MCRB Seres Therapeutics Inc.

24.17
-1.23  -5%
Previous Close 25.4
Open 25.63
52 Week Low 2.52
52 Week High 38.5
Market Cap $2,205,469,912
Shares 91,248,238
Float 53,715,689
Enterprise Value $2,021,463,020
Volume 1,488,238
Av. Daily Volume 1,122,156
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Upcoming Catalysts

Drug Stage Catalyst Date
SER-287
Mild-to-Moderate Ulcerative Colitis
Phase 2b
Phase 2b
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Drug Pipeline

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

Latest News

  1. - New data from microbiome and metabolomic endpoints provide mechanistic support of the positive Phase 3 study results -

    - Enrollment ongoing in SER-109 open-label study in patients with recurrent C. difficile infection to support a Biologics Licensing Application for U.S. FDA product approval -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that it will present new data from its SER-109 Phase 3 ECOSPOR III clinical study that confirm the intended pharmacological properties of this investigational microbiome therapeutic for recurrent C. difficile infection (CDI). The data presentation, entitled "Microbiome therapeutics to treat bacterial infections and inflammatory disease," will take place virtually at the Keystone Symposium Harnessing…

    - New data from microbiome and metabolomic endpoints provide mechanistic support of the positive Phase 3 study results -

    - Enrollment ongoing in SER-109 open-label study in patients with recurrent C. difficile infection to support a Biologics Licensing Application for U.S. FDA product approval -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) announced today that it will present new data from its SER-109 Phase 3 ECOSPOR III clinical study that confirm the intended pharmacological properties of this investigational microbiome therapeutic for recurrent C. difficile infection (CDI). The data presentation, entitled "Microbiome therapeutics to treat bacterial infections and inflammatory disease," will take place virtually at the Keystone Symposium Harnessing the Microbiome for Disease Prevention and Therapy on January 20, 2021.

    The new study data examined the pharmacokinetics (i.e., drug bacterial species engraftment) and pharmacodynamics (i.e., metabolic changes) following SER-109 dosing. The data demonstrate that SER-109 administration resulted in the rapid engraftment of SER-109-derived bacterial species into the gastrointestinal tract as soon as one week following dosing and that this engraftment was maintained at subsequent timepoints evaluated, including at the eight-week timepoint corresponding to the study's primary endpoint. Seres utilized advanced microbiome biomarker analytics and proprietary genomic reference datasets to identify, at a bacterial species resolution level, the gastrointestinal microbiome signatures associated with SER-109 engraftment.

    SER-109 administration also resulted in modulation of the gastrointestinal metabolic landscape. Notably, data demonstrated a significant decrease in primary bile acids and an increase in secondary bile acids. Published research and preclinical studies conducted by the Company have demonstrated that primary bile acids support germination of C. difficile spores that are the source of disease recurrence. In contrast, secondary bile acids have been reported to inhibit the growth of C. difficile (Theriot and Young, Annu. Rev. Microbiol. 2015).

    "We have completed several predefined exploratory endpoints that provide high-resolution pharmacokinetic and pharmacodynamic data from our SER-109 Phase 3 study, and these data support the drug candidate's intended mechanisms of action to reduce the recurrence of C. difficile infection. SER-109-derived bacterial species were found to rapidly and persistently engraft into the gastrointestinal microbiome and this engraftment was associated with broad metabolic changes, resulting in a gut environment that is unfavorable for C. difficile growth," said Matthew Henn, Ph.D., Executive Vice President and Chief Scientific Officer of Seres. "Since Seres' founding, the Company has invested in building proprietary capabilities to enable generation of detailed scientific data from clinical samples, as illustrated by these results. Clinically derived mechanistic datasets are a core component of our R&D engine as they provide in-depth insights that inform the specific bacteria and metabolic pathways to be targeted with our microbiome therapeutic candidates. These types of data, combined with nonclinical data based on human cell-based assays and in vivo models, provide critical insights that extend to our other therapeutic programs."

    The ECOSPOR III Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiply recurrent CDI. Patients were randomized 1:1 to receive either SER-109 or placebo, after standard of care antibiotic treatment. Previously reported topline data from ECOSPOR III showed that SER-109 met the study's primary endpoint, and demonstrated a sustained clinical response rate of 88.9% compared to placebo at eight weeks post-treatment. SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm, and an adverse event profile comparable to placebo.

    Seres is sponsoring an ongoing open-label study of SER-109 in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183141). Additional information can be found at serescdiffstudy.com.

    About SER-109

    SER-109 is an investigational, oral, biologically-sourced microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome. SER-109 is a consortium of purified Firmicute bacteria in spore form, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of recurrent CDI.

    SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT) and FMT-like products. SER-109 is comprised of a highly purified consortia of commensal bacteria in spore form, manufactured in accordance with Current Good Manufacturing Practice (cGMP) conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process designed to inactivate numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.

    About C. difficile Infection (CDI) and Current Treatments

    C. difficile infection (CDI) is one of the top three most urgent antibiotic-resistant bacterial threats in the U.S., according to the Centers for Disease Control, and is a leading cause of hospital-acquired infection in the U.S. It is responsible for the deaths of approximately 20,000 Americans each year. CDI is associated with debilitating diarrhea, which significantly impacts quality of life in every functional domain. Since the discovery of C. difficile more than four decades ago, vancomycin has been the drug most commonly used for patient management. Current approaches provide only modest improvements in sustained clinical response rates, leaving behind a significant pool of patients with recurrent disease. Unapproved FMT, used in cases that are not responsive to approved drugs, remains poorly characterized clinically and has been associated with serious safety concerns, including the transmission of bacterial pathogens and the potential transmission of viruses such as SARS-CoV-2, the virus that causes COVID-19. The ongoing quarantine and shipping hold of FMT material from a major stool bank highlights the urgent need for an approved effective and safe treatment for recurrent CDI.

    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-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-109, the impact of the microbiome and metabolomic data on our other programs, the potential approval of SER-109, the promise of our microbiome therapeutics, the potential impact of the COVID-19 pandemic, 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.

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  2. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14 at 11:40 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…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14 at 11:40 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-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.

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  3. - Phase 1b study results demonstrate an impact on clinical remission and endoscopic improvement with a favorable safety profile in patients with mild-to-moderate ulcerative colitis-

    - Detailed microbiome and metabolomic study results provide scientific insights into the SER-287 mechanism of action and support for additional ongoing Seres pipeline programs -

    - SER-287 Phase 2b study enrollment is ongoing; Topline data are expected in the second half of 2021 -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the publication of data analyses from the Company's Phase 1b trial of SER-287 in patients with active mild-to-moderate ulcerative colitis (UC), most of whom were failing current therapies. The study results demonstrated that SER-287…

    - Phase 1b study results demonstrate an impact on clinical remission and endoscopic improvement with a favorable safety profile in patients with mild-to-moderate ulcerative colitis-

    - Detailed microbiome and metabolomic study results provide scientific insights into the SER-287 mechanism of action and support for additional ongoing Seres pipeline programs -

    - SER-287 Phase 2b study enrollment is ongoing; Topline data are expected in the second half of 2021 -

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the publication of data analyses from the Company's Phase 1b trial of SER-287 in patients with active mild-to-moderate ulcerative colitis (UC), most of whom were failing current therapies. The study results demonstrated that SER-287 administration was associated with positive impacts on clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210106005265/en/

    (Photo: Business Wire)

    (Photo: Business Wire)

    The paper, titled "A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, For Active Mild-To-Moderate Ulcerative Colitis," was published as the highlighted cover article in the January 2021 print edition of the leading journal Gastroenterology.

    "Individuals with ulcerative colitis are in need of effective therapies with a favorable safety profile, and this Phase 1b study provided promising evidence suggesting that SER-287 has the potential to transform how this disease is managed," said Lisa von Moltke, M.D., Chief Medical Officer of Seres. "We look forward to furthering our understanding of SER-287 in our ongoing Phase 2b ECO-RESET study. The Phase 2b study continues to recruit patients, and though COVID-19 continues to impact operations, we're encouraged to see that many clinical sites remain active. The study is nearly 90% enrolled, and we expect to obtain topline results in the second half of 2021."

    "The SER-287 Phase 1b clinical and pharmacological data are highly encouraging and suggest that SER-287 could represent a new therapeutic paradigm for ulcerative colitis by targeting underlying biological drivers of the disease. The SER-287 program, and our highly positive SER-109 Phase 3 study results for recurrent C. difficile infection, support the broad opportunity for microbiome therapeutics. We believe that our programs provide clear clinical evidence demonstrating the therapeutic potential of bacterial consortia that target multiple disease-relevant pathways simultaneously and further validate Seres' reverse translational microbiome platforms for drug discovery and development," said Matthew Henn, Ph.D., Executive Vice President and Chief Scientific Officer of Seres and the manuscript's senior author. "The mechanistic data that we obtain from our clinical studies are invaluable, as these enable us to refine our understanding of how the microbiome can modulate the metabolic landscape in the gastrointestinal tract and, in combination with our preclinical platforms, propel both the discovery of novel microbiome disease targets and the expansion of our microbiome therapeutics pipeline."

    Phase 1b Study Details

    The randomized, double-blind, placebo-controlled, multiple-dose, Phase 1b induction trial randomized 58 patients to one of four arms: daily SER-287 (preceded by short vancomycin conditioning regimen), weekly SER-287 (preceded by short vancomycin conditioning regimen), weekly SER-287 (preceded by placebo), and daily placebo (preceded by placebo).

    The highest efficacy was observed in the daily SER-287 arm of the study, with a remission rate of 40% compared to 0% in the placebo group. SER-287 engraftment was dose-dependent, durable for four weeks post-dosing, and associated with clinical remission across arms. An SER-287-associated benefit in endoscopic improvement was also observed. SER-287 engraftment, reflecting the germination and growth of drug bacteria, was associated with compositional and functional changes in the microbiome, including increased diversity of spore-forming Firmicutes implicated in colonic homeostasis, declines in non-spore forming species such as pro-inflammatory Enterobacteriaceae, and changes in the abundance of microbe-associated metabolites that impact epithelial barrier function and immune signaling. The SER-287 safety and tolerability profile were favorable, and study results demonstrated no imbalance in adverse events in patients treated with SER-287 compared to patients treated with placebo. There were no drug-related serious adverse events (SAEs) associated with SER-287.

    About SER-287

    SER-287 is an oral, biologically-derived microbiome therapeutic candidate designed to have pharmacological effects on multiple pathways relevant to ulcerative colitis that can be modulated by the gastrointestinal microbiome. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate UC. The SER-287 ECO-RESET induction study in patients with active mild-to-moderate UC remains ongoing. Seres has implemented a number of COVID-19-related mitigation strategies, and the study continues to enroll patients.

    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-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 timing and results of our clinical studies, the potential impact of SER-287 on patients and the treatment of UC overall, the promise of our microbiome therapeutics, the potential impact of the COVID-19 pandemic, 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; the success of our leadership transition; 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.

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  4. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that management will participate in two upcoming investor conferences:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020 where management will participate in 1x1 meetings. A fireside chat held with Seres management will be made available on the News and Events section of the Company's website on November 23, 2020.
    • 3rd Annual Evercore ISI HealthCONx Virtual Conference on December 2, 2020. Management will participate in 1x1 meetings.

    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…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that management will participate in two upcoming investor conferences:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020 where management will participate in 1x1 meetings. A fireside chat held with Seres management will be made available on the News and Events section of the Company's website on November 23, 2020.
    • 3rd Annual Evercore ISI HealthCONx Virtual Conference on December 2, 2020. Management will participate in 1x1 meetings.

    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-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.

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  5. – Reported ECOSPOR III Phase 3 study of SER-109 met primary endpoint, demonstrated statistically significant absolute reduction of 30.2% in rate of C. difficile infection recurrence compared to placebo –

    – SER-109 anticipated to be first-ever FDA-approved microbiome therapy –

    – First patient dosed in SER-301 Phase 1b study in mild-to-moderate ulcerative colitis –

    – Strengthened balance sheet with $264 million financing to support R&D and CMC capabilities expansion, ongoing clinical studies, and pre-commercial launch activities –

    – Conference call at 8:30 a.m. ET today –

    Seres Therapeutics, Inc., (NASDAQ:MCRB) today reported financial results from the third quarter ended September 30, 2020, and provided business updates.

    "Supported by…

    – Reported ECOSPOR III Phase 3 study of SER-109 met primary endpoint, demonstrated statistically significant absolute reduction of 30.2% in rate of C. difficile infection recurrence compared to placebo –

    – SER-109 anticipated to be first-ever FDA-approved microbiome therapy –

    – First patient dosed in SER-301 Phase 1b study in mild-to-moderate ulcerative colitis –

    – Strengthened balance sheet with $264 million financing to support R&D and CMC capabilities expansion, ongoing clinical studies, and pre-commercial launch activities –

    – Conference call at 8:30 a.m. ET today –

    Seres Therapeutics, Inc., (NASDAQ:MCRB) today reported financial results from the third quarter ended September 30, 2020, and provided business updates.

    "Supported by our positive, highly significant SER-109 Phase 3 results, we expect SER-109 to be the first-ever microbiome therapy approved by the U.S. FDA. Following those remarkable SER-109 study data and a significant capital infusion, Seres is in the midst of transformational growth toward becoming a commercial-stage microbiome company, with a broad portfolio of promising therapeutic candidates. We are expanding our field-leading capabilities across R&D, manufacturing, and commercial operations to maximize the multitude of opportunities we see for our approach," said Eric Shaff, President and Chief Executive Officer of Seres. "Our immediate priorities are to drive enrollment in our SER-109 open-label study to fulfill our safety database requirements and prepare to file a Biologics License Application (BLA), while also preparing the Company for the potential commercialization of SER-109."

    "In tandem, we continue to advance our deep microbiome pipeline, including SER-287, SER-301, SER-401, and SER-155. These therapeutic candidates span infectious diseases, inflammatory disease, and cancer, and we believe all have the potential to fundamentally improve upon the current standard of care. Most recently, we were pleased to dose the first subject in our SER-301 Phase 1b study in patients with ulcerative colitis. Moving forward, we expect to reach a number of value-creating milestones across multiple therapeutic areas," concluded Mr. Shaff.

    Program and Corporate Updates

    SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an investigational, oral, biologically-derived microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome.

    In August, Seres announced topline results from ECOSPOR III, demonstrating that SER-109 met the study's primary endpoint, showing a 30.2% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. Based on feedback from the FDA and the strength of the SER-109 Phase 3 data, Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration.

    In October, Seres presented the Phase 3 study result and additional data from ECOSPOR III at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting. These new data showed that at 12 weeks post-treatment the rate of recurrence in the SER-109 arm was 16.7%, compared to a rate of 47.8% in the placebo arm, representing an absolute risk reduction of 31.1% (relative risk 0.35; 95% CI=0.21-0.58; p-value <0.001), consistent with the results seen at eight weeks. Additionally, these new findings demonstrate that SER-109 administration resulted in similar efficacy when groups are stratified by age (i.e., ≥ or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin), which is important in this patient population. The number needed to treat (NNT) at 12 weeks is approximately 3, similar to the figure calculated based on eight-week study results.

    The SER-109 manufacturing process inactivates vegetative bacteria and other potential pathogens, which have been linked with fecal microbiota transplant (FMT)-associated disease transmission. Seres believes that this unique manufacturing process provides a critically important safety advantage.

    Following the topline Phase 3 study results, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, and reaffirmed its prior guidance that the safety database prelicensure should be at least 300 subjects.

    Seres is conducting an ongoing SER-109 open-label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128), which also admits patients with a single recurrence of CDI, to expand the SER-109 safety database. The Company continues to make progress activating new clinical sites and enrolling subjects into the study. Additional information is available at serescdiffstudy.com.

    SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, biologically-derived microbiome therapeutic candidate designed to have pharmacological effects on multiple pathways relevant to ulcerative colitis that can be modulated by the gastrointestinal microbiome. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate UC.

    The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate UC is ongoing. Seres has implemented a number of COVID-19-related mitigation strategies and the study continues to enroll patients. The study is over 75% enrolled.

    SER-301 Phase 1b study first patient dosed: In November, the Company announced that the first patient has been dosed in its Phase 1b study for SER-301, an oral, rationally-designed, fermented microbiome therapeutic. SER-301 is being evaluated in a Phase 1b study in adults with mild-to-moderate ulcerative colitis. The study is being conducted in Australia and New Zealand and targets the enrollment of approximately 65 subjects.

    A first open-label cohort of 15 subjects will evaluate safety and pharmacokinetics (PK), as measured by bacterial engraftment. In the subsequent second cohort, 50 subjects will be randomized to receive either SER-301 or placebo. The objectives for this cohort are to evaluate drug safety and PK, and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

    The consortium of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract and modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. The design of SER-301 has incorporated learnings from the SER-287 Phase 1b study related to the microbiome signatures associated with clinical efficacy.

    Seres is entitled to receive a $10 million milestone payment associated with the Phase 1b SER-301 clinical study initiation from Nestlé Health Science, the Company's ex-North American collaborative partner for this program.

    SER-401 Phase 1b study in metastatic melanoma: SER-401 is an orally-administered, biologically-derived, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with patient response to checkpoint inhibitor immunotherapy.

    The ongoing placebo-controlled Phase 1b study in patients with metastatic melanoma is supported by the Parker Institute for Cancer Immunotherapy and the University of Texas MD Anderson Cancer Center. The trial is examining safety, tolerability, and drug activity via microbiome engraftment and its association with biomarkers of clinical response in tumor biopsies in patients treated with SER-401 in combination with nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy.

    SER-155 Phase 1b clinical study activities: Seres continues to advance SER-155, an oral, rationally-designed, fermented microbiome therapeutic, toward a Phase 1b clinical study. SER-155 is designed to prevent mortality due to gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models. The composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.

    The SER-155 program is supported by a CARB-X grant that provides financial and operational support through Phase 1b clinical development. The Company intends to advance SER-155 into a Phase 1b study early next year in collaboration with Memorial Sloan Kettering Cancer Center.

    Strengthened leadership team: In October, Seres announced the appointments of David Ege Ph.D., as Executive Vice President and Chief Technology Officer, and Jayne Gansler as Executive Vice President and Chief People Officer. John Aunins, Seres' prior Chief Technology Officer, will continue to provide support to the Company as a Senior Advisor.

    Dr. Ege joins Seres from Merck, where he held a variety of technical and leadership roles in R&D and manufacturing in the U.S. and Switzerland. He has more than 15 years of experience in the pharmaceutical industry, with a focus on vaccine and biologics manufacturing, facility development and process optimization.

    Ms. Gansler has more than 20 years of global human resources experience in the biotechnology, pharmaceutical, and medical device industries. Prior to Seres, she was Head of Human Resources of ARIAD Pharmaceuticals. Earlier in her career, she served as Global Head of Human Resources for Genzyme, a Sanofi Company.

    Financial Results

    Seres reported a net loss of $30.3 million for the third quarter of 2020, as compared with a net loss of $16.4 million for the same period in 2019. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company's microbiome therapeutics platform.

    Research and development expenses for the third quarter of 2020 were $23.9 million, compared with $18.3 million for the same period in 2019. The research and development expenses were primarily related to Seres' late-stage SER-109 and SER-287 clinical development programs.

    General and administrative expenses for the third quarter of 2020 were $7.6 million, compared with $5.9 million for the same period in 2019. General and administrative expenses were primarily due to consulting fees and professional fees and included expenses to support SER-109 commercialization readiness activities.

    Seres ended the third quarter with approximately $320.3 million in cash, cash equivalents and short and long-term investments compared with $63.9 million at the end of the second quarter 2020. In August 2020, the Company completed a public equity offering and sold common stock to Nestlé through a private Securities Purchase Agreement, which together provided approximately $264 million in net proceeds.

    Conference Call Information

    Seres' management will host a conference call today, November 9, 2020, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 1038426. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

    A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

    About SER-109

    SER-109 is an investigational, oral, biologically-sourced microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome. SER-109 is a consortium of purified Firmicute bacteria in spore form, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of recurrent CDI.

    SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT) and FMT-like products. SER-109 is comprised of a highly purified consortium of commensal bacteria in spore form, manufactured in accordance with Current Good Manufacturing Practice (cGMP) conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process designed to inactivate numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.

    About C. difficile Infection (CDI) and Current Treatments

    C. difficile infection (CDI) is one of the top three most urgent antibiotic-resistant bacterial threats in the U.S., according to the Centers for Disease Control, and is a leading cause of hospital-acquired infection in the U.S. It is responsible for the deaths of approximately 20,000 Americans each year. CDI is associated with debilitating diarrhea, which significantly impacts quality of life in every functional domain. Since the discovery of C. difficile more than four decades ago, vancomycin has been the drug most commonly used for patient management. Current approaches provide only modest improvements in sustained clinical response rates, leaving behind a significant pool of patients with recurrent disease. Unapproved FMT, used in cases that are not responsive to approved drugs, remains poorly characterized clinically and has been associated with serious safety concerns, including the transmission of bacterial pathogens and the potential transmission of viruses such as SARS-CoV-2, the virus that causes COVID-19. The recent quarantine and shipping hold of FMT material from a major stool bank highlights the urgent need for an approved effective and safe treatment for recurrent CDI.

    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-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 for the Company to file a BLA and/or commercialize SER-109, the promise and potential impact of our microbiome therapeutics platform, the results from ECOSPOR III providing an efficacy basis for a BLA submission, any requirements for additional safety data, the receipt of milestone payments, the timing and results of studies related to the Company's therapeutic candidates, ability of SER-109 to transform the treatment of CDI, inferences related to the currently-observed efficacy and safety profile of SER-109, 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; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development; our reliance on third parties to manufacture, develop, and commercialize our product candidates, if approved; the ability to develop and commercialize our product candidates, if approved; the potential impact of the COVID-19 pandemic; our ability to retain key personnel and to manage our growth; and that 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 July 28, 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.

     

    SERES THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands, except share and per share data)

     

     

     

    September 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    207,326

     

     

    $

    65,126

     

    Short term investments

     

     

    90,588

     

     

     

    29,690

     

    Prepaid expenses and other current assets

     

     

    6,703

     

     

     

    3,588

     

    Accounts receivable

     

     

    3,393

     

     

     

    1,785

     

    Total current assets

     

     

    308,010

     

     

     

    100,189

     

    Property and equipment, net

     

     

    14,729

     

     

     

    19,495

     

    Operating lease assets

     

     

    9,664

     

     

     

    11,356

     

    Restricted investments

     

     

    1,400

     

     

     

    1,400

     

    Long term investments

     

     

    22,398

     

     

     

     

    Total assets

     

    $

    356,201

     

     

    $

    132,440

     

    Liabilities and Stockholders' Equity (Deficit)

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    6,201

     

     

    $

    4,859

     

    Accrued expenses and other current liabilities

     

     

    11,318

     

     

     

    10,884

     

    Operating lease liabilities

     

     

    4,950

     

     

     

    4,456

     

    Deferred revenue - related party

     

     

    16,517

     

     

     

    20,960

     

    Deferred revenue

     

     

    6,784

     

     

     

    4,834

     

    Total current liabilities

     

     

    45,770

     

     

     

    45,993

     

    Note payable, net of discount

     

     

    24,977

     

     

     

    24,648

     

    Operating lease liabilities, net of current portion

     

     

    11,894

     

     

     

    15,676

     

    Deferred revenue, net of current portion - related party

     

     

    82,826

     

     

     

    89,111

     

    Deferred revenue, net of current portion

     

     

    1,695

     

     

     

    4,834

     

    Other long-term liabilities

     

     

    987

     

     

     

    502

     

    Total liabilities

     

     

    168,149

     

     

     

    180,764

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' deficit:

     

     

     

     

     

     

     

     

    Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2020 and December 31, 2019; no shares issued and outstanding at September 30, 2020 and December 31, 2019

     

     

     

     

     

     

    Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2020 and December 31, 2019; 91,214,536 and 70,143,252 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

     

     

    91

     

     

     

    70

     

    Additional paid-in capital

     

     

    718,483

     

     

     

    411,255

     

    Accumulated other comprehensive income

     

     

    2

     

     

     

     

    Accumulated deficit

     

     

    (530,524

    )

     

     

    (459,649

    )

    Total stockholders' equity (deficit)

     

     

    188,052

     

     

     

    (48,324

    )

    Total liabilities and stockholders' equity (deficit)

     

    $

    356,201

     

     

    $

    132,440

     

     

    SERES THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (unaudited, in thousands, except share and per share data)

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Collaboration revenue - related party

    $

    80

     

     

    $

    4,840

     

     

    $

    10,728

     

     

    $

    21,909

     

    Grant revenue

     

    1,337

     

     

     

    85

     

     

     

    2,907

     

     

     

    791

     

    Collaboration revenue

     

     

     

     

    2,106

     

     

     

    2,016

     

     

     

    4,183

     

    Total revenue

     

    1,417

     

     

     

    7,031

     

     

     

    15,651

     

     

     

    26,883

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development expenses

     

    23,861

     

     

     

    18,317

     

     

     

    65,703

     

     

     

    59,109

     

    General and administrative expenses

     

    7,551

     

     

     

    5,897

     

     

     

    20,180

     

     

     

    18,966

     

    Restructuring expenses

     

     

     

     

     

     

     

     

     

     

    1,492

     

    Total operating expenses

     

    31,412

     

     

     

    24,214

     

     

     

    85,883

     

     

     

    79,567

     

    Loss from operations

     

    (29,995

    )

     

     

    (17,183

    )

     

     

    (70,232

    )

     

     

    (52,684

    )

    Other (expense) income:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

    100

     

     

     

    335

     

     

     

    333

     

     

     

    744

     

    Interest expense

     

    (730

    )

     

     

     

     

     

    (2,165

    )

     

     

     

    Other income

     

    345

     

     

     

    439

     

     

     

    1,189

     

     

     

    439

     

    Total other (expense) income, net

     

    (285

    )

     

     

    774

     

     

     

    (643

    )

     

     

    1,183

     

    Net loss

    $

    (30,280

    )

     

    $

    (16,409

    )

     

    $

    (70,875

    )

     

    $

    (51,501

    )

    Net loss per share attributable to common stockholders, basic and

    diluted

    $

    (0.36

    )

     

    $

    (0.23

    )

     

    $

    (0.93

    )

     

    $

    (0.99

    )

    Weighted average common shares outstanding, basic and diluted

     

    83,531,617

     

     

     

    69,944,068

     

     

     

    75,914,361

     

     

     

    52,143,492

     

    Net loss

     

    (30,280

    )

     

     

    (16,409

    )

     

     

    (70,875

    )

     

     

    (51,501

    )

    Other comprehensive loss:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Unrealized gain on investments, net of tax of $0

     

    1

     

     

     

    7

     

     

     

    2

     

     

     

    7

     

    Total other comprehensive gain

     

    1

     

     

     

    7

     

     

     

    2

     

     

     

    7

     

    Comprehensive loss

    $

    (30,279

    )

     

    $

    (16,402

    )

     

    $

    (70,873

    )

     

    $

    (51,494

    )

     

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