MCRB Seres Therapeutics Inc.

26.36
0  0%
Previous Close 26.36
Open
52 Week Low 2.52
52 Week High 33
Market Cap $2,353,751,170
Shares 89,292,533
Float 51,759,984
Enterprise Value $2,332,643,169
Volume 5
Av. Daily Volume 3,513,850
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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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SER-401
Melanoma
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
SER-109 - ECOSPOR III
Recurrent C. Difficile infection
Phase 3
Phase 3
Phase 3 data met primary endpoint - August 10, 2020.
SER-155
Gastrointestinal infections, bacteremia and graft versus host disease (GvHD)
Phase 1b
Phase 1b
Phase 1b trial to be initiated later in 2020.

Latest News

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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