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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 13, 2025

 

 

SERES THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-37465   27-4326290

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

101 Cambridgepark Drive  
Cambridge, MA   02140
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 945-9626

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common stock, par value $0.001 per share   MCRB  

The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On March 13, 2025, Seres Therapeutics, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2024 and provided operational updates. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).

 

Item 7.01.

Regulation FD Disclosure.

On March 13, 2025, the Company posted an updated corporate presentation in the “Investors and News” portion of its website at www.serestherapeutics.com. A copy of the slide presentation is attached as Exhibit 99.2 to this Current Report and incorporated herein by reference.

The information in Items 2.02 and 7.01 of this Current Report, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

The following Exhibits 99.1 and 99.2 relate to Items 2.02 and 7.01, respectively, and shall be deemed to be furnished, and not filed:

 

Exhibit
No.
   Description
99.1    Seres Therapeutics, Inc. Press Release issued March 13, 2025
99.2    Seres Therapeutics, Inc. Corporate Presentation as of March 2025
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    SERES THERAPEUTICS, INC.
Date: March 13, 2025     By:  

/s/ Thomas J. DesRosier

    Name:   Thomas J. DesRosier
    Title:   Chief Legal Officer and Executive Vice President
EX-99.1 2 d914751dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

SERES THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2024

FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES

Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025

SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative risk reduction) in BSIs, and support potential for live biotherapeutics to address inflammatory and immune diseases 

Company advances SER-155 strategic partnership discussions to accelerate next study in allo-HSCT

and support potential expansion into other target populations

With current cash, expected second installment payment from Nestlé, and based on current

operating plans, Seres expects to fund operations into Q1 2026

Conference call at 8:30 a.m. ET today

CAMBRIDGE, Mass.—March 13, 2025 — Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, today reported fourth quarter and full year 2024 financial results and provided business updates.

“We have made significant progress advancing SER-155 as a novel live biotherapeutic candidate designed to prevent life-threatening bloodstream infections in allo-HSCT recipients,” said Eric Shaff, President and Chief Executive Officer of Seres. “Based on the strength of our Phase 1b placebo-controlled clinical results showing a relative risk reduction of 77% in bloodstream infections (BSIs), SER-155 received Breakthrough Therapy designation from the FDA. Our productive interactions with the FDA regarding plans to advance SER-155 in allo-HSCT patients have supported and informed our development plans. We are formulating the next SER-155 study design, which could be either a standalone Phase 2 or a Phase 2/3 seamless design, and plan to submit a draft protocol to the FDA in the second quarter of this year. Based on potential additional agency feedback and perspectives we expect to gain from further partnership discussions, we plan to decide upon the optimal path forward for further SER-155 development.”


Mr. Shaff continued, “Recently released exploratory translational biomarker results from our SER-155 Phase 1b study provide supportive mechanistic data, consistent with the observed clinical results that showed a reduction in the risk of BSIs. We believe the data also offer further evidence of the potential of Seres’ biotherapeutic approach to benefit patients living with inflammatory and immune diseases such as ulcerative colitis and Crohn’s disease. The market opportunity for SER-155 is significant, with clinician and payer research indicating that SER-155, if approved, could result in rapid and deep utilization in allo-HSCT, as well as other sizable patient groups at high risk of BSIs. Our efforts and investments this year are focused on preparing for the next study of SER-155 in allo-HSCT and continued pursuit of an external partnership with a counterparty who shares our vision to maximize the SER-155 clinical and commercial opportunity.”

Pipeline Highlights

 

   

In September 2024, Seres reported topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled study in patients undergoing allo-HSCT. Study results demonstrate that SER-155 was associated with a 77% relative risk reduction in bloodstream infections, a significant reduction in systemic antibiotic exposure, as well as a lower incidence of febrile neutropenia, in each case as compared to placebo, through day 100 post-HSCT. SER-155 was generally well tolerated, with no observed treatment-related serious adverse events.

 

   

In December 2024, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to SER-155 for reduction of bloodstream infections in adults undergoing allo-HSCT. Breakthrough Therapy designation grants access to senior management at FDA and more communication and guidance from FDA to expedite the development of medicines where preliminary clinical evidence indicates that a drug may demonstrate substantial improvement over existing therapies, on one or more clinically significant endpoints, and which are intended to treat a serious or life-threatening disease or condition.

 

   

Seres recently received constructive feedback from the FDA regarding the development strategy for SER-155 in patients undergoing allo-HSCT. The FDA provided input on important elements of the next study, including a recommendation for a Phase 2 and support for a reduction in bloodstream infections 30 days post HSCT as the primary endpoint, and confirmed their expectations for the manufacture and control of SER-155. Incorporating the feedback, Seres is designing the next SER-155 allo-HSCT study, which the Company believes could be either a standalone Phase 2, or a Phase 2 as part of a Phase 2/3 seamless design. Both development paths are expected to include an adaptive design, with meaningful interim data analysis, when approximately half of the enrolled patients have reached the primary endpoint timepoint, informing the study path forward and potential indication expansion. The next study protocol will preserve many elements of the successful SER-155 Phase 1b study. Seres plans to submit the draft protocol, which the Company anticipates will be informed by potential further FDA interaction and partnership discussions, to the FDA in Q2 2025 to obtain further feedback.

 

   

In January 2025, the Company reported exploratory translational biomarker data from its SER-155 Phase 1b study which provided evidence supporting the intended therapeutic mechanisms, including promotion of intestinal epithelial barrier integrity to reduce the potential of bacterial translocation into the bloodstream, and reduction of systemic inflammatory responses. Results from this exploratory biomarker analysis showed that SER-155 was associated with lower levels of fecal albumin and lower concentrations of various plasma biomarkers associated with systemic inflammation (i.e., IFN-g, TNF-α, IL-17, and IL-8) in the HSCT peri-transplant period, the period from the end of the first SER-155 treatment course through to neutrophil engraftment. The results support SER-155’s intended mechanisms of action and reinforce the previously


 

reported promising clinical study efficacy and safety data. These systemic inflammatory response observations further support the potential to develop Seres’ live biotherapeutics to address inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease. The SER-155 biomarker results were presented as a poster at the February 2025 Tandem Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR). SER-155 Phase 1b clinical study data were also featured in an oral presentation in the Best Abstracts in Infectious Diseases track at the Tandem meeting.

 

   

Market research conducted with US healthcare professionals (HCPs) and payers supported the high unmet need to prevent BSIs in allo-HSCT patients. Both HCPs and payers indicated an awareness of the high clinical burden of BSIs, driven by the high frequency of occurrences and poor associated outcomes. Both groups cited a lack of efficacious prophylactic therapies and expressed significant ongoing concerns around the risk of BSIs, febrile neutropenia, sepsis, and antibiotic-resistant infections. The observed degree of SER-155 risk reduction of BSIs and related clinical benefits were seen as clinically meaningful and supportive of a strong value proposition. US payers shared an expectation that coverage of SER-155 would be under the outpatient pharmacy benefit, given its oral administration, which would allow for dosing outside of the inpatient hospital setting. SER-155 in allo-HSCT alone represents a significant commercial opportunity based on market research indicating broad adoption by clinicians of an efficacious and well-tolerated option to prevent BSIs in these patients. There are an estimated 9,300 allo-HSCT procedures conducted annually in the US. The European Society for Bone Marrow Transplant recently updated its incidence estimates for Europe, reporting approximately 20,000 procedures in 2023. The opportunity in Europe is expected to be similarly robust to the US, driven by shared market dynamics such as unmet need and cost of HSCT and BSIs to the healthcare system.

 

   

Seres continues to evaluate broader opportunities to address life-threatening infections, including anti-microbial resistance (AMR) infections, for SER-155 and other cultivated live biotherapeutic candidates, including pipeline candidate SER-147, in other medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. The Company is also exploring targeting inflammatory and immune diseases, specifically ulcerative colitis and Crohn’s disease, with support from the Crohn’s & Colitis Foundation.

Recent Corporate Updates

 

   

In September 2024, Seres announced the sale of its VOWST business to Société des Produits Nestlé S.A (SPN, and with certain of its affiliates, collectively, Nestlé Health Science or Nestlé). Seres received gross proceeds of approximately $175 million, including payment of an up-front, prepaid milestone and equity investment, less approximately $20 million in settlement of net obligations payable to Nestlé. Seres received an installment payment of $50 million in January 2025 and expects to receive a second installment payment of $25 million (less up to approximately $1.5 million in employment-related obligations) in July 2025, subject to the Company’s material compliance with its transition obligations. The Company is also eligible to receive future milestone payments of up to $275 million based on VOWST worldwide net sales.


   

In February 2025, the Company appointed Hans-Juergen Woerle, M.D., as a director and member of the Science and Clinical Development Committee. Dr. Woerle is the Chief Medical Officer and Chief Scientific Officer at Nestlé Health Science S.A. His appointment fulfills the rights granted to Nestlé upon their equity investment in Seres pursuant to the VOWST transaction in September 2024.

Anticipated Upcoming Milestones and Events

 

   

Submit to FDA a draft protocol for the next study of SER-155 in allo-HSCT in Q2 2025.

 

   

Present SER-155 Phase 1b clinical and exploratory translational biomarker data as a Top 100 abstract at the European Bone Marrow Transplant meeting in March 2025, facilitating engagement with potential European investigators in support of the Company’s planned global study. Additionally, exploratory translational biomarker data from across Seres’ programs, including in allo-HSCT and IBD, have been accepted for poster presentations at Digestive Disease Week (DDW) in May 2025.

 

   

Expecting receipt of a $25 million (less approximately $1.5 million in employment related obligations) installment payment from Nestlé in July 2025.

Financial Results

In the December 31, 2024 financial statements, the Company has classified the VOWST business as discontinued operations in the consolidated balance sheet for the comparative period (December 31, 2023), and all historical operating results for the VOWST business are reflected within discontinued operations in the consolidated statements of operations for all periods presented.

 

   

Seres reported a net loss from continuing operations of $125.8 million for the full year 2024, as compared to a net loss from continuing operations of $190.1 million for 2023. Seres reported a net loss from continuing operations of $15.7 million for the fourth quarter of 2024, as compared to a net loss from continuing operations of $34.7 million for the same period in 2023.

 

   

Research and development (R&D) expenses for the year ended December 31, 2024 were $64.6 million, compared with $117.6 million for the same period in 2023. The year-over-year decrease in R&D expenses was primarily driven by lower personnel expenses and a decrease in platform investments as the Company focuses on its lead program, SER-155. R&D expenses for the fourth quarter of 2024 were $12.8 million, compared with $23.0 million for the fourth quarter of 2023.

 

   

General and administrative (G&A) expenses for the year ended December 31, 2024 were $53.2 million, compared with $77.5 million for the same period in 2023. The year-over-year decrease in G&A expenses was primarily a result of reduced personnel and contractor expenses and cost management activities. G&A expenses for the fourth quarter of 2024 were $12.5 million, compared with $14.0 million for the fourth quarter of 2023.

 

   

Manufacturing Services expenses, a new category in 2024, were $3.5 million for the year and the quarter ended December 31, 2024. These costs relate to the provision of manufacturing services under the transition services agreement with Nestlé. The associated reimbursement received from Nestlé related to these expenses is recognized in other (expense) income, net.


   

Net income from discontinued operations, net of tax, was $125.9 million for 2024, as compared to $76.4 million for the same period in 2023. The difference was primarily the result of the gain on the sale of the VOWST business, net of tax, of approximately $146.7 million, which was recognized upon completion of the VOWST sale in September 2024.

Cash Runway

As of December 31, 2024, Seres had $30.8 million in cash and cash equivalents. Based on the Company’s current cash (including the $50 million installment payment received from Nestlé in January 2025), an anticipated second installment payment to be received from Nestlé in July 2025, transaction-related obligations and current operating plans, the Company expects to fund operations into the first quarter of 2026.

Conference Call Information

Seres’ management will host a conference call today, March 13, 2025, at 8:30 a.m. ET. The conference call may be accessed by calling 1-800-715-9871 (international callers dial 1-646-307-1963) and referencing the conference ID number 6331602. 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-155

SER-155 is an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and induce immune tolerance to prevent bacterial bloodstream and antimicrobial resistant (AMR) infections, as well as other pathogen associated negative clinical outcomes, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

SER-155 has been evaluated in a Phase 1b placebo-controlled study in patients undergoing allo-HSCT, which demonstrated a significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia. SER-155 has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HCST and Fast Track designation for reducing the risk of infection and graft-versus-host disease in patients undergoing allo-HCST. The early development of the program was supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria.

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. Seres led the successful development and approval of VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024. The Company is developing SER-155, which has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in adults undergoing allo-HSCT, and which has demonstrated a significant reduction in bloodstream infections and related complications (as compared to placebo) in a Phase 1b clinical study in patients undergoing allo-HSCT.


SER-155 and the Company’s other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation, rather than from the donor-sourced production process used for VOWST. In addition to allo-HSCT, the Company intends to evaluate SER-155 and other cultivated live biotherapeutic candidates in other medically vulnerable patient populations including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. For more information, 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 statements about: the timing and results of our clinical studies and data readouts; future product candidates, clinical development plans and commercial opportunities; communications with, feedback from, or submissions to the FDA; future payments related to the VOWST sale; operating plans and our future cash runway; our ability to secure a partnership and/or generate additional capital; our planned strategic focus; anticipated timing of any of the foregoing; and other statements that 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: (1) our need for additional funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our history of operating losses; (5) the expected payments from the VOSWT sale are subject to risks and uncertainties; (6) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (7) we have received a notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (8) our novel approach to therapeutic intervention; (9) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (10) our ability to achieve market acceptance necessary for commercial success; (11) the competition we will face; (12) our ability to protect our intellectual property; and (13) our ability to retain key personnel and to manage our growth. 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 (SEC), on March 13, 2025, 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.

CONSOLIDATED BALANCE SHEETS

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

 

     December 31,  
     2024     2023  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 30,793     $ 127,965  

Accounts receivable due from SPN - related party

     2,068       —   

Prepaid expenses and other current assets (1)

     5,813       8,049  

Current assets of discontinued operations

     —        39,396  
  

 

 

   

 

 

 

Total current assets

     38,674       175,410  

Property and equipment, net

     11,534       17,614  

Operating lease assets

     80,903       90,417  

Restricted cash

     8,668       8,185  

Restricted investments

     —        1,401  

Other non-current assets

     31       2,187  

Non-current assets of discontinued operations (2)

     —        63,386  
  

 

 

   

 

 

 

Total assets

   $ 139,810     $ 358,600  
  

 

 

   

 

 

 

Liabilities and Stockholder’s Equity

    

Current liabilities:

    

Accounts payable

   $ 4,079     $ 3,641  

Accrued expenses and other current liabilities

     10,719       22,509  

Accrued liabilities due to SPN - related party

     17,750       —   

Operating lease liabilities

     8,674       5,587  

Current liabilities of discontinued operations (3)

     —        66,922  
  

 

 

   

 

 

 

Total current liabilities

     41,222       98,659  

Long term portion of note payable, net of discount

     —        101,544  

Operating lease liabilities, net of current portion

     82,966       91,652  

Warrant liability

     —        546  

Other long-term liabilities

     1,838       1,628  

Non-current liabilities of discontinued operations

     —        109,427  
  

 

 

   

 

 

 

Total liabilities

     126,026       403,456  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity (deficit):

    

Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2024 and 2023; no shares issued and outstanding at December 31, 2024 and 2023

     —        —   

Common stock, $0.001 par value; 360,000,000 and 240,000,000 shares authorized at December 31, 2024 and 2023, respectively; 173,008,198 and 135,041,467 shares issued and outstanding at December 31, 2024 and 2023, respectively

     173       135  

Additional paid-in capital

     991,710       933,244  

Accumulated deficit

     (978,099     (978,235
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     13,784       (44,856
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 139,810     $ 358,600  
  

 

 

   

 

 

 

 

[1] 

Includes $2,683 as of December 31, 2024 of unbilled receivable from SPN (related party) related to certain costs of the transition services performed by the Company. See Note 3, Discontinued Operations and TSA, for further details.

[2] 

Includes $38,877 as of December 31, 2023 of milestones related to the construction of the Company’s dedicated manufacturing suite at BacThera AG, or Bacthera.

[3] 

Includes related party amounts of $35,783 at December 31, 2023.


SERES THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

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

 

     Year Ended December 31,  
     2024     2023     2022  

Operating expenses:

      

Research and development expenses

   $ 64,600     $ 117,597     $ 109,651  

General and administrative expenses

     53,183       77,500       70,263  

Manufacturing services

     3,532       —        —   
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     121,315       195,097       179,914  
  

 

 

   

 

 

   

 

 

 

Loss from operations

     (121,315     (195,097     (179,914
  

 

 

   

 

 

   

 

 

 

Other (expense) income:

      

Gain on sale of VOWST Business

     5,684       —        —   

Interest income

     3,967       7,301       3,058  

Interest expense

     —        (2,468     (6,020

Other (expense) income, net

     (14,107     134       (705
  

 

 

   

 

 

   

 

 

 

Total other (expense) income, net

     (4,456     4,967       (3,667
  

 

 

   

 

 

   

 

 

 

Net loss from continuing operations

   $ (125,771   $ (190,130   $ (183,581

Net income (loss) from discontinued operations, net of tax

   $ 125,907     $ 76,406     $ (66,576
  

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 136     $ (113,724   $ (250,157
  

 

 

   

 

 

   

 

 

 

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

   $ (0.81   $ (1.49   $ (1.70

Net income (loss) from discontinued operations per share attributable to common stockholders, basic and diluted

   $ 0.81     $ 0.60     $ (0.62

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

   $ 0.00     $ (0.89   $ (2.31
  

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     155,400,760       128,003,294       108,077,043  
  

 

 

   

 

 

   

 

 

 

Other comprehensive income:

      

Unrealized gain on investments, net of tax of $0

     —        10       49  

Currency translation adjustment

     —        2       (1
  

 

 

   

 

 

   

 

 

 

Total other comprehensive income

     —        12       48  
  

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

   $ 136     $ (113,712   $ (250,109
  

 

 

   

 

 

   

 

 

 

Investor and Media Contact:

IR@serestherapeutics.com

Carlo Tanzi, Ph.D.

Kendall Investor Relations

ctanzi@kendallir.com

EX-99.2 3 d914751dex992.htm EX-99.2 EX-99.2

Exhibit 99.2 Seres Therapeutics Investor Presentation March 2025


Seres Therapeutics Investor Presentation March 2025


Transforming patient outcomes using proprietary consortia of live biotherapeutics Strong Foundation Positive SER-155 Phase Blockbuster SER-155 Expansive Platform 1b Data in Allo-HSCT Opportunity Potential • Validated platform ® highlighted by VOWST • 77% relative risk reduction • Initial SER-155 development • Systemic inflammation and FDA approval as first ever for bloodstream infections in allo-HSCT immune homeostasis oral microbiome therapy biomarker data support the • Well tolerated safety profile; • Potential to initiate multiple with outstanding clinical potential in inflammatory no treatment-related SAEs clinical trials for additional results and immune diseases, such indications as IBD (e.g., ulcerative • Exploratory biomarker data • VOWST asset sale colitis and Crohn's disease) reinforce SER-155 • SER-155 represents multi- strengthened balance mechanisms of action billion net sales opportunity sheet and streamlined • SER-147 designed to across indications (e.g., organization prevent infections in chronic • Constructive FDA feedback autologous-HSCT, blood liver disease on next study; received • Cash into Q1 2026 cancers, CAR-T recipients) Breakthrough Designation Pursuing SER-155 strategic partnership to accelerate next study in allo-HSCT and expand to multiple target populations Seres Therapeutics, Inc. © 2025 3


Validated therapeutic modality and platform: Seres pioneered the development and FDA approval of VOWST as the first-ever oral live microbiome therapeutic DRAMATIC CLINICAL BENEFIT – Preventing infection recurrence Approximately 88% FDA approved (April 2023) to prevent the recurrence of sustained clinical response rate (C. diff. recurrence, at up to 8 weeks) C. difficile infection in adults VOWST asset sale (completed September 2024) provided capital to support pipeline advancement and resulted in a more streamlined, focused organization Source: Feuerstadt P et al. N Engl J Med. 2022;386(3):220-229 Seres Therapeutics, Inc. © 2025 4


VOWST asset sale completed September 30, 2024: transformational for Seres – provides resources to support SER-155 advancement KEY FINANCIAL TERMS $100M upfront payment to Seres, less ~$20M in net obligations due to an affiliate of SPN* • VOWST asset purchase agreement $15M equity investment by SPN at closing provided infusion of capital and $60M prepaid sales-based milestone at closing supports SER-155 development $50M received in January 2025; $25M in deferred • Asset sale extended operational payments (less ~$1.5M in employment-related runway into Q4 ‘25; now into Q1 ‘26 payments) remaining due in July 2025 • Retires debt and other obligations $275M in potential future sales-based milestone payments (subject to reductions for interest on prepaid • Many transition activities complete by milestone payment) end of Q1 ‘25; Manufacturing services through end ‘25 Transaction results in a more streamlined, focused Seres organization and lower cash burn rate *SPN: Société des Produits Nestlé S.A. Seres Therapeutics, Inc. © 2025 5


The gut microbiome has substantial untapped therapeutic potential to both prevent and treat diseases The genetic content of the microbes living within and on your body is at least 100-fold greater than that contained in the human genome Sources: Ley et al. (2006) Cell; Qin et al. (2010) Nature Seres Therapeutics, Inc. © 2025 6


Disrupted gastrointestinal microbiome is mechanistically linked to infections and disease Disrupted & Disease Susceptible Not Disrupted Impacted Biology & Disease Relevance Pathogen or “undesirable” microbe abundance Increased pathogen abundance, in combination with impaired barrier integrity Lost epithelial barrier & and decreased immune mucosal integrity function… …enables bacterial and antigen translocation leading Unfavorable immune to infections & inflammation responses Seres Therapeutics, Inc. © 2025 7


Consortia of live commensal bacteria can be used as therapeutics Live Biotherapeutics Consortia of PD PK bacterial strains Optimized to target Engraftment Restructure Change in Change Disrupted Microbiome multiple of drug microbiome microbiome in host with functional disease-relevant strains composition function function deficiencies pathways (Disease susceptible) Other Bile acids Tryptophan metabolites Short-chain fatty acids Seres Therapeutics, Inc. © 2025 8


Seres’ biotherapeutics and pipeline candidates are expected to have well tolerated safety profile, reducing development risk ✓Based on GI bacteria naturally found in healthy humans, and not associated with disease ✓VOWST product profile includes well tolerated safety without drug-related serious adverse events ✓Well tolerated safety profile in multiple clinical trials and patient populations, including medically vulnerable allo-HSCT recipients Safety profile has potential to mitigate a primary cause of drug development failure Sources: Nanayakkara et al, CA Cancer J Clin 2021; Penack et al, Blood Adv 2020; Seres Therapeutics, Inc. © 2025 9 Zheng et al, Infect Dis Ther 2021


Seres’ initial focus is preventing infections in allo-HSCT; potential is broad Allo-HSCT Autologous HSCT Chronic Liver Disease Survival by microbiome diversity Survival by microbiome diversity Survival by microbiome diversity Lower microbiome diversity post allo- Lower microbiome diversity post Microbiome diversity decreases with HSCT is associated with increased auto-HSCT is associated with worse disease severity and is associated with blood stream infections and overall and progression-free survival increased risk of infection & death decreased overall survival Common biology across vulnerable populations: pathogen domination in the GI microbiome, loss of epithelial barrier integrity, impacted immune function Sources: Peled, et al, NEJM 2020; Khan et al, Blood 2021; Bajaj et al, Clin Gastroenterol Seres Therapeutics, Inc. © 2025 10 Hepatol 2019; Odenwald, et al. Nature Micro. 2023


Near-term focus on SER-155 as anchor biotherapeutic program; constructive FDA engagement on path forward in addition to Breakthrough and Fast Track designations Lead Indication & Therapeutic Potential Additional Program Development Stage Objectives Indications Allogeneic HSCT: provides clinical Phase 1b Reduce incidence of • Autologous HSCT proof of concept Cohort 2 (placebo serious bacterial infections • Reduces risk of SER-155 • Blood cancers controlled) data announced (e.g., BSIs), febrile recurrent C. diff • CAR-T Sept. ‘24 and exploratory neutropenia, and GvHD infections biomarker data in Jan ‘25 • Well tolerated safety profile • Solid organ Reduce incidence of transplant Chronic liver disease: serious bacterial infections SER-147 • ICU patients IND-enabling activities (e.g., SBP, BSIs) and • Long-term care related complications patients FDA feedback included support for primary efficacy endpoint of BSI reduction at 30 days and recommendation that next study be a Phase 2; Seres plans to submit proposed protocol to FDA in Q2 '25 BSI: bloodstream infection; SBP: spontaneous bacterial peritonitis Seres Therapeutics, Inc. © 2025 11


Allo-HSCT regimen can result in infectious consequences and increased mortality Allo-HSCT treatment regimen Treatment consequences • Only ~60% survival 3 years post- Chemotherapy Allo-HSCT Increased risk of infection, GvHD Anti-infectives infusion transplant in US and EU • Significant immune compromise • ~10% transplant mortality for adults in first 100 days post- -14 0 +100 Days transplant Conditioning Immunosuppression • Infections are a leading cause of death Extensive GI microbiome disruption • Gut microbiome disruption frequently observed globally (US, Germany, Japan) Sources: CIBMTR 2023 US summary slides; Passweg et al BMT 2025; Penack et al, Blood Adv 2020; Khan et al, Blood Seres Therapeutics, Inc. © 2025 12 2021; Peled et al, NEJM 2020; Stein-Thoeringer et al, Science 2019; Bleakley & Riddell, Nat Rev Cancer 2004


Bloodstream infections (BSIs) are a leading cause of death post-transplant and are increasing in incidence Bacterial BSI in first 30 days • BSI risk increasing due to recent adoption post-HSCT Incidence of post-transplant cyclophosphamide (PTCy) 50% for GvHD prophylaxis 40% • BSI prevalence high despite standard of 30% care use of antibacterial prophylaxis 43% 20% • ~50% of infections are gut-seeded 10% 14% • 50-80% febrile neutropenia incidence 0% Non-PTCy PTCy Salas et al 2024 • Infection is leading cause of death in first 100 days post-HSCT for adults Impact • ~7.5% mortality rate from bloodstream infections • Complications including infection associated with longer hospital stay and ICU utilization, driving substantial cost increase Sources: Gill et al, Microorganisms 2023; Sava et al, Bone Marrow Transplantation 2022; Carreira et al, Transplant Cell Ther 2022; Youssef et al, Pediatric Transplantation 2020; Song et al, Infect Drug Resist 2023; Bolaños-Meade J et al, NEJM 2023; Salas et al, Transplant Cell Ther 2024; Rearigh Seres Therapeutics, Inc. © 2025 13 et al, Annals of Hematology 2020; CIBMTR 2023 US summary slides; Perales et al Biol Blood Marrow Transplant 2017; Taplitz et al, J Clin Oncol 2018; 2024 Seres physician market research


Standards of care to prevent bloodstream infections in allo-HSCT patients are poor and decreasing in efficacy Joint ASCO* and IDSA EBMT guidelines and Infectious Disease recommendation Working Party recommendations • Fluoroquinolones (FQ) recommended • 2022 Workshop recommends move to for antibacterial prophylaxis targeted antibacterial prophylaxis • Prophylaxis recommended during • Multiple analyses suggest reduced infections window of expected neutropenia from antibacterial prophylaxis but no overall survival benefit • High BSI rate happening despite broad FQ prophylaxis in the US • Prophylaxis efficacy decreasing as bacteria become resistant to antibiotics Trends • PTCy adoption for GvHD prophylaxis is increasing BSI rates * ASCO: American Society of Clinical Oncology; IDSA; Infectious Diseases Society of America; EBMT: formerly known as the European Society for Blood and Marrow Transplantation; PTCy: post-transplant cyclophosphamide Seres Therapeutics, Inc. © 2025 14 Sources: Taplitz et al, J Clin Oncol 2018; EBMT 2022 report; Neuerberg et al Transplant Cell Ther 2024; Bolaños-Meade et al, NEJM 2023


SER-155 Phase 1b study evaluated safety, pharmacology, and efficacy in adult allo- HSCT recipients COHORT 1 COHORT 2 Open-label (n=15 enrolled) Placebo-controlled 1:1 (n=45 enrolled) SER-155 SER-155 Placebo results reported May 2023 results announced Sept. 2024 Primary Endpoints: Key Secondary Endpoints through HSCT Day 100: • Safety and tolerability • Incidence of bloodstream infections (BSI), GI infections, and acute GvHD ≥ Grade 2 • SER-155 bacterial strain engraftment • Incidence and duration of febrile neutropenia • Bacterial pathogen abundance Seres Therapeutics, Inc. © 2025 15


SER-155 Safety: SER-155 was generally well tolerated with no treatment-related SAEs • All but one subject in the placebo arm experienced at least 1 TEAE • Most common for SER-155 treated subjects (≥50% and with Δ ≥5% greater than placebo): Treatment-emergent diarrhea (86% vs. 74% placebo), nausea (62% vs. 53% placebo) adverse events • 1/40 (3%) subject experienced a TEAE leading to treatment discontinuation (active = 0; placebo = 1) (TEAEs) • 3/40 (8%) subjects experienced a TEAE leading to study discontinuation (active = 1; placebo = 2) • 19/40 (48%) subjects experienced an SAE: 11/21 (52%) SER-155-treated subjects vs. 8/19 (42%) placebo-treated subjects; none considered related to SER-155 (no SUSARs) Serious adverse events o Most common SAE SOC: infections & infestations (24% active vs. 37% placebo) (SAEs) o 3 deaths prior to Day 100 (active = 1; placebo = 2), 1 death after Day 100 (active), none considered related to SER-155 Adverse events of • AESIs (bloodstream infections, GI infection, invasive infection): 14/40 (35%) subjects special interest • Rates of AESIs were lower in SER-155 arm vs placebo arm (29% vs 42% respectively) (AESIs) • No SER-155 species were identified in culture from any subject Seres Therapeutics, Inc. © 2025 16


SER-155 Efficacy: SER-155 associated with 77% relative risk reduction in bacterial BSIs and reduction in systemic antibiotic exposure Significant decrease in bacterial bloodstream infections in SER-155-treated subjects vs. Bloodstream infections placebo with 77% relative risk reduction Significantly lower mean cumulative exposure (days) and exposure rate to systemic Antibiotic exposures antibacterials / antimycotics for SER-155-treated subjects vs. placebo Numerically lower incidence rate of febrile neutropenia in SER-155-treated subjects vs. Febrile neutropenia placebo * CDI: C. difficile infection Seres Therapeutics, Inc. © 2025 17


Bloodstream infections from HSCT Day 0 to Day 100: Lower incidence in SER-155 treated subjects vs. placebo Bloodstream infections from Day 0 SER-155 Placebo to Day 100 n=20 n=14 (# patients) n (%) n (%) Subjects with confirmed BSI 2 (10.0%) 6 (42.9%) 95% confidence interval (1.2, 31.7) (17.7, 71.1) mITT-1 population Odds ratio 0.15 95% confidence interval (0.01, 1.13) p-value 0.0423 Organisms in SER-155 patients: Finegoldia magna; E. coli/Strep mitis Organisms in placebo patients: E.coli; Enterococcus faecium/staph haemolyticus/Candida krusei; Staph aureus; Staph haemolyticus; Pseudomonas aeruginosa; E coli • CI: 95% 2-sided Clopper-Pearson confidence interval of incidence is applied • Odds ratio: for incidence between treatment groups (SER-155 and placebo) with 95% 2-sided confidence Seres Therapeutics, Inc. © 2025 18 interval and the corresponding p-value calculated based on the Fisher’s Exact test


Cumulative exposure to systemic antibacterials / antimycotics through HSCT Day 100: Lower incidence in SER-155 treated subjects vs. placebo Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure n=20 n=14 (HSCT Days) n (SD) n (SD) Mean (SD) 9.2 (5.44) 21.1 (20.31) Median 9.0 14.0 Min, Max 0, 19 0, 74 mITT-1 population Mean Difference (95% CI) -11.9 (-23.85, -0.04) p-value 0.0494 • Cumulative exposure is the sum of all days a subject received systemic antibacterials and/or antimycotics between HSCT Day 0 through Day 100; counting once per day regardless of number of agents taken Seres Therapeutics, Inc. © 2025 19 • 95% confidence interval and p-value based on independent samples t-test of the difference in mean days between SER- 155 and placebo


Cumulative exposure rate to systemic antibacterials / antimycotics through HSCT Day 100: Lower incidence in SER-155 treated subjects vs. placebo Cumulative Antibacterial or SER-155 Placebo Antimycotic Exposure Rate n=20 n=14 Rate (SD) Rate (SD) Mean (SD) 0.090 (0.0530) 0.305 (0.2898) Median 0.089 0.244 Min, Max 0.00, 0.18 0.00, 0.90 mITT-1 population Mean Difference (95% CI) -0.2 (-0.38, -0.05) p-value 0.0163 • Cumulative exposure rate is calculated as the sum of all days a subject received systemic antibacterials and/or antimycotics on or after HSCT Day 0 (counting once per day, regardless of number of antibacterial/antimycotic medications taken in a day) through HSCT Day 100 over the total number of days a subject was on the study from HSCT Day 0 to the earliest of EOS, or HSCT Day 100 Seres Therapeutics, Inc. © 2025 20 • 95% confidence interval and p-value are based on independent samples t-test of the difference in mean days or mean rate of cumulative exposure between SER-155 and Placebo


SER-155 Pharmacodynamics: the Phase 1b study included multiple measures of drug pharmacodynamics SER-155 Mechanism of Action Preclinical Clinical Support Measurements on Ph1b clinical study Optimization for MoA Targets Inhibit Pathogens Genomic measurements of pathogen or “Undesirable” abundance in gastrointestinal tract, including Microbes domination by pathogenic bacteria Repair & Protect Concentration of fecal albumin in subject stool, Mucosal Epithelial reflecting barrier damage and leakage of serum Barrier Integrity albumin into the GI tract Concentrations of plasma cytokines, Modulate Immune chemokines and signaling molecules reflecting GI inflammation, systemic inflammation, and Function immune homeostasis Seres Therapeutics, Inc. © 2025 21


SER-155 Pharmacodynamics (pathogen domination): prevalence in SER-155 Cohort 2 was substantially lower relative to Historical Control Cohort • Pathogen domination (i.e., relative abundance in the GI ≥30%) has been associated with risk of BSIs and other 1, 2 negative clinical outcomes • Observed pathogen domination events were low in both the placebo and SER-155 arms with no significant differences observed • The ability to detect pathogen domination in the placebo arm was constrained due to the imbalance in the number of available stool samples between the arms. • Pathogen domination was substantially lower in SER-155 3 Cohort 2 compared to Historical Control Cohort 1 - Peled et al, NEJM 2020; Stein-Thoeringer et al, Science 2019; Kusakabe et al, BBMT 2020 2 - Bacteria in the families: ESKAPE (Enterococcaceae, Enterobacteriaceae & Staphylococcaceae​) & Streptococcaceae; domination defined as ≥30% relative abundance in the GI Seres Therapeutics, Inc. © 2025 22 3 - Subjects that are sampled at similar time points as SER-155 Phase 1b subjects; microbiome data produced using same protocols as SER-155 Phase 1b subjects


Clinical: Epibarrier exploratory translational biomarker results support intended mechanisms of action and clinical safety and efficacy results Repair & Protect Intestinal p = 0.0007 Epithelial Barrier Integrity Following SER-155 treatment course 1 (“post-155 T1”), fecal albumin levels were significantly lower in SER-155 compared to placebo At the post-155 T1 timepoint, fecal albumin levels in N= placebo were significantly higher than levels observed in Post- Baseline HCT Neutrophil Healthy healthy volunteers, consistent with barrier damage SER-155 Day 0 engraftment induced by HCT conditioning. Box plots (SER-155 = blue; Placebo = grey; Healthy Control = green) represent the 25th and 75th percentiles of the inter-quartile range (IQR) of distribution with Fecal albumin levels remained low in SER-155 subjects median value indicated by horizontal marker; vertical whiskers extend 1.5 * IQR. and similar to healthy volunteers throughout the peri- Green dashed line corresponds to 75th percentile of IQR of fecal albumin concentrations measured in healthy control population; LLOD for assay = 3125 transplant period suggesting barrier protection. ng/mL. P-values reported for general linear model (GLM) that includes biomarker concentrations at baseline in model. Seres Therapeutics, Inc. © 2025 23 Fecal Albumin (ng/ML)


Clinical: Anti-inflammatory translational biomarker results support intended mechanisms of action and clinical safety and efficacy results Neutrophil Biomarker Post-155 T1 HCT Day 0 Modulate / Regulate Immune recovery Responses and Function 155 < PBO IFN-γ 155 < PBO p<0.05 TNF-α 155 < PBO 155 < PBO 155 < PBO In the peri-transplant period, treatment with SER-155 was associated with lower plasma concentrations of 155 < PBO 155 < PBO IL-17 155 < PBO p<0.1 p<0.05 several pro-inflammatory cytokines relative to placebo 155 < PBO including: IFN-g, TNF-a, IL-17 & IL-8. IL-8 155 < PBO p<0.05 155 < PBO indicates time points with lower biomarker concentrations in SER-155 arm compared to placebo. P-values reported for general linear model (GLM) that includes biomarker concentrations at baseline in model; blue shaded cells indicate time points with statistical significance based on GLM. Seres Therapeutics, Inc. © 2025 24


US HCPs seek significant reduction of infection risk without compromising patient safety and would incorporate such a therapeutic into standard of care • Reduce incidence of bloodstream infections: target 20% BSI rate vs. current 40% rate • Reduce systemic antibiotic use that is contributing to rising resistance Efficacy • Reduce incidence of febrile neutropenia: target 60% FN rate vs. current 80% rate • No major adverse event signals Safety • Expect translation to fewer deaths in the active study arm Health economics • Shorten hospital stay, reduce readmissions & reduce ICU utilization SER-155 Phase 1b data suggest potential to deliver this profile in a pivotal study Seres Therapeutics, Inc. © 2025 Source: Seres primary market research 2024 25 Profile of SER-155


HCPs see SER-155 as a potentially transformative means to eliminate complications that get in the way of achieving transplant success Reducing the risk of HSCT-related complications, thus ensuring successful engraftment Primary Value Driver for and long-term health of the patient SER-155 A relative risk reduction of 50% in BSIs is seen as “transformative” and would support broad inclusion in standard protocols for allo-HSCT patients The benefit would be massive because Health Care Providers people die from these infections and so “ preventing them, the biggest benefit is Streamlines the transplant process so they can spend more time treating mortality. The rest of the stuff with ICU the patient’s underlying conditions and less time dealing with potential admits and sepsis protocols and all…I morbidities think some of that also gets averted. That would be huge.” Patients One less thing to worry about for patients already dealing with a lot; additional financial and QoL benefits due to shortened hospital stays “This would probably be standard of “ “ care. It would be all eligible patients minus those who cannot tolerate it or are allergic.” Healthcare System Reduced healthcare costs due to shorter hospital stays, fewer ICU visits, fewer antibiotic days and lower incidence of severe negative outcomes Seres Therapeutics, Inc. © 2025 Source: Seres primary market research 2024 26


US payers confirm high unmet clinical need for infection prophylaxis in allo- HSCT recipients and robust profile of SER-155 Clinical Burden Rating • High perceived clinical burden of BSIs within the allo-HSCT patient population is driven by high frequency of occurrences and poor associated outcomes HIGH • Lack of an efficacious prophylactic therapy that successfully limits incidence of High clinical burden BSIs is considered a key unmet need and current driver of clinical burden and unmet need • Top unaided clinical concerns raised by payers include risk of febrile neutropenia, sepsis, and antibiotic-resistant infection LOW • Proposed risk reduction of BSIs and related endpoints were seen as clinically meaningful and supportive of value proposition Profile of SER-155 • “The reductions in primary and secondary endpoints are encouraging and brings positively received hope that you are going to escape this risky scary complication of cancer therapy.” Site of dispensing • Oral administration is viewed as convenient by payers, with most expecting coverage under outpatient pharmacy benefit given oral administration likely outside of the drives reimbursement hospital setting pathway Seres Therapeutics, Inc. © 2025 Source: Q4 2024 US market research with sample including national and regional health plans + PBMs representing ~128M covered lives 27


Viral prophylaxis provides precedent in medically vulnerable patients Prevymis - increasingly used for viral infection prophylaxis (e.g., allo-HSCT and • Overall cost of allo-HSCT is high solid organ transplant populations) (~$400K US year 1 allo-HSCT costs) • Transplant-related complications (e.g., $605M ‘23 infections) raise cost by ~$180K WW sales • Infections result in longer hospital stays, readmissions, increased ICU utilization • Reduces CMV infection in allo-HSCT recipients • Lowers mortality rate Sources: CMS.gov; Broder et al, Am Drug Health Benefits 2017; Perales et al, Biol Seres Therapeutics, Inc. © 2025 28 Blood Marrow Transplant 2017; Merck SEC filings


SER-155 has blockbuster commercial potential, driven by a robust SER-155 profile and substantial unmet needs in allo-HSCT and additional groups ✓ High unmet need to prevent frequent and serious infections ✓ ~40K annual transplants worldwide; 3% annual growth from aging population and transplant success rates ✓ Costly procedure (~$400K US year 1 allo-HSCT per patient cost) with high incremental costs of infections (incremental ~$180K/patient) ✓ SER-155 has potentially transformational profile with robust efficacy and safety ✓ Highly concentrated universe of transplant centers conducting stem cell transplant procedures allows for an efficient commercial model with rapid education on new standard of care Sources: CIBMTR; HRSA; Passweg et al, BMT 2021; IQVIA; Broder et al, Am Drug Health Benefits 2017; Seres Therapeutics, Inc. © 2025 29 Perales et al, Biol Blood Marrow Transplant 2017 CMS.gov; Merck SEC filings


Indication expansion: potential 10x addressable population Broader leukemia & Allo-HSCT Autologous HSCT lymphoma population* WW annual ~40,000 ~60,000 ~500,000 diagnoses or transplants US annual ~9,300 ~13,500 ~87,000 diagnoses or initial focus transplants Unmet needs Prevent mortality and Prevent mortality and Reduce morbidity, addressed by cost of post- costs of post- mortality, and cost of SER-155 transaction infections transplant infections infections and febrile neutropenia from chemotherapy *Includes acute myeloid leukemia, multiple myeloma, and aggressive B cell non-Hodgkin lymphomas (diffuse large B-cell lymphoma, mantle cell, Burkitt’s lymphoma) Seres Therapeutics, Inc. © 2025 30 Sources: CIBMTR, US NCI SEER, Thandra et al 2021 report of WHO data, Niederwieser et al Haematologica 2022; WHO Global Cancer Observatory; American Cancer Society


Accelerating SER-155 clinical development with positive Ph1b outcomes Aim to accelerate SER-155 development in allo-HSCT • Potential to follow successful precedent from VOWST development with single registrational study for efficacy Seeking SER-155 Positive engagement with FDA on advancement of SER-155 allo- strategic partnership to HSCT program accelerate next study in • Support for primary efficacy endpoint of BSI reduction at HSCT Day 30 allo-HSCT • Recommendation for next study as a Phase 2; potential for stand- and expand to multiple alone Phase 2 or seamless Phase 2/3 • Received Breakthrough Therapy designation in December 2024 target populations Intend to evaluate SER-155 in additional patient populations with high risk of serious bacterial infections Seres Therapeutics, Inc. © 2025 31


Advancing SER-147 to prevent infections in chronic liver disease patients Substantial unmet need Promising preclinical data SER-147 is an investigational live oral biotherapeutic designed to reduce pathogens 0.5M 2.1M causing gut-seeded SBP and BSIs in liver disease patients Declining E. coli titers experience bacterial Example: 1-3 log ~50% infections in a 6 month period reduction of E. coli in in vitro models, of infections are spontaneous plus reduction of bacterial peritonitis (SBP) and ~20-25% other pathogens bloodstream infections likely to be gut-seeded Sources: GBD 2017 Cirrhosis Collaborators, Lancet Gastroenterology & Hepatology 2020; United Nations world population data; Seres Therapeutics, Inc. © 2025 32 Trebicka et al, J Hepatol 2020; Seres preclinical data from 2023 IDWeek


Manufacturing platform delivers defined consortia in oral formulation using cost-effective production Strain isolation and characterization pipeline to rapidly identify cGMP- suitable medium components Highly intensive strain bioprocessing leveraging flexible, single-use manufacturing technology for cost-effective production Novel formulations enabling consistent drug product composition, drug stability for distribution, and targeted drug delivery Quality systems to ensure product quality and stability, extending prior regulatory successes, including developing product release specifications with the FDA Seres Therapeutics, Inc. © 2025 33


Maximizing opportunity of live biotherapeutics going forward • Prevent life-threatening bacterial infections, including antimicrobial resistant infections in additional populations Additional • Treat immune-related diseases (e.g., IBD, GvHD, checkpoint Opportunities colitis) • Infections in Chronic liver disease: Progressing towards IND readiness SER-147 • Indication expansion (e.g., radiation enteritis, ICU and long-term care patients, organ transplant) • Bloodstream infections in Allo-HSCT: Engaging with FDA to advance; constructive feedback on SER-155 development strategy; received Breakthrough Therapy designation SER-155 • Evaluate in additional cancer treatment populations with high risk of serious bacterial infections VOWST • rCDI: Proven clinical and regulatory success; asset sale to Nestlé; Seres to participate in future milestones Seres Therapeutics, Inc. © 2025 34


Summary and path forward SER-155 Phase 1b placebo-controlled clinical efficacy data further support Seres’ strategy • Developing a pipeline of novel live biotherapeutics Pipeline aims to bring transformative medicines to a wider set of patients, led by SER-155 while • advancing SER-147 in areas with large commercial potential VOWST approval validates using live biotherapeutics to prevent life-threatening infections • Administration associated with 77% relative risk reduction for BSIs, significant reduction in systemic • antibiotic exposure and lower incidence of febrile neutropenia vs placebo Exploratory biomarker data support SER-155 MOA and potential role for Seres’ platform to provide • SER-155 Phase 1b clinical benefit to patients with inflammatory & immune diseases (e.g. UC & Crohn’s disease) placebo-controlled clinical FDA feedback on SER-155 development strategy supports primary endpoint of BSI reduction and • results promising recommends next study as a Phase 2; protocol planned to be submitted in Q2 '25 Company pursuing SER-155 strategic partnership to accelerate next study in allo-HSCT and • expand to multiple target populations • ~$31M in cash/cash equivalents at Dec 31, 2024; cash runway projected into Q1 2026 VOWST asset sale • Fully retired debt strengthens financial • VOWST asset sale closed in Sept 2024; $25M received in January 2025 and $25M (less ~$1.5M in position employment-related payments) due in July 2025 + $275M potential future milestones Seres Therapeutics, Inc. © 2025 35