Company Overview and Strategy - Evelo is developing oral biologics targeting SINTAX for favorable safety and efficacy profiles[5] - The company aims to create a new market as a mid-line therapy, potentially deferring the use of biologics and specialty drugs[9] - Evelo's strategy involves serving individuals across all stages of diseases globally in the long term[9] EDP1815 Clinical Development - Interim Phase 1b clinical data for EDP1815 shows an attractive profile in psoriasis and broad potential in treating inflammatory disease[6] - In a Phase 1b trial, a mean PASI reduction of 21% was observed at day 42 at the high dose compared to a 3% reduction in the placebo group[21] - 50% of individuals dosed with EDP1815 achieved at least PASI 25 at Day 42 vs 10% with placebo[22] - A Phase 2 trial for EDP1815 in psoriasis is planned for initiation in 2Q 2020, with interim data expected in late 2020[7, 26] Pipeline and Platform - Evelo's platform discovers and develops oral biologics targeting SINTAX, modulating clinically validated cytokines[12] - EDP1503, in collaboration with Merck, is undergoing Phase 1/2 trials in MSS Colorectal Cancer, Triple-negative Breast Cancer, and Anti-PD-1 Relapsed responders[7, 18] - The company had approximately $77.8 million in cash and cash equivalents as of December 31, 2019[42]

Financial Data and Key Metrics Changes - The company ended 2019 with cash and cash equivalents of $77.8 million, down from $147.9 million at the end of 2018, primarily due to operating expenses [29] - R&D expenses for Q4 were $16.4 million and $63.1 million for the full year, compared to $11.3 million and $39 million in the previous year, indicating a significant increase in clinical program costs [30] - General and administrative expenses were $6.3 million for Q4 and $23.2 million for the full year, up from $4.7 million and $18.2 million in 2018, reflecting increased personnel and consulting fees [31] - The net loss was $22.6 million for Q4 and $85.5 million for the full year, compared to a net loss of $15.4 million and $60.9 million in 2018, showing a worsening financial position [32] Business Line Data and Key Metrics Changes - The company reported positive clinical data for EDP1815, its lead inflammation candidate, in two cohorts of individuals with psoriasis, validating its hypothesis regarding the small intestinal axis [7][8] - EDP1815 is advancing into Phase II trials with an improved formulation, expected to initiate in Q2 2020 [8][15] - The company is also exploring EDP1815 for atopic dermatitis, with initial data expected from a Phase Ib trial in Q2 2020 [19] Market Data and Key Metrics Changes - Chronic inflammation affects 1 in 7 people globally, indicating a significant market opportunity for the company's therapies targeting inflammatory diseases [11] - Atopic dermatitis affects 18 million to 25 million people in the U.S., with a high percentage being mild to moderate cases, highlighting the unmet need in this market [19] Company Strategy and Development Direction - The company is focused on the small intestinal axis (SINTAX) to develop new oral biologic therapies for various diseases, aiming for superior efficacy, safety, convenience, and affordability [6] - The strategy includes advancing clinical programs in inflammation and oncology, with a broad pipeline across multiple therapeutic areas [17][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for a "cash-rich" 2020, anticipating significant updates as clinical programs progress [33] - The company emphasized the importance of safety and tolerability in its therapies, noting that current treatment options for mild to moderate psoriasis are limited [38] Other Important Information - The company has decided to discontinue development of EDP1066 due to its less marked effect on systemic immunology compared to EDP1815 [21] - The new formulation of EDP1815 is designed to maximize drug release in the upper small intestine, which is associated with better anti-inflammatory effects [25][51] Q&A Session Summary Question: What data should be expected regarding the interim for EDP1815 by the end of the year? - Management indicated that the trial is designed flexibly, allowing for interim analysis once 50% of subjects have reached 12 weeks of treatment, with various endpoints to be evaluated [34][35] Question: What effect would be needed to move a dose level forward in Phase II for EDP1815? - Management noted that the bar for response is low due to the limited therapies available for mild to moderate patients, emphasizing safety and tolerability as critical factors [37][38] Question: What formulation will be used in Phase II for EDP1815? - The new formulation with improved release characteristics will be used in the Phase II dose-ranging study, which has received positive feedback from regulators [50]

Table of Contents Non-accelerated filer ☐ Smaller reporting company x UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES For the Fiscal Year Ended December 31, 2019 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38473 Evelo Biosciences, Inc. (Exact name of registrant as specified in its cha ...

Financial Data and Key Metrics Changes - The company reported positive interim clinical data for EDP1815, indicating a mean reduction in lesion severity score of 15% at day 28 and a continued reduction to 24% at day 42 post-dosing, suggesting a sustained clinical effect [19][23] - The mean reduction in PASI score was 16% at day 28, improving to 21% at day 42, with maximum observed reductions of 80% and 61% respectively [23][36] Business Line Data and Key Metrics Changes - EDP1815 is being developed as a potential oral therapy for mild to moderate psoriasis, with a focus on safety and tolerability as competitive advantages [8][9] - The high dose cohort showed consistent results with the low dose cohort, indicating a possible dose response [11][19] Market Data and Key Metrics Changes - Chronic inflammation affects 1 in 7 people globally, with significant unmet needs in treating mild to moderate psoriasis, where many patients are dissatisfied with current treatment options [11][12] - The company aims to address the needs of millions of patients with effective, safe, and affordable oral therapies [7][12] Company Strategy and Development Direction - The company plans to advance EDP1815 into Phase II trials early next year, focusing on its potential as a midline therapy to defer the use of injectable biologics [24][34] - The strategy includes expanding the application of its platform to other inflammatory diseases and potentially to neuroinflammation and metabolic diseases [25][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of EDP1815 based on positive interim data and the unique approach of targeting the small intestinal axis [6][36] - The company anticipates a catalyst-rich 2020 with expected data from various clinical stage programs [35] Other Important Information - The company has completed enrollment for a cohort of patients with microsatellite stable colorectal carcinoma and observed extended stable disease in several patients [66][68] - The new formulation of EDP1815 shows a 30-fold improvement in activity based on preclinical data, which is expected to enhance efficacy in clinical trials [38][41] Q&A Session Summary Question: How does the data reported today frame expectations for the next-generation formulation? - Management indicated that the new formulation will be compared with the existing formulation in Phase II studies, with optimism based on preclinical data showing significant improvements [38] Question: Will there be an active comparator study for EDP1815? - Management stated that while the focus is currently on demonstrating clinical benefits, active comparators will be introduced at appropriate stages of development [39] Question: What kind of expectation should be set for the new formulation's data? - Management expects the new formulation to provide greater depth of responses and quicker onset based on preclinical findings [41][44] Question: How does the psoriasis data inform the approach to atopic dermatitis? - Management emphasized the relevance of the small intestinal axis across inflammatory diseases, suggesting predictive value for atopic dermatitis studies [51][54] Question: Will dosing be extended from daily to weekly? - Management clarified that while the therapy is intended to be daily, it is forgiving, allowing for missed doses without losing clinical effect [57]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 | --- | --- | |--------------------------------------------------------------|---------------------------------| | For the transition period from | to | | Commission Fil ...

Evelo Biosciences (OTC:EVLO) Q2 2019 Earnings Conference Call August 6, 2019 8:30 AM ET Â Company Participants Stefan Riley - Former Executive Officer Simba Gill - Chief Executive Officer Duncan McHale - Chief Medical Officer Mark Bodmer - Chief Scientific Officer Conference Call Participants Vikram Purohit - Morgan Stanley Chris Shibutani - Cowen Matthew Luchini - BMO Capital Chris Howerton - Jefferies Taylor Feeley - Chardan Operator Good morning and welcome to EveloÂ's Conference Call for initial data re ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 | --- | --- | |--------------------------------------------------------------|---------------------------------| | For the transition period from | to | | Commission File Num ...

Evelo Biosciences, Inc. (OTC:EVLO) Q1 2019 Earnings Conference Call May 2, 2019 8:30 AM ET Company Participants Stefan Riley - IR Balkrishan Gill - CEO Mark Bodmer - Chief Scientific Officer Duncan McHale - Chief Medical Officer Jonathan Poole - CFO Conference Call Participants Connor Meehan - Morgan Stanley Matthew Luchini - BMO Capital Rogers Song - Jefferies Taylor Feehley - Chardan Operator Good morning, and welcome to the Evelo First Quarter 2019 Financial Results Conference Call. [Operator Instruction ...

PART I: FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents Evelo Biosciences' unaudited condensed consolidated financial statements, detailing balance sheets, operations, equity, cash flows, and explanatory notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Assets/Liabilities/Equity (in thousands) | March 31, 2019 | December 31, 2018 | | :--------------------------------------- | :------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $105,490 | $93,101 | | Short-term investments | $23,949 | $54,818 | | Total current assets | $133,282 | $151,622 | | Total assets | $141,934 | $159,867 | | **Liabilities** | | | | Total current liabilities | $11,216 | $9,235 | | Total liabilities | $23,051 | $22,918 | | **Stockholders' Equity** | | | | Total stockholders' equity | $118,883 | $136,949 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over a period, showing revenues, expenses, and the resulting net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Operating Expenses/Loss (in thousands) | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $15,680 | $7,143 | | General and administrative | $5,124 | $3,282 | | Total operating expenses | $20,804 | $10,425 | | Loss from operations | $(20,804) | $(10,425) | | Net loss | $(20,299) | $(10,500) | | Net loss per share (basic and diluted) | $(0.64) | $(3.29) | - The company's net loss increased from **$10.5 million** in **Q1 2018** to **$20.3 million** in **Q1 2019**, primarily due to increased operating expenses[19](index=19&type=chunk) [Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20%28Deficit%29) This section details changes in the company's equity structure, including common shares, additional paid-in capital, and accumulated deficit Equity Item (in thousands) | Equity Item (in thousands) | December 31, 2018 | March 31, 2019 | | :----------------------------------- | :---------------- | :------------- | | Common Shares Outstanding | 31,825,769 | 32,030,635 | | Additional Paid-in Capital | $250,316 | $252,533 | | Accumulated Deficit | $(113,381) | $(133,680) | | Total Stockholders' Equity | $136,949 | $118,883 | - Total stockholders' equity decreased from **$136.9 million** at December 31, 2018, to **$118.9 million** at March 31, 2019, mainly due to the accumulated deficit increasing by **$20.3 million**[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities over a period Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Operating activities | $(17,993) | $(8,316) | | Investing activities | $30,124 | $(1,000) | | Financing activities | $258 | $85,381 | | Net increase in cash | $12,389 | $76,065 | | Cash, cash equivalents & restricted cash – end of period | $106,740 | $115,811 | - Net cash used in operating activities increased significantly from **$8.3 million** in **Q1 2018** to **$18.0 million** in **Q1 2019**. Investing activities provided **$30.1 million** in **Q1 2019**, primarily from investment maturities, a shift from cash used in **Q1 2018**[26](index=26&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Organization](index=9&type=section&id=1.%20Organization) This note describes Evelo Biosciences, Inc.'s business, its development-stage status, and its financial viability outlook - Evelo Biosciences, Inc. is a biotechnology company focused on discovering and developing therapies that engage immune cells in the small intestine to treat inflammatory diseases and oncology[29](index=29&type=chunk) - The company has incurred operating losses since inception and expects this to continue, with an accumulated deficit of **$133.7 million** as of March 31, 2019[31](index=31&type=chunk)[32](index=32&type=chunk) - Management believes existing cash, cash equivalents, and short-term investments (**$129.4 million** at March 31, 2019) are sufficient to fund operations for at least the next twelve months[31](index=31&type=chunk)[32](index=32&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including those for emerging growth companies - The unaudited interim condensed consolidated financial statements are prepared in accordance with U.S. GAAP, with certain information condensed or omitted as permitted[33](index=33&type=chunk) - Evelo is an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised accounting standards, which may affect comparability[38](index=38&type=chunk) - Research and development costs are expensed as incurred, and stock-based compensation is recorded based on grant date fair value over the vesting period[51](index=51&type=chunk)[54](index=54&type=chunk) Cash, Cash Equivalents, and Restricted Cash (in thousands) | Item | March 31, 2019 | December 31, 2018 | | :------------------------------------- | :------------- | :---------------- | | Cash | $953 | $1,300 | | Money market funds | $104,537 | $91,801 | | Total cash and cash equivalents | $105,490 | $93,101 | | Restricted cash | $1,250 | $1,250 | | Cash, cash equivalents and restricted cash | $106,740 | $94,351 | [3. Investments](index=14&type=section&id=3.%20Investments) This note details the company's investment portfolio, primarily consisting of available-for-sale U.S. treasury securities - All of the Company's investments are classified as available-for-sale securities, consisting entirely of U.S. treasury securities[43](index=43&type=chunk)[63](index=63&type=chunk) Short-term Investments (in thousands) | Description | March 31, 2019 (Fair Value) | December 31, 2018 (Fair Value) | | :------------------- | :-------------------------- | :----------------------------- | | U.S. treasury securities | $23,949 | $54,818 | | Total | $23,949 | $54,818 | [4. Fair Value Measurements](index=14&type=section&id=4.%20Fair%20Value%20Measurements) This note explains the valuation techniques and hierarchy used for financial instruments, categorizing assets by their input levels - The company uses a three-tier fair value hierarchy (Level 1, 2, 3) for financial instruments, with money market funds classified as Level 1 and U.S. treasury securities as Level 2[47](index=47&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) Fair Value Measurements (in thousands) | Description (Assets) | March 31, 2019 | Level 1 | Level 2 | Level 3 | | :------------------------------------------------- | :------------- | :--------- | :--------- | :------ | | Money market funds | $104,537 | $104,537 | — | — | | U.S. treasury securities | $23,949 | — | $23,949 | — | | Total | $128,486 | $104,537 | $23,949 | — | [5. Property and Equipment, Net](index=15&type=section&id=5.%20Property%20and%20Equipment%2C%20Net) This note provides a breakdown of the company's tangible assets, including lab equipment and leasehold improvements, and related depreciation Property and Equipment, Net (in thousands) | Item | March 31, 2019 | December 31, 2018 | | :--------------------------------- | :------------- | :---------------- | | Lab equipment | $6,051 | $5,393 | | Leasehold improvements | $1,873 | $1,824 | | Construction-in-process | $924 | $1,011 | | Total property and equipment, net | $7,332 | $6,925 | - Depreciation expense was **$0.4 million** for **Q1 2019**, compared to **$0.6 million** for **Q1 2018**[67](index=67&type=chunk) [6. Loan and Security Agreement](index=15&type=section&id=6.%20Loan%20and%20Security%20Agreement) This note describes the company's credit facility, its terms, and future payment obligations - The company has a **$15.0 million** credit facility secured by a lien on all company assets, excluding intellectual property[68](index=68&type=chunk) - In February 2018, the remaining **$5.0 million** was drawn, increasing the interest rate and extending the interest-only period to August 15, 2019[69](index=69&type=chunk) Minimum Aggregate Future Loan Payments (in thousands) | Period Ending March 31, | Amount | | :---------------------- | :----- | | 2020 | $5,175 | | 2021 | $7,913 | | 2022 | $3,170 | | Total minimum payments | $16,258 | [7. In-License Agreements](index=16&type=section&id=7.%20In-License%20Agreements) This note details the company's licensing arrangements for intellectual property and microbial strains, including milestone and royalty obligations - The company has license agreements with Mayo Foundation for Medical Education and Research and the University of Chicago for intellectual property and microbial strains[75](index=75&type=chunk)[76](index=76&type=chunk)[78](index=78&type=chunk) - Under these agreements, Evelo has paid upfront fees and annual maintenance fees, and may owe significant milestone payments (up to **$56.0 million** to Mayo and **$60.9 million** to University of Chicago) and royalties on net sales[76](index=76&type=chunk)[78](index=78&type=chunk) - As of March 31, 2019, milestone payments incurred totaled approximately **$0.2 million** for Mayo and **$0.4 million** for the University of Chicago[76](index=76&type=chunk)[78](index=78&type=chunk) [8. Commitments and Contingencies](index=17&type=section&id=8.%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, such as lease commitments and manufacturing agreements, and potential legal contingencies - The company has operating lease arrangements for office and research space, with a primary sublease expiring in September 2025[79](index=79&type=chunk) Minimum Aggregate Future Lease Commitments (in thousands) | Year | Amount | | :--------- | :----- | | 2020 | $3,304 | | 2021 | $2,989 | | 2022 | $2,995 | | 2023 | $3,085 | | 2024 | $3,178 | | Thereafter | $4,934 | | Total | $20,485 | - Evelo has an exclusivity and commitment agreement with Biose Industrie for manufacturing microbial biotherapeutic products, incurring annual exclusivity fees of **$0.3 million**[82](index=82&type=chunk) - In April **2019**, the USPTO granted a petition for post-grant review of a University of Chicago patent licensed by Evelo, which could potentially invalidate or narrow the patent claims[84](index=84&type=chunk) [9. Stockholders' Equity and Convertible Preferred Stock](index=18&type=section&id=9.%20Stockholders%27%20Equity%20and%20Convertible%20Preferred%20Stock) This note details changes in the company's equity, including the impact of its initial public offering and authorized share capital - On May 11, 2018, the company completed its IPO, issuing **5,312,500 shares** of common stock for **$85.0 million** gross proceeds, and all outstanding convertible preferred stock converted into **22,386,677 shares** of common stock[86](index=86&type=chunk)[87](index=87&type=chunk) - The restated certificate of incorporation authorizes **200,000,000 shares** of common stock and **10,000,000 shares** of preferred stock[86](index=86&type=chunk) [10. Stock-Based Compensation](index=19&type=section&id=10.%20Stock-Based%20Compensation) This note explains the company's equity incentive plan and the associated compensation expense recognized for stock options and awards - The **2018** Incentive Award Plan, effective May 8, 2018, allows for grants of cash and equity-based awards, with **1,273,031 additional shares** authorized on January 1, **2019**[90](index=90&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------- | :-------------------------------- | :-------------------------------- | | General and administrative | $1,062 | $410 | | Research and development | $891 | $242 | | Total stock-based compensation expense | $1,953 | $652 | - Total unrecognized stock-based compensation expense for unvested stock options was **$25.3 million** as of March 31, **2019**, to be recognized over a weighted average period of **3.18 years**[99](index=99&type=chunk) [11. Income Taxes](index=21&type=section&id=11.%20Income%20Taxes) This note discusses the company's income tax position, including the impact of operating losses and valuation allowances on deferred tax assets - No significant income tax provisions or benefits were recorded for **Q1 2019** due to incurred losses and uncertainty of realizing favorable tax attributes, resulting in a full valuation allowance against net deferred tax assets[104](index=104&type=chunk)[105](index=105&type=chunk) [12. Net Loss Per Share](index=22&type=section&id=12.%20Net%20Loss%20Per%20Share) This note explains the calculation of net loss per common share, identifying anti-dilutive securities excluded from diluted EPS - Basic and diluted net loss per common share are equivalent due to net losses, making potential common shares anti-dilutive[107](index=107&type=chunk) Anti-Dilutive Securities Excluded from Diluted EPS | Security Type | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Unvested common stock from early exercise | 102,436 | 226,319 | | Stock options to purchase common stock | 5,685,275 | 3,227,795 | | Total | 5,787,711 | 25,896,792 | [13. Related Party Transactions](index=22&type=section&id=13.%20Related%20Party%20Transactions) This note discloses transactions with entities or individuals having a close relationship with the company, such as advisory services and sublease arrangements - The company paid Weatherden Ltd. **$0.3 million** in **Q1 2019** (**$0.2 million** in **Q1 2018**) for clinical advisory services; Duncan McHale, CMO, is a part owner[109](index=109&type=chunk) - A sublease arrangement with Ring Therapeutics (an affiliate of Flagship Venture Funds) generated **$0.2 million** in rental income offset against rent expense in **Q1 2019**[110](index=110&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes Evelo Biosciences' Q1 2019 financial condition and operations, covering development status, clinical trials, expenses, and future funding needs [Overview](index=23&type=section&id=Overview) This section introduces Evelo Biosciences' therapeutic approach, clinical pipeline, financial status as a development-stage company, and future funding expectations - Evelo Biosciences is developing oral biologics (monoclonal microbials) targeting the small intestine for systemic therapeutic effects in inflammatory diseases and cancer[113](index=113&type=chunk) - Current clinical candidates include EDP1066 and EDP1815 for inflammatory diseases, and EDP1503 for oncology, with initial clinical data expected from EDP1066 in **Q3 2019**[114](index=114&type=chunk)[117](index=117&type=chunk) - New formulations significantly enhance pharmacological potency (up to **30-fold** in preclinical models) and will be introduced into clinical trials starting in **H2 2019**[115](index=115&type=chunk)[118](index=118&type=chunk) - The company is a development-stage company with no revenue to date, incurring a net loss of **$20.3 million** for **Q1 2019** and an accumulated deficit of **$133.7 million**[126](index=126&type=chunk) - Expenses are expected to increase substantially due to ongoing clinical trials, new trials, preclinical development, potential manufacturing investments, and intellectual property maintenance[127](index=127&type=chunk)[128](index=128&type=chunk) - Existing cash, cash equivalents, and investments (**$129.4 million**) are expected to fund operations into the second half of **2020**, with additional financing anticipated[132](index=132&type=chunk) [Financial Operations Overview](index=25&type=section&id=Financial%20Operations%20Overview) This section describes the company's revenue strategy, primary operating expenses (R&D, G&A), and how interest income/expense is recognized - The company has not generated any revenue since inception and does not expect to in the near future, relying on product sales or collaboration/license agreements for future revenue[133](index=133&type=chunk) - Operating expenses primarily consist of research and development (R&D) and general and administrative (G&A) costs[134](index=134&type=chunk) - R&D expenses include third-party agreements (CROs, CMOs), personnel costs, technology acquisition, and facility-related expenses, expensed as incurred[135](index=135&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - G&A expenses cover executive, finance, corporate, business development, and administrative functions, including salaries, legal fees, professional fees, and facility costs[145](index=145&type=chunk) - Interest income (expense), net, includes interest on cash/investments offset by interest on debt[147](index=147&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three months ended March 31, 2019, compared to 2018, focusing on changes in expenses and net loss Comparison of Three Months Ended March 31, 2019 and 2018 (in thousands) | Item | 2019 | 2018 | Change | | :--------------------------- | :---------- | :---------- | :---------- | | Research and development | $15,680 | $7,143 | $8,537 | | General and administrative | $5,124 | $3,282 | $1,842 | | Total operating expenses | $20,804 | $10,425 | $10,379 | | Loss from operations | $(20,804) | $(10,425) | $(10,379) | | Interest income (expense), net | $505 | $46 | $459 | | Net loss | $(20,299) | $(10,500) | $(9,799) | - Research and development expenses increased by **$8.5 million** (**119.5%**) to **$15.7 million** in **Q1 2019**, driven by inflammation and oncology program costs (clinical trials, manufacturing) and personnel costs[152](index=152&type=chunk) - General and administrative expenses increased by **$1.8 million** (**56.1%**) to **$5.1 million** in **Q1 2019**, primarily due to increased headcount, compensation (including stock-based), and facility costs supporting growth and public company status[154](index=154&type=chunk) - Other income (expense), net, shifted from a **$0.1 million** expense in **Q1 2018** to a **$0.5 million** income in **Q1 2019**, mainly due to higher interest income from larger cash balances[155](index=155&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its financial obligations, detailing funding sources, cash position, and future capital needs - The company has incurred significant losses and negative operating cash flows since inception, with a net loss of **$20.3 million** in **Q1 2019** and an accumulated deficit of **$133.7 million**[156](index=156&type=chunk) - Primary funding sources include IPO proceeds (**$75.8 million** net in May 2018), convertible preferred stock sales, and debt financing, totaling **$257.6 million** gross proceeds through March 31, **2019**[156](index=156&type=chunk)[157](index=157&type=chunk) - Existing cash, cash equivalents, and short-term investments (**$129.4 million** as of March 31, 2019) are projected to fund operations into the second half of **2020**[158](index=158&type=chunk) - Future financing needs are expected to be met through equity offerings, debt financings, or collaborations, with risks of dilution or restrictive covenants[159](index=159&type=chunk) Cash Flows Summary (in thousands) | Activity | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :----------------------------------------- | :-------------------------------- | :-------------------------------- | | Cash used in operating activities | $(17,993) | $(8,316) | | Cash provided by/(used in) investing activities | $30,124 | $(1,000) | | Cash provided by financing activities | $258 | $85,381 | | Net increase in cash | $12,389 | $76,065 | | Cash, cash equivalents & restricted cash – end of period | $106,740 | $115,811 | - Net cash used in operating activities increased to **$18.0 million** in **Q1 2019**, primarily due to the net loss, partially offset by non-cash charges[163](index=163&type=chunk) - Net cash provided by investing activities was **$30.1 million** in **Q1 2019**, mainly from maturities of investments, a significant change from **$1.0 million** used in **Q1 2018**[165](index=165&type=chunk) - Net cash provided by financing activities was **$0.3 million** in **Q1 2019**, primarily from stock option exercises, a decrease from **$85.4 million** in **Q1 2018** which included proceeds from preferred stock and long-term debt issuance[166](index=166&type=chunk) [Critical Accounting Policies and Use of Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section highlights the accounting policies that require significant management judgment and estimates, such as for R&D expenses and stock-based compensation - The financial statements require management to make estimates and assumptions, particularly for accrued research and development expenses and stock-based compensation[170](index=170&type=chunk) - No material changes to critical accounting policies were reported from the previous Annual Report on Form 10-K[171](index=171&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) Discusses the company's exposure to market risks, including interest rate, foreign currency, and inflation, and their potential financial impact - The company is exposed to interest rate risk from cash, cash equivalents, short-term investments (money market, U.S. treasuries) and variable-rate debt (**$15.0 million** outstanding)[172](index=172&type=chunk)[173](index=173&type=chunk) - An immediate **10%** change in market interest rates or the Prime Rate would not have a material impact on the fair value of the investment portfolio or debt obligations[172](index=172&type=chunk)[173](index=173&type=chunk) - The company is not currently exposed to significant foreign currency fluctuation risk but may be in the future due to foreign vendors[174](index=174&type=chunk) - Inflation did not have a material effect on the business during the three months ended March 31, **2019** and **2018**[175](index=175&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the effectiveness of disclosure controls and procedures and reports on any changes in internal control over financial reporting - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, **2019**[178](index=178&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this report[179](index=179&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) Discloses material legal proceedings, specifically a post-grant review of a licensed patent - In April **2019**, the USPTO granted a third-party petition for post-grant review of a University of Chicago patent, exclusively licensed by Evelo[182](index=182&type=chunk) - The outcome is uncertain, with a possibility of patent invalidation or narrowing of claims, and Evelo is responsible for defense costs[182](index=182&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) Outlines significant risks for investors in Evelo Biosciences' common stock, covering financial, development, manufacturing, commercial, IP, and operational challenges [Risks Related to Our Financial Position and Need for Additional Capital](index=33&type=section&id=Risks%20Related%20to%20Our%20Finaconcial%20Position%20and%20Need%20for%20Additional%20Capital) This section details financial risks, including accumulated losses, the need for substantial future funding, limited operating history, and restrictions from debt agreements - The company is a development-stage entity with significant accumulated losses (**$133.7 million** as of March 31, **2019**) and expects to incur further losses, potentially never achieving profitability[184](index=184&type=chunk)[185](index=185&type=chunk) - Substantial additional funding will be required to complete product development and commercialization, with current capital expected to last into the second half of **2020**[192](index=192&type=chunk)[193](index=193&type=chunk) - The limited operating history since **2014** makes it difficult to assess future viability, as no clinical trials have been completed, and no products have received regulatory approval[198](index=198&type=chunk) - Restrictions from the **$15.0 million** loan and security agreement with Pacific Western Bank limit operating and financial flexibility, with potential for acceleration of repayment upon default[200](index=200&type=chunk)[201](index=201&type=chunk) [Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates](index=35&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) This section covers risks inherent in drug development, such as unproven platforms, potential side effects, clinical trial failures, and regulatory approval challenges - The company's monoclonal microbial platform is unproven, and there is no assurance it will lead to approvable or marketable products, especially for new disease areas[204](index=204&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) - Product candidates rely on modulating the immune system via the gut-body network, a mechanism not yet fully proven in humans, and may require inconvenient dosing or fail to achieve sufficient immune activity[208](index=208&type=chunk)[209](index=209&type=chunk) - Potential immunotoxicity from systemic immunomodulation or undesirable side effects (e.g., infections from live biological material) could delay or halt clinical trials, or result in restrictive labels[214](index=214&type=chunk)[217](index=217&type=chunk) - Negative clinical data from other microbiome or microbial therapies could adversely affect public perception and regulatory approval of Evelo's products[222](index=222&type=chunk)[223](index=223&type=chunk) - Catastrophic loss or destruction of master cell banks (MCBs) could impair manufacturing and supply of product candidates[225](index=225&type=chunk)[226](index=226&type=chunk) - Clinical drug development is lengthy, expensive, and uncertain, with high risk of failure; delays in patient enrollment or unforeseen events could prevent or delay commercialization[227](index=227&type=chunk)[228](index=228&type=chunk)[231](index=231&type=chunk) - Failure to obtain or delays in regulatory approvals (FDA, EMA, etc.) would materially impair revenue generation, as the process is expensive, lengthy, and subject to regulatory discretion[238](index=238&type=chunk)[239](index=239&type=chunk)[242](index=242&type=chunk) - Strategic resource allocation to specific product candidates or indications may cause the company to miss more profitable opportunities[246](index=246&type=chunk)[247](index=247&type=chunk) - Fast track, breakthrough therapy, or orphan drug designations, if obtained, do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[250](index=250&type=chunk)[253](index=253&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk) [Risks Related to our Dependence on Third Parties and Manufacturing](index=44&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties%20and%20Manufacturing) This section addresses risks associated with relying on external partners for clinical trials and manufacturing, including compliance issues and supply chain disruptions - The company relies heavily on third parties (CROs, CMOs, etc.) for clinical trials and manufacturing, which reduces control and increases risks of delays, non-compliance, or insufficient supply[260](index=260&type=chunk)[261](index=261&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk)[268](index=268&type=chunk) - Third-party manufacturers may fail to comply with cGMP regulations, leading to sanctions, clinical holds, or delays in approval, especially since they have not produced FDA-approved therapeutics[270](index=270&type=chunk) - The company lacks experience in commercial-scale manufacturing and establishing its own facility would require substantial funds, qualified personnel, and stringent regulatory qualification[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) [Risks Related to Commercialization of Our Product Candidates and Other Legal Compliance Matters](index=46&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) This section outlines challenges in bringing products to market, including market acceptance, competition, pricing, reimbursement, product liability, and regulatory compliance - Even if approved, product candidates may fail to achieve market acceptance due to competition, physician reliance on existing treatments, pricing, or convenience[276](index=276&type=chunk)[277](index=277&type=chunk) - The company lacks a sales organization and faces risks in establishing effective sales, marketing, and distribution capabilities, or in securing favorable third-party arrangements[278](index=278&type=chunk)[279](index=279&type=chunk)[280](index=280&type=chunk) - Substantial competition from major pharmaceutical and biotechnology companies, with greater resources and market presence, could reduce or eliminate commercial opportunities[284](index=284&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk) - Unfavorable pricing regulations or inadequate third-party coverage and reimbursement policies could harm business, as government and private payors increasingly focus on cost containment[290](index=290&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk) - Product liability lawsuits related to clinical trials or commercial sales could result in substantial liabilities, regulatory actions, and reputational harm, potentially exceeding insurance coverage[295](index=295&type=chunk)[296](index=296&type=chunk)[298](index=298&type=chunk) - Approved biologic products may face competition sooner than anticipated from biosimilars, potentially shortening market exclusivity periods (e.g., **12 years** in the U.S., **10-11 years** in Europe)[299](index=299&type=chunk)[300](index=300&type=chunk)[302](index=302&type=chunk) - Failure to obtain international marketing approvals or delays in foreign regulatory processes would prevent product commercialization abroad, as requirements vary significantly by country[304](index=304&type=chunk)[305](index=305&type=chunk) - Post-marketing restrictions, withdrawal from the market, or penalties for non-compliance with regulatory requirements (e.g., cGMP, safety reporting, off-label marketing) could significantly impact approved products[306](index=306&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk) - Relationships with healthcare providers and payors are subject to anti-kickback, fraud and abuse, and other healthcare laws (e.g., federal Anti-Kickback Statute, False Claims Act, HIPAA), risking criminal sanctions, civil penalties, and exclusion from government programs[317](index=317&type=chunk)[318](index=318&type=chunk)[322](index=322&type=chunk) - Recent and future healthcare legislation, such as the Affordable Care Act, may increase costs, delay approvals, and exert downward pressure on drug prices and reimbursement[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk)[330](index=330&type=chunk) - Strict price controls in foreign countries, particularly in the European Union, could adversely affect revenues and the ability to recoup investment[333](index=333&type=chunk) - Non-compliance with environmental, health, and safety laws (e.g., handling hazardous materials like human stool) could lead to fines, penalties, or substantial costs[335](index=335&type=chunk)[336](index=336&type=chunk)[338](index=338&type=chunk) [Risks Related to Our Intellectual Property](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section details risks concerning the protection and enforcement of the company's intellectual property, including patent challenges, licensing obligations, and trade secret protection - Inadequate protection of proprietary technology and patents could allow competitors to directly compete, materially harming the business[339](index=339&type=chunk) - The patent prosecution process is expensive, time-consuming, and uncertain; pending applications may not issue, or issued patents may not provide sufficient scope or competitive advantage[341](index=341&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk) - Adverse determinations in patent challenges (e.g., post-grant review of a University of Chicago patent) could reduce the scope or invalidate patent rights[348](index=348&type=chunk) - Failure to comply with obligations in third-party license agreements (e.g., with University of Chicago, Mayo Clinic) could result in loss of important rights[354](index=354&type=chunk)[355](index=355&type=chunk) - Licensed intellectual property from government-funded programs may be subject to federal regulations like 'march-in' rights and U.S. manufacturing preferences, limiting exclusive rights and manufacturing flexibility[359](index=359&type=chunk)[360](index=360&type=chunk)[361](index=361&type=chunk) - Inability to protect trade secrets and know-how, or their independent development by competitors, would harm the company's competitive position[362](index=362&type=chunk)[363](index=363&type=chunk) - Changes in U.S. patent law (e.g., Leahy-Smith Act, Supreme Court rulings on patent eligibility) could diminish patent value, increase prosecution costs, and weaken enforcement capabilities[365](index=365&type=chunk)[366](index=366&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk)[371](index=371&type=chunk) - Third-party allegations of intellectual property infringement could lead to costly litigation, require licensing, or force cessation of product development/commercialization[375](index=375&type=chunk)[376](index=376&type=chunk)[379](index=379&type=chunk)[381](index=381&type=chunk) - Issued patents could be found invalid or unenforceable if challenged in court, leading to loss of patent protection[383](index=383&type=chunk)[384](index=384&type=chunk) - Noncompliance with procedural requirements of patent agencies could result in abandonment or lapse of patent rights[385](index=385&type=chunk)[386](index=386&type=chunk) - Claims challenging inventorship or ownership of patents and intellectual property, or allegations of misappropriation by employees, could lead to litigation and loss of valuable rights[388](index=388&type=chunk)[389](index=389&type=chunk)[390](index=390&type=chunk)[391](index=391&type=chunk) - Inadequate protection of trademarks and trade names could impede brand recognition and competitive effectiveness[393](index=393&type=chunk)[394](index=394&type=chunk) - Not seeking patent protection in all jurisdictions, or weaker enforcement in foreign countries, could allow competitors to use technologies and export infringing products[396](index=396&type=chunk)[397](index=397&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk) [Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business](index=63&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth%20and%20Other%20Risks%20Related%20to%20Our%20Business) This section covers operational risks such as talent retention, managing organizational growth, international operations, cybersecurity, and the impact of government agency funding - Future success depends on retaining key executives and attracting/retaining qualified scientific, clinical, manufacturing, and sales/marketing personnel, which is challenging due to intense competition[402](index=402&type=chunk)[404](index=404&type=chunk) - Anticipated significant growth in employees and operations (development, regulatory, sales, marketing) may lead to difficulties in management, requiring improved systems and additional personnel[405](index=405&type=chunk)[406](index=406&type=chunk) - International operations expose the company to risks including conflicting laws, regulatory hurdles, intellectual property enforcement challenges, staffing difficulties, and financial risks (e.g., currency fluctuations)[407](index=407&type=chunk) - Brexit creates uncertainty regarding trade, regulatory arrangements, and movement of goods between the UK, EU, and US, potentially disrupting manufacturing and clinical trials[411](index=411&type=chunk)[412](index=412&type=chunk) - Information technology and system failures, security breaches, or unauthorized access to systems (including cloud-based services) could disrupt operations, lead to data loss, and incur liability[413](index=413&type=chunk)[415](index=415&type=chunk)[416](index=416&type=chunk)[419](index=419&type=chunk) - Changes in funding for government agencies like the FDA and SEC could hinder their ability to perform functions, delaying regulatory reviews and impacting business operations[422](index=422&type=chunk)[423](index=423&type=chunk)[424](index=424&type=chunk) - Acquisitions or joint ventures could disrupt business, cause stockholder dilution, incur liabilities, and divert management attention[425](index=425&type=chunk) [Risks Related to Our Common Stock](index=67&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section addresses risks specific to the company's stock, including price volatility, control by principal stockholders, potential dilution, and public company compliance costs - The price of common stock is likely to be volatile due to various factors, including clinical trial results, competitive developments, regulatory actions, and financial performance, potentially leading to substantial losses for investors[428](index=428&type=chunk)[430](index=430&type=chunk) - Executive officers, directors, and principal stockholders collectively hold approximately **73%** of voting stock, enabling them to control or significantly influence matters submitted to stockholders, potentially against minority interests[433](index=433&type=chunk)[434](index=434&type=chunk) - A significant portion of outstanding shares are eligible for sale, which could cause the market price of common stock to drop[435](index=435&type=chunk)[436](index=436&type=chunk) - As an 'emerging growth company' and 'smaller reporting company,' reduced disclosure requirements may make the common stock less attractive to investors, potentially leading to a less active trading market or lower stock price[437](index=437&type=chunk)[438](index=438&type=chunk)[442](index=442&type=chunk)[443](index=443&type=chunk) - Operating as a public company incurs increased costs and requires substantial management time for compliance initiatives and corporate governance, especially after no longer being an emerging growth company[444](index=444&type=chunk)[445](index=445&type=chunk)[448](index=448&type=chunk) - Disclosure controls and procedures, despite being well-conceived, can only provide reasonable assurance and may not prevent or detect all errors or fraud[450](index=450&type=chunk)[451](index=451&type=chunk) - Lack of research or adverse opinions from securities analysts could cause the stock price and trading volume to decline[452](index=452&type=chunk)[453](index=453&type=chunk) - Provisions in the restated certificate of incorporation and bylaws (e.g., classified board, no cumulative voting, board's right to fill vacancies) could make company acquisition more difficult and prevent changes in management[454](index=454&type=chunk)[455](index=455&type=chunk)[457](index=457&type=chunk)[458](index=458&type=chunk) - The Court of Chancery of the State of Delaware is the exclusive forum for most disputes, potentially limiting stockholders' ability to choose a favorable judicial forum[459](index=459&type=chunk)[460](index=460&type=chunk) - No cash dividends are anticipated in the foreseeable future, making capital appreciation the sole source of gain for stockholders[461](index=461&type=chunk)[462](index=462&type=chunk) - The ability to use net operating losses (NOLs) and research and development credits to offset future taxable income may be limited by ownership changes (Sections 382 and 383 of the Code) and the Tax Cuts and Jobs Act of **2017** (TCJA)[464](index=464&type=chunk)[465](index=465&type=chunk) - Recent U.S. tax legislation (TCJA) may materially adversely affect financial condition, results of operations, and cash flows, including reducing the corporate tax rate and limiting NOL utilization[466](index=466&type=chunk)[467](index=467&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Details the use of proceeds from the company's IPO, confirming no material change in expected fund utilization - The company completed its IPO on May 11, 2018, issuing **5,312,500 shares** of common stock for **$85.0 million** gross proceeds, and all outstanding convertible preferred stock converted into **22,386,677 shares** of common stock[468](index=468&type=chunk)[470](index=470&type=chunk) - Net proceeds have been invested in government-backed money market funds and U.S. treasury securities[470](index=470&type=chunk) - As of March 31, **2019**, **$62.2 million** of the net IPO proceeds had been used, with no material change in the expected use of funds[470](index=470&type=chunk) [Item 3. Defaults Upon Senior Securities](index=74&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reported period - There were no defaults upon senior securities during the reported period[473](index=473&type=chunk) [Item 4. Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to Evelo Biosciences, Inc[474](index=474&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) No other information is reported in this section - No other information is reported in this section[475](index=475&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, agreements, certifications, and XBRL taxonomy - Exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, Loan and Security Agreement, employment terms, and various certifications (e.g., Section 302, Section 906)[478](index=478&type=chunk)[479](index=479&type=chunk)[480](index=480&type=chunk)[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk) - XBRL Instance Document and Taxonomy Extension documents are also filed[486](index=486&type=chunk)[488](index=488&type=chunk)[489](index=489&type=chunk)[490](index=490&type=chunk)[491](index=491&type=chunk)[492](index=492&type=chunk) [SIGNATURES](index=76&type=section&id=SIGNATURES) Contains signatures of the principal executive and financial officers, certifying the report's submission - The report is signed by Balkrishan (Simba) Gill, Ph.D., President and Chief Executive Officer, and Jonathan Poole, Chief Financial Officer, on May 3, **2019**[495](index=495&type=chunk)

Table of Contents x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES For the Fiscal Year Ended December 31, 2018 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38473 Evelo Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 46-5594527 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (State or other juris ...