Duyuru • Sep 12

Seres Therapeutics, Inc. Announces Topline Clinical Data from Cohort 2 of its SER-155 Phase 1b Placebo-Controlled Study in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Seres Therapeutics, Inc. announced on September 12, 2024, the company announced topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Study results demonstrate that SER-155 was associated with a significant reduction in both bloodstream infections (BSIs) and systemic antibiotic exposure, as well as a lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT. The Company believes that the SER-155 Phase 1 study results support the Company’s corporate strategy to develop its platform, comprised of a pipeline of designed live biotherapeutics, in multiple medically vulnerable patient populations at high risk of life-threatening bacterial infections and associated negative clinical outcomes. The Company intends to seek Breakthrough Therapy designation, given the high unmet medical need associated with BSIs, and discuss advancing development of SER-155 for allo-HSCT with the U.S. Food and Drug Administration (FDA). The Company also intends to evaluate SER-155 in additional patient populations that have a high risk of serious bacterial infections. SER-155 Phase 1b Study Design: The SER-155 Phase 1b study (NCT04995653) included two cohorts. Cohort 1 was designed to assess safety and drug pharmacology, specifically the drug strain engraftment in the gastrointestinal tract. Cohort 1 included 13 subjects who received any dosing of the SER-155 regimen, with 11 subjects subsequently receiving an allo-HSCT. Results from this cohort, announced in May 2023, showed SER-155 was generally well tolerated and resulted in successful drug strain engraftment and a reduction in pathogen domination in the GI microbiome relative to a historical control cohort. Study Cohort 2 utilized a randomized, double-blinded 1:1 placebo-controlled design to further evaluate safety and drug strain engraftment, as well as key secondary and exploratory endpoints such as the incidence of bacterial bloodstream infections and related medical consequences such as febrile neutropenia and antibiotic use. Cohort 2 included 45 patients in the intention-to-treat (ITT) population. Of the ITT population, 20 received SER-155 and 14 received placebo, each of whom subsequently received an allo-HSCT, with data available for clinical evaluation through day 100, the study’s prespecified primary observation point. Exploratory hypothesis testing was conducted at the two-sided a=0.05 level. 95% 2-sided confidence intervals (CIs) were determined, where specified. No adjustment for multiplicity was done. A subset of patient samples was available for drug pharmacology analysis. The median age in Cohort 2 was 63, and most subjects had acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome or myeloproliferative neoplasia as their primary disease and received reduced-intensity conditioning pre-transplant. Most patients received peripheral blood stem cells from a matched unrelated donor. A majority received post-transplant cyclophosphamide as part of their graft-versus-host disease (GvHD) prophylaxis. Summary of Cohort 2 Study Results: Consistent with the observations from the Phase 1b study Cohort 1, SER-155 was generally well-tolerated, and no treatment-emergent serious adverse events related to drug were observed. SER-155 bacterial strains engrafted into the gastrointestinal tract of patients following the administration of SER-155. The incidence of BSIs was significantly lower in the SER-155 arm compared with the placebo arm (2/20 (10%) vs. 6/14 (42.9%), respectively; [Odds Ratio: 0.15; 95% CI: 0.01, 1.13, p=0.0423]). In addition, while antibiotic starts were similar in each arm, patients administered SER-155 were treated with antibiotics for a significantly shorter duration compared to patients in the placebo arm (9.2 days vs. 21.1 days, respectively, with a mean difference of -11.9 days [95% CI: -23.85, -0.04; p=0.0494]). The incidence of febrile neutropenia was lower in patients administered SER-155 compared to placebo (65% vs. 78.6%, respectively; [Odds Ratio: 0.51; 95% CI: 0.07, 2.99; p=0.4674]). Six cases of gastrointestinal infections (C. difficile infections) were observed in the study, with four cases (20%) in the SER-155 arm and two cases (14.3%) in the placebo arm. Recent changes in the allo-HSCT standard of care and the increasing use of post-transplant cyclophosphamide as part of prophylactic therapy for GvHD have reduced rates of GvHD overall in this patient population. The rates of GvHD in the study were low, with two cases of grade 2 GvHD observed in each arm, and no cases of grade 3 or 4 GvHD were observed. In Cohort 2, the ability to detect pathogen domination (i.e., relative abundance in the GI =30%) in the placebo arm, and differences between the study arms, was constrained due to the limited number of placebo stool samples and an imbalance in the number of available stool samples between the arms. Observed pathogen domination events were low in the placebo and SER-155 arms with no significant differences identified. In a comparison of the prevalence of pathogen domination versus a larger allo-HSCT historical control cohort, pathogen domination in SER-155 subjects was substantially lower, providing further evidence of SER-155 activity. The overall safety results in the first 100 days showed that SER-155 was generally well-tolerated, with no observed treatment-related serious adverse events. In Cohort 2, all but one subject in the placebo arm experienced at least one treatment-emergent adverse event (“TEAE”). The most common TEAEs were diarrhea and nausea. Four subjects experienced TEAEs that led to discontinuation. Nineteen subjects, or 48% of subjects, experienced serious adverse events, none of which were considered related to SER-155. Three deaths were reported in the study, none of which were considered related to SER-155. Fourteen subjects, or 35% of the subjects, experienced adverse events of special interest, including bloodstream infections, GI infection and invasive infection. Seres fully owns worldwide rights for the commercialization of SER-155.

Duyuru • May 10

Seres Therapeutics Reports SER-155 Phase 1b Cohort 1 Results Showing Successful Drug Bacteria Engraftment and Substantial Reduction in Pathogen Domination in the Gastrointestinal Microbiome

Seres Therapeutics, Inc. reported initial clinical data about SER-155. SER-155 is an oral, cultivated bacterial consortia investigational therapeutic designed to prevent enteric-derived infections and resulting blood stream infections, as well as induce immune tolerance responses to reduce the incidence of graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Gastrointestinal (GI) microbiome data from the first 100 days post HSCT in Cohort 1 of the SER-155 Phase 1b open-label study showed the successful engraftment of SER-155 bacterial strains and a substantial reduction in the cumulative incidence of pathogen domination, a biomarker associated with the risk of serious enteric infections and bloodstream infections, as well as GvHD. The tolerability profile observed was favorable, with no serious adverse events attributed to SER-155 administration. Enrollment in the placebo-controlled Cohort 2 portion of the study is ongoing and topline results are anticipated in mid-2024. SER-155 Phase 1b Study Design and Summary of Cohort 1 Results: SER-155 is an investigational, oral, 16 strain, cultivated microbiome therapeutic designed to prevent colonization and reduce the abundance of ESKAPE pathogens (e.g., from families such as Enterococcaceae, Enterobacteriaceae, Streptococcaceae, Staphylococcaceae) in the GI tract to reduce the risk of enteric driven bloodstream infections and other downstream consequences, such as GvHD, in patients receiving allo-HSCT. SER-155 has the potential to impact antimicrobial resistance (AMR), including infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococci (VRE). The development of SER-155 is informed by preclinical data that showed that allo-HSCT patients across multiple study sites had disrupted microbiomes and were susceptible to pathogen overgrowth in the GI tract, as well as in vivo studies that demonstrated SER-155's ability to significantly decolonize VRE and CRE, and further modulate epithelial barrier integrity and T cell biology or relevance to GvHD. Previously published exploratory results from the SER-109 ECOSPOR III Phase 3 study showed decolonization of gut pathogens, including bacteria that carry antibiotic resistance genes, providing clinical proof-of-concept for the SER-155 program. The SER-155 Phase 1b study includes two cohorts, with Cohort 1 designed to assess safety and drug pharmacology, including the engraftment of drug bacteria in the gastrointestinal tract. Cohort 1 included 13 subjects who received any dosing of the SER-155 regimen, with 11 of these subjects subsequently receiving an allo-HSCT. Nine subjects had evaluable samples for microbiome data analyses. The average age in Cohort 1 was 60, and most subjects had acute myeloid leukemia, myelodysplastic syndrome or myeloproliferative neoplasia as their primary disease and received reduced-intensity conditioning pre-transplant. Most subjects received peripheral blood stem cells from a matched unrelated donor. Neutrophil engraftment was observed in all subjects. The majority of subjects received a tacrolimus-based regimen for GvHD prophylaxis. Published data have demonstrated an association between the incidence of GI domination with ESKAPE pathogens in allo-HSCT patients and the risk of serious infections, GvHD, and mortality. Reducing the incidence of domination of ESKAPE pathogens in the GI microbiome through administration of a microbiome therapeutic has the potential to meaningfully reduce enteric infections, enteric driven blood stream infections and GvHD in this medically compromised patient population and more broadly. Enrollment of Cohort 2 is ongoing, incorporating a randomized, double-blinded placebo-controlled design to further evaluate safety, drug strain engraftment, and incidence of gastrointestinal ESKAPE pathogen domination, as well as the incidence of enteric infections, enteric driven blood stream infections and GvHD. Cohort 2 will enroll approximately 60 subjects administered either SER-155 or placebo at a 1:1 ratio. The Company anticipates obtaining top-line placebo-controlled day-100 data from study Cohort 2 in mid-2024. Seres believes that the medical benefit and commercial potential for SER-155 is substantial. Nearly 30,000 allo-HSCT procedures are performed in the U.S. and Europe per year. Complications are frequent and costly, with additional costs for patients with complications averaging approximately $180,000/year. Infections and GvHD are estimated to result in nearly half of mortality associated with allo-HSCT.4 With the exception of an exclusive license from MSK, Seres fully owns worldwide rights for commercialization of SER-155. In addition to SER-155, the Company is evaluating other microbiome therapeutic preclinical programs for additional medically compromised patient populations who are at risk of life-threatening infections.

Toplam Hissedar Getirisi	-17.9%
Gelecekteki Temettü Verimi	0%
Temettü Büyümesi	n/a
Bir sonraki temettü ödeme tarihi	n/a
Eski temettü tarihi	n/a
Hisse başına temettü	n/a
Ödeme oranı	n/a

Segment	Temettü Verimi
Şirket (MCRB)	n/a
Pazarın Alt %25'i (US)	1.4%
Pazarın En İyi %25'i (US)	4.2%
Sektör Ortalaması (Biotechs)	2.4%
Analist tahmini (MCRB) (3 yıla kadar)	0%

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/05/29 18:56
Gün Sonu Hisse Fiyatı	2026/05/29 00:00
Kazançlar	2026/03/31
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Tazeen Ahmad	BofA Global Research
John Newman	Canaccord Genuity
John Tanner	Cantor Fitzgerald & Co.

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Recent updates

New major risk - Financial position

Seres Therapeutics Presents Preclinical Data At Digestive Disease Week 2026 Supporting Ser-603, A Next-Generation Cultivated Live Biotherapeutic Candidate, for Inflammatory Bowel Disease

Investor sentiment deteriorates as stock falls 18%

Seres Therapeutics Showcases Ser-155 Data And Live Biotherapeutic Insights At Escmid Global

Seres Therapeutics, Inc., Annual General Meeting, Jun 09, 2026

Seres Therapeutics, Inc. Announces Executive and Management Changes

New major risk - Share price stability

Investor sentiment deteriorates as stock falls 39%

Seres Therapeutics, Inc. Provides Program and Corporate Updates and Prioritizes Emerging Programs in Inflammatory & Immune Diseases

Seres Therapeutics: Strong SER-155 Data, But Dilution Risk Now Warrants A 'Hold'

Insufficient new directors

Price target increased by 58% to US$21.00

Seres Therapeutics, Inc. to Report Q3, 2025 Results on Nov 05, 2025

Seres Therapeutics, Inc. Reports on Cost Reduction Measures and Workforce Adjustment to Manage Expenses

Consensus EPS estimates fall by 118%

Seres Therapeutics, Inc. Announces Further Constructive Feedback from FDA on Ser-155 Phase 2 Study Protocol

New major risk - Share price stability

Seres Therapeutics, Inc. Announces Management Changes, Effective August 5, 2025

Seres Therapeutics, Inc. to Report Q2, 2025 Results on Aug 06, 2025

New major risk - Financial position

New major risk - Revenue and earnings growth

Forecast to breakeven in 2025

Seres Therapeutics, Inc. to Report Q1, 2025 Results on May 07, 2025

New major risk - Share price stability

Price target increased by 19% to US$4.59

New minor risk - Market cap size

New minor risk - Shareholder dilution

Forecast to breakeven in 2027

Seres Therapeutics, Inc., Annual General Meeting, Apr 10, 2025

Seres Therapeutics, Inc. to Report Q4, 2024 Results on Mar 13, 2025

Seres Therapeutics, Inc. Receives Feedback from Fda on Ser-155 Allogeneic Hematopoietic Stem Cell Transplant (Allo-Hsct) Development Approach

Seres Therapeutics, Inc. Appoints Hans-Juergen Woerle as Class III Director

New major risk - Shareholder dilution

Seres Therapeutics Announces New Translational Biomarker Results from Ser-155 Phase 1B Clinical Study and Provides Corporate Updates

FDA Grants Breakthrough Therapy Designation to Seres Therapeutics’ SER-155 for Reduction of Bloodstream Infections in Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT)

New minor risk - Market cap size

Little Excitement Around Seres Therapeutics, Inc.'s (NASDAQ:MCRB) Revenues As Shares Take 30% Pounding

New major risk - Financial position

Seres Therapeutics, Inc. to Report Q3, 2024 Results on Nov 13, 2024

Price target increased by 18% to US$3.89

Lucien Selce and MKT Capital Issue Open Letter to Board of Seres Therapeutics Regarding Reported Engagement with Nestlé

Seres Therapeutics' Strategic Sale Of Vowst Warrants A Rating Upgrade

Seres Therapeutics, Inc. Announces Topline Clinical Data from Cohort 2 of its SER-155 Phase 1b Placebo-Controlled Study in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

First half 2024 earnings released: US$0.49 loss per share (vs US$0.20 loss in 1H 2023)

Consensus EPS estimates upgraded to US$0.85 loss

Seres Therapeutics, Inc. announced that it expects to receive $15.000001 million in funding from Société des Produits Nestlé S.A.

Seres Therapeutics, Inc. to Report Q2, 2024 Results on Aug 13, 2024

Seres Therapeutics, Inc. (NASDAQ:MCRB) Shares Fly 44% But Investors Aren't Buying For Growth

Nestle's Health Unit to Take Full Control of Microbiota-Based Therapeutic

New minor risk - Market cap size

Price target decreased by 14% to US$6.20

First quarter 2024 earnings released: US$0.28 loss per share (vs US$0.56 loss in 1Q 2023)

Seres Therapeutics, Inc. (NASDAQ:MCRB) Shares Fly 46% But Investors Aren't Buying For Growth

Seres Therapeutics, Inc. to Report Q1, 2024 Results on May 08, 2024

Seres Therapeutics Receives Non-Compliance Letter from The Nasdaq Stock Market LLC Related to Nasdaq Listing Rule 5450(a)(1)

New minor risk - Market cap size

Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT

Benign Growth For Seres Therapeutics, Inc. (NASDAQ:MCRB) Underpins Stock's 30% Plummet

Consensus revenue estimates decrease by 63%, EPS upgraded

New minor risk - Financial position

Full year 2023 earnings: EPS exceeds analyst expectations

No longer forecast to breakeven

Seres Therapeutics Appoints Marella Thorell as Executive Vice President

Price target increased by 7.7% to US$9.02

Price target increased by 15% to US$9.80

Seres Therapeutics' Balancing Act: Breakthrough IP And Financing Concerns

Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155

Forecast to breakeven in 2026

Lacklustre Performance Is Driving Seres Therapeutics, Inc.'s (NASDAQ:MCRB) 30% Price Drop

Consensus EPS estimates upgraded to US$0.98 loss, revenue downgraded

Price target decreased by 13% to US$8.54

Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

Seres Therapeutics, Inc. to Report Q3, 2023 Results on Nov 02, 2023

New minor risk - Share price stability

Lacklustre Performance Is Driving Seres Therapeutics, Inc.'s (NASDAQ:MCRB) 27% Price Drop