MCRB Seres Therapeutics Inc.

20.58
+0.02  (+0%)
Previous Close 20.56
Open 20.24
52 Week Low 3.35
52 Week High 38.5
Market Cap $1,884,086,899
Shares 91,549,412
Float 54,016,863
Enterprise Value $1,669,408,910
Volume 543,235
Av. Daily Volume 1,068,511
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
SER-287
Mild-to-Moderate Ulcerative Colitis
Phase 2b
Phase 2b
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
SER-401
Melanoma
Phase 1b
Phase 1b
Phase 1b enrollment discontinued - March 8, 2021.
SER-155
Gastrointestinal infections, bacteremia and graft versus host disease (GvHD)
Phase 1b
Phase 1b
Phase 1b trial to be initiated 1H 2021.
SER-109
Recurrent C. Difficile infection
Phase 3
Phase 3
Phase 3 data met primary endpoint - August 10, 2020. Open-label trial ongoing.
SER-301
Ulcerative Colitis
Phase 2
Phase 2
Phase 1b initiation announced November 6, 2020.

Latest News

  1. David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development…

    David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development of multiple therapeutic programs.

    "David, Hari and Lin all bring a wealth of strategic leadership and deep expertise to Tessera at an exciting time in our growth," said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera. "Together and alongside our current senior leadership team, they will be instrumental in advancing Tessera's mission to bring forth innovative and curative medicines that go beyond the limitations of current technologies."

    Dr. Davidson brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy to his new role as Tessera's Chief Medical and Development Officer. For nearly a decade, Dr. Davidson served as Chief Medical Officer of bluebird bio, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering multiple first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird, Dr. Davidson led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy. He completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine, and an endocrinology research fellowship at the University of Chicago Hospitals. Dr. Davidson received his M.D. from New York University and B.A. from Columbia University.

    "I have been privileged to lead the clinical development of gene therapy programs from inception through approval to deliver these transformative medicines to patients with life-threatening diseases. I am excited to join the team at Tessera Therapeutics to bring innovative Gene Writing therapies into the clinic," said Dr. David Davidson. "By harnessing the power of mobile genetic elements, Tessera's Gene Writing platform is poised to realize the full potential of genetic medicine and make an unprecedented impact on human health. I am honored to help move this vision forward."

    Dr. Pujar, an Operating Partner at Flagship Pioneering since October 2020, will also serve as Tessera's Chief Operating Officer. Dr. Pujar brings more than 20 years of drug development, manufacturing and commercialization experience spanning AAV gene therapy, mRNA vaccines and therapeutics, and traditional vaccines and biologics. Most recently, Dr. Pujar served as Chief Technology Officer at Spark Therapeutics, a pioneer in AAV gene therapy, and Head of Technical Development and Manufacturing at Moderna, where he led mRNA and lipid nanoparticle development and manufacturing. Previously, Dr. Pujar spent 18 years at Merck & Co., developing and commercializing vaccines and biologics. Dr. Pujar received his Ph.D. in Chemical Engineering from the University of Delaware and his M.B.A. from the University of Pennsylvania.

    "As medicine continues to move up the central dogma of molecular biology from proteins to mRNA to DNA, the opportunity to cure diseases will continue to expand. I'm excited to help shape Tessera Therapeutics, whose Gene Writing technology has the potential to address many of the limitations of current genetic medicine technologies," said Dr. Hari Pujar.

    Dr. Guey, Tessera's Senior Vice President of Rare Diseases Program Strategy and Operations, will oversee the execution of Tessera's genetic medicine programs in Rare Diseases. Dr. Guey brings over 13 years of drug development experience in program leadership, research and nonclinical development, pharmacogenomics and epidemiology. Prior to joining Tessera, Dr. Guey served in senior leadership roles for Moderna, Xilio Therapeutics, Shire, and Pfizer. Dr. Guey received her Ph.D. in Statistics and B.S. in Mathematics from Stony Brook University.

    "With its pioneering and versatile Gene Writing technology, Tessera Therapeutics is at the very forefront of genetic medicine," said Dr. Lin Guey. "I look forward to working with the Tessera team to find new ways to cure rare genetic diseases at their source."

    For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.

    About Tessera Therapeutics

    Tessera Therapeutics is a life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

    View Full Article Hide Full Article
  2. CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Invaio Sciences, Inc., a Flagship Pioneering company focused on unlocking the potential of the planet's interdependent natural systems to solve pressing agriculture, nutrition and environmental challenges, announced today the appointment of Peleg Chevion as President and Chief Commercial Officer.  Chevion, who joined the company in late 2020, will focus on accelerating the commercial activities of the company.

    "Our goal at Invaio is to accelerate the transition in agriculture from a chemical-based industry to a biological-based industry that addresses the needs of farmers and society, while protecting the environment," said Ignacio Martinez, Co-Founder and CEO, Invaio. "The company is now transitioning from an R&D-focused organization to a full commercial enterprise."

    Martinez continued, "Peleg has already made a significant impact at Invaio since he joined the company in late 2020. He brings a very unique set of experiences, commercial leadership, and an entrepreneurial mindset perfectly suited for the next phase of the company."

    Prior to joining Invaio, Chevion was President and Chief Commercial Officer of Blendhub, a global leader in food and ingredients production. Before Blendhub, Peleg worked with Lindsey Goldberg, a leading global private equity firm based in New York. Chevion also worked for seven years as a senior executive at Syngenta where he started and then led the Abiotic Stress Management indication across the spectrum of chemical, biological, genetics and digital platforms. Prior to Syngenta, Chevion spent several years leading Business Development at Crucell before the company was acquired by J&J.

    Chevion began his career as an officer in the Israeli Air Force, and later held diverse roles in the Israeli startup ecosystem.  Chevion graduated from the IDF Computer Academy. He received an L.L.B from Tel Aviv University, an MBA from INSEAD and is a licensed attorney in Israel.

    "Since joining Invaio last year, I have been impressed by the breakthrough platform technologies we are developing, our integrated solutions approach and the commercial traction of the company," said Peleg Chevion, President and Chief Commercial Officer, Invaio. "We are curing diseases like Greening in Citrus and Xylella in Olives, significantly reducing the use of chemicals with our precision delivery systems, and discovering biological products with consistent performance using proprietary Artificial Intelligence and Machine Learning technologies"

    Chevion continues, "We are laser focused on developing unique solutions for our partner growers and other stakeholders in three segments: perennials, row crops and vegetable crops. We see the opportunity and have a sense of urgency to deliver."

    About Invaio Sciences:

    Invaio Sciences is a multi-platform technology company that unlocks the potential of the planet's interdependent systems to address pressing agricultural, nutritional, and environmental challenges. Founded by Flagship Pioneering in 2018, Invaio leverages discoveries from diverse fields including human therapeutics, agriculture, environmental science, and advanced manufacturing. The company's deep understanding of the physiology of insects, plants and trees, together with its novel integrated solutions approach, promises to refine agricultural practices and reduce the need for pesticides globally. Invaio Sciences is dedicated to developing solutions that are mindful of beneficial insects, bad for pests, and safer for us all.  For more information, please visit www.invaio.com

    About Flagship Pioneering:

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Inari Agriculture, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/invaio-sciences-strengthens-leadership-team-with-appointment-of-peleg-chevion-as-president-and-chief-commercial-officer-301258544.html

    SOURCE Invaio Sciences

    View Full Article Hide Full Article
  3. Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, announced that managment will present a corporate overview at the 31st Annual Oppenheimer Healthcare Conference on Tuesday, March 16 at 9:20 a.m. ET.

    A live audio webcast of the presentation will be available under the "Investors and Media" section of Seres' website. A replay of the presentation will become available approximately one hour after the event and will be archived for 21 days.

    About Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease…

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, announced that managment will present a corporate overview at the 31st Annual Oppenheimer Healthcare Conference on Tuesday, March 16 at 9:20 a.m. ET.

    A live audio webcast of the presentation will be available under the "Investors and Media" section of Seres' website. A replay of the presentation will become available approximately one hour after the event and will be archived for 21 days.

    About Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres' SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis, and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease. For more information, please visit www.serestherapeutics.com.

    View Full Article Hide Full Article
  4.  - Enrollment meaningfully impacted by COVID-19 -

    - The Company reiterates opportunity in oncology and continues advancement of its preclinical efforts -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that the Company, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy (PICI) and The University of Texas MD Anderson Cancer Center, has voluntarily discontinued further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma.

    "While we are disappointed to discontinue enrollment, we are encouraged…

     - Enrollment meaningfully impacted by COVID-19 -

    - The Company reiterates opportunity in oncology and continues advancement of its preclinical efforts -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that the Company, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy (PICI) and The University of Texas MD Anderson Cancer Center, has voluntarily discontinued further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma.

    "While we are disappointed to discontinue enrollment, we are encouraged by the opportunity to apply the learnings from this study towards future development programs at Seres that can directly benefit the oncology community in search of new treatment options," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "We want to thank the patients, their care partners, our collaborators and the medical professionals who participated in this study, despite the COVID-19 pandemic, and helped further advance our understanding of the role microbiome therapeutics play in the treatment of cancer."

    A preliminary analysis of results from 10 subjects who received either SER-401 or placebo in combination with nivolumab indicated that SER-401 was safe and well-tolerated. There were no patients enrolled in the FMT portion of the study. Subjects currently enrolled in the study will complete the study protocol. Given challenges in enrollment due to the COVID-19 pandemic, subsequent anticipated time to study completion, and progress in its preclinical oncology pipeline, Seres has decided to deprioritize further development of SER-401. The Company will continue to advance its research and development efforts in cancer, applying learnings from the SER-401 trial.

    Evidence continues to emerge that suggests gut microbiome modulation may augment responses to cancer immunotherapy, including improving responses in PD-1 refractory patients1.

    Seres and its collaborators continue to be excited about the opportunity to develop next-generation therapeutics targeting gut microbes for the treatment of individuals living with cancer. Seres will continue to engage with MD Anderson and PICI to advance the development of medicines in this field, and maintains a robust preclinical program in oncology as well as a collaboration with Memorial Sloan Kettering Cancer Center centered on advancing microbiome therapeutics in various settings of oncology. Seres' immuno-oncology patent portfolio includes the option to exclusively license foundational intellectual property from MD Anderson, based upon the work of Jennifer Wargo, M.D., professor of Surgical Oncology and Genomic Medicine.

    About Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres' SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate UC. Seres is evaluating SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 in a Phase 1b study in patients with ulcerative colitis, and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease. For more information, please visit www.serestherapeutics.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the receipt of additional data from clinical studies, the potential role and advancement of microbiome therapeutics in the treatment of cancer, the promise of our microbiome therapeutics, and other statements that are not historical facts.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; our ability to retain key personnel and to manage our growth; and our management and principal stockholders have the ability to control or significantly influence our business. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 2, 2021, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    1 Davar et al. 2021. Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients. Science, DOI: 10.1126/science.abf3363; Baruch et al. 2021. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science, DOI: 10.1126/science.abb5920

    View Full Article Hide Full Article
  5. - Topline clinical data expected in mid-2021 -

    - Results will inform Seres' broader development efforts in UC and other programs targeting modulation of host inflammation and immunity -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that the Company has achieved target enrollment of the Phase 2b ECO-RESET clinical study of SER-287 in patients with mild-to-moderate ulcerative colitis (UC) in both the U.S. and Canada. SER-287, Seres' second microbiome therapeutic to reach late-stage clinical trials following a successful Phase 3 readout for SER-109, could represent a new therapeutic paradigm for UC by targeting underlying biological drivers of the disease. The results of this study will inform Seres' broader development efforts in ulcerative…

    - Topline clinical data expected in mid-2021 -

    - Results will inform Seres' broader development efforts in UC and other programs targeting modulation of host inflammation and immunity -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that the Company has achieved target enrollment of the Phase 2b ECO-RESET clinical study of SER-287 in patients with mild-to-moderate ulcerative colitis (UC) in both the U.S. and Canada. SER-287, Seres' second microbiome therapeutic to reach late-stage clinical trials following a successful Phase 3 readout for SER-109, could represent a new therapeutic paradigm for UC by targeting underlying biological drivers of the disease. The results of this study will inform Seres' broader development efforts in ulcerative colitis and other programs that target modulation of host inflammation and immunity.

    "People with ulcerative colitis and other inflammatory bowel diseases are in need of safe and effective treatment options, especially for mild-to-moderate forms of the disease. ECO-RESET achieved its target enrollment even amid the ongoing COVID-19 pandemic, a reflection of this high unmet need," said Lisa von Moltke, M.D., Chief Medical Officer of Seres. "We believe microbiome therapeutics offer the potential for an alternative treatment approach for inflammatory bowel diseases and have been committed to advancing microbiome therapeutics to address this need. We're pleased that SER-287, our most advanced UC program, has now reached this trial enrollment milestone."

    The Phase 2b ECO-RESET study (Clinicaltrials.gov identifier: NCT03759041) is a multicenter, randomized, placebo-controlled study which has enrolled the targeted 201 patients with active mild-to-moderate UC. Two groups of patients are receiving different doses of SER-287, both following pre-conditioning with a short course of oral vancomycin. A third group is receiving placebo. The study's primary endpoint will evaluate clinical remission measured after 10 weeks of SER-287 administration. Endoscopic improvement will be measured as a secondary efficacy measure.

    Based upon feedback obtained from the U.S. Food and Drug Administration (FDA) on the SER-287 Phase 2b study design, Seres believes the study could serve as one of two required pivotal trials supporting a Biologics License Application (BLA). The Company expects to share topline clinical data from ECO-RESET in mid-2021.

    Mild-to-moderate UC is the most common form of the disease, representing a majority of the patient population in the U.S. First-line therapies for UC are only modestly effective. Non-responders have limited treatment options because potent immunosuppressive therapies have serious side effects which may be hard to justify in patients with mild-to-moderate disease. An unmet need exists for an effective, safer alternative therapeutic approach for mild-to-moderate UC patients that is not immunosuppressive.

    "Seres is grateful to the patients, principal investigators and clinical research teams who have made this study possible. Their commitment to the trial's successful execution despite the challenges of COVID-19 has been remarkable," said Eric Shaff, President and Chief Executive Officer of Seres. "The data generated from this important study will inform our ongoing clinical efforts for SER-287 and SER-301 in UC as well as other indications through our reverse translational approach, supporting Seres' efforts to continue driving forward microbiome therapeutics that can transform the standard of care for patients."

    About SER-287

    SER-287, an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicute spores, is designed to normalize the gastrointestinal microbiome of individuals with UC. Preclinical colitis animal models and in vitro screens provide evidence that SER-287 administration has the potential to reduce pathology and modulate inflammatory and immunological functional pathways. SER-287 has been granted Fast Track Designation by the FDA for the induction and maintenance of clinical remission in adult subjects with active mild-to-moderate UC. SER-287 has been designated an Orphan Drug for pediatric UC by the FDA.

    About Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres' SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres' SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate UC. Seres is evaluating SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 in a Phase 1b study in patients with ulcerative colitis, and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease. For more information, please visit www.serestherapeutics.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the potential market for SER-287, the timing of clinical study results, the ability for the ECO-RESET study to serve as one of two pivotal trials, the results of our clinical studies, potential approval of SER-287, potential market acceptance, the promise of our microbiome therapeutics, and other statements that are not historical facts.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; our ability to retain key personnel and to manage our growth; and our management and principal stockholders have the ability to control or significantly influence our business. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 9, 2020, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    View Full Article Hide Full Article
View All Seres Therapeutics Inc. News