaaf for his significant contributions to the company. Over the past decade during Eric's tenure series LED the maturation of the Pio therapeutic 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 series board.

We also welcome Rob rossiello, an executive partner at Flagship pioneering who will be joining our board as Paul biondi. Also, a flagship transitions off,

We thank Paul for his service on the board.

To summarize. We are making good progress advancing CR, 155 to enable Readiness for the phase 2 study.

We are also progressing our efforts to secure capital and resources to enable the continued development of CR 155, which could capture substantial therapeutic and commercial opportunities.

Operator. You may now open the call for questions.

At this time, I would like to remind everyone in order to ask a question. Press star, then the number 1 on your telephone keypad. We will pause for just a moment to compile the Q&A roster.

Your first question comes from the line of Joseph foam with TD cowins. Please go ahead. The Line is now open

Hi there. Good morning, and thank you for taking my questions. Um, maybe the first 1, just on the potential deals, obviously indicated, a, a various, uh, amount of options with different structures here. I guess, how will you decide the best structure, um, for series? When when finishing up a deal, a potential deal going forward, what what would be the ideal structure for the team? Um,

And the investor base, uh, in your opinion. And then second, um, I saw in the corporate deck that you highlighted, encouraging feedback from European Physicians on s155. Um, I guess is there plans to include the EU in the phase 2? Um, and do you believe that the, uh, the EMA would accept, uh, the, the trial design that you've been going back and forth on with the um, the FDA? Thank you.

Would be helpful and um additive to uh to our resources and experience. For example uh experience conducting a global study. Um there are also structures. We mentioned mergers as a potential where we could also uh, leverage or the counterparty could Leverage The expertise and success. That Series has had getting a product approved through the FDA in the microbiome field. Um, but I lost also offer my co-ceo Tom to uh to provide his thoughts.

Yes, sure. Thanks morala. Hey Joe, uh

The um, as as you recall from months, we've uh, been talking about our 155 partnership process. Uh and that continues. We are having discussions with companies about uh uh somewhat simple partnership process with 155. But interestingly during that process, uh, a banker called us and um, and suggested that maybe as the leader in the space, uh, with all the success we've had with FDA that maybe we would be interested in interested in, uh, leading a rollup of the microbiome company space. Um,

That uh seemed to us to be a bit a bit too complex. Uh, but it did get us thinking that

Perhaps a merger with a live bio therapeutic company with clinical stage assets and a new different set of investors. Uh might uh, might be an interesting thing to uh, to explore. Particularly a company who needs our expertise in clinical and Regulatory and Manufacturing. So we actually reached out to a few and coincidentally or maybe not coincidentally 1 reached out to us. Uh and we continue to be in multiple discussions on on uh such a merger. Uh of of course,

Your question, what would be best for us? Uh, we are certainly looking for substantial financial support for what we're doing and in any such of a merger process. Uh, we would need to have it be financeable. Uh, but but we're optimistic given the activity that we have going. Now we're optimistic that that will will have a deal to decide whether to do and maybe multiple deals to pick from. Uh, I'd also say, it's been really interesting to hear commissioner McCary talk about the importance of microbiome healthy microbiome in, in the health of, of, of the population. And we're excited that FDA is so excited about the microbiome opportunity. Uh, so we, uh, we we remain optimistic as Morales.

Said, the Market's tough out there, no guarantees, but, uh, we're going to continue to work hard on our on our BD process.

Thanks Tom and your second question regarding EU feedback. Yes, we've had robust interaction with the EU kol's. They have been to study will be a global study uh including uh European countries. Uh, importantly, the design of the phase 2 study is very robust. It's well powered. And so um, we are excited about um you know, the potential receptivity of EMA whom we will engage at at the appropriate time, uh, regarding the study design, but I'll ask Dennis if he has any further, uh, comments to add.

Yes, thank you Mela. Um I would like to add that uh you know, we did have a number of Engagement conversations with uh kol's in the EU and we heard the same message that we have heard from our us-based. Kols that is bloodstream infections. Um, in this uh, lhsc population are still a major problem and a major unmet need and you know, they they every 1 of them was absolutely uh, you know, excited to be able to participate in um, a study looking at c155 with, with such a a novel, uh, approach to a problem that has not been solved yet.

Perfect, thank you so much.

Thank you, Joe.

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.

Everyone have a great day.