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Delaware
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51-0596811
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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100 Acorn Park Drive
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Cambridge, Massachusetts
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02140
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(Address of principal executive offices)
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(Zip Code)
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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, $0.001 par value
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NASDAQ Global Market
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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•
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the timing of results of our ongoing and planned clinical trials;
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our planned clinical trials for GEN-003;
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our estimates regarding the amount of funds we require to complete our clinical trials for GEN-003 and to continue our investments in our immuno-oncology and infectious disease pipeline;
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our estimate for when we will require additional funding;
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our plans to commercialize GEN-003 and our other vaccine candidates;
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the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;
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the rate and degree of market acceptance and clinical utility of any approved product candidate;
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the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
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our ability to quickly and efficiently identify and develop product candidates;
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our commercialization, marketing and manufacturing capabilities and strategy;
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our intellectual property position; and
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our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing.
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Vaccine
Candidate
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Program
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Stage of Development
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Next Milestone
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Anticipated Timeline
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GEN-003
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Genital herpes Therapeutic
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Phase 2
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12-month data from Phase 2 dose optimization trial
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Later in first quarter of 2016
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GEN-004
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Pneumococcus Prophylaxis
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Suspended development pending further data analysis and consultation advisors
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||||
GEN-002
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Genital Herpes Prophylaxis
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Pre-clinical
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File investigational new drug ("IND")
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2017
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GEN-001
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Chlamydia Prophylaxis
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Pre-clinical
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File IND
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2018
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GEN-005
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Malaria Prophylaxis
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Research
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Complete current Gates Foundation collaboration
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First half of 2016
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Epstein-Barr Virus
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Research
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Initiate screening studies
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2016
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Immuno-oncology
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Research
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Present data from ongoing academic collaborations
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2016
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*
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Note: Each bar represents 1 swab; 2 swabs collected per day; the absence of a bar means no shedding was detected on the swab on a particular day.
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•
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completion of nonclinical laboratory tests and animal studies according to good laboratory practices ("GLP") and applicable requirements for the humane use of laboratory animals or other applicable regulations;
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•
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submission to the FDA of an application for an IND which must become effective before human clinical trials may begin;
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•
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performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices ("GCP") and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;
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•
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submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, and potency from results of nonclinical testing and clinical trials;
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•
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with good manufacturing practices ("GMPs") to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current good tissue practices ("GTP") for the use of human cellular and tissue products;
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•
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potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; and
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FDA review and approval, or licensure, of the BLA.
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Phase 1.
The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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•
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Phase 2.
The biological product is evaluated in a limited patient population to identify possible AEs and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.
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Phase 3.
Clinical studies are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling.
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continue our Phase 2 program for GEN-003, our most advanced product candidate that we are developing for the treatment of genital herpes infections;
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initiate additional non-clinical, clinical or other studies for our other product candidates;
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manufacture material for clinical trials and for commercial sale;
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seek regulatory approvals for any product candidates that successfully complete clinical trials;
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establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
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seek to discover and develop additional product candidates;
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acquire or in-license other product candidates and technologies;
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make royalty milestone or other payments under any in-license agreements;
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maintain, protect and expand our intellectual property portfolio;
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•
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attract and retain skilled personnel; and
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•
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create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts.
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the progress, results and costs of our ongoing Phase 2 program for GEN-003;
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the number and development requirements of other product candidates that we pursue;
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the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates if clinical trials are successful and the outcome of regulatory review of our product candidates;
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the cost and timing of future commercialization activities for our products, if any of our product candidates are approved for marketing, including product manufacturing, marketing, sales and distribution costs;
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•
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the cost of our general and administrative functions;
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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 cost of manufacturing our product candidates for clinical trials in preparation for regulatory approval and in preparation for commercialization;
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our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements;
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the costs involved in preparing, filing, prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights, including litigation costs and the outcome of such litigation;
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the timing, receipt, and amount of sales of, or royalties or milestone payments on, our future products, if any; and
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the extent to which we acquire or in-license other products or technologies.
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Successful completion of our ongoing and additional clinical studies of GEN-003;
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Obtaining marketing approvals from regulatory authorities for GEN-003;
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Establishing manufacturing and commercialization arrangements between ourselves and third parties;
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A continued acceptable safety and efficacy profile of GEN-003; and
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The availability of reimbursement to patients from healthcare payors for GEN-003.
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severity of the disease under investigation;
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design of the study protocol;
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size of the patient population;
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eligibility criteria for the trial in question;
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perceived risks and benefits of the product candidate under study;
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proximity and availability of clinical trial sites for prospective patients;
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availability of competing therapies and clinical trials;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians; and
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ability to monitor patients adequately during and after treatment.
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difficulty in establishing or managing relationships with contract research organizations ("CROs") and physicians;
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different standards for the conduct of clinical trials;
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our inability to locate qualified local consultants, physicians and partners;
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he potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatment; and
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the acceptability of data obtained from studies conducted outside the United States to the FDA in support of a BLA.
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delays by us in reaching a consensus with regulatory agencies on trial design;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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delays in obtaining required IRB approval at each clinical trial site;
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imposition of a clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar vaccines that may reflect an unacceptable risk with GEN-003 or after an inspection of clinical operations or trial sites;
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failure to perform in accordance with the FDA’s GCPs or applicable regulatory guidelines in other countries;
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delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;
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delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;
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clinical trial sites or patients dropping out of a trial or failing to complete dosing;
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occurrence of serious AEs in clinical trials that are associated with the product candidates that are viewed to outweigh its potential benefits; or
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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
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fines, warning letters, or holds on clinical trials;
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refusal by the FDA to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; and
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injunctions or the imposition of civil, criminal and/or administrative penalties, damages, monetary fines, disgorgement, exclusion from participation in Medicare, Medicaid and other federal health care programs, and curtailment or restructuring of our operations.
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the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
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reduced control as a result of using third party manufacturers for all aspects of manufacturing activities, including regulatory compliance and quality assurance;
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termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
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•
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the possible misappropriation of our proprietary information, including our trade secrets and know-how or infringement of third party intellectual property rights by our contract manufacturers; and
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disruptions to the operations of our third party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier.
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difficulties with production costs, scale-up and yields;
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•
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unavailability of raw materials and supplies;
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•
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insufficient quality control and assurance;
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•
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shortages of qualified personnel;
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•
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failure to comply with strictly enforced federal, state and foreign regulations that vary in each country where product might be sold; and
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•
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lack of capital funding.
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•
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the efficacy and safety of the product, as demonstrated in clinical trials;
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•
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the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any warnings that may be required on the label;
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•
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acceptance by physicians and patients of the product as a safe and effective treatment and the willingness of the target patient population to try new therapies and of physicians to prescribe new therapies;
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•
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the cost, safety and efficacy of treatment in relation to alternative treatments;
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•
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the availability of adequate course and reimbursement by third-party payors and government authorities;
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•
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relative convenience and ease of administration;
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•
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the prevalence and severity of adverse side effects;
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•
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the effectiveness of our sales and marketing efforts; and
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•
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the restrictions on the use of our products together with other medications, if any.
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•
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our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
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•
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the inability of sales personnel to obtain access to physicians;
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•
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the lack of adequate numbers of physicians to prescribe any future products;
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•
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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; and
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•
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unforeseen costs and expenses associated with creating an independent sales and marketing organization.
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•
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a covered benefit under its health plan;
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•
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safe, effective and medically necessary;
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•
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appropriate for the specific patient;
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•
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cost-effective; and
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•
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neither experimental nor investigational.
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•
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the demand for any drug products for which we may obtain regulatory approval;
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•
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our ability to set a price that we believe is fair for our products;
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•
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our ability to obtain coverage and reimbursement approval for a product;
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•
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our ability to generate revenues and achieve or maintain profitability; and
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•
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the level of taxes that we are required to pay.
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•
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our clinical trials may be put on hold;
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•
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we may be unable to obtain regulatory approval for our vaccine candidates;
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•
|
regulatory authorities may withdraw approvals of our vaccines;
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•
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regulatory authorities may require additional warnings on the label;
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•
|
a medication guide outlining the risks of such side effects for distribution to patients may be required;
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•
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we could be sued and held liable for harm caused to patients; and
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•
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our reputation may suffer.
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•
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we will need to repay our indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance our operations, our research and development efforts and other general corporate activities; and
|
•
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our failure to comply with the restrictive covenants in our 2014 Term Loan could result in an event of default that, if not cured or waived, would accelerate our obligation to repay this indebtedness, and Hercules could seek to enforce its security interest in the assets securing such indebtedness.
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•
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dispose of certain assets;
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•
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change our lines of business;
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•
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engage in mergers or consolidations;
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•
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incur additional indebtedness;
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•
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create liens on assets;
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•
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pay dividends and make distributions or repurchase our capital stock; and
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•
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engage in certain transactions with affiliates.
|
•
|
decreased demand for any product candidates or products that we may develop;
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•
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injury to our reputation and significant negative media attention;
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•
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withdrawal of clinical trial participants;
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•
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significant costs to defend the related litigations;
|
•
|
a diversion of management’s time and our resources;
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•
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substantial monetary awards to trial participants or patients;
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•
|
product recalls, withdrawals, or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue;
|
•
|
the inability to commercialize any product candidates that we may develop; and
|
•
|
a decline in our stock price.
|
•
|
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;
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•
|
not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
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•
|
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board providing for supplemental auditor’s reports for 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.
|
•
|
the success of competitive products or technologies;
|
•
|
results of clinical trials of our product candidates;
|
•
|
the timing of the release of results of our clinical trials;
|
•
|
results of clinical trials of our competitors’ products;
|
•
|
regulatory actions or legal developments with respect to our products or our competitors’ products;
|
•
|
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
•
|
the results of our efforts to discover, develop, acquire or in-license additional product candidates or products;
|
•
|
actual or anticipated fluctuations in our financial condition and operating results;
|
•
|
publication of research reports by securities analysts about us or our competitors or our industry;
|
•
|
our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
|
•
|
additions and departures of key personnel;
|
•
|
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
|
•
|
the passage of legislation or other regulatory developments affecting us or our industry;
|
•
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
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•
|
sales of our common stock by us, our insiders or our other stockholders;
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•
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speculation in the press or investment community;
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•
|
announcement or expectation of additional financing efforts;
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•
|
changes in accounting principles;
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•
|
terrorist acts, acts of war or periods of widespread civil unrest;
|
•
|
natural disasters and other calamities;
|
•
|
changes in market conditions for biopharmaceutical stocks; and
|
•
|
changes in general market and economic conditions.
|
•
|
authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock;
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•
|
create a classified board of directors whose members serve staggered three-year terms;
|
•
|
specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, our chief executive officer or our president;
|
•
|
prohibit stockholder action by written consent;
|
•
|
establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;
|
•
|
provide that our directors may be removed only for cause;
|
•
|
provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum
|
•
|
specify that no stockholder is permitted to cumulate votes at any election of directors;
|
•
|
expressly authorize our board of directors to modify, alter or repeal our by-laws; and
|
•
|
require supermajority votes of the holders of our common stock to amend specified provisions of our by-laws.
|
|
|
Year ended December 31, 2015
|
|
Year ended December 31, 2014
|
||||||||||
|
|
High
|
Low
|
|
High
|
Low
|
||||||||
First quarter (1)
|
|
$
|
12.50
|
|
$
|
6.15
|
|
|
$
|
23.99
|
|
$
|
10.90
|
|
Second quarter
|
|
$
|
14.29
|
|
$
|
9.00
|
|
|
$
|
23.99
|
|
$
|
16.76
|
|
Third quarter
|
|
$
|
16.18
|
|
$
|
6.63
|
|
|
$
|
20.00
|
|
$
|
8.90
|
|
Fourth quarter
|
|
$
|
8.20
|
|
$
|
4.27
|
|
|
$
|
9.44
|
|
$
|
7.00
|
|
(1)
|
For the quarter ended March 31, 2014, the period is from February 5, 2014, the date on which our common stock first began to trade on the NASDAQ Global Market after the pricing of our initial public offering, through March 31, 2014, the end of our first fiscal quarter.
|
*
|
$100 invested on 2/5/2014 in stock or index, including reinvestment of dividends. Fiscal year ending December 31, 2015.
|
|
2/5/2014
|
|
Mar-14
|
|
Jun-14
|
|
Sep-14
|
|
Dec-14
|
|
Mar-15
|
|
Jun-15
|
|
Sep-15
|
|
Dec-15
|
|||||||||
Genocea Biosciences, Inc.
|
100.00
|
|
|
165.36
|
|
|
170.45
|
|
|
82.27
|
|
|
63.64
|
|
|
107.82
|
|
|
124.82
|
|
|
62.27
|
|
|
47.91
|
|
NASDAQ Composite
|
100.00
|
|
|
104.67
|
|
|
109.89
|
|
|
112.01
|
|
|
118.06
|
|
|
122.17
|
|
|
124.31
|
|
|
115.17
|
|
|
124.82
|
|
NASDAQ Biotechnology
|
100.00
|
|
|
99.66
|
|
|
108.44
|
|
|
115.41
|
|
|
128.26
|
|
|
145.21
|
|
|
156.00
|
|
|
127.93
|
|
|
142.91
|
|
|
|
Years Ended December 31
|
||||||||||||||||||
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Grant revenue
|
|
$
|
670
|
|
|
$
|
308
|
|
|
$
|
731
|
|
|
$
|
1,977
|
|
|
$
|
1,820
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
28,049
|
|
|
23,727
|
|
|
15,695
|
|
|
11,240
|
|
|
13,543
|
|
|||||
General and administrative
|
|
13,987
|
|
|
9,747
|
|
|
4,961
|
|
|
3,690
|
|
|
3,004
|
|
|||||
Total operating expenses
|
|
42,036
|
|
|
33,474
|
|
|
20,656
|
|
|
14,930
|
|
|
16,547
|
|
|||||
Loss from operations
|
|
(41,366
|
)
|
|
(33,166
|
)
|
|
(19,925
|
)
|
|
(12,953
|
)
|
|
(14,727
|
)
|
|||||
Other expense:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Change in fair value of warrants
|
|
—
|
|
|
(725
|
)
|
|
(222
|
)
|
|
93
|
|
|
75
|
|
|||||
Loss on debt extinguishment
|
|
—
|
|
|
(435
|
)
|
|
(200
|
)
|
|
—
|
|
|
—
|
|
|||||
Interest expense, net
|
|
(1,117
|
)
|
|
(970
|
)
|
|
(459
|
)
|
|
(507
|
)
|
|
(33
|
)
|
|||||
Other expense
|
|
(1,117
|
)
|
|
(2,130
|
)
|
|
(881
|
)
|
|
(414
|
)
|
|
42
|
|
|||||
Net loss
|
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
|
$
|
(13,367
|
)
|
|
$
|
(14,685
|
)
|
Comprehensive loss
|
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
|
$
|
(13,367
|
)
|
|
$
|
(14,685
|
)
|
Reconciliation of net loss to net loss applicable to common stockholders
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net loss
|
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
|
$
|
(13,367
|
)
|
|
$
|
(14,685
|
)
|
Accretion of redeemable convertible preferred stock to redemption value
|
|
—
|
|
|
(180
|
)
|
|
(1,605
|
)
|
|
(1,781
|
)
|
|
(1,605
|
)
|
|||||
Net loss attributable to common stockholders
|
|
$
|
(42,483
|
)
|
|
$
|
(35,476
|
)
|
|
$
|
(22,411
|
)
|
|
$
|
(15,148
|
)
|
|
$
|
(16,290
|
)
|
Net loss per share attributable to common stockholders - basic and diluted (1)
|
|
$
|
(1.74
|
)
|
|
$
|
(2.27
|
)
|
|
$
|
(75.46
|
)
|
|
$
|
(51.35
|
)
|
|
$
|
(55.41
|
)
|
Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted
|
|
24,460
|
|
|
15,618
|
|
|
297
|
|
|
295
|
|
|
294
|
|
|
|
At December 31
|
||||||||||||||||||
(in thousands)
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and investments
|
|
$
|
106,432
|
|
|
$
|
47,079
|
|
|
$
|
12,208
|
|
|
$
|
11,516
|
|
|
$
|
5,742
|
|
Working Capital
|
|
89,226
|
|
|
42,173
|
|
|
8,382
|
|
|
7,932
|
|
|
3,852
|
|
|||||
Total assets
|
|
112,142
|
|
|
50,332
|
|
|
15,761
|
|
|
13,531
|
|
|
6,940
|
|
|||||
Preferred stock warrant liability
|
|
—
|
|
|
—
|
|
|
656
|
|
|
246
|
|
|
339
|
|
|||||
Preferred stock
|
|
—
|
|
|
—
|
|
|
81,562
|
|
|
64,707
|
|
|
47,848
|
|
|||||
Common Stock and additional paid-in capital
|
|
247,578
|
|
|
147,941
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total stockholders’ equity (deficit)
|
|
89,661
|
|
|
32,507
|
|
|
(80,131
|
)
|
|
(58,402
|
)
|
|
(43,562
|
)
|
(1)
|
See Note 2 within the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K for a description of the method used to calculate basic and diluted net loss per common share.
|
•
|
personnel-related expenses, including salaries, benefits, stock-based compensation expense and travel;
|
•
|
expenses incurred under agreements with contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), consultants and other vendors that conduct our clinical trials and preclinical activities;
|
•
|
costs of acquiring, developing and manufacturing clinical trial materials and lab supplies; and
|
•
|
facility costs, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies.
|
|
|
Years ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Genital herpes (GEN-003)(1)
|
|
$
|
15,555
|
|
|
$
|
15,147
|
|
|
$
|
7,730
|
|
Pneumococcus (GEN-004)(1)
|
|
3,260
|
|
|
4,778
|
|
|
5,848
|
|
|||
Other research and development (2)
|
|
9,234
|
|
|
3,802
|
|
|
2,117
|
|
|||
Total research and development
|
|
$
|
28,049
|
|
|
$
|
23,727
|
|
|
$
|
15,695
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development
|
|
$
|
1,690
|
|
|
$
|
1,511
|
|
|
$
|
322
|
|
General and administrative
|
|
2,158
|
|
|
1,394
|
|
|
350
|
|
|||
Total
|
|
$
|
3,848
|
|
|
$
|
2,905
|
|
|
$
|
672
|
|
|
|
Years ended December 31,
|
||||
|
|
2015
|
|
2014
|
|
2013
|
Expected Volatility
|
|
68.5%-85.3%
|
|
86.2%-103.6%
|
|
97.1%
|
Risk-free interest rate
|
|
1.56%-1.94%
|
|
1.75%-2.00%
|
|
0.59%-1.83%
|
Expected term (in years)
|
|
5.50 - 6.08
|
|
6.08
|
|
6.25
|
Expected dividend yield
|
|
0%
|
|
0%
|
|
0%
|
|
|
Years Ended
December 31,
|
|
Increase
|
||||||||
(in thousands)
|
|
2015
|
|
2014
|
|
(Decrease)
|
||||||
Grant revenue
|
|
$
|
670
|
|
|
$
|
308
|
|
|
$
|
362
|
|
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
28,049
|
|
|
23,727
|
|
|
4,322
|
|
|||
General and administrative
|
|
13,987
|
|
|
9,747
|
|
|
4,240
|
|
|||
Total operating expenses
|
|
42,036
|
|
|
33,474
|
|
|
8,562
|
|
|||
Loss from operations
|
|
(41,366
|
)
|
|
(33,166
|
)
|
|
(8,200
|
)
|
|||
Other expense:
|
|
|
|
|
|
|
|
|||||
Other expense, net
|
|
—
|
|
|
(1,160
|
)
|
|
1,160
|
|
|||
Interest expense, net
|
|
(1,117
|
)
|
|
(970
|
)
|
|
(147
|
)
|
|||
Other expense
|
|
(1,117
|
)
|
|
(2,130
|
)
|
|
1,013
|
|
|||
Net loss
|
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(7,187
|
)
|
|
|
Years Ended December 31,
|
|
Increase
|
||||||||
(in thousands)
|
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Grant revenue
|
|
$
|
308
|
|
|
$
|
731
|
|
|
$
|
(423
|
)
|
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
23,727
|
|
|
15,695
|
|
|
8,032
|
|
|||
General and administrative
|
|
9,747
|
|
|
4,961
|
|
|
4,786
|
|
|||
Total operating expenses
|
|
33,474
|
|
|
20,656
|
|
|
12,818
|
|
|||
Loss from operations
|
|
(33,166
|
)
|
|
(19,925
|
)
|
|
(13,241
|
)
|
|||
Other expense, net
|
|
|
|
|
|
|
|
|
||||
Other expense, net
|
|
(1,160
|
)
|
|
(422
|
)
|
|
(738
|
)
|
|||
Interest expense, net
|
|
(970
|
)
|
|
(459
|
)
|
|
(511
|
)
|
|||
Other expense
|
|
(2,130
|
)
|
|
(881
|
)
|
|
(1,249
|
)
|
|||
Net loss
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
|
$
|
(14,490
|
)
|
•
|
the timing and costs of our ongoing and planned clinical trials for GEN-003;
|
•
|
the progress, timing and costs of manufacturing GEN-003 for current and planned clinical trials;
|
•
|
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our other product candidates and potential product candidates;
|
•
|
the outcome, timing and costs of seeking regulatory approvals;
|
•
|
the costs of commercialization activities for GEN-003 and other product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
|
•
|
the receipt of marketing approval, revenue received from commercial sales of our product candidates;
|
•
|
the terms and timing of any future collaborations, grants, licensing, consulting or other arrangements that we may establish;
|
•
|
the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone and royalty payments and patent prosecution fees that we are obligated to pay pursuant to our license agreements;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims; and
|
•
|
the extent to which we in-license or acquire other products and technologies.
|
|
|
Years ended December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Net cash used in operating activities
|
|
$
|
(38,356
|
)
|
|
$
|
(27,604
|
)
|
Net cash used in investing activities
|
|
(64,937
|
)
|
|
(28,573
|
)
|
||
Net cash provided by financing activities
|
|
100,494
|
|
|
64,027
|
|
||
Net increase in cash and cash equivalents
|
|
$
|
(2,799
|
)
|
|
$
|
7,850
|
|
|
|
Years Ended December 31,
|
||||||
|
|
2014
|
|
2013
|
||||
Net cash used in operating activities
|
|
$
|
(27,604
|
)
|
|
$
|
(19,873
|
)
|
Net cash used in investing activities
|
|
(28,573
|
)
|
|
(389
|
)
|
||
Net cash provided by financing activities
|
|
64,027
|
|
|
20,954
|
|
||
Net increase in cash and cash equivalents
|
|
$
|
7,850
|
|
|
$
|
692
|
|
|
|
Total
|
|
Less Than 1 Year
|
|
1 - 3 Years
|
|
3 - 5 Years
|
|
More than 5 Years
|
||||||||||
Long-term debt(1)
|
|
$
|
17,842
|
|
|
$
|
—
|
|
|
$
|
9,808
|
|
|
$
|
8,034
|
|
|
$
|
—
|
|
Operating leases
|
|
1,610
|
|
|
1,379
|
|
|
231
|
|
|
—
|
|
|
—
|
|
|||||
|
|
$
|
19,452
|
|
|
$
|
1,379
|
|
|
$
|
10,039
|
|
|
$
|
8,034
|
|
|
$
|
—
|
|
(1)
|
As of December 31, 2015, we had a total of $17.0 million in long-term debt due consisting of amounts due under the 2014 Term Loan. We are obligated to pay an end of term charge of 4.95% of the balance drawn when the principal balance is repaid. We have included $0.8 million in this table for the end of term charge based upon the debt outstanding at December 31, 2015.
|
(1)
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets;
|
(2)
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures are being made only in accordance with the authorizations of management and directors; and
|
(3)
|
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.
|
Name
|
|
Age
|
|
Position
|
|
William Clark
|
|
47
|
|
|
President and Chief Executive Officer; Director (Class III)
|
Seth Hetherington, M.D.
|
|
63
|
|
|
Chief Medical Officer
|
Jonathan Poole
|
|
41
|
|
|
Chief Financial Officer
|
Eric Hoffman, Ph.D.
|
|
46
|
|
|
Chief Business Officer
|
Jessica Baker Flechtner, Ph.D.
|
|
44
|
|
|
Senior Vice President of Research
|
Paul Giannasca, Ph.D.
|
|
52
|
|
|
Vice President, Biopharmaceutical Development & Production
|
Kenneth Bate
|
|
65
|
|
|
Director (Class I)
|
Kevin Bitterman, Ph.D.
|
|
39
|
|
|
Director (Class I)
|
Katrine Bosley
|
|
47
|
|
|
Director (Class II)
|
Michael Higgins
|
|
53
|
|
|
Director (Class II)
|
Stephen Hoffman, M.D., Ph.D.
|
|
61
|
|
|
Director (Class II)
|
George Siber, M.D.
|
|
71
|
|
|
Director (Class III)
|
•
|
the class I directors are Mr. Bate and Dr. Bitterman, whose terms expire in 2018;
|
•
|
the class II directors are Ms. Bosley, Mr. Higgins, and Dr. Hoffman, whose terms expire in 2016; and
|
•
|
the class III directors are Mr. Clark and Dr. Siber, whose terms expire in 2017.
|
•
|
appointing, approving the compensation of, and assessing the qualifications, performance and independence of our independent registered public accounting firm;
|
•
|
pre-approving audit and permissible non-audit services, and the terms of such services, to be provided by our independent registered public accounting firm;
|
•
|
reviewing the internal audit plan with the independent registered public accounting firm and members of management responsible for preparing our financial statements;
|
•
|
reviewing and discussing with management and the independent registered public accounting firm our annual and quarterly financial statements and related disclosures as well as critical accounting policies and practices used by us;
|
•
|
reviewing the adequacy of our internal control over financial reporting;
|
•
|
establishing policies and procedures for the receipt and retention of accounting-related complaints and concerns;
|
•
|
recommending, based upon the audit committee’s review and discussions with management and the Company's independent registered public accounting firm, whether our audited financial statements shall be included in our Annual Report on Form 10-K;
|
•
|
monitoring our compliance with legal and regulatory requirements as they relate to our financial statements and accounting matters;
|
•
|
preparing the audit committee report required by the rules of the SEC to be included in our annual proxy statement;
|
•
|
viewing all related party transactions for potential conflict of interest situations and approving all such transactions; and
|
•
|
reviewing and discussing with management and our independent registered public accounting firm our earnings releases and scripts.
|
•
|
annually reviewing and approving corporate goals and objectives relevant to the compensation of our chief executive officer;
|
•
|
evaluating the performance of our chief executive officer in light of such corporate goals and objectives and determining and approving the compensation of our chief executive officer;
|
•
|
reviewing and approving the compensation of our other executive officers;
|
•
|
appointing, compensating and overseeing the work of any compensation consultant, legal counsel or other advisor retained by the compensation committee;
|
•
|
conducting the independence assessment outlined in NASDAQ rules with respect to any compensation consultant, legal counsel or other advisor retained by the compensation committee;
|
•
|
annually reviewing and reassessing the adequacy of the committee charter in its compliance with the listing requirements of NASDAQ;
|
•
|
reviewing and establishing our overall management compensation philosophy and policy;
|
•
|
overseeing and administering our equity compensation and other compensatory plans;
|
•
|
reviewing and approving our equity and incentive policies and procedures for the grant of equity-based awards and approving the grant of such equity-based awards;
|
•
|
reviewing and making recommendations to the board of directors with respect to director compensation; and
|
•
|
reviewing and discussing with management the compensation discussion and analysis to be included in our annual proxy statement or Annual Report on Form 10-K.
|
•
|
developing and recommending to the board of directors criteria for board and committee membership;
|
•
|
establishing procedures for identifying and evaluating board of director candidates, including nominees recommended by stockholders;
|
•
|
identifying individuals qualified to become members of the board of directors;
|
•
|
recommending to the board of directors the persons to be nominated for election as directors and to each of the board’s committees;
|
•
|
developing and recommending to the board of directors a set of corporate governance principles;
|
•
|
articulating to each director what is expected, including reference to the corporate governance principles and directors’ duties and responsibilities;
|
•
|
reviewing and recommending to the board of directors practices and policies with respect to directors;
|
•
|
reviewing and recommending to the board of directors the functions, duties and compositions of the committees of the board of directors;
|
•
|
reviewing and assessing the adequacy of the committee charter and submitting any changes to the board of directors for approval;
|
•
|
consider and report to the board of directors any questions of possible conflicts of interest of board of directors members;
|
•
|
provide for new director orientation and continuing education for existing directors on a periodic basis;
|
•
|
performing an evaluation of the performance of the committee; and
|
•
|
overseeing the evaluation of the board of directors and management.
|
Name and principal position
|
|
Year
|
|
Salary
($)(2) |
|
Bonus
($)(3) |
|
Option
awards ($)(4) |
|
Nonequity incentive
plan compensation ($)(5) |
|
All other compensation
($)(6) |
|
Total
($) |
|||||||
William Clark,
|
|
2015
|
|
427,392
|
|
|
|
|
|
1,253,040
|
|
|
173,200
|
|
|
4,162
|
|
1,901,094,000
|
|
1,857,794
|
|
President and Chief Executive Officer
|
|
2014
|
|
393,561
|
|
|
—
|
|
|
—
|
|
|
179,744
|
|
|
—
|
|
573,305,000
|
|
573,305
|
|
|
|
2013
|
|
334,280
|
|
|
—
|
|
|
413,842
|
|
|
107,320
|
|
|
—
|
|
855,442,000
|
|
855,442
|
|
Seth Hetherington, M.D.,
|
|
2015
|
|
378,695
|
|
|
—
|
|
|
463,080
|
|
|
109,881
|
|
|
7,950
|
|
982,915,000
|
|
959,606
|
|
Chief Medical Officer
|
|
2014
|
|
366,074
|
|
|
—
|
|
|
—
|
|
|
119,612
|
|
|
—
|
|
485,686,000
|
|
485,686
|
|
|
|
2013
|
|
331,459
|
|
|
—
|
|
|
176,616
|
|
|
88,989
|
|
|
—
|
|
597,064,000
|
|
597,064
|
|
Jonathan Poole,
|
|
2015
|
|
328,000
|
|
|
|
|
|
862,600
|
|
|
115,360
|
|
|
7,295
|
|
1,313,255,000
|
|
1,313,255
|
|
Chief Financial Officer (1)
|
|
2014
|
|
235,151
|
|
|
50,000
|
|
|
2,904,505
|
|
|
78,540
|
|
|
—
|
|
3,218,196,000
|
|
3,218,196
|
|
(1)
|
Mr. Poole commenced employment with the Company in April 2014. As a result, no amounts with respect to fiscal year 2013 have been included for Mr. Poole in the table above. Amounts in the table for fiscal year 2014 represent Mr. Poole’s compensation for the period he was employed by us.
|
(2)
|
Salaries include amounts contributed by the named executive officer to our 401(k) plan.
|
(3)
|
Amount reflects the signing bonus paid to Mr. Poole in connection with the commencement of his employment with us.
|
(4)
|
Amounts shown reflect the aggregate grant date fair value of time-vesting stock options awarded in the respective fiscal year computed in accordance with Financial Accounting Standards Board Accounting Standards Codification ("FASB ASC"), Topic 718,
Compensation — Stock Compensation
(
"
ASC 718"), and exclude the value of estimated forfeitures. Assumptions used in the calculation of these amounts are included in Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. Mr. Clark was also granted a performance-vesting stock option in 2013. The grant date fair value of the performance-vesting stock option granted to Mr. Clark in fiscal
|
(5)
|
Amounts shown reflect the annual cash bonuses paid, or to be paid, in the case of fiscal year 2015, to the named executive officers that was earned based on the achievement of Company performance goals, in the case of Mr. Clark, and Company and individual performance goals, in the case of Dr. Hetherington and Mr. Poole.
|
(6)
|
Amounts shown reflect employer matching contributions under our 401(k) plan during fiscal year 2015.
|
Name
|
|
Number of
securities
underlying
unexercised
options (#)
exercisable)
|
|
Number of
securities
underlying
unexercised
options (#)
unexercisable
|
|
Equity incentive
plan awards:
number of
securities
underlying
unexercised
unearned
options (#)
|
|
Option
Exercise
Price
($)(5)
|
|
Option
Expiration
Date(6)
|
|||||||||||||
William Clark
|
|
24,716
|
|
|
(1
|
)
|
|
—
|
|
|
|
|
—
|
|
|
|
|
$
|
2.86
|
|
|
12/17/2020
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
39,807
|
|
|
(2)
|
|
$
|
2.86
|
|
|
12/17/2020
|
||
|
|
340,568
|
|
|
(1
|
)
|
|
—
|
|
|
|
|
—
|
|
|
|
|
$
|
2.02
|
|
|
2/17/2021
|
|
|
|
97,418
|
|
|
(3
|
)
|
|
36,184
|
|
|
(3)
|
|
—
|
|
|
|
|
$
|
3.45
|
|
|
7/25/2023
|
|
|
|
81,670
|
|
|
(2
|
)
|
|
—
|
|
|
|
|
—
|
|
|
|
|
$
|
3.45
|
|
|
7/25/2023
|
|
|
|
28,750
|
|
|
(1
|
)
|
|
109,250
|
|
|
(1
|
)
|
|
—
|
|
|
|
|
$
|
9.08
|
|
|
2/26/2025
|
Seth Hetherington, M.D.
|
|
66,955
|
|
|
(4
|
)
|
|
—
|
|
|
|
|
—
|
|
|
|
|
$
|
2.02
|
|
|
2/17/2021
|
|
|
|
11,562
|
|
|
(2
|
)
|
|
—
|
|
|
|
|
—
|
|
|
|
|
$
|
2.02
|
|
|
2/17/2021
|
|
|
|
41,575
|
|
|
(3
|
)
|
|
15,442
|
|
|
(3)
|
|
—
|
|
|
|
|
$
|
3.45
|
|
|
7/25/2023
|
|
|
|
10,625
|
|
|
(1
|
)
|
|
40,375
|
|
|
(1)
|
|
—
|
|
|
|
|
$
|
9.08
|
|
|
2/26/2025
|
|
Jonathan Poole
|
|
83,636
|
|
|
(4
|
)
|
|
117,090
|
|
|
(4)
|
|
—
|
|
|
|
|
$
|
17.89
|
|
|
4/7/2024
|
|
|
|
19,791
|
|
|
(1
|
)
|
|
75,209
|
|
|
(1)
|
|
—
|
|
|
|
|
$
|
9.08
|
|
|
2/26/2025
|
(1)
|
Reflects time-based stock options to purchase shares of our common stock that vest in 48 equal monthly installments following the date of grant, generally subject to the executive’s continued employment.
|
(2)
|
Reflects performance-based stock options to purchase shares of our common stock that vest as to 100% of the shares subject to the stock option, in the case of Mr. Clark, upon the company’s achievement of specified strategic financing or development milestones, and in the case of Dr. Hetherington, upon the company’s achievement of a milestone related to the initiation of a clinical trial, in each case, generally subject to the executive’s continued employment. The performance-based stock option awarded to Mr. Clark on July 25, 2013 vested in full upon the completion of our IPO on February 10, 2014. The performance-based stock option awarded to Mr. Clark on December 17, 2010 remains
|
(3)
|
Reflects time-based stock options to purchase shares of our common stock that vested as to 1/8th of the shares subject to the stock option on the date of grant and that continue to vest in equal monthly installments over 42 months following the date of grant, generally subject to the executive’s continued employment.
|
(4)
|
Reflects time-based stock options to purchase shares of our common stock that vest as to 25% of the shares subject to the stock option on the vesting commencement date (approximately 12 months from the grant date) and thereafter vest in equal monthly installments over the following 36 months, generally subject to the executive’s continued employment.
|
(5)
|
The exercise price of the stock options is not less than the fair market value of a share of our common stock, as determined by our board of directors. For stock options granted following our IPO, the exercise price is the closing price of a share of our common stock on the date of grant of the stock option.
|
(6)
|
All stock options have a 10-year term measured from the date of grant.
|
Name
|
|
Fees earned or
paid in cash
($)(1)
|
|
Option
awards
($)(2)(3)
|
|
Total
($)
|
|||
Kenneth Bate
|
|
53,334
|
|
|
45,781
|
|
|
99,115
|
|
Kevin Bitterman, Ph.D.
|
|
43,500
|
|
|
45,781
|
|
|
89,281
|
|
Katrine Bosley
|
|
74,500
|
|
|
45,781
|
|
|
120,281
|
|
Michael Higgins
|
|
42,014
|
|
|
91,563
|
|
|
133,577
|
|
Stephen Hoffman, M.D., Ph.D.
|
|
41,083
|
|
|
45,781
|
|
|
86,864
|
|
George Siber, M.D.
|
|
138,681
|
|
|
45,781
|
|
|
184,462
|
|
(1)
|
Amounts represent annual director fees and, in the case of Dr. Siber, include consulting fees, for services rendered. Consulting fees paid to Dr. Siber were paid in equal bi-monthly installments and all other fees were paid quarterly in arrears.
|
(2)
|
As of December 31, 2015, our directors held the following aggregate number of options to purchase shares of our common stock: Mr. Bate held options to purchase 15,126 shares of our common stock, Dr. Bitterman held options to purchase 5,042 shares of our common stock, Ms. Bosley held options to purchase 42,008 shares of our common stock, Mr. Higgins held options to purchase 10,084 shares of our common stock, Dr. Hoffman held options to purchase 5,042 shares of our common stock, and Dr. Siber held options to purchase 138,708 shares of our common stock. As of December 31, 2015, Ms. Bosley held 9,717 restricted shares, which she received upon the exercise of the option granted to her on February 4, 2013.
|
(3)
|
Amount in the table represent the aggregate grant date fair value of the option to purchase 10,084 shares of our common stock granted to Mr. Higgins in February 2015, upon his election to our board of directors, pursuant to our non-employee director compensation policy. This stock option award will vest in equal installments on each of the first three anniversaries of the date of grant. All other directors received grants of time-based stock options to purchase 5,042 shares of our common stock that vest in full on the one-year anniversary of the respective dates of grant. These grant date fair value amounts were computed in accordance with ASC 718 and exclude the value of estimated forfeitures. Assumptions used in the calculation of these amounts are included in Note 10 to our financial statements included elsewhere in this Annual Report on Form 10-K.
|
|
Annual
Retainer
|
||
Board of Directors:
|
|
||
All non-employee members
|
$
|
35,000
|
|
Additional retainer for chair (1)
|
$
|
25,000
|
|
Audit Committee:
|
|
||
Members
|
$
|
7,500
|
|
Additional retainer for chair
|
$
|
7,500
|
|
Compensation Committee:
|
|
||
Members
|
$
|
5,000
|
|
Additional retainer for chair
|
$
|
5,000
|
|
Nominating and Corporate Governance Committee:
|
|
||
Members
|
$
|
3,500
|
|
Additional retainer for chair
|
$
|
3,500
|
|
(1)
|
Effective January 1, 2016, the non-employee director compensation policy was amended to increase the annual additional retainer for the non-employee chair of the board of directors from $25,000 to $40,000. Our compensation committee recommended, and our board of directors approved, this increase after reviewing market data for board chairs of comparable companies.
|
|
|
Column A
|
|
Column B
|
|
Column C (2)
|
||||
Plan Category
|
|
Number of securities
to be issued upon
exercise of
outstanding stock
options, warrants
and rights
|
|
Weighted-
average exercise
price of
outstanding
options,
warrants and
rights
|
|
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in column
A)
|
||||
Equity compensation plans approved by security holders (1)
|
|
2,723,311
|
|
|
$
|
7.60
|
|
|
666,948
|
|
Equity compensation plans not approved by security holders
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Total
|
|
2,723,311
|
|
|
$
|
7.60
|
|
|
666,948
|
|
(1)
|
Includes information regarding our 2007 Equity Plan, 2014 Equity Plan, and 2014 Employee Stock Purchase Plan.
|
(2)
|
Includes 522,706 shares of our Common Stock available for issuance under our 2014 Equity Plan and 144,242 shares of our Common Stock available for issuance under our 2014 Employee Stock Purchase Plan.
|
|
|
Number of
|
|
Percentage of Shares
|
||
Name and Address of Beneficial Owned
|
|
Shares Beneficially Owned
|
|
Beneficially Owned
|
||
5% or greater stockholders:
|
|
|
|
|
||
FMR LLC, and related funds(1)
|
|
|
|
|
||
245 Summer Street
|
|
|
|
|
||
Boston, MA 02210
|
|
4,217,255
|
|
|
15.0
|
%
|
Franklin Advisers, Inc.(2)
|
|
|
|
|
||
One Franklin Parkway
|
|
|
|
|
||
San Mateo, CA 94403
|
|
2,886,600
|
|
|
10.3
|
%
|
S.R. One, Limited(3)
|
|
|
|
|
||
c/o Corporation Service Company
|
|
|
|
|
||
2595 Interstate Drive, Suite 103
|
|
|
|
|
||
Harrisburg, PA 17110
|
|
2,121,668
|
|
|
7.5
|
%
|
Skyline Venture Partners V, L.P.(4)
|
|
|
|
|
||
525 University Avenue, Suite 610
|
|
|
|
|
||
Palo Alto, CA 94301
|
|
1,992,415
|
|
|
7.1
|
%
|
Polaris Venture Partners, and related funds(5)
|
|
|
|
|
||
650 East Kendall Street, 4th Floor
|
|
|
|
|
||
Cambridge, MA 02142
|
|
1,968,606
|
|
|
7.0
|
%
|
|
|
|
|
|
||
Directors and Named Executive Officers:
|
|
|
|
|
||
William Clark(6)
|
|
637,501
|
|
|
2.3
|
%
|
Seth Hetherington, M.D.(7)
|
|
158,466
|
|
|
*
|
|
Jonathan Poole(8)
|
|
126,122
|
|
|
*
|
|
Kenneth Bate (9)
|
|
8,403
|
|
|
*
|
|
Katrine Bosley(10)
|
|
50,694
|
|
|
*
|
|
Kevin Bitterman, Ph.D.(11)
|
|
1,973,648
|
|
|
7.0
|
%
|
Michael Higgins(12)
|
|
3,361
|
|
|
*
|
|
Stephen Hoffman, M.D., Ph.D.(13)
|
|
1,997,457
|
|
|
7.1
|
%
|
George Siber, M.D.(14)
|
|
115,569
|
|
|
*
|
|
All executive officers and directors as a group (12 persons)(15)
|
|
5,274,995
|
|
|
18.7
|
%
|
*
|
Represents beneficial ownership of less than one percent of our outstanding common stock.
|
(1)
|
Consists of 4,217,255 shares of common stock held by FMR LLC. Abigail Johnson, the Vice Chairman, the Chief Executive Officer, and the President of FMR LLC, has sole power to dispose of the 4,217,255 shares owned by FMR LLC. Members of the family of Johnson Family, including Abigail Johnson, are the predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC, representing 49% of the voting power of FMR LLC. For information regarding FMR LLC and its affiliates, we have relied on the Schedule 13G filed by FMR LLC with the SEC on February 12, 2016.
|
(2)
|
Consists of 2,886,600 shares of common stock beneficially owned by one or more open- or closed-end investment companies or other managed accounts that are investment management clients of investment managers that are direct and indirect subsidiaries (each, an “Investment Management Subsidiary” and, collectively, the “Investment Management Subsidiaries”) of Franklin Resources Inc. (“FRI”), including Franklin Advisers, Inc. Investment management contracts grant to the Investment Management Subsidiaries investment and/or voting power over the securities owned by such investment management clients. Franklin Advisers, Inc. has sole voting power over 2,886,600 shares of common stock. Franklin Biotechnology Discovery Fund, a sub-fund of Franklin Templeton Investment Funds, a Luxembourg registered SICAV has an interest in 1,796,800 shares of common stock. Charles B. Johnson and Rupert H. Johnson, Jr. (the “Principal Shareholders”) each own in excess of 10% of the outstanding common stock of FRI and are the principal shareholders of FRI. FRI, the Principal Shareholders and each of the Investment Management Subsidiaries disclaim any pecuniary interest or beneficial ownership in any of these shares. For information regarding Franklin Advisers, Inc. and FRI, we have relied on the Schedule 13G/A filed by Franklin Advisers, Inc. with the SEC on February 10, 2016.
|
(3)
|
Consists of 2,121,668 shares of common stock held by S.R. One, Limited, an indirect, wholly-owned subsidiary of GlaxoSmithKline plc.
|
(4)
|
Consists of 1,992,415 shares of common stock held by Skyline Venture Partners V, L.P. ("Skyline"). The general partner of Skyline is Skyline Venture Management V, LLC. John G. Freund and Yasunori Kaneko are Managers of Skyline Venture Management V, LLC and hereby disclaim beneficial ownership of all the shares held by Skyline except to the extent of his respective proportionate pecuniary interest therein. Stephen Hoffman has an assignee interest in Skyline. To the extent that he is deemed to share voting and investment powers with respect to the shares held by the Skyline Venture Funds, Dr. Hoffman disclaims beneficial ownership of all the shares held by the funds except to the extent of his proportionate pecuniary interest therein.
|
(5)
|
Consists of (i) 1,899,578 shares of common stock held by Polaris Venture Partners V, L.P., (ii) 37,019 shares of common stock held by Polaris Venture Partners Entrepreneurs’ Fund, L.P., (iii) 13,012 shares of common stock held by Polaris Venture Partners Founders’ Fund V, L.P., and (iv) 18,997 shares of common stock held by Polaris Venture Partners Special Founders’ Fund V, L.P. (together with Polaris Venture Partners V, L.P., Polaris Venture Partners Entrepreneurs’ Fund, L.P. and Polaris Venture Partners Founders’ Fund V, L.P., the "Polaris Funds"). North Star Venture Management 2000, LLC directly or indirectly provides investment advisory services to various venture capital funds, including the Polaris Funds. Jonathan Flint and Terrance McGuire, managing members of North Star Venture Management 2000, LLC, exercise voting and investment power with respect to North Star Venture Management, 2000. Each of the Polaris Funds has the sole voting and investment power with respect to the shares of the Company directly held by the applicable Polaris Fund. The respective general partners of the Polaris Funds may be deemed to have sole voting and investment power with respect to the shares held by such funds. The respective general partners disclaim beneficial ownership of all the shares held by the Polaris Funds except to the extent of their proportionate pecuniary interests therein. The members of North Star Venture Management 2000, LLC (the Polaris Management Members) are also members of Polaris Venture Management Co., V, L.L.C. (the general partner of each of the Polaris Funds). Jonathan Flint and Terrance McGuire, managing members of Polaris Venture Management Co. V, L.L.C., exercise voting and investment power with respect to Polaris Venture Management Co. V, L.L.C. As members of the general partner and North Star Venture Management 2000, LLC, the Polaris Management Members may be deemed to share voting and investment powers for the shares held by the Polaris Funds. The Polaris Management Members disclaim beneficial ownership of all such shares held by the funds except to the extent of their proportionate pecuniary interests therein. Kevin Bitterman, a director of the Company, has an assignee interest in Polaris Venture Management Co. V, L.L.C. To the extent that he is deemed to share voting and investment powers with respect to the shares held by the Polaris Funds, Dr. Bitterman disclaims beneficial ownership of all the shares held by the funds except to the extent of his proportionate pecuniary interest therein.
|
(6)
|
Consists of 47,405 shares of common stock, 578,779 shares of common stock that can be acquired upon the exercise of outstanding options and 11,317 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(7)
|
Consists of 21,000 shares of common stock, 132,967 shares of common stock that can be acquired upon the exercise of outstanding options and 4,499 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(8)
|
Consists of 4,213 shares of common stock, 109,587 shares of common stock that can be acquired upon the exercise of outstanding options and 12,322 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(9)
|
Consists of 3,361 shares of common stock that can be acquired upon the exercise of outstanding options and 5,042 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(10)
|
Consists of 31,092 shares of common stock, 11,724 shares of common stock that can be acquired upon the exercise of outstanding options and 7,878 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(11)
|
Consists of 1,968,606 shares of common stock held by Polaris Venture Partners or related funds. By virtue of the relationships described in footnote 5 above, Dr. Bitterman may be deemed to share beneficial ownership in the shares held by Polaris Venture Partners or related funds. Dr. Bitterman disclaims beneficial ownership of the shares referred to in footnote 5 above. Also consists of 5,042 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(12)
|
Consists of 3,361 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(13)
|
Consists of 1,992,415 shares of common stock held by Skyline or related funds. By virtue of the relationships described in footnote 4 above, Dr. Hoffman may be deemed to share beneficial ownership in the shares held by Skyline or related funds. Dr. Hoffman disclaims beneficial ownership of the shares referred to in footnote 4 above. Also consists of 5,042 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(14)
|
Consists of 2,016 shares of common stock, 107,229 shares of common stock that can be acquired upon the exercise of outstanding options and 6,324 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
(15)
|
Consists of 4,080,324 shares of common stock, 1,116,602 shares of common stock that can be acquired upon the exercise of outstanding options, and 78,069 shares of common stock that can be acquired upon the exercise of options within 60 days of February 1, 2016.
|
|
|
Number of Shares of Common Stock
|
||||
Investor
|
|
March 2015 Offering
|
|
August 2015 Offering
|
||
FMR LLC
|
|
730,000
|
|
|
550,000
|
|
S.R. One, Limited
|
|
300,000
|
|
|
150,000
|
|
Polaris Venture Partners
|
|
—
|
|
|
—
|
|
Franklin Advisers
|
|
850,000
|
|
|
175,000
|
|
Skyline Venture Partners
|
|
700,000
|
|
|
—
|
|
Fee Category
|
|
2015
|
|
2014
|
||||
Audit Fees
|
|
$
|
636,922
|
|
|
$
|
559,117
|
|
Audit-Related Fees
|
|
—
|
|
|
—
|
|
||
Tax Fees
|
|
—
|
|
|
—
|
|
||
All Other Fees
|
|
—
|
|
|
—
|
|
||
Total Fees
|
|
$
|
636,922
|
|
|
$
|
559,117
|
|
|
Pages
|
|
December 31,
2015 |
|
December 31,
2014 |
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
17,259
|
|
|
$
|
20,058
|
|
Investments, current portion
|
77,069
|
|
|
27,021
|
|
||
Prepaid expenses and other current assets
|
865
|
|
|
934
|
|
||
Total current assets
|
95,193
|
|
|
48,013
|
|
||
Property and equipment, net
|
4,083
|
|
|
1,956
|
|
||
Restricted cash
|
316
|
|
|
316
|
|
||
Investments, net of current portion
|
12,104
|
|
|
—
|
|
||
Other non-current assets
|
446
|
|
|
47
|
|
||
Total assets
|
$
|
112,142
|
|
|
$
|
50,332
|
|
|
|
|
|
||||
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,757
|
|
|
$
|
2,692
|
|
Accrued expenses and other current liabilities
|
3,975
|
|
|
2,593
|
|
||
Deferred revenue
|
235
|
|
|
555
|
|
||
Current portion of long-term debt
|
—
|
|
|
—
|
|
||
Other current liabilities
|
—
|
|
|
—
|
|
||
Total current liabilities
|
5,967
|
|
|
5,840
|
|
||
Non-current liabilities:
|
|
|
|
||||
Long-term debt
|
16,477
|
|
|
11,389
|
|
||
Deferred revenue, net of current portion
|
—
|
|
|
350
|
|
||
Other non-current liabilities
|
37
|
|
|
246
|
|
||
Total liabilities
|
22,481
|
|
|
17,825
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Common stock
|
28
|
|
|
18
|
|
||
Authorized – 175,000 shares at December 31, 2015; Issued – 28,161 and 17,869 shares at December 31, 2015 and December 31, 2014, respectively; outstanding – 28,152 and 17,852 at December 31, 2015 and December 31, 2014, respectively
|
|
|
|
||||
Additional paid-in-capital
|
247,550
|
|
|
147,923
|
|
||
Accumulated other comprehensive loss
|
(7
|
)
|
|
(7
|
)
|
||
Accumulated deficit
|
(157,910
|
)
|
|
(115,427
|
)
|
||
Total stockholders’ equity
|
89,661
|
|
|
32,507
|
|
||
Total liabilities and stockholders’ equity
|
$
|
112,142
|
|
|
$
|
50,332
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Grant revenue
|
$
|
670
|
|
|
$
|
308
|
|
|
$
|
731
|
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
28,049
|
|
|
23,727
|
|
|
15,695
|
|
|||
General and administrative
|
13,987
|
|
|
9,747
|
|
|
4,961
|
|
|||
Total operating expenses
|
42,036
|
|
|
33,474
|
|
|
20,656
|
|
|||
Loss from operations
|
(41,366
|
)
|
|
(33,166
|
)
|
|
(19,925
|
)
|
|||
Other expense:
|
|
|
|
|
|
||||||
Change in fair value of warrants
|
—
|
|
|
(725
|
)
|
|
(222
|
)
|
|||
Loss on debt extinguishment
|
—
|
|
|
(435
|
)
|
|
(200
|
)
|
|||
Interest expense, net
|
(1,117
|
)
|
|
(970
|
)
|
|
(459
|
)
|
|||
Other expense
|
(1,117
|
)
|
|
(2,130
|
)
|
|
(881
|
)
|
|||
Net loss
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
Reconciliation of net loss to net loss applicable to common stockholders
|
|
|
|
|
|
||||||
Net loss
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
Accretion of redeemable convertible preferred stock to redemption value
|
—
|
|
|
(180
|
)
|
|
(1,605
|
)
|
|||
Net loss attributable to common stockholders
|
$
|
(42,483
|
)
|
|
$
|
(35,476
|
)
|
|
$
|
(22,411
|
)
|
Net loss per share attributable to common stockholders-basic and diluted
|
$
|
(1.74
|
)
|
|
$
|
(2.27
|
)
|
|
$
|
(75.46
|
)
|
Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted
|
24,460
|
|
|
15,618
|
|
|
297
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized loss on available-for-sale securities
|
(7
|
)
|
|
(7
|
)
|
|
—
|
|
|||
Comprehensive loss
|
$
|
(42,490
|
)
|
|
$
|
(35,303
|
)
|
|
$
|
(20,806
|
)
|
|
|
|
|
|
Series A Redeemable
|
|
Series B Redeemable
|
|
Series C Redeemable
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
||||||||||||||||||||
|
Seed Convertible
|
|
Convertible
|
|
Convertible
|
|
Convertible
|
|
|
|
|
|
|
Additional
|
|
Other
|
|
|
|
Stockholders’
|
||||||||||||||||||||||
|
Preferred Shares
|
|
Preferred Shares
|
|
Preferred Shares
|
|
Preferred Shares
|
|
|
Common Shares
|
|
Paid-In
|
|
Comprehensive
|
|
Accumulated
|
|
Equity
|
||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Income
|
|
Deficit
|
|
(Defi
c
it)
|
||||||||||||||
Balance at December 31, 2012
|
4,615
|
|
|
3,000
|
|
|
35,577
|
|
|
23,125
|
|
|
34,581
|
|
|
23,332
|
|
|
26,293
|
|
|
15,250
|
|
|
|
295
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(58,402
|
)
|
|
(58,402
|
)
|
Issuance of Series C Preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,293
|
|
|
15,250
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Accretion of dividends on redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,605
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
(682
|
)
|
|
—
|
|
|
(923
|
)
|
|
(1,605
|
)
|
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
7
|
|
|
—
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
9
|
|
Vesting of restricted stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
1
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
1
|
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
672
|
|
|
—
|
|
|
—
|
|
|
672
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,806
|
)
|
|
(20,806
|
)
|
Balance at December 31, 2013
|
4,615
|
|
|
3,000
|
|
|
35,577
|
|
|
23,125
|
|
|
34,581
|
|
|
24,937
|
|
|
52,586
|
|
|
30,500
|
|
|
|
303
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(80,131
|
)
|
|
(80,131
|
)
|
Accretion of dividends on redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
180
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
(180
|
)
|
|
—
|
|
|
—
|
|
|
(180
|
)
|
Exercise of warrants for cash
|
—
|
|
|
—
|
|
|
51
|
|
|
33
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Cashless exercise of warrants
|
—
|
|
|
—
|
|
|
317
|
|
|
98
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
54
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Conversion of redeemable convertible preferred stock into common stock
|
(4,615
|
)
|
|
(3,000
|
)
|
|
(35,945
|
)
|
|
(23,256
|
)
|
|
(34,581
|
)
|
|
(25,117
|
)
|
|
(52,586
|
)
|
|
(30,500
|
)
|
|
|
11,466
|
|
|
11
|
|
|
81,763
|
|
|
—
|
|
|
—
|
|
|
81,774
|
|
Reclassification of warrants to additional paid-in capital
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
1,381
|
|
|
—
|
|
|
—
|
|
|
1,381
|
|
Issuance of common stock upon IPO, net of issuance costs of $2,403
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
5,500
|
|
|
6
|
|
|
58,971
|
|
|
—
|
|
|
—
|
|
|
58,977
|
|
Issuance of common Stock; ESPP purchase
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
16
|
|
|
—
|
|
|
93
|
|
|
—
|
|
|
—
|
|
|
93
|
|
Issuance of common Stock upon private placement offering, net of issuance costs of $36
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
223
|
|
|
—
|
|
|
1,964
|
|
|
—
|
|
|
—
|
|
|
1,964
|
|
Issuance of warrants, net of issuance costs of $6
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
334
|
|
|
—
|
|
|
—
|
|
|
334
|
|
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
282
|
|
|
1
|
|
|
682
|
|
|
—
|
|
|
—
|
|
|
683
|
|
Vesting of restricted stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
8
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
|
10
|
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
2,905
|
|
|
—
|
|
|
—
|
|
|
2,905
|
|
Unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7
|
)
|
|
—
|
|
|
(7
|
)
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(35,296
|
)
|
|
(35,296
|
)
|
Balance at December 31, 2014
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
17,852
|
|
|
18
|
|
|
147,923
|
|
|
(7
|
)
|
|
(115,427
|
)
|
|
32,507
|
|
Issuance of common stock upon secondary public offering, net of issuance costs of $509
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
10,123
|
|
|
10
|
|
|
95,173
|
|
|
—
|
|
|
—
|
|
|
95,183
|
|
Issuance of common Stock; ESPP purchase
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
41
|
|
|
—
|
|
|
213
|
|
|
—
|
|
|
—
|
|
|
213
|
|
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
128
|
|
|
—
|
|
|
383
|
|
|
—
|
|
|
—
|
|
|
383
|
|
Vesting of restricted stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
8
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
|
10
|
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
3,848
|
|
|
—
|
|
|
—
|
|
|
3,848
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(42,483
|
)
|
|
(42,483
|
)
|
Balance at December 31, 2015
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
28,152
|
|
|
28
|
|
|
247,550
|
|
|
(7
|
)
|
|
(157,910
|
)
|
|
89,661
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(42,483
|
)
|
|
$
|
(35,296
|
)
|
|
$
|
(20,806
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
||||||
Depreciation and amortization
|
1,051
|
|
|
469
|
|
|
318
|
|
|||
Stock-based compensation
|
3,848
|
|
|
2,905
|
|
|
672
|
|
|||
Change in fair value of warrants liability
|
—
|
|
|
725
|
|
|
222
|
|
|||
Non-cash interest expense
|
369
|
|
|
254
|
|
|
22
|
|
|||
Loss on debt extinguishment
|
—
|
|
|
435
|
|
|
200
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Restricted cash
|
—
|
|
|
—
|
|
|
97
|
|
|||
Prepaid expenses and other current assets
|
266
|
|
|
(442
|
)
|
|
27
|
|
|||
Other long-term assets
|
(399
|
)
|
|
782
|
|
|
(1,539
|
)
|
|||
Accounts payable
|
(1,431
|
)
|
|
524
|
|
|
724
|
|
|||
Deferred revenue
|
(670
|
)
|
|
893
|
|
|
12
|
|
|||
Accrued expenses and other liabilities
|
1,093
|
|
|
1,147
|
|
|
178
|
|
|||
Net cash used in operating activities
|
(38,356
|
)
|
|
(27,604
|
)
|
|
(19,873
|
)
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(2,784
|
)
|
|
(1,520
|
)
|
|
(389
|
)
|
|||
Proceeds from maturities of investments
|
27,498
|
|
|
—
|
|
|
—
|
|
|||
Purchase of investments
|
(89,651
|
)
|
|
(27,053
|
)
|
|
—
|
|
|||
Net cash used in investing activities
|
(64,937
|
)
|
|
(28,573
|
)
|
|
(389
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from IPO, net of issuance costs
|
—
|
|
|
59,974
|
|
|
—
|
|
|||
Proceeds from underwritten public offering, net of issuance costs
|
95,183
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from issuance of preferred stock, net
|
—
|
|
|
—
|
|
|
15,250
|
|
|||
Proceeds from issuance of long-term debt, net of issuance costs
|
4,719
|
|
|
11,784
|
|
|
9,965
|
|
|||
Repayment of long-term debt
|
—
|
|
|
(10,401
|
)
|
|
(4,245
|
)
|
|||
Proceeds from sale of common stock, net of issuance costs
|
—
|
|
|
1,964
|
|
|
—
|
|
|||
Proceeds from issuance of common stock under ESPP
|
213
|
|
|
93
|
|
|
—
|
|
|||
Proceeds from exercise of stock options
|
383
|
|
|
683
|
|
|
42
|
|
|||
Proceeds from the exercise of warrants
|
—
|
|
|
33
|
|
|
—
|
|
|||
Payments made under capital lease
|
(4
|
)
|
|
—
|
|
|
—
|
|
|||
Payments for debt issuance costs
|
—
|
|
|
(103
|
)
|
|
(58
|
)
|
|||
Net cash provided by financing activities
|
100,494
|
|
|
64,027
|
|
|
20,954
|
|
|||
Net increase in cash and cash equivalents
|
$
|
(2,799
|
)
|
|
$
|
7,850
|
|
|
$
|
692
|
|
Cash and cash equivalents at beginning of period
|
20,058
|
|
|
12,208
|
|
|
11,516
|
|
|||
Cash and cash equivalents at end of period
|
$
|
17,259
|
|
|
$
|
20,058
|
|
|
$
|
12,208
|
|
Supplemental cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
897
|
|
|
$
|
815
|
|
|
$
|
426
|
|
Supplemental disclosure of non-cash investing and financing activities
|
|
|
|
|
|
||||||
Conversion of preferred stock to common stock upon closing of IPO
|
$
|
—
|
|
|
$
|
81,774
|
|
|
$
|
—
|
|
Reclassification of prepaid IPO closing costs from non-current assets to additional paid-in capital
|
$
|
—
|
|
|
$
|
997
|
|
|
$
|
—
|
|
Reclassification of warrants to additional paid-in capital
|
$
|
—
|
|
|
$
|
1,381
|
|
|
$
|
—
|
|
Accretion of redeemable convertible preferred stock to redemption value
|
$
|
—
|
|
|
$
|
180
|
|
|
$
|
1,605
|
|
Vesting of restricted stock
|
$
|
10
|
|
|
$
|
10
|
|
|
$
|
1
|
|
Cashless exercise of warrants
|
$
|
—
|
|
|
$
|
98
|
|
|
$
|
—
|
|
Issuance of common stock warrant
|
$
|
—
|
|
|
$
|
340
|
|
|
$
|
—
|
|
Equipment purchased under capital lease
|
$
|
—
|
|
|
$
|
21
|
|
|
$
|
—
|
|
Property and equipment, net included in accounts payable and accrued expense
|
$
|
394
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
|
•
|
Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.
|
•
|
persuasive evidence of an arrangement exist
|
•
|
delivery has occurred or services have been rendered
|
•
|
the fee is fixed or determinable
|
•
|
collectability is reasonably assured
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU 2014-09,
Revenue from Contracts with Customers
(Topic 606)
|
|
The standard will replace existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date.
In July 2015, the FASB affirmed its proposal to defer the effective date of the new revenue standard for all entities by one year. As a result, public business entities will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017. The standard will become effective for us on January 1, 2018 (the first quarter of the 2018 fiscal year). Early adoption is not permitted under GAAP. |
|
At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position. For the foreseeable future, the Company’s revenues will be limited to grants received from government agencies or nonprofit organizations. The Company is currently evaluating the method of adoption and the impact of this standard on the financial statements.
|
ASU No. 2014-15,
Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern
(“ASU 2014-15”).
|
|
The standard requires a company to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. This ASU is effective for annual and interim periods ending after December 15, 2016 and earlier application is permitted.
|
|
The Company is evaluating the effects of the new standard, but does not expect it will have a material impact on its financial conditions, results of operations, or cash flows.
|
|
Total
|
|
Quoted prices
in active
markets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
||||||||
December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money Market funds, included in cash equivalents
|
$
|
14,207
|
|
|
$
|
14,207
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S treasuries, included in cash equivalents
|
$
|
2,203
|
|
|
2,203
|
|
|
—
|
|
|
—
|
|
|||
Investments - U.S. treasuries
|
$
|
27,924
|
|
|
27,924
|
|
|
—
|
|
|
—
|
|
|||
Investments - certificates of deposit
|
61,249
|
|
|
—
|
|
|
61,249
|
|
|
—
|
|
||||
Total
|
$
|
105,583
|
|
|
$
|
44,334
|
|
|
$
|
61,249
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
0
|
|
|||||||
December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money Market funds, included in cash equivalents
|
$
|
18,992
|
|
|
$
|
18,992
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Marketable securities - U.S. treasuries
|
27,021
|
|
|
27,021
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
46,013
|
|
|
$
|
46,013
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Contracted
Maturity
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
||||||||
Cash equivalents and investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasuries
|
60-184 days
|
|
$
|
30,120
|
|
|
$
|
7
|
|
|
$
|
—
|
|
|
$
|
30,127
|
|
Certificates of deposit
|
91-365 days
|
|
49,145
|
|
|
—
|
|
|
—
|
|
|
49,145
|
|
||||
Certificates of deposit
|
greater than 365 days
|
|
12,104
|
|
|
—
|
|
|
—
|
|
|
12,104
|
|
||||
Total
|
|
|
$
|
91,369
|
|
|
$
|
7
|
|
|
$
|
—
|
|
|
$
|
91,376
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Laboratory equipment
|
$
|
3,943
|
|
|
$
|
2,510
|
|
Furniture office equipment
|
610
|
|
|
186
|
|
||
Computer hardware
|
259
|
|
|
257
|
|
||
Leasehold improvements
|
1,433
|
|
|
799
|
|
||
Computer software
|
338
|
|
|
—
|
|
||
Total property and equipment
|
6,583
|
|
|
3,752
|
|
||
Accumulated depreciation
|
(2,500
|
)
|
|
(1,796
|
)
|
||
Property and equipment, net
|
$
|
4,083
|
|
|
$
|
1,956
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Payroll and employee-related costs
|
$
|
1,736
|
|
|
$
|
1,066
|
|
Research and development costs
|
1,359
|
|
|
1,117
|
|
||
Other current liabilities
|
880
|
|
|
410
|
|
||
Total
|
$
|
3,975
|
|
|
$
|
2,593
|
|
|
December 31,
|
||
|
2015
|
||
2016
|
$
|
—
|
|
2017
|
3,149
|
|
|
2018
|
6,659
|
|
|
2019
|
8,034
|
|
|
Total
|
$
|
17,842
|
|
|
November 20,
2014 |
|||
Fair value of underlying instrument
|
$
|
9.05
|
|
|
Expected volatility
|
70.0
|
|
%
|
|
Expected term (in years)
|
5
|
|
|
|
Risk-free interest rate
|
1.64
|
|
%
|
|
Expected dividend yield
|
0.0
|
|
%
|
|
|
Years ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Beginning balance
|
|
$
|
—
|
|
|
$
|
656
|
|
|
$
|
246
|
|
Warrants issued
|
|
—
|
|
|
—
|
|
|
188
|
|
|||
Change in fair value
|
|
—
|
|
|
725
|
|
|
222
|
|
|||
Warrants exercised
|
|
—
|
|
|
(323
|
)
|
|
—
|
|
|||
Reclassification to accumulated paid-in capital
|
|
—
|
|
|
(1,058
|
)
|
|
—
|
|
|||
Ending balance
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
656
|
|
|
January 29,
2014 |
|||
Fair value of underlying instrument
|
$
|
0.65
|
|
|
Expected Volatility
|
55.57
|
|
%
|
|
Expected term (in years)
|
0.04
|
|
|
|
Risk-free interest rate
|
1.52
|
|
%
|
|
Expected dividend yield
|
0.0
|
|
%
|
|
February 4,
2014 |
|||
Fair value of underlying instrument
|
$
|
0.65
|
|
|
Expected Volatility
|
55.03
|
|
%
|
|
Expected term (in years)
|
0.02
|
|
|
|
Risk-free interest rate
|
1.46
|
|
%
|
|
Expected dividend yield
|
0.0
|
|
%
|
|
February 10,
2014 |
|||
Fair value of underlying instrument
|
$
|
7.74
|
|
|
Expected Volatility
|
50.81
|
|
%
|
|
Expected term (in years)
|
1
|
|
|
|
Risk-free interest rate
|
1.48
|
|
%
|
|
Expected dividend yield
|
0.0
|
|
%
|
|
February 10,
2014 |
|||
Fair value of underlying instrument
|
$
|
6.96
|
|
|
Expected Volatility
|
92.9
|
|
%
|
|
Expected term (in years)
|
8.66
|
|
|
|
Risk-free interest rate
|
2.43
|
|
%
|
|
Expected dividend yield
|
0.0
|
|
%
|
|
December 31, 2015
|
||
2016
|
$
|
1,379
|
|
2017
|
231
|
|
|
Total
|
$
|
1,610
|
|
|
|
Years ended December 31,
|
|||||||
|
|
2015
|
|
2014
|
|
2013
|
|||
Preferred stock
|
|
—
|
|
|
—
|
|
|
11,409
|
|
Warrants
|
|
78
|
|
|
78
|
|
|
193
|
|
Outstanding options
|
|
2,723
|
|
|
2,290
|
|
|
1,576
|
|
Total
|
|
2,801
|
|
|
2,368
|
|
|
13,178
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development
|
|
$
|
1,690
|
|
|
$
|
1,511
|
|
|
$
|
322
|
|
General and administrative
|
|
2,158
|
|
|
1,394
|
|
|
350
|
|
|||
Total
|
|
$
|
3,848
|
|
|
$
|
2,905
|
|
|
$
|
672
|
|
|
|
Shares
|
|
Weighted-
Average
Exercise
Price
|
|
Weighted-
Average
Remaining
Contractual
Term (years)
|
|
Aggregate
Intrinsic
Value
|
|||||
Outstanding at December 31, 2014
|
|
2,290
|
|
|
$
|
7.26
|
|
|
8.08
|
|
$
|
5,332
|
|
Granted
|
|
715
|
|
|
$
|
9.12
|
|
|
|
|
|
||
Exercised
|
|
(128
|
)
|
|
$
|
3.00
|
|
|
|
|
|
||
Canceled
|
|
(154
|
)
|
|
$
|
13.41
|
|
|
|
|
|
||
Outstanding at December 31, 2015
|
|
2,723
|
|
|
$
|
7.60
|
|
|
7.61
|
|
$
|
2,840
|
|
Exercisable at December 31, 2015
|
|
1,410
|
|
|
$
|
5.71
|
|
|
6.66
|
|
$
|
2,507
|
|
Vested or expected to vest at December 31, 2015
|
|
2,605
|
|
|
$
|
7.54
|
|
|
7.58
|
|
$
|
2,793
|
|
|
|
Years ended December 31,
|
||||
|
|
2015
|
|
2014
|
|
2013
|
Expected Volatility
|
|
68.5% - 85.3%
|
|
86.2% - 103.6%
|
|
97.1%
|
Risk-free interest rate
|
|
1.56% - 1.94%
|
|
1.75% - 2.00%
|
|
0.59% - 1.83%
|
Expected term (in years)
|
|
5.50 - 6.08
|
|
6.25
|
|
6.25
|
Expected dividend yield
|
|
0%
|
|
0%
|
|
0%
|
|
|
December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
|
||||
U.S and state net operating loss carryforwards
|
|
$
|
54,570
|
|
|
$
|
39,721
|
|
Research and development credits
|
|
5,226
|
|
|
3,655
|
|
||
Stock based compensation
|
|
1,410
|
|
|
770
|
|
||
Purchased intangibles
|
|
220
|
|
|
245
|
|
||
Capitalized organizational and start up expenditures
|
|
133
|
|
|
153
|
|
||
Accruals and other temporary differences
|
|
1,119
|
|
|
659
|
|
||
Total deferred tax assets
|
|
62,678
|
|
|
45,203
|
|
||
Less valuation allowance
|
|
(62,678
|
)
|
|
(45,203
|
)
|
||
Net deferred tax assets
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Years ended December 31,
|
|||||||
|
|
2015
|
|
2014
|
|
2013
|
|||
Federal income tax expense at statutory rate
|
|
34.0
|
%
|
|
34.0
|
%
|
|
34.0
|
%
|
State income tax, net of federal benefit
|
|
6.1
|
%
|
|
4.6
|
%
|
|
5.1
|
%
|
Permanent differences
|
|
(1.6
|
)%
|
|
(2.1
|
)%
|
|
(0.9
|
)%
|
Research and development credit
|
|
2.6
|
%
|
|
1.8
|
%
|
|
3.6
|
%
|
Other
|
|
0.0
|
%
|
|
0.1
|
%
|
|
0.0
|
%
|
Change in valuation allowance
|
|
(41.1
|
)%
|
|
(38.4
|
)%
|
|
(41.8
|
)%
|
Effective tax rate
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
|
Three Months Ended,
|
||||||||||||||
|
|
March 31, 2015
|
|
June 30, 2015
|
|
September 30, 2015
|
|
December 31, 2015
|
||||||||
Revenue
|
|
$
|
121
|
|
|
$
|
115
|
|
|
$
|
213
|
|
|
$
|
221
|
|
Operating expenses
|
|
11,898
|
|
|
10,141
|
|
|
9,703
|
|
|
10,294
|
|
||||
Net loss
|
|
(12,084
|
)
|
|
(10,314
|
)
|
|
(9,771
|
)
|
|
(10,314
|
)
|
||||
Net loss per share - basic and diluted
|
|
$
|
(0.64
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.37
|
)
|
Weighted-average number of common shares used in net loss per share - basic and diluted
|
|
18,834
|
|
|
24,154
|
|
|
26,610
|
|
|
28,118
|
|
|
|
Three Months Ended,
|
||||||||||||||
|
|
March 31, 2014
|
|
June 30, 2014
|
|
September 30, 2014
|
|
December 31, 2014
|
||||||||
Revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
308
|
|
Operating expenses
|
|
6,373
|
|
|
6,909
|
|
|
8,958
|
|
|
11,234
|
|
||||
Net loss
|
|
(7,329
|
)
|
|
(7,146
|
)
|
|
(9,171
|
)
|
|
(11,650
|
)
|
||||
Net loss per attributable to common stockholders
|
|
(7,509
|
)
|
|
(7,146
|
)
|
|
(9,171
|
)
|
|
(11,650
|
)
|
||||
Net loss per share attributable to common stockholders - basic and diluted
|
|
$
|
(0.76
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.66
|
)
|
Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic and diluted
|
|
9,859
|
|
|
17,346
|
|
|
17,465
|
|
|
17,696
|
|
|
GENOCEA BIOSCIENCES, INC.
|
|
|
|
|
|
By:
|
/s/ William Clark
|
|
|
|
|
|
William Clark
|
|
|
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ William Clark
|
|
President and Chief Executive Officer and Director
|
|
|
William Clark
|
|
(Principal Executive Officer)
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Jonathan Poole
|
|
Chief Financial Officer
|
|
|
Jonathan Poole
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Kenneth Bate
|
|
|
|
|
Kenneth Bate
|
|
Director
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Kevin Bitterman
|
|
|
|
|
Kevin Bitterman, Ph.D.
|
|
Director
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Katrine Bosley
|
|
|
|
|
Katrine Bosley
|
|
Director
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Michael Higgins
|
|
|
|
|
Michael Higgins
|
|
Director
|
|
February 17, 2016
|
|
|
|
|
|
/s/ Stephen Hoffman
|
|
|
|
|
Stephen Hoffman, M.D., Ph.D.
|
|
Director
|
|
February 17, 2016
|
|
|
|
|
|
/s/ George Siber
|
|
|
|
|
George Siber, M.D.
|
|
Director
|
|
February 17, 2016
|
Exhibit
Number
|
|
Exhibit
|
|
|
|
3.1
|
|
Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on February 12, 2014)
|
|
|
|
3.2
|
|
Amended and Restated By-laws (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on February 12, 2014)
|
|
|
|
4.1
|
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
4.2
|
|
Form of Warrant to Purchase Preferred Stock, dated January 7, 2008 (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
4.3
|
|
Fourth Amended and Restated Registration Rights Agreement (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
4.4
|
|
Warrant Agreement between the Company and Hercules Technology Growth Capital, Inc., dated November 20, 2014 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on November 21, 2014)
|
|
|
|
10.1
|
|
Form of Director Indemnification Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.2+
|
|
Amended and Restated Exclusive License Agreement between Children’s Medical Center Corporation and Genocea Biosciences, Inc., dated March 23, 2012 (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.3+
|
|
Amended and Restated License Agreement between Genocea Biosciences, Inc. and President and Fellows of Harvard College, dated November 19, 2012 (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.4+
|
|
License and Collaboration Agreement between Genocea Biosciences, Inc. and Isconova AB, dated August 5, 2009, as amended on March 19, 2010, June 18, 2010, August 17, 2010, October 19, 2011 and February 6, 2012 (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.5+
|
|
Exclusive License Agreement for Escherichia Coli K12 to Deliver Protein to the Macrophage Cytosol between Genocea Biosciences, Inc. and The Regents of the University of California, dated August 18, 2006 (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.6
|
|
Lease, dated as of July 3, 2012, between TBCI, LLC and Genocea Biosciences, Inc. (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.7
|
|
Agreement Regarding Sublease, dated as of July 9, 2012, by TBCI, LLC, FoldRx Pharmaceuticals, Inc., Pfizer Inc. and Genocea Biosciences, Inc. (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
Exhibit
Number
|
|
Exhibit
|
|
|
|
10.8
|
|
Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan, as amended on June 24, 2013 (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.9†
|
|
Consulting Agreement between Genocea Biosciences, Inc. and George Siber, dated May 16, 2007, as amended on June 30, 2009, December 16, 2010, June 15, 2011 and June 5, 2013 (incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.10†
|
|
Amended and Restated Employment Letter Agreement between William Clark and Genocea Biosciences, Inc., dated January 16, 2014 (incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 23, 2014)
|
|
|
|
10.11†
|
|
Amended and Restated Employment Letter Agreement between Seth Hetherington, M.D. and Genocea Biosciences, Inc., dated January 16, 2014 (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 23, 2014)
|
|
|
|
10.12†
|
|
Letter Agreement, dated April 7, 2014, between the Company and Jonathan Poole (incorporated by referenced to Exhibit 10.1 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on April 8, 2014)
|
|
|
|
10.13†
|
|
Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.14†
|
|
Genocea Biosciences, Inc. Cash Incentive Plan (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.15†
|
|
Form of Nonstatutory Stock Option Granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan (incorporated by reference to Exhibit 10.20 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.16†
|
|
Form of Incentive Stock Option Granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan (incorporated by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013)
|
|
|
|
10.17†
|
|
Form of Incentive Stock Option under the Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference to Exhibit 10.22 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.18†
|
|
Form of Nonstatutory Stock Option under the Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.19†
|
|
Restricted Stock Agreement between Genocea Biosciences, Inc. and Katrine Bosley, dated November 7, 2013 (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.20†
|
|
Genocea Biosciences, Inc. 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.26 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 23, 2014)
|
|
|
|
Exhibit
Number
|
|
Exhibit
|
|
|
|
10.21
|
|
Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan to Katrine Bosley, dated May 13, 2013 (incorporated by reference to Exhibit 10.28 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.22†
|
|
Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan to Katrine Bosley, dated November 5, 2013 (incorporated by reference to Exhibit 10.29 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014)
|
|
|
|
10.23+
|
|
Bioprocessing Services Agreement between the Company and FUJIFILM Diosynth Biotechnologies U.S.A., Inc. dated February 26, 2014 (incorporated by reference to Exhibit 10.1 to the Company’s Form 10-Q, File No. 001-36289, filed on May 9, 2014)
|
|
|
|
10.24
|
|
Loan and Security Agreement between the Company and Hercules Technology Growth Capital, Inc., dated November 20, 2014 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on November 21, 2014)
|
|
|
|
10.25
|
|
Equity Rights Letter Agreement between the Company and Hercules Technology Growth Capital, Inc., dated November 20, 2014 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on November 21, 2014)
|
|
|
|
10.26+
|
|
Product Development and Clinical Supply Agreement between the Company and Baxter Pharmaceutical Solutions LLC, dated October 23, 2014 (incorporated by reference to Exhibit 10.32 to the Company’s Annual Report on Form 10-K File No. 001-36289, filed on February 27, 2015)
|
|
|
|
10.27†
|
|
Fifth Amendment to the Consulting Agreement between Genocea Biosciences, Inc. and George Siber, dated June 15, 2015 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on June 19, 2015)
|
|
|
|
10.28
|
|
Amendment No. 1 to Loan and Security Agreement between the Company and Hercules Technology Growth Capital, Inc., dated December 17, 2015 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K File No. 001-36289, filed on December 18, 2015)
|
|
|
|
10.29
|
|
Sublease Agreement between the Company and the Smithsonian Institution, dated June 15, 2015 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on June 19, 2015)
|
|
|
|
21.1*
|
|
List of Subsidiaries of the Company
|
|
|
|
23.1*
|
|
Consent of Ernst & Young LLP
|
|
|
|
31.1*
|
|
Certification pursuant to Section 302 of Sarbanes Oxley Act of 2002 by Chief Executive Officer
|
|
|
|
31.2*
|
|
Certification pursuant to Section 302 of Sarbanes Oxley Act of 2002 by Chief Financial Officer
|
|
|
|
32.1**
|
|
Certification of periodic financial report pursuant to Section 906 of Sarbanes Oxley Act of 2002 by Chief Executive Officer
|
|
|
|
32.2**
|
|
Certification of periodic financial report pursuant to Section 906 of Sarbanes Oxley Act of 2002 by Chief Financial Officer
|
Exhibit
Number
|
|
Exhibit
|
|
|
|
|
|
|
101. INS*
|
|
XBRL Instance Document
|
|
|
|
101. SCH*
|
|
XBRL Taxonomy Extension Schema
|
|
|
|
101. CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
|
|
101. DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
|
|
101. LAB*
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
|
|
101. PRE*
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
†
|
Indicates a management contract or compensatory plan.
|
+
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been submitted separately to the Securities and Exchange Commission.
|
(1)
|
Registration Statement (Form S-8 No. 333-194021) pertaining to the Amended and Restated 2007 Equity Incentive Plan and 2014 Equity Incentive Plan of Genocea Biosciences, Inc.,
|
(2)
|
Registration Statement (Form S-8 No. 333-197127) pertaining to the 2014 Employee Stock Purchase Plan of Genocea Biosciences, Inc.,
|
(3)
|
Registration Statement (Form S-8 No. 333-202333) pertaining to the 2014 Equity Incentive Plan of Genocea Biosciences, Inc., and
|
(4)
|
Registration Statement (Form S-3 No. 333-203981) of Genocea Biosciences, Inc.;
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark
|
|
President & Chief Executive Officer
|
|
|
Date: February 17, 2016
|
|
|
/s/ JONATHAN POOLE
|
|
Jonathan Poole
|
|
Chief Financial Officer
|
|
|
Date: February 17, 2016
|
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark*
|
|
President &Chief Executive Officer
|
|
|
Date: February 17, 2016
|
|
|
/s/ JONATHAN POOLE
|
|
Jonathan Poole*
|
|
Chief Financial Officer
|
|
|
Date: February 17, 2016
|
|