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Seres Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed May 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 5, 2026

MCRB$1.98-5.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0001193125-25-266011

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-05.

0001193125-26-205434

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 202 previous paragraphs and 179 current paragraphs.

93 unchanged; 45 reworded; 40 added; 50 removed; 14 previous and 1 current paragraphs rearranged.

Tables are not compared: 7 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (40)

Current report

We are a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through discovery and development of novel live biotherapeutic product, or LBP, candidates. We led the successful development and approval of VOWST, the first FDA-approved orally administered microbiome biotherapeutic and a Breakthrough Therapy designated drug, which was sold to Société des Produits Nestlé S.A., or SPN, and with certain of its affiliates, collectively, Nestlé Health Science, in September 2024. We have established field-leading capabilities and platforms that are powered by best-in-field human data sets to advance a portfolio of products that can uniquely address diseases by targeting host pathways that are modulated by microbes in the human body, and, in particular, diseases associated with mucosal barrier-immune interface targets. We believe clinical and nonclinical data across our programs support the development of LBPs to target the prevention and treatment of a broad swath of infections, and to treat inflammatory and immune, or I&I, diseases. Our pipeline consists of SER-155, SER-603, SER-428, and SER-147, as well as other potential candidates in earlier development.

Current report

Our current strategy prioritizes advancing our programs that target I&I indications. We have meaningfully advanced over the past decade our scientific understanding of how microbes in the GI functionally modulate pathways at the mucosal barrier-immune interface that are associated with inflammatory and immune-related disease. The clinical data from our SER-155 Phase 1b study in allo-HSCT, along with our extensive preclinical and translational clinical data compiled over the past decade support and inform the advancement of our earlier stage programs targeting I&I diseases. We are evaluating SER-155 in immune checkpoint-related enterocolitis, or irEC, through an investigator-sponsored trial, or IST, with Memorial Sloan Kettering Cancer Center, an institution with whom we have had a decade-long collaboration. irEC is among the most frequent and severe immune-related adverse events, or irAEs, in recipients of immune checkpoint inhibitor, or ICI, therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. We expect to report initial clinical results, including preliminary safety, efficacy, pharmacology, and exploratory biomarker data in the coming weeks. We believe data from this IST could further support the potential for live biotherapeutics to address a significant unmet need among the large population of cancer patients receiving ICIs and may further support evaluation of our biotherapeutic approach in this setting. We are also developing SER-603, broadly in inflammatory bowel disease, or IBD, including ulcerative colitis, or UC, and Crohn's disease. SER-603 is a novel, LBP candidate optimized to address disruptions in the GI microbiome and to improve GI mucosal barrier integrity through the inhibition of inflammatory bacteria and associated metabolites, the promotion of epithelial barrier integrity to reduce the translocation of inflammatory molecules and barrier inflammation, and to induce immune homeostasis through non-immunosuppressive regulatory T cell, or T-reg, induction via T cell signaling. We believe that our LBPs could represent a non-immunosuppressive treatment option for I&I diseases that are linked to colitis and could broadly address immune therapy toxicities, both of which represent significant unmet medical needs and potential commercial opportunities. We are currently exploring potential collaborations related to those I&I disease programs.

Current report

Emerging clinical and preclinical evidence suggests that microbiome functional disruption contributes to disease activity in a defined subset of IBD patients. Observational and translational data from our prior SER-287 Phase 2b study and SER-301 Phase 1b study indicate that pharmacodynamic responses were greater in microbiome-defined subpopulations. These findings, along with external data demonstrating heterogeneity in microbiome-associated inflammatory responses, support the development of targeted, biomarker-informed live biotherapeutic strategies. We have discovered more than fifty GI bacterial features linked to inflammatory outcomes and have nominated and validated microbe associated biomarkers that can predict a response to current advanced therapies for IBD. Leveraging these biomarkers and our integrated preclinical and clinical data sets, SER-603 is optimized to address epithelial barrier dysfunction and microbiome-driven inflammation without systemic immunosuppression.

Current report

SER-603 is in preclinical development, with IND-enabling activities ongoing. SER-603 is being developed for use as a stand-alone therapy and/or as a mechanism-distinct adjunctive therapy in combination with biologics or small molecules. We continue to evaluate biomarker-based patient selection approaches and functional characterization strategies to inform future clinical development.

Current report

In April 2026, Dr. Ines Moura of the University of Leeds gave a presentation at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) global congress describing the use of an in vitro colonic model (MiGut) to recapitulate patient-specific microbiome composition and inflammatory responses in IBD. We are co-developing with Leeds models to evaluate drug strain engraftment in different patient microbiome backgrounds and measure resulting metabolic and immune functional responses. The collaboration with Leeds on MiGut enables the modeling of patient stratification, conditioning, and live biotherapeutic effects in a pharmacological model, to inform clinical development in IBD and broader opportunities in other diseases.

Current report

In May 2026, we presented data at the Digestive Disease Week, or DDW conference highlighting preclinical data supporting the design and potential of SER-603 in IBD. The poster, titled “The Rational Design of SER-603: A Next Generation Cultivated Microbial Consortia to Treat IBD,” which was selected as a DDW ‘Poster of Distinction,’ highlights our integrated approach to the design of microbiome therapeutics, combining rational strain selection and biomarker-driven patient stratification. SER-603 incorporates strains selected for engraftment and delivery of clinically relevant metabolites, including short-chain fatty acids, secondary bile acids, and tryptophan-derived molecules, with a therapeutic goal of inducing mucosal healing and regulating inflammatory pathways central to IBD pathophysiology, without immunosuppression. Its design integrates insights from human clinical datasets and reverse translational approaches to identify strains linked to key functional outputs, potentially enabling targeted modulation of inflammatory microbiome features, and is complemented by microbiome-based biomarkers associated with GI inflammation, to support patient stratification and to enrich for those patients most likely to benefit.

Current report

We are nearing completion of a single-arm, open-label Phase 1b investigator-sponsored trial conducted with Memorial Sloan Kettering Cancer Center evaluating SER-155 as first-line treatment of irEC. The study was fully enrolled (n=15) in the first quarter of 2026, and we expect to report initial clinical results, including preliminary safety, efficacy, pharmacology, and exploratory biomarker data in the coming weeks. We believe data from this IST could further support the potential for live biotherapeutics to address a significant unmet need among the large population of cancer patients receiving ICIs and may further support evaluation of our biotherapeutic approach in this setting.

Current report

We believe this approach may also enable us to reduce AMR, which the World Health Organization declared as a top ten global public health threat facing humanity, and with estimates that yearly deaths may reach 10 million by 2050, putting mortality due to AMR on par with deaths due to cancer. Recently, two manuscripts were published in Nature Medicine (Bryant et al. 2026) and the Journal of Infectious Diseases(Bryant et al. 2025) highlighting new insights into the functional mechanism and clinical impact of VOWST. The Nature Medicine article, titled “The impact of an oral purified microbiome therapeutic on the GI microbiome”, confirmed our pharmacological hypotheses from earlier VOWST studies, with higher VOWST dosing associated with enhanced pharmacokinetics, as assessed by faster and more robust therapeutic species engraftment in the gut. Treatment also significantly altered the composition of the intestinal microbiome and microbe-associated metabolites, including decreased primary and increased secondary bile acids, as well as elevated short- and medium-chain fatty acids, functional changes that inhibit C. difficile spore germination and vegetative growth. Further, in vitro analyses confirmed that VOWST batches induced production of these metabolites that disrupt C. difficile life cycle and growth. Collectively, these findings support VOWST’s role in restoring microbe-associated metabolic functions critical to preventing CDI recurrence. A complementary publication in the Journal of Infectious Diseases, titled “Comparability of Gastrointestinal Microbiome and Bile Acid Profiles in Patients With First or Multiply Recurrent Clostridioides difficile Infection”, reported a post hoc analysis of the ECOSPOR IV Phase 3 trial, evaluating differences in gastrointestinal microbiome and bile acid profiles between patients experiencing a first recurrence C. difficile infection (frCDI) versus multiply recurrence infection (mrCDI). These data demonstrate that the underlying functional disease etiology is consistent in both first and multiply recurrent CDI patient populations, with VOWST demonstrating similar efficacy and drug pharmacology across the broad patient population.

Current report

We believe these data provide important clinical translation and further demonstrate the potential of live biotherapeutics to target specific microbiome functions that are linked to serious disease, including those that are not effectively treated with other drug modalities. The underlying data supporting these publications was developed using Seres' MbTx platform, which provides high-resolution assessment of drug pharmacology and functional mechanism of action. These data on bacterial function and pharmacology anchored the preclinical development of SER-155 and inform the continued development of Seres’ pipeline of next-generation live biotherapeutic products.

Current report

SER-155 Phase 1b Study (including placebo-controlled Cohort)

Current report

In April 2026, we presented SER-155 Phase 1b study results, including biomarker and clinical pharmacology data, at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) global congress. Data showed that administration of SER-155 induced a significant and durable shift in GI microbiome composition relative to placebo, characterized by high relative abundance of SER-155 species. This shift is associated with improved GI epithelial barrier integrity that could reduce the likelihood of bacterial translocation from the GI to the bloodstream. These pharmacology results are consistent with the intended SER-155 mechanisms of action as well as the observation of significantly lower bloodstream infection incidence post allo-HCT in SER-155-administered participants.

Current report

Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HSCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Current report

Infections with pathogenic, often MDR, bacteria are the leading cause of mortality in the medical ICU, causing up to 9 deaths for every 100 ICU patients admitted (Vincent, 2009). Most patients are admitted to the medical ICU with a known or suspected infection (i.e., sepsis) but, with targeted or empiric antibiotics, most recover from this initial infection. Once in the ICU, secondary, healthcare-associated infections frequently develop during the prolonged recovery from sepsis and are a significant driver of mortality. SER-428 is a novel approach that addresses both gut colonization and subsequent translocation by E. coli and other gut-derived pathogens to prevent a significant proportion of these secondary hospital acquired infections. SER-428 is in preclinical development, with IND-enabling activities ongoing and IND-readiness targeted by the end of 2026. We have advanced development and manufacturing of SER-428 and are designing a Phase 1b open label trial in collaboration with Columbia University to evaluate this therapeutic candidate in medical ICU patients at high risk of infection.

Current report

In the advanced stages of CLD, known as decompensated cirrhosis, patients exhibit significant immune dysfunction, microbiome disruption, and increased contact with the healthcare system, all of which drive increased susceptibility to bacterial infections such as SBP and BSIs (Bajaj et al., 2021, Albillos et al., 2022). Over 40% of patients with decompensated cirrhosis experience an infection within the first year of diagnosis. Antibiotics are the only prophylactic option for patients at high risk of infections like SBP, resulting in exposure to antibiotics for months or years. To combat increasing rates of AMR, antibacterial prophylaxis for primary SBP is no longer recommended for the majority of patients outside of those at very high-risk, leaving significant unmet need. Many cultivated live biotherapeutics currently in clinic are constrained by formulation technologies incompatible with concomitant medications commonly used in CLD.

Current report

SER-147 is in preclinical development. The program is ready to progress to IND-enabling activities, including manufacturing, in order to advance to clinical development, pending availability of funding.

Current report

We provided the manufacturing services until December 31, 2025. We do not expect to incur any expenses related to manufacturing services related to the VOWST business in the future, as the TSA and other Transaction-related obligations concluded on December 31, 2025.

Current report

Research and development expenses were $13.2 million for the three months ended March 31, 2026 and $11.8 million for the three months ended March 31, 2025. The increase of $1.4 million was primarily due to the following:

Current report

an increase of $1.4 million in expenses related to our live biotherapeutics platform and research and development operations primarily due to the conclusion of the TSA with Nestlé as of December 31, 2025, under which a portion of our facility costs and other operational costs were included within manufacturing services expenses and were reimbursed by Nestlé in 2025, and

Current report

an increase of $0.1 million in expenses related to our SER-155 program due to startup activities performed for the SER-155 Phase 2 study in allo-HSCT, prior to the pause in investment announced in February 2026, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance,

Current report

an increase of $0.1 million in expenses related to our early stage programs primarily related to activities associated with the development of SER-428, for which the related reimbursements received from CARB-X are included within grant revenue, partially offset by

Current report

a decrease in personnel-related costs of $0.2 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expense of $1.5 million due to lower headcount, partially offset by an increase of $0.6 million of severance expense related to the cost reduction actions announced in February 2026 and an increase of

Current report

$0.7 million related to personnel costs for employees providing manufacturing services related to VOWST in 2025 that were reimbursed by Nestlé who were performing research and development activities in 2026.

Current report

a decrease in professional fees of $1.4 million due to lower legal and consulting fees, and

Current report

During the three months ended March 31, 2026, there was no net cash used in investing activities.

Current report

invest in our early-stage pipeline product candidates, including SER-603 in IBD and SER-155 in irEC;

Current report

conduct clinical trials for SER-155 in allo-HSCT and other medically vulnerable populations, including potentially SER-428 in ICU patients;
Removed paragraphs (50)

Previous report

We are a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. We led the successful development and approval of VOWST, the first FDA-approved orally administered microbiome therapeutic, which was sold to Société des Produits Nestlé S.A., or SPN, and with certain of its affiliates, collectively, Nestlé Health Science, in September 2024. We are progressing the development of SER-155, an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal, or GI, pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial bloodstream infections, or BSIs, including those that can harbor antimicrobial resistance, or AMR, as well as other pathogen-associated negative clinical outcomes in patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HSCT. We also continue to develop another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including chronic liver disease, or CLD. SER-155 and our other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via single-strain cultivation, rather than from the donor-sourced production process used for VOWST.

Previous report

On July 17, 2025, Eric D. Shaff, President, Chief Executive Officer and Director of the Company, resigned from his positions as President and Chief Executive Officer of the Company, effective July 31, 2025 (the “Effective Date”). Mr. Shaff continues in his role as a Class I member of the Company’s board of directors (the “Board“). As of the Effective Date, each of the Company’s Executive Vice President and Chief Financial Officer, Marella Thorell, and the Company’s Executive Vice President and Chief Legal Officer, Thomas J. DesRosier, were appointed as the Co-Presidents and Co-Chief Executive Officers of the Company.

Previous report

VOWST (previously referred to as SER-109) was approved by the FDA on April 26, 2023, to prevent recurrence of CDI in individuals 18 years of age or older following antibacterial treatment for recurrent CDI. We launched VOWST in the United States with our then collaborator, Nestlé Health Science, in June 2023. On August 5, 2024, we entered into an Asset Purchase Agreement, or Purchase Agreement, with Société des Produits Nestlé S.A., or SPN, a wholly-owned subsidiary of Nestlé S.A., pursuant to which, after approval by our stockholders at a special meeting of stockholders held on September 26, 2024, we sold our VOWST microbiome therapeutic business, or the VOWST Business, to SPN and its designated affiliates on September 30, 2024, or the Transaction. Following the completion of the Transaction, or the Closing, our headcount decreased by approximately 100 employees, principally due to the transition of manufacturing and quality team members from Seres to Nestlé Health Science, positioning us to efficiently progress SER-155 and our other wholly-owned cultivated live biotherapeutic candidates.

Previous report

See Risk Factors— Risks Related to Our Financial Position and Need for Additional Capital— The total amount of the Milestone Payments we may receive from the Transaction, and the amounts payable or due under the Profit Sharing Payments, are subject to various risks and uncertainties.

Previous report

We and SPN share 50/50 in the net profit or net loss achieved during the period from the Closing Date until December 31, 2025, or the Profit Sharing Period, with the net profit or net loss calculated as (i) the net sales of VOWST in the United States and Canada, plus (ii) other income received in connection with the grant of a license or sublicense with respect to VOWST in the United States and Canada as described in the Purchase Agreement, minus (iii) allowable expenses directly attributable or reasonably allocable to certain development activities, commercialization activities, medical affairs activities, manufacturing activities or other relevant activities, as described in the Purchase Agreement. During the Profit Sharing Period, we will reimburse SPN for (i) certain payments under the exclusive license agreement between us and Memorial Sloan Kettering Cancer Center, (ii) certain costs incurred in connection with an ongoing post-marketing safety study of VOWST and (iii) 80.1% of all rent and other costs due to the landlord under the lease for our Waltham facility.

Previous report

We estimated the costs associated with these future payments and recorded them within accrued liabilities due to SPN - related party on our condensed consolidated balance sheets as of the Closing. The contingent liabilities are remeasured at each reporting period based on (i) cash payments made by the Company to reduce the accrued liabilities due to SPN - related party and (ii) revised estimates of the total remaining liabilities due to SPN - related party. As of September 30, 2025, the contingent liabilities included $1.7 million associated with the Profit Sharing Payments, $2.2 million associated with the MSK Agreement, $0.4 million associated with our obligation to pay 80.1% of the costs associated with the lease of the Waltham facility through December 31, 2025, and $0.2 million associated with the ongoing post-marketing safety study of VOWST. We recorded a gain of $2.2 million for the three months ended September 30, 2025 primarily as a result of SPN's actual and forecasted Profit Sharing Payments as compared to the previous estimate.

Previous report

At Closing, in exchange for a payment to be made by SPN to Bacthera AG, the Long Term Manufacturing Agreement, dated November 8, 2021, between the Company and Bacthera AG, or the Bacthera Manufacturing Agreement, was terminated and each of Bacthera and Seres released one another from any and losses, liabilities or other obligations arising thereunder with respect to the period ending as of the Closing Date, including without limitation any milestone payments required to be paid to Bacthera thereunder.

Previous report

In connection with the Closing, we and SPN entered into a securities purchase agreement, or the Securities Purchase Agreement, pursuant to which SPN purchased 714,285 shares of our common stock, or the Shares, at Closing, at a purchase price per share of $21.00, for an aggregate purchase price of $15 million. Under the terms of the Securities Purchase Agreement, SPN agreed not to sell or transfer the Shares for a period of six months after Closing, subject to certain customary exceptions. We agreed to register the resale of the Shares by SPN within 90 days of Closing. On October 1, 2024, we filed a registration statement to register the Shares, which became effective on October 11, 2024. In addition, under the terms of the Securities Purchase Agreement, for as long as SPN, together with its affiliates, beneficially owns at least 10% of our outstanding shares of common stock, we agreed to take such action within our control to include one individual designated by SPN in the slate of nominees recommended by our Board (or the applicable committee of the board of directors) to our stockholders for election to the Board at the applicable stockholder meeting. SPN designated Hans-Juergen Woerle, M.D., Ph.D., and on February 4, 2025, our Board appointed Dr. Woerle to the Board as a Class III director, with a term expiring at our 2027 annual meeting of stockholders. The Securities Purchase Agreement contains customary representations and warranties and closing conditions.

Previous report

In connection with the Closing, we entered into a Transition Services Agreement, or the TSA, with NESA, which provides for services to be performed by us in order to facilitate a transition of the business associated with the VOWST Business to NESA and its affiliates. The scope of the transition services includes the provision of certain manufacturing services and certain administrative functions related to the VOWST Business and operations, including the maintenance of certain manufacturing services and the related facility in which such services are currently conducted. NESA has agreed to pay us for certain fixed costs, including a monthly fixed fee and a variable per batch fee for preserved raw material suspension manufacturing, or PRMS, and will reimburse us for certain costs of the transition services performed by us under the TSA, including labor. We will provide the manufacturing services until December 31, 2025 and other services for the duration specified in the schedule to the TSA for each service. Following the completion of PRMS manufacturing in the second quarter of 2025, manufacturing services primarily consist of costs incurred to ensure compliance of the facility and management of in-process inventories and samples. The know-how and other intellectual property generated in connection with the performance of the TSA will be owned by NESA with us having a non-exclusive license to such know-how and other intellectual property under the Cross-License Agreement. During the term of the TSA, upon NESA's request, we will transfer the specifications for materials and documentation necessary to enable PRMS manufacturing services to a third party service provider designated by NESA. In the event of a material failure by us to deliver PRMS under the TSA, NESA will have step-in rights to negotiate to enter into a direct lease with the landlord of the manufacturing facility with respect to the portion of such facility used in connection with the VOWST Business or to cause such services to be performed, with any reasonable out-of-pocket costs and expenses incurred in connection therewith reimbursed by us.

Previous report

In connection with the Closing, the parties entered into assignment and assumption of lease agreements, or the Assignment and Assumption Agreements. Under the Assignment and Assumption Agreements, we assigned to SPN or its designated affiliates, our rights in, to and under certain real property leases, and SPN or its designated affiliates assumed the liabilities related thereto.

Previous report

In connection with the Closing, the parties entered into an employee support agreement, or the Employee Support Agreement. Under the Employee Support Agreement, among other things and subject to the terms and conditions therein, certain of our employees related to the VOWST Business who accepted employment with SPN or one of its designated affiliates provided the services they provided to us prior to the Transaction to SPN, as well as other services as SPN may reasonably request, from Closing until the day prior to the beginning of SPN’s or its designated affiliate’s next pay period following the Closing. SPN will reimburse our out of pocket costs in connection with such employees’ services, including certain compensation and benefits paid or provided to such employees pursuant to the terms of the Employee Support Agreement. All such employees have transferred to SPN as of December 31, 2024.

Previous report

In April 2025, we presented SER-155 Phase 1b clinical and exploratory biomarker results at the 51st annual meeting of the European Society for Blood and Marrow Transplantation, or EBMT. Our presented poster was recognized by the EBMT scientific organizing committee and obtained the “Best Clinical Poster Award.”

Previous report

In May 2025, we presented data at the Digestive Disease Week, or DDW conference highlighting preclinical and clinical data that enable identification of patients with a disease etiology linked to the gastrointestinal microbiome, and the identification of microbiome-based biomarkers that are predictive of response and suitable for patient selection and stratification in clinical trials. 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 Therapies subgroup. We believe that the data generated suggest that live biotherapeutics could provide a novel treatment modality that could benefit patients living with gut-related inflammatory and immune diseases that are not effectively addressed today. Furthermore, research indicates that specific patient subpopulations optimally suited for biotherapeutic-based treatments may be identifiable. We are exploring options, including potential partnerships, to advance the development of our biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.

Previous report

In May 2025, we presented new exploratory biomarker data from the SER-155 Phase 1b study in a poster session at the 2025 American Society of Clinical Oncology, or ASCO, Annual Meeting. The biomarker data presented at ASCO demonstrate the potential of SER-155 to promote immune reconstitution following allo-HSCT by modulating homeostatic cytokines and peripheral T-cell expansion. In post hoc analyses from the SER-155 Phase 1b study, significantly higher levels of the homeostatic cytokine IL-7 were observed both after the second course of SER-155 (administered after neutrophil recovery) and at HSCT Day 100, as compared to placebo. Additionally, a higher frequency of CD4+ T cells was observed in peripheral blood at these same timepoints in the SER-155 arm. We believe the results support the ability of SER-155 to promote peripheral T-cell recovery and immune reconstitution to support favorable outcomes post allo-HSCT.

Previous report

We will provide the manufacturing services until December 31, 2025. We expect manufacturing services expenses to increase in 2025 as compared to 2024, given the TSA obligations exist for the full year in 2025 as compared to one quarter in 2024.

Previous report

changes in the fair values of our warrant liabilities associated with the Oaktree Term Loan;

Previous report

We completed the sale of the VOWST Business to SPN on September 30, 2024. The financial results of the VOWST Business have been classified as discontinued operations in the condensed consolidated statements of operations and the related assets and liabilities of the VOWST Business have been classified as assets and liabilities of discontinued operations in the condensed consolidated balance sheets. Unless otherwise noted, amounts and disclosures in this section relate to our continuing operations (except for the Liquidity and Capital Resources section).

Previous report

Research and development expenses were $12.6 million for the three months ended September 30, 2025 and $16.5 million for the three months ended September 30, 2024. The decrease of $3.8 million was primarily due to the following:

Previous report

a decrease in personnel-related costs of $2.1 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expense due to lower headcount;

Previous report

a decrease of $1.3 million in expenses related to our live biotherapeutics platform and research and development operations due to a decrease of $0.5 million of facilities and depreciation expense, $0.5 million of lab assays and clinical storage costs, as well as $0.3 million of consulting and other costs, and

Previous report

a decrease of $0.4 million in expenses related to our SER-155 program due to lower clinical trial costs of $0.7 million as the Phase 1b study has largely been completed, partially offset by an increase of $0.2 million of lab supplies and consumables due to the commencement of manufacturing for the planned Phase 2 study.

Previous report

Comparison of Nine Months Ended September 30, 2025 and 2024

Previous report

Research and development expenses were $37.4 million for the nine months ended September 30, 2025 and $51.8 million for the nine months ended September 30, 2024. The decrease of $14.4 million was primarily due to the following:

Previous report

a decrease of $6.2 million in expenses related to our live biotherapeutics platform and research and development operations due to a decrease of $4.4 million of facilities and depreciation expense primarily related to the impairment charge that we recorded in the first quarter of 2024, as well as decreases of $0.7 million of consulting and other costs, $0.5 million of clinical storage costs, and $0.5 million of lab assays;

Previous report

a decrease in personnel-related costs of $4.7 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expense due to lower headcount, and

Previous report

a decrease of $3.4 million in expenses related to our SER-155 program due to lower clinical trial costs of $3.9 million as the Phase 1b study has largely been completed, partially offset by an increase of $0.3 million of lab supplies and consumables due to the commencement of manufacturing for the planned Phase 2 study and an increase of $0.3 million of regulatory consulting.

Previous report

General and administrative expenses were $31.6 million for the nine months ended September 30, 2025 compared to $40.7 million for the nine months ended September 30, 2024. The decrease of $9.1 million was primarily due to the following:

Previous report

a decrease in facility-related and other costs of $3.3 million primarily related to headcount-based information technology costs that were reduced as a result of lower headcount, as well as impairment charges recorded in the first quarter of 2024 related to our idled donor collection facility in Cambridge, Massachusetts.

Previous report

These decreases were partially offset by an increase in professional fees of $0.4 million due to an increase in legal and consulting fees.

Previous report

Manufacturing services costs began with the effectiveness of the TSA with Nestlé in the fourth quarter of 2024 and resulted in $6.0 million of expenses for the nine months ended September 30, 2025. The expenses are associated with the PRMS manufacturing performed on behalf of Nestlé, including labor, materials, allocated facility-related, lab supplies and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business.

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Reworded paragraphs (45)

Previous wording

Our live biotherapeutic candidates are consortia of bacteria designed to optimize specific, targeted pharmacological properties, and are formulated for oral delivery. We maintain a differentiated live biotherapeutics drug discovery and development platform that includes good manufacturing practices, or GMP, manufacturing capabilities for this novel drug modality. We are designing live biotherapeutic candidates optimized to prevent the colonization and overgrowth of pathogens in the gastrointestinal tract and modulate host function to increase epithelium integrity and to induce immune homeostasis and tolerance. We believe clinical and nonclinical data across our programs support the development of live biotherapeutics to target the prevention and treatment of a broad swath of infections, and in inflammatory and immune diseases. We believe that the scientific and clinical data from the development of VOWST (our then product candidate SER-109 program) and the data from the SER-155 Phase 1b study validate this novel therapeutic approach in the context of infection. We believe this approach may be replicable across different bacterial pathogens to develop live biotherapeutics with the potential to protect a range of medically compromised patients from infections, including pathogens that harbor AMR.

Current wording

We are designing LBP candidates to modulate host function to increase epithelium integrity and to induce immune homeostasis and tolerance, as well as to prevent the colonization and overgrowth of pathogens in the gastrointestinal, or GI, tract. We believe that the scientific and clinical data from the development of VOWST (our then product candidate SER-109 program) and the data from the SER-155 Phase 1b study in allo-HSCT (described below) validate our novel therapeutic approach in both infectious disease and I&I diseases. In the context of infection, we believe that our technology may be replicable across different bacterial pathogens with the potential to develop live biotherapeutics to protect a range of medically compromised patients at risk of antimicrobial resistance, or AMR, infections and bloodstream infections, or BSIs, that can result from a compromised epithelial barrier and that can be a major cause of mortality.

Previous wording

In our placebo-controlled Phase 1b study of SER-155 in allo-HSCT, Cohort 2 results demonstrated that SER-155 was associated with a 77% relative risk reduction in bacterial BSIs and a significant reduction in systemic antibiotic exposure as well as a lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. In December 2024, the FDA granted Breakthrough Therapy designation to SER-155 for the reduction of BSIs in patients 18 years and older undergoing allo-HSCT. In January 2025, we reported exploratory translational biomarker data from the SER-155 Phase 1b study which provided evidence supporting the intended therapeutic mechanisms, including promotion of intestinal epithelial barrier integrity to reduce the potential of bacterial translocation into the bloodstream, and reduction of systemic inflammatory responses.

Current wording

SER-155, our most advanced LBP candidate, is an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor antimicrobial resistance, as well as other pathogen-associated negative clinical outcomes in patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HSCT. In our placebo-controlled Phase 1b study of SER-155 in allo-HSCT, SER-155 was associated with a 77% relative risk reduction in bacterial BSIs and a significant reduction in systemic antibiotic exposure as well as a lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. Following advancement of key startup activities for the SER-155 Phase 2 study in allo-HSCT, including the submission of a final protocol to the FDA in January 2026, study site evaluation and qualification with our CRO, and manufacturing of drug substance, we have paused additional investment in that program while continuing to seek funding for the Phase 2 study.

Previous wording

Our business development discussions are focused on supporting SER-155 clinical advancement to reduce the risk of BSIs, including life-threatening and antimicrobial resistant infections, in medically vulnerable patient populations. We believe that SER-155 and other cultivated live biotherapeutic candidates could be developed in additional patient populations beyond allo-HSCT, including autologous-HSCT patients, cancer patients with neutropenia, chimeric antigen receptors therapy recipients, or CAR-T, individuals with chronic liver disease, or CLD, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities.

Current wording

We believe that SER-155 and other cultivated live biotherapeutic candidates could be developed in additional patient populations to address barrier compromise and bloodstream and AMR infections beyond allo-HSCT, including autologous-HSCT patients, cancer patients with neutropenia, chimeric antigen receptors therapy, or CAR-T, recipients, individuals with chronic liver disease, or CLD, solid organ transplant recipients, as well as patients in the intensive care unit, or ICU, and long-term acute care facilities. In 2025, we received a non-dilutive award from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) for up to $3.6 million, representing our second CARB-X award, to support the development of an oral liquid formulation based on SER-155 strains, now referred to as SER-428, for dosing in patients who cannot take oral capsules such as intubated patients in the medical ICU, and other medically vulnerable patients at high risk of AMR infections. We have advanced development and manufacturing of SER-428 and are designing a Phase 1b open label trial in collaboration with Columbia University to evaluate this LBP candidate in medical ICU patients at high risk of infection. Additionally, we continue to develop another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including CLD. We continue to leverage microbiome pharmacokinetic and pharmacodynamic data from across our clinical and preclinical portfolios, using our reverse translational development platform to prioritize future drug targets and to identify opportunities for monotherapy treatment and in combination with existing therapies across various indications, including inflammatory and immune diseases, cancer, and metabolic diseases.

Previous wording

We have built and deploy a reverse translational platform and knowledge base, which we call our MbTx Platform, for the discovery and development of live biotherapeutics, and maintain extensive proprietary know-how that may be used to support future research and development efforts. This platform incorporates high-resolution analysis of human clinical data to identify microbiome biomarkers associated with disease and non-disease states; preclinical screening using human cell-based assays and in vitro/ex vivo and in vivo disease models customized for live biotherapeutics; and microbiological capabilities and a strain library that spans broad biological and functional breadth. This platform and knowledge base enables identification of specific microbes, microbial genes, and microbial metabolites/peptides associated with disease and the design of therapeutic consortia of bacteria for specific pharmacological properties to restructure the gut microbiome and modulate functional pathways associated with disease. In addition, we own a valuable intellectual property estate related to the development and manufacture of live biotherapeutics.

Current wording

We have built and deploy a reverse translational platform and knowledge base for the discovery and development of live biotherapeutics, and maintain extensive proprietary know-how that may be used to support future research and development efforts. This platform incorporates high-resolution analysis of human clinical data to identify microbiome biomarkers associated with disease and non-disease states; preclinical screening using human cell-based assays and in vitro/ex vivo and in vivo disease models customized for live biotherapeutics; and a strain library and associated microbiological capabilities that span broad biological and functional breadth. This platform and knowledge base are integrated through a proprietary knowledge graph and agentic artificial intelligence, enabling rapid identification of specific microbes, microbial genes, and microbial metabolites/peptides associated with disease and the design of therapeutic consortia of bacteria for specific pharmacological properties to restructure the gut microbiome and modulate functional pathways associated with disease. In addition, we own a valuable intellectual property estate related to the development and manufacture of live biotherapeutics.

Previous wording

Our product candidates are in early-stage clinical or preclinical development. Our ability to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since our inception, we have incurred significant operating losses. Our loss from operations was $74.6 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $957.1 million.

Current wording

Our product candidates are in early-stage clinical or preclinical development. Our ability to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since our inception, we have incurred significant operating losses. Our net loss was $19.9 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $992.3 million.

Previous wording

While we plan to focus our investment on progressing the development of SER-155 and advancing our other wholly-owned live biotherapeutic candidates in the near-term, our expenses may increase in connection with these future activities. See “Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital—We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.”

Current wording

While we plan to focus our investment on advancing our early-stage live biotherapeutic candidates, starting with SER-603, in the near-term, and, subject to receiving additional funding, progressing the development of SER-155 into a Phase 2 study in allo-HSCT, our expenses may increase in connection with these future activities. See “Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital—We are a clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.”

Previous wording

As a result, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of collaborations with third parties, public or private equity or debt financings or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of factors such as the impacts of pandemics, such as COVID-19, and increases in inflation rates, interest rates and tariffs. As a result, we may face difficulties raising capital through sales of our common stock and any such sales may be on unfavorable terms. Our inability to raise capital or secure a partnership would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

Current wording

As a result, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of business development transactions including collaborations with third parties, public or private equity or debt financings or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. For example, the trading prices for our and other biopharmaceutical companies’ stock have been highly volatile as a result of factors such as the impacts of pandemics, increases in inflation rates, interest rates and tariffs. As a result, we may face difficulties raising capital through sales of our common stock and any such sales may be on unfavorable terms. Our inability to raise capital or secure a partnership as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

Previous wording

As of September 30, 2025, we had cash and cash equivalents totaling $47.6 million. Based on our currently available cash resources, including proceeds received in the fourth quarter from our at the market equity offering, and considering our future operating plans and our ongoing obligations related to the Transaction, we anticipate that we will fund our operations through the second quarter of 2026. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In performing this analysis, we excluded certain elements of our operating plan that cannot be considered probable of occurring. Under the applicable accounting standards, any future transactions or equity issuances cannot be considered probable, as these events are outside our control. Accordingly, management has concluded that substantial doubt exists about our ability to continue as a going concern for 12 months from the date the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, are issued. See “Risk Factors— Risks Related to Our Financial Position and Need for Additional Capital —We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.”

Current wording

As of March 31, 2026, we had cash and cash equivalents totaling $29.8 million. Based on our currently available cash resources, and considering our future operating plans, we anticipate that we will require additional funding following the third quarter of 2026. In accordance with applicable accounting standards, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within 12 months after the date of the issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In performing this analysis, we excluded certain elements of our operating plan that cannot be considered probable of occurring. Under the applicable accounting standards, any future transactions or equity issuances cannot be considered probable, as these events are outside our control. Accordingly, management has concluded that substantial doubt exists about our ability to continue as a going concern for 12 months from the date the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. See “Risk Factors— Risks Related to Our Financial Position and Need for Additional Capital —We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.”

Previous wording

On September 23, 2025, we announced that we implemented cost reduction actions, including reducing our workforce by approximately 25% (including reductions that were effective in August 2025). During the three and nine months ended September 30, 2025, we incurred approximately $1.0 million in restructuring costs, primarily related to severance costs. These costs are expected to be paid out in the fourth quarter of 2025.

Current wording

On February 12, 2026, we announced that we implemented cost reduction actions, including reducing our workforce by approximately 30%. During the three months ended March 31, 2026, we incurred approximately $0.9 million in restructuring costs, primarily related to severance costs, of which $0.7 million was paid as of March 31, 2026. The remainder of these costs are expected to be paid out by the second quarter of 2026.

Previous wording

Additional efforts in the early-stage portfolio are focused on inflammatory bowel disease, or IBD, with programmatic objectives supported through a partnership with the Crohn’s and Colitis Foundation, or CCF. These efforts aim to (i) confirm the functional phenotype and inflammatory state of patient subpopulations observed in our prior ulcerative colitis, or UC, clinical trials, and (ii) prioritize inflammatory targets and evaluate the potential to utilize biomarker-based patient selection and stratification for future studies. In addition, we continue to leverage microbiome pharmacokinetic and pharmacodynamic data from across our clinical and preclinical portfolios, using our reverse translational development platform to prioritize future drug targets and to identify opportunities for monotherapy treatment and in combination with existing therapies across various indications, including inflammatory and immune diseases, cancer, and metabolic diseases.

Current wording

SER-603 is a novel, LBP candidate designed to improve response rates and durability of remission in patients with IBD, including ulcerative colitis, or UC, and Crohn's disease. SER-603 is optimized to address disruptions in the GI microbiome and to improve GI mucosal barrier integrity through the inhibition of inflammatory bacteria and associated metabolites, the promotion of epithelial barrier integrity to reduce the translocation of inflammatory molecules and barrier inflammation, and to induce immune homeostasis through non-immunosuppressive regulatory T cell, or T-reg, induction via T cell signaling. Our research on SER-603 has been primarily supported through a partnership with the Crohn’s and Colitis Foundation, or CCF. These efforts aim to (i) confirm the functional phenotype and inflammatory state of patient subpopulations observed in our prior ulcerative colitis, or UC, clinical trials, and (ii) prioritize inflammatory targets and evaluate the potential to utilize biomarker-based patient selection and stratification for future studies.

Previous wording

In addition to SER-155 development in allo-HSCT, we are expanding our understanding of the broader SER-155 therapeutic opportunity through an ongoing investigator-sponsored trial (IST) with Memorial Sloan Kettering Cancer Center to evaluate SER-155 in patients with immune checkpoint related enterocolitis (irEC). IrEC is among the most frequent and severe immune-related adverse events (irAEs) 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 irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. We believe that supportive data from this study could provide further support for the expansion of indications that may be well suited for our biotherapeutic approach. Enrollment in the study is ongoing and is expected to complete by the end of 2025 with a clinical readout expected in early 2026.

Current wording

We have been collaborating with Memorial Sloan Kettering Cancer Center for over a decade on the impact of the GI microbiome on immune related diseases and cancer; recently this long-standing collaboration included an investigator-sponsored trial, or IST, evaluating SER-155 in 15 participants with irEC. irEC is among the most frequent and severe immune-related adverse events, or irAEs, in recipients of immune checkpoint inhibitor, or ICI, therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. ICIs can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. The program is designed to promote mucosal healing and modulate inflammation without systemic immunosuppression, with the goal of reducing or eliminating the need for high-dose corticosteroids, which carry the risk of toxicity and ICI efficacy impact. We believe SER-155 could be a first-in-class therapy; current approaches manage toxicity reactively with immunosuppression, which can negatively impact cancer treatment.

Previous wording

We believe that the scientific and clinical data from our SER-109 program validate our novel approach of using live biotherapeutics to decolonize GI pathogens and improve GI epithelial barrier integrity, resulting in reduced rate of infections in medically compromised patients. Data from the SER-109 ECOSPOR III and ECOSPOR IV Phase 3 trial published in the New England Journal of Medicine (Feuerstadt et al., 2022) and Journal of the American Medical Association (Sims et al., 2023) suggest that live biotherapeutics have the potential to restructure the gut microbiome and shift the gut metabolic landscape. Additional data show that SER-109 rapidly reduced the abundance of bacteria associated with common antibiotic resistance genes, or ARGs, and reduced ARG abundance in the gut (Straub et al., 2023). Collectively, we believe these data suggest the potential for live biotherapeutics to prevent the colonization and overgrowth of pathogens that can establish in the gut and ultimately to reduce infections. We believe that reducing pathogen colonization in the GI tract and improving GI epithelial barrier integrity to reduce the risk of infection may be replicable in a range of medically compromised patients, protecting them from infections and resulting downstream clinical sequelae. We believe this approach may also enable us to reduce AMR, which the World Health Organization declared as a top ten global public health threat facing humanity, and with estimates that yearly deaths may reach 10 million by 2050, putting mortality due to AMR on par with deaths due to cancer.

Current wording

We continue to be invested in the infectious disease space, with a renewed focus on leveraging our existing clinical data, translational insights, and manufacturing capabilities to support targeted development efforts across a defined set of related indications. We believe that the scientific and clinical data from our VOWST program (our then product candidate SER-109 program) validate our novel approach of using live biotherapeutics to decolonize pathogens and improve epithelial barrier integrity, resulting in reduced rate of infections in medically compromised patients. Data from the ECOSPOR III and ECOSPOR IV Phase 3 trial published in the New England Journal of Medicine (Feuerstadt et al., 2022) and Journal of the American Medical Association(Sims et al., 2023) suggest that live biotherapeutics have the potential to restructure the gut microbiome and shift the gut metabolic landscape. Additional data show that VOWST rapidly reduced the abundance of bacteria associated with common antibiotic resistance genes, or ARGs, and reduced ARG abundance in the gut (Straub et al., 2023). Collectively, we believe these data suggest the potential for live biotherapeutics to prevent the colonization and overgrowth of pathogens that can establish in the gut and ultimately to reduce infections. We believe that reducing pathogen colonization in the GI and improving GI epithelial barrier integrity to reduce the risk of infection may be replicable in a range of medically compromised patients, protecting them from infections and resulting downstream clinical sequelae.

Previous wording

We are developing SER-155, an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor AMR, as well as other pathogen associated negative clinical outcomes in patients undergoing allo-HSCT. SER-155 contains 16 bacterial strains selected using our reverse translation discovery and development platform technologies to optimize SER-155’s functional profile. The design incorporates biomarker data from human clinical data and screening data from nonclinical human cell-based assays and in vivo disease models. The bacteria consortia is designed to optimize: (i) the prevention of the growth of various Enterococcaceae and Enterobacteriaceae species known to potentially dominate the GI tract and lead to downstream negative clinical outcomes in medically compromised patients and that can harbor antibacterial resistance, (ii) the production of multiple bacterial metabolites that can promote mucosal and epithelial barrier integrity with the goal of reducing the likelihood of harmful bacteria translocating from the gut to the bloodstream through a compromised epithelium, and (iii) the production of multiple bacterial metabolites that can modulate immune pathways to induce immune tolerance with a potential impact on graft versus host disease, or GvHD.

Current wording

SER-155 contains 16 bacterial strains selected using our reverse translation discovery and development platform technologies to optimize SER-155’s functional profile. The design incorporates biomarker data from human clinical data and screening data from nonclinical human cell-based assays and in vivo disease models. The bacteria consortia is designed to optimize: (i) the prevention of the growth of various Enterococcaceae and Enterobacteriaceae species known to potentially dominate the GI tract and lead to downstream negative clinical outcomes in medically compromised patients and that can harbor antibacterial resistance, (ii) the production of multiple bacterial metabolites that can promote mucosal and epithelial barrier integrity with the goal of reducing the likelihood of harmful bacteria translocating from the gut to the bloodstream through a compromised epithelium, and (iii) the production of multiple bacterial metabolites that can modulate immune pathways to induce immune tolerance with a potential impact on graft versus host disease, or GvHD.

Previous wording

In October 2025, we presented new post hoc data from our SER-155 Phase 1b trial in an oral presentation at IDWeek in Atlanta, Georgia. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of AMR among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agents was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HSCT patients, especially those BSIs associated with AMR that increases the risk of morbidity and mortality.

Current wording

In October 2025, we presented new post hoc data from our SER-155 Phase 1b trial in an oral presentation at IDWeek in Atlanta, Georgia. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of AMR among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agent classes was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HSCT patients, especially those BSIs associated with AMR that increases the risk of morbidity and mortality.

Previous wording

In February 2025, clinical and biomarker results from our biotherapeutic programs were presented as a poster at the 2025 Tandem Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR). SER-155 Phase 1b clinical study data were also featured in an oral presentation in the Best Abstracts in Infectious Diseases track at the Tandem meeting.

Current wording

In 2025, clinical and biomarker results from our biotherapeutic programs were presented at multiple leading industry meetings and conferences, including the 2025 Tandem Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR), European Society for Blood and Marrow Transplantation (EBMT), Digestive Disease Week (DDW), and the 2025 American Society of Clinical Oncology (ASCO). We believe that exploratory biomarker data presented at recent medical meetings have supported the intended mechanisms of SER-155. We believe that the data generated suggest that live biotherapeutics could provide a novel treatment modality that could benefit patients living with gut-related inflammatory and immune diseases that are not effectively addressed today. Furthermore, research indicates that specific patient subpopulations optimally suited for biotherapeutic-based treatments may be identifiable.

Previous wording

Based on prior FDA feedback, we are progressing start-up activities for our SER-155 Phase 2 study in allo-HSCT that could provide a time and capital-efficient path to obtaining clinical results. We require additional capital to begin this study. In May 2025, we filed the SER-155 Phase 2 protocol with the FDA. In September 2025, the FDA provided us with feedback on the SER-155 Phase 2 protocol and we continue to work with the FDA to finalize the study protocol. The SER-155 Phase 2 study will incorporate a well-powered, placebo-controlled design, which provides for a planned interim analysis to enable an expedited initial data readout. The SER-155 Phase 2 study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. We expect to obtain the interim clinical results within twelve months following study initiation, which we believe will facilitate timely engagement with the FDA on the design of a Phase 3 study and inform development in adjacent medically vulnerable patient populations. We believe that positive results, if achieved, from the Phase 2 study could enable advancement into a single Phase 3 trial to support registration.

Current wording

The SER-155 Phase 2 study is expected to incorporate a well-powered, placebo-controlled design, which provides for a planned interim analysis to enable an expedited initial data readout. The SER-155 Phase 2 study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. We expect to obtain the interim clinical results within twelve months following study initiation, which we believe will facilitate timely engagement with the FDA on the design of a Phase 3 study and inform development in adjacent medically vulnerable patient populations. We believe that positive results, if achieved, from the Phase 2 study could enable advancement into a single Phase 3 trial to support registration.

Previous wording

In July 2025, we were awarded a grant from CARB-X to support the development of an oral liquid formulation of SER-155 for medically vulnerable patient populations at risk of BSIs, including antimicrobial resistant infections, who cannot be dosed with oral capsules, such as intubated patients in the ICU. The CARB-X grant provides us with up to $3.6 million of funding for research, manufacture, and design of a Phase 1 clinical trial in ICU patients. The Company recognized $0.4 million of grant revenue from CARB-X in the three months ended September 30, 2025.

Current wording

In July 2025, we were awarded a grant from CARB-X to support the development of SER-428, an oral liquid formulation of an LBP based on SER-155 strains for medically vulnerable patient populations at risk of BSIs, including AMR infections, who cannot be dosed with oral capsules, such as intubated patients in the medical ICU. The CARB-X grant provides us with up to $3.6 million of funding for research, manufacture, and design of a Phase 1 clinical trial in ICU patients. SER-428 is designed to target the prevention of bloodstream infections in medical ICU patients by Escherichia coli and other gut-derived bacteria capable of harboring antibiotic resistance. Up to 50% of all preventable medical ICU deaths have been attributed to infections with E. coli and other gut-derived bacteria (Mayr, 2006). These infections are also the leading cost in the medical ICU (Neidell, 2012). When ICU patients with multidrug resistant, or MDR, infections survive hospitalization, they have high long-term morbidity with over 20% 30-day readmission rates (Chang, 2015; Mayr, 2017). Over 5 million patients are admitted to ICUs in the U.S. annually, and these admissions account for approximately 20% of all acute care hospitalizations (Barrett et al. 2024).

Previous wording

We continue to develop another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including chronic liver disease, or CLD. SER-147 was designed and optimized using our reverse translational therapeutics development platform. CLD is a progressive condition marked by deterioration of liver function and is reaching epidemic proportions affecting nearly 1.7 billion people worldwide, causing substantial health burden on afflicted countries (GBD 2017 Cirrhosis Collaborators, 2020, Clinical Liver Disease, 2021). In the advanced stages of CLD, known as decompensated cirrhosis, patients exhibit significant immune dysfunction, microbiome disruption, and increased contact with the healthcare system, all of which drive increased susceptibility to bacterial infections (Bajaj et al., 2021, Albillos et al., 2022). The Company is conducting IND-enabling activities for SER-147.

Current wording

We are also developing another proprietary live biotherapeutic composition, SER-147, designed to prevent bacterial bloodstream and spontaneous bacterial peritonitis, or SBP, infections in patients with metabolic disease, including chronic liver disease, or CLD. SER-147 was designed and optimized using our reverse translational therapeutics development platform. CLD is a progressive condition marked by deterioration of liver function and is reaching epidemic proportions affecting nearly 1.7 billion people worldwide, causing substantial health burden on afflicted countries (GBD 2017 Cirrhosis Collaborators, 2020, Clinical Liver Disease, 2021).

Previous wording

On April 10, 2025, at our 2025 annual meeting of stockholders, our stockholders approved an amendment to our certificate of incorporation to effect a reverse stock split of all outstanding shares of our common stock. On April 21, 2025, we effected a 1-for-20 reverse stock split of our common stock. The reverse stock split had no impact on the number of authorized shares or the par value of preferred and common stock. Trading of our common stock on The Nasdaq Global Select Market commenced on a split-adjusted basis on April 22, 2025. On May 6, 2025, we were notified by the Nasdaq Listing Qualifications staff that the closing bid price of our common stock had been at $1.00 per share or greater for 10 consecutive business days, from April 22, 2025 to May 5, 2025. Accordingly, we have regained compliance with the Bid Price Requirement and this matter is now closed.

Current wording

On April 21, 2025, we effected a 1-for-20 reverse stock split of our common stock. The reverse stock split had no impact on the number of authorized shares or the par value of preferred and common stock. Trading of our common stock on The Nasdaq Global Select Market commenced on a split-adjusted basis on April 22, 2025 and, in May 2025, we regained compliance with the Bid Price Requirement.

Previous wording

We have an extensive patent portfolio directed to rationally designed ecologies of spores and microbes. The portfolio includes both company-owned patents and applications, and those that we have rights to as licensee. The patents and applications included in our portfolio cover both composition of matter and methods (e.g., method of treating). Our intellectual property rights related to SER-155 and SER-147 extend through at least 2043 (not including any potential term extension). We plan on continuing to broaden our patent portfolio. Currently, we have 24 active patent families, which includes 20 nationalized applications and four at the provisional stage. To date, we have obtained issuance of 33 U.S. patents (which includes three as licensee). Of the issued U.S. patents, 13 U.S. patents (including one as licensee) have been assigned to Nestlé Health Science as part of its purchase of VOWST.

Current wording

We have an extensive patent portfolio directed to rationally designed ecologies of spores and microbes. The portfolio includes both company-owned patents and applications, and those that we have rights to as licensee. The patents and applications included in our portfolio cover both composition of matter and methods (e.g., method of treating). Our intellectual property rights related to SER-155, SER-147 and/or SER-603 extend through at least part of 2046 (not including any potential term extension). We plan on continuing to broaden our patent portfolio. Currently, we have 21 active patent families, which includes 18 nationalized applications and two at the provisional stage. To date, we have obtained issuance of 33 U.S. patents (which includes three as licensee). Of the issued U.S. patents, 13 U.S. patents (including one as licensee) have been assigned to Nestlé Health Science as part of its purchase of VOWST.

Previous wording

Our operating expenses since inception have consisted primarily of research and development activities and general and administrative costs. In connection with the TSA the Company entered into with NESA following the sale of the VOWST Business during the third quarter of 2024, our operating expenses also consisted of certain passthrough costs incurred in performing duties under the TSA and manufacturing services related to the VOWST Business and operations.

Current wording

Our operating expenses since inception have consisted primarily of research and development activities and general and administrative costs. In connection with the TSA we entered into with NESA following the sale of the VOWST Business during the third quarter of 2024 through December 31, 2025, our operating expenses also consisted of certain passthrough costs incurred in performing duties under the TSA and manufacturing services related to the VOWST Business and operations.

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We anticipate an overall decrease in research and development expenses in 2025 as compared to 2024, following the sale of the VOWST Business and completion of the Phase 1b study of SER-155 in allo-HSCT. Research and development expenses may increase in the future if and as we continue the clinical development of SER-155 in patients undergoing allo-HSCT and for other medically vulnerable populations and resume development of any other clinical or preclinical programs. In 2025, research and development expenses continue to include labor and passthrough costs, reimbursable by Nestlé, incurred in performing obligations under the TSA.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We anticipate an overall decrease in research and development expenses in 2026 as compared to 2025, following the conclusion of the TSA, completion of the Phase 1b study of SER-155 in allo-HSCT, and the cost reduction actions that were implemented in September 2025 and February 2026, including pausing investment in the SER-155 Phase 2 study and headcount reductions. Research and development expenses may increase in the future if and as we resume development of any clinical or preclinical programs. In 2025, research and development expenses included labor and passthrough costs, reimbursable by Nestlé, incurred in performing obligations under the TSA. Given the conclusion of the TSA as of December 31, 2025, these costs and related reimbursements are not expected to reoccur in 2026.

Previous wording

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, commercial, business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. Beginning in the fourth quarter of 2024, general and administrative expenses also include labor and passthrough costs, reimbursable by Nestlé, incurred in performing duties under the TSA.

Current wording

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, commercial, business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities, information technology costs and other operating costs. In 2025, general and administrative expenses also included labor and passthrough costs, reimbursable by Nestlé, incurred in performing duties under the TSA.

Previous wording

We expect that our general and administrative expenses will decrease in 2025 as compared to 2024, following the sale of VOWST Business, reduction of our workforce and overall cost containment efforts. General and administrative expenses may increase in the future as we continue to incur increased expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing rules and the requirements of the SEC, director and officer insurance costs and investor and public relations costs. In 2025, general and administrative expenses continue to include labor and passthrough costs, reimbursable by Nestlé, incurred in performing obligations under the TSA.

Current wording

We expect that our general and administrative expenses will decrease in 2026 as compared to 2025, following the conclusion of the TSA as of December 31, 2025, reductions of our workforce and overall cost containment efforts. Over the longer term, general and administrative expenses may increase in the future as we continue to incur increased expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing rules and the requirements of the SEC, director and officer insurance costs and investor and public relations costs.

Previous wording

Under the TSA with NESA, beginning in the fourth quarter of 2024, we provide certain manufacturing services and related functions of the VOWST Business and operations. Expenses associated with the manufacturing services include certain facility-related, labor, lab supplies and consumables, and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business.

Current wording

Under the TSA with NESA, beginning in the fourth quarter of 2024, we provided certain manufacturing services and related functions of the VOWST Business and operations. Expenses associated with the manufacturing services included certain facility-related, labor, lab supplies and consumables, and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business.

Previous wording

the amount Nestlé agrees to pay for costs associated with PRMS manufacturing; and reimbursement for certain labor and other passthrough costs of the transition services performed by the Company under the TSA; and

Current wording

the amount Nestlé paid for costs associated with PRMS manufacturing; and reimbursement for certain labor and other passthrough costs of the transition services performed by the Company under the TSA; and

Previous wording

Since our inception in 2010, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. We did not provide for any income taxes in the three and nine months ended September 30, 2025 or 2024.

Current wording

Since our inception in 2010, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. We did not provide for any income taxes in the three months ended March 31, 2026 or 2025.

Previous wording

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires the application of appropriate technical accounting rules and guidance, as well as the use of estimates. The application of these policies necessarily involves judgments regarding future events. These estimates and judgments, in and of themselves, could materially impact the condensed consolidated financial statements and disclosures based on varying assumptions. The accounting policies discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 13, 2025, or the Annual Report, are considered by management to be the most important to an understanding of the consolidated financial statements because of their significance to the portrayal of our financial condition and results of operations. There have been no material changes to that information disclosed in our Annual Report during the three and nine months ended September 30, 2025.

Current wording

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires the application of appropriate technical accounting rules and guidance, as well as the use of estimates. The application of these policies necessarily involves judgments regarding future events. These estimates and judgments, in and of themselves, could materially impact the condensed consolidated financial statements and disclosures based on varying assumptions. The accounting policies discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 12, 2026, or the Annual Report, are considered by management to be the most important to an understanding of the consolidated financial statements because of their significance to the portrayal of our financial condition and results of operations. There have been no material changes to that information disclosed in our Annual Report during the three months ended March 31, 2026.

Previous wording

General and administrative expenses were $9.5 million for the three months ended September 30, 2025 compared to $12.7 million for the three months ended September 30, 2024. The decrease of $3.2 million was primarily due to the following:

Current wording

General and administrative expenses were $8.1 million for the three months ended March 31, 2026 compared to $11.9 million for the three months ended March 31, 2025. The decrease of $3.8 million was primarily due to the following:

Previous wording

a decrease in personnel-related costs of $1.7 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expenses due to lower headcount; and

Current wording

a decrease in personnel-related costs of $0.9 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expenses due to lower headcount;

Previous wording

a decrease in facility-related and other costs of $1.3 million primarily related to headcount-based information technology costs that were reduced as a result of lower headcount.

Current wording

a decrease in facility-related and other costs of $1.5 million primarily related to information technology costs that were incurred as part of the TSA and reimbursed by Nestlé that did not reoccur in 2026.

Previous wording

Manufacturing services costs began with the effectiveness of the TSA with Nestlé in the fourth quarter of 2024 and resulted in $0.7 million of expenses for the three months ended September 30, 2025. The expenses are associated with the PRMS manufacturing performed on behalf of Nestlé, including labor, materials, allocated facility-related, lab supplies and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business.

Current wording

Manufacturing services costs were incurred between the fourth quarter of 2024 and the end of 2025 as we performed PRMS manufacturing on behalf of Nestlé in accordance with the TSA. The expenses associated with manufacturing services included labor, materials, allocated facility-related, lab supplies and other manufacturing costs that would have been capitalized into inventory prior to the sale of VOWST Business. Following the conclusion of the TSA on December 31, 2025, no manufacturing services costs were incurred during the three months ended March 31, 2026 and none are expected moving forward.

Previous wording

Other income (expense) , net was $30.7 million of income and $21.9 million of expense for the three months ended September 30, 2025 and 2024, respectively. The increase of $52.6 million in other income, net was due to the $27.2 million gain on sale of the VOWST business primarily due to the installment payment received from Nestlé in July 2025 that was conditioned on our material compliance with obligations under the TSA, as well as $2.0 million of reimbursement income associated with the performance of TSA services. Additionally, the three months ended September 30, 2024 included a $23.4 million loss associated with the extinguishment of the Oaktree Term Loan recorded inconnection with the sale of the VOWST Business to SPN.

Current wording

Other income (expense), net was $1.0 million of income and $59.9 million of income for the three months ended March 31, 2026 and 2025, respectively. The decrease of $58.9 million in other income, net was due to the $52.2 million gain on sale of the VOWST business recognized in the three months ended March 31, 2025, primarily due to the installment payment received from Nestlé in January 2025 that was conditioned on our material compliance with obligations under the TSA, as well as $6.3 million of reimbursement income associated with the performance of TSA services in the first quarter of 2025 that did not reoccur due to the conclusion of the TSA at the end of 2025, and a decrease in interest income of $0.3 million due to our lower cash balance.

Previous wording

Since our inception, we have generated revenue only from collaborations and have incurred recurring losses from operations. We anticipate that we will continue to incur losses for at least the next several years. We will need additional capital to fund our operations, which include our research and development and general and administrative expenses, which we may obtain from additional financings, public offerings, research funding, additional collaborations, contract and grant revenue or other sources.

Current wording

Since our inception, we have generated revenue only from collaborations and have incurred recurring net losses from operations. We anticipate that we will continue to incur losses for at least the next several years. We will need additional capital to fund our operations, which include our research and development and general and administrative expenses, which we may obtain from additional financings, public offerings, research funding, additional collaborations, contract and grant revenue or other sources.

Previous wording

In May 2021, we entered into a Sales Agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, with aggregate gross sales proceeds of up to $150.0 million, from time to time, through an “at the market” equity offering program under which Cowen acts as sales agent. As of October 31, 2025, we have sold 1,772,037 shares of common stock under the Sales Agreement, at an average price of approximately $30.66 per share, raising aggregate net proceeds of approximately $52.2 million after deducting an aggregate commission of approximately 3% and other issuance costs.

Current wording

In May 2021, we entered into a Sales Agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, with aggregate gross sales proceeds of up to $150.0 million, from time to time, through an “at the market” equity offering program under which Cowen acts as sales agent. During the three months ended March 31, 2026, we sold 25,796 shares of common stock under the Sales Agreement, at an average price of approximately $15.90 per share, raising aggregate net proceeds of approximately $0.4 million after deducting an aggregate commission of approximately 3%. During the three months ended March 31, 2025, we sold 54,806 of common stock under the Sales Agreement, at an average price of approximately $18.60 per share, raising aggregate net proceeds of approximately $1.0 million after deducting an aggregate commission of approximately 3% and other issuance costs. As of March 31, 2026, we have sold 2,214,491 shares of common stock under the Sales Agreement, at an average price of approximately $28.07 per share, raising aggregate net proceeds of approximately $59.7 million after deducting an aggregate commission of approximately 3% and other issuance costs.

Previous wording

As of September 30, 2025, we had cash and cash equivalents totaling $47.6 million and an accumulated deficit of $957.1 million. For the nine months ended September 30, 2025, we incurred a loss from operations of $74.6 million. We expect that our operating losses and negative cash flows will continue for the foreseeable future.

Current wording

As of March 31, 2026, we had cash and cash equivalents totaling $29.8 million and an accumulated deficit of $992.3 million. For the three months ended March 31, 2026, we incurred a net loss of $19.9 million. We expect that our operating losses and negative cash flows will continue for the foreseeable future.

Previous wording

Under applicable accounting standards, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within 12 months after the date the consolidated financial statements are issued. The ability to obtain sufficient proceeds from additional equity offerings, collaborations or other financing with terms favorable or acceptable to us cannot be considered probable, as these events are outside of our control. Based on our currently available cash resources, including proceeds received in the fourth quarter from our at the market equity offering, and considering our future operating plans and our ongoing obligations related to the Transaction, we anticipate that we will fund our operations through the second quarter of 2026. Accordingly, management has concluded that these circumstances raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. We will need to generate significant revenues to achieve profitability, and we may never do so. Because of the numerous risks and uncertainties associated with the development of our current and any future product candidates, the development of our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses required for completing the research and development of our product candidates.

Current wording

Under applicable accounting standards, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within 12 months after the date the consolidated financial statements are issued. The ability to obtain sufficient proceeds from additional equity offerings, collaborations or other financing with terms favorable or acceptable to us cannot be considered probable, as these events are outside of our control. Based on our currently available cash resources, and considering our future operating plans, we anticipate that we will require additional funding following the third quarter of 2026. Accordingly, management has concluded that these circumstances raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. We will need to generate significant revenues to achieve profitability, and we may never do so. Because of the numerous risks and uncertainties associated with the development of our current and any future product candidates, the development of our platform and technology and because the extent to which we may enter into collaborations with third parties for development of any of our product candidates is unknown, we are unable to estimate the amounts of increased capital outlays and operating expenses required for completing the research and development of our product candidates.

Previous wording

During the nine months ended September 30, 2024, operating activities used $109.7 million of cash, primarily due to non-cash charges of $90.1 million and changes in our operating assets and liabilities of $35.4 million, partially offset by net income of $15.8 million. Non-cash charges consisted of stock-based compensation expense of $17.2 million, $7.2 million related to the amortization of right-of-use assets, $4.4 million of depreciation and amortization, $1.4 million of amortization of debt issuance costs, $23.4 million of loss associated with the extinguishment of the Oaktree Term Loan, $0.3 million loss on disposal of fixed assets, and $3.3 million of impairment charges related to our long-lived assets. These were partially offset by the $146.7 million gain on sale of VOWST Business and $0.5 million decrease in the fair value of warrants. Changes in our operating assets and liabilities during the nine months ended September 30, 2024 consisted of a decrease in operating lease liabilities of $4.4 million, a decrease in deferred income - related party of $4.1 million, a decrease in accrued expenses and other current and long-term liabilities of $3.3 million, and a decrease in inventories of $33.8 millionin connection with the sale of the VOWST Business to SPN, partially offset by a decrease in collaboration receivable - related party of $8.7 million, a decrease in prepaid expenses and other current and other non-current assets of $0.3 million, and an increase in accounts payable of $1.2 million.

Current wording

During the three months ended March 31, 2026, cash used in operating activities was $16.4 million due to a net loss of $19.9 million and changes in our operating assets and liabilities of $1.2 million, partially offset by non-cash charges of $4.7 million. Non-cash charges consisted of stock-based compensation expense of $1.7 million, $2.2 million related to the amortization of right-of-use assets, and $0.8 million of depreciation and amortization. Changes in our operating assets and liabilities during the three months ended March 31, 2026 consisted of a decrease in operating lease liabilities of $2.5 million, a decrease in accrued expenses and other current and long-term liabilities of $1.0 million, and an increase in accounts receivable relating to the CARB-X program of $0.1 million, partially offset by a decrease in prepaid expenses and other current and other non-current assets of $1.3 million, an increase in accounts payable of $0.7 million, and a decrease in accounts receivable due from SPN of $0.4 million.

Previous wording

During the nine months ended September 30, 2025, cash provided by operating activities was $15.8 million due to net income of $21.0 million and non-cash charges of $17.1 million, partially offset by changes in our operating assets and liabilities of $22.3 million. Non-cash charges consisted of stock-based compensation expense of $7.6 million, $6.2 million related to the amortization of right-of-use assets, and $3.2 million of depreciation and amortization. Changes in our operating assets and liabilities during the nine months ended September 30, 2025 consisted of a decrease in accrued liabilities due to SPN of $13.3 million, a decrease in operating lease liabilities of $6.4 million, a decrease in accrued expenses and other current and long-term liabilities of $4.2 million, a decrease in accounts payable of $2.4 million, and an increase in accounts receivable relating to the CARB-X program of $0.4 million, partially offset by a decrease in prepaid expenses and other current and other non-current assets of $2.7 million, and a decrease in accounts receivable due from SPN of $1.6 million.

Current wording

During the three months ended March 31, 2025, cash provided by operating activities was $26.9 million due to net income of $32.7 million and non-cash charges of $5.9 million, partially offset by changes in our operating assets and liabilities of $11.0 million. Non-cash charges consisted of stock-based compensation expense of $2.8 million, $2.0 million related to the amortization of right-of-use assets, and $1.1 million of depreciation and amortization. Changes in our operating assets and liabilities during the three months ended March 31, 2025 consisted of an increase in accounts receivable due from SPN of $0.7 million, a decrease in accrued liabilities due to SPN of $3.9 million, a decrease in operating lease liabilities of $2.1 million, a decrease in accrued expenses and other current and long-term liabilities of $4.4 million, and a decrease in accounts payable of $2.0 million, partially offset by a decrease in prepaid expenses and other current and other non-current assets of $1.3 million.

Previous wording

During the nine months ended September 30, 2025, net cash used in investing activities was $0.2 million, consisting entirely of purchases of property and equipment.

Current wording

During the three months ended March 31, 2025, net cash used in investing activities was $0.1 million, consisting entirely of purchases of property and equipment.

Showing the first 40 of 45 pairs. Open the source sections for the rest.

Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

We are developing SER-155, an investigational, oral, live biotherapeutic designed to decolonize GI pathogens, improve GI epithelial barrier integrity, and induce immune homeostasis to prevent bacterial BSIs, including those that can harbor AMR, as well as other pathogen associated negative clinical outcomes in patients undergoing allo-HSCT. SER-155 is a live biotherapeutic candidate designed to prevent frequent, expensive, and fatal infections in blood cancer patients.
Rearranged previous paragraphs (14)

Previous report — wording carried elsewhere

Under the terms of the Purchase Agreement, we sold the VOWST Business, including inventory and equipment, certain patents and patent applications, know-how, trade secrets, trademarks, domain names, marketing authorizations and related rights, documents, materials, business records and data and contracts that are used or held for use primarily in the development, commercialization and manufacturing of the microbiome product sold under the brand name VOWST, or the Product, to SPN, and SPN assumed certain liabilities from us. As consideration for the Transaction, SPN paid or agreed to pay us, as applicable, the following Transaction Consideration:

Previous report — wording carried elsewhere

a cash payment, which was paid upon Closing, of $100 million, less approximately $17.9 million owed by us to an affiliate of SPN as of March 31, 2024 under the prior license agreement between us and the SPN affiliate, and less approximately CHF 2.0 million in satisfaction of fees due under an existing manufacturing agreement between us and Bacthera;

Previous report — wording carried elsewhere

cash installment payments of $50 million, which was received on January 15, 2025, and $25 million, which was received on July 1, 2025 (offset by $1.4 million paid by us to Nestlé on July 1, 2025 related to certain employment obligations assumed by SPN, as described below), conditioned on our material compliance with obligations under the TSA (as defined below), which was entered into at Closing between us and Nestlé Enterprises S.A., an affiliate of SPN, or NESA;

Previous report — wording carried elsewhere

prepayment of the $60 million milestone payment tied to the achievement of worldwide annual net sales of the Product of $150 million, or the First Sales Milestone, which was paid in cash at Closing, or the Prepaid Milestone, which Prepaid Milestone will accrue interest at a fixed rate of 10% per annum until the First Sales Milestone is achieved and 5% per annum thereafter until the earlier of (x) the date on which the Prepaid Milestone, plus accrued interest thereon, has been repaid in full by set-off and (y) the last day of the Milestone Period (as defined below); and

Previous report — wording carried elsewhere

future milestone payments of (x) $125 million tied to the achievement of worldwide annual net sales of the Product of $400 million and (y) $150 million tied to the achievement of worldwide annual net sales of the Product of $750 million, during the period from Closing until December 31 of the calendar year in which the tenth anniversary of Closing occurs, or the Milestone Period, and together, the Future Milestone Payments and, together with the Prepaid Milestone, the Milestone Payments.

Previous report — wording carried elsewhere

As they are earned, the Milestone Payments will be satisfied as follows: (1) first, by set-off against all accrued interest on the Prepaid Milestone until the amount of such accrued interest has been paid in full, (2) second, by set-off against the outstanding balance of the Prepaid Milestone until the Prepaid Milestone has been repaid in full and (3) thereafter, in cash. If any amount of the

Previous report — wording carried elsewhere

Prepaid Milestone (and any accrued interest thereon) remains outstanding as of following the last day of the Milestone Period (defined below), the balance thereof (together with any interest accrued thereon) will be forgiven and the right of set-off of SPN with respect thereto will be deemed forfeited. The installment payment received on July 1, 2025 was offset by $1.4 million we paid to Nestlé on the same date related to certain employment obligations assumed by SPN with respect to the period ending as of the Closing Date.

Previous report — wording carried elsewhere

In connection with the Closing, we entered into a cross-license agreement with SPN under which, we granted to SPN a perpetual, worldwide, non-exclusive, fully paid-up license under certain Seres patents that have been issued or will issue in the future and current know-how controlled by us that is not transferred to SPN pursuant to the Purchase Agreement. In the field of the treatment of Clostridioides difficile infections, or CDI, and rCDI and associated complications, or collectively, the CDI Field, the license to SPN under such Seres patents and know-how is exclusive to SPN for five years after the Closing and co-exclusive between SPN and Seres following that five year period. The license from Seres to SPN is to issued Seres patents that currently or in the future cover the Product or improvements thereof and know-how that is used or reasonably useful in connection with the exploitation of the VOWST Business. See “Intellectual Property” below.

Previous report — wording carried elsewhere

Based on prior FDA feedback, we are progressing start-up activities for our SER-155 Phase 2 study in allo-HSCT that could provide a time and capital-efficient path to obtaining clinical results. We require additional capital to begin this study. In May 2025, we filed the SER-155 Phase 2 protocol with the FDA. In September 2025, the FDA provided us with feedback on the SER-155 Phase 2 protocol and we continue to work with the FDA to finalize the study protocol. The SER-155 Phase 2 study will incorporate a well-powered, placebo-controlled design, which provides for a planned interim analysis to enable an expedited initial data readout. The SER-155 Phase 2 study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. We expect to obtain the interim clinical results within twelve months following study initiation, which we believe will facilitate timely engagement with the FDA on the design of a Phase 3 study and inform development in adjacent medically vulnerable patient populations. We believe that positive results, if achieved, from the Phase 2 study could enable advancement into a single Phase 3 trial to support registration.

Previous report — wording carried elsewhere

We continue our efforts to obtain capital and other resources to support further development of SER-155 and our broader portfolio of live biotherapeutic product candidates with applications for inflammatory diseases. We are evaluating a range of potential deal structures that we believe could leverage our live biotherapeutics expertise and success, as demonstrated by bringing VOWST from early development through FDA approval.

Previous report — wording carried elsewhere

We believe that exploratory biomarker data presented at recent medical meetings have supported the intended mechanisms of SER-155 and demonstrated the broader potential of live biotherapeutics in inflammatory and immune mediated diseases.

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Previous report — wording carried elsewhere

Total revenue was $0.4 million for the nine months ended September 30, 2025, consisting of costs reimbursable under the CARB-X grant that we were awarded in the third quarter of 2025.

Previous report — wording carried elsewhere

a decrease in personnel-related costs of $6.2 million primarily due to a decrease in salaries, bonuses, employee benefits expenses, and stock-based compensation expenses due to lower headcount; and