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Seres Therapeutics, Inc. (Nasdaq: MCRB) is a pioneering clinical-stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products. These novel drugs aim to treat significant diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is at the forefront of creating the first therapeutics that induce a shift towards health by enhancing the microbiome's biology.
The company operates primarily in the United States, leveraging its microbiome therapeutics platform to develop Ecobiotic™ microbiome therapeutics. These therapies are designed to restore health by repairing the function of a dysbiotic microbiome, particularly in the colon. Seres' lead product, SER-109, is developed to prevent the recurrence of Clostridium difficile infection (CDI), a severe infection of the colon. Additional product candidates include SER-262, SER-287, and SER-401.
Recently, Seres announced the sale of its VOWST assets to Nestlé Health Science under a non-binding memorandum of understanding. This transaction will provide Seres with capital infusions, including an upfront payment, and is expected to be completed in the next 90 days, subject to shareholder approval and other conditions. VOWST, the first FDA-approved oral microbiome therapy, prevents the recurrence of CDI in adults following antibacterial treatment for recurrent CDI.
Seres plans to use the capital from this transaction to retire its existing debt and strengthen its financial position. The company is also advancing SER-155, evaluated in a Phase 1b study in patients undergoing allogeneic hematopoietic stem cell transplantation. SER-155 has the potential to reduce gastrointestinal and related bloodstream infections, as well as acute graft-versus-host disease.
Seres Therapeutics continues to innovate in microbiome therapeutics, aiming to benefit multiple underserved patient groups, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. The company's approach could protect millions of medically vulnerable patients from life-threatening infections while addressing the global public health issue of antimicrobial resistance (AMR).
Seres Therapeutics (MCRB) reported its Q4 and full year 2020 results, confirming progress in its microbiome therapeutics portfolio. Key highlights include the advancement of SER-109 towards a Biologics License Application (BLA) and achieving target enrollment for the SER-287 ECO-RESET Phase 2b study. SER-109 demonstrated an 88% sustained clinical response in a Phase 3 study for recurrent C. difficile infection, with a significant reduction in recurrence rates. The company enters 2021 with a solid financial position and a robust pipeline targeting multiple diseases.
Seres Therapeutics, Inc. (Nasdaq: MCRB) has announced the successful enrollment of 201 patients in the Phase 2b ECO-RESET clinical trial for SER-287, targeting mild-to-moderate ulcerative colitis (UC). This study aims to assess clinical remission and endoscopic improvement after treatment. The FDA has indicated that this trial may support a Biologics License Application (BLA). The company anticipates sharing topline results in mid-2021, highlighting SER-287's potential as a new therapeutic approach amidst a significant unmet need for safer UC treatments.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced its participation in two upcoming investor conferences. The Cowen 41st Annual Health Care Conference is set for March 2, 2021, featuring a Microbiome panel discussion and 1x1 meetings. The Chardan 3rd Annual Microbiome Medicines Summit will take place on March 8, 2021, where management will present a corporate overview at 2:30 p.m. ET and conduct 1x1 meetings. An audio webcast for the Chardan presentation will be available on Seres’ website. The company is at the forefront of microbiome therapeutics, with notable programs for recurrent C. difficile infection and ulcerative colitis.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on March 2, 2021, at 8:30 a.m. ET to discuss its fourth quarter and full year 2020 results. The company is a leader in microbiome therapeutics, focusing on multifunctional bacterial therapeutics. Notably, Seres’ SER-109 program has shown positive pivotal clinical results and received Breakthrough Therapy and Orphan Drug designations from the FDA. Additionally, SER-287 is under Phase 2b evaluation for ulcerative colitis, while other programs are in various stages of clinical trials.
Seres Therapeutics (Nasdaq: MCRB) announced new findings from its SER-109 Phase 3 ECOSPOR III clinical study related to recurrent C. difficile infection. The study demonstrated rapid engraftment of SER-109-derived bacteria in the gastrointestinal tract, achieving significant metabolic changes that create an unfavorable environment for C. difficile growth. The data revealed an 88.9% sustained clinical response rate at eight weeks post-treatment, with no serious adverse events reported. SER-109 has received FDA Breakthrough Therapy and Orphan Drug designations.
Seres Therapeutics (Nasdaq: MCRB) announced promising results from its Phase 1b trial of SER-287 for treating active mild-to-moderate ulcerative colitis (UC). The study demonstrated a 40% clinical remission rate in patients receiving daily SER-287 compared to 0% in the placebo group. Data highlighted SER-287's safety and favorable tolerability profile, with no serious adverse events noted. The ongoing Phase 2b ECO-RESET study continues to enroll patients, aiming to provide topline results in late 2021. FDA Fast Track designation for SER-287 reinforces its potential as a transformative therapy for UC.
Seres Therapeutics (Nasdaq: MCRB) will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 14 at 11:40 a.m. ET. A live audio webcast will be accessible in the ‘Investors and Media’ section of their website, with a replay available an hour post-event for 21 days.
Seres is focused on microbiome therapeutics, with its SER-109 program achieving positive pivotal clinical results for C. difficile infection and receiving FDA Breakthrough Therapy status. Other programs include SER-287 for ulcerative colitis and SER-401 for metastatic melanoma.
Seres Therapeutics (Nasdaq: MCRB) has announced participation in two virtual investor conferences. The Piper Sandler 32nd Annual Virtual Healthcare Conference will take place on December 1, 2020, featuring management in 1x1 meetings and a fireside chat available from November 23, 2020. The 3rd Annual Evercore ISI HealthCONx Virtual Conference is scheduled for December 2, 2020, also including management 1x1 meetings. Seres is a leader in microbiome therapeutics with advanced programs for recurrent C. difficile infection and ulcerative colitis.
Seres Therapeutics (MCRB) reported a net loss of $30.3 million for Q3 2020, up from $16.4 million in Q3 2019, primarily due to clinical and development expenses. The company announced that SER-109, its lead microbiome therapy, showed a 30.2% absolute reduction in recurrent C. difficile infections in its Phase 3 study, supporting its potential FDA approval. Following a successful capital raise, Seres has $320.3 million in cash, enhancing its growth prospects. Additionally, SER-287 and SER-301 are in clinical trials, advancing the company’s broad microbiome pipeline.
Seres Therapeutics (Nasdaq: MCRB) has initiated the dosing of participants in its Phase 1b trial for SER-301, aimed at treating active mild-to-moderate ulcerative colitis (UC). SER-301 is a microbiome therapeutic designed to counteract gastrointestinal inflammation and is based on insights from the earlier SER-287 trial. The study in Australia and New Zealand will involve 65 patients, focusing on safety and pharmacokinetics. Seres will receive a $10 million milestone payment from Nestlé Health Science upon trial initiation.