Seres Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Seres Therapeutics, Inc. has filed its 2023 10-K report detailing its financial performance and business operations.</b>

AI Summary

Seres Therapeutics, Inc. (MCRB) filed a Annual Report (10-K) with the SEC on March 5, 2024. Seres Therapeutics, Inc. filed its annual report for the fiscal year ended December 31, 2023. The company's principal executive offices are located at 200 Sidney Street, Cambridge, MA 02139. Seres Therapeutics, Inc. was formerly known as Seres Health, Inc., with a name change effective June 3, 2014. The filing includes information related to various financial instruments and agreements, including warrants and loan facilities. The company operates within the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Seres Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Seres Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. The detailed information on financial instruments, agreements, and industry classification helps stakeholders understand the company's market position, potential risks, and regulatory environment.

Risk Assessment

Risk Level: medium — Seres Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by its SIC code and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the company's financial position and operational challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the report)
• 2024-03-05 — Filing Date (Date the report was filed)
• 001-37465 — SEC File Number (SEC file number for the company)
• 0000950170-24-025464 — Accession Number (Unique identifier for the filing)

Key Players & Entities

• Seres Therapeutics, Inc. (company) — Filer name
• 200 Sidney Street, Cambridge, MA 02139 (location) — Business address
• Seres Health, Inc. (company) — Former company name
• 2834 (industry_code) — Standard Industrial Classification
• Nestle Health Science (company) — Mentioned in relation to agreements and licenses
• Hercules Credit Facility (financial_instrument) — Mentioned in relation to loan agreements
• Oaktree Fund Administration LLC (company) — Mentioned in relation to loan facility
• Cowen and Company, LLC (company) — Mentioned in relation to an equity offering program

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government authorities, which can impact product development, approval, manufacturing, and marketing.
• Market Competition [high — market]: The company faces intense competition from other biotechnology and pharmaceutical companies, which could affect its ability to gain market share.
• Clinical Trial Risks [high — operational]: The success of Seres Therapeutics' product candidates depends on the outcomes of clinical trials, which are inherently uncertain and can fail at various stages.
• Funding and Liquidity [medium — financial]: The company may require significant additional capital to fund its ongoing operations and clinical development, and there is no assurance it will be able to secure such funding.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share MCRB The Nasdaq Global Se
• $5.6 million — ber 31, 2023, we incurred approximately $5.6 million in restructuring costs, primarily relat
• $5.3 million — ed to the workforce reduction, of which $5.3 million are expected to result in cash expendit
• $0.3 million — in cash expenditures, and the remaining $0.3 million relates to stock-based compensation exp
• $75.0 million — ve annual cash savings of approximately $75.0 million to $85.0 million in 2024, of which appr
• $85.0 million — vings of approximately $75.0 million to $85.0 million in 2024, of which approximately $35.0 m
• $35.0 million — million in 2024, of which approximately $35.0 million is expected to result from the reductio
• $500,000 — IBD. In October 2023, we were awarded a $500,000 grant from the Crohn's & Colitis Founda

Filing Documents

• mcrb-20231231.htm (10-K) — 3571KB
• mcrb-ex4_2.htm (EX-4.2) — 27KB
• mcrb-ex10_6.htm (EX-10.6) — 815KB
• mcrb-ex10_26.htm (EX-10.26) — 331KB
• mcrb-ex23_1.htm (EX-23.1) — 3KB
• mcrb-ex31_1.htm (EX-31.1) — 11KB
• mcrb-ex31_2.htm (EX-31.2) — 11KB
• mcrb-ex32_1.htm (EX-32.1) — 7KB
• mcrb-ex32_2.htm (EX-32.2) — 7KB
• mcrb-ex97_1.htm (EX-97.1) — 31KB
• img233233405_0.jpg (GRAPHIC) — 10KB
• img233233405_1.jpg (GRAPHIC) — 10KB
• img233233405_2.jpg (GRAPHIC) — 10KB
• img233233405_3.jpg (GRAPHIC) — 10KB
• img233233405_4.jpg (GRAPHIC) — 10KB
• 0000950170-24-025464.txt (&nbsp;) — 15387KB
• mcrb-20231231.xsd (EX-101.SCH) — 2008KB
• mcrb-20231231_htm.xml (XML) — 2329KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 32 Item 1B. Unresolved Staff Comments 70 Item 1C. Cybersecurity 70 Item 2.

Properties

Properties 71 Item 3.

Legal Proceedings

Legal Proceedings 71 Item 4. Mine Safety Disclosures 71 PART II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 72 Item 6. [Reserved] 72 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 73 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 93 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 93 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 93 Item 9A.

Controls and Procedures

Controls and Procedures 93 Item 9B. Other Information 93 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 94 PART III. Item 10. Directors, Executive Officers and Corporate Governance 95 Item 11.

Executive Compensation

Executive Compensation 98 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 98 Item 13. Certain Relationships and Related Transactions and Director Independence 98 Item 14. Principal Accountant Fees and Services 98 PART IV. Item 15. Exhibits and Financial Statement Schedules 99 Item 16. Form 10-K Summary 101

SIGNATURES

SIGNATURES 102 2

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including without limitation statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, manufacturing activities and related timing, expected benefits of our restructuring initiative and cost saving measures, commercialization efforts and related timing, our ability to continue as a going concern, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements 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. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of t

B usiness

Item 1. B usiness Overview We are a commercial-stage microbiome therapeutics company focused on the development and commercialization of a novel class of biological drugs, which are designed to treat disease by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. Our first drug, VOWST (fecal microbiota spores, live-brpk), formerly called SER-109, was approved by the U.S. Food and Drug Administration, or FDA, on April 26, 2023, to prevent recurrence of Clostridioides difficile infection, or CDI, in patients 18 or older following antibacterial treatment for recurrent CDI. Our drug discovery and development pipeline includes other pre-clinical and clinical-stage assets. VOWST and our microbiome therapeutic candidates are consortia of bacteria designed to optimize specific, targeted pharmacological properties, and are formulated for oral delivery. We maintain a differentiated microbiome therapeutics drug discovery and development platform that includes good manufacturing practices, or GMP, manufacturing capabilities for this novel drug modality. Our highest priority is the commercialization of VOWST in the United States, the first orally administered microbiome therapeutic approved by the FDA. We launched VOWST in the United States with our collaborator, Nestl Health Science, or Nestl, in June 2023. We are also designing microbiome therapeutics optimized to decolonize pathogens and to modulate host function to both reduce and prevent infections and induce immune tolerance. We believe that the scientific and clinical data from our SER-109 program validate this novel approach, which we refer to as Infection Protection. We believe the Infection Protection approach may be replicable across different bacterial pathogens to develop microbiome therapeutics with the potential to protect a range of medically compromised patients from infections, including pathogens that harbor antimicrobial resistance, or

View Full Filing

View this 10-K filing on SEC EDGAR