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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934
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Delaware
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2834
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46-5594527
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(State or other jurisdiction of
incorporation or organization)
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification No.)
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Title of each class
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Name of each exchange on which registered
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Common Stock, par value $0.001 per share
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NASDAQ Global Select Market
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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x
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Smaller reporting company
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x
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Emerging growth company
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x
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Page
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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PART I
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Item 1.
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Business
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Item 1A.
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Risk Factors
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Item 1B.
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Unresolved Staff Comments
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Item 2.
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Properties
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Item 3.
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Legal Proceedings
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Item 4.
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Mine Safety Disclosures
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PART II
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Item 5.
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Market for Registrant's Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities
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Item 6.
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Selected Financial Data
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Item 7.
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Management's Discussion and Analysis of Financial Condition and Results of Operations
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Item 7A.
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Quantitative and Qualitative Disclosures about Market Risk
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Item 8.
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Financial Statements and Supplementary Data
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Item 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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Item 9A.
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Controls and Procedures
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Item 9B.
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Other Information
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PART III
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Item 10
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Directors, Executive Officers and Corporate Governance
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Item 11.
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Executive Compensation
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related stockholder Matters
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence
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Item 14.
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Principal Accountant Fees and Services
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PART IV
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Item 15.
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Exhibits and Financial Statement Schedules
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Item 16.
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Form 10-K Summary
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SIGNATURES
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our status as a development-stage company and our expectation to incur losses in the future;
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our estimates regarding our expenses, future revenues, anticipated future capital requirements and our need to raise additional funds;
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our ability to build a pipeline of product candidates and develop and commercialize drugs;
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our unproven approach to therapeutic intervention;
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our ability to enroll patients and volunteers in clinical trials, timely and successfully complete those trials and receive necessary regulatory approvals;
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the timing of the progress and receipt of data from our clinical trials of EDP-1066, EDP-1815, EDP-1503 and the potential use of those candidates to treat various indications;
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our ability to establish our own manufacturing facilities and to receive or manufacture sufficient quantities of our product candidates;
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our expectations regarding the potential safety, efficacy or clinical utility of our product candidates;
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our ability to protect and enforce our intellectual property rights;
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federal, state, and foreign regulatory requirements, including FDA regulation of our product candidates;
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the timing of clinical trials and the likelihood of regulatory filings and approvals;
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our ability to obtain and retain key executives and attract and retain qualified personnel;
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our ability to successfully manage our growth; and
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developments relating to our competitors and our industry.
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We have observed activity in preclinical animal models for each of our lead product candidates. Each of our monoclonal microbials acts through multiple clinically relevant and validated biological pathways. By acting on multiple pathways simultaneously, we believe monoclonal microbials can impact disease in ways that are not addressable with current single-target therapies.
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We believe our monoclonal microbials are likely to be well tolerated given that they are naturally occurring, specific single strains of human microbes that engage immune cells in the small intestine and drive changes in systemic biology without systemic exposure and without colonizing the gut. If we validate this profile in clinical trials, we believe monoclonal microbials have the potential to be used at all stages of disease and in many more patients than current immunomodulatory drugs.
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Our development of monoclonal microbials has the potential to be more efficient than those of other therapeutic classes such as cell therapy, monoclonal antibodies and small molecules. We believe that monoclonal microbials do not require the lengthy target validation and compound discovery requirements of conventional drug discovery. Additionally, we believe the manufacture of monoclonal microbials is meaningfully faster than that of certain other biologics and can further accelerate our path to clinical testing and commercialization.
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Explore the full potential of the gut-body network to create an expansive and diversified product portfolio
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We believe the gut-body network has applicability across a range of disease areas and we are committed to pursuing the many opportunities in which our platform has the potential to transform the treatment of a broad range of diseases. Our initial focus is on inflammatory diseases and oncology, and we intend to expand into other disease areas, such as autoimmune diseases, respiratory diseases, neuro-inflammation and degeneration, liver diseases, type I diabetes, food allergy, neurobehavior, cardiovascular disease and diseases of metabolism.
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Develop best-in-class therapies to improve outcomes across various stages of disease
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We intend to develop best-in-class orally-delivered therapies and intend to explore the potential of monoclonal microbials across the full spectrum of disease severity, not only in patients with severe or advanced disease. We intend to pursue what we believe to be the inherent advantages of monoclonal microbials to enable use in all stages of disease.
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Generate early clinical readouts with biomarker-driven validation to efficiently advance our product candidates
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We have prioritized indications with ease of accessibility to tissue biopsies for biomarker analysis.
We intend to use these biomarkers to clinically validate the immunological activity and dose of our monoclonal microbials and to guide subsequent clinical expansion and patient selection.
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Industrialize monoclonal microbials to advance and scale our platform
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We plan to continue to invest in our platform, which integrates microbiology, immunology and computational biology capabilities. We intend to expand the diversity of our monoclonal microbial library and enhance our proprietary
in vitro
and
in vivo
models to optimize selection of our future product candidates. Our manufacturing processes are designed to ensure the quality and scalability of our products. We plan to continue to invest in novel methods for process development, manufacturing and formulation for our monoclonal microbials. Future plans include investment in clinical and commercial scale manufacturing. We plan to leverage the efficiency of our integrated capabilities to accelerate the clinical development of many product candidates.
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Strengthen and expand our intellectual property to protect our platform
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We have exclusive rights to our technologies including issued composition of matter and method of use patents in the United States for our product candidates. We intend to diligently pursue patent protection for our scientific innovations and to maintain a strong and broad estate of patents and trade secrets in the United States and other geographies.
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Collaborate to realize the potential of the gut-body network and monoclonal microbials
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We intend to continue to seek collaborations with academic groups, biotech and pharmaceutical companies to realize the value of our broad platform and extend the range of our development activities and disease areas in a timely and cost-effective manner. We plan to commercialize products in multiple geographies both on our own and with collaborators.
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Single strain
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Our product candidates are pharmaceutical compositions of single strain monoclonal microbials that we have selected for their specific pharmacology. Our preclinical data suggests that various strains of microbes within the same genus or species can have vastly different immunomodulatory properties. We extensively characterize the ability of our product candidates to elicit a desired immunomodulatory effect. We also believe monoclonal microbials have manufacturing advantages over biologics.
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Orally-administered formulation
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We intend to deliver our initial product candidates orally in formulations designed for targeted release of the monoclonal microbials in the small intestine. Patients typically prefer oral administration to intravenous infusion, subcutaneous injection, and topical administration, which we believe will facilitate the adoption of our product candidates, if approved.
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Limited systemic exposure
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In preclinical studies, we observed that monoclonal microbials had limited systemic exposure, that they cleared from the gut within 24 to 48 hours and that colonization was not required for beneficial activity. We believe that these factors suggest that monoclonal microbials may have limited systemic off-target side-effects.
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Action on multiple clinically relevant and validated pathways
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Our preclinical data has shown that monoclonal microbials may act simultaneously on multiple clinically relevant and validated biological pathways. The diseases we intend to treat are multifactorial, and we believe that our potential therapies will be advantageous over single-target treatments.
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Manufacturing capabilities
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Although manufacturing of monoclonal microbials is complex, we believe that we have developed capabilities that will accelerate the process from strain identification to clinical supply. We have been able to manufacture monoclonal microbials in a relatively short timeframe compared to other biologic therapies, which we believe may accelerate our speed into the clinic. Additionally, we believe that we may be able to cost-effectively manufacture monoclonal microbials.
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An oral oncology platform exclusively licensed from the University of Chicago, consisting of one issued patent and 23 pending applications. Patents in this family are expected to expire in 2036.
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A translational
in vitro
assay platform developed by us, consisting of one pending provisional application. Any applications claiming priority to this provisional application that issue as patents are expected to expire in 2038.
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A formulation platform consisting of one pending provisional application. Any applications claiming priority to this provisional application that issue as a patent are expected to expire in 2038.
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A modality platform consisting of two pending provisional applications. Any applications claiming priority to these provisional applications that issue as a patent are expected to expire in 2038.
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Inflammation portfolio:
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EDP1815, consisting of four issued patents in-licensed from Mayo Clinic, covering compositions and methods of use, one pending application in-licensed from Mayo Clinic (the patents and application from Mayo Clinic expected to expire in 2030) and twelve (12) Evelo-owned pending applications directed to compositions and methods of use. Any applications claiming priority to these applications that issue as patents are expected to expire in 2038; and
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EDP1066, consisting of seven (7) pending applications directed to compositions and methods of use. Any applications claiming priority to these applications that issue as patents are expected to expire in 2038.
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Oncology portfolio:
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EDP1503, consisting of protection under the oral oncology platform exclusively licensed from the University of Chicago covering methods of use and four (4) Evelo-owned pending applications directed to compositions and methods of use. Any applications claiming priority to these applications that issue as patents are expected to expire in 2038.
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Checkpoint inhibitors
: Agenus Inc., AstraZeneca plc, Bristol-Myers Squibb, F. Hoffmann-La Roche A.G., Incyte Corporation, Merck, Pfizer Inc., Regeneron Pharmaceuticals Inc.; and
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Cell therapy
: Celgene Corporation, Gilead Sciences, Inc., and Novartis International A.G.
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completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s good laboratory practice, or GLP, regulations;
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submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials in the United States may begin;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication, conducted in accordance with the FDA’s good clinical practice, or GCP, regulations;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP regulations; and
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FDA review and approval of the BLA prior to any commercial marketing, sale or shipment of the product.
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Phase 1
—Phase 1 clinical trials involve initial introduction of the investigational product into healthy human subjects or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.
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Phase 2
—Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
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Phase 3
—Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and physician labeling.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, warning letters or holds on post-approval clinical trials;
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refusal of the FDA to approve applications or supplements to approved applications, or suspension or revocation of product approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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Decentralized procedure.
Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one EU country of medicinal products that have not yet been authorized in any EU country and that do not fall within the mandatory scope of the centralized procedure.
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Mutual recognition procedure.
In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance with the national procedures of that country. Following this, additional marketing authorizations can be sought from other EU countries in a procedure whereby the countries concerned recognize the validity of the original, national marketing authorization.
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seek to enhance our monoclonal microbial platform and discover and develop additional product candidates;
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seek regulatory approvals for any product candidates that successfully complete clinical trials;
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seek to establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;
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maintain, expand and protect our intellectual property portfolio; and
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add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and to support our transition to a public company.
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the progress and results of any ongoing and future clinical trials;
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the cost of manufacturing clinical supplies of our product candidates, including EDP1066, EDP1815 and EDP1503;
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the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for any other future product candidates;
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the costs, timing and outcome of regulatory review of our product candidates;
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the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
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the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
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the effect of competing technological and market developments; and
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the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates, although we currently have no commitments or agreements to complete any such transactions.
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completion of preclinical studies and clinical trials with positive results;
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receipt of marketing approvals from applicable regulatory authorities;
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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
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making arrangements with third-party manufacturers for, or establishing our own, commercial manufacturing capabilities;
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launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;
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entering into new collaborations throughout the development process as appropriate, from preclinical studies through to commercialization;
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acceptance of our products, if and when approved, by patients, the medical community and third-party payors;
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effectively competing with other therapies;
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obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our products, if approved;
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protecting our rights in our intellectual property portfolio;
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operating without infringing or violating the valid and enforceable patents or other intellectual property of third parties;
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maintaining a continued acceptable safety profile of the products following approval; and
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maintaining and growing an organization of scientists and business people who can develop and commercialize our products and technology.
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regulatory authorities may withdraw their approval of the product;
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we may be required to recall a product or change the way such product is administered to patients;
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additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
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we may be required to conduct post-marketing studies or clinical trials;
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regulatory authorities may require the addition of labeling statements, such as a ‘‘black box’’ warning or a contraindication;
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we may be required to implement a risk evaluation and mitigation strategy or create a medication guide outlining the risks of such side effects for distribution to patients;
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we could be sued and held liable for harm caused to patients;
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the product may become less competitive; and
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our reputation may suffer.
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regulators, IRBs or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
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clinical trials of our product candidates may demonstrate undesirable side effects or produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
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the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
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we may have to, or regulators, IRB or ethics committees may require that we or our investigators, suspend or terminate clinical trials of our product candidates for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
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the cost of clinical trials of our product candidates may be greater than we anticipate;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
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regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate; and
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regarding trials managed by any future collaborators, our collaborators may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but potentially suboptimal for us.
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be delayed in obtaining marketing approval for our product candidates;
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lose the support of any future collaborators, requiring us to bear more of the burden of developing certain microbial strains;
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not obtain marketing approval at all;
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obtain marketing approval in some countries and not in others;
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obtain approval for indications or patient populations that are not as broad as we intend or desire;
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obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
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be subject to additional post-marketing testing requirements; or
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have the product removed from the market after obtaining marketing approval.
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the severity of the disease under investigation;
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the patient eligibility criteria for the study in question;
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the perceived risks and benefits of the product candidate under study;
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the availability of other treatments for the disease under investigation;
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the existence of competing clinical trials;
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the efforts to facilitate timely enrollment in clinical trials;
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our payments for conducting clinical trials;
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the patient referral practices of physicians;
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the ability to monitor patients adequately during and after treatment; and
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the proximity and availability of clinical trial sites for prospective patients.
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failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;
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breach of manufacturing agreements by the third-party manufacturers;
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failure to manufacture our product according to our specifications;
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failure to manufacture our product according to our schedule or at all;
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misappropriation or disclosure of our proprietary information, including our trade secrets and know-how; and
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termination or nonrenewal of agreements by third-party manufacturers at times that are costly or inconvenient for us.
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their efficacy, safety and other potential advantages compared to alternative treatments;
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the clinical indications for which our products are approved;
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our ability to offer them for sale at competitive prices;
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their convenience and ease of administration compared to alternative treatments;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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the strength of marketing and distribution support;
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the availability of third-party coverage and adequate reimbursement for our product candidates;
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the prevalence and severity of their side effects and their overall safety profiles;
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any restrictions on the use of our products together with other medications;
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interactions of our products with other medicines patients are taking; and
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the inability of certain types of patients to take our product.
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our inability to recruit, train and retain an adequate number of effective sales and marketing personnel;
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the inability of sales personnel to obtain access to or educate physicians on the benefits of our products;
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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
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unforeseen costs and expenses associated with creating an independent sales and marketing organization; and
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the inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.
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regulatory investigations, product recalls or withdrawals, or labeling, marketing or promotional restrictions;
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decreased demand for any product candidates or products that we may develop;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial participants;
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significant costs to defend the related litigation;
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substantial monetary awards to trial participants or patients;
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loss of revenue;
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reduced resources of our management to pursue our business strategy; and
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the inability to commercialize any products that we may develop.
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litigation involving patients taking our products;
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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restrictions on product distribution or use;
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requirements to conduct post-marketing studies or clinical trials;
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warning letters;
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withdrawal of products from the market;
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suspension or termination of ongoing clinical trials;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products;
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fines, restitution or disgorgement of profits or revenues;
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suspension or withdrawal of marketing approvals;
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damage to relationships with potential collaborators;
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unfavorable press coverage and damage to our reputation;
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refusal to permit the import or export of our products;
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product seizure or detention;
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injunctions; or
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imposition of civil or criminal penalties.
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the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program, such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (described below);
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the false claims and civil monetary penalties laws, including the federal False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim or from knowingly or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of these statutes or specific intent to violate them to have committed a violation;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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the federal Physician Payment Sunshine Act requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; manufacturers are required to submit subsequent reports to the government by the 90
th
day of each calendar year;
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to our business practices, including but not limited to, research, distribution, sales or marketing arrangements and claims involving healthcare items or services reimbursed by non- governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, pricing information or marketing expenditures; and
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state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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establishment of a new pathway for approval of lower-cost biosimilars to compete with biologic products, such as those we are developing;
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an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
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expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices;
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extension of manufacturers’ Medicaid rebate liability;
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expansion of eligibility criteria for Medicaid programs;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements to report financial arrangements with physicians and teaching hospitals;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research.
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any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our product candidates or any other products or product candidates;
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•
|
any of our pending patent applications will issue as patents;
|
•
|
we will be able to successfully commercialize our product candidates, if approved, before our relevant patents expire;
|
•
|
we were the first to make the inventions covered by any existing patent and pending patent applications;
|
•
|
we were the first to file patent applications for these inventions;
|
•
|
others will not develop similar or alternative technologies that do not infringe or design around our patents;
|
•
|
others will not use pre-existing technology to effectively compete against us;
|
•
|
any of our patents, if issued, will be found to ultimately be valid and enforceable;
|
•
|
third parties will not compete with us in jurisdictions where we do not pursue and obtain patent protection;
|
•
|
we will be able to obtain and/or maintain necessary or useful licenses on reasonable terms or at all;
|
•
|
any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties;
|
•
|
we will develop additional proprietary technologies or product candidates that are separately patentable; or
|
•
|
our commercial activities or products will not infringe upon the patents or proprietary rights of others.
|
•
|
the scope of rights granted under the license agreement and other interpretation-related issues;
|
•
|
the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; and
|
•
|
our diligence obligations under the license agreement and what activities satisfy those obligations.
|
•
|
cease developing, selling or otherwise commercializing our product candidates;
|
•
|
pay substantial damages for past use of the asserted intellectual property;
|
•
|
obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all; and
|
•
|
in the case of trademark claims, redesign, or rename, some or all of our product candidates or other brands to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming.
|
•
|
multiple, conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;
|
•
|
failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;
|
•
|
additional potentially relevant third-party patent rights;
|
•
|
complexities and difficulties in obtaining protection and enforcing our intellectual property;
|
•
|
difficulties in staffing and managing foreign operations;
|
•
|
complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;
|
•
|
limits in our ability to penetrate international markets;
|
•
|
financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;
|
•
|
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions;
|
•
|
certain expenses including, among others, expenses for travel, translation and insurance; and
|
•
|
regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions.
|
•
|
discontinuing or limiting our access to its platform;
|
•
|
increasing pricing terms;
|
•
|
terminating or seeking to terminate our contractual relationship altogether;
|
•
|
establishing more favorable relationships with one or more of our competitors; or
|
•
|
modifying or interpreting its terms of service or other policies in a manner that impacts our ability to run our business and operations.
|
•
|
disruption in our relationships with future customers or with current or future distributors or suppliers as a result of such a transaction;
|
•
|
unanticipated liabilities related to acquired companies;
|
•
|
difficulties integrating acquired personnel, technologies and operations into our existing business;
|
•
|
diversion of management time and focus from operating our business to acquisition integration challenges;
|
•
|
increases in our expenses and reductions in our cash available for operations and other uses;
|
•
|
possible write-offs or impairment charges relating to acquired businesses; and
|
•
|
inability to develop a sales force for any additional product candidates.
|
•
|
the success of competitive products or technologies;
|
•
|
actual or anticipated changes in our growth rate relative to our competitors;
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
developments related to any future collaborations;
|
•
|
regulatory or legal developments in the United States and other countries;
|
•
|
adverse actions taken by regulatory agencies with respect to our preclinical studies or clinical trials, manufacturing or sales and marketing activities;
|
•
|
any adverse changes to our relationship with third party contractors or manufacturers;
|
•
|
development of new product candidates that may address our markets and may make our existing product candidates less attractive;
|
•
|
changes in physician, hospital or healthcare provider practices that may make our product candidates less useful;
|
•
|
announcements by us, our collaborators or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
|
•
|
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
•
|
the recruitment or departure of key personnel;
|
•
|
the level of expenses related to any of our product candidates or product development programs;
|
•
|
failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
|
•
|
press reports or other negative publicity, whether or not true, about our business;
|
•
|
the results of our efforts to discover, develop, acquire or in-license additional product candidates or products;
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this Annual Report on Form 10-K;
|
•
|
not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
|
•
|
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
|
•
|
reduced disclosure obligations regarding executive compensation; and
|
•
|
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
|
•
|
a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;
|
•
|
no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
|
•
|
the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on our board of directors;
|
•
|
the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;
|
•
|
the ability of our board of directors to alter our bylaws without obtaining stockholder approval;
|
•
|
the required approval of the holders of at least two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or repeal the provisions of our restated certificate of incorporation regarding the election and removal of directors;
|
•
|
a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;
|
•
|
the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and
|
•
|
advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
|
(in thousands, except share and per share amounts)
|
||||||||||
Statement of Operations Data:
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
39,885
|
|
|
$
|
19,957
|
|
|
$
|
9,134
|
|
General and administrative
|
18,218
|
|
|
7,574
|
|
|
3,891
|
|
|||
Total operating expenses
|
58,103
|
|
|
27,531
|
|
|
13,025
|
|
|||
Loss from operations
|
(58,103
|
)
|
|
(27,531
|
)
|
|
(13,025
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest income (expense), net
|
1,563
|
|
|
(215
|
)
|
|
(287
|
)
|
|||
Other expenses
|
(406
|
)
|
|
(301
|
)
|
|
(20
|
)
|
|||
Other income (expense), net
|
1,157
|
|
|
(516
|
)
|
|
(307
|
)
|
|||
Net loss
|
$
|
(56,946
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
Convertible preferred stock dividends
|
(3,937
|
)
|
|
(6,085
|
)
|
|
(1,645
|
)
|
|||
Net loss attributable to common stockholders
|
$
|
(60,883
|
)
|
|
$
|
(34,132
|
)
|
|
$
|
(14,977
|
)
|
Net loss per share attributable to common stockholders, basic and diluted(1)
|
$
|
(2.78
|
)
|
|
$
|
(9.10
|
)
|
|
$
|
(5.28
|
)
|
Weighted average number of common shares outstanding, basic and diluted(1)
|
21,871,029
|
|
|
3,750,790
|
|
|
2,834,733
|
|
|
As of December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
|
(in thousands)
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
||||||
Cash and cash equivalents and short-term investments
|
$
|
147,919
|
|
|
$
|
38,246
|
|
|
$
|
15,536
|
|
Working capital(2)
|
142,387
|
|
|
34,938
|
|
|
13,472
|
|
|||
Total assets
|
159,867
|
|
|
43,788
|
|
|
18,570
|
|
|||
Long-term debt
|
12,305
|
|
|
9,966
|
|
|
9,931
|
|
|||
Convertible preferred stock
|
—
|
|
|
83,702
|
|
|
33,863
|
|
|||
Accumulated deficit
|
(113,381
|
)
|
|
(56,411
|
)
|
|
(28,341
|
)
|
|||
Total stockholders’ equity (deficit)
|
136,949
|
|
|
(54,723
|
)
|
|
(28,337
|
)
|
•
|
continue the ongoing proof of concept trials for EDP1066, EDP1815 and EDP1503;
|
•
|
potentially initiate additional clinical trials for EDP1066, EDP1815 and EDP1503;
|
•
|
initiate or advance the clinical development of any additional monoclonal microbial product candidates;
|
•
|
conduct research and continue preclinical development of potential product candidates;
|
•
|
make strategic investments in manufacturing capabilities, including potentially planning and building our own manufacturing facility;
|
•
|
maintain our current intellectual property portfolio and opportunistically acquire complementary intellectual property;
|
•
|
increase research and development employees and employee-related expenses including salaries, benefits, travel and stock-based compensation expense; and
|
•
|
seek to obtain regulatory approvals for our product candidates.
|
•
|
expenses incurred under agreements with third parties, including investigative sites, external laboratories and contract research organizations, or CROs, that conduct research, preclinical activities and clinical trials on our behalf
|
•
|
manufacturing process-development costs as well as technology transfer and other expenses incurred with contract manufacturing organizations, or CMOs, that manufacture drug substance and drug product for use in our preclinical activities and any current or future clinical trials;
|
•
|
salaries, benefits and other related costs, including stock-based compensation expense, for personnel in our research and development functions;
|
•
|
expenses to acquire technologies to be used in research and development;
|
•
|
costs of outside consultants, including their fees, stock-based compensation and related travel expenses;
|
•
|
the cost of laboratory supplies and acquiring, developing and manufacturing preclinical and clinical trial materials;
|
•
|
costs related to compliance with regulatory requirements; and
|
•
|
facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
|
•
|
our ability to add and retain key research and development personnel;
|
•
|
our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize, our product candidates;
|
•
|
our successful enrollment in and completion of clinical trials;
|
•
|
the costs associated with the development of our current product candidates and/or any additional product candidates we identify in-house or acquire through collaborations;
|
•
|
our ability to discover, develop and utilize biomarkers to demonstrate target engagement, pathway engagement and the impact on disease progression of our product candidates;
|
•
|
our ability to establish an appropriate safety profile with Investigational New Drug-enabling toxicology studies;
|
•
|
our ability to establish and maintain agreements with third-party manufacturers and other entities for clinical trial supply and future commercial supply, if our product candidates are approved;
|
•
|
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder;
|
•
|
our ability to obtain and maintain patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates if and when approved;
|
•
|
our receipt of marketing approvals from applicable regulatory authorities;
|
•
|
our ability to commercialize products, if and when approved, whether alone or in collaboration with others; and
|
•
|
the continued acceptable safety profiles of the product candidates following approval.
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2018
|
|
2017
|
|
|||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
39,885
|
|
|
$
|
19,957
|
|
|
$
|
19,928
|
|
General and administrative
|
18,218
|
|
|
7,574
|
|
|
10,644
|
|
|||
Total operating expenses
|
58,103
|
|
|
27,531
|
|
|
30,572
|
|
|||
Loss from operations
|
(58,103
|
)
|
|
(27,531
|
)
|
|
(30,572
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest income (expense), net
|
1,563
|
|
|
(215
|
)
|
|
1,778
|
|
|||
Other expense
|
(406
|
)
|
|
(301
|
)
|
|
(105
|
)
|
|||
Other income (expense), net
|
1,157
|
|
|
(516
|
)
|
|
1,673
|
|
|||
Net loss
|
$
|
(56,946
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(28,899
|
)
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2018
|
|
2017
|
|
|||||||
Gut-body network platform expenses
|
$
|
7,972
|
|
|
$
|
3,806
|
|
|
$
|
4,166
|
|
Inflammation programs
|
13,852
|
|
|
4,284
|
|
|
9,568
|
|
|||
Oncology programs
|
6,012
|
|
|
3,706
|
|
|
2,306
|
|
|||
Other program expenses
|
—
|
|
|
566
|
|
|
(566
|
)
|
|||
Research and development personnel costs (including stock-based compensation)
|
12,049
|
|
|
7,595
|
|
|
4,454
|
|
|||
Total research and development expenses
|
$
|
39,885
|
|
|
$
|
19,957
|
|
|
$
|
19,928
|
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2018
|
|
2017
|
|
|||||||
General and administrative personnel costs (including stock-based compensation)
|
$
|
8,816
|
|
|
$
|
3,237
|
|
|
$
|
5,579
|
|
Professional fees
|
5,377
|
|
|
2,758
|
|
|
2,619
|
|
|||
Facility costs, office expense and other
|
4,025
|
|
|
1,579
|
|
|
2,446
|
|
|||
Total general and administrative expenses
|
$
|
18,218
|
|
|
$
|
7,574
|
|
|
$
|
10,644
|
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2017
|
|
2016
|
|
|||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
19,957
|
|
|
$
|
9,134
|
|
|
$
|
10,823
|
|
General and administrative
|
7,574
|
|
|
3,891
|
|
|
3,683
|
|
|||
Total operating expenses
|
27,531
|
|
|
13,025
|
|
|
14,506
|
|
|||
Loss from operations
|
(27,531
|
)
|
|
(13,025
|
)
|
|
(14,506
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest expense, net
|
(215
|
)
|
|
(287
|
)
|
|
72
|
|
|||
Other expense
|
(301
|
)
|
|
(20
|
)
|
|
(281
|
)
|
|||
Other (expense) income, net
|
(516
|
)
|
|
(307
|
)
|
|
(209
|
)
|
|||
Net loss
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
|
$
|
(14,715
|
)
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2017
|
|
2016
|
|
|||||||
Gut-body network platform expenses
|
$
|
3,806
|
|
|
$
|
2,064
|
|
|
$
|
1,742
|
|
Inflammation programs
|
4,284
|
|
|
—
|
|
|
4,284
|
|
|||
Oncology programs
|
3,706
|
|
|
2,581
|
|
|
1,125
|
|
|||
Other program expenses
|
566
|
|
|
393
|
|
|
173
|
|
|||
Research and development personnel costs (including stock-based compensation)
|
7,595
|
|
|
4,096
|
|
|
3,499
|
|
|||
Total research and development expenses
|
$
|
19,957
|
|
|
$
|
9,134
|
|
|
$
|
10,823
|
|
|
Year Ended December 31,
|
|
Increase/
(Decrease)
|
||||||||
|
2017
|
|
2016
|
|
|||||||
General and administrative personnel costs (including stock-based compensation)
|
$
|
3,237
|
|
|
$
|
2,035
|
|
|
$
|
1,202
|
|
Professional fees
|
2,758
|
|
|
826
|
|
|
1,932
|
|
|||
Facility costs, office expense and other
|
1,579
|
|
|
1,030
|
|
|
549
|
|
|||
Total general and administrative expenses
|
$
|
7,574
|
|
|
$
|
3,891
|
|
|
$
|
3,683
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Cash used in operating activities
|
$
|
(47,279
|
)
|
|
$
|
(23,265
|
)
|
|
$
|
(12,314
|
)
|
Cash (used in)/provided by investing activities
|
(60,128
|
)
|
|
(1,742
|
)
|
|
9,263
|
|
|||
Cash provided by financing activities
|
162,012
|
|
|
48,967
|
|
|
15,742
|
|
|||
Net increase in cash, cash equivalents and restricted cash
|
$
|
54,605
|
|
|
$
|
23,960
|
|
|
$
|
12,691
|
|
•
|
continue our proof of concept clinical trials of EDP1066, EDP1815 and EDP1503;
|
•
|
advance the clinical development of any additional monoclonal microbial product candidates;
|
•
|
conduct research and continue preclinical development of potential product candidates;
|
•
|
make strategic investments in manufacturing capabilities, including potentially planning and building a small-scale commercial manufacturing facility;
|
•
|
maintain our current intellectual property portfolio and opportunistically acquire complementary intellectual property;
|
•
|
seek to obtain regulatory approvals for our product candidates;
|
•
|
potentially establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;
|
•
|
add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and to support our transition to a public company; and
|
•
|
experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges.
|
•
|
the progress and results of our proof of concept clinical studies of EDP1066, EDP1815 and EDP1503;
|
•
|
the cost of manufacturing clinical supplies of our product candidates;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing for any other potential product candidates;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
|
•
|
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates, although we currently have no commitments or agreements to complete any such acquisitions or investments in businesses.
|
|
Payments Due by Period
|
||||||||||||||||||
|
Total
|
|
Less Than 1
Year
|
|
1 – 3 Years
|
|
4 – 5 Years
|
|
More Than 5
Years
|
||||||||||
Operating lease commitments(1)
|
$
|
20,620
|
|
|
$
|
2,803
|
|
|
$
|
5,860
|
|
|
$
|
6,217
|
|
|
$
|
5,740
|
|
Debt obligations(2)
|
16,471
|
|
|
3,342
|
|
|
13,129
|
|
|
—
|
|
|
—
|
|
|||||
Obligations for research, development, manufacturing and other(3)
|
3,875
|
|
|
2,422
|
|
|
1,453
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
40,966
|
|
|
$
|
8,567
|
|
|
$
|
20,442
|
|
|
$
|
6,217
|
|
|
$
|
5,740
|
|
(1)
|
Amounts in the table reflect payments due for our laboratory and office space in Cambridge, Massachusetts under two operating lease agreements that are scheduled to expire in 2020 and 2025, net of future minimum sublease payments.
|
(2)
|
Reflects the contractually required principal and interest payments payable pursuant to our loan and security agreement, which was amended in February 2018.
|
(3)
|
Amounts represent the minimum cash amounts due on contractually obligated research, development and manufacturing contracts. Amounts exclude royalties and future milestones under current license agreements as we cannot estimate if they will occur.
|
•
|
CROs in connection with performing research services on our behalf including, but not limited to, clinical trials and preclinical studies;
|
•
|
investigative sites and other providers in connection with clinical trials and preclinical studies;
|
•
|
other research and development service providers such as academic institutions and laboratory services providers in connection with discovery, preclinical and clinical development activities; and
|
•
|
vendors related to product manufacturing, development and distribution of clinical supplies.
|
•
|
the prices at which we sold shares of preferred stock and the preferential rights and preferences of the preferred stock relative to our common stock at the time of each grant;
|
•
|
the progress of our research and development programs, including the status of preclinical studies for our product candidates;
|
•
|
our stage of development and our business strategy;
|
•
|
external market conditions affecting the biotechnology and pharmaceutical industries;
|
•
|
trends within the biotechnology and pharmaceutical industries;
|
•
|
our financial position, including cash and cash equivalents on hand, and our historical and forecasted performance and operating results;
|
•
|
the lack of an active public market for our common stock and our preferred stock;
|
•
|
the likelihood of achieving a liquidity event, such as an initial public offering (“IPO”), or sale of our company in light of prevailing market conditions; and
|
•
|
the analysis of IPOs and the market performance of similar companies in the biotechnology and pharmaceutical industries.
|
|
|
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants, and Rights
|
|
Weighted-Average Exercise Price of Outstanding Options, Warrants, and Rights
|
|
Number of Securities Available for Future Issuance Under Equity Compensation Plans (excludes securities reflected in column (a))
|
||||
Plan category:
|
|
(a)
|
|
(b)
|
|
(c)
|
||||
Equity compensation plans approved by stockholders
|
|
|
|
|
|
|
||||
2015 Plan (1)
|
|
4,213,835
|
|
|
$
|
4.33
|
|
|
—
|
|
2018 Plan (2)
|
|
703,976
|
|
|
$
|
13.49
|
|
|
844,853
|
|
2018 ESPP
|
|
—
|
|
|
$
|
—
|
|
|
336,356
|
|
Equity compensation plans not approved by stockholders
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
Total
|
|
4,917,811
|
|
|
$
|
5.64
|
|
|
1,181,209
|
|
|
|
|
|
Incorporated by Reference
|
||||||||
Exhibit
Number
|
|
Description of Exhibit
|
|
Form
|
|
File
No.
|
|
Exhibit
|
|
Filing
date
|
|
Filed
Herewith
|
3.1
|
|
|
8-K
|
|
001-38473
|
|
3.1
|
|
5/11/18
|
|
|
|
3.2
|
|
|
8-K
|
|
001-38473
|
|
3.2
|
|
5/11/18
|
|
|
|
4.1
|
|
|
S-1/A
|
|
333-224278
|
|
4.1
|
|
4/30/18
|
|
|
|
4.2
|
|
|
S-1/A
|
|
333-224278
|
|
4.2
|
|
4/30/18
|
|
|
|
10.1#
|
|
|
S-1/A
|
|
333-224278
|
|
10.1
|
|
4/30/18
|
|
|
|
10.2#
|
|
|
S-1/A
|
|
333-224278
|
|
10.2
|
|
4/30/18
|
|
|
|
10.3#
|
|
|
S-1/A
|
|
333-224278
|
|
10.3
|
|
4/30/18
|
|
|
|
10.4#
|
|
|
S-1/A
|
|
333-224278
|
|
10.4
|
|
4/30/18
|
|
|
|
10.5#
|
|
|
S-1/A
|
|
333-224278
|
|
10.5
|
|
4/30/18
|
|
|
|
10.6#
|
|
|
S-1/A
|
|
333-224278
|
|
10.6
|
|
4/30/18
|
|
|
|
10.7
|
|
|
S-1/A
|
|
333-224278
|
|
10.7
|
|
4/30/18
|
|
|
|
10.8
|
|
|
S-1/A
|
|
333-224278
|
|
10.8
|
|
4/30/18
|
|
|
|
10.9#
|
|
|
S-1/A
|
|
333-224278
|
|
10.9
|
|
4/30/18
|
|
|
|
10.10#
|
|
|
S-1/A
|
|
333-224278
|
|
10.11
|
|
4/30/18
|
|
|
10.11#
|
|
|
S-1/A
|
|
333-224278
|
|
10.10
|
|
4/30/18
|
|
|
|
10.12
|
|
|
|
|
|
|
|
|
|
|
*
|
|
10.13†
|
|
|
S-1/A
|
|
333-224278
|
|
10.14
|
|
4/30/18
|
|
|
|
10.14†
|
|
|
S-1/A
|
|
333-224278
|
|
10.15
|
|
4/30/18
|
|
|
|
10.15†
|
|
|
S-1/A
|
|
333-224278
|
|
10.16
|
|
4/30/18
|
|
|
|
10.16
|
|
|
S-1/A
|
|
333-224278
|
|
10.17
|
|
4/30/18
|
|
|
|
21.1
|
|
|
S-1
|
|
333-224278
|
|
21.1
|
|
4/13/18
|
|
|
|
23.1
|
|
|
|
|
|
|
|
|
|
|
*
|
|
31.1
|
|
|
|
|
|
|
|
|
|
|
*
|
|
31.2
|
|
|
|
|
|
|
|
|
|
|
*
|
|
32.1
|
|
|
|
|
|
|
|
|
|
|
**
|
|
32.2
|
|
|
|
|
|
|
|
|
|
|
**
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
*
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
*
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
*
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
*
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
|
*
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Filed herewith
|
**
|
Furnished herewith
|
#
|
Indicates management contract or compensatory plan.
|
†
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment.
|
|
EVELO BIOSCIENCES, INC.
|
||
Date: February 15, 2019
|
By:
|
|
/s/ Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Balkrishan (Simba) Gill
|
|
President, Chief Executive Officer and Director
(principal executive officer)
|
|
February 15, 2019
|
Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Jonathan Poole
|
|
Chief Financial Officer
(principal financial and accounting officer)
|
|
February 15, 2019
|
Jonathan Poole
|
|
|
|
|
|
|
|
|
|
/s/ Noubar B. Afeyan
|
|
Chairman of the Board of Directors
|
|
February 15, 2019
|
Noubar B. Afeyan, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Ara Darzi
|
|
Director
|
|
February 15, 2019
|
Lord Ara Darzi
|
|
|
|
|
|
|
|
|
|
/s/ David R. Epstein
|
|
Director
|
|
February 15, 2019
|
David R. Epstein
|
|
|
|
|
|
|
|
|
|
/s/ Theodose Melas-Kyriazi
|
|
Director
|
|
February 15, 2019
|
Theodose Melas-Kyriazi
|
|
|
|
|
|
|
|
|
|
/s/ David P. Perry
|
|
Director
|
|
February 15, 2019
|
David P. Perry
|
|
|
|
|
|
|
|
|
|
/s/ Nancy A. Simonian
|
|
Director
|
|
February 15, 2019
|
Nancy A. Simonian, M.D.
|
|
|
|
|
|
Page
|
Report of Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets
|
|
Consolidated Statements of Operations and Comprehensive Loss
|
|
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
|
|
Consolidated Statements of Cash Flows
|
|
Notes to Consolidated Financial Statements
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
93,101
|
|
|
$
|
38,246
|
|
Short-term investments
|
54,818
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
3,703
|
|
|
531
|
|
||
Total current assets
|
151,622
|
|
|
38,777
|
|
||
Property and equipment, net
|
6,925
|
|
|
3,496
|
|
||
Other assets
|
1,320
|
|
|
1,515
|
|
||
Total assets
|
$
|
159,867
|
|
|
$
|
43,788
|
|
Liabilities, convertible preferred stock, and stockholders’ equity (deficit)
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,519
|
|
|
$
|
1,411
|
|
Accrued expenses
|
4,965
|
|
|
2,199
|
|
||
Other current liabilities
|
2,751
|
|
|
229
|
|
||
Total current liabilities
|
9,235
|
|
|
3,839
|
|
||
Noncurrent liabilities:
|
|
|
|
||||
Long-term debt, net of current portion
|
12,305
|
|
|
9,966
|
|
||
Deferred rent, net of current portion
|
1,071
|
|
|
478
|
|
||
Other noncurrent liabilities
|
307
|
|
|
526
|
|
||
Total liabilities
|
22,918
|
|
|
14,809
|
|
||
Commitments and contingencies
|
|
|
|
||||
Convertible preferred stock:
|
|
|
|
||||
Convertible preferred stock, $0.001 par value; none and 66,311,563 shares authorized at December 31, 2018 and 2017, respectively; none and 65,833,096 shares issued and outstanding at December 31, 2018 and 2017, respectively; aggregate liquidation preference of $0 and $89,975 at December 31, 2018 and 2017, respectively
|
—
|
|
|
83,702
|
|
||
Stockholder’s equity (deficit):
|
|
|
|
||||
Preferred stock, $0.001 par value; 10,000,000 and no shares authorized at December 31, 2018 and 2017, respectively; no shares issued and outstanding at December 31, 2018 and 2017, respectively
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 200,000,000 and 23,780,338 shares authorized at December 31, 2018 and 2017, respectively; 31,951,540 and 4,138,483 shares issued and 31,825,769 and 3,880,607 shares outstanding at December 31, 2018 and 2017, respectively
|
32
|
|
|
4
|
|
||
Additional paid-in capital
|
250,316
|
|
|
1,684
|
|
||
Accumulated other comprehensive loss
|
(18
|
)
|
|
—
|
|
||
Accumulated deficit
|
(113,381
|
)
|
|
(56,411
|
)
|
||
Total stockholders’ equity (deficit)
|
136,949
|
|
|
(54,723
|
)
|
||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
|
$
|
159,867
|
|
|
$
|
43,788
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
39,885
|
|
|
$
|
19,957
|
|
|
$
|
9,134
|
|
General and administrative
|
18,218
|
|
|
7,574
|
|
|
3,891
|
|
|||
Total operating expenses
|
58,103
|
|
|
27,531
|
|
|
13,025
|
|
|||
Loss from operations
|
(58,103
|
)
|
|
(27,531
|
)
|
|
(13,025
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income (expense), net
|
1,563
|
|
|
(215
|
)
|
|
(287
|
)
|
|||
Other expenses
|
(406
|
)
|
|
(301
|
)
|
|
(20
|
)
|
|||
Other income (expense), net
|
1,157
|
|
|
(516
|
)
|
|
(307
|
)
|
|||
Net loss
|
$
|
(56,946
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
Convertible preferred stock dividends
|
(3,937
|
)
|
|
(6,085
|
)
|
|
(1,645
|
)
|
|||
Net loss attributable to common stockholders
|
$
|
(60,883
|
)
|
|
$
|
(34,132
|
)
|
|
$
|
(14,977
|
)
|
|
|
|
|
|
|
||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(2.78
|
)
|
|
$
|
(9.10
|
)
|
|
$
|
(5.28
|
)
|
Weighted-average number of common shares outstanding, basic and diluted
|
21,871,029
|
|
|
3,750,790
|
|
|
2,834,733
|
|
|||
|
|
|
|
|
|
||||||
Comprehensive loss:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(56,946
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
||||||
Unrealized loss on investments, net of tax of $0
|
(18
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive loss
|
$
|
(56,964
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
|
Convertible Preferred
Stock
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total
|
||||||||||||||||||
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
Balance-January 1, 2016
|
12,536,945
|
|
|
$
|
7,773
|
|
|
|
1,961,265
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(4,473
|
)
|
|
$
|
(4,471
|
)
|
Issuance of Series A-1 and A-3 Preferred Stocks and Common Stock as part of the acquisition of Epiva
|
18,851,705
|
|
|
16,950
|
|
|
|
1,389,939
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
(9,409
|
)
|
|
(9,407
|
)
|
||||||
Issuance of Series A and A-2 Preferred Stocks for cash, net of issuance costs
|
6,666,668
|
|
|
7,495
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Vesting of restricted common stock
|
—
|
|
|
—
|
|
|
|
216,146
|
|
|
—
|
|
|
67
|
|
|
—
|
|
|
—
|
|
|
67
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
|
51,193
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
—
|
|
|
32
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
419
|
|
|
—
|
|
|
—
|
|
|
419
|
|
||||||
Accretion of preferred stock to redemption value
|
—
|
|
|
1,645
|
|
|
|
—
|
|
|
—
|
|
|
(518
|
)
|
|
—
|
|
|
(1,127
|
)
|
|
(1,645
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,332
|
)
|
|
(13,332
|
)
|
||||||
Balance-December 31, 2016
|
38,055,318
|
|
|
$
|
33,863
|
|
|
|
3,618,543
|
|
|
$
|
4
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(28,341
|
)
|
|
$
|
(28,337
|
)
|
Issuance of Series B Preferred Stock for cash, net of issuance costs
|
27,777,778
|
|
|
49,807
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Vesting of restricted common stock
|
—
|
|
|
—
|
|
|
|
154,920
|
|
|
—
|
|
|
57
|
|
|
—
|
|
|
—
|
|
|
57
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
|
106,654
|
|
|
—
|
|
|
79
|
|
|
—
|
|
|
—
|
|
|
79
|
|
||||||
Other issuances of common stock
|
—
|
|
|
—
|
|
|
|
490
|
|
|
—
|
|
|
15
|
|
|
—
|
|
|
—
|
|
|
15
|
|
||||||
Accretion of preferred stock to redemption value
|
—
|
|
|
32
|
|
|
|
—
|
|
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
(23
|
)
|
|
(32
|
)
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
1,542
|
|
|
—
|
|
|
—
|
|
|
1,542
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(28,047
|
)
|
|
(28,047
|
)
|
||||||
Balance-December 31, 2017
|
65,833,096
|
|
|
$
|
83,702
|
|
|
|
3,880,607
|
|
|
$
|
4
|
|
|
$
|
1,684
|
|
|
$
|
—
|
|
|
$
|
(56,411
|
)
|
|
$
|
(54,723
|
)
|
Issuance of Series B and Series C Preferred Stock, net of issuance costs
|
25,482,199
|
|
|
82,076
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Proceeds from Initial Public Offering, net of underwriting costs and commissions
|
—
|
|
|
—
|
|
|
|
5,312,500
|
|
|
5
|
|
|
75,809
|
|
|
—
|
|
|
—
|
|
|
75,814
|
|
||||||
Conversion of preferred stock into common stock
|
(91,315,295
|
)
|
|
(165,778
|
)
|
|
|
22,386,677
|
|
|
22
|
|
|
165,756
|
|
|
—
|
|
|
—
|
|
|
165,778
|
|
||||||
Reclassification of warrant liability
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
819
|
|
|
—
|
|
|
—
|
|
|
819
|
|
||||||
Vesting of restricted common stock
|
—
|
|
|
—
|
|
|
|
113,641
|
|
|
—
|
|
|
36
|
|
|
—
|
|
|
—
|
|
|
36
|
|
||||||
Exercise of stock options and warrants
|
—
|
|
|
—
|
|
|
|
132,344
|
|
|
1
|
|
|
129
|
|
|
—
|
|
|
—
|
|
|
130
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
6,059
|
|
|
—
|
|
|
—
|
|
|
6,059
|
|
||||||
Unrealized loss on investments
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(18
|
)
|
|
—
|
|
|
(18
|
)
|
||||||
Retroactive adjustment to beginning accumulated deficit and additional paid-in capital resulting from adoption of ASU 2016-09
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
(24
|
)
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(56,946
|
)
|
|
(56,946
|
)
|
||||||
Balance-December 31, 2018
|
—
|
|
|
$
|
—
|
|
|
|
31,825,769
|
|
|
$
|
32
|
|
|
$
|
250,316
|
|
|
$
|
(18
|
)
|
|
$
|
(113,381
|
)
|
|
$
|
136,949
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(56,946
|
)
|
|
$
|
(28,047
|
)
|
|
$
|
(13,332
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Stock-based compensation expense
|
6,059
|
|
|
1,542
|
|
|
419
|
|
|||
Depreciation expense
|
1,935
|
|
|
834
|
|
|
495
|
|
|||
Change in fair value of warrant and debt derivative liability
|
406
|
|
|
301
|
|
|
20
|
|
|||
Non-cash interest expense
|
103
|
|
|
35
|
|
|
28
|
|
|||
Changes in assets and liabilities excluding effect of assets and liabilities assumed in 2016 acquisition of Epiva (Note 7):
|
|
|
|
|
|
||||||
Prepaid expenses and other current assets
|
(3,052
|
)
|
|
(347
|
)
|
|
(3
|
)
|
|||
Accounts payable
|
(221
|
)
|
|
774
|
|
|
(43
|
)
|
|||
Accrued expenses and other current liabilities
|
3,594
|
|
|
1,733
|
|
|
273
|
|
|||
Other liabilities
|
843
|
|
|
(90
|
)
|
|
(171
|
)
|
|||
Net cash used in operating activities
|
(47,279
|
)
|
|
(23,265
|
)
|
|
(12,314
|
)
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchase of investments
|
(136,087
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from sales and maturities of investments
|
81,250
|
|
|
—
|
|
|
—
|
|
|||
Cash acquired in the 2016 acquisition of Epiva
|
—
|
|
|
—
|
|
|
10,486
|
|
|||
Purchases of property and equipment
|
(5,462
|
)
|
|
(1,742
|
)
|
|
(1,250
|
)
|
|||
Proceeds from the sale of fixed assets
|
171
|
|
|
—
|
|
|
27
|
|
|||
Net cash used in investing activities
|
(60,128
|
)
|
|
(1,742
|
)
|
|
9,263
|
|
|||
Financing activities
|
|
|
|
|
|
||||||
Net proceeds from the issuance of common stock upon completion of initial public offering
|
75,829
|
|
|
—
|
|
|
—
|
|
|||
Deferred issuance costs
|
—
|
|
|
(15
|
)
|
|
—
|
|
|||
Net proceeds from the issuance of convertible preferred stock
|
81,336
|
|
|
48,903
|
|
|
7,495
|
|
|||
Net proceeds from the issuance of long-term debt
|
4,975
|
|
|
—
|
|
|
11,000
|
|
|||
Settlement of derivative liability
|
(250
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from the exercise of stock options, restricted common stock and warrants
|
122
|
|
|
79
|
|
|
247
|
|
|||
Repayment of long-term debt
|
—
|
|
|
—
|
|
|
(4,000
|
)
|
|||
Change in stockholders' payable
|
—
|
|
|
—
|
|
|
1,000
|
|
|||
Net cash provided by financing activities
|
162,012
|
|
|
48,967
|
|
|
15,742
|
|
|||
Net increase in cash, cash equivalents and restricted cash
|
54,605
|
|
|
23,960
|
|
|
12,691
|
|
|||
Cash, cash equivalents and restricted cash – beginning of year
|
39,746
|
|
|
15,786
|
|
|
3,095
|
|
|||
Cash, cash equivalents and restricted cash – end of year
|
$
|
94,351
|
|
|
$
|
39,746
|
|
|
$
|
15,786
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
742
|
|
|
$
|
437
|
|
|
$
|
204
|
|
Noncash investing and financing activities
|
|
|
|
|
|
||||||
Conversion of convertible preferred stock into common stock upon closing of initial public offering
|
$
|
165,778
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Conversion of convertible preferred stock warrants into common stock warrants
|
$
|
819
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Property and equipment additions in accounts payable and accrued expenses
|
$
|
348
|
|
|
$
|
84
|
|
|
$
|
—
|
|
Issuance of debt derivative liability in connection with long-term debt facility
|
$
|
150
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of warrants in connection with long-term debt facility
|
$
|
89
|
|
|
$
|
—
|
|
|
$
|
76
|
|
Accretion of convertible preferred stock to redemption value
|
$
|
—
|
|
|
$
|
32
|
|
|
$
|
1,645
|
|
Long-term debt assumed in acquisition of Epiva, net of discount
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,923
|
|
Net non-cash assets acquired in acquisition of Epiva
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
57
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash and cash equivalents:
|
|
|
|
||||
Cash
|
$
|
1,300
|
|
|
$
|
13,204
|
|
Money Market Funds
|
91,801
|
|
|
25,042
|
|
||
Total cash and cash equivalents
|
93,101
|
|
|
38,246
|
|
||
Restricted cash
|
1,250
|
|
|
1,500
|
|
||
Cash, cash equivalents and restricted cash
|
$
|
94,351
|
|
|
$
|
39,746
|
|
•
|
Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities;
|
•
|
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and
|
•
|
Level 3 inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
|
Classification
|
|
Estimated Useful Life
|
Computer hardware
|
|
3 - 5 Years
|
Computer software
|
|
3 years
|
Furniture and fixtures
|
|
7 years
|
Research and lab equipment (new/used)
|
|
5 years / 3 years
|
Leasehold improvements
|
|
Lesser of asset life or
remaining life of lease |
Description
|
|
Amortized Cost
|
|
Unrealized Gain
|
|
Unrealized Loss
|
|
Fair Value
|
||||||||
December 31, 2018:
|
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
|
$
|
54,836
|
|
|
$
|
—
|
|
|
$
|
(18
|
)
|
|
$
|
54,818
|
|
Total
|
|
$
|
54,836
|
|
|
$
|
—
|
|
|
$
|
(18
|
)
|
|
$
|
54,818
|
|
Description
|
|
December 31, 2018
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Money market funds included within cash and cash equivalents
|
|
$
|
91,801
|
|
|
$
|
91,801
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. treasury securities included within short-term investments
|
|
$
|
54,818
|
|
|
$
|
—
|
|
|
$
|
54,818
|
|
|
$
|
—
|
|
Total
|
|
$
|
146,619
|
|
|
$
|
91,801
|
|
|
$
|
54,818
|
|
|
$
|
—
|
|
Description
|
|
December 31, 2017
|
|
Active
Markets
(Level 1)
|
|
Observable
Inputs
(Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Money market funds included within cash and cash equivalents
|
|
$
|
25,042
|
|
|
$
|
25,042
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
|
$
|
25,042
|
|
|
$
|
25,042
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Preferred Stock Warrant Liability
|
|
$
|
424
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
424
|
|
Total
|
|
$
|
424
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
424
|
|
|
December 31, 2017
|
|
Risk-free interest rate
|
2.3 - 2.4 %
|
|
Expected dividend yield
|
0.00
|
%
|
Expected term (in years)
|
7.9 - 8.6
|
|
Expected volatility
|
81 - 82 %
|
|
Fair value of preferred stock
|
$2.41 - 2.56
|
|
Risk-free interest rate
|
2.3 - 2.4 %
|
|
|
Expected dividend yield
|
0.00
|
%
|
|
Expected term (in years)
|
7.5 - 9.8
|
|
|
Expected volatility
|
81 - 82 %
|
|
|
Fair value of common stock
|
$
|
16.00
|
|
|
Warrant
Liability
|
Debt Derivative Liability
|
||||
Balance at December 31, 2017
|
$
|
424
|
|
$
|
—
|
|
Issuance of embedded derivative instrument
|
—
|
|
150
|
|
||
Change in fair value of derivative instrument included in other income (expense), net
|
—
|
|
100
|
|
||
Settlement of derivative instrument
|
—
|
|
(250
|
)
|
||
Issuance of warrants to purchase convertible preferred stock
|
89
|
|
—
|
|
||
Balance at Change in fair value of warrant liability, included in other income (expense), net
|
306
|
|
—
|
|
||
Exercise of warrants
|
(819
|
)
|
—
|
|
||
Balance at December 31, 2018
|
$
|
—
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Property and equipment:
|
|
|
|
||||
Lab equipment
|
$
|
5,393
|
|
|
$
|
3,189
|
|
Leasehold improvements
|
1,824
|
|
|
1,334
|
|
||
Furniture and fixtures
|
525
|
|
|
217
|
|
||
Computers and software
|
115
|
|
|
77
|
|
||
Office equipment
|
9
|
|
|
9
|
|
||
Construction-in-process
|
1,011
|
|
|
99
|
|
||
Property and equipment
|
8,877
|
|
|
4,925
|
|
||
Less: accumulated depreciation
|
(1,952
|
)
|
|
(1,429
|
)
|
||
Property and equipment, net
|
$
|
6,925
|
|
|
$
|
3,496
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Accrued external research and development expenses
|
$
|
1,587
|
|
|
$
|
715
|
|
Accrued payroll and related expenses
|
2,198
|
|
|
256
|
|
||
Accrued professional fees
|
1,010
|
|
|
1,081
|
|
||
Accrued other
|
170
|
|
|
147
|
|
||
Total accrued expenses
|
$
|
4,965
|
|
|
$
|
2,199
|
|
2019
|
$
|
3,342
|
|
2020
|
8,021
|
|
|
2021
|
5,108
|
|
|
Total minimum payments
|
$
|
16,471
|
|
Less amounts representing interest and discount
|
(1,666
|
)
|
|
Less current portion
|
(2,500
|
)
|
|
Long-term debt, net of current portion
|
$
|
12,305
|
|
2019
|
$
|
3,280
|
|
2020
|
3,088
|
|
|
2021
|
2,973
|
|
|
2022
|
3,062
|
|
|
2023
|
3,154
|
|
|
Thereafter
|
5,740
|
|
|
|
$
|
21,297
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Research and development
|
$
|
2,508
|
|
|
$
|
849
|
|
|
$
|
205
|
|
General and administrative
|
3,551
|
|
|
693
|
|
|
214
|
|
|||
Total stock-based compensation expense
|
$
|
6,059
|
|
|
$
|
1,542
|
|
|
$
|
419
|
|
|
Shares
|
|
Weighted
Average -
Exercise Price
|
|
Weighted
Average -
Remaining
Contractual Life
|
|
Aggregate
Intrinsic
Value(1)
(in thousands)
|
|||||
Options outstanding at December 31, 2017
|
3,179,536
|
|
|
$
|
1.88
|
|
|
9.05
|
|
$
|
19,803
|
|
Granted
|
2,013,157
|
|
|
$
|
11.27
|
|
|
|
|
|
||
Exercised
|
(84,801
|
)
|
|
$
|
0.83
|
|
|
|
|
|
||
Canceled
|
(190,081
|
)
|
|
$
|
4.56
|
|
|
|
|
|
||
Options outstanding at December 31, 2018
|
4,917,811
|
|
|
$
|
5.64
|
|
|
8.52
|
|
$
|
37,395
|
|
Exercisable at December 31, 2018
|
1,465,230
|
|
|
$
|
1.57
|
|
|
7.63
|
|
$
|
16,775
|
|
Vested and expected to vest as of December 31, 2018 (2)
|
4,917,811
|
|
|
$
|
5.64
|
|
|
8.52
|
|
$
|
37,395
|
|
(1)
|
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period.
|
(2)
|
This reflects the Company’s adoption and election under ASU 2016-9 to recognize forfeitures as they occur.
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Risk-free interest rate
|
2.74
|
%
|
|
2.03
|
%
|
|
1.33
|
%
|
Expected life (in years)
|
6.17
|
|
|
6.18
|
|
|
5.66
|
|
Volatility
|
77.0
|
%
|
|
79.5
|
%
|
|
87.2
|
%
|
Expected dividend rate
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Risk-free interest rate
|
2.71
|
%
|
|
2.30
|
%
|
|
2.35
|
%
|
Expected life (in years)
|
8.29
|
|
|
9.43
|
|
|
9.51
|
|
Volatility
|
75.6
|
%
|
|
78.9
|
%
|
|
89.0
|
%
|
Expected dividend rate
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
|
Shares
|
|
Weighted-
Average Price
|
|||
Outstanding at December 31, 2017
|
257,876
|
|
|
$
|
0.40
|
|
Vested
|
(113,627
|
)
|
|
$
|
0.32
|
|
Repurchased
|
(18,468
|
)
|
|
$
|
0.49
|
|
Outstanding at December 31, 2018
|
125,781
|
|
|
$
|
0.45
|
|
|
December 31,
|
||||
|
2018
|
|
2017
|
||
U.S. federal tax statutory rate
|
21.0
|
%
|
|
34.0
|
%
|
State taxes, net of federal benefit
|
6.5
|
%
|
|
5.6
|
%
|
Non-deductible stock compensation
|
(1.0
|
)%
|
|
(1.0
|
)%
|
Other non-deductible expenses
|
(0.6
|
)%
|
|
(0.5
|
)%
|
Credits
|
2.3
|
%
|
|
0.8
|
%
|
Change in federal tax rate due to tax reform
|
—
|
%
|
|
(22.5
|
)%
|
Change in valuation allowance
|
(28.2
|
)%
|
|
(16.5
|
)%
|
Other
|
—
|
%
|
|
0.1
|
%
|
|
—
|
%
|
|
—
|
%
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
26,339
|
|
|
$
|
13,183
|
|
Research and development credits
|
2,721
|
|
|
1,175
|
|
||
Capitalized research and development, patent and start-up costs
|
360
|
|
|
241
|
|
||
Accrued expenses
|
918
|
|
|
267
|
|
||
Stock based compensation
|
1,017
|
|
|
217
|
|
||
Depreciation
|
(281
|
)
|
|
(66
|
)
|
||
Deferred tax assets before valuation allowance
|
31,074
|
|
|
15,017
|
|
||
Valuation allowance
|
(31,074
|
)
|
|
(15,017
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
|||||||
|
2018
|
|
2017
|
|
2016
|
|||
Convertible preferred shares (as converted to common stock)
|
—
|
|
|
16,139,518
|
|
|
9,329,570
|
|
Warrant to purchase convertible preferred shares (as converted to common stock) and common shares
|
—
|
|
|
47,628
|
|
|
47,628
|
|
Unvested common stock from early exercise of options
|
125,781
|
|
|
257,876
|
|
|
412,796
|
|
Stock options to purchase common stock
|
4,917,811
|
|
|
3,179,536
|
|
|
2,127,261
|
|
Total
|
5,043,592
|
|
|
19,624,558
|
|
|
11,917,255
|
|
|
Three Months Ended
|
||||||||||||||
|
2018
|
||||||||||||||
(in thousands except per share data)
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Total operating expenses
|
$
|
10,425
|
|
|
$
|
15,228
|
|
|
$
|
16,457
|
|
|
$
|
15,993
|
|
Total other expense (income), net
|
75
|
|
|
(82
|
)
|
|
(600
|
)
|
|
(550
|
)
|
||||
Net loss
|
$
|
(10,500
|
)
|
|
$
|
(15,146
|
)
|
|
$
|
(15,857
|
)
|
|
$
|
(15,443
|
)
|
Convertible preferred stock dividends
|
(2,417
|
)
|
|
(1,520
|
)
|
|
—
|
|
|
—
|
|
||||
Net loss attributable to common stockholders
|
$
|
(12,917
|
)
|
|
$
|
(16,666
|
)
|
|
$
|
(15,857
|
)
|
|
$
|
(15,443
|
)
|
Net loss per share applicable to common stockholders, basic and diluted
|
$
|
(3.29
|
)
|
|
$
|
(0.85
|
)
|
|
$
|
(0.50
|
)
|
|
$
|
(0.49
|
)
|
|
Three Months Ended
|
||||||||||||||
|
2017
|
||||||||||||||
(in thousands except per share data)
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Total operating expenses
|
$
|
5,208
|
|
|
$
|
6,218
|
|
|
$
|
8,038
|
|
|
$
|
8,067
|
|
Total other expense, net
|
162
|
|
|
143
|
|
|
135
|
|
|
76
|
|
||||
Net loss
|
$
|
(5,370
|
)
|
|
$
|
(6,361
|
)
|
|
$
|
(8,173
|
)
|
|
$
|
(8,143
|
)
|
Convertible preferred stock dividends
|
(1,225
|
)
|
|
(1,422
|
)
|
|
(1,708
|
)
|
|
(1,730
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(6,595
|
)
|
|
$
|
(7,783
|
)
|
|
$
|
(9,881
|
)
|
|
$
|
(9,873
|
)
|
Net loss per share applicable to common stockholders, basic and diluted
|
$
|
(1.81
|
)
|
|
$
|
(2.09
|
)
|
|
$
|
(2.61
|
)
|
|
$
|
(2.57
|
)
|
A
|
WEATHERDEN LTD
a company incorporated in England & Wales (registration number 09241011) whose registered office is Units 4 & 5, Swinford Farm, Eynsham, Oxford, OX29 4BL (‘the Consultancy’ or ‘Weatherden’), and
|
B
|
EVELO BIOSCIENCES, INC
a company incorporated in Delaware whose registered office is 620 Memorial Drive, Suite 200 West, Cambridge, Ma, Massachusetts, 02139 (‘the Client’ or ‘Evelo’).
|
1.
|
Nature of this Agreement
|
1.1
|
This is a Master Agreement and defines the terms under which the Consultancy will undertake such Services for the Client as may be agreed between the parties from time to time. No changes will apply unless in writing and signed by both parties.
|
1.2
|
Entering this Agreement does not of itself oblige the Client to offer any work to the Consultancy nor for the Consultancy to provide or the Client to accept or pay for any particular consultancy services. Neither party wishes to create or imply any mutuality of obligation between themselves either in the course of or between any performance of the services or during any notice period.
|
1.3
|
Where it is agreed between the parties that any Services are to be provided, a schedule in the form annexed to this Agreement setting out the nature of the Services, the charging basis, and any other material terms (a ‘Schedule’) will be produced by the Consultancy and provided to the Client.
|
1.4
|
On receipt of a Schedule
|
1.4.1
|
if the Client accepts its terms, the Client will promptly sign and return one copy to the Consultancy
|
1.4.2
|
if the Client does not accept its terms, the Client will promptly advise the Consultancy.
|
1.5
|
Upon a Schedule being signed by both parties, it will become a contract binding on the parties.
|
1.6
|
A contract formed on the basis of a Schedule referencing these terms is governed only by the terms of this Agreement, and by no others, except where both parties expressly agree in writing. In particular, it is agreed that any purchase order or other such document from the Client or Consultancy is intended for the Client’s own administrative purposes only, and that notwithstanding its wording, neither a Purchase Order nor its content will have any legal effect. Save to the extent expressly provided, all conditions, warranties or other terms implied by statute or common law are hereby excluded to the fullest extent permitted by law.
|
1.7
|
Either party may request change to the nature or scope of Services covered by a Schedule. Any such request shall be sufficiently detailed to enable the other party to assess the impact of the proposed change. No such change will become effective until agreed in writing between the parties and shall become a change order as discussed in Section 5.
|
1.8
|
This Agreement is not exclusive; the Client acknowledges that the Consultancy enters this Agreement in the course of its business of providing services to its customers, and the Consultancy is and remains at liberty to also provide services to third parties; it is the Consultancy’s responsibility to ensure it does not enter any third-party engagement which might cause a conflict of interest to arise or violate any of the terms herein. The Client is and remains at liberty to engage services (including similar services) from third parties. The Consultancy reserves the right to decline to provide any advice and assistance outside the scope of the Services as specified in Schedules agreed between the parties, even if the Consultancy may previously have provided such additional advice and assistance.
|
2.
|
Services
|
2.1
|
The Consultancy will provide Services as agreed from time to time in Schedules, so far as is reasonably practicable within any agreed timescale, in compliance with applicable laws and regulations, written instructions from Client, and with all proper skill and care.
|
2.2
|
As an independent agency,
|
2.2.1
|
the Consultancy will not require or be subject to supervision direction or control as to its daily activities or the manner of performance thereof, and itself accepts the responsibility for the proper provision of Services
|
2.2.2
|
for the avoidance of doubt, the Client shall not (and does not have the right to) exercise supervision, direction or control as to the manner of performance of the Services
|
2.2.3
|
it is the Consultancy’s responsibility to (and the Consultancy shall) maintain Professional Indemnity, Employer's Liability (where legally required), and Public Liability insurance reasonably sufficient to cover such liabilities and obligations of the Consultancy as may arise in connection with the provision of the Services (in each on such terms and in such amount as a reasonably prudent person would consider to be adequate).
|
2.3
|
The Consultancy is responsible for providing personnel who have sufficient qualifications and training to perform the Services herein and for maintaining reasonable continuity in personnel providing Services on its behalf,
|
2.3.1
|
but reserves the right to make changes to those personnel providing the Services from time to time upon written approval from Client;
|
2.3.2
|
no additional charge will be made for any handover period, and
|
2.3.3
|
the Consultancy remains responsible
|
2.3.3.1
|
for any supervision and direction of its personnel in the provision of the Services, and
|
2.3.3.2
|
in any event for all Services performed on its behalf.
|
2.4
|
Where the Consultancy’s charges are on a time and materials basis, or where any individual who will provide Services is named in a Schedule (or the Client has a reasonable expectation that the Services will primarily be provided by a specific individual), it is the Consultancy’s responsibility to ensure
|
2.4.1
|
that the relevant skills and experience of any replacement personnel remain commensurate with the fee rates charged, and
|
2.4.2
|
that any replacement personnel have the necessary skills to perform the Services without the need for additional training by the Client.
|
2.5
|
It is the Client’s responsibility
|
2.5.1
|
to afford the Consultancy with such reasonable access, information and staff cooperation as the Consultancy may reasonably require for the proper performance of any Services, and
|
2.5.2
|
where the Consultancy provides the Services at the premises of the Client, to ensure that all relevant Health and Safety policies, risks, information and relevant statutory compliance measures are disclosed to the Consultancy to the extent required by applicable law.
|
2.6
|
Consultancy will not use a subcontractor to perform the Services or otherwise subcontract its obligations hereunder without the prior written consent of Client, other than team members operating through companies as individuals as listed in the Schedules, for the agreed upon amounts as listed in the Schedules. Any permitted subcontractor will be obligated to perform in accordance with this Agreement and Consultancy will be responsible for the actions and omissions of such subcontractor as if Consultancy had made such actions or omissions itself.
|
3.
|
Confidentiality
|
3.1
|
Unless the parties have signed a separate agreement containing more specific provisions in relation to confidentiality (in which case the provisions of such agreement will continue to apply in lieu of this clause), each party
|
3.1.1
|
will keep any confidential information disclosed by the other secret, and
|
3.1.2
|
on termination (or sooner if required) will at the option of the owner thereof return or destroy such confidential information of the owner, however that the party may retain one (1) copy in its confidential files solely for purposes of exercising the party’s rights hereunder, satisfying its obligations hereunder or complying with any legal proceeding or requirement with respect thereto and further, provided, that the party shall not be required to erase electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files. Such retained copies of confidential information shall remain subject to the confidentiality and non-use obligations herein.
|
3.1.3
|
shall only share confidential information with its employees and agents who are bound by confidentiality agreements with terms at least as restrictive as those herein and provided that the disclosing partner shall be responsible for any breach of this section by its employees and agents.
|
3.1.4
|
Neither anything contained in this Agreement, nor any delivery of any confidential information to the other Party will be deemed to grant to the Receiving Party any rights or licenses under any intellectual property rights (including, without limitation, patent applications, patents, extensions, trade secrets, trademarks, copyrights and/or rights in non-public information) of the disclosing party, except as necessary for Consultancy to perform the Services or for Client to make use of the Services, Data, Deliverables and/or any intellectual property rights.
|
3.1.5
|
For clarity, Client’s confidential information will further include the Data, and Materials, both as further defined herein.
|
3.2
|
Neither party may use or take advantage of any such confidential information of the other party without the discloser’s consent, even after the end of this Agreement.
|
3.3
|
This obligation does not apply to
|
3.3.1
|
information known to the party subject to the obligation of confidentiality before disclosure by the other party, and free of any obligation of confidentiality, or
|
3.3.2
|
information independently developed or acquired by the party subject to the obligation of confidentiality, without reference or access to the other party’s confidential information, and free of any obligation of confidentiality, or
|
3.3.3
|
information which becomes public knowledge without fault on the part of the party subject to the obligation of confidentiality.
|
3.4
|
The provisions of clause 3.1 shall not prevent a party disclosing confidential information of the other party if and to the extent such disclosure is required pursuant to any legal or regulatory requirement applicable provided advance written notice is provided to the other party where reasonably possible to allow the other party to seek a protective order or otherwise attempt to limit.
|
4.
|
Copyright and Intellectual Property Rights
|
4.1
|
‘Deliverable’ means a work produced by the Consultancy in the course of Services for delivery to the Client.
|
4.1.1
|
Where Consultancy’s pre-existing works are with the knowledge and written consent of the Client incorporated in any Deliverable, Consultancy hereby grants to Client a non-exclusive, irrevocable, world-wide, royalty free licence to use, modify and distribute such pre-existing works, but only as part of the Deliverable; all other rights in the pre-existing works are reserved.
|
4.1.2
|
Subject thereto, all rights in any Deliverable pass to the Client upon payment of all fees not in dispute due to the Consultancy which relate to that Deliverable, and the Consultancy hereby assigns and such rights, and if necessary, will execute a formal assignment thereof on request by the Client.
|
4.1.3
|
Further, Consultancy agrees that, as between Consultancy and Client, Client owns all rights, title, and interest in any data generated from the Services ("Data"), Deliverables, and/or rights (including, without limitation, intellectual property rights such as patent applications, patents, extensions, trade secrets, trademarks, copyrights and/or rights in non-public information) related to the (a) Material or its uses, (b) Data, (c) Deliverables and/or (d) improvements, developments, discoveries, and designs which are conceived, recorded, and/or reduced to practice by Consultancy, alone or jointly with others, (1) in connection with the Services or (2) which are related to the Material or its uses or (3) are developed using the Material or the Confidential Information (collectively with the rights in 4.1.2, "Inventions"). Consultancy hereby assigns to Client all of Consultancy’s rights to and interest in any Inventions. If any of Client’s ownership rights contemplated under this section is not perfected, fails to arise, reverts or terminates by operation of law, then Consultancy hereby grants to Client an exclusive (even to Consultancy), irrevocable, perpetual, fully paid-up, royalty-free, transferable, sub-licensable (through multiple layers of sub-licensees), worldwide license to all rights, title and interest in the Inventions. Consultancy will act as necessary to perfect, maintain, and/or enforce (to “Protect”) Client’s rights in the Inventions, including, without limitation, reviewing, executing and delivering all requested supporting documents. Client will reimburse Consultancy’s reasonable out-of-pocket costs for such assistance.
|
4.2
|
The Consultancy will indemnify the Client against infringement of third party rights by a Deliverable, provided that the Client notifies the Consultancy of any relevant third-party rights promptly on such rights becoming known to or reasonably suspected by the Client.
|
4.3
|
Nothing shall prevent the Consultancy from using techniques, ideas, and other know-how gained during the performance of Services under this Agreement in the furtherance of its own business, provide that such techniques, ideas and other know-how do not contain or rely upon any Client Confidential Information and only to the extent that such does not result in disclosure or abuse of confidential information in breach hereof, or any infringement of any Intellectual Property Rights of the Client.
|
4.4
|
Consultancy acknowledges that, as between Consultancy and Client, Client owns any reagents, compounds, biological material, devices or other technology provided to Consultancy in connection with the Services, and any modifications, improvements, fragments, analogs or homologs thereof and/or derivatives of the foregoing (“Materials”). Consultancy will not provide or offer to provide any Material to any third-party or person not performing Services hereunder, without the prior written consent of Client. The Materials are to be used by Consultancy solely for completing the Services. Furthermore, upon Client’s request or completion of Services, any unused Material will be, at Client’s discretion and instruction, either destroyed or returned to Client.
|
5.
|
Charges and Payment
|
5.1
|
All sums due shall be invoiced and paid as specified in the applicable Schedule.
|
5.2
|
The Client will pay the Consultancy’s invoices within 30 days of receipt of invoice, plus VAT where applicable.
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5.3
|
Unless otherwise specified, where payment is on a time and materials basis, the Consultancy may invoice monthly.
|
5.4
|
If any of the Consultancy’s invoices becomes overdue and are not in dispute and Consultant has notified Client in writing,
|
5.4.1
|
the Consultancy may suspend provision of Services, and any agreed timescale will be automatically extended;
|
5.4.2
|
the Consultancy may also terminate this Agreement and any current Schedule for material breach whilst any payment is more than 14 business days overdue.
|
5.5
|
Unless noted otherwise in the Schedule, all invoices will be in GB Pounds Sterling and must contain an itemized breakdown of all fees and expenses (and be accompanied by relevant supporting documentation), All invoices must reference a valid Client Purchase Order Number in order for payment to be processed. All other payment terms will be included in the Schedule but under no circumstances will the total payments prior to the initiation of service exceed 20% of the total payments provided in the Schedule.
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5.6
|
Prior to the first payment, Consultancy will submit a completed W-8 or W-9 to Client. Invoices should be sent to Client as specified in the corresponding Schedule. If the Schedule does not specify where invoices should be sent to Client, invoices should be sent to:
|
5.7
|
If Client requests any changes in the nature, scope, or cost of the Services or if pricing herein is dependent on incorrect information provided by the Client, or if any specified dependencies / facilities are not available on time not due to any fault of Consultancy, or if any equipment required to be provided by the Client fails to operate correctly (save where the engagement itself is for the repair thereof), the parties will agree on a change order. Consultancy will first notify Client in writing of the cost of such changes and will not proceed without Client’s prior written consent. Any such approved changes to Services will be considered an amendment to the applicable Schedule and governed by this Agreement and must be accompanied by a separate PO number and referenced when billing.
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5.8
|
If while performing Services Consultancy will compensate any health care providers for their support of the Services, Consultancy will follow Client’s requirements for determining the fair market value for such health care provider support and will reasonably report such compensation and other transfers of value to health care providers to Client in a format and frequency to enable Client to comply with applicable laws and regulations.
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6.
|
Liability
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6.1
|
Neither party excludes liability for death, personal injury, fraud, or otherwise where it is not lawful to do so. Subject thereto, and except for any breach of the confidentiality section or intellectual property sections herein,
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6.1.1
|
each party expressly excludes liability for economic, consequential or indirect loss or damage of any kind, or for loss of profit, business, revenue, goodwill or anticipated savings.
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6.1.2
|
Except for the indemnity or for claims due to its gross negligence, neither party shall be liable for any loss or damage in excess of three times the total sums payable under a Schedule, except where it may not lawfully exclude or limit liability
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6.2
|
Consultancy shall indemnify, defend and hold harmless Client, and its respective officers, directors, employees and agents (collectively, the “Client Indemnitees”) against any third party claims, to the extent arising out of or relating to: (i) Consultancy or any of its employees or agents’ negligence or wilful misconduct in performing obligations under this Agreement; or (iii) Consultancy’s breach of this Agreement.
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7.
|
Termination
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7.1
|
Either party may terminate this Agreement at any time when there is no current Schedule, by immediate written notice.
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7.2
|
Client may terminate any Schedule upon thirty days’ written notice with or without cause.
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7.3
|
Either party may terminate this Agreement and any current Schedule at any time if the other is in material breach or if the other becomes insolvent, by immediate written notice.
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7.4
|
Any provision of this agreement which expressly or by implication is intended to come into or continue in force on or after termination of this agreement shall remain in full force and effect.
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8.
|
Force Majeure
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9.
|
Staff obligations and third-party rights
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9.1
|
The Client is a client of a business undertaking carried on by the Consultancy, and it is not the intention of either to create or allow to arise any employee/employer relationship between the Client and any individual providing Services on behalf of the Consultancy.
|
9.2
|
Each party solely retains all the responsibilities and rights of an employer towards and in relation to its own employees. Neither party seconds its employees or any of them to the other. No person providing Services is expected or required to integrate into the Client’s business organisation or employed workforce.
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9.3
|
With the exception of agreed subcontractors where it is mutually agreed that Company shall pay the subcontractor directly, the Consultancy will ensure that all remuneration it pays any personnel engaged on the Services is paid and taxed as employment income, within the meaning of the Income Tax (Earnings and Pensions) Act 2003 as amended. Consultancy shall be responsible for the payment of all taxes, for all employment, insurance and other similar taxes with respect to any compensation provided by the Client to Consultancy. Consultant will indemnify Client against any claims brought by or in relation to its own employees, whether such claims relate to employment, tax, national insurance, or otherwise
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9.4
|
Where applicable, the Consultancy is solely responsible for complying with the requirements of the Working Time Regulations 1998 (as amended) and any other legislation relating to workers, in relation to any individual providing Services on its behalf.
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9.5
|
Other than by general advertisement for such position or in response to an initiative by an employee responding to such general advertisement, neither party will employ, engage, or otherwise solicit any person who during the previous 6 months was an officer, employee or sub‑contractor of the other and with whom such party had material contact in connection with Services performed under any Schedule, until 6 months after that Schedule has terminated.
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9.6
|
Other than by general advertisement for such position or in response to an initiative by an employee responding to such general advertisement neither party will solicit any person who during the previous 6 months was a client of the other and with whom such party had material contact in connection with Services performed under any Schedule, until 6 months after that Schedule has terminated, unless a fee is mutually agreed by the Consultancy and the Client, typically to be equal 33% of the remuneration of the person hired
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9.7
|
No third-party rights are intended to be conferred or created by this Agreement or any Schedule.
|
9.8
|
In this term, ‘employees’ includes, so far as the context permits:
|
9.8.1
|
in the case of an LLP or partnership, its partners and employees
|
9.8.2
|
in the case of a company, its officers and employees.
|
10.
|
Data Protection
|
10.1
|
The parties mutually acknowledge their respective responsibilities (a) to comply with the applicable provisions of the Data Protection Act 1998, General Data Protection Regulation 2016/679/EC
and any applicable data protection laws ("(“Data Protection Laws”) with respect to Personal Data, as defined in the Data Protection Laws, and (b) to use Personal Data provided by the other so far as necessary for the proper performance of this Agreement or any Schedule hereto, but not further or otherwise.
|
10.2
|
Consultancy shall assist and cooperate as is reasonably necessary or reasonably requested by Client to ensure Client complies with the Data Protection Laws. For Personal Data disclosed to Consultancy in connection with this Agreement (and whether disclosed by Client, data subjects or otherwise), Consultancy will only process such Personal Data as permitted by the Data Protections Laws and for purposes requested by Client and for which Consultancy has appropriate measures (including, without limitation, communicating appropriate policies to employees, managing ongoing compliance, and implementing effective information security) for the Personal Data to prevent (1) unauthorised or unlawful processing of the Personal Data and (2) accidental loss or destruction of, or damage to, the Personal Data.
|
10.3
|
Consultancy will not disclose to any third-party or provide to Client any personal data unless the individual to whom such personal data pertains has granted his or her informed written consent to such disclosure. This includes unambiguous and explicit written consent to the potential transfer of personal data outside such person’s country of residence to another jurisdiction, including, without limitation, the United States of America where different data protection rules apply. Consultancy will take all steps required and communicated in writing to Consultancy by Client that Client reasonably considers are necessary to comply with Client’s own obligations under Data Protection Laws.
|
10.4
|
Consultancy will ensure that all employees, independent contractors or agents involved in providing Services under this Agreement have granted their written consent to the processing of their personal data by Client for the purposes of this Agreement and to the possible transfer of this data outside their country of residence to another jurisdiction, including, without limitation, the United States of America where different data protection rules apply.
|
10.5
|
If either party becomes aware of any unauthorised, unlawful or dishonest conduct or activities, or any breach of the terms of this Agreement relating to Personal Data, such Party will promptly notify the other Party in writing thereof and the Parties will take such action as such party may deem reasonably necessary to prevent any further unauthorised, unlawful or dishonest conduct or activities or breach of the terms of this Agreement relating to Personal Data.
|
10.6
|
Appendix 1 shall apply if Consultancy is processing Personal Data on behalf of Client. The Schedules shall include any Personal Data being processed.
|
11.
|
Bribery and Corruption
|
11.1
|
The parties shall each comply with all applicable legal requirements relating to bribery and corruption.
|
11.2
|
The Consultancy shall comply with any Client policies relating to bribery and corruption that may be disclosed to the Consultancy, as though such policies applied to and had been adopted by the Consultancy.
|
12.
|
Notices
|
13.
|
Electronic signatures
|
14.
|
Representations and Warranties
|
(a)
|
neither it, nor any of its management or any other employees or independent contractors or agents who will have any involvement in the Services supplied under this Agreement, have (i) been excluded, debarred, suspended or otherwise made ineligible to exercise their profession and activities; or (ii) engaged in any act that would be grounds for such exclusion, debarment or suspension. Upon learning or acquiring knowledge of any facts or circumstances that may lead to actions relating to the representations above (including, without limitation, criminal actions), Consultancy will immediately disclose such facts or circumstances to Client; and Client may immediate terminate the Agreement.
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15.
|
Records, Reports and Audits.
|
16.
|
Publicity/Publication.
|
17.
|
Law.
|
18.
|
Entire Agreement.
This Agreement, together with any Schedule, constitutes the entire agreement between the Parties and supersedes and supplants all prior and contemporaneous representations, agreements, and understandings, whether oral, written or otherwise, between the Parties.
|
Title:
|
Chairman
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Date:
|
14 September 2018
|
Title:
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VP, Finance and Operations
|
Date:
|
14 September 2018
|
|
(iv) Process the Personal Data only on documented instructions from Client, including with regard to transfers of Personal Data to a third country or an international organization; unless required to do so by law; in such a case, Consultancy shall inform the Client of such legal requirement before processing. If Consultancy is required to use the Personal Data for another purpose by EU or Member State law to which the Consultancy is subject, Consultancy will, unless prohibited by applicable law, promptly (and in no event more than twenty-four (24) hours after receipt of such information) notify Client in writing of that legal requirement before Processing such Personal Data; and to the extent permitted by applicable EU or Member State law, Consultancy will comply with the written directions of Client, limit the nature and scope of the requested disclosure, and disclose the minimum Personal Data necessary;
|
1.
|
I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2018 of Evelo Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
[intentionally omitted];
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
|
Date: February 15, 2019
|
|
|
By:
|
|
/s/ Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
|
|
Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K for the fiscal year ended December 31, 2018 of Evelo Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
[intentionally omitted];
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
|
|
Date: February 15, 2019
|
|
|
By:
|
|
/s/ Jonathan Poole
|
|
|
|
|
|
Jonathan Poole
|
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
(Principal Financial and Accounting Officer)
|
(1)
|
The Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the “Report”) fully complies with the requirements of Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
|
|
|
|
|
Date: February 15, 2019
|
|
|
By:
|
|
/s/ Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
|
|
Balkrishan (Simba) Gill, Ph.D.
|
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
(Principal Executive Officer)
|
(1)
|
The Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the “Report”) fully complies with the requirements of Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
|
|
|
|
|
Date: February 15, 2019
|
|
|
By:
|
|
/s/ Jonathan Poole
|
|
|
|
|
|
Jonathan Poole
|
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
(Principal Financial and Accounting Officer)
|