Seres Therapeutics(MCRB) - 2022 Q1 - Quarterly Report

FORM 10-Q Cover Page This document is a quarterly report on Form 10-Q for Seres Therapeutics, Inc for the period ending March 31, 2022 - The report is a Quarterly Report on Form 10-Q for the period ended March 31, 2022, filed by Seres Therapeutics, Inc[2] | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | |---|---|---| | Common Stock, par value $0.001 | MCRB | The Nasdaq Stock Market LLC | | | | (Nasdaq Global Select Market) | - The registrant is a Large accelerated filer and had 92,230,428 shares of common stock outstanding as of April 27, 2022[4] INDEX This section provides an index of the financial and other information contained within the report | PART I – FINANCIAL INFORMATION | | |---|---| | Item 1. Condensed Consolidated Financial Statements (unaudited) | 5 | | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations | 23 | | Item 3. Quantitative and Qualitative Disclosures About Market Risk | 36 | | Item 4. Controls and Procedures | 37 | | PART II – OTHER INFORMATION | | | Item 1. Legal Proceedings | 38 | | Item 1A. Risk Factors | 38 | | Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 78 | | Item 3. Defaults Upon Senior Securities | 78 | | Item 4. Mine Safety Disclosures | 78 | | Item 5. Other Information | 78 | | Item 6. Exhibits | 79 | | SIGNATURES | 80 | FORWARD-LOOKING STATEMENTS This section outlines the forward-looking statements in the report and the associated risks and uncertainties - The report contains forward-looking statements intended to be covered by safe harbor provisions, indicating future results, financial position, business strategy, and product development plans[10] - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially from those expressed or implied[10] - Readers are advised to read the report completely, especially sections on 'Summary Risk Factors,' 'Risk Factors,' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations,' as the company does not plan to publicly update or revise forward-looking statements unless required by law[11][13] TRADEMARKS, SERVICE MARKS AND TRADENAMES This section clarifies the company's rights to its trademarks and its use of others' trademarks within the report - The company has proprietary rights to trademarks used in the report, many of which are registered under applicable intellectual property laws[15] - The omission of ® and ™ symbols does not indicate a waiver of rights to these trademarks, service marks, and trade names[15] - The report also contains trademarks, service marks, and trade names of others, which are the property of their respective owners, and their use does not imply a relationship or endorsement[15] SUMMARY RISK FACTORS This section summarizes the principal risks facing the company, including financial viability and product development challenges - The company is a development-stage company with significant accumulated losses and expects to incur losses for the foreseeable future, potentially never achieving profitability[17] - Additional funding is required to complete product candidate development and commercialization; inability to raise capital could force delays or elimination of programs[17] - The company's product candidates are based on microbiome therapeutics, an unproven approach, and clinical drug development is risky, lengthy, and expensive with uncertain outcomes, potentially leading to delays or inability to complete development and commercialization[18] - Other risks include reliance on third parties for clinical trials and manufacturing, competition, intellectual property protection challenges, and the adverse impact of the COVID-19 pandemic[18] PART I – FINANCIAL INFORMATION This part presents the company's unaudited financial statements and management's discussion and analysis for the quarter Item 1. Condensed Consolidated Financial Statements (unaudited) This section presents the unaudited condensed consolidated financial statements for the periods ended March 31, 2022, and December 31, 2021 Condensed Consolidated Balance Sheets The balance sheets show a decrease in total assets and stockholders' equity alongside an increase in total liabilities Condensed Consolidated Balance Sheets (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Cash and cash equivalents | $153,192 | $180,002 | | Short term investments | $94,809 | $110,704 | | Total current assets | $263,250 | $303,628 | | Total assets | $319,889 | $354,859 | | Total current liabilities | $82,359 | $82,258 | | Long term portion of note payable, net of discount | $50,437 | $24,643 | | Total liabilities | $238,933 | $223,352 | | Total stockholders' equity | $80,956 | $131,507 | | Accumulated deficit | $(670,978) | $(614,354) | Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income The statements of operations show a significant increase in net loss driven by lower revenue and higher operating expenses Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Collaboration revenue - related party | $1,493 | $4,648 | | Grant revenue | $0 | $1,070 | | Total revenue | $1,493 | $5,718 | | Research and development expenses | $39,649 | $29,303 | | General and administrative expenses | $18,571 | $11,741 | | Collaboration (profit) loss sharing - related party | $(976) | $0 | | Total operating expenses | $57,244 | $41,044 | | Loss from operations | $(55,751) | $(35,326) | | Net loss | $(56,624) | $(35,465) | | Net loss per share, basic and diluted | $(0.61) | $(0.39) | | Comprehensive loss | $(56,779) | $(35,433) | Condensed Consolidated Statement of Stockholders' Equity (Deficit) This statement details the changes in stockholders' equity, primarily impacted by the quarterly net loss Condensed Consolidated Statement of Stockholders' Equity (Deficit) (in thousands) | Item | Balance at Dec 31, 2021 | Issuances/Expenses | Net Loss | Balance at Mar 31, 2022 | |---|---|---|---|---| | Common Stock Par Value | $92 | $0 | $0 | $92 | | Additional Paid-in Capital | $745,829 | $6,228 | $0 | $752,057 | | Accumulated Deficit | $(614,354) | $0 | $(56,624) | $(670,978) | | Accumulated Other Comprehensive Loss | $(60) | $(155) | $0 | $(215) | | Total Stockholders' Equity | $131,507 | $6,073 | $(56,624) | $80,956 | Condensed Consolidated Statements of Cash Flows The cash flow statements show increased cash usage in operations, offset by proceeds from investments and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Net cash used in operating activities | $(66,445) | $(29,496) | | Net cash provided by (used in) investing activities | $12,972 | $(20,738) | | Net cash provided by financing activities | $26,848 | $764 | | Net decrease in cash, cash equivalents, and restricted cash | $(26,625) | $(49,470) | | Cash, cash equivalents and restricted cash at end of period | $161,377 | $66,579 | Notes to Condensed Consolidated Financial Statements These notes provide detailed explanations and disclosures for the condensed consolidated financial statements Note 1. Nature of the Business and Basis of Presentation This note describes the company's business as a microbiome therapeutics platform and its financial condition - Seres Therapeutics, Inc is a microbiome therapeutics platform company developing biological drugs, with SER-109 as its lead product candidate for recurrent CDI[30] - As of March 31, 2022, the company had an accumulated deficit of $671.0 million and incurred a net loss of $56.6 million for the three months ended March 31, 2022[34] - Cash, cash equivalents, and investments totaled $248.0 million as of March 31, 2022, expected to fund operations for at least the next 12 months, but future viability depends on raising additional capital[34][36] Note 2. Summary of Significant Accounting Policies This note outlines the significant accounting policies and estimates used in preparing the financial statements - Significant accounting policies and estimates, including those for revenue recognition and R&D expenses, remain consistent with the prior annual report[39][40] - The company adopted ASU No 2016-13 (Credit Losses) on January 1, 2022, with no material impact on the financial statements[42] Restricted Cash (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Restricted cash, non-current | $8,185 | $8,000 | | Total cash, cash equivalents and restricted cash | $161,377 | $188,002 | Note 3. Fair Value Measurements This note details the fair value measurements of the company's financial assets, categorized by input level Fair Value Measurements (in thousands) | Item | March 31, 2022 Total | December 31, 2021 Total | |---|---|---| | Money market funds | $86,994 | $70,322 | | Commercial paper | $750 | $3,999 | | Corporate bonds | $21,598 | $40,095 | | Government securities | $73,211 | $64,854 | | Total | $185,553 | $185,520 | - Money market funds are valued using Level 1 inputs, while commercial paper, corporate bonds, and government securities use Level 2 inputs[43] - A restricted investment of $1.4 million (certificate of deposit) is classified as Level 2 for both periods[44] Note 4. Investments This note provides a breakdown of the company's investments by security type and contractual maturity Investments by Security Type (in thousands) | Item | March 31, 2022 Fair Value | December 31, 2021 Fair Value | |---|---|---| | Corporate bonds | $21,598 | $40,095 | | Government securities | $73,211 | $64,854 | | Commercial paper | $0 | $6,250 | | Total Investments | $94,809 | $111,199 | Investments by Contractual Maturity (in thousands) | Item | March 31, 2022 Fair Value | December 31, 2021 Fair Value | |---|---|---| | Due in 1-year or less | $94,809 | $110,704 | | Due after 1-year through 5-years | $0 | $495 | | Total | $94,809 | $111,199 | Note 5. Property and Equipment, Net This note details the components of the company's net property and equipment, showing a slight increase Property and Equipment, Net (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Laboratory equipment | $20,623 | $19,137 | | Leasehold improvements | $32,975 | $32,925 | | Construction in progress | $2,547 | $1,670 | | Total gross property and equipment | $60,904 | $58,206 | | Less: Accumulated depreciation and amortization | $(41,838) | $(40,268) | | Net property and equipment | $19,066 | $17,938 | - Depreciation and amortization expense for the three months ended March 31, 2022, was $1.6 million, up from $1.5 million in the prior year[48] Note 6. Accrued Expenses and Other Current Liabilities This note provides a breakdown of accrued expenses, which increased primarily due to a liability from a license agreement Accrued Expenses and Other Current Liabilities (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Development and manufacturing costs | $11,732 | $11,147 | | Payroll and payroll-related costs | $5,290 | $9,216 | | Liability related to 2021 License Agreement | $29,809 | $21,098 | | Facility and other | $1,447 | $3,633 | | Total | $48,278 | $45,094 | Note 7. Leases This note details the company's operating lease assets and liabilities, which increased due to new lease agreements - The company entered into new lease agreements in July and August 2021 for a donor collection facility in Tempe, Arizona, and additional laboratory space in Waltham, Massachusetts, both with 10-year terms commencing March 2022[51][52] Operating Lease Balances (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Operating lease assets | $26,246 | $18,208 | | Total operating lease liabilities | $27,195 | $24,568 | Total Lease Costs (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Operating lease costs | $1,672 | $1,040 | | Short-term lease costs | $355 | $366 | | Variable lease costs | $1,032 | $703 | | Sublease income | $0 | $461 | | Total lease costs | $3,059 | $2,570 | | Cash paid for operating leases | $2,113 | $1,618 | Note 8. Note Payable This note describes the company's amended loan agreement, which increased its credit facility and outstanding debt - The company entered into a Second Amendment to its Loan and Security Agreement with Hercules Capital, Inc on February 24, 2022, increasing the aggregate principal amount available to $100.0 million across five tranches[56][57] - As of March 31, 2022, the carrying value of the debt was $50.4 million, up from $24.6 million at December 31, 2021, with an effective interest rate of 11.19%[64] - Interest-only payments are due through December 31, 2023 (extendable to 2024), with principal repayment in equal monthly installments after the Amortization Date through October 1, 2024 (extendable to 2025)[58] Note 9. Common Stock and Stock-Based Awards This note summarizes the activity and status of the company's stock options and restricted stock units Stock Option Activity (as of March 31, 2022) | Item | Number of Shares | Weighted Average Exercise Price | |---|---|---| | Outstanding as of Dec 31, 2021 | 11,517,189 | $11.10 | | Granted | 3,638,997 | $7.41 | | Exercised | (92,478) | $2.78 | | Forfeited | (243,395) | $10.19 | | Outstanding as of Mar 31, 2022 | 14,820,313 | $10.26 | | Options exercisable as of Mar 31, 2022 | 6,183,983 | $9.53 | Restricted Stock Unit Activity (as of March 31, 2022) | Item | Number of Shares | Weighted Average Grant Date Fair Value | |---|---|---| | Unvested RSUs as of Dec 31, 2021 | 734,755 | $17.68 | | Granted | 989,544 | $7.43 | | Vested | (69,195) | $24.32 | | Forfeited | (72,463) | $13.11 | | Unvested RSUs as of Mar 31, 2022 | 1,582,641 | $11.19 | Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Research and development expenses | $2,483 | $2,137 | | General and administrative expenses | $2,596 | $1,487 | | Total | $5,079 | $3,624 | Note 10. Net Income (Loss) per Share This note presents the calculation of net loss per share, which widened compared to the prior year Net Loss per Share (Basic and Diluted) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Net loss | $(56,624) | $(35,465) | | Weighted-average shares outstanding | 92,164,419 | 91,527,800 | | Net loss per share | $(0.61) | $(0.39) | - Anti-dilutive potential common stock equivalents, including 14.8 million stock options and 1.6 million unvested restricted stock units as of March 31, 2022, were excluded from diluted EPS calculation due to their anti-dilutive impact[73] Note 11. Collaboration Revenue This note details revenue recognized from collaboration and license agreements with Nestlé - The 2021 License Agreement with Nestlé (NHSc Pharma Partners) granted a co-exclusive license for SER-109 in the US and Canada, with an upfront payment of $175.0 million received in July 2021[74][76] - For the three months ended March 31, 2022, $768 thousand of collaboration revenue was recognized under the 2021 License Agreement related to services, and $725 thousand under the 2016 License Agreement[85][98] Collaboration Revenue and Deferred Revenue (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Collaboration revenue - related party | $1,493 | $4,648 | | Deferred revenue - related party (as of period end) | $102,324 | $103,526 | Note 12. Commitments and Contingencies This note discusses the company's commitments, including leases and indemnification agreements - The company provides indemnification to various parties, with maximum potential payments often unlimited, but has not incurred material costs to date[103] - No liabilities were accrued for legal contingencies as of March 31, 2022, or December 31, 2021, as the company accrues only when a liability is probable and estimable[104][107] Note 13. Income Taxes This note explains that no income tax provision was made due to cumulative net losses and a full valuation allowance - No income taxes were provided for the three months ended March 31, 2022, or 2021, due to cumulative net losses and a full valuation allowance against deferred tax assets[108][109] - The company is currently under IRS examination for R&D tax credits for the period ended December 31, 2018, with tax years open from 2011 to present for carryforwards[110] Note 14. Related Party Transactions This note details transactions with related parties, primarily collaboration agreements with Nestlé - Collaboration revenue from related party Nestlé (an affiliate of significant stockholders) was $768 thousand from the 2021 License Agreement and $725 thousand from the 2016 License Agreement for the three months ended March 31, 2022[111][112] Related Party Deferred Revenue (in thousands) | Item | March 31, 2022 | December 31, 2021 | |---|---|---| | Deferred revenue - 2021 License Agreement | $5,321 | $6,089 | | Deferred revenue - 2016 License Agreement | $97,003 | $97,728 | | Total deferred revenue - related party | $102,324 | $103,817 | - Sublease income from Flagship Pioneering (a significant stockholder) was $0 for Q1 2022, down from $461 thousand in Q1 2021, as the sublease ended in November 2021[113] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results Overview This overview describes the company's focus on microbiome therapeutics and its current financial and operational status - Seres Therapeutics is a microbiome therapeutics company developing live biotherapeutic drugs, with a primary focus on SER-109 for recurrent CDI, anticipating a potential product launch in the first half of 2023[117][118] - The company is advancing SER-155 in a Phase 1b study for infection protection in allo-HSCT patients and has decided not to proceed with the planned SER-301 Phase 1b second study cohort for ulcerative colitis, continuing data analysis to inform next steps[119][120] - Net loss for the three months ended March 31, 2022, was $56.6 million, with an accumulated deficit of $671.0 million; existing cash, cash equivalents, and investments of $248.0 million are expected to fund operations for at least the next 12 months, but additional financing will be needed[123][124] SER-109 This section details the clinical progress and regulatory plans for SER-109, the company's lead product candidate - SER-109 is an oral microbiome therapeutic for recurrent CDI, designed to reduce recurrence by modulating the microbiome[128] - Phase 3 ECOSPOR III study showed SER-109 was superior to placebo, with an 88% sustained clinical response rate and a 68% relative risk reduction of CDI recurrence at eight weeks[130] - The company achieved target enrollment for the ECOSPOR IV open-label study, meeting the FDA's safety database requirement of 300 subjects; a rolling BLA submission is planned to begin soon, with completion by mid-2022, and a potential product launch in H1 2023, supported by Breakthrough Therapy designation[131] SER-155 This section describes SER-155, a therapeutic candidate aimed at reducing infections in transplant patients - SER-155 is an oral microbiome therapeutic candidate designed to decrease infection and translocation of antibiotic resistant bacteria and modulate host immune responses to decrease GvHD in allo-HSCT patients[133] - The Phase 1b study for SER-155, which enrolled its first patient in November 2021, will evaluate safety, tolerability, engraftment, and efficacy in preventing infections and GvHD[133] SER-301 This section discusses the status of SER-301 for ulcerative colitis, including recent study results and development decisions - SER-301 is an oral microbiome therapeutic candidate for mild-to-moderate UC, designed to reduce pro-inflammatory activity and improve epithelial barrier integrity[135][136] - Preliminary analysis of the Phase 1b study's first cohort showed engraftment of SER-301 strains and baseline-dependent modulation of the metabolic landscape, with changes observed in various metabolites[137][138][139] - In April 2022, the company decided not to proceed with the planned SER-301 Phase 1b second study cohort, continuing data analysis to inform next steps for UC development[140] Intellectual Property This section outlines the company's extensive patent portfolio and expected market exclusivity for its products - The company has an extensive patent portfolio for rationally designed ecologies of spores and microbes, including 24 active patent application families (21 nationalized, 3 PCT stage) and 18 issued U.S. patents[142] - Intellectual property rights related to SER-109 and SER-287 extend through 2034[142] - Upon marketing approval, the company expects to receive 12 years of exclusivity in the U.S. and 10 years in Europe for new biological compositions[143] Financial Operations Overview This overview explains the primary sources of revenue and the main components of operating expenses - Revenue is derived primarily from collaboration agreements, with no product sales to date[145] - Research and development expenses are expensed as incurred and are expected to increase due to clinical development, manufacturing scale-up, regulatory approval, and commercialization preparations for SER-109, as well as continued development of other product candidates[146][148] - General and administrative expenses are expected to increase to support R&D growth, potential commercialization, and public company operating costs, including pre-launch activities for SER-109[151] Critical Accounting Policies and Significant Judgments and Estimates This section confirms that the company's critical accounting policies and estimates have not materially changed - Critical accounting policies and significant judgments and estimates, as described in the Annual Report, have not materially changed during the three months ended March 31, 2022[158] - The preparation of financial statements requires management to make estimates and assumptions, particularly related to revenue recognition and the accrual of research and development expenses[158] Results of Operations This section provides a detailed comparison of the company's operating results for the current and prior-year periods Summary of Results of Operations (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | |---|---|---|---| | Total revenue | $1,493 | $5,718 | $(4,225) | | Research and development | $39,649 | $29,303 | $10,346 | | General and administrative | $18,571 | $11,741 | $6,830 | | Collaboration (profit) loss sharing - related party | $(976) | $0 | $(976) | | Total operating expenses | $57,244 | $41,044 | $16,200 | | Net loss | $(56,624) | $(35,465) | $(21,159) | - Total revenue decreased by $4.2 million, primarily due to lower collaboration revenue (due to updated cost estimates) and the absence of $1.1 million in grant revenue from the prior year[162] - Research and development expenses increased by $10.3 million, mainly due to higher personnel-related costs ($8.0 million) and increased SER-109 program expenses ($4.0 million), partially offset by a decrease in SER-287 program expenses ($2.9 million)[163][164] - General and administrative expenses increased by $6.8 million, driven by higher personnel-related costs ($3.1 million) and professional fees ($2.7 million), including pre-launch commercial expenses[165][173] Liquidity and Capital Resources This section discusses the company's liquidity position, capital resources, and cash flow activities - The company has incurred recurring net losses and will need additional capital to fund operations, which may be obtained through equity/debt financings or collaborations[169] - As of March 31, 2022, cash, cash equivalents, and investments totaled $248.0 million, expected to fund operating expenses, capital expenditures, and debt service for at least the next 12 months[171] - The company entered into a Second Amendment to its loan agreement with Hercules in February 2022, increasing the credit facility to $100.0 million, with $50.0 million outstanding as of March 31, 2022[191][198] Cash Flow Summary (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | |---|---|---| | Cash used in operating activities | $(66,445) | $(29,496) | | Cash provided by (used in) investing activities | $12,972 | $(20,738) | | Cash provided by financing activities | $26,848 | $764 | | Net decrease in cash, cash equivalents and restricted cash | $(26,625) | $(49,470) | Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discloses the company's exposure to market risks, primarily related to interest rate fluctuations - The company's primary market risk exposure is interest income sensitivity from cash, cash equivalents, and investments[215] - An immediate 10% change in market interest rates would not materially impact the fair market value of the investment portfolio or financial results due to the short-term nature of instruments[215] - The New Credit Facility's interest rate is variable (Prime Rate + 6.40% or 9.65%), but a 10% change in Prime Rate is not expected to materially impact debt obligations[216] Item 4. Controls and Procedures This section provides management's conclusion on the effectiveness of the company's disclosure controls and procedures - Disclosure controls and procedures were evaluated by management and deemed effective at the reasonable assurance level as of March 31, 2022[218] - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2022[219] PART II – OTHER INFORMATION This part contains other required information, including legal proceedings, risk factors, and exhibits Item 1. Legal Proceedings This section describes an ongoing opposition proceeding at the European Patent Office - The company filed a notice of opposition in April 2017 against European Patent No 2 575 835 B1 granted to The University of Tokyo at the European Patent Office[222] - The Opposition Division required The University of Tokyo to narrow the scope of the patent claims, and both parties, along with other opponents, have appealed aspects of this decision[222] Item 1A. Risk Factors This section details significant risks and uncertainties facing the company's business and financial condition Risks Related to Our Financial Position and Need for Additional Capital This section details financial risks, including a history of losses and the need for substantial additional funding - The company has incurred significant operating losses since inception, with a net loss of $56.6 million for Q1 2022 and an accumulated deficit of $671.0 million as of March 31, 2022[225] - Substantial additional funding is required to complete product candidate development and commercialization, and the inability to raise capital could force delays, reductions, or elimination of product development programs[230] - The company's limited operating history makes it difficult to evaluate past success and future viability, and profitability is uncertain and may never be achieved or sustained[227][235] Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates This section outlines risks associated with the unproven nature of microbiome therapeutics and the drug development process - The company's product candidates are based on microbiome therapeutics, an unproven approach, and success in developing marketable drugs is uncertain[239] - Clinical drug development is risky, lengthy, and expensive, with uncertain outcomes; delays in patient enrollment or negative/inconclusive trial results could prevent or delay marketing approval[241][249] - Failure or delays in obtaining required regulatory approvals (including for SER-109 despite Breakthrough Therapy designation) would materially impair the ability to commercialize product candidates and generate revenue[256][265] - Regulatory policies, especially for novel microbiome therapeutics, are evolving (e.g., EU Clinical Trials Regulation, UK legislation changes), potentially increasing development costs and delaying approvals[246][257] Risks Related to our Dependence on Third Parties and Manufacturing This section details risks from reliance on collaborators and third-party manufacturers for development and production - Collaboration and license agreements with Nestlé are critical; failure to perform or termination could delay or end development and commercialization of CDI and IBD product candidates (SER-109, SER-287, SER-301)[278][279][281] - Reliance on third parties (CROs, CMOs) for clinical trials and manufacturing increases risks of unsatisfactory performance, missed deadlines, non-compliance with regulatory requirements (GCPs, cGMP), and supply disruptions[283][288][289] - The company has no commercial manufacturing experience and may face challenges in scaling up production, meeting cGMP regulations, or obtaining sufficient donor material for product candidates[292][293][295] Risks Related to Commercialization of Our Product Candidates and Other Legal Matters This section outlines challenges in market acceptance, competition, pricing, and legal liabilities for product candidates - Approved product candidates may fail to achieve market acceptance due to competition (e.g., FMT for CDI), efficacy/safety concerns, pricing, or physician/patient willingness to adopt new therapies[297] - The company has limited sales/marketing infrastructure and relies on collaborators like Nestlé for commercialization, which may not align with its interests or allocate sufficient resources[299][302] - Substantial competition from major pharmaceutical and biotechnology companies, along with potential biosimilar competition, could reduce or eliminate commercial opportunities[303][307][315] - Unfavorable pricing regulations, inadequate third-party coverage and reimbursement policies, and strict government price controls in international markets could harm business and revenues[308][309][312] - Product liability lawsuits could lead to substantial liabilities, regulatory investigations, product recalls, and reputational harm, potentially limiting commercialization[313] Risks Related to Our Intellectual Property This section details risks associated with obtaining, maintaining, and defending intellectual property rights - The company's success relies on obtaining and maintaining patent and intellectual property protection, which is expensive, time-consuming, and uncertain, with risks that pending applications may not issue or issued patents may be found invalid/unenforceable[344][345][351][352] - Changes in U.S patent law (e.g., Leahy-Smith Act, Supreme Court rulings on patent eligibility for natural products) and varying foreign intellectual property laws could diminish patent value and protection[358][360][362][381] - The company faces risks of third-party infringement claims, challenges to inventorship or ownership of its intellectual property, and the potential for trade secrets to be disclosed or independently developed by competitors[365][366][375][377][356] Risks Related to Our Operations This section covers operational risks including the COVID-19 pandemic, personnel retention, and data security - The COVID-19 pandemic has caused and could continue to cause delays in clinical trials, supply chain disruptions, and market volatility, adversely impacting business operations and financial condition[387][388] - Future success is highly dependent on retaining key executives and attracting/motivating qualified scientific, clinical, manufacturing, and sales personnel, with intense competition for talent[390][391] - Operating internationally and managing growth present risks, including compliance with diverse laws, currency fluctuations, political unrest, and difficulties in staffing and managing foreign operations[392][393] - Security breaches, data loss, and non-compliance with evolving data protection laws (e.g., HIPAA, CCPA, GDPR) could compromise sensitive information, lead to legal claims, regulatory penalties, and reputational damage[396][397][401] - The company's ability to use net operating loss carryforwards and R&D credits may be limited by ownership changes, and its credit facility imposes restrictions on operating and financial flexibility[412][415] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities or use of proceeds to report[438] Item 3. Defaults Upon Senior Securities This section indicates that there were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[439] Item 4. Mine Safety Disclosures This section states that there are no mine safety disclosures to report for the period - No mine safety disclosures to report[440] Item 5. Other Information This section indicates that there is no other information to report for the period - No other information to report[441] Item 6. Exhibits This section lists the exhibits filed as part of the Form 10-Q - The exhibits include corporate governance documents (Restated Certificate of Incorporation, Amended and Restated Bylaws), key agreements (Employment Agreement, Second Amendment to Loan and Security Agreement, Amendment No 1 to License Agreement), and required certifications (CEO, CFO)[444] - Interactive Data Files (Inline XBRL) are also furnished as exhibits[444] SIGNATURES This section contains the official signatures authorizing the report filing - The report is signed on behalf of Seres Therapeutics, Inc by David Arkowitz, Executive Vice President, Chief Financial Officer and Head of Business Development (Principal Financial and Accounting Officer)[446][448] - The signing date for the report is May 4, 2022[448]