1. Seres Therapeutics, Inc., (NASDAQ:MCRB), today announced that management will participate in a panel discussion at the RBC Capital Markets 2021 Global Healthcare Conference on Tuesday, May 18 at 4:15 p.m. ET.

    A live audio webcast of the panel will be available under the "Investors and News" 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 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 management will participate in a panel discussion at the RBC Capital Markets 2021 Global Healthcare Conference on Tuesday, May 18 at 4:15 p.m. ET.

    A live audio webcast of the panel will be available under the "Investors and News" 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 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 plans to initiate a clinical program with 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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  2. - Data demonstrates Seres' leadership in microbiome sciences and therapeutics across multiple diseases -

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that it will present recent research findings from its microbiome drug development portfolio at Digestive Disease Week® (DDW), which is taking place virtually from May 21-23, 2021. With two oral presentations and two posters of distinction, Seres will demonstrate the potential of microbiome-based therapies for patients with serious diseases like recurrent Clostridioides difficile infection (CDI) and ulcerative colitis (UC).

    CDI is one of the top three most urgent bacterial threats in the U.S., according to the Centers for Disease Control…

    - Data demonstrates Seres' leadership in microbiome sciences and therapeutics across multiple diseases -

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that it will present recent research findings from its microbiome drug development portfolio at Digestive Disease Week® (DDW), which is taking place virtually from May 21-23, 2021. With two oral presentations and two posters of distinction, Seres will demonstrate the potential of microbiome-based therapies for patients with serious diseases like recurrent Clostridioides difficile infection (CDI) and ulcerative colitis (UC).

    CDI is one of the top three most urgent bacterial threats in the U.S., according to the Centers for Disease Control, and is a leading cause of hospital-acquired infection. It is associated with significant morbidity and mortality, with one study showing that the annual cost to the U.S. healthcare system is approximately $6.3 billion. UC is a serious chronic condition marked by persistent inflammation in the gastrointestinal tract and can greatly reduce an individual's quality of life.

    "As the world's largest gathering of physicians and researchers in the digestive disease field, the DDW Annual Meeting is a great opportunity to highlight the potential of microbiome therapeutics as an alternative treatment approach for hard-to-treat diseases like recurrent CDI and UC," said Lisa von Moltke, MD, Chief Medical Officer at Seres. "These patients face a significant unmet need for safer, more effective treatments that alleviate the medical and economic burden of disease, and we're committed to delivering a new class of therapeutic options that will make a meaningful difference in their lives."

    Seres' data at DDW feature three orally administered, live microbiome therapeutic candidates: SER-109, SER-287, and SER-301, all of which are part of a novel class of multifunctional bacterial consortia designed to functionally interact with other microbes, host cells and tissues to treat disease. Data highlights include:

    • Poster of Distinction Presentation: 24-Week Efficacy and Safety Data from ECOSPOR-III: A Phase 3 Double-Blind, Placebo-Controlled, Randomized Trial of SER-109, an Investigational Microbiome Therapeutic for Recurrent Clostridioides Difficile Infection, May 21, 12:15 PM – 1:00 PM; Lead Author: Louis Korman, MD
    • Poster of Distinction Presentation: In Vivo Characterization of SER-301, A Rationally-Designed Investigational Microbiome Therapeutic for Patients with Active Mild-To-Moderate Ulcerative Colitis, May 21, 12:15 – 1:00 PM; Lead Author: Tim Nelson, MS
    • Oral Presentation: SER-301, An Investigational, Rationally-Designed Bacterial Consortium for Mild-To-Moderate Ulcerative Colitis, Recapitulates the Effects of SER-287 on Remission Associated Microbial Metabolites and Host Gene Expression, May 23, 10:00 – 11:30 AM; Lead Author: Asunción Martínez, PhD
    • Oral Presentation: Rapid Conversion of Primary to Secondary Bile Acids in Subjects with Recurrent Clostridioides Difficile Infection (CDI) Following SER-109, An Investigational Microbiome Therapeutic, May 23, 3:30 – 5:30 PM; Lead Author: Jessica Bryant, PhD

    Posters and presentations will be available for 90 days on the DDW conference website.

    About SER-109

    SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicute spores, which normally live in the healthy microbiome. SER-109 is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes thereby reducing the risk of pathogen transmission beyond donor screening alone. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of recurrent CDI.

    About SER-287

    SER-287, an investigational 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 SER-301

    SER-301 is a consortium of cultivated bacteria designed using our reverse translational discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments using human cell-based assays and in vitro/ex vivo and in vivo disease models. SER-301 is designed to reduce induction of pro-inflammatory activity, improve epithelial barrier integrity and TNF-α driven inflammation in intestinal epithelial cells, or IECs, and modulate UC-relevant anti-inflammatory, innate and adaptive immune pathways. SER-301 is being produced using our advanced fermentation, formulation and delivery platforms. It includes strains delivered in spore form, as well as strains cultivated in non-spore (vegetative) form and delivered using enterically-protected technology designed to release in the colon.

    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-301 in a Phase 1b study in patients with ulcerative colitis, and plans to initiate a clinical program with 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 of microbiome therapeutics to treat and prevent disease, the potential approval of any of our products, the ultimate safety and efficacy data for our products; and other statements which are not historical fact.

    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 May 4, 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.

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  3. – Topline clinical data from SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis expected in mid-2021, microbiome biomarker data anticipated in H2 2021 –

    – Ongoing enrollment in SER-109 open label study for recurrent C. difficile infection; On track to achieve 300 subject enrollment target in Q3 2021 –

    – Virtual ulcerative colitis microbiome therapeutic investor event to be held June 21, 2021 –

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

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today reported first quarter 2021 financial results and provided…

    – Topline clinical data from SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis expected in mid-2021, microbiome biomarker data anticipated in H2 2021 –

    – Ongoing enrollment in SER-109 open label study for recurrent C. difficile infection; On track to achieve 300 subject enrollment target in Q3 2021 –

    – Virtual ulcerative colitis microbiome therapeutic investor event to be held June 21, 2021 –

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

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today reported first quarter 2021 financial results and provided business updates.

    "We continue to make steady progress across our broad microbiome pipeline and we look forward to an eventful remainder of the year with important clinical milestones," said Eric Shaff, President and Chief Executive Officer of Seres. "Our SER-287 ECO-RESET Phase 2b study in mild-to-moderate ulcerative colitis patients is fully enrolled and we anticipate topline clinical results in mid-year. Following successful SER-109 Phase 3 pivotal results in patients with recurrent C. difficile infection, we continue to enroll an open label study to expand our safety database. We are very pleased with the pace of study enrollment and we anticipate achieving target enrollment during the third quarter of 2021. Completion of the required SER-109 safety database will support a Biologics License Application (BLA) filing, and potentially pave the way for SER-109 to become the first-ever FDA-approved microbiome therapeutic."

    Program and Corporate Updates

    SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved a high rate of sustained clinical response in Seres' Phase 3 clinical trial in patients with recurrent C. difficile infection (CDI).

    In August 2020, Seres announced positive topline interim results from the SER-109 Phase 3 study, ECOSPOR III. The Phase 3 study (ClinicalTrials.gov identifier: NCT03183128) was 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. Study results demonstrated that ECOSPOR III achieved the study's primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. 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. In addition, subsequent 24-week end-of-study data indicate that the clinical effect of SER-109 is durable.

    Following the topline Phase 3 study results, the FDA reaffirmed its prior position regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, as well as its prior position that the safety database should be at least 300 subjects. Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration and expects to reach target enrollment for the safety database study in the third quarter of 2021.

    In January 2021, Seres presented Phase 3 microbiome and metabolomic endpoint data at the Keystone Symposium, which provide mechanistic support for the SER-109 efficacy observed. The study data demonstrate that SER-109 bacterial species rapidly engraft into the gastrointestinal tract; engraftment was observed as early as one week post-treatment and was durable through eight weeks, confirming the biological activity of SER-109. SER-109 administration was also observed to rapidly shifted the gastrointestinal metabolic landscape, including a significant decrease in primary bile acids and an increase in secondary bile acids, providing a mechanistic basis for inhibition of C. difficile spore germination and vegetative growth.

    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 SER-109 open label study is being enrolled at more than 100 sites across the U.S. and Canada, representing a substantial increase over those that recruited subjects into the SER-109 Phase 3 ECOSPOR III study. Additional information is available at serescdiffstudy.com.

    Seres continues to execute activities necessary to enable a SER-109 BLA submission. The Company is completing supportive market assessment work, including primary research with physicians and payers, and pricing and reimbursement analyses. Seres continues to hire, train, and deploy a medical science liaison team in order to increase market education efforts. The Company believes that a substantial commercial opportunity exists for SER-109. The recurrent CDI population includes approximately 170,000 patients in the U.S.

    SER-287 Phase 2b ECO-RESET study in ulcerative colitis (UC): SER-287, an oral microbiome therapeutic candidate consisting of a bacterial consortium, is designed to restructure the gastrointestinal microbiome and reduce inflammation in individuals with UC. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate ulcerative colitis. SER-287 targets restructuring the microbiome to reduce proinflammatory activity and modulate UC-relevant inflammatory pathways, potentially providing a much-needed non-immunosuppressive treatment option to patients suffering from ulcerative colitis. SER-287 has the potential to be used as both a monotherapy and in combination with other approved agents.

    The SER-287 Phase 2b ECO-RESET study is a randomized, placebo-controlled, three-arm induction trial that has enrolled 203 patients with active mild-to-moderate ulcerative colitis who have had inadequate response or loss of response on prior therapy. In arm A, patients receive a short course of vancomycin preconditioning followed by ten weeks of the same daily regimen used in the arm of the Phase 1b trial that showed the highest clinical remission rate. In arm B, patients receive vancomycin preconditioning followed by two weeks of the SER-287 daily regimen as in the first arm, followed by eight weeks of a lower dose of SER-287. In arm C, patients receive placebo. The study's primary endpoint is the proportion of patients achieving clinical remission at ten weeks. The study will assess endoscopic improvement as a secondary endpoint, as well as a range of microbiome and metabolomic measures.

    Seres has completed enrollment in the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis and expects to report topline clinical study results in mid-2021, with additional microbiome biomarker data becoming available in H2 2021.

    Publication of SER-287 Phase 1b study results: Data from a Phase 1b study demonstrated that SER-287 administration was associated with high rates of clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile. 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.

    SER-301 Phase 1b study in adults with mild-to-moderate ulcerative colitis: Seres is enrolling its Phase 1b study for SER-301, an investigational oral, rationally-designed, cultivated microbiome therapeutic, and study enrollment is ongoing. 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 is designed to enroll approximately 65 subjects. The study objectives are to evaluate drug safety and pharmacokinetics and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

    The consortia 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. SER-301 was designed using Seres' reverse translation discovery and development platforms. The design incorporated learnings from the SER-287 Phase 1b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy. Additionally, the design incorporated insights on the engraftment dynamics of different bacteria and also the association of specific bacteria with the modulation of inflammatory and immune pathways in human subjects that have been observed across our broader clinical portfolio and confirmed using our nonclinical human-cell based assays and in vivo models.

    In December 2020, Seres received a $10 million milestone payment associated with the Phase 1b SER-301 clinical study initiation from Nestlé, the Company's ex-North American collaborative partner for this program.

    SER-155 Phase 1b clinical study activities: SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of 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 selected using microbiome biomarker data and from human clinical data and nonclinical 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. Seres continues to advance SER-155 toward a Phase 1b clinical study initiation in collaboration with Memorial Sloan Kettering Cancer Center.

    SER-401 program update: Seres, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy and The University of Texas MD Anderson Cancer Center, had announced the voluntary discontinuation of 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. Seres has deprioritized further development of SER-401, and will prioritize rationally-designed, cultivated leads designed using the Company's reverse translational platforms and learnings from the SER-401 trial. Future oncology programs aim to modulate host immunity/inflammation to improve response and tolerability of cancer drugs.

    Upcoming investor event: Seres plans to hold a webcast and conference call on June 21, 2021 with a focus on the Company's efforts to develop microbiome therapeutics for ulcerative colitis and the substantial opportunity for safe, effective alternative therapeutics for the over 700,000 individuals (U.S. estimate) suffering from UC. The event will include discussion of the ongoing SER-287 Phase 2b study, and SER-301 Phase 1b study. The Company anticipates topline SER-287 Phase 2b study clinical results in mid-2021, and additional microbiome biomarker data in H2 2021. Further details will be provided closer to the event.

    Financial Results

    Seres reported a net loss of $35.5 million for the first quarter of 2021, as compared with a net loss of $19.9 million for the same period in 2020. The first 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 first quarter of 2021 were $29.3 million, compared with $21.7 million for the same period in 2020. 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 first quarter of 2021 were $11.7 million, compared with $6.1 million for the same period in 2020. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

    Seres ended the first quarter of 2021 with approximately $272.5 million in cash, cash equivalents and short and long-term investments.

    Conference Call Information

    Seres' management will host a conference call today, May 4, 2021, 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 9967338. 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 Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics 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.

    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 timing of study enrollment, the impact of the microbiome and metabolomic data on our other programs, the potential approval of SER-109 and its potential status as a first-in-class therapeutic, the timing of topline results and microbiome analysis from the SER-287 study, the safety results observed to-date in our clinical studies, the promise of our microbiome therapeutics, our development plans, 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 and manufacture 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.

    SERES THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

     

     

     

    March 31,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    66,579

     

     

    $

    116,049

     

    Short term investments

     

     

    176,221

     

     

     

    137,567

     

    Prepaid expenses and other current assets

     

     

    6,574

     

     

     

    5,774

     

    Accounts receivable

     

     

    2,604

     

     

     

    9,387

     

    Total current assets

     

     

    251,978

     

     

     

    268,777

     

    Property and equipment, net

     

     

    13,580

     

     

     

    13,897

     

    Operating lease assets

     

     

    8,386

     

     

     

    9,041

     

    Restricted investments

     

     

    1,400

     

     

     

    1,400

     

    Long term investments

     

     

    29,749

     

     

     

    49,825

     

    Other non-current assets

     

     

    602

     

     

     

     

    Total assets

     

    $

    305,695

     

     

    $

    342,940

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    4,879

     

     

    $

    4,018

     

    Accrued expenses and other current liabilities

     

     

    13,153

     

     

     

    14,226

     

    Operating lease liabilities

     

     

    5,250

     

     

     

    5,115

     

    Short term portion of note payable, net of discount

     

     

    3,339

     

     

     

    454

     

    Deferred revenue - related party

     

     

    21,242

     

     

     

    22,602

     

    Total current liabilities

     

     

    47,863

     

     

     

    46,415

     

    Long term portion of note payable, net of discount

     

     

    21,872

     

     

     

    24,639

     

    Operating lease liabilities, net of current portion

     

     

    9,194

     

     

     

    10,561

     

    Deferred revenue, net of current portion - related party

     

     

    82,284

     

     

     

    85,572

     

    Other long-term liabilities

     

     

    777

     

     

     

    1,003

     

    Total liabilities

     

     

    161,990

     

     

     

    168,190

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' deficit:

     

     

     

     

     

     

     

     

    Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding at March 31, 2021 and December 31, 2020

     

     

     

     

     

     

    Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 91,588,264 and 91,459,239 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

    92

     

     

     

    91

     

    Additional paid-in capital

     

     

    727,869

     

     

     

    723,482

     

    Accumulated other comprehensive (loss)

     

     

    (15

    )

     

     

    (47

    )

    Accumulated deficit

     

     

    (584,241

    )

     

     

    (548,776

    )

    Total stockholders' equity

     

     

    143,705

     

     

     

    174,750

     

    Total liabilities and stockholders' equity

     

    $

    305,695

     

     

    $

    342,940

     

    SERES THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share data)

     

     

    Three Months Ended

    March 31,

     

     

    2021

     

     

    2020

     

    Revenue:

     

     

     

     

     

     

     

    Collaboration revenue - related party

    $

    4,648

     

     

    $

    5,462

     

    Grant revenue

     

    1,070

     

     

     

    739

     

    Collaboration revenue

     

     

     

     

    1,988

     

    Total revenue

     

    5,718

     

     

     

    8,189

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development expenses

     

    29,303

     

     

     

    21,743

     

    General and administrative expenses

     

    11,741

     

     

     

    6,138

     

    Total operating expenses

     

    41,044

     

     

     

    27,881

     

    Loss from operations

     

    (35,326

    )

     

     

    (19,692

    )

    Other (expense) income:

     

     

     

     

     

     

     

    Interest income

     

    966

     

     

     

    159

     

    Interest expense

     

    (696

    )

     

     

    (716

    )

    Other (expense) income

     

    (409

    )

     

     

    368

     

    Total other (expense) income, net

     

    (139

    )

     

     

    (189

    )

    Net loss

    $

    (35,465

    )

     

    $

    (19,881

    )

    Net loss per share attributable to common stockholders, basic and diluted

    $

    (0.39

    )

     

    $

    (0.28

    )

    Weighted average common shares outstanding, basic and diluted

     

    91,527,800

     

     

     

    70,821,514

     

    Net loss

     

    (35,465

    )

     

     

    (19,881

    )

    Other comprehensive income (loss):

     

     

     

     

     

     

     

    Unrealized gain (loss) on investments, net of tax of $0

     

    32

     

     

     

    (10

    )

    Total other comprehensive income (loss)

     

    32

     

     

     

    (10

    )

    Comprehensive loss

    $

    (35,433

    )

     

    $

    (19,891

    )

     

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  4. Seres Therapeutics, Inc. (NASDAQ:MCRB) a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast on May 4, 2021 at 8:30 a.m. ET to discuss first quarter 2021 results and provide a general business update.

    To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 9967338. To join the live webcast, please visit the "Investors and Media" 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 approximately 21 days.

    About Seres Therapeutics

    Seres Therapeutics, Inc…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast on May 4, 2021 at 8:30 a.m. ET to discuss first quarter 2021 results and provide a general business update.

    To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 9967338. To join the live webcast, please visit the "Investors and Media" 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 approximately 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.

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  5. Seres Therapeutics, Inc. (NASDAQ:MCRB) a leading microbiome therapeutics company, today announced that Eric Shaff, President and Chief Executive Officer of Seres Therapeutics, will present at the Jefferies Microbiome-Based Therapeutics Summit being held on Thursday, April 22, 2021.

    The pre-recorded presentation will be made available under the "Investors and Media" section of Seres' website on Thursday, April 22, 2021 at 8:00 a.m. ET and will be archived for approximately 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…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) a leading microbiome therapeutics company, today announced that Eric Shaff, President and Chief Executive Officer of Seres Therapeutics, will present at the Jefferies Microbiome-Based Therapeutics Summit being held on Thursday, April 22, 2021.

    The pre-recorded presentation will be made available under the "Investors and Media" section of Seres' website on Thursday, April 22, 2021 at 8:00 a.m. ET and will be archived for approximately 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.

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  6. 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).

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  7. 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

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  8. 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.

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  9.  - 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

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  10. - 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.

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  11. – SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis has achieved target enrollment; topline data expected in mid-2021 –

    – Continued enrollment in SER-109 open label study in recurrent C. difficile infection to support planned BLA filing; potential to be first FDA-approved microbiome therapeutic –

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

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2020 financial results and provided business updates.

    "Seres continues to make progress executing against our top corporate priorities. We are enrolling our open label study to support a Biologics License Application (BLA) for SER-109, a potential first-ever…

    – SER-287 Phase 2b study in patients with mild-to-moderate ulcerative colitis has achieved target enrollment; topline data expected in mid-2021 –

    – Continued enrollment in SER-109 open label study in recurrent C. difficile infection to support planned BLA filing; potential to be first FDA-approved microbiome therapeutic –

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

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2020 financial results and provided business updates.

    "Seres continues to make progress executing against our top corporate priorities. We are enrolling our open label study to support a Biologics License Application (BLA) for SER-109, a potential first-ever FDA approved microbiome therapeutic. We have also advanced our clinical pipeline and expanded our core microbiome therapeutic drug discovery and CMC capabilities," said Eric Shaff, President and Chief Executive Officer of Seres.

    "We enter 2021 with a strong balance sheet, poised to continue leading the microbiome therapeutic field. Our pipeline spans infectious diseases, inflammatory diseases, and oncology, and we look forward to continued progress during the year, including our development stage pipeline candidates and earlier stage drug discovery efforts. We are pleased to have achieved target enrollment for the SER-287 ECO-RESET Phase 2b study and look forward to obtaining topline results mid-year, an acceleration compared to our prior projections. Our SER-287 program is another embodiment of our mission to develop product candidates with the potential to fundamentally transform patients' lives by providing substantial clinical benefit over today's standard of care," concluded Mr. Shaff.

    Program and Corporate Updates

    SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved a high rate of sustained clinical response in our Phase 3 clinical trial by repairing the disrupted microbiome in patients with recurrent C. difficile infection (CDI).

    In August 2020, Seres announced positive topline interim results from the SER-109 Phase 3 study, ECOSPOR III. The 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. Final end-of-study 24-week results reiterated that ECOSPOR III achieved the study's primary endpoint and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at 8 weeks post-treatment, which is a relative risk reduction of 69%. 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.

    Following the topline Phase 3 study results, the FDA reaffirmed its prior position regarding the efficacy requirements to support an SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, as well as its prior position that the safety database should be at least 300 subjects. Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration.

    In October 2020, Seres presented SER-109 Phase 3 topline results along with additional clinical data at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting. These new data demonstrated that the 12-week treatment difference between SER-109 and placebo remained consistent with the 8-week treatment difference. In addition, subsequent 24-week data demonstrate that the clinical effect of SER-109 is durable.

    In January 2021, at the Keystone Symposium, Seres presented Phase 3 microbiome and metabolomic endpoint data that provide mechanistic support for the SER-109 efficacy observed. The study data demonstrate that SER-109 bacterial species rapidly engraft into the gastrointestinal tract; engraftment was observed as early as 1-week post-treatment and was durable through eight weeks, confirming the biological activity of SER-109. SER-109 administration also rapidly shifted the gastrointestinal metabolic landscape, including a significant decrease in primary bile acids and an increase in secondary bile acids, providing a mechanistic basis for inhibition of C. difficile spore germination and vegetative growth.

    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 at clinical sites across the U.S. and Canada. Additional information is available at serescdiffstudy.com.

    SER-287 Phase 2b ECO-RESET study in ulcerative colitis: 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. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate ulcerative colitis. SER-287 targets restructuring the microbiome to reduce proinflammatory activity and modulate UC-relevant inflammatory pathways, potentially providing a much-needed non-immunosuppressive treatment option to patients suffering from ulcerative colitis. SER-287 has the potential to be used as both a monotherapy and potentially in combination with other approved agents.

    The SER-287 Phase 2b ECO-RESET study is a randomized, placebo-controlled, three-arm induction trial designed to enroll 201 patients with active mild-to-moderate ulcerative colitis who have failed prior therapy. In arm A, patients receive a short course of vancomycin preconditioning followed by ten weeks of the same daily regimen used in the arm of the Phase 1b trial that showed the highest clinical remission rate. In arm B, patients receive vancomycin preconditioning followed by two weeks of the SER-287 daily regimen as in the first arm, followed by eight weeks of a lower dose of SER-287. In arm C, patients receive placebo.

    The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis has achieved target enrollment. Topline study results are anticipated in mid-2021. The timing of anticipated study results represents an acceleration compared to the Company's prior expectations.

    Publication of SER-287 Phase 1b study results: The Phase 1b study results demonstrated that SER-287 administration was associated with high rates of clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile. 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.

    SER-301 Phase 1b study in adults with mild-to-moderate ulcerative colitis: In November 2020, the Company dosed the first patient in its Phase 1b study for SER-301, an investigational oral, rationally-designed, cultivated microbiome therapeutic and study enrollment is ongoing. 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 is designed to enroll approximately 65 subjects. The study objectives are to evaluate drug safety and pharmacokinetics and to evaluate clinical remission and other measures of efficacy as secondary endpoints.

    The consortia 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. SER-301 was designed using Seres' reverse translation discovery and development platforms. The design incorporated learnings from the SER-287 Phase 1b study related to the bacterial species and the microbiome functional signatures associated with clinical efficacy. Additionally, the design incorporated insights on the engraftment dynamics of different bacteria and also the association of specific bacteria with the modulation of inflammatory and immune pathways in human subjects that have been observed across our broader clinical portfolio and confirmed using our nonclinical human-cell based assays and in vivo models.

    In December 2020, Seres received 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-155 Phase 1b clinical study activities: SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to prevent or reduce 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 selected 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. Seres continues to advance SER-155 toward a Phase 1b clinical study in collaboration with Memorial Sloan Kettering Cancer Center.

    SER-401 Phase 1b study in metastatic melanoma: SER-401 is an orally-administered, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with patient response to checkpoint inhibitor immunotherapy. SER-401 Phase 1b study enrollment has been impacted by COVID-19-related operation disruptions and enrollment has been slower than anticipated. Further development plans for SER-401 are being assessed by Seres and its study collaborators, the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center.

    Financial Results

    Seres reported a net loss of $89.1 million for the full year of 2020, as compared to a net loss of $70.3 million for the prior year. Seres reported a net loss of $18.3 million for the fourth quarter of 2020, as compared to a net loss of $18.8 million for the same period in 2019.

    Research and development expenses for the fourth quarter of 2020 were $24.9 million, as compared to $21.0 million for the same period in 2019. The research and development expenses were primarily related to Seres' microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the Company's immuno-oncology efforts.

    General and administrative expenses for the fourth quarter were $10.6 million, as compared to $5.8 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, including costs related to infrastructure supporting commercialization, professional fees and facility costs.

    Seres ended the 2020 year with approximately $303.4 million in cash, cash equivalents and short and long-term investments.

    Conference Call Information

    Seres' management team will host a conference call today, March 2, 2021, 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 7338026. 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 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 and its potential status as a first-in-class therapeutic, the timing of our clinicial studies, the safety results observed to-date in our clinical studies, 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, 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, including the Annual Report we intend to file later today, 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.

    CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

     

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    116,049

     

     

    $

    65,126

     

    Short term investments

     

     

    137,567

     

     

     

    29,690

     

    Prepaid expenses and other current assets

     

     

    5,774

     

     

     

    3,588

     

    Accounts receivable

     

     

    9,387

     

     

     

    1,785

     

    Total current assets

     

     

    268,777

     

     

     

    100,189

     

    Property and equipment, net

     

     

    13,897

     

     

     

    19,495

     

    Operating lease assets

     

     

    9,041

     

     

     

    11,356

     

    Restricted investments

     

     

    1,400

     

     

     

    1,400

     

    Long term investments

     

     

    49,825

     

     

     

     

    Total assets

     

    $

    342,940

     

     

    $

    132,440

     

    Liabilities and Stockholder's Equity (Deficit)

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    4,018

     

     

    $

    4,859

     

    Accrued expenses and other current liabilities

     

     

    14,226

     

     

     

    10,884

     

    Operating lease liabilities

     

     

    5,115

     

     

     

    4,456

     

    Short term portion of note payable, net of discount

     

     

    454

     

     

     

     

    Deferred revenue - related party

     

     

    22,602

     

     

     

    20,960

     

    Deferred revenue

     

     

     

     

     

    4,834

     

    Total current liabilities

     

     

    46,415

     

     

     

    45,993

     

    Long term portion of note payable, net of discount

     

     

    24,639

     

     

     

    24,648

     

    Operating lease liabilities, net of current portion

     

     

    10,561

     

     

     

    15,676

     

    Deferred revenue, net of current portion - related party

     

     

    85,572

     

     

     

    89,111

     

    Deferred revenue, net of current portion

     

     

     

     

     

    4,834

     

    Other long-term liabilities

     

     

    1,003

     

     

     

    502

     

    Total liabilities

     

     

    168,190

     

     

     

    180,764

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

     

     

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

     

     

     

     

     

     

    Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2020 and 2019; 91,459,239 and 70,143,252 shares issued and outstanding at December 31, 2020 and 2019

     

     

    91

     

     

     

    70

     

    Additional paid-in capital

     

     

    723,482

     

     

     

    411,255

     

    Accumulated other comprehensive loss

     

     

    (47

    )

     

     

     

    Accumulated deficit

     

     

    (548,776

    )

     

     

    (459,649

    )

    Total stockholders' equity (deficit)

     

     

    174,750

     

     

     

    (48,324

    )

    Total liabilities and stockholders' equity (deficit)

     

    $

    342,940

     

     

    $

    132,440

     

    SERES THERAPEUTICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share data)

     

     

     

    Year Ended December 31,

     

     

     

    2020

     

     

    2019

     

     

    2018

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

    Collaboration revenue - related party

     

    $

    11,897

     

     

    $

    27,188

     

     

    $

    26,917

     

    Grant revenue

     

     

    4,157

     

     

     

    1,102

     

     

     

    1,350

     

    Collaboration revenue

     

     

    17,161

     

     

     

    6,215

     

     

     

     

    Total revenue

     

     

    33,215

     

     

     

    34,505

     

     

     

    28,267

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development expenses

     

    $

    90,570

     

     

    $

    80,141

     

     

    $

    95,955

     

    General and administrative expenses

     

     

    30,775

     

     

     

    24,748

     

     

     

    32,596

     

    Restructuring expenses

     

     

     

     

     

    1,492

     

     

     

     

    Total operating expenses

     

     

    121,345

     

     

     

    106,381

     

     

     

    128,551

     

    Loss from operations

     

     

    (88,130

    )

     

     

    (71,876

    )

     

     

    (100,284

    )

    Other (expense) income:

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    946

     

     

     

    1,033

     

     

     

    1,172

     

    Interest expense

     

     

    (2,924

    )

     

     

    (502

    )

     

     

     

    Other income

     

     

    981

     

     

     

    1,066

     

     

     

    170

     

    Total other (expense) income, net

     

     

    (997

    )

     

     

    1,597

     

     

     

    1,342

     

    Net loss

     

    $

    (89,127

    )

     

    $

    (70,279

    )

     

    $

    (98,942

    )

    Net loss per share attributable to common stockholders, basic and diluted

     

    $

    (1.12

    )

     

    $

    (1.24

    )

     

    $

    (2.43

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    79,789,220

     

     

     

    56,649,220

     

     

     

    40,743,492

     

    Other comprehensive (loss) income:

     

     

     

     

     

     

     

     

     

     

     

     

    Unrealized (loss) gain on investments, net of tax of $0

     

     

    (47

    )

     

     

     

     

     

    146

     

    Total other comprehensive income (loss)

     

     

    (47

    )

     

     

     

     

     

    146

     

    Comprehensive loss

     

    $

    (89,174

    )

     

    $

    (70,279

    )

     

    $

    (98,796

    )

     

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  12. Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that management will participate in two upcoming investor conferences:

    • Cowen 41st Annual Health Care Conference on Tuesday, March 2, 2021. Management will participate in a Microbiome panel discussion as well as 1x1 meetings.
    • Chardan 3rd Annual Microbiome Medicines Summit on Monday, March 8, 2021. Management will present a corporate overview at 2:30 p.m. ET and participate in 1x1 meetings.

    An audio webcast of the Chardan Summit 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…

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

    • Cowen 41st Annual Health Care Conference on Tuesday, March 2, 2021. Management will participate in a Microbiome panel discussion as well as 1x1 meetings.
    • Chardan 3rd Annual Microbiome Medicines Summit on Monday, March 8, 2021. Management will present a corporate overview at 2:30 p.m. ET and participate in 1x1 meetings.

    An audio webcast of the Chardan Summit 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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  13. CAMBRIDGE, Mass., Feb. 25, 2021 /PRNewswire/ -- Cellarity, a life sciences company founded by Flagship Pioneering to develop a new method of drug discovery targeting the cell, announced today that it raised $123 million in Series B financing. The round included contributions from funds and accounts managed by BlackRock, The Baupost Group, Banque Pictet on behalf of their clients and eight other investors alongside Flagship Pioneering.

    Founded in 2017 within Flagship Labs, Cellarity's new approach to drug discovery is based on the computational modeling of cell behavior, leading to a more complete understanding of system and network biology to uncover cell-behavior-targeted medicines for a wide variety of diseases.

    Cellarity's medicines are developed to address disease at the level of the cell and are not aimed at single molecular targets, the approach pursued in much of traditional drug discovery. The successful financing round validates the strength of Cellarity's science and its potential to redefine drug discovery through its cell-centric approach.

    "All diseases stem from a disorder at the cellular level, but until now most drug discovery efforts have relied upon single molecular targets that overlook the potent networked relationships of biology," said Fabrice Chouraqui, CEO of Cellarity and a CEO-Partner at Flagship Pioneering. "By working at the level of the entire cell, Cellarity's drug discovery platform harnesses the complexity of human biology to uncover breakthrough treatments in a wide range of disease areas."

    Cellarity is generating unprecedented biological insights by combining its unique expertise in network biology, high-resolution data, and machine learning. The result is a new understanding of the cell's trajectory from health to disease, and how cells relate to one another in tissues. Because the cell and its network of transcripts and proteins offer a more complete view of the complexity of human biology than any individual molecular target, Cellarity's approach allows for more efficient drug discovery and is designed to drive higher rates of clinical success. Already, the company has seven drug discovery programs underway in diverse therapeutic areas that range from metabolic disease to immuno-oncology.

    "Cellarity's cell-centric platform has the potential to engineer a shift in how the world approaches the discovery of medicine," said Noubar Afeyan, CEO of Flagship Pioneering and Co-founder and Chairman of the Board of Cellarity. "It is another example of Flagship Pioneering's relentless efforts to push the boundaries of the life sciences to uncover breakthrough technologies and identify innovative treatments that will change the lives of patients."

    About Cellarity

    Cellarity's mission is to bring breakthrough medicines to patients by completely redefining the way drugs are discovered. Founded by Flagship Pioneering in 2017, Cellarity is designing medicines against the cell as opposed to a single molecular target. The company has developed a unique combination of expertise across system and network biology, high-resolution data, and machine learning to unlock treatments in a large number of therapeutic areas.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences 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 $50B in aggregate value. To date, Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B 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).

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cellarity-raises-123-million-in-series-b-funding-to-pioneer-a-new-approach-to-drug-discovery-treating-disease-at-the-level-of-the-cell-as-opposed-to-a-single-molecular-target-301235332.html

    SOURCE Cellarity

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  14. Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome platform company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today announced that management will host a conference call and live audio webcast on March 2, 2021 at 8:30 a.m. ET to discuss fourth quarter and full year 2020 results and provide a general business update.

    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 Media" section of the Seres website at www.serestherapeutics.com.

    A webcast replay will be available on the Seres…

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome platform company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today announced that management will host a conference call and live audio webcast on March 2, 2021 at 8:30 a.m. ET to discuss fourth quarter and full year 2020 results and provide a general business update.

    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 Media" 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 approximately 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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  15. - 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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  16. 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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  17. - 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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  18. 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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  19. – 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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  20. –  SER-301 is designed to target the physiological triggers of inflammation believed to be central to the underlying pathology of ulcerative colitis  

    –  Program represents Seres' second active clinical program targeting ulcerative colitis, in addition to its ongoing SER-287 Phase 2b study –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it has dosed the first patient in its Phase 1b trial evaluating SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC). SER-301 is an oral, rationally-designed microbiome therapeutic designed to dampen the aberrant gastrointestinal inflammation central to ulcerative colitis and induce clinical remission in patients suffering from active UC.

    SER-301 is designed to modify…

    –  SER-301 is designed to target the physiological triggers of inflammation believed to be central to the underlying pathology of ulcerative colitis  

    –  Program represents Seres' second active clinical program targeting ulcerative colitis, in addition to its ongoing SER-287 Phase 2b study –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it has dosed the first patient in its Phase 1b trial evaluating SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC). SER-301 is an oral, rationally-designed microbiome therapeutic designed to dampen the aberrant gastrointestinal inflammation central to ulcerative colitis and induce clinical remission in patients suffering from active UC.

    SER-301 is designed to modify the gastrointestinal microbiome and microbe-associated metabolites to modulate multiple pathways associated with ulcerative colitis. SER-301 is a consortium of bacteria designed using Seres' reverse translational discovery platform that incorporates analysis of microbiome biomarkers from human clinical data and preclinical assessments using human cell-based assays and in vitro and in vivo disease models. SER-301 is designed to reduce induction of pro-inflammatory activity, improve epithelial barrier integrity and TNF-α driven inflammation in intestinal epithelial cells, and modulate UC-relevant anti-inflammatory, innate and adaptive immune pathways. The design of SER-301 incorporated learnings obtained through the Company's prior SER-287 Phase 1b clinical study conducted in patients with ulcerative colitis. SER-287 Phase 1b study results demonstrated favorable pharmacodynamic changes, signals of clinical activity, and a favorable safety profile.

    SER-301 was developed with innovative and novel manufacturing methods that do not require human donor material. It includes strains delivered in spore form and strains fermented in non-spore (vegetative) form. The product candidate is delivered using enterically-protected technology designed to release in the colon. GMP manufacturing technologies developed through the SER-301 program broaden the breadth of biology that can be incorporated into Seres' microbiome therapeutics.

    "Ulcerative colitis is a serious disease impacting approximately 700,000 individuals in the U.S. alone, and effective patient management can be challenging. Currently approved treatments are unable to induce disease remission in the large majority of patients, and many existing drugs are associated with a suboptimal safety profile," said Matthew Henn, Ph.D., Executive Vice President and Chief Scientific Officer of Seres. "We believe that microbiome therapeutic approaches have the opportunity to address this condition in an entirely novel way which targets the underlying drivers of disease by modulating multiple disease-relevant pathways simultaneously, and with a favorable safety profile. We are pleased to have applied the deep scientific and clinical learnings obtained from our SER-287 and other clinical programs combined with our advanced microbiology and functional modeling capabilities to bring SER-301 into this Phase 1b study."

    The SER-301 Phase 1b study is being conducted in Australia and New Zealand in subjects with mild-to-moderate UC and is designed to include approximately 65 patients distributed across two cohorts. A first open-label cohort of 15 subjects will evaluate safety and pharmacokinetics (PK), as measured by bacterial engraftment. In the second cohort, 50 subjects will be randomized to receive either SER-301 or placebo, with a 3:2 randomization, respectively. The study utilizes an independent blinded central reader for the endoscopic component. The objectives for this cohort are to evaluate safety and PK, clinical remission, and other measures of drug pharmacology and efficacy as secondary endpoints.

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

    About SER-301

    SER-301 is an investigational, oral, rationally-designed, fermented microbiome therapeutic for the treatment of mild-to-moderate ulcerative colitis (UC). SER-301 is a consortium of multiple bacterial strains manufactured by fermenting each strain individually and then combining to form drug product. The composition includes strains formulated in spore form and strains fermented in non-spore, vegetative form. The product candidate is delivered using enterically-protected technology designed to release in the colon. SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate pathways linked to gastrointestinal inflammation and to improve epithelial barrier integrity in patients with ulcerative colitis.

    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 ability of SER-301 to modulate the microbiome of UC patients, the safety profile of our product candidates, the receipt of milestone payments, the promise and success of 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; 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.

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  21. Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome platform company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today announced that management will host a conference call and live audio webcast on November 9, 2020 at 8:30 a.m. ET to discuss third quarter 2020 results and provide a general business update.

    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 Media" section of the Seres website at www.serestherapeutics.com.

    A webcast replay will be available on the Seres website…

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome platform company developing a novel class of multifunctional bacterial therapeutics designed to functionally interact with host cells and tissues to treat disease, today announced that management will host a conference call and live audio webcast on November 9, 2020 at 8:30 a.m. ET to discuss third quarter 2020 results and provide a general business update.

    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 Media" 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 approximately 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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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  22. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the expansion of its leadership team with the appointments of David S. Ege, Ph.D., as Executive Vice President, Chief Technology Officer (CTO) and Jayne M. Gansler as Executive Vice President, Chief People Officer (CPO).

    "Supported by our highly positive SER-109 Phase 3 results, we are expanding our capabilities and strengthening the Seres team as we move towards what we expect to be the first-ever FDA-approved microbiome therapy. We have taken meaningful steps to prepare for our anticipated growth into a commercial-stage enterprise. Earlier this year, we appointed Lisa von Moltke, M.D., FCP, as Seres' Chief Medical Officer and Terri Young, Ph.D., R.Ph., as Chief Commercial and Strategy…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the expansion of its leadership team with the appointments of David S. Ege, Ph.D., as Executive Vice President, Chief Technology Officer (CTO) and Jayne M. Gansler as Executive Vice President, Chief People Officer (CPO).

    "Supported by our highly positive SER-109 Phase 3 results, we are expanding our capabilities and strengthening the Seres team as we move towards what we expect to be the first-ever FDA-approved microbiome therapy. We have taken meaningful steps to prepare for our anticipated growth into a commercial-stage enterprise. Earlier this year, we appointed Lisa von Moltke, M.D., FCP, as Seres' Chief Medical Officer and Terri Young, Ph.D., R.Ph., as Chief Commercial and Strategy Officer, and we are pleased to now add two additional highly accomplished professionals to Seres' executive team. Dave's experience successfully leading the manufacturing of prominent pharmaceuticals, including Keytruda®, will be vital as we look ahead to the expected commercialization of SER-109. Jayne has held critical roles building global biopharmaceutical companies and this experience will be central to attracting top talent to Seres, an effort which is well underway. I am honored to work with such a talented and diverse team," said Eric D. Shaff, President and Chief Executive Officer of Seres.

    Mr. Shaff continued: "I also want to take this opportunity to express our deep appreciation to John Aunins, Ph.D. John has led Seres' manufacturing efforts since soon after the company was formed, and he has been critical in building our field-leading CMC capabilities in this new therapeutic modality. We are pleased that John will continue to support Seres in a Senior Advisor capacity."

    Dr. Ege brings to the role of CTO more than 15 years of experience in the pharmaceutical industry with a focus on manufacturing and developing vaccines and biologics. He joins Seres after an extensive career at Merck, where he worked on a number of breakthrough, novel products with complex manufacturing. Dr. Ege joined Merck in 2003 and served in a variety of technical and leadership roles in R&D and manufacturing. He was most recently Global Lead for Digital Strategy in Merck's Manufacturing Division, in charge of driving business optimization, leading digital innovation, and helping advance products to market. Dr. Ege also held roles as Executive Director of Vaccines & Biologics Manufacturing and Head of Commercial Manufacturing Operations during his time at Merck. Dr. Ege graduated summa cum laude from Princeton with a BSE in chemical engineering and earned his Ph.D. in chemical engineering from the University of Pennsylvania.

    Ms. Gansler brings to the newly created role of CPO more than 25 years of experience leading global human resources organizations in the biotechnology, pharmaceutical and medical device industries. Prior to joining Seres, Ms. Gansler was Senior Vice President, Head of Human Resources at ARIAD Pharmaceuticals and served as a key leader during a time of significant change that included the sale and integration of ARIAD with Takeda Pharmaceuticals. She served as Senior Vice President, Global Head of Human Resources for Genzyme, a Sanofi Company, following Sanofi's acquisition of Genzyme Corporation and led the integration and rebuilding of the HR strategy for Genzyme, a Sanofi Company. Ms. Gansler's strong business acumen and relationship-building skills helped lead Genzyme to be recognized by Fortune Magazine as one of the 100 Best Companies to Work For. Prior to joining Genzyme, Jayne began her career at Johnson & Johnson where she held various senior human resources roles. She earned her B.A. in human resource management and labor relations from the University of Massachusetts, Amherst.

    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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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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  23. - New data demonstrate a sustained patient benefit following SER-109 administration with a highly statistically significant 31.1% absolute reduction in the rate of C. difficile infection recurrence over 12 weeks, compared to placebo –

    - Additional new findings show similar SER-109 efficacy across stratified age groups and prior antibiotic treatment regimen cohorts –

    - Well tolerated, with a safety profile comparable to placebo –

    - SER-109 open label study enrolling individuals with recurrent C. difficile infection –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the presentation of previously announced positive Phase 3 results from the ECOSPOR III trial of SER-109 at the Virtual American College of Gastroenterology (ACG) Annual…

    - New data demonstrate a sustained patient benefit following SER-109 administration with a highly statistically significant 31.1% absolute reduction in the rate of C. difficile infection recurrence over 12 weeks, compared to placebo –

    - Additional new findings show similar SER-109 efficacy across stratified age groups and prior antibiotic treatment regimen cohorts –

    - Well tolerated, with a safety profile comparable to placebo –

    - SER-109 open label study enrolling individuals with recurrent C. difficile infection –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced the presentation of previously announced positive Phase 3 results from the ECOSPOR III trial of SER-109 at the Virtual American College of Gastroenterology (ACG) Annual Scientific Meeting taking place October 23-28, 2020. New data to be presented in Seres' late-breaker oral presentation show that SER-109 led to a sustained highly statistically significant absolute reduction in C. difficile infection recurrence at 12 weeks post-treatment when compared to placebo. Additionally, new findings demonstrate that SER-109 administration resulted in similar efficacy when stratified by age groups (i.e., > or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin).

    The ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128) is a multicenter, randomized, placebo-controlled study that enrolled 182 patients with multiply recurrent C. difficile infection (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 with a 30.2% absolute reduction of recurrence of CDI compared to placebo at 8 weeks post-treatment.

    New data show 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.

    "These new SER-109 Phase 3 data extend the dramatic topline findings previously reported. The results demonstrate the remarkable efficacy levels are sustained over a twelve-week period, and similar treatment benefits are seen in both younger and older patients. In addition, the data show consistent patient benefits regardless of the baseline antibiotic treatment," said Bret Lashner, M.D., FACG, Professor of Medicine, Cleveland Clinic. "SER-109 has the potential to lead a paradigm shift in the clinical management of patients suffering from recurrent C. difficile infection."

    Seres is sponsoring an ongoing SER-109 open label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128). Please inquire for additional information at serescdiffstudy.com.

    Presentation details are shown below, and abstracts have been made available by ACG on their ACG2020 conference website.

    Title: "8- and 12-week Efficacy and Safety Data from ECOSPOR-III a Phase 3 Double-blind, Placebo-Controlled Randomized Trial of SER-109, an Investigational Microbiome Therapeutic for the Treatment of Patients with Recurrent Clostridioides difficile Infection (rCDI)"

    Presenter: Bret Lashner, M.D., FACG, Professor of Medicine, Cleveland Clinic

    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 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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 ability of SER-109 to transform the treatment of CDI or be a much-needed effective oral treatment option for recurrent 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.

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  24. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it will present a corporate overview at the Jefferies Next Generation IBD Therapeutics Summit on Wednesday, September 23 at 8:00 a.m. E.T.

    A webcast of the presentation will be available under the "Investors and Media" section of Seres' website 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…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it will present a corporate overview at the Jefferies Next Generation IBD Therapeutics Summit on Wednesday, September 23 at 8:00 a.m. E.T.

    A webcast of the presentation will be available under the "Investors and Media" section of Seres' website 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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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  25. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that management will present at two upcoming investor conferences:

    • H.C. Wainwright 22nd Annual Global Investment Conference: Seres will present a corporate overview on Wednesday, September 16 at 11:00 a.m. ET.
    • Oppenheimer Fall Healthcare Summit: Seres will present a corporate overview on Wednesday, September 23 at 11:40 a.m. ET.

    A live audio webcast of each presentation will be available under the "Investors and Media" section of Seres' website. A replay of the presentations 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…

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

    • H.C. Wainwright 22nd Annual Global Investment Conference: Seres will present a corporate overview on Wednesday, September 16 at 11:00 a.m. ET.
    • Oppenheimer Fall Healthcare Summit: Seres will present a corporate overview on Wednesday, September 23 at 11:40 a.m. ET.

    A live audio webcast of each presentation will be available under the "Investors and Media" section of Seres' website. A replay of the presentations 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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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  26. Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it has obtained correspondence from the Office of Vaccines Research and Review of the U.S. Food and Drug Administration (FDA) regarding the Company's plans to submit a Biologics License Application (BLA) to support product approval of SER-109 for recurrent C. difficile infection (CDI). After obtaining highly statistically significant topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI, Seres requested a Breakthrough Therapy Designation meeting with the FDA. In response to the meeting request, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the recent positive SER-109 Phase 3 study results…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today announced that it has obtained correspondence from the Office of Vaccines Research and Review of the U.S. Food and Drug Administration (FDA) regarding the Company's plans to submit a Biologics License Application (BLA) to support product approval of SER-109 for recurrent C. difficile infection (CDI). After obtaining highly statistically significant topline Phase 3 ECOSPOR III SER-109 study results in recurrent CDI, Seres requested a Breakthrough Therapy Designation meeting with the FDA. In response to the meeting request, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the recent positive SER-109 Phase 3 study results, reaffirmed its prior guidance that at least 300 patients will be required for the safety database, and indicated there was not a reason for a meeting at this time.

    Seres is using its SER-109 open-label study, which also admits patients with a single recurrence of CDI as previously discussed with the FDA, to expand the SER-109 safety database. Seres is taking various measures to expedite open-label study enrollment, including increasing the number of SER-109 clinical study sites across the U.S. and Canada. Seres also anticipates that the quarantine of material used for unapproved Fecal Microbiota Transplantation (FMT) by a national provider will accelerate SER-109 open-label study enrollment.

    "Our SER-109 ECOSPOR III Phase 3 study results at eight weeks demonstrated an impressive 30.2% absolute reduction in CDI recurrence, an 88.9% SER-109 sustained clinical response, and a highly favorable safety profile. We believe SER-109 has the potential to transform the outcomes for patients living with recurrent CDI. We are very pleased that the FDA has reaffirmed the efficacy requirements for a BLA filing, and we expect that our Phase 3 data will provide the efficacy basis for product approval," said Eric D. Shaff, President and Chief Executive Officer of Seres. "Patients suffering from recurrent CDI have no attractive treatment options today, and some resort to unapproved FMT, which is unproven and is documented to transmit infectious diseases. There is an urgent need for a new effective and safe therapeutic option for this disease."

    Mr. Shaff continued: "Seres is committed to serving patients with recurrent CDI, a devastating and often fatal disease, and we are working expeditiously to bring SER-109 forward to patients in need. Our team is diligently executing our open-label study, activating many new clinical sites in the process, and we expect to expand the SER-109 safety database so that we can file a BLA as soon as possible. We also plan to seek continued FDA dialogue to discuss a rapid path to product approval."

    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). SER-109 is comprised of a highly purified consortia of commensal bacteria in spore form and designed to be 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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, content, and outcome of any potential meetings with the FDA, the potential approval of SER-109 by the FDA, the results from ECOSPOR III providing an efficacy basis for a BLA submission, the ability of SER-109 to transform the treatment of CDI or be a much-needed effective oral treatment option for recurrent CDI, the potential requirements by the FDA for additional safety data, the initiation of additional clinical sites in the open-label study of SER-109, the speed of patient enrollment in the open-label study, including the potential impact from the quarantine of material used for FMT, the development of an adequate safety database, 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.

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  27. Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced the closing of an underwritten public offering of 12,075,000 shares of its common stock, at a public offering price of $21.50 per share, before underwriting discounts and commissions, and including the exercise in full of the underwriters' option to purchase an additional 1,575,000 shares of common stock. The net proceeds from the offering, together with the net proceeds from a substantially concurrent registered direct offering of 959,002 shares of common stock to Société des…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced the closing of an underwritten public offering of 12,075,000 shares of its common stock, at a public offering price of $21.50 per share, before underwriting discounts and commissions, and including the exercise in full of the underwriters' option to purchase an additional 1,575,000 shares of common stock. The net proceeds from the offering, together with the net proceeds from a substantially concurrent registered direct offering of 959,002 shares of common stock to Société des Produits Nestlé S.A., after deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $263.7 million. All of the shares in the offerings were sold by Seres.

    Cowen and Company, LLC and Piper Sandler & Co. acted as joint book-running managers for the underwritten offering. Canaccord Genuity LLC and Oppenheimer & Co. Inc. acted as co-managers.

    Seres intends to use the net proceeds from the offerings, in addition to its existing cash resources, to advance the clinical development of its product candidates, for commercialization and manufacturing activities and for other general corporate and working capital purposes.

    The common stock sold in the public offering was offered by Seres pursuant to a shelf registration statement on Form S-3 (File No. 333-244401), including a prospectus, which was automatically effective upon filing on August 11, 2020. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on August 11, 2020, and a final prospectus supplement was filed with the SEC on August 14, 2020. The offering was made only by means of a written prospectus and prospectus supplement that formed a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by telephone at (833) 297-2926, or by email at or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated net proceeds of the registered offering to Société des Produits Nestlé S.A. ("Nestlé") and the proposed offering and the use of such proceeds. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties relate to market fluctuations in Seres' common stock price and changes in market conditions, as well as the other factors discussed in the "Risk Factors" section in the prospectus supplement and registration statement referenced above, in the "Risk Factors" section in Seres' Quarterly Report on Form 10-Q filed with the SEC on July 28, 2020, and in other reports that Seres files with the SEC. All information in this press release is as of the date of this release, and Seres undertakes no duty to update this information, even if subsequent events cause its views to change, unless required by law.

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  28. Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced the pricing of an underwritten public offering of 10,500,000 shares of its common stock, at a public offering price of $21.50 per share, before underwriting discounts and commissions. Seres also granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of its common stock on the same terms and conditions. The gross proceeds from the offering, together with the gross proceeds from a registered offering of 959,002 shares of common stock to Société…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced the pricing of an underwritten public offering of 10,500,000 shares of its common stock, at a public offering price of $21.50 per share, before underwriting discounts and commissions. Seres also granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of its common stock on the same terms and conditions. The gross proceeds from the offering, together with the gross proceeds from a registered offering of 959,002 shares of common stock to Société des Produits Nestlé S.A., before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $245.7 million, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares in the offering are to be sold by Seres.

    Cowen and Company, LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Canaccord Genuity LLC and Oppenheimer & Co. Inc. are acting as co-managers. The offering is expected to close on or about August 17, 2020, subject to customary closing conditions.

    Seres intends to use the net proceeds from the offering, in addition to its existing cash resources, to advance the clinical development of its product candidates, for commercialization and manufacturing activities and for other general corporate and working capital purposes.

    The common stock being sold in the public offering are being offered by Seres pursuant to a shelf registration statement on Form S-3 (File No. 333-244401), including a prospectus, which was automatically effective upon filing on August 11, 2020. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on August 11, 2020, and a final prospectus supplement will be filed with the SEC. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by telephone at (833) 297-2926, or by email at or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the completion of the proposed offering, anticipated proceeds of the registered offering to Société des Produits Nestlé S.A. ("Nestlé") and the proposed offering, and the use of such proceeds. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties relate to market fluctuations in Seres' common stock price, changes in market conditions and satisfaction of customary closing conditions related to the registered offering to Nestlé and the proposed offering, as well as the other factors discussed in the "Risk Factors" section in the prospectus supplement and registration statement referenced above, in the "Risk Factors" section in Seres' Quarterly Report on Form 10-Q filed with the SEC on July 28, 2020, and in other reports that Seres files with the SEC. There can be no assurance that Seres will be able to complete the proposed offering on the anticipated terms. All information in this press release is as of the date of this release, and Seres undertakes no duty to update this information, even if subsequent events cause its views to change, unless required by law.

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  29. Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced that it is commencing an underwritten registered public offering of 8,000,000 shares of its common stock. As part of this offering, Seres intends to grant the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock on the same terms and conditions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the proposed…

    Seres Therapeutics, Inc. (NASDAQ:MCRB) ("Seres"), 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, today announced that it is commencing an underwritten registered public offering of 8,000,000 shares of its common stock. As part of this offering, Seres intends to grant the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock on the same terms and conditions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the proposed offering. All of the shares in the proposed offering are to be sold by Seres.

    Cowen and Company, LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. Canaccord Genuity LLC and Oppenheimer & Co. Inc. are acting as co-managers.

    The common stock described are being offered by Seres pursuant to a shelf registration statement on Form S-3, including a prospectus, which was automatically effective upon filing on August 11, 2020. A preliminary prospectus supplement and a final prospectus supplement to the prospectus describing the terms of the offering will be filed with the SEC. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by telephone at (833) 297-2926, or by email at or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

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  30. SER-109 met Phase 3 primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo

    SER-109 was well tolerated, with a safety profile comparable to placebo

    Efficacy results substantially exceeded FDA regulatory guidance to support BLA filing as a single pivotal trial; Company to meet with agency to discuss filing for product approval as soon as possible

    Positive SER-109 Phase 3 data provide validation for Seres' microbiome therapeutics platform and further development of its pipeline of product candidates

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

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported positive topline results from…

    SER-109 met Phase 3 primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo

    SER-109 was well tolerated, with a safety profile comparable to placebo

    Efficacy results substantially exceeded FDA regulatory guidance to support BLA filing as a single pivotal trial; Company to meet with agency to discuss filing for product approval as soon as possible

    Positive SER-109 Phase 3 data provide validation for Seres' microbiome therapeutics platform and further development of its pipeline of product candidates

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

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study showed that SER-109 administration resulted in a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration versus placebo, the study's primary endpoint. 11.1% of patients administered SER-109 experienced a CDI recurrence, versus 41.3% of placebo patients. 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.

    The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo.

    "We are extremely pleased with these highly clinically meaningful SER-109 Phase 3 study results, greatly exceeding the statistical threshold provided by the FDA. Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval. We look forward to meeting with the FDA as soon as possible to discuss the regulatory path forward with the goal of bringing SER-109 to patients as a first-in-class microbiome therapeutic," said Eric D. Shaff, President and Chief Executive Officer of Seres. "Our results represent the first-ever positive pivotal clinical study results for a targeted microbiome drug candidate. We believe these Phase 3 data provide strong validation for our underlying microbiome therapeutics platform, which has been the scientific basis for the Company, as well as persuasive clinical evidence supporting our other active pipeline programs."

    "We would like to thank all those who participated in this landmark study. Based on these highly positive SER-109 ECOSPOR III results, we believe that this novel microbiome therapeutic candidate could potentially provide a much-needed effective oral treatment option for the approximately 170,000 patients in the U.S. that suffer from recurrent CDI annually," said Lisa von Moltke, M.D., FCP, Chief Medical Officer of Seres. "Seres applied a data-driven and scientifically rigorous approach to develop SER-109. The proprietary scientific learnings we have obtained continue to drive our overall R&D efforts and the advancement of our other ongoing microbiome therapeutic programs."

    "Recurrent C. difficile infection is a serious disease that devastates patients' quality of life, and in many severe cases may result in a patient's death. Today's treatment options have important shortcomings related to efficacy, safety and route of administration, and novel approaches that target the root causes of the disease are urgently needed. The SER-109 Phase 3 results are highly impressive and represent an exceptional advance in the fight against this disease. I believe that SER-109 has the potential to fundamentally transform the treatment of recurrent C. difficile infection," said Mark Wilcox, M.D., Professor of Medical Microbiology, University of Leeds.

    ECOSPOR III Study Design and Results

    The ECOSPOR III 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. SER-109, or placebo, was administered orally for three consecutive days. All patients were required to have a positive C. difficile toxin diagnostic test both at study entry and in the case of suspected recurrence to ensure the selection of individuals with active disease and to confirm the accuracy of the primary endpoint.

    The primary efficacy endpoint of ECOSPOR III was the proportion of patients with recurrent CDI at up to eight weeks following administration of SER-109 or placebo. As a secondary endpoint, patients are evaluated for CDI recurrence through 24 weeks post-treatment, and the Company plans to present those results at a future date.

    SER-109 met the study's primary endpoint with a significantly lower recurrence rate of 11.1% in SER-109 patients versus 41.3% in placebo patients at eight weeks; p<0.001 tested at the one-sided 0.25 level. Patients administered SER-109 experienced a 30.2% lower rate of recurrence, on an absolute basis, compared to placebo. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The ECOSPOR III recurrence rates translate into a sustained clinical response rate of 88.9% versus 58.7% with SER-109 and placebo, respectively. The SER-109 Number Needed to Treat (NNT) was approximately 3.

    In prior discussions, the FDA communicated that demonstration of a statistically very persuasive efficacy finding in the ECOSPOR III primary endpoint, defined as demonstrating a 95% upper confidence level of relative risk lower than 0.833, could support a BLA submission on the basis of this single study. The results of ECOSPOR III demonstrated a SER-109 relative risk of 0.27 (95% CI=0.15 to 0.51) compared to placebo. As a result, Seres believes that this study should support the efficacy basis for BLA submission. SER-109 has obtained FDA Breakthrough Therapy and Orphan Drug designations.

    SER-109 was well tolerated, with no treatment-related serious adverse events (SAEs) observed in the active arm, and an adverse event profile similar to placebo. The overall incidence of patients who experienced AEs during the eight-week study period was similar between SER-109 and placebo arms. The most commonly observed treatment-related AEs were flatulence, abdominal distention and abdominal pain, which were generally mild to moderate in nature, and these were observed at a similar rate in both the SER-109 and placebo arms.

    A SER-109 open-label study is ongoing (ClinicalTrials.gov identifier: NCT03183141) at selected clinical sites that participated in the ECOSPOR III study, and the Company may initiate the program at additional clinical sites. The FDA has previously indicated that SER-109 administration to at least 300 patients, consistent with standard FDA guidance, would be required to support BLA submission. The ongoing SER-109 open-label study is continuing to contribute to the SER-109 safety database.

    The Company plans to immediately request a Breakthrough Therapy designation meeting with the FDA to discuss the requirements to submit a BLA seeking regulatory approval of SER-109. Given the favorable efficacy and safety results seen in ECOSPOR III, the safety results observed in prior SER-109 clinical studies, and the critical unmet need for a therapeutic option for recurrent CDI patients, the Company plans to discuss with the FDA the safety data requirements for a BLA filing.

    Seres continues to advance its commercial readiness for the potential launch of SER-109. In June 2020, Seres appointed Terri Young, Ph.D., R.Ph., as Chief Commercial and Strategy Officer. The Company has been conducting activities to support successful future potential commercialization. Seres believes that the commercial opportunity for SER-109 could be substantial, given the dire need for an effective, safe, oral therapeutic, and the strength of the SER-109 Phase 3 study results.

    Conference Call Information

    Seres' management will host a conference call today, August 10, 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 3216859. Accompanying slides will be posted on the Seres website ahead of the conference call. To join the live webcast, and to view the accompanying slides, please visit the "Investors and Media" 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 approximately 21 days.

    About SER-109

    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. SER-109 is a consortium of purified bacterial spores of multiple Firmicute species, 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 CDI.

    SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT). SER-109 is comprised of a highly-purified consortia of spore-based commensal bacteria and designed to be manufactured in accordance with Good Manufacturing Practice conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process that inactivates 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 most commonly used drug 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 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 developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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 approval of SER-109 by the FDA, the potential for SER-109 to be a first-in-class therapy, the timing, content and outcome of any meetings with the FDA, the results from ECOSPOR III providing an efficacy basis for a BLA submission, the potential number of patients who could be treated by SER-109, the ability of SER-109 to transform the treatment of CDI or be a much-needed effective oral treatment option for recurrent CDI, the potential requirements by the FDA for additional safety data, initiation of additional clinical sites in the open-label study of SER-109, commercial opportunity of SER-109, the impact of SER-109 data on the Seres pipeline programs and platform overall, the design of SER-109 and its treatment potential, and the presentation of ECOSPOR III 24-week data, 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.

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  31. – Topline data from SER-109 Phase 3 study in recurrent C. difficile infection expected in August 2020; Potential to be the single pivotal study supporting FDA product registration –

    – Company continues to advance multiple additional clinical-stage microbiome therapeutic programs, including SER-287, SER-301, SER-401 and SER-155 –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported financial results from the second quarter ended June 30, 2020, and provided an operational update.

    "In the coming weeks, we are eagerly looking forward to topline results from our SER-109 Phase 3 study in recurrent C. difficile infection. We believe that positive ECOSPOR III data would be an important advance for the C. difficile community. Recurrent C. difficile

    – Topline data from SER-109 Phase 3 study in recurrent C. difficile infection expected in August 2020; Potential to be the single pivotal study supporting FDA product registration –

    – Company continues to advance multiple additional clinical-stage microbiome therapeutic programs, including SER-287, SER-301, SER-401 and SER-155 –

    Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported financial results from the second quarter ended June 30, 2020, and provided an operational update.

    "In the coming weeks, we are eagerly looking forward to topline results from our SER-109 Phase 3 study in recurrent C. difficile infection. We believe that positive ECOSPOR III data would be an important advance for the C. difficile community. Recurrent C. difficile infection is a debilitating and deadly disease and there is a tremendous need for a safe, FDA-approved treatment that prevents disease recurrence. In addition, we expect that positive ECOSPOR III results would also be a validating milestone for Seres' pipeline of microbiome therapeutics. Based on prior FDA discussions, we expect that clinically compelling data could support a regulatory filing with the FDA for SER-109 product approval. The SER-109 Phase 3 study could potentially enable a first-in-class approved therapy designed to target the underlying cause of this devastating disease," said Eric D. Shaff, President and Chief Executive Officer at Seres. "In addition to SER-109, we have made continued progress advancing our pipeline of promising microbiome therapeutic development candidates, including SER-287, SER-301, SER-401 and SER-155. Each program is targeting a serious disease, and each has the potential to transform the standard of care. Across our portfolio, we are driving towards meaningful, clinically interpretable datasets to enable well-informed decisions on future development."

    Program Updates and Corporate Highlights

    SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection (CDI): Seres previously reported the completion of enrollment in the SER-109 Phase 3 ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128). The multicenter placebo-controlled study enrolled 182 patients with multiply recurrent CDI who were randomized 1:1. ECOSPOR III study results remain blinded to the Company and topline study results are anticipated in August 2020.

    Based on prior discussions with the U.S. Food & Drug Administration (FDA), Seres believes that ECOSPOR III has the potential to be the single pivotal study supporting product registration; however, this will depend on the strength of the data and additional safety data may be required.

    All patients enrolled into ECOSPOR III were required to undergo a rigorous C. difficile cytotoxin diagnostic test to confirm active CDI, both at entry into the study and to confirm recurrence of CDI during the study. The primary objective of ECOSPOR III is to demonstrate a reduction of CDI recurrence at up to eight weeks following SER-109 administration.

    SER-109 is an orally-administered, biologically-derived, microbiome therapeutic candidate designed to restore the gastrointestinal microbiome of patients with recurrent CDI. SER-109 has been granted Orphan Drug and Breakthrough Therapy designations by the FDA. With positive study results, the Company plans to meet with the FDA to discuss requirements for filing for product approval.

    SER-109 is comprised of a highly purified consortia of spore-based commensal bacteria and manufactured under Good Manufacturing Practices conditions using stringent standards to ensure product quality and consistency. To maximize product safety, Seres utilizes a unique manufacturing process that inactivates numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.

    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 ulcerative colitis.

    The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis remains ongoing. Seres has implemented a number of COVID-19 related mitigation strategies and the study continues to enroll patients. In recent weeks, the Company has observed an increase in ECO-RESET clinical site activity, the availability of endoscopies, and in the volume of clinical study subject screening.

    SER-301 clinical candidate for ulcerative colitis: Seres has nominated SER-301, an oral, rationally-designed, fermented microbiome therapeutic, as a clinical candidate for ulcerative colitis. Innovative and novel manufacturing methods have been utilized to produce SER-301. The composition includes strains delivered in spore form, as well as strains fermented in non-spore, vegetative form and delivered using enterically-protected technology designed to release in the colon. The consortium of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate pathways linked to gastrointestinal inflammation and to improve epithelial barrier integrity in patients with ulcerative colitis.

    The Company has initiated clinical development and continues to execute on activities for a SER-301 Phase 1 study in patients with ulcerative colitis. That study is planned to enroll subjects in Australia and New Zealand later this year. Seres is entitled to receive a $10 million milestone payment associated with the Phase 1 SER-301 clinical study initiation from Nestlé Health Science, the Company's 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 evaluating the potential of SER-401 to improve clinical response to nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy, and will evaluate safety, efficacy and tumor biopsies for various biomarkers of response.

    SER-155 Phase 1b clinical study activities: Seres is working to advance SER-155, an oral, rationally designed, fermented microbiome therapeutic, into 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 in 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 move SER-155 into a Phase 1b study later this year in collaboration with Memorial Sloan Kettering Cancer Center.

    Chief Commercial and Strategy Officer appointment: In June, Seres announced that Terri Young, Ph.D., R.Ph., was appointed as Executive Vice President and Chief Commercial and Strategy Officer. Dr. Young joins Seres with over 20 years of commercial and marketing leadership experience, having successfully led the growth of several important biopharmaceutical products.

    Financial Results

    Seres reported a net loss of $20.7 million for the second quarter of 2020, as compared with a net loss of $10.8 million for the same period in 2019. The second 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 second quarter of 2020 were $20.1 million, compared with $17.9 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 second quarter of 2020 were $6.5 million, compared with $5.6 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 second quarter with approximately $63.9 million in cash, cash equivalents and investments compared with $75.1 million at the end of the first quarter 2020. Cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the second quarter of 2021.

    Seres will not be holding a conference call with today's quarterly update and does not intend to meet with investors until the pending SER-109 Phase 3 study results are reported. Seres intends to hold a conference call following release of the SER-109 Phase 3 study results.

    About Seres Therapeutics

    Seres Therapeutics, Inc., (NASDAQ:MCRB) is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. Seres' SER-109 program has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and is in Phase 3 development for recurrent C. difficile infection. Seres' SER-287 program has obtained Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres' SER-109 program has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and is in Phase 3 development for recurrent C. difficile infection. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for 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, results and initiation of our clinical studies, the potential for any of the Company's studies to serve as a pivotal trial to enable a BLA submission, the receipt of future milestone payments, the potential impact of any of Seres' development candidates, the potential impact of the COVID-19 pandemic, the sufficiency of the Company's cash resources to fund operating expenses and capital expenditure requirements, the availability of additional cash resources 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 May 7, 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)

     

     

     

    June 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    61,536

     

     

    $

    65,126

     

    Investments

     

     

    2,404

     

     

     

    29,690

     

    Prepaid expenses and other current assets

     

     

    5,847

     

     

     

    3,588

     

    Accounts receivable

     

     

    2,929

     

     

     

    1,785

     

    Total current assets

     

     

    72,716

     

     

     

    100,189

     

    Property and equipment, net

     

     

    16,305

     

     

     

    19,495

     

    Operating lease assets

     

     

    10,257

     

     

     

    11,356

     

    Restricted investments

     

     

    1,400

     

     

     

    1,400

     

    Total assets

     

    $

    100,678

     

     

    $

    132,440

     

    Liabilities and Stockholders' Deficit

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    4,163

     

     

    $

    4,859

     

    Accrued expenses and other current liabilities

     

     

    10,604

     

     

     

    10,884

     

    Operating lease liabilities

     

     

    4,788

     

     

     

    4,456

     

    Deferred revenue - related party

     

     

    19,040

     

     

     

    20,960

     

    Deferred revenue

     

     

    5,653

     

     

     

    4,834

     

    Total current liabilities

     

     

    44,248

     

     

     

    45,993

     

    Note payable, net of discount

     

     

    24,863

     

     

     

    24,648

     

    Operating lease liabilities, net of current portion

     

     

    13,181

     

     

     

    15,676

     

    Deferred revenue, net of current portion - related party

     

     

    80,383

     

     

     

    89,111

     

    Deferred revenue, net of current portion

     

     

    2,826

     

     

     

    4,834

     

    Other long-term liabilities

     

     

    752

     

     

     

    502

     

    Total liabilities

     

     

    166,253

     

     

     

    180,764

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' deficit:

     

     

     

     

     

     

     

     

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

    Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2020 and December 31, 2019; 75,131,834 and 70,143,252 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

    75 

    70 

    Additional paid-in capital

    434,593

    411,255

    Accumulated other comprehensive income

    1

    Accumulated deficit

    (500,244

    )

    (459,649

    )

    Total stockholders' deficit

    (65,575

    )

    (48,324

    )

    Total liabilities and stockholders' deficit

    $

    100,678

    $

    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

    June 30,

     

     

    Six Months Ended

    June 30,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Collaboration revenue - related party

    $

    5,186

     

     

    $

    10,454

     

     

    $

    10,648

     

     

    $

    17,069

     

    Grant revenue

     

    831

     

     

     

    260

     

     

     

    1,570

     

     

     

    706

     

    Collaboration revenue

     

    28

     

     

     

    1,817

     

     

     

    2,016

     

     

     

    2,077

     

    Total revenue

     

    6,045

     

     

     

    12,531

     

     

     

    14,234

     

     

     

    19,852

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development expenses

     

    20,099

     

     

     

    17,905