MCRB Seres Therapeutics Inc.

7.09
+0.13  (+2%)
Previous Close 6.96
Open 6.84
52 Week Low 4.09
52 Week High 38.5
Market Cap $649,993,135
Shares 91,677,452
Float 51,839,567
Enterprise Value $447,764,909
Volume 2,492,770
Av. Daily Volume 1,589,033
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Upcoming Catalysts

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

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

Latest News

  1. – SER-109 open-label study in patients with recurrent C. difficile infection on track to achieve enrollment target in late Q3 2021 –

    – SER-109 co-commercialization agreement with Nestlé Health Science provides $310 million in upfront and contingent approval milestones, additional $225 million in contingent sales milestones, and future payments equal to 50% of profits –

    – Microbiome analyses from SER-287 Phase 2b ulcerative colitis study anticipated in H2 2021 –

    – Continued clinical development progress with SER-155 and SER-301, next-generation rationally designed pipeline candidates –

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

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome company developing a novel class of multifunctional…

    – SER-109 open-label study in patients with recurrent C. difficile infection on track to achieve enrollment target in late Q3 2021 –

    – SER-109 co-commercialization agreement with Nestlé Health Science provides $310 million in upfront and contingent approval milestones, additional $225 million in contingent sales milestones, and future payments equal to 50% of profits –

    – Microbiome analyses from SER-287 Phase 2b ulcerative colitis study anticipated in H2 2021 –

    – Continued clinical development progress with SER-155 and SER-301, next-generation rationally designed pipeline candidates –

    – 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 second quarter 2021 financial results and provided business updates.

    "We have made strong progress advancing SER-109, which we expect will become the first-ever FDA-approved microbiome therapeutic. We are nearing target enrollment in our open-label safety study and preparing to file a Biologics License Application (BLA) to support SER-109 product approval. In addition, we recently entered into a license agreement with Nestlé Health Science to co-commercialize SER-109 in North America, which we believe will most effectively bring SER-109 to patients suffering from recurrent CDI. Furthermore, this transaction provides Seres with substantial capital to extend our leadership position in the development of our platform technologies and pipeline of microbiome therapeutics, including SER-301 and SER-155, as well as our preclinical stage programs," said Eric Shaff, President and Chief Executive Officer of Seres. "Earlier this month we announced topline clinical results from our SER-287 donor-derived investigational microbiome candidate Phase 2b study in ulcerative colitis. We look forward to learning more about this trial from the microbiome results anticipated during the second half of this year, and we expect these scientific data to inform both the continued advancement of our microbiome therapeutic approach in UC and future development candidates more broadly."

    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 its primary endpoint of superiority to placebo in reducing CDI recurrence at week 8 in Seres' Phase 3 clinical trial in patients with recurrent C. difficile infection (CDI).

    In May, Seres presented final 24-week clinical data from the pivotal SER-109 Phase 3 ECOSPOR III study as a poster of distinction at the Digestive Disease Week® 2021 conference. Study results demonstrated that SER-109 significantly reduced recurrence rates compared to placebo over 24 weeks (21.3% vs. 47.3%, respectively). SER-109 was observed to be well tolerated, with no treatment-related serious adverse events observed in the active arm and an adverse event profile comparable to placebo.

    Seres is conducting an ongoing open-label study of SER-109 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. Based on U.S. Food and Drug Administration (FDA) commentary, Seres believes the ECOSPOR III efficacy results should support a BLA filing as a single pivotal study supporting product registration and expects to reach target enrollment for the safety database late in the third quarter of 2021.

    Seres continues to execute activities necessary to support a SER-109 BLA submission, while also preparing for a successful product launch with Nestlé Health Science. The Company believes that a substantial commercial opportunity exists for SER-109. Each recurrence of CDI has been estimated to result in approximately $34,000 in direct healthcare expenses. There are approximately 170,000 cases of recurrent CDI annually in the U.S.

    In July, Seres announced that it had entered into an agreement with Nestlé Health Science to jointly commercialize SER-109 in the United States and Canada. Under the terms of the agreement, Seres received an upfront license payment of $175 million, and is eligible for an additional $125 million upon FDA approval of SER-109 and $10 million upon approval in Canada. The agreement includes sales target milestones which, if achieved, could total up to $225 million. Seres will be responsible for development and pre-commercialization costs in the U.S. Upon commercialization, Seres will be entitled to an amount equal to 50% of the commercial profits.

    SER-287 Phase 2b ECO-RESET study in ulcerative colitis: In July, Seres announced topline results from the Phase 2b ECO-RESET study evaluating SER-287, a donor-derived investigational microbiome therapeutic candidate, in patients with mild-to-moderate ulcerative colitis (UC). The SER-287 Phase 2b ECO-RESET study was a randomized, placebo-controlled, three-arm induction trial that enrolled 203 patients with active mild-to-moderate UC who had inadequate response or loss of response on prior therapy. The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of SER-287 were generally well tolerated. Given the lack of a clinical efficacy signal identified in ECO-RESET, the Company decided to close the open-label and maintenance portions of the study. The Company expects to obtain SER-287 Phase 2b study microbiome data in H2 2021.

    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. SER-301 is being evaluated in adults with mild-to-moderate UC. 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 UC. SER-301 was designed and optimized using Seres' reverse translation discovery and development platforms. The SER-301 composition 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 Seres' broader clinical portfolio and confirmed using Seres' nonclinical human-cell based assays and in vivo models.

    SER-155 Phase 1b clinical study activities: In June, Seres announced that the FDA had indicated that studies for SER-155 may proceed under an Investigational New Drug application. Seres expects to soon begin enrolling a SER-155 Phase 1b clinical study in collaboration with Memorial Sloan Kettering Cancer Center and the University of Chicago.

    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 (allo-HSCT). SER-155 is a consortium of bacterial species selected using Seres' reverse translation discovery and development platforms. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.

    In June, Seres announced data from its collaboration with the University of Cologne demonstrating that decreased microbiome diversity in allo-HSCT recipients is associated with poor clinical outcomes including mortality and increased incidence of intestinal GvHD. The data were presented at the 2021 American Society of Clinical Oncology Annual Meeting. A separate poster presentation, including data from a collaboration with Memorial Sloan Kettering Cancer Center, established a significant association between microbiome composition and response to immune checkpoint inhibitor treatment in patients who have metastatic melanoma, metastatic lung, urothelial, or renal cancer.

    Appointment of Chief Financial Officer and Head of Business Development: In May, Seres announced that David Arkowitz was appointed as Executive Vice President, Chief Financial Officer (CFO) and Head of Business Development. Mr. Arkowitz brings to Seres more than 30 years of finance, operations, business development and commercial leadership experience in the life sciences and biotech industries. He joins Seres from Flexion Therapeutics, Inc., where he served as CFO. Prior to Flexion, Mr. Arkowitz served as Chief Operating Officer and CFO at Visterra, Inc., a biotech company that was acquired by Otsuka Pharmaceutical Co. He previously served as CFO at Mascoma Corporation, AMAG Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc., and held additional leadership positions within each company. Earlier, Mr. Arkowitz spent more than 13 years at Merck & Co., Inc. where he held roles of increasing responsibility, including Vice President and Controller of the U.S. operations, Controller of the global research and development division, and CFO of the Canadian subsidiary. Mr. Arkowitz earned a B.A. in mathematics from Brandeis University and a M.B.A. in finance from Columbia University Business School.

    Financial Results

    Seres reported a net loss of $48.3 million for the second quarter of 2021, as compared with a net loss of $20.7 million for the same period in 2020. 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 2021 were $36.0 million, compared with $20.1 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, as well as personnel expenses.

    General and administrative expenses for the second quarter of 2021 were $17.5 million, compared with $6.5 million for the same period in 2020. General and administrative expenses were primarily due to personnel expenses, professional fees and facility costs.

    As of June 30, 2021, Seres had approximately $229.4 million in cash, cash equivalents and marketable securities. The June 30, 2021, cash balance does not include the upfront fee of $175.0 million that has been received by Seres following the SER-109 Co-Commercialization License Agreement announced on July 1, 2021, with Nestlé Health Science. As a result, the June 30, 2021, pro-forma cash balance, inclusive of the upfront fee from Nestlé, was approximately $404 million.

    Conference Call Information

    Seres' management will host a conference call today, August 3, 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 6519859. 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 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 safety, efficacy and regulatory and clinical progress of our product candidates; the potential market for SER-109; the potential approval of SER-109; the timing of study enrollment; and its potential status as a first-in-class therapeutic; the ultimate success and ability to achieve targets and receive milestones payments from the Nestlé Health Science agreement; the timing and impact of microbiome analysis from the SER-287 study; the timing and development of our early stage pipeline, the promise of our microbiome therapeutics; our development plans; 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 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.

    SERES THERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

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

     

     

     

    June 30,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    73,997

     

     

    $

    116,049

     

    Short term investments

     

     

    140,556

     

     

     

    137,567

     

    Prepaid expenses and other current assets

     

     

    8,751

     

     

     

    5,774

     

    Accounts receivable

     

     

    1,251

     

     

     

    9,387

     

    Total current assets

     

     

    224,555

     

     

     

    268,777

     

    Property and equipment, net

     

     

    15,047

     

     

     

    13,897

     

    Operating lease assets

     

     

    12,415

     

     

     

    9,041

     

    Restricted investments

     

     

    2,150

     

     

     

    1,400

     

    Long term investments

     

     

    14,879

     

     

     

    49,825

     

    Other non-current assets

     

     

    602

     

     

     

     

    Total assets

     

    $

    269,648

     

     

    $

    342,940

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    5,450

     

     

    $

    4,018

     

    Accrued expenses and other current liabilities

     

     

    18,913

     

     

     

    14,226

     

    Operating lease liabilities

     

     

    5,675

     

     

     

    5,115

     

    Short term portion of note payable, net of discount

     

     

    6,298

     

     

     

    454

     

    Deferred revenue - related party

     

     

    19,829

     

     

     

    22,602

     

    Total current liabilities

     

     

    56,165

     

     

     

    46,415

     

    Long term portion of note payable, net of discount

     

     

    19,036

     

     

     

    24,639

     

    Operating lease liabilities, net of current portion

     

     

    13,828

     

     

     

    10,561

     

    Deferred revenue, net of current portion - related party

     

     

    78,434

     

     

     

    85,572

     

    Other long-term liabilities

     

     

    1,119

     

     

     

    1,003

     

    Total liabilities

     

     

    168,582

     

     

     

    168,190

     

    Commitments and contingencies

     

     

     

     

     

     

    Stockholders' deficit:

     

     

     

     

     

     

    Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30,

    2021 and December 31, 2020; no shares issued and outstanding at June 30,

    2021 and December 31, 2020

     

     

     

     

     

     

    Common stock, $0.001 par value; 200,000,000 shares authorized at June 30,

    2021 and December 31, 2020; 91,713,810 and 91,459,239 shares issued and

    outstanding at June 30, 2021 and December 31, 2020, respectively

     

     

    92

     

     

     

    91

     

    Additional paid-in capital

     

     

    733,533

     

     

     

    723,482

     

    Accumulated other comprehensive income (loss)

     

     

    12

     

     

     

    (47

    )

    Accumulated deficit

     

     

    (632,571

    )

     

     

    (548,776

    )

    Total stockholders' equity

     

     

    101,066

     

     

     

    174,750

     

    Total liabilities and stockholders' equity

     

    $

    269,648

     

     

    $

    342,940

     

    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,

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Revenue:

     

     

     

     

     

     

     

     

     

     

     

    Collaboration revenue - related party

    $

    5,263

     

     

    $

    5,186

     

     

    $

    9,911

     

     

    $

    10,648

     

    Grant revenue

     

     

     

     

    831

     

     

     

    1,070

     

     

     

    1,570

     

    Collaboration revenue

     

     

     

     

    28

     

     

     

     

     

     

    2,016

     

    Total revenue

     

    5,263

     

     

     

    6,045

     

     

     

    10,981

     

     

     

    14,234

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

    Research and development expenses

     

    35,954

     

     

     

    20,099

     

     

     

    65,257

     

     

     

    41,842

     

    General and administrative expenses

     

    17,451

     

     

     

    6,491

     

     

     

    29,192

     

     

     

    12,629

     

    Total operating expenses

     

    53,405

     

     

     

    26,590

     

     

     

    94,449

     

     

     

    54,471

     

    Loss from operations

     

    (48,142

    )

     

     

    (20,545

    )

     

     

    (83,468

    )

     

     

    (40,237

    )

    Other (expense) income:

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

    829

     

     

     

    74

     

     

     

    1,795

     

     

     

    233

     

    Interest expense

     

    (732

    )

     

     

    (719

    )

     

     

    (1,428

    )

     

     

    (1,435

    )

    Other (expense) income

     

    (285

    )

     

     

    476

     

     

     

    (694

    )

     

     

    844

     

    Total other (expense) income, net

     

    (188

    )

     

     

    (169

    )

     

     

    (327

    )

     

     

    (358

    )

    Net loss

    $

    (48,330

    )

     

    $

    (20,714

    )

     

    $

    (83,795

    )

     

    $

    (40,595

    )

    Net loss per share attributable to common stockholders,

    basic and diluted

    $

    (0.53

    )

     

    $

    (0.28

    )

     

    $

    (0.91

    )

     

    $

    (0.56

    )

    Weighted average common shares outstanding, basic and

    diluted

     

    91,659,829

     

     

     

    73,306,248

     

     

     

    91,593,845

     

     

     

    72,063,881

     

    Net loss

     

    (48,330

    )

     

     

    (20,714

    )

     

     

    (83,795

    )

     

     

    (40,595

    )

    Other comprehensive income (loss):

     

     

     

     

     

     

     

     

     

     

     

    Unrealized gain on investments, net of tax of $0

     

    27

     

     

     

    11

     

     

     

    59

     

     

     

    1

     

    Total other comprehensive income (loss)

     

    27

     

     

     

    11

     

     

     

    59

     

     

     

    1

     

    Comprehensive loss

    $

    (48,303

    )

     

    $

    (20,703

    )

     

    $

    (83,736

    )

     

    $

    (40,594

    )

     

    View Full Article Hide Full Article
  2. Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast on August 3, 2021 at 8:30 a.m. ET to discuss second 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 6519859. 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…

    Seres Therapeutics, Inc., (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast on August 3, 2021 at 8:30 a.m. ET to discuss second 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 6519859. 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 is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis, and SER-155 in a Phase 1b study to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease. For more information, please visit www.serestherapeutics.com.

    View Full Article Hide Full Article
  3. Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC).

    To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 5155278. 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…

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC).

    To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 5155278. 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 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 is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address 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 without limitation: the potential impact of microbiome therapeutics; the safety, efficacy and regulatory and clinical progress of our product candidates; plans, timing and potential impact of the release of additional preclinical and clinical data, including with respect to the SER-287 microbiome analyses; our development opportunities, including the future of development in UC; 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; and our ability to retain key personnel and to manage our growth. 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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  4. —Primary endpoint of clinical remission compared to placebo was not achieved—

    —Both dosing regimens of SER-287 were generally well tolerated—

    —Open label and maintenance portions of the SER-287 study will be closed—

    — Microbiome endpoints and analyses expected in the second half of 2021—

    —Company to host a conference call at 8:30 a.m. ET—

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of SER-287 were generally well tolerated. Given the lack…

    —Primary endpoint of clinical remission compared to placebo was not achieved—

    —Both dosing regimens of SER-287 were generally well tolerated—

    —Open label and maintenance portions of the SER-287 study will be closed—

    — Microbiome endpoints and analyses expected in the second half of 2021—

    —Company to host a conference call at 8:30 a.m. ET—

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of SER-287 were generally well tolerated. Given the lack of a clinical efficacy signal identified in ECO-RESET, the Company has decided to close the open label and maintenance portions of the study.

    "While these outcomes were not what we, nor the UC community, were hoping for, we remain committed to leading the creation of a new class of medicines designed to impact how diseases like ulcerative colitis are treated. As with SER-109, we will again follow the science and the data, conduct a rigorous scientific analysis, and determine the optimal path forward for our UC franchise," said Eric Shaff, Chief Executive Officer at Seres. "We are well resourced and continue to prepare for SER-109 commercialization, in collaboration with Nestlé Health Science, and we are excited about advancing the development of our SER-301 and SER-155 investigational candidates as well as our earlier stage pipeline."

    The primary objective of the induction portion of the Phase 2b study was to evaluate the safety and efficacy of SER-287, after 10 weeks of induction dosing (following vancomycin pre-conditioning) in achieving clinical remission in participants with mild-to-moderate UC. The trial was a randomized, placebo controlled, double blind, parallel group multicenter study which enrolled 203 UC patients in 104 sites throughout the U.S. and Canada. Dosing was explored in two SER-287 cohorts (full induction dose and step-down induction dose) or placebo (randomized 1:1:1). Clinical remission was analyzed and defined by a 3-component modified Mayo Score. No meaningful clinical differences and no statistical significance were observed in absolute clinical remission rates among the three treatment arms (10.3% for the full induction dose, n=68 and 10.6% for the step-down induction dose, n=66 versus 11.6% for placebo, n=69). There were also no meaningful differences observed across the three treatment groups for endoscopic improvement, endoscopic remission or symptomatic remission.

    "While the efficacy results in this trial did not meet the pre-defined threshold, we believe this data-rich study, including microbiome analyses expected in the second half of 2021, will provide valuable insights to inform continued development of our pipeline, including SER-301, our next generation investigational candidate for UC," said Lisa von Moltke, M.D., Chief Medical Officer at Seres. "We are grateful for everyone who made this study possible, including the study investigators, and in particular, the patients and their families."

    Treatment emergent adverse events (AEs) were observed in 67.6%, 46.2% and 50.7% of subjects in the induction dose, step-down dose (both of which included six days of oral vancomycin preconditioning) and placebo treatment arms, respectively. The majority of observed AEs were mild or moderate in intensity. The most commonly observed AEs were worsening of UC, diarrhea, nausea and abdominal distension. Four participants on active treatment reported serious treatment emergent adverse events (worsening ulcerative colitis, colonic dysplasia, congestive heart failure with decreased hemoglobin, and appendicitis), as did one on placebo (worsening ulcerative colitis).

    The Company continues to advance its SER-301 program currently in a Phase 1b study that is testing the hypothesis that engraftment of drug product species modulates microbe-associated metabolites to reduce intestinal inflammation and improve epithelial barrier integrity in adults with mild-to-moderate UC. The Phase 1b is currently enrolling in Australia and New Zealand.

    SER-287 and SER-301 are both consortia of bacteria found in the gastrointestinal tract of healthy individuals. However, important compositional and potential therapeutic differences exist between the investigational drugs. SER-287 is a donor-derived product candidate, whereas SER-301 utilizes Seres' next generation technology and is based on rationally designed, cultivated consortia of bacteria. The design of SER-301 has leveraged the Company's reverse translation platforms and capabilities that can evaluate at high resolution how microbes in the gastrointestinal tract are interacting with one another and human cells and tissues to impact disease pathways. The bacteria in SER-301 are targeted at, and specifically selected in, an effort to optimize the reduction of pro-inflammatory activity, improve epithelial barrier integrity and TNF-a driven inflammation in intestinal epithelial cells, and modulate UC-relevant anti-inflammatory, innate and adaptive immune pathways.

    Results from the SER-287 ECO-RESET study, including additional efficacy and safety results as well as microbiome analyses, will be submitted for presentation at a future scientific meeting.

    As of June 30, 2021, Seres had approximately $229 million in cash, cash equivalents and marketable securities. The June 30, 2021 cash balance does not include the upfront fee of $175 million that has been received by Seres following the SER-109 Co-Commercialization License Agreement announced on July 1, 2021 with Nestlé Health Science.

    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 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 is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address 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 without limitation: the potential impact of microbiome therapeutics; the safety, efficacy and regulatory and clinical progress of our product candidates; plans, timing and potential impact of the release of additional preclinical and clinical data, including with respect to the SER-287 microbiome analyses; our development opportunities, including the future of development in UC; 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; and our ability to retain key personnel and to manage our growth. 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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    • Companies Agree to Jointly Commercialize SER-109 Investigational Microbiome Therapeutic to Treat Recurrent C. difficile Infection, Leading the Way for Entirely New Treatment Modality
    • Deal calls for more than $500 million in upfront and contingent milestone payments
    • Seres Therapeutics to conduct a conference call at 8:30 a.m. ET

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced today that it has entered into an agreement with Nestlé Health Science to jointly commercialize SER-109, Seres' investigational oral microbiome therapeutic for recurrent Clostridioides difficile infection (CDI), in the United States (U.S.) and Canada. If approved, SER-109 would become the first-ever FDA-approved microbiome…

    • Companies Agree to Jointly Commercialize SER-109 Investigational Microbiome Therapeutic to Treat Recurrent C. difficile Infection, Leading the Way for Entirely New Treatment Modality
    • Deal calls for more than $500 million in upfront and contingent milestone payments
    • Seres Therapeutics to conduct a conference call at 8:30 a.m. ET

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced today that it has entered into an agreement with Nestlé Health Science to jointly commercialize SER-109, Seres' investigational oral microbiome therapeutic for recurrent Clostridioides difficile infection (CDI), in the United States (U.S.) and Canada. If approved, SER-109 would become the first-ever FDA-approved microbiome therapeutic.

    Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will assume the role of lead commercialization party. Seres will receive license payments of $175 million up front, and an additional $125 million upon FDA approval of SER-109. The agreement also includes sales target milestones which, if achieved, could total up to $225 million. Seres will be responsible for development and pre-commercialization costs in the U.S. Upon commercialization, Seres will be entitled to an amount equal to 50% of the commercial profits.

    The agreement to co-commercialize SER-109 in the U.S. and Canada represents the expansion of an existing strategic collaboration between the companies. Nestlé Health Science already has commercial rights to Seres' investigational treatments for CDI and inflammatory bowel disease outside of the U.S. and Canada, and with this expansion, Nestlé Health Science becomes Seres' global collaborator in SER-109.

    A leading cause of hospital-acquired infections in the U.S., CDI is associated with debilitating diarrhea and claims the lives of more than 20,000 Americans each year. SER-109 is comprised of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. The bacterial consortium in SER-109 rapidly repopulates the microbiome in the gut to produce compositional and functional changes that are critical to a sustained clinical response.

    "Nestlé Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need," Seres Therapeutics CEO, Eric Shaff, said. "We conducted a competitive process to select a collaborator for SER-109. As we prepare for potential approval and commercialization, we are eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI."

    "We are excited to expand our existing collaboration with Seres Therapeutics at this pivotal time, given the promise SER-109 holds for patients trapped in the debilitating cycle of recurrent C. difficile infection," CEO of Nestlé Health Science, Greg Behar, added. "Nestlé Health Science is focused on the fast-developing areas of gut health, food allergies and metabolic health within our global pharmaceutical business, Aimmune Therapeutics. We look forward to leveraging Aimmune's existing, fully integrated commercial infrastructure and capability to launch this important medicine, once approved."

    Nestlé Health Science continues to make significant investments in innovation while leveraging leading-edge science. Its pharma arm, Aimmune Therapeutics, has a strong presence in the field of gastroenterology, allowing it to lead the commercialization of SER-109 while providing Seres the ability to retain a strategic role and actively participate in the launch.

    SER-109 Clinical & Regulatory Milestones

    • In August 2020, Seres announced that SER-109 had met the primary endpoint from the pivotal Phase 3 ECOSPOR III study, showing a highly statistically significant reduction in the rate of CDI recurrence compared to placebo at 8 weeks, with an absolute reduction of 27% and a relative risk reduction of 68%. In a separate measure, approximately 88% of patients achieved sustained clinical response at week 8.
    • The Company expects that the ECOSPOR III efficacy results should support a BLA filing as a single pivotal trial once the SER-109 safety database includes at least 300 treated subjects monitored for 24 weeks, based on feedback from the FDA.
    • A SER-109 open-label study is ongoing and continues to contribute to the SER-109 safety database. Completion of target enrollment is anticipated in Q3 of 2021.

    Responsibility for oversight of activities to support SER-109 will be governed by a Joint Steering Committee composed of an equal number of members from each company. Seres is responsible for the manufacturing and supply of SER-109 for all geographies contemplated in the collaboration in addition to ex-North America. Seres will lead medical affairs activities pre-launch and Aimmune Therapeutics will lead commercialization and medical affairs activities post-launch.

    Conference Call Information

    Seres' management team will host a conference call today, July 1, 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 5382249. 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 pediatric 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 in a Phase 1b study to address gastrointestinal infections, bacteremia and graft-versus-host disease. For more information, please visit www.serestherapeutics.com.

    About Nestlé Health Science and Aimmune Therapeutics

    Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 7,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com

    Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening gastrointestinal, metabolic, and food-mediated allergic conditions. www.aimmune.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 our development plans; the timing and results of the SER-109 safety data; the ability of our clinical trials to support approval of SER-109; the size of the market for SER-109; our ability to achieve the targets and receive any milestones payments from Nestlé Health Science; Nestlé Health Science's obligation to share responsibility and costs for the commercialization of SER-109; and the potential benefits of our collaboration with Nestlé Health Science.

    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; and our ability to retain key personnel and to manage our growth. 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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