Genocea Biosciences Inc
Annual Report 2017

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549_______________________________________________________FORM 10-K(Mark One)x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2017oro TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Commission file number 001-36289Genocea Biosciences, Inc.(Exact name of registrant as specified in its charter)Delaware 51-0596811(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.)100 Acorn Park Drive Cambridge, Massachusetts 02140(Address of principal executive offices) (Zip Code)Registrant’s telephone number, including area code: (617) 876-8191Securities registered pursuant to Section 12(b) of the Act:Title of each class Name of each exchange on which registeredCommon Stock, $0.001 par value Nasdaq Global MarketSecurities registered pursuant to Section 12(g) of the Act: None_______________________________________________________Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. o Yes x NoIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. o Yes x NoIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes o NoIndicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’sknowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. xIndicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted andposted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit andpost such files). x Yes o NoIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growthcompany. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Checkone):Large accelerated filer o Accelerated filer xNon-accelerated filer o Smaller reporting company o(Do not check if a smaller reporting company) Emerging growth company xIf an emerging growth company, indicate by a check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act. xIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x NoThe aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price for such stock as reported on TheNasdaq Global Market on June 30, 2017, the last business day of the registrant’s most recently completed second quarter, was: $100,317,709.The number of shares outstanding of the registrant’s common stock as of February 14, 2018 was 82,099,898. TABLE OF CONTENTSPART I Item 1.Business4Item 1A.Risk Factors20Item 1B.Unresolved Staff Comments46Item 2.Properties46Item 3.Legal Proceedings46Item 4.Mine Safety Disclosures47 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities48Item 6.Selected Financial Data50Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations51Item 7A.Quantitative and Qualitative Disclosures About Market Risk65Item 8.Financial Statements and Supplementary Data66Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure66Item 9A.Controls and Procedures66Item 9B.Other Information67 PART III Item 10.Directors, Executive Officers and Corporate Governance68Item 11.Executive and Director Compensation68Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters68Item 13.Certain Relationships and Related Transactions, and Director Independence68Item 14.Principal Accountant Fees and Services68 PART IV Item 15.Exhibits and Financial Schedules69Item 16.Form 10-K Summary692FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statementsare neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding thefuture of our business, future plans and strategies, our clinical results and other future conditions. The words “anticipate”, “believe”, “contemplate”,“continue”, “could”, “estimate”, “expect”, “forecast”, “goal”, “intend”, “may”, “plan”, “potential”, “predict”, “project”, “should”, “target”, “will”, “would”,or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statementscontain these identifying words.The forward-looking statements in this Annual Report on Form 10-K include, among other things, statements about:•our estimates regarding the timing and amount of funds we require to file our investigational new drug ("IND") application and initiate clinical trialsfor GEN-009 and to continue our investments in immuno-oncology;•our estimate for when we will require additional funding;•our plans to commercialize GEN-009 and our other product candidates;•the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;•the rate and degree of market acceptance and clinical utility of any approved product candidate;•the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;•our ability to quickly and efficiently identify and develop product candidates;•our commercialization, marketing and manufacturing capabilities and strategy;•our intellectual property position; and•our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need foradditional financing.We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place unduereliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in theforward-looking statements we make. We have included important factors in the cautionary statements included in this Annual Report on Form 10-K,particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that wemake. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments wemay make or collaborations or strategic partnerships we may enter into.You should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to the Annual Report on Form 10-K completelyand with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update anyforward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.3PART IItem 1. BusinessUnless the context requires otherwise, references in this Annual Report on Form 10-K to “Genocea”, “we”, “us” and “our” refer to GenoceaBiosciences, Inc.OverviewWe are a biopharmaceutical company that discovers and develops novel cancer vaccines. We use our proprietary discovery platform, ATLAS, torecall a patient’s pre-existing CD4+ and CD8+ T cell immune responses to their tumor to identify antigens for inclusion in vaccines that are designed to actthrough T cell (or cellular) immune responses. We believe that using ATLAS to identify antigens for inclusion in cancer vaccines could lead to moreimmunogenic and efficacious cancer vaccines.In September 2017, we announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines. Currently,all of our research programs and product candidates in active development are at the preclinical stage. Our most advanced program is our preclinical immuno-oncology program, GEN-009, a neoantigen cancer vaccine. The GEN-009 program uses ATLAS to identify patient neoantigens, or newly formed antigensunique to each patient, that are associated with that individual’s tumor. We are also exploring partnering opportunities in the development of cancer vaccinestargeting tumor-associated antigens and a vaccine targeting cancers caused by Epstein-Barr Virus, or EBV.We have one Phase 3-ready product candidate, GEN-003, an investigational immunotherapy for the treatment of genital herpes. In September 2017,we announced that we are exploring strategic alternatives to maximize value for GEN-003 through sale, partnership or other means. Consequently,substantially all GEN-003 spending and activities were ceased and we reduced our workforce by approximately 40 percent. We continue to believe that GEN-003 could address unmet medical needs of genital herpes patients.ATLAS PlatformThe importance of the T cell arm of the immune system is increasingly understood to be critical in the treatment of certain cancers. However, thediscovery of effective T cell targets has been particularly challenging for two reasons. First, the diversity of human T cell responses means that an effective Tcell target for one person may be different from an effective T cell target for another person. Second, the number of candidate targets for T cell responses canbe very large with up to thousands of candidate antigens per patient in some cancers. These complexities represent fundamental barriers that traditionalcancer vaccine target discovery tools, which rely largely on computer modeling - so-called predictive algorithms - have, as yet, only been poorly addressed.We have designed the ATLAS platform to overcome these T cell target discovery challenges by identifying true neoantigens in an individual ratherthan using traditional predictive methods. We believe ATLAS represents the most comprehensive and accurate high throughput system for T cell vaccine andimmunotherapy discovery in the biopharmaceutical industry. ATLAS is designed to mimic the T cell arm of the human immune system in a laboratorysetting. Using ATLAS, we are able to measure T cell responses to the entire set of potential T cell targets for an individual’s cancer, allowing us to identifyvaccine and immunotherapy targets associated with T cell responses which may kill an individual’s cancer.We believe we are a leader in the field of T cell vaccine and immunotherapy discovery and development. Our management and scientific teamspossess considerable experience in vaccine, immunotherapy and anti-infective research, manufacturing, clinical development and regulatory matters.Our Immuno-Oncology ProgramWe are focused on combining our antigen selection and vaccine development expertise to create new immuno-oncology treatments. Our potentialcancer vaccines will be designed to educate T cells to recognize and attack specific targets and thereby kill cancer cells. We are working to developpersonalized cancer vaccines by applying ATLAS to identify patient neoantigens that are associated with that individual’s pre-existing immune responses toa tumor.Neoantigens are personalized tumor mutations that are seen as “foreign” by an individual’s immune system. Data published in recent years haveindicated that an individual’s response to neoantigens drives checkpoint inhibitor efficacy and that it is possible to vaccinate an individual against their ownneoantigens. If approved, neoantigen vaccines could be used in4combination with existing treatment approaches for cancer, including immune checkpoint inhibitors, to potentially direct and enhance an individual’s T cellresponse to the individual’s cancer, thereby potentially affording better clinical outcomes.Our lead immuno-oncology program, GEN-009, is an adjuvanted neoantigen peptide vaccine candidate designed to direct a patient’s immunesystem to attack their tumor. GEN-009’s neoantigens are identified by our proprietary ATLAS platform, which recalls a patient’s pre-existing CD4+ andCD8+ cell immune responses to their tumor. Following ATLAS neoantigen identification, we will manufacture a personal vaccine for each patient.We anticipate filing a personalized cancer vaccine IND application with the FDA in the first quarter of 2018 for GEN-009. We plan to initiate aPhase 1/2a clinical trial for GEN-009 in a range of tumor types in subjects with no evidence of disease but a high risk of relapse in mid-2018. We expect toreport initial immunogenicity data from this trial in the first half of 2019.We are also using ATLAS to develop cancer vaccines targeting tumor-associated, or shared, antigens and vaccines against cancers of viral origin.Our strategy in immuno-oncology combines our own internal neoantigen vaccine development programs with a focus on partnering ATLAS for these otherimmuno-oncology applications.In November 2015, we commenced a program focused on EBV. EBV infection has been linked to cancers with high unmet needs such as non-Hodgkin’s lymphoma, nasopharyngeal carcinoma and gastric carcinoma. We believe that ATLAS is highly suited to the creation of a new immunotherapy forEBV, given that T cell responses are understood to be crucial for protection against EBV. Furthermore, EBV is part of the herpes virus family, in which wehave deep experience through our development of GEN-003. We are currently seeking a partner to advance the development of this vaccine.We have had and continue to conduct a number of research collaborations which provide blood and tumor samples to support the development ofATLAS for application in neoantigen vaccines, shared antigen cancer vaccines and immune response profiling as follows:•Neoantigen vaccine applications: Memorial Sloan Kettering Cancer Center (completed) and US Oncology Research (ongoing)•Shared antigen cancer vaccines and immune response profiling: Dana-Farber Cancer Institute (completed) and Checkmate Pharmaceuticals(ongoing)The Company is not dependent on these research collaborations to develop its product candidates and no material financial obligations exist as partof these collaborations.Our Immuno-oncology Product Candidate PipelineThe following table describes our active programs in development:VaccineCandidate Program Stage of Development Next Milestone Anticipated TimelineGEN-009 Neoantigen cancer vaccine Pre-clinical File IND; commence Phase 1/2clinical proof of concept trial First quarter of 2018; mid-2018GEN-010 Second generationneoantigen cancer vaccine Pre-clinical Select delivery technologyplatform OngoingGEN-007 Epstein-Barr Virus Research Select antigen candidates Ongoing, exploring partneringopportunitiesGEN-006 Immuno-oncology -tumor‑associatedantigen vaccine Research Select antigen candidates Ongoing, exploring partneringopportunitiesGEN-003 — Phase 2 immunotherapy for genital herpes, currently exploring strategic alternativesPrior to our September 2017 strategic shift announcement, our lead program was GEN-003, a Phase 3-ready investigational immunotherapy for thetreatment of genital herpes. We completed three positive clinical trials for which key data from those clinical trials is described below. We are currentlyexploring strategic alternatives to maximize shareholder value from GEN-003, during which time we have ceased substantially all activities under the GEN-003 program.5Phase 1/2 TrialFinal analysis of the data from the Phase 1/2a trial showed that, for the best performing 30µg dose group, there was a sustained reduction in the viralshedding rate. After completion of dosing for this group, the viral shedding rate showed a statistically significant reduction of 52% versus baseline and, at sixmonths after the final dose, the shedding rate remained at 40% below baseline. The reduction in the genital lesion rate after completion of the third dose wasgreatest for the 30 µg dose group at 48%. After six months, the reduction from baseline in genital lesion rate for this dose group was 65% and, after 12months, the genital lesion rate was 42% lower than baseline. GEN-003 was well tolerated over the 12 months of this clinical trial.Phase 2 Dose Optimization TrialA 310-subject Phase 2 dose optimization trial was completed in March 2016. The objective of this trial was to confirm the results of the Phase 1/2atrial and to test six combinations of proteins and adjuvant to determine the optimal dose for future trials and potentially improve on the profile of GEN-003.Subjects were randomized to one of six dosing groups of either 30μg or 60μg per protein paired with one of three adjuvant doses (25 μg, 50 μg, or 75 μg). Aseventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rateswere established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day),which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period wasrepeated immediately after the completion of dosing, and at six and twelve months following dosing. No maintenance doses were given. After the 28-dayobservation period immediately after dosing, patients in the placebo arm were rolled over across the six active dose combinations under a separate protocol.Subsequent to March 2016, we extended this clinical trial to include a separate protocol for an extension study which includes a 28-day observation periodat 24 months post-dosing to evaluate the reduction versus baseline in both the viral shedding rate and the genital lesion rate.The primary endpoint of the trial was the reduction in viral shedding rate versus baseline, a measure of anti-viral activity. A number of exploratorysecondary endpoints were also studied, including, the reduction in genital lesion rates, the percent of patients who were recurrence free from lesions up to sixand 12 months after dosing, and the time to first recurrence of lesions after dosing. We advanced the two most promising doses from this dose optimizationstudy, the 60 µg per protein combined with either 50 or 75 µg of Matrix-M2 adjuvant ("60/50 Dose" and "60/75 Dose" respectively), into a Phase 2b efficacytrial for which positive twelve-month, placebo-controlled clinical efficacy data was announced in July 2017 (see Phase 2b trial below).Phase 2b TrialIn December 2015, a Phase 2b clinical trial was initiated as our first study testing potential Phase 3 endpoints with a Phase 3-ready formulation ofGEN-003, manufactured with commercially-scalable processes. The trial enrolled 131 subjects that were randomized to one of three dose groups - placebo,60/50 Dose, and 60/75 Dose. All subjects received three injections at 21-day intervals.In September 2016, we announced positive viral shedding rate reductions from the ongoing Phase 2b study. The study achieved its primaryendpoint, with GEN-003 demonstrating a statistically significant (versus placebo and baseline) 40% reduction in the viral shedding rate compared tobaseline immediately after dosing in the 60/50 Dose group, using a new Phase 3-ready formulation. This result was consistent with a statistically significant(versus placebo and baseline) viral shedding rate reduction of 41% at this same dose and time point in a prior Phase 2 clinical trial. In addition, thereactogenicity profile of this dose, an indication of the strength of the immune response to GEN-003, was consistent between the trials. This same dose in theprior Phase 2 clinical trial subsequently demonstrated virologic and clinical efficacy that was durable for at least one year after dosing.The 60/75 Dose group reduced the viral shedding rate by 27%, which is lower than the rate observed in the prior trial, and also showed a lessacceptable reactogenicity profile than the prior trial. We believe that the increase in reactogenicity of this dose indicates an overstimulation of the T cellimmune system leading to the reduced efficacy with this dose in this trial, as would be expected with the known bell-shaped T cell dose response curve. Thelikely driver of this effect is a more potent adjuvant formulation following customary manufacturing process changes to prepare for Phase 3 clinical trials andcommercialization of GEN-003. In July 2017, we announced positive clinical results from the Phase 2b trial. At twelve months after dosing, GEN-003 demonstrated statisticallysignificant improvements versus placebo in both the median genital lesion rate and across multiple clinical endpoints. The 60/50 Dose significantly reducedthe median rate of genital lesions during the twelve months following6dosing compared to placebo (49% reduction versus placebo). The median genital lesion rate is an important overall measure of disease that captures both thefrequency and duration of recurrences, both of which are important to both patients and their caregivers. Importantly, these results were achieved at the Phase3 dose and expected Phase 3 primary endpoint. GEN-003 also consistently demonstrated significant benefits versus placebo across several other clinicalendpoints across the dose groups.GEN-003 demonstrated no grade 4 reactogenicity or related serious adverse events ("AEs") and discontinuations due to AEs were low and similarlydistributed across active dose groups and placebo.Around the end of the first quarter of 2017, we had a successful end-of-Phase 2 meeting with the U.S Food and Drug Administration ("FDA"). Webelieve that progress made and data generated to date in the GEN-003 preclinical and clinical trials remains valuable to the Company for the future.CompetitionThe biotechnology and pharmaceutical industries are characterized by intense and rapidly changing competition to develop new technologies andproprietary products. Although we believe that our proprietary patent portfolio and T cell vaccine expertise provide us with competitive advantages, we facepotential competition from many different sources, including larger and better-funded pharmaceutical companies. Not only must we compete with othervaccine companies but any products that we may commercialize will have to compete with existing therapies and new therapies that may become availablein the future.There are other organizations working to improve existing therapies or to develop new vaccines or therapies for our initially selected indications.Depending on how successful these efforts are, it is possible they may increase the barriers to adoption and success of our product candidates, including GEN-009, if approved.There are several companies attempting to develop new neoantigen cancer vaccines, including Neon Therapeutics, Gritstone Oncology, ImmaticsBiotechnologies GmbH, Aduro, Advaxis, Agenus, Moderna, CureVac and BioNTech. We believe that GEN-009 has advantages against each of these productcandidates based on the potential power of the ATLAS platform to comprehensively identify for each cancer patient the neoantigens to which such patienthas a pre-existing immune response. We believe that selecting neoantigens for personal cancer vaccines using ATLAS will lead to more effective vaccines.However, there can be no assurance that one or more of these companies or other companies will not achieve similar or superior clinical results in the future ascompared to GEN-009 or that our future clinical trials will be successful.Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we doand significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of vaccines andthe commercialization of those vaccines. Accordingly, our competitors may be more successful than us in obtaining approval for vaccines and achievingwidespread market acceptance. Our competitors’ vaccines may be more effective, or more effectively marketed and sold, than any vaccine we maycommercialize and may render our vaccines obsolete or non-competitive.Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smallernumber of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel andestablishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, ourprograms. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large andestablished companies.We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available. Weexpect any vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration anddelivery, price, the level of generic competition and the availability of reimbursement from government and other third-party payors.Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDAor other regulatory approval for their products more rapidly than we may obtain approval for our products, which could result in our competitors establishinga strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products.Intellectual Property7We strive to protect and enhance the proprietary technology, inventions and improvements that are commercially important to our business,including seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. We also rely on trade secretsrelating to our proprietary technology platform and on know-how, continuing technological innovation and in-licensing opportunities to develop,strengthen and maintain our proprietary position in the vaccine field. We additionally rely on regulatory protection afforded through data exclusivity, marketexclusivity and patent term extensions where available. Still further, we utilize trademark protection for our company name, and expect to do so for productsand/or services as they are marketed.Our commercial success may depend in part on our ability to obtain and maintain patent and other proprietary protection for commerciallyimportant technology, inventions and know-how related to our business; defend and enforce our patents; preserve the confidentiality of our trade secrets; andoperate without infringing the valid enforceable patents and proprietary rights of third parties. Our ability to stop third parties from making, using, selling,offering to sell or importing our products may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that coverthese activities. With respect to both licensed and company-owned intellectual property, we cannot be sure that patents will be granted with respect to any ofour pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or anypatents that may be granted to us in the future will be commercially useful in protecting our commercial products and methods of manufacturing the same.We have developed or in-licensed numerous patents and patent applications and possess substantial know-how and trade secrets relating to thedevelopment and commercialization of vaccine products. The term of individual patents depends upon the legal term of the patents in the countries in whichthey are obtained. In most countries in which we file, the patent term is 20 years from the date of filing the non-provisional application. In the United States, apatent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent andTrademark Office ("U.S. PTO") in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent.The term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration of aUnited States patent as compensation for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent termextension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is underregulatory review. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval andonly one patent applicable to an approved drug may be extended. Moreover, a patent can only be extended once, and thus, if a single patent is applicable tomultiple products, it can only be extended based on one product. Similar provisions are available in Europe and other foreign jurisdictions to extend the termof a patent that covers an approved drug. When possible, depending upon the length of clinical trials and other factors involved in the filing of a biologicslicense application ("BLA") we expect to apply for patent term extensions for patents covering our product candidates and their methods of use.As of the date of this Annual Report on Form 10-K, our patent portfolio includes the following:ATLASOur discovery platform patent portfolio includes four patent families, currently comprising seven issued U.S. patents. We hold an exclusive licensefrom The Regents of the University of California ("UC") to the first patent family, including U.S. Patent 6,004,815 and the related U.S. Patents 6,287,556 and6,599,502. This first family includes claims to fundamental aspects of the ATLAS platform, developed by our scientific founder, Darren Higgins, Ph.D. whilehe was employed at the University of California, Berkeley. Patents in this family have a patent term until August 2018. We hold a further exclusive licensefrom President and Fellows of Harvard College ("Harvard") to the second patent family, which covers methods related to the ATLAS discovery platform,including discovery of antigens expressed in neoplastic cells. This second patent family includes U.S. Patent 9,051,564, a pending and allowed U.S.application, issued patents in Europe and Australia and pending applications in Europe and Canada. Patents issuing from these applications are expected toexpire in 2027 with the exception of U.S. Patent 9,051,564 which includes a Patent Term Adjustment and extends until December 2031. We wholly own thethird patent family, which is specifically directed to the ATLAS platform as utilized by us, including for discovery of cancer-or tumor-related antigens. Thisthird patent family includes U.S. Patents 8,313,894, 9,045,791, and 9,873,370, a pending and U.S. patent application, an issued patent in Australia, anallowed application in Canada, and pending applications in Europe, Canada and Australia. Patents issuing from applications in this family are expected tohave a patent term until at least July 2029. U.S. Patents 8,313,894 and 9,045,791 have terms that include Patent Term Adjustments and extend untilAugust 2030 and August 2029, respectively. U.S. Patent 9,873,870 has a term that extends until July 2029. We wholly own the fourth patent family, which isdirected to methods for cancer diagnosis, prognosis, and patient selection, as well as related compositions. This fourth family currently comprises threeprovisional applications.8GEN-003 (Genital Herpes)We wholly own a portfolio of patent applications directed to HSV-2 vaccines, including GEN-003. This portfolio includes three patent familiescovering HSV-2 vaccine compositions and methods for inhibiting or treating HSV-2 infections, combination treatment with antiviral medications, andmaintenance dosing. The first patent family includes U.S. Patent 8,617,564, a pending and allowed U.S. application, and patents granted in Australia, China,Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Russia, Singapore, and South Africa. Applications in Europe, Canada, Brazil, India, Chinaand Hong Kong are pending in the first patent family. Patents that issue from applications in the first family are expected to expire in 2030. The term for U.S.Patent 8,617,564 includes Patent Term Adjustment and extends until at least November 2030. The second family includes a pending PCT application and apending U.S. application. The third family comprises one provisional application. Patents that issue from applications in these families are expected to expirein 2037 and 2038, respectively.We own two further patent families covering follow-on HSV-2 vaccine compositions. The first family includes U.S. Patent 9,782,474 and patentsissued in Australia and Japan. The second family includes U.S. Patent 9,624,273, patents granted in Australia and Japan, and pending applications in Europeand Canada. Patents that issue from applications in these families are expected to expire in 2031 and 2032, respectively.We hold a license from Isconova AB (now Novavax, Inc.) to two patent families covering Matrix-M2, the adjuvant used in GEN-003. The first patentfamily includes a pending U.S. application and issued patents in Europe, Canada, Australia, Japan, Brazil, New Zealand and South Africa. The second patentfamily includes U.S. Patent 8,821,881 and issued patents in Europe, Canada, Australia, Japan, Brazil, New Zealand and South Africa. These issued patentshave patent terms until at least July 2023 and July 2024. The issued U.S. patent in the second patent family, U.S. Patent 8,821,881, has a term that extendsuntil August 2026 inclusive of a Patent Term Adjustment.In addition to the above, we have established expertise and development capabilities focused in the areas of preclinical research and development,manufacturing and manufacturing process scale-up, quality control, quality assurance, regulatory affairs and clinical trial design and implementation. Webelieve that our focus and expertise will help us develop products based on our proprietary intellectual property.In-License AgreementsUniversity of CaliforniaIn August 2006, we entered into an exclusive license agreement with UC granting us an exclusive, royalty-bearing sublicensable license to a patentfamily that includes claims to fundamental aspects of the ATLAS platform, to make, use, offer for sale, import and sell licensed products and services, and topractice licensed methods in all fields of use in the United States. This patent family consists entirely of issued United States patents with a patent term untilAugust 2018. UC retains the right to practice and to allow other educational and non-profit institutions to practice, the licensed intellectual property licensedunder the agreement for educational and research purposes.Until first commercial sale of a licensed product or service, we are obligated to pay UC an annual license maintenance fee in the low five figures.Upon commercialization of our products and services covered by the licensed patents, we are obligated to pay UC royalties in the low single digits, subject toa minimum annual royalty in the low five figures, on the net sales of such products and services sold by us or our affiliates for the life of any licensed patentscovering the products or services. The royalties payable to UC are subject to reduction for any third party payments required to be made, with a minimumfloor in the low single digits. In addition, we agreed to pay UC a flat royalty in the low single digits on net sales of products sold by us or our affiliates whichinclude a polypeptide, nucleotide sequence, biological organism or chemical entity identified in the practice of a licensed method or service, but nototherwise covered, by the licensed patent for the life of the licensed patents. If we receive any revenue (cash or non-cash) from any sublicensees, we must payUC a percentage of such revenue, excluding certain categories of payments but including royalties on net sales by sublicensees, varying in the low-doubledigits for any sublicense depending on the scope of the license. Under the terms of the agreement, we are obligated to pay UC a specified developmentmilestone payment and a specified commercial milestone payment up to $500 thousand in the aggregate for the first licensed product covered by the licensedpatents, plus up to an additional $250 thousand if specified development and commercial milestones are met for each subsequent licensed product coveredby the licensed patents. As of December 31, 2017, we have not made any milestone payments.9We are required to diligently develop and market licensed products, services and methods. If we are unable to meet our diligence obligations, evenafter any extension thereof, UC has the right, depending on the number of years the agreement has been effective, to either terminate the agreement or convertour exclusive license to a non-exclusive license.Unless earlier terminated, the agreement with UC will remain in effect until the expiration of the last-to-expire patent under the licensed patent rightsin August 2018. We may terminate the agreement at any time by giving UC advance written notice. The agreement may also be terminated by UC in theevent of a material breach by us that remains uncured after a specified period of time.Harvard UniversityIn November 2007, we entered into an exclusive license agreement with Harvard, granting us an exclusive, worldwide, royalty-bearing,sublicensable license to three patent families, to develop, make, have made, use, market, offer for sale, sell, have sold and import licensed products and toperform licensed services. This agreement was amended and restated in November 2012. The Harvard intellectual property covers methods related to theATLAS discovery platform, including discovery of antigens expressed in neoplastic cells, as well as certain chlamydia immunogenic compositions andmethods for inhibiting or treating chlamydia infections. Any patents within this portfolio that have issued or may be issued will expire normally in 2027 and2028. Harvard retains the right to make and use, and to grant licenses to other not-for-profit research organizations to make and use, the licensed intellectualproperty for internal research, teaching and other educational purposes. We notified Harvard of our partial termination of the license agreement with regard tointellectual property covering chlamydia antigens on December 8, 2014. Effective March 8, 2015, the license agreement with Harvard with regard tointellectual property covering chlamydia antigens was terminated and we no longer hold a license to two of the three in-licensed Harvard patent families, orto a chlamydia antigen covered by the remaining family. The remaining family covers certain aspects of the ATLAS platform, as well as one chlamydiaantigen, and we continue to maintain exclusive rights to aspects of the ATLAS platform covered by this family.We are obligated to pay Harvard an annual license maintenance fee ranging from the low five figures to the mid-five figures depending on the typeof product and the number of years after the effective date of the agreement. For products covered by the licensed patent rights, we are obligated to payHarvard milestone payments up to $1.8 million in the aggregate upon the achievement of certain development and regulatory milestones. For productsdiscovered using the licensed methods, we are obligated to pay Harvard milestone payments up to $600 thousand in the aggregate for each of the first threeproducts and up to $300 thousand in the aggregate for each additional product under the agreement upon the achievement of certain development andregulatory milestones. As of December 31, 2017, we paid $198 thousand in aggregate milestone payments. Upon commercialization of our products coveredby the licensed patent rights or discovered using the licensed methods, we are obligated to pay Harvard royalties on the net sales of such products andservices sold by us, our affiliates and our sublicensees. This royalty varies depending on the type of product or service but is in the low single digits. Theroyalty based on sales by our sublicensees is the greater of the applicable royalty rate or a percentage in the high single digits or the low double digits of theroyalties we receive from such sublicensee depending on the type of product. Depending on the type of commercialized product or service, royalties arepayable until the expiration of the last-to-expire valid claim under the licensed patent rights or for a period of 10 years from first commercial sale of suchproduct or service. The royalties payable to Harvard are subject to reduction, capped at a specified percentage, for any third party payments required to bemade. In addition to the royalty payments, if we receive any additional revenue (cash or non-cash) under any sublicense, we must pay Harvard a percentage ofsuch revenue, excluding certain categories of payments, varying from the low single digits to up to the low double digits depending on the scope of thelicense that includes the sublicense.We are required to use commercially reasonable efforts to develop licensed products, introduce them into the commercial market and market them,in compliance with an agreed upon development plan. We are also obligated to achieve specified development milestones. If we are unable to meet ourdevelopment milestones for any type of product or service, absent any reasonable proposed extension or amendment thereof, Harvard has the right,depending on the type of product or service, to terminate this agreement with respect to such products or to convert the license to a non-exclusive, non-sublicensable license with respect to such products and services.Our agreement with Harvard will expire on a product-by-product or service-by-service and country-by-country basis until the expiration of the last-to-expire valid claim under the licensed patent rights. We may terminate the agreement at any time by giving Harvard advance written notice. Harvard mayalso terminate the agreement in the event of a material breach by us that remains uncured; in the event of our insolvency, bankruptcy, or similarcircumstances; or if we challenge the validity of any patents licensed to us.Other Collaborations10NovavaxIn August 2009, we entered into an exclusive license and collaboration agreement with Isconova AB, a Swedish company which has subsequentlybeen acquired by Novavax. The agreement grants us a worldwide, sublicensable, exclusive license to two patent families, to import, make, have made, use,sell, offer for sale and otherwise exploit licensed vaccine products containing an adjuvant which incorporates or is developed from Matrix-A, Matrix-Cand/or Matrix-M technology, in the fields of HSV and chlamydia, and the time-limited exclusive fields of Neisseria gonorrhoeae, cytomegalovirus andMycobacterium tuberculosis. In July 2015, upon expiration of the five-year exclusivity term included in the agreement, the license granted to us converted toa non-exclusive license with respect to all licensed intellectual property rights that were not jointly invented by us and Novavax under the collaboration.Under the terms of this agreement, Novavax also grants us a worldwide, sublicensable, non-exclusive license under such licensed intellectual property rightsto import, make, have made, use, sell, offer for sale and otherwise exploit licensed products in the field of Streptococcus pneumoniae. Our rights in the fieldof Streptococcus pneumoniae are exclusive with respect to all intellectual property rights jointly invented by us and Novavax under the collaboration. Theagreement further grants us certain limited rights to use Novavax trademarks.For licensed products in each unique disease field under the agreement, we are obligated to pay Novavax milestone payments up to approximately$3.0 million in the aggregate upon the achievement of certain development and commercial milestones. As of December 31, 2017, we paid $275 thousand inaggregate milestone payments. Upon commercialization of our products, we are obligated to pay Novavax royalties on the net sales of licensed products soldby us, our affiliates and our sublicensees. The royalties payable to Novavax are in the low single digits and vary on a country-by-country and licensedproduct-by-licensed product basis based on the amount of net sales and the nature and timing of the licensed product’s development. The royalties payableto Novavax are subject to reduction if the licensed product is not covered by one or more valid claims of the licensed patent rights, or if we are required tomake any third-party payments. Royalties are payable for 10 years from first commercial sale in any particular country or until the date on which offer for saleof a licensed product is no longer covered by a valid claim of the licensed patent rights in such country, whichever period is longer. In addition to the royaltypayments, if we receive any additional revenue (cash or non-cash) under any sublicenses, we must pay Novavax a percentage of such revenue, up to the lowdouble digits.We are required to use commercially reasonable efforts to perform specified research activities in accordance with an agreed-upon research plan. Weare also obligated to use commercially reasonable efforts consistent with prudent business judgment and business and market conditions to research, developand carry out the commercialization of licensed products in HSV and chlamydia.Our agreement with Novavax will expire on a country-by-country and licensed product-by-licensed product basis on the date of the expiration of theroyalty term with respect to such licensed product in such country. We may terminate the agreement on a country-by-country and licensed product-by-licensed product basis or in its entirety at any time by giving Novavax advance written notice. Both parties may also terminate the agreement in the event ofa material breach by the other party that remains uncured or for bankruptcy, insolvency or similar circumstances. Novavax may terminate this agreement if wechallenge the validity of any patents licensed to us.The agreement also contained a research funding clause for which we made monthly payments to Novavax between August 2009 and March 2012 ofapproximately $1.6 million. All amounts of research funding provided were to be refunded by Novavax. After December 31, 2015, any amounts remainingdue from Novavax, including accrued interest, could be received in cash upon 30-day written notice provided by us. We provided this notice in January 2016and received the $1.6 million refund in February 2016.Manufacture ContractsFujifilmIn February 2014, we entered into a supply agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. ("Fujifilm") for the manufacture andsupply of antigens for future GEN-003 clinical trials. In June and September 2016, the Company entered into new statements of work under the agreementwith Fujifilm for the manufacture and supply of antigens for the Company's Phase 3 clinical trials. Under these agreements, we are obligated to pay Fujifilmmilestone payments up to the low-eight figures upon the achievement of certain manufacturing milestones. Additionally, raw materials, resins andconsumables purchased for the vaccine production are invoiced separately as such costs are incurred by Fujifilm. We pay Fujifilm’s actual costs plus apercentage fee in the mid-single digits for these raw materials, resins and consumables. We also are required to pay reservation fees, which equal a percentageof production fees in the low-double digits, to reserve11manufacturing slots in the production timeframe as agreed upon under the agreement. We are required to use commercially reasonable efforts to timelyprovide Fujifilm with the technology, materials and resources needed to produce and supply the recombinant protein antigen. As of December 31, 2017, wehave incurred expenses under the agreement of approximately $16.0 million.In September 2017, the Company notified Fujifilm to cease all manufacturing activities of antigens for GEN-003. Amounts recorded as of December31, 2017 represent all liabilities for manufacturing services complete or in process prior to the notification date, materials purchased which cannot be re-usedor re-purposed by Fujifilm and charges for terminating services within a certain time frame of the anticipated start dates.Our agreement with Fujifilm will expire on February 25, 2024. Subject to termination fees under applicable circumstances, we may terminate theagreement at any time by giving Fujifilm advance written notice. The agreement may also be terminated by either party due to a material uncured breach bythe other party.OncovirIn January 2018, we entered into a License and Supply Agreement with Oncovir, Inc. (“Oncovir”). The agreement provides the terms and conditionsunder which Oncovir will manufacture and supply an immunomodulator and vaccine adjuvant, Hiltonol® (poly-ICLC) (“Hiltonol”), to us for use inconnection with the research, development, use, sale, manufacture, commercialization and marketing of products combining Hiltonol with the ourtechnology (the “Combination Product”). Hiltonol is the adjuvant component of GEN-009, which will consist of synthetic long peptides or neoantigensidentified using our proprietary ATLAS platform, formulated with Hiltonol. When paired with synthetic long peptides, Hiltonol has shown the ability toinduce T cell responses, which we believe will be important for driving the clinical efficacy of GEN-009. Hiltonol is manufactured under good manufacturingpractice ("GMP") conditions, has an existing drug master file and has an extensive tolerability record when used alone and in combination with vaccineantigens. We are not required to purchase any minimum quantity of Hiltonol from Oncovir.Oncovir granted us a non-exclusive, assignable, royalty-bearing worldwide license, with the right to grant sublicenses through one tier, to certain ofOncovir’s intellectual property in connection with the research, development or commercialization of Combination Products, including the use of Hiltonol,but not the use of Hiltonol for manufacturing or the use or sale of Hiltonol alone. The license shall become perpetual, fully paid-up and royalty-free on thelater of January 25, 2028 or the date on which the last valid claim of any patent licensed to us under the agreement expires.Under this agreement, we are obligated to pay Oncovir (i) an up-front payment in the mid-six figures in consideration of the license granted to us andfor the initial supply of Hiltonol for the planned GEN-009 Phase 1/2 trial, (ii) a supply price for Hiltonol in the low-three figures per vial of Hiltonol for use inclinical trials or commercial use, (iii) a milestone payment in the low-six figures upon the achievement of certain clinical trial milestones for eachCombination Product, (iv) a milestone payment in the mid-six figures upon the first marketing approval for each Combination Product in certain territories,and (v) tiered royalties in the low-single digits on a product-by-product basis based on the net sales of Combination Products.We may terminate the agreement upon a decision to discontinue the development of the Combination Product or upon a determination by us or anapplicable regulatory authority that Hiltonol or a Combination Product is not clinically safe or effective. The agreement may also be terminated by eitherparty due to a material uncured breach by the other party, or due to the other party’s bankruptcy, insolvency or dissolution.Trade SecretsWe may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to protect. We seek to protectour proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors andcontractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises andphysical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems,agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwisebecome known or be independently discovered by competitors. To the extent that our consultants, contractors or collaborators use intellectual propertyowned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.United States Government Regulation12Biological products such as vaccines are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and the Public HealthService Act ("PHS Act"), and other federal, state, local and foreign statutes and regulations. Both the FD&C and PHS Acts and their corresponding regulationsgovern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution, reporting, advertising andother promotional practices involving biological products. Clinical testing of biological products is subject to FDA review before initiation. In addition,FDA approval must be obtained before marketing of biological products. The process of obtaining regulatory review and approval and the subsequentcompliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources andwe may not be able to obtain the required regulatory approvals.United States Biological Products Development ProcessThe process required by the FDA before a biological product may be marketed in the United States generally involves the following:•completion of nonclinical laboratory tests and animal studies according to good laboratory practices ("GLP") and applicable requirementsfor the humane use of laboratory animals or other applicable regulations;•submission to the FDA of an application for an IND which must become effective before human clinical trials may begin;•performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as goodclinical practices ("GCP") and any additional requirements for the protection of human research subjects and their health information, toestablish the safety and efficacy of the proposed biological product for its intended use, including approval by an independent InstitutionalReview Board (“IRB”), representing each clinical site before each clinical trial may be initiated;•submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, and potency from results ofnonclinical testing and clinical trials;•satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assesscompliance with 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 tissueproducts;•potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; and•FDA review and approval, or licensure, of the BLA.Before testing any biological product candidate in humans, the product candidate enters the preclinical study stage. Preclinical studies, also referredto as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potentialsafety and activity of the product candidate. The conduct of the preclinical studies must comply with federal regulations and requirements including GLPs.The clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any availableclinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical studies may continue even after the IND issubmitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that30-day time period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA also mayimpose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance. If the FDAimposes a clinical hold, studies may not recommence without FDA authorization and then only under terms authorized by the FDA. Accordingly, we cannotbe sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminatesuch studies.Clinical trials involve the administration of the biological product candidate to healthy volunteers or patients under the supervision of qualifiedinvestigators, generally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols detailing, among otherthings, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety,including stopping rules that assure a clinical trial will be stopped if certain AEs should occur. Each protocol and any amendments to the protocol must besubmitted13to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the GCP requirements,including the requirement that all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an IRB, at orservicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants andconsiders such items as whether the risks to individuals participating in the clinical studies are minimized and are reasonable in relation to anticipatedbenefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legalrepresentative and must monitor the clinical trial until completed.Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:•Phase 1. The biological product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption,metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the productmay be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.•Phase 2. The biological product is evaluated in a limited patient population to identify possible AEs and safety risks, to preliminarilyevaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.•Phase 3. Clinical studies are undertaken to further evaluate safety, purity, and potential of biological product in an expanded patientpopulation at geographically dispersed clinical trial sites. These clinical studies are intended to establish the overall risk/benefit ratio of theproduct and provide an adequate basis for product approval and product labeling.Post-approval clinical studies, sometimes referred to as Phase 4 clinical studies, may be conducted after initial marketing approval. These clinicalstudies are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data andclinical trial investigators. Annual progress reports detailing the results of the clinical studies must be submitted to the FDA. Written IND safety reports mustbe promptly submitted to the FDA and the investigators for serious and unexpected AEs, any findings from other studies, tests in laboratory animals or invitro testing that suggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over thatlisted in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that theinformation qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within sevencalendar days after the sponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully withinany specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend or terminate a clinical trial at any time on variousgrounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend orterminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biologicalproduct has been associated with unexpected serious harm to patients. Sponsors of all controlled clinical trials, except for Phase 1 trials, are required tosubmit certain clinical trial information for inclusion in the public clinical trial registry and results data bank maintained by the National Institutes of Health,which are publicly available at http://clinicaltrials.gov.Concurrent with clinical studies, companies usually complete additional animal studies and must also develop additional information about thephysical characteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance withGMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the importanceof manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producingquality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency andpurity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted todemonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.United States Review and Approval ProcessesAfter the completion of clinical trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of thebiological product. The BLA must include results of product development, laboratory and animal14studies, human studies, information on the manufacture and composition of the product, proposed labeling and other relevant information. In addition, underthe Pediatric Research Equity Act, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the biological product for theclaimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the productis safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. The testing and approval processes require substantial timeand effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if atall, and for what indications will be approved, if any.Under the Prescription Drug User Fee Act ("PDUFA"), as re-authorized for an additional five years in 2017, each BLA must be accompanied by asignificant user fee. PDFUA also imposes annual product fees based on each approved biologic. Fee waivers or reductions are available in certaincircumstances, including a waiver of the application fee for the first application filed by a small business.Within 60 days following submission of the application, the FDA reviews the BLA to determine if it is substantially complete before the agencyaccepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may requestadditional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to reviewbefore the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviewsthe BLA to determine, among other things, whether the proposed product is safe and potent, or effective, for its intended use, and has an acceptable purityprofile, and whether the product is being manufactured in accordance with GMP regulations to assure and preserve the product’s identity, safety, strength,quality, potency and purity. The FDA may refer applications for novel biological products or biological products that present difficult questions of safety orefficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether theapplication should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers suchrecommendations carefully when making decisions. During the biological product approval process, the FDA also will determine whether a Risk Evaluationand Mitigation Strategy ("REMS"), is necessary to assure the safe use of the biological product. If the FDA concludes a REMS is needed, the sponsor of theBLA must submit a proposed REMS; the FDA will not approve the BLA without a REMS, if required.Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless itdetermines that the manufacturing processes and facilities are in compliance with GMP requirements and adequate to assure consistent production of theproduct within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that theclinical trials were conducted in compliance with IND study requirements and GCP requirements. To assure GMP, GTP and GCP compliance, an applicantmust incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatorycriteria for approval and deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than weinterpret the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter that usually describesall of the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major,for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might take toplace the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing all of thedeficiencies identified in the letter, or withdraw the application.If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use mayotherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings orprecautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in theform of a REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to asPhase 4 clinical trials, designed to further assess a biological product’s safety and effectiveness, and testing and surveillance programs to monitor the safetyof approved products that have been commercialized.One of the performance goals agreed to by the FDA under the PDUFA is to review 90% of standard BLAs in 10 months from filing and 90% ofpriority BLAs in six months from filing, whereupon a review decision is to be made. The FDA does not always meet its PDUFA goal dates for standard andpriority BLAs and its review goals are subject to change from time to time. The review process and the PDUFA goal date may be extended by three months ifthe FDA requests or the BLA sponsor otherwise provides additional information or clarification regarding information already provided in the submissionwithin the last three months before the PDUFA goal date.15United States Fraud and Abuse, Transparency and Privacy LawsIn the United States, our business activities are subject to numerous other laws by federal and state authorities, in addition to the FDA, including butnot limited to, the United States Department of Health and Human Services ("HHS"), and its various divisions, including but not limited to, the Centers forMedicare & Medicaid Services ("CMS"). These laws are enforced by various federal and state enforcement authorities, including but not limited to, theUnited States Department of Justice, and individual United States Attorney offices within the Department of Justice, HHS’ various enforcement divisions,including but not limited to, the Office of Inspector General, the Office for Human Research Protections, and the Office of Research Integrity, and other stateand local government agencies.Although we currently have no products approved for commercial sale, we may be subject to various federal and state laws pertaining to health care“fraud and abuse,” including anti-kickback laws and false claims laws, for activities related to future sales of any of our product candidates that may in thefuture receive regulatory and marketing approval. Anti-kickback laws generally prohibit a pharmaceutical manufacturer from soliciting, offering, receiving,or paying any remuneration to generate business, including the purchase, prescription or use of a particular drug. Although the specific provisions of theselaws vary, their scope is generally broad and there may not be regulations, guidance or court decisions that apply the laws to particular industry practices.There is therefore a possibility that our practices might be challenged under such anti-kickback laws. False claims laws prohibit anyone from knowingly andwillingly presenting, or causing to be presented, any claims for payment for reimbursed drugs or services to third party payors (including Medicare andMedicaid) that are false or fraudulent.Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices ofpharmaceutical manufacturers with marketed products. The laws and regulations generally limit financial interactions between manufacturers and health careproviders and/or require disclosure to the government and public of such interactions. Many of these laws and regulations contain ambiguous requirementsor require administrative guidance for implementation. Given the lack of clarity in laws and their implementation, any future activities (if we obtain approvaland/or reimbursement from federal healthcare programs for our product candidates) could be subject to challenge.In addition, we may be subject to, or our marketing activities may be limited by, data privacy and security regulation by both the federalgovernment and the states in which we conduct our business.If our operations are found to be in violation of any of the health regulatory laws described above, or any other laws that apply to us, we may besubject to penalties, including, without limitation, civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, possible exclusionfrom participation in Medicare, Medicaid and other federal health care programs, contractual damages, reputational harm, diminished profits and futureearnings, and curtailment or restructuring of our operations.ReimbursementIn both domestic and foreign markets, the commercial success of any approved products will depend, in part, on the availability of coverage andadequate reimbursement of such products from third-party payors, such as government health care programs, commercial insurance and managed careorganizations. Patients who are provided vaccinations, and providers providing vaccinations, generally rely on third-party payors to reimburse all or part ofthe associated health care costs. Sales of any approved vaccines will therefore depend substantially, both domestically and abroad, on the extent to which thecosts of our approved vaccines will be paid by third-party payors. These third-party payors are increasingly challenging the prices charged for medicalproducts and services and imposing controls to manage costs. The containment of health care costs has become a priority of federal and state governmentsand the prices of drugs have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, includingprice controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containmentmeasures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for aparticular indication. In addition, there is significant uncertainty regarding the reimbursement status of newly approved health care products. Third-partypayors are increasingly examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. Wemay need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectiveness of our products. If third-party payors do notconsider our products to be cost-effective compared to other therapies, the payors may not cover our products after approval as a benefit under their plans or,if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.16Within the United States, if we obtain appropriate approval in the future to market any of our current product candidates, we may seek approval andcoverage for those products under Medicaid, Medicare and the PHS Act, pharmaceutical pricing program and also seek to sell the products to federalagencies. These programs are administered by various federal and state agencies to allow for individuals age 65 and over, low income, and disabledbeneficiaries access to approved medicines and treatments. Under these programs, manufacturers are required to pay rebates, and the pricing of an approvedtreatment may be subject to various forms of price modifications.In the United States, federal and state governments continue to propose and pass legislation designed to reform delivery of, or payment for, healthcare, which include initiatives to reduce the cost of healthcare. For example, in March 2010, the United States Congress enacted the Patient Protection andAffordable Care Act and the Health Care and Education Reconciliation Act (the "Healthcare Reform Act") which expanded health care coverage throughMedicaid expansion and the implementation of the individual mandate for health insurance coverage and which included changes to the coverage andreimbursement of drug products under government healthcare programs. Under the Trump administration, there have been ongoing efforts to modify or repealall or certain provisions of the Healthcare Reform Act. The Trump administration may also take executive action in the absence of legislative action. Forexample, in October 2017, the President announced that his administration will withhold the cost-sharing subsidies paid to health insurance exchange plansserving low-income enrollees. Actions by the administration are widely expected to lead to fewer Americans having more comprehensive health insurancecompliant with the Healthcare Reform Act, even in the absence of a legislative repeal. Tax reform legislation was also enacted at the end of 2017 thatincludes provisions that will affect healthcare insurance coverage and payment, such as the elimination of the tax penalty for individuals who do notmaintain sufficient health insurance coverage beginning in 2019 (the so-called “individual mandate”). In a November, 2017 report, the CongressionalBudget Office estimates that the elimination will increase the number of uninsured by 4 million in 2019 and 13 million in 2027.There have also been efforts by government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products,including legislation on drug importation. Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposals toaddress the perceived high cost of pharmaceuticals. There have also been recent state legislative efforts to address drug costs, which generally have focusedon increasing transparency around drug costs or limiting drug prices.Adoption of new legislation at the federal or state level could affect demand for, or pricing of, our product candidates if approved for sale. Wecannot, however, predict the ultimate content, timing or effect of any changes to the Healthcare Reform Act or other federal and state reform efforts. There isno assurance that federal or state health care reform will not adversely affect our future business and financial results.Outside the United States, ensuring adequate coverage and payment for our products will face challenges. In international markets, reimbursementand health care payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. Pricingof prescription pharmaceuticals is subject to governmental control in many countries. Pricing negotiations with governmental authorities can extend wellbeyond the receipt of regulatory marketing approval for a product and may require us to conduct a clinical trial that compares the cost effectiveness of ourproduct candidates or products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in ourcommercialization efforts. Third-party payors are challenging the prices charged for medical products and services, and many third-party payors limitreimbursement for newly-approved health care products. Recent budgetary pressures in many European Union countries are also causing governments toconsider or implement various cost-containment measures, such as price freezes, increased price cuts and rebates. If budget pressures continue, governmentsmay implement additional cost-containment measures. Cost-control initiatives could decrease the price we might establish for products that we may developor sell, which would result in lower product revenues or royalties payable to us. There can be no assurance that any country that has price controls orreimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.Foreign RegulationIn addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial salesand distribution of our product candidates. Whether or not we obtain FDA approval for a product candidate, we must obtain approval from the comparableregulatory authorities of foreign countries or economic areas, such as the European Union, before we may commence clinical trials or market products inthose countries or areas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement varygreatly from place to place, and the time may be longer or shorter than that required for FDA approval.17Certain countries outside of the United States have a process that requires the submission of a clinical trial application ("CTA") much like an INDprior to the commencement of human clinical trials. In Europe, for example, a CTA must be submitted to the competent national health authority and toindependent ethics committees in each country in which a company intends to conduct clinical trials. Once the CTA is approved in accordance with acountry’s requirements, clinical trial development may proceed in that country. In all cases, the clinical trials must be conducted in accordance with GCPsand other applicable regulatory requirements.Under European Union regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralizedprocedure. The centralized procedure is compulsory for medicinal products produced by biotechnology or those medicinal products containing new activesubstances for specific indications such as the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, viral diseases and designated orphanmedicines, and optional for other medicines which are highly innovative. Under the centralized procedure, a marketing application is submitted to theEuropean Medicines Agency where it will be evaluated by the Committee for Medicinal Products for Human Use and a favorable opinion typically results inthe grant by the European Commission of a single marketing authorization that is valid for all European Union member states within 67 days of receipt of theopinion. The initial marketing authorization is valid for five years, but once renewed is usually valid for an unlimited period. The decentralized procedureprovides for approval by one or more “concerned” member states based on an assessment of an application performed by one member state, known as the“reference” member state. Under the decentralized approval procedure, an applicant submits an application, or dossier, and related materials to the referencemember state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days afterreceipt of a valid application. Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whetherto approve the assessment report and related materials. If a member state does not recognize the marketing authorization, the disputed points are eventuallyreferred to the European Commission, whose decision is binding on all member states. In light of the United Kingdom’s vote in 2016 to leave the EuropeanUnion, the so-called Brexit vote, there may be changes forthcoming in the scope of the centralized approval procedure as the terms of that exit are negotiatedbetween the United Kingdom and the European Union.ManufacturingWe do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our productcandidates for non-clinical studies and clinical trials, as well as for commercial manufacture if our product candidates receive marketing approval. To date, inpreparation for the filing of our GEN-009 IND application, we have obtained materials for GEN-009 from third-party manufacturers who are sole sourcesuppliers to us. We intend to identify and qualify contract manufacturers to provide peptide production, adjuvant production, and fill-and-finish servicesprior to submission of a BLA to the FDA.Executive Officers of the RegistrantThe following table sets forth the name, age and position of each of our executive officers as of February 16, 2018.Name Age PositionWilliam Clark 49 President and Chief Executive OfficerJonathan Poole 43 Chief Financial OfficerEric Hoffman, Ph.D. 48 Chief Business OfficerJessica Baker Flechtner, Ph.D. 46 Chief Scientific OfficerWilliam Clark has served as our President and Chief Executive Officer since February 2011. Previously he served as our Chief Business Officer fromAugust 2010 to February 2011. Mr. Clark has served on our board of directors since February 2011. Prior to joining our Company, he served as ChiefBusiness Officer at Vanda Pharmaceuticals, Inc. ("Vanda"), a biopharmaceutical company he co-founded in 2004. While at Vanda, he lead the company’sstrategic and business development activities, and played a central role in raising more than $220 million in multiple public and private financings. Prior toVanda, Mr. Clark was a principal at Care Capital, LLC, a venture capital firm investing in biopharmaceutical companies, after serving in a variety ofcommercial and strategic roles at SmithKline Beecham (now GlaxoSmithKline). Mr. Clark holds a B.A. from Harvard University and an M.B.A. from TheWharton School at the University of Pennsylvania.Jonathan Poole has served as our Chief Financial Officer since joining our Company in April 2014. Prior to joining our Company, Mr. Poole servedas Senior Vice President of Finance for Pipeline and Technical Operation at Shire plc (“Shire”) from June 2013 through March 2014, leading finance supportfor Shire’s global business development, research and18development and technical operations activities. Mr. Poole previously served as divisional Chief Financial Officer of Shire HGT, Shire’s rare disease division,from May 2010 through June 2013 and held various positions of increasing responsibility in finance at Shire from 2006 through May 2010. He began hiscareer in the United Kingdom in investment banking at UBS Warburg and ING Barings and also worked as an investment manager for Avanti Capital plc, aUnited Kingdom private equity investment firm. Mr. Poole holds an M.B.A. from London Business School and a BSc in biological sciences from DurhamUniversity in the United Kingdom.Eric Hoffman, Ph.D. has served as our Chief Business Officer since joining our Company in December 2014. Prior to joining our Company, Dr.Hoffman served as Vice President of Corporate and Business Development, and also oversaw Program Management and Commercial Operations, at IdenixPharmaceuticals, Inc. ("Idenix") from January 2012 until its acquisition by Merck & Co. in August 2014. Dr. Hoffman also held a role overseeing InvestorRelations and Corporate Communications while at Idenix from January 2011 to December 2011. Prior to Idenix, Dr. Hoffman spent nearly five years, from2006 to 2011, at Biogen Idec in investor relations and business development roles and spent more than five years from 2001 to 2006 on Wall Street as anequity research analyst at J.P. Morgan, Schwab Soundview Capital Markets and Bear Stearns. Before starting on Wall Street in 2001, he was a post-doctoralresearch scientist in the Department of Immunobiology at King's College London School of Medicine at Guy’s Hospital, studying T-cell development from1999 to 2000. He has authored several book chapters and peer-reviewed articles, including in Cell, Immunity, and Genes & Development. Dr. Hoffman holds aPh.D. in Immunobiology from Yale University and a B.S. in Biology from Trinity University.Jessica Baker Flechtner, Ph.D. has held multiple scientific roles since joining our Company in March 2007 and has served as our Chief ScientificOfficer since February 2016, Senior Vice President of Research from February 2014 to January 2016, Vice President of Research from January 2010 toFebruary 2014, and Senior Director, Research and Development from 2007 to 2010. Prior to joining our Company, Dr. Flechtner was an ImmunologyConsultant at BioVest International, Inc. from June 2006 to March 2007, where she guided the development of assays to evaluate the success of thecompany’s autologous Follicular (Non-Hodgkin’s) Lymphoma vaccine in patients. As a researcher at Mojave Therapeutics, Inc., or Mojave, and AntigenicsInc. (now Agenus), which acquired Mojave’s intellectual property, from 2001 to 2005, Dr. Flechtner developed protein and peptide-based vaccines andimmunotherapies for cancer, infectious disease, autoimmunity and allergy. She is an inventor on various pending or issued patents and has multiple peer-reviewed scientific publications. Dr. Flechtner performed her post-doctoral work in the laboratory of Dr. Harvey Cantor at the Dana Farber Cancer Instituteand Harvard Medical School and holds a Ph.D. in Cellular Immunology and B.S. in Animal Science from Cornell University. She is a member of the AmericanAssociation of Immunologists, American Association for Cancer Research, Society for the Immunotherapy of Cancer, the President’s Council of CornellWomen, and Women in Bio.EmployeesAs of December 31, 2017, we had 52 full-time employees. Of these 52 employees, 41 employees are engaged in research and development and 11employees are engaged in finance, human resources, facilities and business and general management. We have no collective bargaining agreements with ouremployees and we have not experienced any work stoppages. We consider our relations with our employees to be good.Our Corporate InformationWe were incorporated under the laws of the State of Delaware in August 2006. Our principal executive offices are located at 100 Acorn Park Drive,5th Floor, Cambridge, Massachusetts 02140 and our telephone number is (617) 876-8191. Genocea® and the Genocea logo are registered trademarks.Available InformationWe maintain an Internet website at http://www.genocea.com where our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, CurrentReports on Form 8-K and other documents and all amendments to those reports and documents are available without charge, as soon as reasonablypracticable following the time they are filed with, or furnished to, the Securities and Exchange Commission ("SEC"). References to our website address do notconstitute incorporation by reference of the information contained on the website, and the information contained on the website is not part of this document.The public may read and copy any materials that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Also, the SEC maintainsan Internet website that contains reports, proxy and information statements, and other information regarding issuers, including the Company, that fileelectronically with the SEC. The public can obtain any documents that we file with the SEC at http://www.sec.gov.19Item 1A. Risk FactorsRisks Related to Our Financial Position and Need for Additional CapitalWe have incurred significant losses since our founding in 2006 and anticipate that we will continue to incur significant losses for the foreseeable futureand may never achieve or maintain profitability.We are a preclinical-stage biotechnology company, and we have not yet generated significant revenues. We have incurred net losses each year sinceour inception, including net losses of $56.7 million, $49.6 million, and $42.5 million for the years ended December 31, 2017, 2016, and 2015, respectively.As of December 31, 2017 and 2016, we had accumulated deficits of approximately $264.2 million and $207.5 million, respectively. To date, we have notcommercialized any products or generated any revenues from the sale of products and have financed our operations primarily through private placements ofour preferred stock, debt financing, our initial public offering ("IPO") completed in February 2014, and follow-on public offerings in March 2015, August2015 and January 2018 and we do not expect to generate any product revenues in the foreseeable future. We do not know whether or when we will generateproduct revenues or become profitable. We have devoted most of our financial resources to research and development, including our clinical and non-clinical technology development anddevelopment activities. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain fundingthrough equity or debt financings, strategic collaborations or additional grants. We have not completed pivotal clinical studies for any product candidateand, as we have ceased development of our most advanced clinical-stage product candidate, GEN-003, and are instead focusing on our earlier stageneoantigen cancer vaccine product candidates, it will be several years, if ever, before we have a product candidate ready for commercialization. Even if weobtain regulatory approval to market a product candidate, our future revenues will depend upon the size of any markets in which our product candidates havereceived approval, our ability to achieve sufficient market acceptance, reimbursement from third-party payors and other factors. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses willincrease significantly if and as we:• file an IND application and initiate clinical trials for GEN-009, our most advanced product candidate in active development focused on neoantigencancer vaccines, and initiate non-clinical or clinical studies for our other product candidates;•manufacture material for clinical trials and for commercial sale;•seek regulatory approvals for any product candidates that successfully complete clinical trials;•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;•seek to discover and develop additional product candidates;•acquire or in-license other product candidates and technologies;•make royalty, milestone or other payments under any in-license agreements;•maintain, protect and expand our intellectual property portfolio;•attract and retain skilled personnel; and•create additional infrastructure to support our operations as a public company and our product development and planned future commercializationefforts.The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results ofoperations may not be a good indication of our future performance. In any particular quarter or quarters, our operating results could be below the expectationsof securities analysts or investors, which could cause our stock price to decline.20 To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. Thiswill require us to be successful in a range of challenging activities, including completing non-clinical studies and clinical trials of our product candidates,discovering additional product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling anyproducts for which we may obtain regulatory approval. We are only in the preliminary stages of most of these activities. We may never succeed in theseactivities and, even if we do, may never generate revenues that are significant enough to achieve profitability. Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict thetiming or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the FDA or the European MedicinesAgency to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of ourproduct candidates, our expenses could increase. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become andremain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research anddevelopment efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose allor part of your investment.We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed would force us to delay,limit, reduce or terminate our product development or commercialization efforts.As of December 31, 2017, our cash and cash equivalents were $12.3 million. On January 19, 2018, we consummated concurrent public offerings ofour common stock and warrants exercisable for shares of our common stock and preferred stock and warrants exercisable for shares of our common stock (the"Concurrent Offerings"), which raised net proceeds of $51.7 million. We believe that we will continue to expend substantial resources for the foreseeablefuture developing GEN-009 and any other neoantigen cancer vaccine product candidates. These expenditures will include costs associated with research anddevelopment, potentially acquiring new technologies, potentially obtaining regulatory approvals and manufacturing products, as well as marketing andselling products approved for sale, if any. In addition, other unanticipated costs may arise. Because the outcome of our planned and anticipated clinical trialsis highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of ourproduct candidates. Furthermore, because of the significant expense associated with conducting clinical trials, we cannot be certain we will have sufficientcapital to complete such trials for a given product candidate. Our future capital requirements depend on many factors, including:•the costs associated with filing an IND application and initiating our planned Phase 1 program for GEN-009;•the number and development requirements of other product candidates that we pursue;•the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates if clinical trials are successful and the outcome ofregulatory review of our product candidates;•the cost and timing of future commercialization activities for our products, if any of our product candidates are approved for marketing, includingproduct manufacturing, marketing, sales and distribution costs;•the cost of our general and administrative functions;•the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;•the cost of manufacturing our product candidates for clinical trials in preparation for regulatory approval and in preparation for commercialization;•our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements;•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;21•the timing, receipt, and amount of sales of, or royalties or milestone payments on, our future products, if any; and•the extent to which we acquire or in-license other products or technologies. In September 2017, we announced that we are exploring strategic alternatives for GEN-003. Consequently, substantially all GEN-003 spending andactivities were ceased and we reduced our workforce by approximately 40 percent.Based on our current operating plan, we believe that our existing cash and cash equivalents, together with the proceeds of the Concurrent Offerings,are sufficient to support our operating expenses and capital expenditure requirements into the second half of 2019, without assuming the expected benefit ofthe restructuring or refinancing of our debt facility. Our operating plan may change as a result of many factors currently unknown to us, and we may need additional funds sooner than planned. Inaddition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for ourcurrent or future operating plans. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds arenot available to us when needed, we would be required to delay, limit, reduce or terminate non-clinical studies, clinical trials or other development activitiesfor one or more of our product candidates or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that maybe necessary to commercialize our product candidates.Our lead product candidate, GEN-009, is in an early stage of development and we cannot be certain that we will be successful in advancing it throughclinical development, obtaining regulatory approval for it, or commercializing it or any of our future product candidates.At this time, GEN-009 is our most advanced product candidate under active development and our future revenues, if any, will depend highly on thesuccessful development, approval, and commercialization of GEN-009. GEN-009 and any future product candidate will require substantial clinicaldevelopment, testing and regulatory approval before we are permitted to commence commercialization. This process can take many years and will require theexpenditure of substantial resources and we expect it will require that we obtain substantial additional funding.Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies orproduct candidates on unfavorable terms to us. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equityofferings, debt financings and license and development agreements with strategic partnerships with third parties. In 2015, we raised additional net capital ofapproximately $95.2 million through follow-on public offerings in March and August along with $4.7 million of net debt financing in December. In January2018, we raised additional net capital of approximately $51.7 million through the Concurrent Offerings. To the extent that we raise additional capitalthrough the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferencesthat adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting ourability to take certain actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds throughstrategic partnerships with third parties, we may have to relinquish valuable rights to our technologies or product candidates, future revenue streams, researchprograms or product candidates or grant licenses on terms that are not favorable to us. If we are unable to raise additional capital when needed, we would berequired to delay, limit, reduce or terminate our product development or commercialization efforts for GEN-009, our immuno-oncology program, or our otherproduct candidates. For example, in September 2017, we ceased substantially all spending and activities related to GEN-003, pending our exploration ofstrategic alternatives for advancing that product candidate. If we are unable to raise additional capital when needed, we may also be required to grant rights todevelop and market product candidates that we would otherwise prefer to develop and market ourselves. Our stockholders will experience substantial additional dilution if shares of our preferred stock are converted into, or outstanding options or warrants areexercised for, common stock.As of February 14, 2018, there were 1,635 shares of our Series A convertible preferred stock outstanding, which are convertible, without payment ofadditional consideration, into 1,635,000 shares of our common stock. As of February 14, 2018, there were 29,108,153 shares of common stock issuable uponthe exercise of warrants, having a weighted average exercise price of $1.22 per share, and 5,516,213 shares of common stock issuable upon the exercise ofstock options outstanding, having a weighted average exercise price of $4.19 per share. The conversion of the outstanding shares of our Series A convertiblepreferred stock into, or exercise of outstanding options or warrants for, common stock would be substantially dilutive to the22outstanding shares of common stock. Any dilution or potential dilution may cause our stockholders to sell their shares, which may contribute to a downwardmovement in the stock price of our common stock.Risks Related to Clinical Development, Regulatory Review and Approval of Our Product Candidates We are substantially dependent on the success of the clinical development of GEN-009, our only product candidate currently in active development. Anyfailure to successfully develop or commercialize the GEN-009 vaccine, or any significant delays in doing so, will have a material adverse effect on ourbusiness, result of operations and financial condition. In September 2017, we ceased substantially all spending and activities related to GEN-003, our Phase 3-ready product candidate, pending ourexploration of strategic alternatives for advancing that product candidate. We are now currently investing a significant portion of our efforts and financialresources in the development of the GEN-009, a neoantigen cancer vaccine which is currently in pre-clinical development. Our ability to generate productrevenue depends heavily on the success of clinical trials for GEN-009 and the successful development and commercialization of GEN-009. The successfuldevelopment and commercialization of GEN-009 will depend on several factors, including the following: •successful filing of an IND application for GEN-009;•successful completion of all required clinical trials of GEN-009;•obtaining marketing approvals from regulatory authorities for GEN-009;•establishing manufacturing and commercialization arrangements between ourselves and third parties;•establishing an acceptable safety and efficacy profile of GEN-009; and•the availability of reimbursement to patients from healthcare payors for GEN-009.Any failure to successfully develop or commercialize GEN-009 or any significant delays in doing so will have a material adverse effect on ourbusiness, results of operations and financial condition. Because our active product candidate is in an early stage of development, there is a high risk of failure, and we may never succeed in developingmarketable products or generating product revenue. We have not conducted any clinical trials for GEN-009. Any successful results in non-clinical studies may not be predictive of similar results inhumans during clinical trials, and successful results from early or small clinical trials of a vaccine candidate may not be replicated in later and larger clinicaltrials. Among other reasons for the potential failure of earlier, smaller clinical trials to be replicated in later, larger clinical trials is the fact that manufacturingscale up is necessary to prepare for Phase 3 development and commercialization. Our product candidates may require complex manufacturing processes, andscaling up these processes can cause changes in the product that may not be apparent until the product is further tested during Phase 3 trials. If the results of our future clinical trials are inconclusive with respect to the efficacy of our product candidates or if we do not meet our clinicalendpoints with statistical significance or if there are safety concerns or AEs associated with our product candidates, we may be prevented or delayed inobtaining marketing approval for our product candidates. Alternatively, even if we obtain regulatory approval, that approval may be for indications orpatient populations that are not as broad as intended or desired or may require labeling that includes significant use or distribution restrictions or safetywarnings. We may also be required to perform additional or unanticipated clinical trials to obtain approval or be subject to additional post-marketing testingrequirements to maintain regulatory approval. In addition, regulatory authorities may withdraw their approval of the product or impose restrictions on itsdistribution in the form of a modified risk evaluation and mitigation strategy. Furthermore, we need to develop the supply chain for any product candidates we identify. If we do not obtain regulatory approval for our current and future product candidates, our business will be adversely affected. Our product candidates are subject to extensive governmental regulations relating to, among other things, research, clinical trials, manufacturing,import, export and commercialization. In order to obtain regulatory approval for the commercial sale of any product candidate, we must demonstrate throughextensive non-clinical studies and clinical trials that the product23candidate is safe and effective for use in each target indication. Clinical trials are expensive, time-consuming and uncertain as to outcome. We may gainregulatory approval for GEN-009 or our other current or potential future clinical and non-clinical product candidates in some but not all of the territoriesavailable or some but not all of the target indications, resulting in limited commercial opportunity for the approved vaccine or immunotherapy, or we maynever obtain regulatory approval for these product candidates for any indication in any jurisdiction. We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates. Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trialsdepends on the speed at which we can recruit patients to participate in testing our product candidates. If patients are unwilling to participate in our studiesbecause of negative publicity from AEs in the biotechnology industries or for other reasons, including competitive clinical trials for similar patientpopulations, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed or prevented.These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology ortermination of the clinical trials altogether. We may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achievediversity in a study, to complete our clinical trials in a timely manner. Patient enrollment is affected by factors including: •severity of the disease under investigation;•design of the study protocol;•size of the patient population;•eligibility criteria for the trial in question;•perceived risks and benefits of the product candidate under study;•proximity and availability of clinical trial sites for prospective patients;•availability of competing therapies and clinical trials;•efforts to facilitate timely enrollment in clinical trials;•patient referral practices of physicians; and•ability to monitor patients adequately during and after treatment.We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trialsrequired by regulatory agencies. If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay,limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business. We may not be able to comply with requirements of foreign jurisdictions in conducting trials outside of the United States. To date, we have not conducted any clinical trials outside of the United States. Our ability to successfully initiate, enroll and complete a clinicaltrial in any foreign country, should we attempt to do so, is subject to numerous risks unique to conducting business in foreign countries, including:•difficulty in establishing or managing relationships with CROs and physicians;•different standards for the conduct of clinical trials;•our inability to locate qualified local consultants, physicians and partners;24•the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulationof pharmaceutical and biotechnology products and treatment; and•the acceptability of data obtained from studies conducted outside the United States to the FDA in support of a BLA.If we fail to successfully meet requirements for the conduct of clinical trials outside of the United States, we may be delayed in obtaining, or beunable to obtain, regulatory approval for our product candidates. We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatoryauthorities. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials todemonstrate the safety and efficacy of the product candidates for the intended indications. Clinical testing is expensive, time-consuming and uncertain as tooutcome. We cannot guarantee that clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials canoccur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:•delays by us in reaching a consensus with regulatory agencies on trial design, including the IND for GEN-009 expected to be filed with theFDA in the first quarter of 2018 and initiation of our Phase 1 clinical trial for GEN-009 expected to occur in mid-2018;•delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;•delays in obtaining required Institutional Review Board ("IRB") approval at each clinical trial site;•imposition of a clinical hold by regulatory agencies or an IRB for any reason, including safety concerns raised by other clinical trials ofsimilar vaccines that may reflect an unacceptable risk with GEN-009 or after an inspection of clinical operations or trial sites;•failure to perform in accordance with the FDA’s good clinical practices ("GCPs") or applicable regulatory guidelines in other countries;•delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;•delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;•clinical trial sites or patients dropping out of a trial or failing to complete dosing;•occurrence of serious AEs in clinical trials that are associated with the product candidates that are viewed to outweigh its potential benefits;or •changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete a clinical trial. We cannotgive any assurance that we will be able to resolve any delay caused by the factors described above or any other factors, on a timely basis or at all. If we are notable to successfully initiate and complete subsequent clinical trials, we will not be able to obtain regulatory approval and will not be able to commercializeour product candidates. Our active product candidate, GEN-009, and our current and future potential product candidates arising out of our immuno-oncology program, are or willbe based on T cell activation, which is a novel approach for vaccines, immunotherapies and medical treatments. We have concentrated our research and development efforts on T cell vaccine and immunotherapy technology, which is a novel approach forvaccines, immuno-therapies and medical treatments, and our future success is highly dependent on the successful development of T cell immunotherapies ingeneral, and our active development product and current and future product candidates in particular. Consequently, it may be difficult for us to predict thetime and cost of product development. Unforeseen problems with the T cell approach to vaccines and immunotherapies may prevent further development orapproval of our current and future product candidates. There can be no assurance that any development problems we or others25researching T cell vaccines and immunotherapies may experience in the future will not cause significant delays or unanticipated costs, or that suchdevelopment problems can be solved. Because of the novelty of this approach, there may be unknown safety risks associated with the vaccines andimmunotherapies that we develop. Regulatory agencies such as the FDA may require us to conduct extensive safety testing prior to approval to demonstrate alow risk of rare and severe AEs caused by the vaccines and immunotherapies. If approved, the novel mechanism of action of the vaccines may adversely affectphysician and patient perception and uptake of our products. Our active development product, GEN-009, includes a novel vaccine adjuvant and our other current and potential future product candidates may includeone or more novel adjuvants, which may make it difficult for us to predict the time and cost of product development as well as the requirements the FDA orother regulatory agencies may impose to demonstrate the safety of such product candidates. Novel vaccine adjuvants, included in some of our product candidates, may pose an increased safety risk to patients. Adjuvants are compounds thatare added to vaccine antigens to enhance the activation of the immune system and improve the immune response and efficacy of vaccines. Development ofvaccines with novel adjuvants requires evaluation in larger numbers of patients prior to approval than would be typical for therapeutic drugs. Guidelines forevaluation of vaccines with novel adjuvants have been established by the FDA and other regulatory bodies and expert committees. Our product candidates,including GEN-009, may include one or more novel adjuvants. Any neoantigen cancer vaccine, because of the presence of an adjuvant, may have side effectsconsidered to pose too great a risk to patients to warrant approval of the vaccine. If we fail to obtain regulatory approval in jurisdictions outside the United States, we will not be able to market our products in those jurisdictions. We intend to market our product candidates, if approved, in international markets. Such marketing will require separate regulatory approvals in eachmarket and compliance with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirementsfor additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. In addition, in many countries outsidethe United States, a vaccine must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that we intend tocharge for our vaccine is also subject to approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions,and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. The foreignregulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timelybasis, if at all. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our vaccines in any market. Even if we receive regulatory approval for our product candidates, such immunotherapies will be subject to ongoing regulatory review, which may resultin significant additional expense. Additionally, our product candidates, including our active development product, GEN-009, and any other current orpotential future immunotherapy product candidates, if approved, could be subject to labeling and other restrictions, and we may be subject to penalties ifwe fail to comply with regulatory requirements or experience unanticipated problems with our products. Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indications for which theproduct may be marketed or to conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials,and surveillance to monitor the safety and efficacy of the vaccine or immunotherapy potentially over many years. In addition, if the FDA approves any of ourproduct candidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion and recordkeeping for theproduct will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketinginformation and reports, registration, as well as continued compliance with current good manufacturing practice (cGMP) and GCP, for any clinical trials thatwe conduct post-approval. Later discovery of previously unknown problems with an approved product, including AEs of unanticipated severity or frequency, or withmanufacturing operations or processes, or failure to comply with regulatory requirements, may result in, among other things:•restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatoryproduct recalls;•fines, warning letters, or holds on clinical trials;26•refusal by the FDA to approve pending applications or supplements to approved applications filed by us, or suspension or revocation ofproduct license approvals;•product seizure or detention, or refusal to permit the import or export of products; and•injunctions or the imposition of civil, criminal and/or administrative penalties, damages, monetary fines, disgorgement, exclusion fromparticipation in Medicare, Medicaid and other federal health care programs, and curtailment or restructuring of our operations.The FDA’s policies may change and additional government regulations may be enacted that could affect regulatory approval that we have receivedfor our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation oradministrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of newrequirements or policies, or not able to maintain regulatory compliance, we may lose any marketing approval that may have been obtained and we may notachieve or sustain profitability, which would adversely affect our business. Risks Related to Our Reliance on Third Parties We rely on third parties to conduct non-clinical studies and clinical trials for our product candidates, including our active development product, GEN-009,and any other current or future product candidates, and if they do not properly and successfully perform their obligations to us, we may not be able toobtain regulatory approvals for our product candidates. We intend to rely on third party CROs and other third parties to assist in managing, monitoring and otherwise carrying out our GEN-009 clinicaltrials. We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators,to conduct our clinical trials. We compete with many other companies for the resources of these third parties. The third parties on whom we rely generallymay terminate their engagements at any time, and having to enter into alternative arrangements would delay development and commercialization of ourproduct candidates. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of ourresponsibilities. For example, the FDA and foreign regulatory authorities require compliance with regulations and standards, including GCP, for designing,conducting, monitoring, recording, analyzing, and reporting the results of clinical trials to assure that the data and results are credible and accurate and thatthe rights, integrity and confidentiality of trial participants are protected. Although we rely on third parties to conduct our clinical trials, we are responsiblefor ensuring that each of these clinical trials is conducted in accordance with its general investigational plan and protocol. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do notsuccessfully carry out their duties under their agreements, if the quality or accuracy of the data they obtain is compromised due to their failure to adhere toclinical trial protocols or to regulatory requirements, or if they otherwise fail to comply with clinical trial protocols or meet expected deadlines, the clinicaltrials of our product candidates may not meet regulatory requirements. If clinical trials do not meet regulatory requirements or if these third parties need to bereplaced, non-clinical development activities or clinical trials may be extended, delayed, suspended or terminated. If any of these events occur, we may notbe able to obtain regulatory approval of our product candidates on a timely basis or at all. We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of ourdistributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additionallosses and depriving us of potential product revenue. We rely on third parties to conduct some or all aspects of our product manufacturing, and these third parties may not perform satisfactorily. We do not have any manufacturing facilities or personnel. We do not expect to independently conduct all aspects of our product manufacturing. Weintend to rely on third parties with respect to manufacturing GEN-009. We have also relied on third party suppliers and manufacturers to manufacture andsupply vaccines for our GEN-003 clinical trials. This reliance on third parties increases the risk that we will not have sufficient quantities of our productcandidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. Any of these third parties may terminate their engagement with us at any time. If we need to enter into alternative arrangements, it could delay ourproduct development activities. Our reliance on these third parties for manufacturing activities27will reduce our control over these activities but will not relieve us of our responsibility to ensure compliance with all required regulations regardingmanufacturing. Reliance on third party manufacturers entails risks to which we would not be subject if we manufactured the product candidates ourselves,including:•the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;•reduced control as a result of using third party manufacturers for all aspects of manufacturing activities, including regulatory complianceand quality assurance;•termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;•the unavailability of a manufacturer that is capable of, or that has the capacity to, manufacture our clinical supply that results in delays oradditional manufacturing costs;•the possible misappropriation of our proprietary information, including our trade secrets and know-how or infringement of third partyintellectual property rights by our contract manufacturers; and•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.Any of these events could lead to clinical trial delays or failure to obtain regulatory approval, or affect our ability to successfully commercializefuture products. Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production. Third party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Ourfailure, or the failure of our third party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinicalholds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates orproducts, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturingfacilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do notcurrently have arrangements in place for redundant supply or a second source for bulk drug substance. If our current contract manufacturers cannot perform asagreed, we may be required to replace such manufacturers. Although we believe that there are several potential alternative manufacturers who couldmanufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement. Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our futureprofit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis. If we are unable to manufacture our products in sufficient quantities, or at sufficient yields, or are unable to obtain regulatory approvals for amanufacturing facility for our products, we may experience delays in product development, clinical trials, regulatory approval and commercialdistribution. Completion of our clinical trials and commercialization of our product candidates require access to, or development of, facilities to manufacture ourproduct candidates at sufficient yields and at commercial-scale. We have no experience manufacturing, or managing third parties in manufacturing, any ofour product candidates in the volumes that will be necessary to support large-scale clinical trials or commercial sales. Efforts to establish these capabilitiesmay not meet initial expectations as to scheduling, scale-up, reproducibility, yield, purity, cost, potency or quality. We expect to rely on third-parties for the manufacture of clinical and, if necessary, commercial quantities of our product candidates. These third-party manufacturers must also receive FDA approval before they can produce clinical material28or commercial products. Our products may be in competition with other products for access to these facilities and may be subject to delays in manufacture ifthird-parties give other products greater priority. We may not be able to enter into any necessary third-party manufacturing arrangements on acceptable terms,or on a timely basis. In addition, we may have to enter into technical transfer agreements and share our know-how with the third-party manufacturers, whichcan be time-consuming and may result in delays. Our reliance on contract manufacturers may adversely affect our operations or result in unforeseen delays or other problems beyond our control.Because of contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities tomanufacture our bulk vaccines on a commercial-scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions inthe production of our vaccine. A third-party manufacturer may also encounter difficulties in production. These problems may include:•difficulties with production costs, scale-up and yields;•unavailability of raw materials and supplies;•insufficient quality control and assurance;•shortages of qualified personnel;•failure to comply with strictly enforced federal, state and foreign regulations that vary in each country where product might be sold; and•lack of capital funding.As a result, any delay or interruption could have a material adverse effect on our business, financial condition, results of operations and cash flows. We may not be successful in establishing and maintaining strategic partnerships, which could adversely affect our ability to develop and commercializeproducts. A part of our strategy is to evaluate and, as deemed appropriate, enter into partnerships in the future when strategically attractive, includingpotentially with major biotechnology or pharmaceutical companies. We face significant competition in seeking appropriate partners for our productcandidates, and the negotiation process is time-consuming and complex. In order for us to successfully partner our product candidates, potential partnersmust view these product candidates as economically valuable in markets they determine to be attractive in light of the terms that we are seeking and otheravailable products for licensing by other companies. Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree uponmay not be favorable to us, and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product is delayed orsales of an approved product are disappointing. Any delay in entering into strategic partnership agreements related to our product candidates could delay thedevelopment and commercialization of our product candidates and reduce their competitiveness even if they reach the market. In addition, our strategic partners may breach their agreements with us, and we may not be able to adequately protect our rights under theseagreements. Furthermore, our strategic partners will likely negotiate for certain rights to control decisions regarding the development and commercializationof our product candidates, if approved, and may not conduct those activities in the same manner as we would do so. If we fail to establish and maintain strategic partnerships related to our product candidates, we will bear all of the risk and costs related to thedevelopment of any such product candidate, and we may need to seek additional financing, hire additional employees and otherwise develop expertisewhich we do not have and for which we have not budgeted. This could negatively affect the development of any unpartnered product candidate. Forexample, in September 2017, we ceased substantially all spending and activities related to GEN-003, pending our exploration of strategic alternatives foradvancing that product candidate.In addition, we are currently seeking to establish strategic partnerships with companies with adjuvant and delivery technologies for our neoantigencancer vaccine candidates. If we are unable to successfully enter into these partnerships, our ability to develop our neoantigen cancer vaccine candidates maybe adversely affected. Risks Related to Our Intellectual Property29 If we are unable to obtain or protect intellectual property rights related to our product candidates, we may not be able to compete effectively in ourmarkets. We rely upon a combination of patents, patent applications, know-how and confidentiality agreements to protect the intellectual property related toour platform technology and product candidates. The patent position of biotechnology companies is generally uncertain because it involves complex legaland factual considerations. The standards applied by the United States Patent and Trademark Office ("U.S. PTO") and foreign patent offices in grantingpatents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scopeof claims allowable in biotechnology patents. The patent applications that we own or in-license may fail to result in issued patents with claims that cover ourdiscovery platform or product candidates in the United States or in other countries. There is no assurance that all potentially relevant prior art relating to ourpatents and patent applications or those of our licensors has been found, and prior art that we have not disclosed could be used by a third party to invalidate apatent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents cover our discoveryplatform or product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed orinvalidated. Furthermore, even if they are unchallenged, our patents and patent applications, or those of our licensors, may not adequately protect ourplatform technology, provide exclusivity for our product candidates, prevent others from designing around our patents with similar products, or preventothers from operating in jurisdictions in which we did not pursue patent protection. Any of these outcomes could impair our ability to prevent competitionfrom third parties, which may have an adverse impact on our business. If patent applications we hold or have in-licensed with respect to our platform or product candidates fail to issue, if their breadth or strength ofprotection is threatened, or if they fail to provide meaningful exclusivity for our product candidates or ATLAS discovery platform, it could dissuadecompanies from collaborating with us and could limit or destroy our ability to develop or commercialize one or more of our products, or even any product.We or our licensors have filed several patent applications covering aspects of our product candidates. We cannot offer any assurances about which, if any,patents will be issued, the breadth of any such patents or whether any issued patents will be found invalid and unenforceable or will be challenged by thirdparties. Any successful opposition to these patent applications, or patents that may issue from them, or to any other patent applications or patents owned byor licensed to us, could deprive us of rights necessary for the successful commercialization of any product candidate that we may develop. Since patentapplications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we cannot becertain that we or our licensors were the first to file a patent application relating to any particular aspect of a product candidate. In the United States, for patent applications filed prior to March 16, 2013, assuming the other requirements for patentability are met, the first toinvent is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. On March 16, 2013, the UnitedStates transitioned to a ‘first to file’ system more like that in the rest of the world in that the first inventor to file a patent application is entitled to the patent.Under either the prior system or current one, third parties are allowed to submit prior art prior to the issuance of a patent. Furthermore, both the U.S. andforeign patent systems permit third parties or, in some cases, the patent authorities themselves, to initiate proceedings challenging the scope and / or validityof issued patents, including for example, opposition, derivation, reexamination, inter partes review or interference proceedings. An adverse determinationagainst our or our licensor's patent rights in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, whichcould adversely affect our competitive position with respect to third parties. In addition, patents have a limited lifespan. In most countries, including the United States, the natural expiration of a patent is 20 years from thedate it is filed. Various extensions of patent term may be available in particular countries, however in all circumstances the life of a patent, and the protectionit affords, has a limited term. If we encounter delays in obtaining regulatory approvals, the period of time during which we could market a product underpatent protection could be reduced. We expect to seek extensions of patent terms where these are available in any countries where we are prosecuting patents.Such possible extensions include those permitted under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States, whichpermits a patent term extension of up to five years to cover an FDA-approved product. However, the applicable authorities, including the FDA in the UnitedStates, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and mayrefuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantageof our investment in development and clinical trials by referencing our clinical and non-clinical data, and then may be able to launch their product earlierthan might otherwise be the case.Filing, prosecuting and enforcing patents on our platform or product candidates in all countries throughout the world would be prohibitivelyexpensive, and our intellectual property rights in some countries outside the United States could be less30extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent asfederal and state laws in the United States. Consequently, we may not be able to prevent third parties from infringing our patents in all countries outside theUnited States, or from selling or importing products that infringe our patents in and into the United States or other jurisdictions. Competitors may use ourtechnologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringingproducts to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with ourproducts and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Any loss of, or failure to obtain, patent protection could have a material adverse impact on our business. We may be unable to prevent competitorsfrom entering the market with a product that is similar to or the same as our products. We may become involved in lawsuits to defend or enforce our intellectual property, which could be expensive, time consuming and unsuccessful. Competitors may infringe our patents or misappropriate or otherwise violate our intellectual property rights, and competitors or other third partiesmay challenge the validity or enforceability of those rights. To counter infringement or unauthorized use, or to defend against other challenges, litigationmay be necessary to enforce or defend our intellectual property rights, to protect our trade secrets and/or to determine the validity and scope of our ownintellectual property rights or the proprietary rights of others. Such litigation can be expensive and time consuming. Many of our current and potentialcompetitors have the ability to dedicate substantially greater resources to litigate intellectual property rights than we can. Accordingly, despite our efforts, wemay not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs anddiversion of management resources, which could harm our business and financial results. In addition, in contested proceedings, a court or agency may decidethat a patent owned by or licensed to us is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the groundsthat our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of beinginvalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectualproperty litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. Third-party claims of intellectual property infringement or misappropriation may prevent or delay our development and commercialization efforts. Our commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates, and to use our or ourlicensors’ proprietary technologies without infringing the patents and proprietary rights of third parties. There is a substantial amount of litigation, bothwithin and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, includingpatent infringement lawsuits, interferences, oppositions, reexamination, and inter partes review proceedings before the U.S. PTO and corresponding foreignpatent offices. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we aredeveloping and may develop our product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the riskincreases that our product candidates may be subject to claims of infringement of the patent rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patentapplications with claims for example to materials, formulations, methods of manufacture, methods of analysis, and/or methods for treatment related to the useor manufacture of our products or product candidates. In some cases, we may have failed to identify such relevant third-party patents or patent applications.For example, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remainconfidential until patents issue. Except for the preceding exceptions, patent applications in the United States and elsewhere are generally published onlyafter a waiting period of approximately 18 months after the earliest filing. Therefore, patent applications covering our platform technology or our products orproduct candidates could have been filed by others without our knowledge. Additionally, pending patent applications which have been published can,subject to certain limitations, be later amended in a manner that could cover our platform technologies, our products or product candidates and/or the use,analysis, and/or manufacture of our product candidates. If any third-party patents were held by a court of competent jurisdiction to cover aspects of our materials, formulations, methods of manufacture,methods of analysis, and/or methods for treatment, the holders of any such patents would be able to block our ability to develop and commercialize theapplicable product candidate until such patent expired or unless we obtain a license. Such licenses may not be available on acceptable terms, if at all. Even ifwe were able to obtain a31license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could beprevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patentinfringement claims, we are unable to enter into licenses on acceptable terms. Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop andcommercialize one or more of our product candidates. Defending against claims of patent infringement or misappropriation of trade secrets could be costlyand time consuming, regardless of the outcome. Thus, even if we were to ultimately prevail, or to settle at an early stage, such litigation could burden us withsubstantial unanticipated costs. In addition, litigation or threatened litigation could result in significant demands on the time and attention of ourmanagement team, distracting them from the pursuit of other company business. In the event of a successful claim of infringement against us, we may have topay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain oneor more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. We may face a claim of misappropriation if a third party believes that we inappropriately obtained and used trade secrets of such third party. If we arefound to have misappropriated a third party’s trade secrets, we may be prevented from further using such trade secrets, limiting our ability to develop ourproduct candidates, and we may be required to pay damages. During the course of any patent or other intellectual property litigation, there could be publicannouncements of the results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard theseannouncements as negative, the perceived value of our products, programs, or intellectual property could be diminished. Accordingly, the market price of ourcommon stock may decline. We have in-licensed a portion of our intellectual property, and, if we fail to comply with our obligations under these arrangements, or our licensors fail toobtain and maintain intellectual property rights, we could lose such intellectual property rights or owe damages to the licensor of such intellectualproperty. We are a party to a number of license and collaboration agreements that are important to our business, and we may enter into additional license orcollaboration agreements in the future. For example, our discovery platform is built, in part, around patents exclusively in-licensed from academic or researchinstitutions. See “Business - In-License Agreements” and “Business - Other Collaborations” for a description of our outstanding license and collaborationagreements with the University of California, Harvard, and Novavax. These and other licenses may not provide exclusive rights to use such intellectualproperty and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and productcandidates in the future. It is possible that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all. As a result, wemay not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses. In that event,we may be required to expend significant time and resources to redesign our product candidates or to develop or license replacement technology, all of whichmay not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected productcandidates, which could harm our business significantly. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royaltyand other obligations on us. For example, in our existing license agreements, and we expect in our future agreements, patent prosecution of our licensedtechnology may be controlled by the licensor, and we may be required to reimburse the licensor for their costs of patent prosecution. If our licensors fail toobtain and maintain patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectualproperty or our exclusivity with respect to those rights, and our competitors could market competing products covered by the intellectual property. Further,in our license agreements we may be responsible for bringing any actions against any third party for infringing the patents we have licensed. If there is anyconflict, dispute, disagreement or issue of non-performance between us and our licensing partners regarding our rights or obligations under the licenseagreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement, we mayowe damages, our licensor may have a right to terminate the affected license, and our ability to utilize the affected intellectual property in our drug discoveryand development efforts, and our ability to enter into collaboration or marketing agreements for an affected product candidate, may be adversely affected. Forexample, disputes may arise regarding intellectual property subject to a licensing agreement, including the scope of rights granted under the licenseagreement and other interpretation-related issues; the extent to which our technology infringes the intellectual property of the licensor that is not subject tothe licensing agreement; the sublicensing of patent and other rights under any collaborative development relationships; our diligence obligations under thelicense agreement and what activities satisfy those diligence obligations; the inventorship or ownership of inventions and know-how resulting from the jointcreation or use of intellectual property by our licensors and us and our partners; and the priority of invention of patented technology. If disputes overintellectual property that we have licensed prevent or impair our32ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected productcandidates.Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of proprietary information. In addition to the protection afforded by patents, we rely on confidentiality agreements to protect proprietary know-how that may not be patentableor that we may elect not to patent, processes for which patents are difficult to enforce and any other elements of our platform technology and discovery anddevelopment processes that involve proprietary know-how, information or technology that is not covered by patents. We seek to protect our proprietarytechnology and processes, in part, by entering into confidentiality agreements with our employees, consultants, and outside scientific advisors, contractorsand collaborators. Although we use reasonable efforts to protect our know-how, our employees, consultants, contractors, or outside scientific advisors mightintentionally or inadvertently disclose our know-how information to competitors. In addition, competitors may otherwise gain access to our know-how orindependently develop substantially equivalent information and techniques. Enforcing a claim that a third party illegally obtained and is using any of our know-how is expensive and time consuming, and the outcome isunpredictable. In addition, courts outside the United States sometimes are less willing than U.S. courts to protect know-how. Misappropriation orunauthorized disclosure of our know-how could impair our competitive position and may have a material adverse effect on our business. Risks Related to Commercialization of Our Product Candidates Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients,third-party payors and others in the medical community. Even if we obtain marketing approval for GEN-009 or any other products that we may develop or acquire in the future, the product may not gainmarket acceptance among physicians, third-party payors, patients and others in the medical community. In addition, market acceptance of any approvedproducts depends on a number of other factors, including:•the efficacy and safety of the product, as demonstrated in clinical trials;•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;•acceptance by physicians and patients of the product as a safe and effective treatment and the willingness of the target patient population totry new therapies and of physicians to prescribe new therapies;•the cost, safety and efficacy of treatment in relation to alternative treatments;•the availability of adequate coverage and reimbursement by third-party payors and government authorities;•relative convenience and ease of administration;•the prevalence and severity of adverse side effects;•the effectiveness of our sales and marketing efforts; and•the restrictions on the use of our products together with other medications, if any.Market acceptance is critical to our ability to generate significant revenue. Any product candidate, if approved and commercialized, may beaccepted in only limited capacities or not at all. If any approved products are not accepted by the market to the extent that we expect, we may not be able togenerate significant revenue and our business would suffer. If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing our product candidates if andwhen they are approved. 33We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. Toachieve commercial success for any product for which we have obtained marketing approval, we will need to establish a sales and marketing organization. In the future, we expect to build a focused sales and marketing infrastructure to market or co-promote some of our product candidates in the UnitedStates, if and when they are approved. There are risks involved with establishing our own sales, marketing and distribution capabilities. For example,recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidatefor which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely orunnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our salesand marketing personnel. Factors that may inhibit our efforts to commercialize our products on our own include:•our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;•the inability of sales personnel to obtain access to physicians;•the lack of adequate numbers of physicians to prescribe any future products;•the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companieswith more extensive product lines; and•unforeseen costs and expenses associated with creating an independent sales and marketing organization.If we are unable to establish our own sales, marketing and distribution capabilities, and instead enter into arrangements with third parties to performthese services, our product revenues and our profitability, if any, are likely to be lower than if we were to market, sell and distribute any products that wedevelop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidatesor may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote thenecessary resources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully,either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates. Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us tosell our products profitably. Market acceptance and sales of any approved products will depend significantly on the availability of adequate coverage and reimbursement fromthird-party payors and may be affected by existing and future health care reform measures. Third-party payors, such as government health care programs,private health insurers and health maintenance organizations, decide which drugs they will provide coverage for and establish reimbursement levels.Coverage and reimbursement decisions by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that useof a product is:•a covered benefit under its health plan;•safe, effective and medically necessary;•appropriate for the specific patient;•cost-effective; and•neither experimental nor investigational.Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controllinghealth care costs. Coverage and reimbursement can vary significantly from payor to payor. As a result, obtaining coverage and reimbursement approval for aproduct from each government and other third-party payor will require us to provide supporting scientific, clinical and cost-effectiveness data for the use ofour products to each payor separately, with no assurance that we will be able to provide data sufficient to gain acceptance with respect to coverage and34reimbursement. We cannot be sure that coverage or adequate reimbursement will be available for any of our product candidates. Also, we cannot be sure thatcoverage determinations or reimbursement amounts will not reduce the demand for, or the price of, our products. If reimbursement is not available or isavailable only to limited levels, we may not be able to commercialize certain of our products. In addition, in the United States, third-party payors areincreasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new drugs. As a result, significantuncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly approved drugs, which in turn will putpressure on the pricing of drugs.Price controls may be imposed, which may adversely affect our future profitability. In international markets, reimbursement and health care payment systems vary significantly by country, and many countries have instituted priceceilings on specific products and therapies. In some countries, particularly member states of the European Union, the pricing of prescription pharmaceuticalsis subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt ofmarketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on coverage, prices andreimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricingnegotiations, and pricing negotiations may continue after coverage and reimbursement has been obtained. Reference pricing used by various EuropeanUnion member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries,we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available vaccines inorder to obtain or maintain coverage, reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to furtherpressure on the prices or reimbursement levels within the country of publication and other countries. There can be no assurance that our vaccine candidateswill be considered cost-effective by third-party payors, that an adequate level of reimbursement will be available or that the third-party payors’reimbursement policies will not adversely affect our ability to sell our products profitably. If reimbursement of our products is unavailable or limited in scopeor amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected. The impact of health care reform legislation and other changes in the health care industry and in health care spending on us is currently unknown, andmay adversely affect our business model. In the United States, and in some foreign jurisdictions, the legislative landscape continues to evolve. Our revenue prospects could be affected bychanges in health care spending and policy in the United States and abroad. We operate in a highly regulated industry and new laws or judicial decisions, ornew interpretations of existing laws or decisions, related to health care availability, the method of delivery or payment for health care products and servicescould negatively impact our business, operations and financial condition. There is significant interest in promoting health care reform, as evidenced by theenactment in the United States of the Healthcare Reform Act, as well as ongoing efforts to eliminate or significantly modify the Healthcare Reform Act. Forexample, recent tax reform legislation eliminating the tax penalty for individuals who do not maintain sufficient health insurance coverage beginning in2019 is expected to increase significantly the number of uninsured. See “Business-United States Government Regulation-Reimbursement”. It is likely thatfederal and state legislatures within the United States as well as foreign governments will continue to consider changes to existing health care legislation.We cannot predict the ultimate content, timing or effect of any changes to the ACA or other federal and state reform efforts within the United Statesor abroad. There is no assurance that health care reform will not adversely affect our business and financial results, and we cannot predict how futurelegislative, judicial or administrative changes relating to healthcare reform will affect our business.The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to contain orreduce costs of health care may adversely affect:•the demand for any drug products for which we may obtain regulatory approval;•our ability to set a price that we believe is fair for our products;•our ability to obtain coverage and reimbursement approval for a product;•our ability to generate revenues and achieve or maintain profitability; and•the level of taxes that we are required to pay.35We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully, than we do. The development and commercialization of new drug products is highly competitive. Our future success depends on our ability to demonstrate andmaintain a competitive advantage with respect to the design, development and commercialization of our product candidates. Our objective is to design,develop and commercialize new products with superior efficacy, convenience, tolerability and safety. In many cases, the products that we commercialize willcompete with existing, market-leading products.Other companies that are seeking to identify antigens for the development of vaccines and T cell receptor therapies using predictive tools includeNeon Therapeutics, Gritstone Oncology, Immatics Biotechnologies GmbH, Aduro, Advaxis, Agenus, Moderna, CureVac and BioNTech. Many of our potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resourcesthan we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, including recruiting patients, obtaining regulatoryapprovals, recruiting patients and in manufacturing pharmaceutical products. In particular, these companies have greater experience and expertise in securinggovernment contracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals tomarket products, manufacturing such products on a broad scale and marketing approved products. These companies also have significantly greater researchand marketing capabilities than we do and may also have products that have been approved or are in late stages of development, and have collaborativearrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily toaccelerate discovery and development of novel compounds or to in-license novel compounds that could make the product that we develop obsolete. As aresult of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing andcommercializing products before we do. In addition, any new product that competes with an approved product must demonstrate compelling advantages inefficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. If we are not able to competeeffectively against potential competitors, our business will not grow and our financial condition and operations will suffer. Our products may cause undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercialpotential. Undesirable side effects caused by our products or even competing products in development that utilize a common mechanism of action could causeus or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatoryauthorities and potential product liability claims. Serious AEs deemed to be caused by our product candidates could have a material AE on the developmentof our product candidates and our business as a whole. The most common AEs to date in the clinical trial evaluating the safety and tolerability of GEN-003have been fatigue, myalgia (muscle pain), pain tenderness and induration (inflammatory hardening of the skin). Our understanding of the relationshipbetween GEN-003 and these events, as well as our understanding of AEs in future clinical trials of other product candidates, may change as we gather moreinformation, and additional unexpected AEs may be observed. We have not yet conducted any clinical trials for GEN-009 and therefore do not yet have anyinformation related to whether GEN-009 may cause AEs or serious AEs. If we or others identify undesirable side effects caused by any of our product candidates either before or after receipt of marketing approval, anumber of potentially significant negative consequences could result, including:•our clinical trials may be put on hold;•we may be unable to obtain regulatory approval for our vaccine candidates;•regulatory authorities may withdraw approvals of our vaccines;•regulatory authorities may require additional warnings on the label;•a medication guide outlining the risks of such side effects for distribution to patients may be required;•we could be sued and held liable for harm caused to patients; and•our reputation may suffer.36Any of these events could prevent us from achieving or maintaining market acceptance of our products and could substantially increasecommercialization costs. Risks Related to Our Indebtedness Our level of indebtedness and debt service obligations could adversely affect our financial condition, and may make it more difficult for us to fund ouroperations. In December 2015, we entered into the First Amendment to the 2014 Term Loan with Hercules. The First Amendment required us to draw anadditional $5.0 million and permitted us to draw two additional $5.0 million tranches, which expired unused at December 15, 2016. At December 31, 2017,$14.3 million was outstanding under the amended 2014 Term Loan. All obligations under our 2014 Term Loan are secured by substantially all of our existing property and assets, excluding our intellectual propertyand in-licensed technology. This indebtedness may create additional financing risk for us, particularly if our business or prevailing financial marketconditions are not conducive to paying off or refinancing our outstanding debt obligations at maturity. This indebtedness could also have importantnegative consequences, including:•we will need to repay our indebtedness by making payments of interest and principal, which will reduce the amount of money available to financeour operations, our research and development efforts and other general corporate activities; and•our failure to comply with the restrictive covenants in our 2014 Term Loan and the First Amendment could result in an event of default that, if notcured or waived, would accelerate our obligation to repay this indebtedness, and Hercules could seek to enforce its security interest in the assetssecuring such indebtedness.To the extent additional debt is added to our current debt levels, the risks described above could increase. We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due. If we donot make scheduled payments when due, or otherwise materially breach or experience an event of default under our 2014 Term Loan, Hercules couldaccelerate our total loan obligation or enforce its security interest against us. Failure to satisfy our current and future debt obligations under our 2014 Term Loan could result in an event of default. In addition, other events,including certain events that are not entirely in our control, such as the occurrence of a material adverse event on our business, could cause an event ofdefault to occur. As a result of the occurrence of an event of default, Hercules could accelerate all of the amounts due. In the event of an acceleration ofamounts due under our 2014 Term Loan, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness. Inaddition, Hercules could seek to enforce its security interests in the assets securing such indebtedness. If we are unable to pay amounts due to Hercules uponacceleration of the 2014 Term Loan or if Hercules enforces its security interest against our assets securing our indebtedness to Hercules, our ability tocontinue to operate our business may be jeopardized. We are subject to certain restrictive covenants which, if breached, could result in the acceleration of our debt under the 2014 Term Loan and have amaterial adverse effect on our business and prospects. Our 2014 Term Loan imposes operating and other restrictions on us. Such restrictions will affect, and in many respects limit or prohibit, our abilityand the ability of any future subsidiary to, among other things:•dispose of certain assets;•change our lines of business;•engage in mergers or consolidations;•incur additional indebtedness;•create liens on assets;•pay dividends and make distributions or repurchase our capital stock; and37•engage in certain transactions with affiliates.These restrictive covenants may prevent us from undertaking an action that we feel is in the best interests of our business. In addition, if we were to breachany of these restrictive covenants, Hercules could accelerate our indebtedness under the 2014 Term Loan or enforce its security interest against our assets,either of which would materially adversely affect our ability to continue to operate our business.Risks Related to Our Business and Industry If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our products, conduct our clinicaltrials and commercialize our product candidates. We are highly dependent on members of our senior management, including William Clark, our President and Chief Executive Officer, JonathanPoole, our Chief Financial Officer, and Jessica Flechtner, Ph.D., our Chief Scientific Officer. The loss of the services of any of these persons could impede theachievement of our research, development and commercialization objectives. We have employment agreements with each of these members of seniormanagement. Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success. The loss ofthe services of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectivesand seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficultand may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required tosuccessfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable tohire, train, retain or motivate these key personnel on acceptable terms as a result of our recent workforce reduction, the status of our clinical developmentprograms and the competition among numerous pharmaceutical and biotechnology companies for similar personnel. The organizational restructuring weundertook in September 2017 may yield unintended consequences, such as attrition beyond our planned reduction in workforce and reduced employeemorale, which may cause our remaining employees to seek alternate employment. We also experience competition for the hiring of scientific and clinicalpersonnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist usin formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us andmay have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attractand retain high quality personnel, our ability to pursue our growth strategy will be limited. We may experience difficulties in managing restructurings.In September 2017, we undertook an organizational restructuring that reduced our workforce by approximately 40%. Effecting any restructuringplaces significant strains on management, our employees and our operational, financial and other resources. Furthermore, restructurings involve certainadditional costs, including severance and benefits payments to terminated employees, and we may also incur liabilities from early termination or assignmentof contracts, potential litigation or other effects from such restructuring. Such effects from our restructuring program could have a material adverse affect onour ability to execute on our business plan. There can be no assurance that we will be successful in implementing our restructuring program.Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain andintegrate additional employees. Our future financial performance and our ability to develop our product candidates, including GEN-009, or additional assetswill depend, in part, on our ability to effectively manage any future growth or restructuring, as the case may be.Our employees, independent contractors, principal investigators, consultants, commercial partners, and vendors may engage in misconduct or otherimproper activities, including noncompliance with regulatory standards and requirements and insider trading. We are exposed to the risk of fraudulent or other illegal activity by our employees, independent contractors, principal investigators, consultants,commercial partners, and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails: to comply with thelaws of the FDA and similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and similar foreign regulatory bodies; tocomply with manufacturing standards we have established; to comply with federal, state and foreign health care fraud and abuse laws and regulations; toreport38financial information or data accurately; or to disclose unauthorized activities to us. In particular, the promotion, sale and marketing of health care items andservices, as well as certain business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent misconduct,including fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,marketing and, structuring and commission(s), certain customer incentive programs and other business arrangements. Activities subject to these laws alsoinvolve the improper use of information obtained in the course of patient recruitment for clinical trials. It is not always possible to identify and deter suchmisconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or inprotecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If anysuch actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impacton our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion fromparticipation in Medicare, Medicaid and other federal health care programs, contractual damages, reputational harm, diminished profits and future earnings,and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. We may encounter difficulties in managing our growth and expanding our operations successfully. As we seek to advance our product candidates through clinical trials and commercialization, we will need to expand our development, regulatory,manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us. As our operations expand, we expect that wewill need to manage additional relationships with various strategic partners, suppliers and other third parties. Future growth will impose significant addedresponsibilities on members of management. Our future financial performance and our ability to commercialize our product candidates and to competeeffectively will depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts andclinical trials effectively and hire, train and integrate additional management, administrative and, if necessary, sales and marketing personnel. We may not beable to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our productcandidates. We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if wecommercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable duringproduct testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, afailure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumerprotection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limitcommercialization of our product candidates. Even a successful defense would require significant financial and management resources. Regardless of themerits or eventual outcome, liability claims may result in:•decreased demand for any product candidates or products that we may develop;•injury to our reputation and significant negative media attention;•withdrawal of clinical trial participants;•significant costs to defend the related litigations;•a diversion of management’s time and our resources;•substantial monetary awards to trial participants or patients;•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.39Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims couldprevent or inhibit the commercialization of products we develop. We currently carry product liability insurance covering our clinical trials in the amount of$5.0 million in the aggregate. Although we maintain product liability insurance, any claim that may be brought against us could result in a court judgment orsettlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurancepolicies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amountsawarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or beable to obtain, sufficient capital to pay such amounts. We must comply with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities. We use hazardous chemicals and radioactive and biological materials in certain aspects of our business and are subject to a variety of federal, stateand local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of these materials. Wecannot eliminate the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardousmaterials. In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws andregulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources. We are uninsured for third-partycontamination injury. We may not be able to win government, academic institution or non-profit contracts or grants. From time to time, we may apply for contracts or grants from government agencies, non-profit entities and academic institutions. Such grants havebeen our only source of revenue to date. Such contracts or grants can be highly attractive because they provide capital to fund the ongoing development ofour technologies and product candidates without diluting our stockholders. However, there is often significant competition for these contracts or grants.Entities offering contracts or grants may have requirements to apply for or to otherwise be eligible to receive certain contracts or grants that our competitorsmay be able to satisfy that we cannot. In addition, such entities may make arbitrary decisions as to whether to offer contracts or make grants, to whom thecontracts or grants will be awarded and the size of the contracts or grants to each awardee. Even if we are able to satisfy the award requirements, there is noguarantee that we will be a successful awardee. Therefore, we may not be able to win any contracts or grants in a timely manner, if at all. Risks Related to Our Common Stock We are eligible to be treated as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"), and wecannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive toinvestors. We are an “emerging growth company”, as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may takeadvantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. Theseexemptions include:•not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;•not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board providing forsupplemental 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 anygolden parachute payments not previously approved.We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our commonstock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. In addition, theJOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accountingstandards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to privatecompanies. We40have irrevocably elected not to avail ourselves of this exemption and, therefore, we will be subject to the same new or revised accounting standards as otherpublic companies that are not emerging growth companies. We could be an emerging growth company for up to five years, until December 31, 2019, although circumstances could cause us to lose that statusearlier, including if the market value of our common stock held by non-affiliates exceeds $700.0 million as of any June 30 before that time or if we have totalannual gross revenue of $1.07 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company asof the following December 31 or, if we issue more than $1.0 billion in non-convertible debt during any three-year period before that time, we would cease tobe an emerging growth company immediately. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reportingcompany” if the market value of our common stock held by non-affiliates is below $75.0 million as of June 30 in any given year, which would allow us totake advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestationrequirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports andproxy statements. Our largest stockholder, New Enterprise Associates (“NEA”), could exert significant influence over us and could limit your ability to influence theoutcome of key transactions, including any change of control. Our largest stockholder, NEA, beneficially owns, in the aggregate, shares representing approximately 30% of our outstanding common stock as ofFebruary 14, 2018. In addition, one member of our board of directors is associated with NEA. As a result, we expect that NEA will be able to exert significantinfluence over our business. NEA may have interests that differ from your interests, and it may vote in a way with which you disagree and that may be adverseto your interests. The concentration of ownership of our capital stock may have the effect of delaying, preventing or deterring a change of control of ourcompany, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and may adverselyaffect the market price of our common stock.We cannot predict what the market price of our common stock will be and, as a result, it may be difficult for you to sell your shares of our common stock. An inactive market may impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategicpartnerships or acquire companies or products by using our shares of common stock as consideration. We cannot predict the prices at which our commonstock will trade. It is possible that in one or more future periods our results of operations may be below the expectations of public market analysts andinvestors and, as a result of these and other factors, the price of our common stock may fall. If our stock price is volatile, our stockholders could incur substantial losses and we may become involved in securities-related litigation, includingsecurities class action litigation, that could divert management’s attention and harm our business and subject us to significant liabilities. Our stock price is likely to be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experiencedextreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, our stockholders couldincur substantial losses. The market price for our common stock may be influenced by many factors, including:•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;41•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 inbusiness 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;•sales of our common stock by us, our insiders or our other stockholders;•speculation in the press or investment community;•announcement or expectation of additional financing efforts;•changes in accounting principles;•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.In addition, the stock market has recently experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and otherlife sciences company stocks. The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate to the operatingperformance of the companies represented by the stock. As we operate in a single industry, we are especially vulnerable to these factors to the extent that theyaffect our industry or our products, or to a lesser extent our markets.On October 31, 2017, a putative class action complaint was filed in the U.S. District Court for the District of Massachusetts (the “District ofMassachusetts” or the "Court”), naming the Company, Chief Executive Officer William D. Clark, and Chief Financial Officer Jonathan Poole as defendants.The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 in connection with disclosures made in and subsequent to theCompany’s Quarterly Report on Form 10-Q for the period ending March 31, 2017, filed with the SEC on May 5, 2017, and the Company’s announcement ofa strategic shift to immuno-oncology on September 25, 2017. The plaintiff sought to represent a class of shareholders who purchased or otherwise acquiredthe Company’s securities between May 5, 2017 and September 25, 2017. The complaint sought unspecified damages and costs. On November 3, 2017,another purported Company shareholder filed a substantially identical complaint in the District of Massachusetts. On December 15, 2017, a purportedCompany shareholder filed a third complaint in the District of Massachusetts, substantially the same as the previous two, but alleging a class periodbeginning on August 4, 2016 and ending on September 25, 2017. The District of Massachusetts designated all three complaints as related, and entered anorder in each action recognizing that the defendants are not obligated to respond to the initial complaint filed in any of the three actions. Per the proceduresset forth by federal securities laws, applications for appointment of lead plaintiff(s) and lead counsel in the three actions were due to the Court on January 2,2018. Three applications for lead plaintiff and lead counsel were submitted to the Court on that date; one of the three movants subsequently withdrew theirapplication. The Court held a hearing on the two remaining motions for lead plaintiff(s) and lead counsel on January 31, 2018. The Court consolidated thethree actions into one case, under the docket number Civil Action No. 17-cv-12137-PBS, U.S. District Court (Mass.), and took the motions for lead plaintiff(s)and counsel under advisement. Counsel for both lead plaintiff movants told the Court that they intended to file an amended complaint in the consolidatedaction, if appointed. On February 12, 2018, the Court appointed the Genocea Investor Group (a group of five purported shareholders) as lead plaintiff, andappointed Scott+Scott LLP, Levi & Korsinsky LLP, and Block & Leviton as lead counsel. On February 14, 2018, the parties submitted a stipulationproposing a briefing schedule with the following deadlines: filing of an amended complaint by the lead plaintiffs and counsel due March 29,422018; filing of an answer or motion to dismiss by defendants on May 14, 2018; filing of any opposition by plaintiffs to a motion to dismiss on June 28, 2018;and filing of any reply by defendants in support of a motion to dismiss on July 30, 2018.On January 31, 2018, a putative shareholder derivative action was filed in the U.S. District Court for the District of Delaware, naming certain of theCompany’s officers and directors as defendants, and naming the Company as a nominal defendant. The complaint alleges violations of the SecuritiesExchange Act of 1934 and Rule 14a-9 in connection with disclosures made in the Company’s Schedule 14A Proxy Statement, filed with the SEC on April 21,2017. The complaint also alleges claims for breach of fiduciary duty, unjust enrichment, and waste of corporate assets.These lawsuits and this type of litigation could result in substantial costs and divert our management’s attention and resources, and could alsorequire us to make substantial payments to satisfy judgments or to settle litigation.Failure to comply with The Nasdaq Global Market continued listing requirements may result in our common stock being delisted from The NASDAQGlobal Market.If our stock price falls below $1.00 per share or the market value of our common stock drops below $50 million, we may not continue to qualify forcontinued listing on The Nasdaq Global Market (“Nasdaq”). To maintain listing, we are required, among other things, to maintain a minimum closing bidprice of $1.00 per share and a market value of our common stock of at least $50 million. If either the closing bid price of our common stock is below $1.00per share for 30 consecutive trading days or the market value of our common stock is below $50 million for 30 consecutive business days, we will receive adeficiency notice from Nasdaq advising us that we have a certain period of time, typically 180 days, to regain compliance by maintaining a minimum closingbid price of at least $1.00 or a minimum market value of our common stock of $50 million for at least ten consecutive business days, as applicable, althoughNasdaq could require a longer period. The delisting of our common stock would significantly affect the ability of investors to trade our common stock andnegatively impact the liquidity and price of our common stock. In addition, the delisting of our common stock could materially adversely impact our abilityto raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including the potential loss of confidence by ourcurrent or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewer licensing and partneringopportunities.Our failure to implement and maintain effective internal control over financial reporting could result in material misstatements in our financial statementswhich could require us to restate financial statements, cause investors to lose confidence in our reported financial information and have a negative effecton our stock price. We cannot assure you that any material weaknesses or significant deficiencies in our internal control over financial reporting will not be identifiedin the future. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could resultin additional material weaknesses or significant deficiencies, cause us to fail to meet our periodic reporting obligations or result in material misstatements inour financial statements. Any such failure could also adversely affect the results of periodic management evaluations regarding the effectiveness of ourinternal control over financial reporting. The existence of a material weakness or significant deficiency could result in errors in our financial statements thatcould result in a restatement of financial statements, cause us to fail to meet our reporting obligations and cause investors to lose confidence in our reportedfinancial information, leading to a decline in our stock price. We incur significant costs as a result of being a public company and our management expects to devote substantial time to public company complianceprograms. As a public company, we incur significant legal, insurance, accounting and other expenses that we did not incur as a private company. In addition,our administrative staff are required to perform additional tasks. We invest resources to comply with evolving laws, regulations and standards, and thisinvestment could result in increased general and administrative expenses and may divert management’s time and attention from product developmentactivities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due toambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed. In the future, it may be moreexpensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs toobtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serveon our audit committee and compensation committee, and qualified executive officers. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting. Anyfailure to develop or maintain effective controls could adversely affect the results of periodic management evaluations. In the event that we are not able todemonstrate compliance with the Sarbanes-Oxley Act, that our43internal control over financial reporting is perceived as inadequate, or that we are unable to produce timely or accurate financial statements, investors maylose confidence in our operating results and the price of our ordinary shares could decline. In addition, if we are unable to continue to meet theserequirements, we may not be able to remain listed on Nasdaq. We are required to comply with certain of the SEC’s rules that implement Section 404 of the Sarbanes-Oxley Act, which require management tocertify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of our internalcontrol over financial reporting commencing with our second annual report. This assessment must include the disclosure of any material weaknesses in ourinternal control over financial reporting identified by our management or our independent registered public accounting firm. To achieve compliance withSection 404 within the prescribed period, we engage in a process to document and evaluate our internal control over financial reporting, which is both costlyand challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed workplan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validatethrough testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control overfinancial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal controlover financial reporting is effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in thefinancial markets due to a loss of confidence in the reliability of our financial statement. Provisions in our charter documents and under Delaware law have anti-takeover effects that could discourage an acquisition of us by others, even if anacquisition would be beneficial to our stockholders, and prevent attempts by our stockholders to replace or remove our current management.Provisions in our amended and restated certificate of incorporation and amended and restated by-laws contain provisions that may have the effect ofdiscouraging, delaying or preventing a change in control of us or changes in our management. These provisions could also limit the price that investorsmight be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because ourboard of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by ourstockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Amongother things, these provisions:•authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may containvoting, liquidation, dividend and other rights superior to our common stock;•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, ourchief 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, includingproposed 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 aquorum;•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.These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management. 44Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law,which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after thedate of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in aprescribed manner. Any provision of our amended and restated certificate of incorporation, our amended and restated by-laws or Delaware law that has the effect ofdelaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, andcould also affect the price that some investors are willing to pay for our common stock. Our ability to use net operating losses to offset future taxable income may be subject to certain limitations. In general, under Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"), a corporation that undergoes an “ownership change”is subject to limitations on its ability to utilize its pre-change net operating losses ("NOLs"), to offset future taxable income. Our existing NOLs are subject tolimitations arising from previous ownership changes, and if we undergo an ownership change in connection any follow-on offerings of our common orpreferred stock, our ability to utilize NOLs could be further limited by Section 382 of the Code. Our NOLs may also be impaired under state law. Accordingly,we may not be able to utilize a material portion of our NOLs. Furthermore, our ability to utilize our NOLs is conditioned upon our attaining profitability andgenerating U.S. federal taxable income. We have incurred net losses since our inception and anticipate that we will continue to incur significant losses for theforeseeable future; thus, we do not know whether or when we will generate the U.S. federal taxable income necessary to utilize our NOLs.Our amended and restated certificate of incorporation designates the state or federal courts located in the State of Delaware as the sole and exclusiveforum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain afavorable judicial forum for disputes with us or our directors, officers or employees. Our amended and restated certificate of incorporation provides that, subject to limited exceptions, the state and federal courts located in the State ofDelaware will be the sole and exclusive forum for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach ofa fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (3) any action asserting a claim against us arisingpursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated by-laws or (4) any other action asserting a claim against us that is governed by the internal affairs doctrine. Any person or entity purchasing or otherwiseacquiring any interest in shares of our capital stock shall be deemed to have notice of and to have consented to the provisions of our amended and restatedcertificate of incorporation described above. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it findsfavorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers andemployees. Alternatively, if a court were to find these provisions of our amended and restated certificate of incorporation inapplicable to, or unenforceable inrespect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in otherjurisdictions, which could adversely affect our business and financial condition. Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the source ofgain for our stockholders. You should not rely on an investment in our common stock to provide dividend income. We do not anticipate that we will pay any cash dividendsto holders of our common stock in the foreseeable future. Instead, we plan to retain any earnings to maintain and expand our operations. In addition, ourability to pay cash dividends is currently prohibited by the terms of our debt financing arrangement, and any future debt financing arrangement may containterms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Accordingly, investors must rely on sales of theircommon stock after price appreciation, which may never occur, as the only way to realize any return on their investment. As a result, investors seeking cashdividends should not purchase our common stock.The recently passed comprehensive tax reform bill could adversely affect our business and financial condition.On December 22, 2017, President Trump signed into law new legislation that significantly revises the Internal Revenue Code of 1986, as amended. The newly enacted federal income tax law, among other things, contains significant changes to corporate taxation, including reduction of the corporate taxrate from a top marginal rate of 35% to a flat rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certainsmall businesses),45limitation of the deduction for net operating losses to 80% of current year taxable income in respect of net operating losses generated during or after 2018and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated,elimination of U.S. tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new investments instead of deductionsfor depreciation expense over time, and modifying or repealing many business deductions and credits. Notwithstanding the reduction in the corporateincome tax rate, the overall impact of the new federal tax law is uncertain and our business and financial condition could be adversely affected. In addition,it is uncertain if and to what extent various states will conform to the newly enacted federal tax law. The impact of this tax reform on holders of our commonstock is also uncertain and could be adverse. We urge you to consult with your legal and tax advisors with respect to this legislation and the potential taxconsequences of investing in or holding our common stock.Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.We are currently subject to taxation in the United States and Massachusetts. In preparing our financial statements, we estimate the amount of taxthat will become payable in each of such places. Nevertheless, our effective tax rate may be different than experienced in the past due to numerous factors,including passage of the newly enacted federal income tax law, changes in the mix of our profitability from state to state, the results of examinations andaudits of our tax filings, our inability to secure or sustain acceptable agreements with tax authorities, changes in accounting for income taxes and changes intax laws. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations andmay result in tax obligations in excess of amounts accrued in our financial statements.Item 1B. Unresolved Staff CommentsNone.Item 2. PropertiesOur principal executive offices are located at 100 Acorn Park Drive, 5th floor, Cambridge, Massachusetts 02140. We have two leases at this address,and in aggregate, we occupy approximately 34,200 square feet of laboratory and office space. Both leases were extended in 2016 and have terms that expirein February 2020. We believe that our existing facilities are sufficient for our present operations, but that over time, our existing facility space will need to beexpanded to meet the demands of our future lab operations.Item 3. Legal ProceedingsFrom time to time we are subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although theresults of litigation and claims cannot be predicted with certainty, as of the date of this Annual Report on Form 10-K, except as discussed below, we do notbelieve we are party to any claim or litigation, the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonablyexpected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense andsettlement costs, diversion of management resources and other factors.On October 31, 2017, a putative class action complaint was filed in the U.S. District Court for the District of Massachusetts (the "District ofMassachusetts" or the "Court"), naming the Company, Chief Executive Officer William D. Clark, and Chief Financial Officer Jonathan Poole as defendants.The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 in connection with disclosures made in and subsequent to theCompany’s Quarterly Report on Form 10-Q for the period ending March 31, 2017, filed with the SEC on May 5, 2017, and the Company’s announcement ofa strategic shift to immuno-oncology on September 25, 2017. The plaintiff sought to represent a class of shareholders who purchased or otherwise acquiredthe Company’s securities between May 5, 2017 and September 25, 2017. The complaint sought unspecified damages and costs. On November 3, 2017,another purported Company shareholder filed a substantially identical complaint in the District of Massachusetts. On December 15, 2017, a purportedCompany shareholder filed a third complaint in the District of Massachusetts, substantially the same as the previous two, but alleging a class periodbeginning on August 4, 2016 and ending on September 25, 2017. The District of Massachusetts designated all three complaints as related, and entered anorder in each action recognizing that the defendants are not obligated to respond to the initial complaint filed in any of the three actions. Per the proceduresset forth by federal securities laws, applications for appointment of lead plaintiff(s) and lead counsel in the three actions were due to the Court on January 2,2018. Three applications for lead plaintiff and lead counsel were submitted to the Court on that date; one of the three movants subsequently withdrew theirapplication. The Court46held a hearing on the two remaining motions for lead plaintiff(s) and lead counsel on January 31, 2018. The Court consolidated the three actions into onecase, under the docket number Civil Action No. 17-cv-12137-PBS, U.S. District Court (Mass.), and took the motions for lead plaintiff(s) and counsel underadvisement. Counsel for both lead plaintiff movants told the Court that they intended to file an amended complaint in the consolidated action, if appointed.On February 12, 2018, the Court appointed the Genocea Investor Group (a group of five purported shareholders) as lead plaintiff, and appointed Scott+ScottLLP, Levi & Korsinsky LLP, and Block & Leviton as lead counsel. On February 14, 2018, the parties submitted a stipulation proposing a briefing schedulewith the following deadlines: filing of an amended complaint by the lead plaintiffs and counsel due March 29, 2018; filing of an answer or motion to dismissby defendants on May 14, 2018; filing of any opposition by plaintiffs to a motion to dismiss on June 28, 2018; and filing of any reply by defendants insupport of a motion to dismiss on July 30, 2018.On January 31, 2018, a putative shareholder derivative action was filed in the U.S. District Court for the District of Delaware, naming certain of theCompany’s officers and directors as defendants, and naming the Company as a nominal defendant. The complaint alleges violations of the SecuritiesExchange Act of 1934 and Rule 14a-9 in connection with disclosures made in the Company’s Schedule 14A Proxy Statement, filed with the SEC on April 21,2017. The complaint also alleges claims for breach of fiduciary duty, unjust enrichment, and waste of corporate assets.The Company does not have contingency reserves established for any litigation liabilities.Item 4. Mine Safety DisclosuresNot applicable.47PART IIItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuers Purchases of Equity SecuritiesMarket InformationOur common stock has been publicly traded on The Nasdaq Global Market under the symbol “GNCA” since February 5, 2014. Prior to that time, therewas no public market for our common stock. The following table sets forth, for the periods indicated, the high and low sales prices for our common stock asreported on The Nasdaq Global Market. HIGH LOW2017 Fourth Quarter$2.15 $1.01Third Quarter$6.78 $1.13Second Quarter$7.29 $4.92First Quarter$6.20 $4.012016 Fourth Quarter$5.22 $3.28Third Quarter$6.39 $3.86Second Quarter$7.74 $3.35First Quarter$8.07 $2.56HoldersAs of February 14, 2018, there were approximately 17 holders of record of our common stock. This number does not include beneficial owners whoseshares are held by nominees in street name.DividendsWe have never declared or paid cash dividends on our common stock, and we do not expect to pay any cash dividends on our common stock in theforeseeable future.Performance GraphThe following performance graph and related information shall not be deemed to be “soliciting material” or to be “filed” with the SEC, nor shallsuch information be incorporated by reference into any future filing under the Securities Act, except to the extent that we specifically incorporate it byreference into such filing.The following graph compares the performance of our common stock to The Nasdaq Composite Index and to The Nasdaq Biotechnology Index fromFebruary 5, 2014 (the first date that shares of our common stock were publicly traded) through December 31, 2017. The comparison assumes $100 wasinvested after the market closed on February 5, 2014 in our common stock and in each of the foregoing indices, and it assumes reinvestment of dividends, ifany.48_________________________*$100 invested on 2/5/2014 in stock or index, including reinvestment of dividends. Fiscal year ending December 31, 2017.Cumulative Total Return Comparison 2/5/2014 Mar-14 Jun-14 Sep-14 Dec-14 Mar-15 Jun-15 Sep-15 Dec-15 Mar-16 Jun-16 Sep-16 Dec-16 Mar-17 Jun-17 Sep-17 Dec-17GenoceaBiosciences, Inc.100.00 165.36 170.45 82.27 63.64 107.82 124.82 62.27 47.91 70.36 37.27 46.55 37.45 55.36 47.45 13.27 10.55NasdaqComposite100.00 104.67 109.89 112.01 118.06 122.17 124.31 115.17 124.82 121.40 120.72 132.42 134.19 147.37 153.07 161.93 172.09NasdaqBiotechnology100.00 99.66 108.44 115.41 128.26 145.21 156.00 127.93 142.91 110.08 108.73 122.20 111.93 123.90 131.02 141.00 135.49Recent Sales of Unregistered SecuritiesNone.Purchase of Equity SecuritiesWe did not purchase any of our registered equity securities during the period covered by this Annual Report on Form 10-K.Securities Authorized for Issuance under Equity Compensation PlansThe following table contains information about our equity compensation plans as of December 31, 2017.Plan category Number of securitiesto be issued upon exerciseof outstanding stock optionsand warrants Weighted-averageexercise price ofoutstanding options andwarrants Number of securitiesremaining availablefor future issuanceunder equitycompensation plans Equity compensation plans approved by securityholders (1) 4,129,178 $5.48 1,114,067(2)49(1) Includes information regarding our 2014 Equity Incentive Plan.(2) Does not include 1,149,396 shares added to the 2014 Equity Incentive Plan under the evergreen provision on January 1, 2018.Item 6. Selected Financial DataThe selected statements of operations data for each of the three years in the period ended December 31, 2017 and the balance sheet data atDecember 31, 2017 and 2016 have been derived from our audited financial statements included elsewhere in this Annual Report on Form 10-K. The selectedstatements of operations data for the years ended December 31, 2014 and 2013 and the balance sheet data at December 31, 2015, 2014 and 2013 have beenderived from our audited financial statements not included in this Annual Report on Form 10-K. Our historical results for any prior period are not necessarilyindicative of results to be expected in any future period.The information set forth below should be read in conjunction with the “Management’s Discussion and Analysis of Financial Condition and Resultsof Operations” section of this Annual Report on Form 10-K and with our consolidated financial statements and notes thereto included elsewhere in thisAnnual Report on Form 10-K. The selected financial data in this section are not intended to replace the consolidated financial statements and are qualified intheir entirety by the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. Years Ended December 31,(In thousands, except per share data) 2017 2016 2015 2014 2013Grant revenue $— $235 $670 $308 $731 Operating expenses: Research and development 39,204 34,645 28,049 23,727 15,695General and administrative 13,433 15,427 13,987 9,747 4,961Restructuring costs 2,618 — — — —Refund of research and development expense — (1,592) — — —Total operating expenses 55,255 48,480 42,036 33,474 20,656Loss from operations (55,255) (48,245) (41,366) (33,166) (19,925)Other expense, net: Interest income 250 410 163 55 6Interest expense (1,705) (1,738) (1,280) (1,025) (465)Change in fair value of warrants — — — (725) (222)Loss on debt extinguishment — — — (435) (200)Total other expense, net (1,455) (1,328) (1,117) (2,130) (881)Net loss $(56,710) $(49,573) $(42,483) $(35,296) $(20,806)Comprehensive loss $(56,710) $(49,573) $(42,490) $(35,303) $(20,806) Reconciliation of net loss to net loss attributable to commonstockholders Net loss $(56,710) $(49,573) $(42,483) $(35,296) $(20,806)Accretion of redeemable convertible preferred stock to redemptionvalue — — — (180) (1,605)Net loss attributable to common stockholders $(56,710) $(49,573) $(42,483) $(35,476) $(22,411)Net loss per share attributable to common stockholders - basic anddiluted (1) $(1.98) $(1.75) $(1.74) $(2.27) $(75.46)Weighted-average number of common shares used in net loss pershare attributable to common stockholders - basic and diluted 28,603 28,299 24,460 15,618 29750 As of December 31,(in thousands) 2017 2016 2015 2014 2013Balance Sheet Data: Cash, cash equivalents and investments $12,273 $63,362 $106,432 $47,079 $12,208Working capital (2,698) 53,918 89,226 42,173 8,382Total assets 17,488 69,896 112,142 50,332 15,761Preferred stock warrant liability — — — — 656Preferred stock — — — — 81,562Common stock and additional paid-in capital 258,143 253,024 247,578 147,941 —Total stockholders’ equity (deficit) (6,050) 45,541 89,661 32,507 (80,131)_________________________(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 ofthe method used to calculate basic and diluted net loss per common share.Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsYou should read the following discussion and analysis of our financial condition and results of operations together with the section entitled“Selected Financial Data” and our financial statements and related notes appearing in this Annual Report on Form 10-K. Some of the informationcontained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans andstrategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors,including those factors set forth in the “Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the resultsdescribed in or implied by the forward-looking statements contained in the following discussion and analysis.OverviewWe are a biopharmaceutical company that discovers and develops novel cancer vaccines. We use our proprietary discovery platform, ATLAS, torecall a patient’s pre-existing CD4+ and CD8+ T cell immune responses to their tumor to identify antigens for inclusion in vaccines that are designed to actthrough T cell (or cellular) immune responses. We believe that using ATLAS to identify antigens for inclusion in cancer vaccines could lead to moreimmunogenic and efficacious cancer vaccines.In September 2017, we announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines. Currently,all of our research programs and product candidates in active development are at the preclinical stage. Our most advanced program is our preclinical immuno-oncology program, GEN-009, a neoantigen cancer vaccine. The GEN-009 program uses ATLAS to identify patient neoantigens, or newly formed antigensunique to each patient, that are associated with that individual’s tumor. We are also exploring partnering opportunities in the development of cancer vaccinestargeting tumor-associated antigens and a vaccine targeting cancers caused by Epstein-Barr Virus, or EBV.We have one Phase 3-ready product candidate, GEN-003, an investigational immunotherapy for the treatment of genital herpes. In September 2017,we announced that we are exploring strategic alternatives to maximize value for GEN-003 through sale, partnership or other means. Consequently,substantially all GEN-003 spending and activities were ceased and we reduced our workforce by approximately 40 percent. We continue to believe that GEN-003 could address unmet medical needs of genital herpes patients.ATLAS PlatformThe importance of the T cell arm of the immune system is increasingly understood to be critical in the treatment of certain cancers. However, thediscovery of effective T cell targets has been particularly challenging for two reasons. First, the diversity of human T cell responses means that an effective Tcell target for one person may be different from an effective T cell target for another person. Second, the number of candidate targets for T cell responses canbe very large with up to thousands of candidate antigens per patient in some cancers. These complexities represent fundamental barriers that traditionalcancer vaccine target discovery tools, which rely largely on computer modeling - so-called predictive algorithms - have, as yet, only been poorly addressed.51We have designed the ATLAS platform to overcome these T cell target discovery challenges by identifying true neoantigens in an individual ratherthan using traditional predictive methods. We believe ATLAS represents the most comprehensive and accurate high throughput system for T cell vaccine andimmunotherapy discovery in the biopharmaceutical industry. ATLAS is designed to mimic the T cell arm of the human immune system in a laboratorysetting. Using ATLAS, we are able to measure T cell responses to the entire set of potential T cell targets for an individual’s cancer, allowing us to identifyvaccine and immunotherapy targets associated with T cell responses which may kill an individual’s cancer.We believe we are a leader in the field of T cell vaccine and immunotherapy discovery and development. Our management and scientific teamspossess considerable experience in vaccine, immunotherapy and anti-infective research, manufacturing, clinical development and regulatory matters.Our Immuno-Oncology ProgramWe are focused on combining our antigen selection and vaccine development expertise to create new immuno-oncology treatments. Our potentialcancer vaccines will be designed to educate T cells to recognize and attack specific targets and thereby kill cancer cells. We are working to developpersonalized cancer vaccines by applying ATLAS to identify patient neoantigens that are associated with that individual’s pre-existing immune responses toa tumor.Neoantigens are personalized tumor mutations that are seen as “foreign” by an individual’s immune system. Data published in recent years haveindicated that an individual’s response to neoantigens drives checkpoint inhibitor efficacy and that it is possible to vaccinate an individual against their ownneoantigens. If approved, neoantigen vaccines could be used in combination with existing treatment approaches for cancer, including immune checkpointinhibitors, to potentially direct and enhance an individual’s T cell response to the individual’s cancer, thereby potentially affording better clinical outcomes.Our lead immuno-oncology program, GEN-009, is an adjuvanted neoantigen peptide vaccine candidate designed to direct a patient’s immunesystem to attack their tumor. GEN-009’s neoantigens are identified by our proprietary ATLAS platform, which recalls a patient’s pre-existing CD4+ andCD8+ cell immune responses to their tumor. Following ATLAS neoantigen identification, we will manufacture a personal vaccine for each patient.We anticipate filing a personalized cancer vaccine IND application with the FDA in the first quarter of 2018 for GEN-009. We plan to initiate aPhase 1/2 clinical trial for GEN-009 in a range of tumor types in subjects with no evidence of disease but a high risk of relapse in mid-2018. We expect toreport initial immunogenicity data from this trial in the first half of 2019.We are also using ATLAS to develop cancer vaccines targeting tumor-associated, or shared, antigens and vaccines against cancers of viral origin.Our strategy in immuno-oncology combines our own internal neoantigen vaccine development programs with a focus on partnering ATLAS for these otherimmuno-oncology applications.In November 2015, we commenced a program focused on EBV. EBV infection has been linked to cancers with high unmet needs such as non-Hodgkin’s lymphoma, nasopharyngeal carcinoma and gastric carcinoma. We believe that ATLAS is highly suited to the creation of a new immunotherapy forEBV, given that T cell responses are understood to be crucial for protection against EBV. Furthermore, EBV is part of the herpes virus family, in which wehave deep experience through our development of GEN-003. We are currently seeking a partner to advance the development of this vaccine.The following table describes our active programs in development:VaccineCandidate Program Stage of Development Next Milestone Anticipated TimelineGEN-009 Neoantigen cancer vaccine Pre-clinical File IND; commence Phase 1/2clinical proof of concept trial First quarter of 2018; mid-2018GEN-010 Second generationneoantigen cancer vaccine Pre-clinical Select delivery technologyplatform OngoingGEN-007 Epstein-Barr Virus Research Select antigen candidates Ongoing, exploring partneringopportunitiesGEN-006 Immuno-oncology -tumor‑associatedantigen vaccine Research Select antigen candidates Ongoing, exploring partneringopportunities52GEN-003 — Phase 2 immunotherapy for genital herpes, currently exploring strategic alternativesPrior to our September 2017 strategic shift announcement, our lead program was GEN-003, a Phase 3-ready investigational immunotherapy for thetreatment of genital herpes that had completed three positive clinical trials. We are currently exploring strategic alternatives to maximize shareholder valuefrom GEN-003, during which time we have ceased substantially all activities under the GEN-003 program.Financing and business operationsWe commenced business operations in August 2006. To date, our operations have been limited to organizing and staffing our company, acquiringand developing our proprietary ATLAS technology, identifying potential product candidates and undertaking preclinical studies and clinical trials for ourproduct candidates. All of our revenue to date has been grant revenue. We have not generated any product revenue and do not expect to do so for theforeseeable future. We have primarily financed our operations through the issuance of our equity securities, debt financings and amounts received throughgrants. As of December 31, 2017, we had received an aggregate of $279.8 million in gross proceeds from the issuance of equity securities and gross proceedsfrom debt facilities and an aggregate of $7.9 million from grants. At December 31, 2017, our cash and cash equivalents were $12.3 million. Since inception, we have incurred significant operating losses. Our net losses were $56.7 million and $49.6 million for the years ended December 31,2017 and 2016, respectively, and our accumulated deficit was $264.2 million as of December 31, 2017. We expect to incur significant expenses andincreasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. We will need togenerate significant revenue to achieve profitability, and we may never do so. In March 2015, we completed an underwritten public offering of 6.3 million shares of our common stock at a public offering price of $8.25 per sharefor an aggregate offering price of $51.7 million. In August 2015, we completed another underwritten public offering of 3.9 million shares of our commonstock at a public offering price of $13.00 per share for an aggregate offering price of $50.1 million. We received net proceeds from these offerings ofapproximately $95.7 million, after deducting approximately $6.1 million in underwriting discounts and commissions, excluding offering costs payable byus.In January 2018, we completed the Concurrent Offerings in which we sold (i) 53.4 million shares of our common stock and accompanying Class Awarrants to purchase up to 26.7 million shares of our common stock, at a combined price of $1.00 per share, and accompanying Class A warrant to purchase0.5 shares of common stock for aggregate gross proceeds of approximately $53.4 million and (ii) 1,635 shares of our Series A convertible preferred stock,which are convertible into 1.6 million shares of our common stock, and accompanying Class A warrants to purchase up to 0.8 million shares of our commonstock for aggregate gross proceeds of approximately $1.6 million. Each Class A warrant has an exercise price of $1.20 per share and will expire five yearsfrom the date of issuance. We received net proceeds from these offerings of approximately $51.7 million, after deducting approximately $3.3 million inunderwriting discounts and commissions, excluding offering costs payable by us. We believe that our cash and cash equivalents at December 31, 2017, together with the proceeds from the Concurrent Offerings, are sufficient tosupport our operating expenses and capital expenditure requirements into the second half of 2019, without assuming the expected benefit of the restructuringor refinancing of our debt facility.Costs related to clinical trials can be unpredictable and therefore there can be no guarantee that our current balances of cash, cash equivalents andinvestments, and any proceeds received from other sources, will be sufficient to fund our studies or operations through this period. These funds will not besufficient to enable us to conduct pivotal clinical trials for, seek marketing approval for or commercially launch GEN-009 or any other product candidate.Accordingly, to obtain marketing approval for and to commercialize these or any other product candidates, we will be required to obtain further fundingthrough public or private equity offerings, debt financings, collaboration and licensing arrangements or other sources. Adequate additional financing maynot be available to us on acceptable terms, or at all. Our failure to raise capital when needed would have a negative effect on our financial condition and ourability to pursue our business strategy.Financial OverviewGrant revenue 53Grant revenue consists of revenue earned to conduct vaccine development research. We have received grants from private not-for-profitorganizations and federal agencies. These grants have related to the discovery and development of several of our non-active product candidates, includingnon-active product candidates for the prevention of pneumococcus, chlamydia, and malaria. Revenue under these grants is recognized as research services areperformed. Funds received in advance of research services being performed are recorded as deferred revenue. We plan to continue to pursue grant funding, butthere can be no assurance we will be successful in obtaining such grants in the future. We have no products approved for sale. We will not receive any revenue from any product candidates that we develop until we obtain regulatoryapproval and commercialize such products or until we potentially enter into agreements with third parties for the development and commercialization ofproduct candidates. If our development efforts for any of our product candidates result in regulatory approval or we enter into collaboration agreements withthird parties, we may generate revenue from product sales or from such third parties. We expect that our revenue will be less than our expenses for the foreseeable future and that we will experience increasing losses as we continue ourdevelopment of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. Our ability to generaterevenue for each product candidate for which we receive regulatory approval will depend on numerous factors, including competition, commercialmanufacturing capability and market acceptance of our products.Research and development expenses Research and development expenses consist primarily of costs incurred to advance our preclinical and clinical candidates, which include:•personnel-related expenses, including salaries, benefits, stock-based compensation expense and travel;•expenses incurred under agreements with CROs, 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 andother supplies. We expense internal research and development costs to operations as incurred. We expense third party costs for research and development activities,such as conducting clinical trials, based on an evaluation of the progress to completion of specific performance or tasks such as patient enrollment, clinicalsite activations or information, which is provided to us by our vendors. The following table identifies research and development expenses on a program-specific basis for our product candidates (in thousands): Years ended December 31, 2017 2016 2015Genital herpes (GEN-003)(1) $21,574 $19,641 $15,555Immuno-oncology program (2) 12,604 3,060 —Other research and development (3) 5,026 11,944 12,494Total research and development $39,204 $34,645 $28,049_________________________(1)Includes direct and indirect internal costs and external costs such as CMO and CRO costs.(2)Includes direct and indirect internal costs and external costs for our immuno-oncology research and development activities.(3) Includes costs that are not specifically allocated by project, including facilities costs, depreciation expense, and other costs. In addition, costs forprograms that were paused in 2016 or earlier are included in this line item.We expect our overall research and development expenses will decrease given the strategic shift and restructuring announced in September 2017that resulted in our ceasing clinical trials for GEN-003. However, we do expect our research and development costs incurred on our immuno-oncologyprograms to increase as we continue to develop our supply chain and54manufacturing capabilities for our GEN-009 program, prepare an IND, prepare for and initiate the clinical trials for GEN-009, and, subject to the selecting andaccessing of a novel delivery technology platform, advance our next generation neoantigen vaccine program, GEN-010, in preclinical development. General and administrative expenses General and administrative expenses consist principally of salaries and related costs for personnel, including stock-based compensation and travelexpenses, in executive and other administrative functions. Other general and administrative expenses include facility-related costs, communication expensesand professional fees associated with corporate and intellectual property legal expenses, consulting and accounting services. We anticipate that our general and administrative expenses will increase in the future to support the continued research and development of ourproduct candidates and to operate as a public company. These increases will likely include higher costs for insurance, hiring activities, and professionalservices, such as outside consultants, lawyers and accountants, among other expenses. Additionally, if and when we believe a regulatory approval of our firstproduct candidate appears likely, we anticipate that we will increase our salary and personnel costs and other expenses as a result of our preparation forcommercial operations. Refund of research and development expenses The refund of research and development expenses recorded in year ended December 31, 2016 related to a one-time payment received from Novavaxpursuant to contractual obligations under the Novavax Agreement that existed to refund research and development expenses paid to Novavax between 2009and 2011.Other expense, netOther expense consists of fair value adjustments on warrants to purchase preferred stock, loss on debt extinguishment, interest income and interestexpense. Upon completion of our IPO on February 10, 2014, warrants to purchase preferred stock were converted to warrants to purchase common stock andas a result, the Company no longer recorded fair value adjustments for its warrants. Losses on debt extinguishment were recorded on the retirement ofoutstanding borrowings due to the refinancing of existing debt with a new lender.Interest income Interest income consists of interest earned on our cash, cash equivalent and investment portfolio.Interest expenseInterest expense consists of interest expense on our long-term debt facilities and non-cash interest related to the amortization of debt discount andissuance costsAccretion of redeemable convertible preferred stock Certain classes of our preferred stock were redeemable beginning in 2017 at the original issuance price plus any declared or accrued but unpaiddividends upon written election of the preferred stockholders in accordance with the terms of our articles of incorporation. Accretion of preferred stockreflects the accretion of issuance costs and, for Series B preferred stock, cumulative dividends based on their respective redemption values. On February 10,2014, we completed our IPO and all shares of preferred stock were converted into 11,466,479 shares of our common stock. No accretion of preferred stock isrecorded after this date as no shares of preferred stock are outstanding.Critical Accounting Policies and Significant Judgments and EstimatesOur management’s discussion and analysis of our financial position and results of operations is based on our financial statements, which have beenprepared in accordance with U.S. generally accepted accounting principles ("GAAP"). The preparation of financial statements in conformity with GAAPrequires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, weevaluate estimates, which include, but are not limited to, estimates related to clinical trial accruals, prepaid and accrued research and development expenses,stock-based compensation expense, common stock warrants, warrants to purchase redeemable securities, and reported amounts of revenues and expensesduring the reported period. We base our estimates on historical experience and55other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially from thoseestimates or assumptions.While our significant accounting policies are described in more detail in the notes to our financial statements appearing elsewhere in this AnnualReport on Form 10-K, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financialstatements.Prepaid and Accrued Research and Development ExpensesAs part of the process of preparing our financial statements, we are required to estimate our prepaid and accrued research and development expenses.This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed for usand estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of theactual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We makeestimates of our prepaid and accrued research and development expenses as of each balance sheet date in our financial statements based on facts andcircumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments, if necessary.Examples of estimated prepaid and accrued research and development expenses include fees paid to CROs in connection with clinical trials, CMOs withrespect to pre-clinical and clinical materials and intermediaries and vendors in connection with preclinical development activities.We base our expenses related to clinical trials on our estimates of the services performed pursuant to contracts with clinical sites that conductclinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in unevenpayment flows. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of required datasubmission. In recording service fees, we make estimates based upon the time period over which services will be performed or other observable andmeasureable progress points as defined in the contracts, such as number of subjects enrolled, number of sites, or quantity of services performed in each period.The calculated amount of service fee expense is compared to the actual payments made pursuant to the contract's billing schedule to determine the resultingprepaid or accrual position. Additionally, for each clinical site, we accrue 10% of the earned amounts which is payable upon completion of the required datasubmission for the clinical trial. If our estimates of the status and timing of services performed differs from the actual status and timing of services performed,we may report amounts that are too high or too low in any particular period. To date, there has been no material differences from our estimates to the amountactually incurred.Stock-Based CompensationWe have applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification ("FASB ASC"),Topic 718, Compensation — Stock Compensation ("ASC 718"), to account for stock-based compensation for employees and ASC 718 and FASB ASC Topic505, Equity ("ASC 505"), for non-employees. We recognize compensation costs related to stock options granted to employees based on the estimated fairvalue of the awards on the date of grant. Stock compensation related to non-employee awards is re-measured at each reporting period until the awards arevested.Determining the amount of stock-based compensation to be recorded requires us to develop estimates of the fair value of stock-based awards as oftheir measurement date. We recognize stock-based compensation expense over the requisite service period, which is the vesting period of the award.Calculating the fair value of stock-based awards requires that we make highly subjective assumptions. We use the Black-Scholes option pricing model tovalue our stock option awards. Use of this valuation methodology requires that we make assumptions as to the volatility of our common stock, the fair valueof our common stock on the measurement date, the expected term of our stock options, the risk free interest rate for a period that approximates the expectedterm of our stock options and our expected dividend yield. Because of our limited operating history as a publicly traded entity, we utilize data from arepresentative group of publicly traded companies to estimate expected stock price volatility. We selected representative companies from thebiopharmaceutical industry with characteristics similar to us. We use the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107,Share-Based Payment as we do not have sufficient historical stock option activity data to provide a reasonable basis upon which to estimate the expectedterm of stock options granted to employees. For non-employee grants, we use an expected term equal to the remaining contractual term of the award. Weutilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention of paying cash dividends. The risk-free interest rate used for each grant is based on the U.S. Treasury yield curve in effect at the time of grant for instruments with a similar expected life.In March 2016, the FASB issued ASU 2016-09, Compensation — Stock Compensation (Topic 718), which provides for improvements to employeeshare-based payment accounting. The Company early adopted ASU 2016-09 as of June 30,562016. In connection with the early adoption, the Company elected an accounting policy to record forfeitures as they occur. There was no financial statementimpact upon adoption as the Company had estimated a forfeiture rate of zero given that most options awards vest on a monthly basis. Stock-basedcompensation expense recognized in the financial statements is based on awards that ultimately vest.Stock-based compensation expense includes options granted to employees and non-employees and has been reported in our statements ofoperations and comprehensive loss as follows (in thousands): Years ended December 31, 2017 2016 2015Research and development $1,310 $1,568 $1,690General and administrative 2,924 2,579 2,158Total $4,234 $4,147 $3,848We estimated the fair value of stock options of each employee stock award at the grant date using the following assumptions: Years ended December 31, 2017 2016 2015Expected Volatility 74.6% - 90.1% 67.4% - 77.9% 68.5% - 85.3%Risk-free interest rate 1.85% - 2.18% 1.14% - 2.09% 1.56% - 1.94%Expected term (in years) 5.5 - 9.88 5.50 - 6.08 5.50 - 6.08Expected dividend yield 0% 0% 0%At December 31, 2017, we had approximately $4.8 million of total unrecognized compensation expense, which we expect to recognize over aweighted-average remaining vesting period of approximately three years. Our stock-based compensation expense for stock options has increased primarilybased upon headcount growth and the related number of stock option awards granted to new and existing employees.Results of OperationsComparison of the Years Ended December 31, 2017 and December 31, 2016 Years EndedDecember 31, Increase(in thousands) 2017 2016 (Decrease)Grant revenue $—$235 $(235) Operating expenses: Research and development 39,204 34,645 4,559General and administrative 13,433 15,427 (1,994)Restructuring costs 2,618 — 2,618Refund of research and development expense — (1,592) (1,592)Total operating expenses 55,255 48,480 6,775Loss from operations (55,255) (48,245) 7,010Other income and expenses: Interest income 250 410 (160)Interest expense (1,705) (1,738) (33)Total other income and expense (1,455) (1,328) 127Net loss $(56,710) $(49,573) 7,137Grant revenue 57We did not record any grant revenue in the year ended December 31, 2017 as compared to $0.2 million for the year ended December 31, 2016. The$0.2 million decrease was due to the completion of work, as of March 31, 2016, related to a $1.2 million grant entered into with the Bill & Melinda GatesFoundation (the "Gates Foundation") in September 2014. Research and development expensesResearch and development ("R&D") expenses increased approximately $4.6 million to $39.2 million for the year ended December 31, 2017 from$34.6 million for the same period ended December 31, 2016. Higher research and development spending was due largely to increases in externalmanufacturing related costs (approximately $4.5 million), compensation, consulting and professional services (approximately $2.2 million), depreciation andfacility costs (approximately $0.5 million), offset by decreased clinical and lab related costs (approximately $2.6 million).On a program basis, GEN-003 costs increased $1.9 million in the year ended December 31, 2017, driven by increased external manufacturing relatedexpenses (approximately $1.7 million) to support the Phase 3 clinical drug supply and increased headcount and consulting and professional service costs(approximately $2.6 million) in advance of the previously planned Phase 3 clinical trials. Increases were offset by decreased clinical and lab related costs(approximately $2.4 million). Spending increases on GEN-009 and other immuno-oncology programs (approximately $9.5 million) were driven primarily byincreased headcount and consulting and professional service costs (approximately $5.0 million), manufacturing related costs (approximately $2.9 million),depreciation and facility related (approximately $0.3 million) and clinical and lab related (approximately $1.2 million) in anticipation of an IND filing in thefirst quarter of 2018. Increased spending on these programs was offset by lower costs on deprioritized infectious disease programs.General and administrative expenses General and administrative expense decreased $2.0 million to $13.4 million for the year ended December 31, 2017 from $15.4 million for the yearended December 31, 2016. Decreases in depreciation (approximately $0.6 million), office and facility related costs (approximately $0.5 million) andconsulting and professional services (approximately $1.0 million) were offset by increased compensation related costs (approximately $0.1 million).Refund of research and development costsIn February 2016, we recorded a gain upon receipt of 1.6 million, including accrued interest, pursuant to contractual obligations under the NovavaxAgreement to refund research and development expenses paid to Novavax between 2009 and 2011.Restructuring costsOn September 25, 2017, the Company announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancervaccines, including GEN-009. Consequently, substantially all GEN-003 spending and activities were ceased and the Company reduced its workforce byapproximately 40 percent. We incurred a charge of approximately $1.1 million for employee severance, benefits and related costs in the third quarter of 2017,of which the majority was paid by December 31, 2017. In addition, we incurred approximately $0.5 million of expense due to contract termination clausesthat we anticipate will result in future cash payments and approximately $1.0 million in non-cash asset impairment charges.Interest Income Interest income decreased $0.2 million for the year ended December 31, 2017 as compared to the year ended December 31, 2016 as a result of lowerinvested balances due to working capital needs to fund operations.Interest ExpenseInterest expense was consistent between the years ended December 31, 2017 and 2016. Interest expense consists of interest expense on our long-termdebt facilities and non-cash interest related to the amortization of debt discount and issuance costs.Comparison of the Years Ended December 31, 2016 and December 31, 201558 Years Ended December 31, Increase(in thousands) 2016 2015 (Decrease)Grant revenue $235 $670 $(435) Operating expenses: Research and development 34,645 28,049 6,596General and administrative 15,427 13,987 1,440Refund of research and development expense (1,592) — 1,592Total operating expenses 48,480 42,036 6,444Loss from operations (48,245) (41,366) 6,879Other income and expenses: Interest income 410 163 247Interest expense (1,738) (1,280) 458Total other income and expense (1,328) (1,117) 211Net loss $(49,573) $(42,483) 7,090Grant revenueGrant revenue decreased by $0.4 million for the year ended December 31, 2016 to $0.2 million from $0.7 million for the year ended December 31,2015. We entered into a $1.2 million grant with the Gates Foundation in September 2014. Grant revenue was earned on activities that occurred throughoutthe twelve-month period in 2015 and were largely completed in the first quarter of 2016.Research and development expensesR&D expenses increased approximately $6.6 million to $34.6 million for the year ended December 31, 2016 from $28.0 million for the same periodended December 31, 2015. Increases in compensation, consulting and professional services (approximately $5.0 million), lab-related costs (approximately$1.4 million), facility costs (approximately $0.9 million), and depreciation expense (approximately $0.4 million), were offset by decreases in manufacturingcosts (approximately $0.8 million) and clinical costs (approximately $0.4 million). The remaining increases, all insignificant by spending category, areattributable to the overall growth of the research and development function.On a program basis, GEN-003 costs increased $4.1 million in the year ended December 31, 2016, driven by increased headcount related costs of $2.1million and higher clinical, consulting and professional service costs of $2.0 million due to the timing of activities in support of our clinical trials. GEN-004clinical costs decreased by $2.6 million following the completion of a clinical trial in November 2015 and the decision to pause further development of thisproduct candidate. Costs to advance our pre-clinical product candidates and develop our ATLAS platform for immuno-oncology increased by $5.1 million,driven by higher headcount and lab-related costs. Development on infectious disease research programs, all of which were paused in November 2016,increased by $2.0 million, and an increase of $3.1 million in spending in our immuno-oncology program.General and administrative expensesGeneral and administrative expense increased $1.4 million to $15.4 million for the year ended December 31, 2016 from $14.0 million for the yearended December 31, 2015. The increase was due largely to market research costs of $0.9 million and higher depreciation costs from facility expansion of $0.5million.Refund of research and development costsIn February 2016, we recorded a gain upon receipt of $1.6 million, including accrued interest, pursuant to contractual obligations under theNovavax Agreement to refund research and development expenses paid to Novavax between 2009 and 2011.Interest Income Interest income increased $0.2 million for the year ended December 31, 2016 due to both higher levels of investing activity (full year of investingexcess cash compared to beginning to invest in September 2015 in the prior year) and a higher interest rate environment.59Interest ExpenseInterest expense increased $0.5 million for the year ended December 31, 2016. The increase was due primarily to the $5.0 million increase inprincipal borrowings under our 2014 Term Loan as a result of the First Amendment entered into in the fourth quarter of 2015.Liquidity and Capital ResourcesOverviewAs of December 31, 2017, we had an accumulated deficit of approximately $264.2 million. We had cash and cash equivalents of $12.3 million atDecember 31, 2017.Since our inception through December 31, 2017, we have received an aggregate of $279.8 million in gross proceeds from the issuance of equitysecurities and gross proceeds from debt facilities and an aggregate of $7.9 million from grants.In February 2014, we completed an IPO of 5.5 million shares of our common stock at a price of $12.00 per share for an aggregate offering price of$66.0 million. We received net proceeds from the offering of approximately $61.4 million, after deducting approximately $4.6 million in underwritingdiscounts and commission, excluding offering costs payable by us. In March 2015, we completed an underwritten public offering of 6.3 million shares of our common stock at a public offering price of $8.25 per sharefor an aggregate offering price of $51.7 million. In August 2015, we completed another underwritten public offering of 3.9 million shares of our commonstock at a public offering price of $13.00 per share for an aggregate offering price of $50.1 million. We received net proceeds from these offerings ofapproximately $95.7 million, after deducting approximately $6.1 million in underwriting discounts and commissions, excluding offering costs payable byus.In January 2018, we completed the Concurrent Offerings in which we sold (i) 53.4 million shares of our common stock and accompanying warrantsto purchase up to 26.7 million shares of our common stock for aggregate gross proceeds of approximately $53.4 million and (ii) 1,635 shares of our Series Aconvertible preferred stock, which are convertible into 1.6 million shares of our common stock and accompanying warrants to purchase up to 0.8 millionshares of our common stock for aggregate gross proceeds of approximately $1.6 million. We expect that our existing cash and cash equivalents, together withthe proceeds from the Concurrent Offerings, are sufficient to support our operating expenses and capital expenditure requirements into the second half of2019, without assuming the expected benefit of the restructuring or refinancing of our debt facility.Debt FinancingsOn November 20, 2014 (the "Closing Date"), we entered into a loan and security agreement (the “Loan Agreement”) with Hercules TechnologyGrowth Capital, Inc. (“Hercules”) which provided up to $27.0 million in debt financing in three separate tranches (“2014 Term Loan”). The first tranche of$17.0 million was available through June 30, 2015, of which $12.0 million was drawn down at loan inception for which approximately $9.8 million of theproceeds were used to repay the previously existing $10.0 million loan agreement (the "2013 Term Loan"). We recorded a $435 thousand loss onextinguishment of debt in other expense on the Statements of Operations related to deferred debt charges, the unamortized portion of the original issuediscount related to the 2013 Term Loan and other fees associated with extinguishing the debt. The option to draw down the remaining $5.0 million under thefirst tranche expired unused on June 30, 2015. The second tranche of $5.0 million was subject to certain eligibility requirements which were achieved as ofJune 30, 2015 and we had the option to draw down the second tranche on or prior to December 15, 2015. The second tranche expired unused on December15, 2015. The third tranche of $5.0 million was not eligible to draw as we did not achieve positive results from its Phase 2a human challenge study of GEN-004.In December 2015, we entered into an amendment to the Loan Agreement (the "First Amendment") with Hercules. The First Amendment required usto draw an additional $5.0 million and permits us to draw two additional $5.0 million tranches. One $5.0 million tranche was immediately available to drawthrough December 15, 2016 and a second $5.0 million tranche would become available through December 15, 2016, subject to us demonstrating sufficientevidence of continued clinical progression of our GEN-003 product and making favorable progress in applying our proprietary technology platform towardthe development of novel immunotherapies with application in oncology. Both tranches expired unused at December 31, 2016, and $14.3 million wasoutstanding under the amended 2014 Term Loan at December 31, 2017.60The 2014 Term Loan had an original maturity of July 1, 2018. The eligibility requirements for the second tranche also contained an election for usto extend the maturity date to January 1, 2019. During the second quarter of 2015, we elected to extend the maturity date of the 2014 Term Loan. Thematurity date of January 1, 2019 remained unchanged by the First Amendment.In January 2018, we entered into an amendment to the Loan Agreement (the "Second Amendment") with Hercules. The Second Amendmentprovides for a deferred payment period of our outstanding principal balance for the three consecutive months commencing on February 1, 2018 through andincluding April 1, 2018. During the deferred payment period, we will continue to make monthly payments of interest. See Note 6 within the notes to ourconsolidated financial statements appearing elsewhere in this Annual Report on Form 10-K for future principal payments, including the end of term charge of4.95%, on the 2014 Term Loan. We have initiated a process to restructure or refinance the debt facility with Hercules to better align repayment of the debtwith our new corporate strategy and anticipated clinical milestones. If this process is successful, we expect to be able to defer certain debt principal payments,thereby reducing expected significant cash payments in 2018 and 2019 relating to our current debt facility with Hercules.Each advance accrues interest at a floating rate per annum equal to the greater of (i) 7.25% or (ii) the sum of 7.25% plus the prime rate minus 5.0%.The 2014 Term Loan provided for interest-only payments until December 31, 2015, which was extended by us for a six-month period as the eligibilityrequirements for the second tranche were met during the second quarter of 2015. The First Amendment subsequently extended the interest only periodthrough June 30, 2017. Thereafter, beginning July 1, 2017, principal and interest payments will be made monthly for 18 months with a payoff schedule basedupon a 30-month amortization schedule, the original amortization term of the 2014 Term Loan. The remaining unpaid principal is due on January 1, 2019.The 2014 Term Loan may be prepaid in whole or in part upon seven business days’ prior written notice to Hercules. Prepayments will be subject toa charge of 3.0% if an advance is prepaid within 12 months following the Closing Date, 2.0%, if an advance is prepaid between 12 and 24 months followingthe Closing Date, and 1.0% thereafter. Amounts outstanding at the time of an event of default shall be payable on demand and shall accrue interest at anadditional rate of 5.0% per annum on any outstanding amounts past due. We also are obligated to pay Hercules an end of term charge of 4.95% of the balancedrawn when the advances are repaid.Events of default under the Loan Agreement include failure to make any payments of principal or interest as due on any outstanding indebtedness,breach of any covenant, any false or misleading representations or warranties, insolvency or bankruptcy, any attachment or judgment on the Company’sassets of at least $100 thousand, or the occurrence of any material default of the Company involving indebtedness in excess of $100 thousand.In connection with the 2014 Term Loan, we issued a common stock warrant to Hercules on November 20, 2014. The warrant is exercisable for73,725 shares of our common stock.Operating Capital RequirementsOur primary uses of capital are for compensation and related expenses, manufacturing costs for pre-clinical and clinical materials, third party clinicaltrial R&D services, laboratory and related supplies, clinical costs, legal and other regulatory expenses, and general overhead costs. We expect these costs willcontinue to be the primary operating capital requirements for the near future.We expect that our existing cash and cash equivalents, together with the proceeds from the Concurrent Offerings, are sufficient to support ouroperating expenses and capital expenditure requirements into the second half of 2019, without assuming the expected benefit of the restructuring orrefinancing of our debt facility. We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we mayuse all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development andcommercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future fundingrequirements will depend on many factors, including, but not limited to:•the timing and costs of our planned clinical trials for GEN-009;•the progress, timing and costs of manufacturing GEN-009 for planned clinical trials;•the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our other product candidates and potential productcandidates;61•the outcome, timing and costs of seeking regulatory approvals;•the costs of commercialization activities for GEN-009 and other product candidates if we receive marketing approval, including the costs andtiming 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 patentprosecution 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 defendingagainst intellectual property related claims; and•the extent to which we in-license or acquire other products and technologies.We will need to obtain substantial additional funding in order to complete clinical trials for GEN-009 and our other product candidates in order toreceive regulatory approval. To the extent that we raise additional capital through the sale of our common stock, convertible securities or other equitysecurities, the ownership interests of our existing stockholders may be materially diluted and the terms of these securities could include liquidation or otherpreferences that could adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased fixedpayment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additionaldebt, making capital expenditures or declaring dividends, that could adversely affect our ability to conduct our business. If we are unable to raise capitalwhen needed or on attractive terms, we could be forced to significantly delay, scale back or discontinue the development of GEN-009 or our other productcandidates, seek collaborators at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, andrelinquish or license, potentially on unfavorable terms, our rights to GEN-003, GEN-009 or our other product candidates that we otherwise would seek todevelop or commercialize ourselves.Cash FlowsThe following table summarizes our sources and uses of cash for the years ended December 31, 2017 and 2016 (in thousands): Years ended December 31, 2017 2016Net cash used in operating activities $(47,599) $(41,835)Net cash provided by investing activities 34,909 50,711Net cash (used in) provided by financing activities (2,461) 1,289Net (decrease) increase in cash and cash equivalents $(15,151) $10,165Operating ActivitiesNet cash used in operations increased $5.8 million to $47.6 million for the year ended December 31, 2017 from $41.8 million for the year endedDecember 31, 2016. The increase was due primarily to a higher net loss of approximately $7.1 million which was offset by an asset impairment charge ofapproximately $1.0 million.Investing ActivitiesNet cash provided by investing activities decreased $15.8 million to $34.9 million for the year ended December 31, 2017 compared to $50.7 millionof cash used in investing activities for the year ended December 31, 2016. The decrease was primarily due to a decrease in net proceeds from investmentpurchases, maturities and sales of $17.3 million and a decrease in cash used to purchase property and equipment of $1.4 million.62Financing ActivitiesNet cash (used in) provided by financing activities decreased $3.8 million to $(2.5) million for the year ended December 31, 2017 from $1.3 millionfor the year ended December 31, 2016. The decrease was due largely to $3.1 million payments on our long-term debt in 2017.The following table summarizes our sources and uses of cash for the years ended December 31, 2016 and 2015 (in thousands): Years Ended December 31, 2016 2015Net cash used in operating activities $(41,835) $(38,360)Net cash provided by (used in) investing activities 50,711 (64,937)Net cash provided by financing activities 1,289 100,498Net increase (decrease) in cash and cash equivalents $10,165 $(2,799)Operating ActivitiesNet cash used in operations increased $3.4 million to $41.8 million for the year ended December 31, 2016 from $38.4 million for the year endedDecember 31, 2015. The increase was due primarily to a higher net loss of approximately $7.1 million, offset by increases in depreciation and amortization of$0.8 million, accounts payable and accrued expenses of $1.9 million, stock based compensation of $0.3 million, and a decrease in deferred revenue of $0.4million. The remaining $0.3 million relates to changes in other working capital accounts.Investing ActivitiesNet cash provided by (used in) investing activities increased $115.6 million to $50.7 million for the year ended December 31, 2016 compared to$64.9 million of cash used in investing activities for the year ended December 31, 2015. The increase was primarily due to net proceeds from investmentmaturities and sales of $53.2 million in 2016 compared to net investments made of $62.2 million in 2015.Financing ActivitiesNet cash provided by financing activities decreased $99.2 million to $1.3 million for the year ended December 31, 2016 from $100.5 million for theyear ended December 31, 2015. The decrease was due largely to a reduction of $94.4 million in net proceeds from public offerings due to two follow-onofferings completed in 2015. In addition, there were no proceeds from debt financing in 2016 compared to $4.7 million of additional borrowing proceedsrelated to the First Amendment of our 2014 Term Loan in 2015.Off-Balance Sheet ArrangementsWe do not have any off-balance sheet arrangements.Net Operating Loss CarryforwardsAt December 31, 2017, we had United States federal and state net operating loss carryforwards of approximately $160.6 million and $145.1 million,respectively, which may be available to offset future income tax liabilities and expire at various dates through 2037. At December 31, 2017, we had federaland state R&D tax credit carryforwards of approximately $6.1 million and $2.9 million available, respectively, to reduce future tax liabilities which expire atvarious dates through 2037. Net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Serviceand state tax authorities and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significantstockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the United States Internal Revenue Code of 1986, asamended, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or taxliabilities. The amount of the annual limitation is determined based on the value of our company immediately prior to the ownership change. Subsequentownership changes may further affect the limitation in future years. At December 31, 2017, we recorded a 100% valuation allowance against our netoperating loss and R&D tax credit carryforwards, as we believe it is more likely than not that the tax benefits63will not be fully realized. In the future, if we determine that a portion or all of the tax benefits associated with our tax carryforwards will be realized, netincome would increase in the period of determination.Contractual ObligationsThe following table summarizes our outstanding contractual obligations as of payment due date by period at December 31, 2017 (in thousands): Total Less Than 1 Year 1 - 3 Years 3 - 5 Years More than 5 YearsLong-term debt(1) $14,693 $6,659 $8,034 $— $—Operating leases 3,518 1,607 1,911 — — $18,211 $8,266 $9,945 $— $—_________________________(1)As of December 31, 2017, we had a total of $14.3 million in long-term debt due consisting of amounts due under the 2014 Term Loan. Weare obligated to pay an end of term charge of 4.95% of the balance drawn when the principal balance is repaid. We have included $0.8million in this table for the end of term charge based upon the debt outstanding at December 31, 2017. In January 2018, we entered into anamendment to the 2014 Term Loan. The amendment provides for a deferred payment period of our outstanding principal balance for thethree consecutive months commencing on February 1, 2018 through and including April 1, 2018. During the deferred payment period wewill continue to make monthly payments of interest.In February 2014, we entered into a supply agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (“Fujifilm”) for the manufacture andsupply of antigens for future GEN-003 clinical trials. Under the agreement, we were obligated to pay Fujifilm manufacturing milestones, in addition toreimbursement of certain material production related costs. Additionally, we were responsible for the partial payment of manufacturing fees to reservemanufacturing slots in the production timeframe. In June and September 2016, we entered into new statements of work under the agreement with Fujifilm forthe manufacture and supply of antigens for our Phase 3 clinical trials for GEN-003. In September 2017, we notified Fujifilm to cease all manufacturingactivities of antigens for GEN-003. Amounts recorded as of December 31, 2017 represent all liabilities for manufacturing services complete or in process priorto the notification date, materials purchased which cannot be re-used or re-purposed by Fujifilm and charges for terminating services within a certain timeframe of the anticipated start dates.We incurred expenses under this agreement of $3.6 million for the year ended December 31, 2017, of which $526 thousand are included inRestructuring costs in the Consolidated Statements of Operations and Comprehensive Loss. We incurred expenses under this agreement of $4.7 million and4.2 million for the years ended December 31, 2016 and 2015, respectively.In January 2018, we entered into a License and Supply Agreement with Oncovir, Inc. (“Oncovir”). The Agreement relates to the manufacture andsupply of Hiltonol® (poly-ICLC) (“Hiltonol”), an immunomodulator and vaccine adjuvant. Hiltonol is the adjuvant component of GEN-009, the Company’sinvestigational personal neoantigen cancer vaccine. Under this Agreement, the Company is obligated to pay Oncovir (i) an up-front payment in the mid-sixfigures in consideration of the license granted to Genocea and for the initial supply of Hiltonol for the planned GEN-009 Phase 1/2 trial, (ii) a supply price forHiltonol in the low-three figures per vial of Hiltonol for use in clinical trials or commercial use, (iii) a milestone payment in the low-six figures upon theachievement of certain clinical trial milestones for each Combination Product, (iv) a milestone payment in the mid-six figures upon the first marketingapproval of commercial sales for each Combination Product in certain territories, and (v) tiered royalties in the low-single digits on a product-by-productbasis based on the net sales of Combination Products. The Company may terminate the Agreement upon a decision to discontinue the development of theCombination Product or upon a determination by the Company or an applicable regulatory authority that Hiltonol or Combination Product is not clinicallysafe or effective. The Agreement may also be terminated by either party due to a material uncured breach by the other party, or due to the other party’sbankruptcy, insolvency or dissolution.We also have obligations to make future payments to third party licensors that become due and payable on the achievement of certain development,regulatory and commercial milestones. We have not included these commitments on our balance sheet or in the table above because the achievement andtiming of these milestones is not fixed or determinable. These additional contractual commitments include the following:64License Agreement with The Regents of the University of California. Under our license agreement with The Regents of the University of California("UC"), in respect of UC patent rights covering aspects of our ATLAS discovery platform, we agreed to pay UC low single digit royalties on net sales by us ofvaccine products comprising antigens identified through use of the ATLAS discovery platform covered by licensed UC patent rights. If we sublicense UCpatent rights, we will owe UC a percentage of sublicensing revenue, including any royalty paid to us on net sales by sublicensees.License Agreement with Harvard. Under our license agreement with President and Fellows of Harvard College ("Harvard"), in respect of Harvardpatent rights covering certain chlamydia antigens, we agreed to pay Harvard royalties in the high single-digits on worldwide net sales by us or oursublicensees of vaccine products comprising such chlamydia antigens. In addition, we are required to pay Harvard specified milestone payments fordevelopment of the first such chlamydia vaccine. Under the same license agreement, in respect of patent rights covering aspects of our antigen discoveryplatform, we agreed to pay Harvard royalties in the low single-digits on worldwide net sales by us or our sublicensees, for a period of 10 years from firstcommercial sale, of vaccine products comprising antigens (other than chlamydia antigens above) identified through use of the antigen discovery platformcovered by licensed Harvard patent rights. In addition, we are required to pay Harvard specified milestone payments for development of such vaccines. We donot expect to make milestone payments in 2018 under this agreement. If we sublicense Harvard patent rights, we will owe Harvard a percentage ofsublicensing revenue, excluding payments we receive based on the level of sales or profits. We notified Harvard of our partial termination of the licenseagreement with regard to the chlamydia antigens on December 8, 2014. Effective March 8, 2015, the license agreement with Harvard with regard to thechlamydia antigens was terminated and we no longer hold a license to two of the three in-licensed Harvard patent families, or to a chlamydia antigen coveredby the remaining family. The remaining family covers certain aspects of the ATLAS platform, as well as one chlamydia antigen, and we continue to maintainexclusive rights to aspects of the ATLAS platform covered by this family.License Agreement with Novavax. Under our license agreement with Isconova AB, now Novavax, Inc., in respect of Novavax patent rights andtrademarks covering adjuvant Matrix-M, we agreed to pay Novavax tranched royalties in the low single-digits on worldwide net sales by us or oursublicensees of vaccine products comprising our antigens and Matrix-M. In addition, we are required to pay Novavax specified milestone payments fordevelopment and commercialization of the first vaccine in each unique disease field. If we sublicense Novavax patent rights, we will owe Novavax apercentage of the initial signing or upfront sublicensing fees we receive.We also enter into contracts in the normal course of business with CROs for clinical trials and clinical supply manufacturing and with vendors forpreclinical safety and research studies, research supplies and other services and products for operating purposes. These contracts generally provide fortermination on notice and do not include any minimum purchase commitments, and therefore are cancelable contracts and not included in the table above.JOBS ActIn April 2012, the JOBS Act was enacted in the United States. Section 107 of the JOBS Act provides that an “emerging growth company” can takeadvantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to privatecompanies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accountingstandards on the relevant dates on which adoption of such standards is required for non-emerging growth public companies.Item 7A. Qualitative and Quantitative Disclosures About Market RiskWe are exposed to market risk related to changes in interest rates. As of December 31, 2017 and 2016, we had cash, cash equivalents and investmentsof $12.3 million and $63.4 million, respectively, consisting primarily of money market funds, U.S Treasury securities, and FDIC insured certificates ofdeposits. The investments in these financial instruments are made in accordance with an investment policy approved by our board of directors, whichspecifies the categories, allocations and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserveprincipal while at the same time maximizing the income we receive without significantly increasing risk. Some of the financial instruments in which weinvest could be subject to market risk. This means that a change in prevailing interest rates may cause the value of the instruments to fluctuate. For example,if we purchase a security that was issued with a fixed interest rate and the prevailing interest rate later rises, the value of that security will probably decline.To minimize this risk, we intend to maintain a portfolio that may include cash, cash equivalents and investment securities available-for-sale in a variety ofsecurities, which may include money market funds, government and non-government debt securities and commercial paper, all65with various maturity dates. Based on our current investment portfolio, we do not believe that our results of operations or our financial position would bematerially affected by an immediate change of 10% in interest rates. We do not hold or issue derivatives, derivative commodity instruments or other financial instruments for speculative trading purposes. Further, wedo not believe our cash equivalents and investment securities have significant risk of default or illiquidity. We made this determination based on discussionswith our investment advisors and a review of our holdings. Although we believe our cash equivalents and investment securities do not contain excessive risk,we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. All of our investments arerecorded at fair value. We are also exposed to market risk related to change in foreign currency exchange rates. We contract with certain vendors that are located in Europewhich have contracts denominated in foreign currencies. We are subject to fluctuations in foreign currency rates in connection with these agreements. We donot currently hedge our foreign exchange rate risk. As of December 31, 2017 and December 31, 2016, we had minimal liabilities denominated in foreigncurrencies.Item 8. Financial Statements and Supplementary DataOur financial statements, together with the report of our independent registered public accounting firm, appear beginning on page F-1 of this AnnualReport on Form 10-K.Item 9. Changes in and Disagreements with Accountants and Accounting and Financial DisclosureNot applicable.Item 9A. Controls and ProceduresEvaluation of Disclosure Controls and ProceduresWe maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file orsubmit under the Securities and Exchange Act of 1934 (the "Exchange Act") is (1) recorded, processed, summarized, and reported within the time periodsspecified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principalfinancial officer, to allow timely decisions regarding required disclosure.Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of ourdisclosure controls and procedures as of December 31, 2017 (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our managementrecognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives,and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executiveofficer and principal financial officer have concluded based upon the evaluation described above that, as of December 31, 2017, our disclosure controls andprocedures were effective at the reasonable assurance level.Management’s Annual Report on Internal Controls Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control overfinancial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as the process designed by, or under the supervision of, our ChiefExecutive Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of ourfinancial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles("GAAP"), and includes those policies and procedures that:(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 withGAAP, and that receipts and expenditures are being made only in accordance with the authorizations of management and directors; and66(3)provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets thatcould have a material effect on our financial statements.Under the supervision and with the participation of our management, including our Chief Executive Officer, we conducted an evaluation of theeffectiveness of our internal control over financial reporting based on the framework provided in Internal Control - Integrated Framework (2013) issued bythe Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, our management concluded that our internalcontrol over financial reporting was effective as of December 31, 2017.Changes in Internal Control Over Financial ReportingDuring the quarter ended December 31, 2017, there have been no changes in our internal control over financial reporting, as such term is defined inRules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internalcontrol over financial reporting.Item 9B. Other InformationNone.67PART IIIItem 10. Directors, Executive Officers and Corporate GovernanceOther than the information regarding our executive officers provided in Part I of this report under the heading“Business—Executive Officers of the Registrant,” the information required to be furnished pursuant to this item isincorporated herein by reference to our definitive proxy statement for the 2018 Annual Meeting of the Stockholders.Item 11. Executive and Director CompensationThe information required by this Item 11 is incorporated herein by reference from our definitive proxy statementfor the 2018 Annual Meeting of Stockholders.Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersThe information required by this Item 12 is incorporated herein by reference from our definitive proxy statementfor the 2018 Annual Meeting of Stockholders.Item 13. Certain Relationships and Related Party Transactions and Director IndependenceThe information required by this Item 13 is incorporated herein by reference from our definitive proxy statementfor the 2018 Annual Meeting of Stockholders.Item 14. Principal Accountant Fees and ServicesThe information required by this Item 14 is incorporated herein by reference from our definitive proxy statementfor the 2018 Annual Meeting of Stockholders.68PART IVItem 15. Exhibits and Financial Statement SchedulesFinancial StatementsThe following financial statements and supplementary data are filed as a part of this Annual Report on Form 10-K.Report of Independent Registered Public Accounting FirmConsolidated Balance Sheets as of December 31, 2017 and 2016Consolidated Statements of Operations and Comprehensive Loss for each of the three years in the period ended December 31, 2017Consolidated Statements of Stockholders’ Equity (Deficit) for each of the three years in the period ended December 31, 2017Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2017Notes to Consolidated Financial StatementsItem 16. Form 10-K SummaryNone.Financial Statement SchedulesAll financial statement schedules are omitted because they are not applicable or the required information is included in the financial statements ornotes thereto.ExhibitsThose exhibits required to be filed by Item 601 of Regulation S-K are listed in the Exhibit Index immediately preceding the exhibits hereto and suchlisting is incorporated herein by reference.69Genocea Biosciences, Inc.Index to Financial Statements PagesReport of Independent Registered Public Accounting FirmF-2Consolidated Balance Sheets as of December 31, 2017 and 2016F-3Consolidated Statements of Operations and Comprehensive Loss for each of the three years in the period ended December 31, 2017F-4Consolidated Statements of Stockholders’ Equity (Deficit) for each of the three years in the period ended December 31, 2017F-5Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2017F-6Notes to Consolidated Financial StatementsF-7F-1Report of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders ofGenocea Biosciences, Inc.Opinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Genocea Biosciences, Inc. (the Company) as of December 31, 2017 and 2016, the relatedconsolidated statements of operations and comprehensive loss, shareholders’ equity (deficit) and cash flows for each of the three years in the period endedDecember 31, 2017, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in allmaterial respects, the consolidated financial position of the Company at December 31, 2017 and 2016, and the consolidated results of its operations and itscash flows for each of the three years in the period ended December 31, 2017, in conformity with U.S. generally accepted accounting principles.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financialstatements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB)and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations ofthe Securities and Exchange Commission and PCAOB.We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonableassurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, norwere we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding ofinternal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control overfinancial reporting.Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements,whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regardingthe amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates madeby management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for ouropinion./s/ Ernst & Young LLPWe have served as the Company’s auditor since 2009Boston, MassachusettsFebruary 16, 2018F-2Genocea Biosciences, Inc.Consolidated Balance Sheets(In thousands, except per share data) December 31, 2017 December 31, 2016Assets Current assets: Cash and cash equivalents$12,273 $27,424Investments, current portion— 35,938Prepaid expenses and other current assets808 926Total current assets13,081 64,288Property and equipment, net3,460 4,871Restricted cash316 316Other non-current assets631 421Total assets$17,488 $69,896 Liabilities and stockholders’ equity Current liabilities: Accounts payable$3,516 $3,043Accrued expenses and other current liabilities5,604 4,178Current portion of long-term debt6,659 3,149Total current liabilities15,779 10,370Non-current liabilities: Long-term debt7,652 13,809Other non-current liabilities107 176Total liabilities23,538 24,355Commitments and contingencies (Note 8) Stockholders’ equity: Common stock, $0.001 par value;29 28Authorized – 175,000 shares; Issued – 28,735 and 28,446 shares at December 31, 2017 and December 31, 2016, respectively;outstanding – 28,735 and 28,445 at December 31, 2017 and December 31, 2016, respectively Additional paid-in-capital258,114 252,996Accumulated deficit(264,193) (207,483)Total stockholders’ equity (deficit)(6,050) 45,541Total liabilities and stockholders’ equity$17,488 $69,896See accompanying notes to consolidated financial statements.F-3Genocea Biosciences, Inc.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except per share data) Years Ended December 31, 2017 2016 2015Grant revenue$— $235 $670 Operating expenses: Research and development39,204 34,645 28,049General and administrative13,433 15,427 13,987Restructuring costs2,618 — —Refund of research and development expense— (1,592) —Total operating expenses55,255 48,480 42,036Loss from operations(55,255) (48,245) (41,366)Other income and expense: Interest income250 410 163Interest expense(1,705) (1,738) (1,280)Total other income and expense(1,455) (1,328) (1,117)Net loss(56,710) (49,573) (42,483)Other comprehensive loss: Unrealized loss on available-for-sale securities— — (7)Comprehensive loss$(56,710) $(49,573) $(42,490)Net loss per share - basic and diluted$(1.98) $(1.75) $(1.74)Weighted-average number of common shares used in computing net loss per share - basic and diluted28,603 28,299 24,460See accompanying notes to consolidated financial statements.F-4Genocea Biosciences, Inc.Consolidated Statements of Stockholders’ Equity (Deficit)(In thousands) Total Additional Other Stockholders’ Common Shares Paid-In Comprehensive Accumulated Equity Shares Amount Capital Loss Deficit (Deficit)Balance at December 31, 201417,852 $18 $147,923 $(7) $(115,427) $32,507Issuance of common stock upon secondary publicoffering, net of issuance costs of $50910,123 10 95,173 — — 95,183Issuance of common Stock; ESPP purchase41 — 213 — — 213Exercise of stock options128 — 383 — — 383Vesting of restricted stock8 — 10 — — 10Stock-based compensation expense— — 3,848 — — 3,848Net loss— — — — (42,483) (42,483)Balance at December 31, 201528,152 28 247,550 (7) (157,910) 89,661Issuance of common stock, net of issuance costs of $3136 — 815 — — 815Issuance of common Stock; ESPP purchase71 — 247 — — 247Exercise of stock options79 — 227 — — 227Vesting of restricted stock7 — 10 — — 10Stock-based compensation expense— — 4,147 — — 4,147Unrealized gain on marketable securities— — — 7 — 7Net loss— — — — (49,573) (49,573)Balance at December 31, 201628,445 28 252,996 — (207,483) 45,541Issuance of common stock, net of issuance costs of $152 1 245 — — 246Issuance of common stock; ESPP purchase73 — 180 — — 180Exercise of stock options163 — 459 — — 459Vesting of restricted stock2 — — — — —Stock-based compensation expense— — 4,234 — — 4,234Net loss— — — — (56,710) (56,710)Balance at December 31, 201728,735 $29 $258,114 $— $(264,193) $(6,050)See accompanying notes to consolidated financial statements.F-5Genocea Biosciences, Inc.Consolidated Statements of Cash Flows(In thousands) Years Ended December 31, 2017 2016 2015Operating activities Net loss$(56,710) $(49,573) $(42,483)Adjustments to reconcile net loss to net cash used in operating activities Depreciation and amortization1,516 1,813 1,051Stock-based compensation4,234 4,147 3,848Non-cash interest expense502 481 369Asset impairment1,028 — —Gain on sale of equipment(22) — —Changes in operating assets and liabilities: Prepaid expenses and other current assets12 (37) 266Other long-term assets(14) 25 (399)Accounts payable491 1,190 (1,431)Deferred revenue— (235) (670)Accrued expenses and other liabilities1,364 354 1,089Net cash used in operating activities(47,599) (41,835) (38,360)Investing activities Purchases of property and equipment(1,178) (2,538) (2,784)Proceeds from sale of equipment150 — —Proceeds from maturities of investments36,090 79,313 27,498Purchases of investments(153) (26,064) (89,651)Net cash provided by (used in) investing activities34,909 50,711 (64,937)Financing activities Proceeds from underwritten public offering, net of issuance costs246 815 95,183Deferred financing costs from 2018 underwritten public offering(197) — —Proceeds from issuance of long-term debt, net of issuance costs— — 4,719Repayment of long-term debt(3,149) — —Proceeds from issuance of common stock under ESPP180 247 213Proceeds from exercise of stock options459 227 383Net cash (used in) provided by financing activities(2,461) 1,289 100,498Net (decrease) increase in cash and cash equivalents$(15,151) $10,165 $(2,799)Cash and cash equivalents at beginning of period27,424 17,259 20,058Cash and cash equivalents at end of period$12,273 $27,424 $17,259Supplemental cash flow information Cash paid for interest$1,189 $1,255 $897Supplemental disclosure of non-cash investing and financing activities Property and equipment, net included in accounts payable and accrued expenses$— $63 $394See accompanying notes to consolidated financial statements.F-6Genocea Biosciences, Inc.Notes to Consolidated Financial Statements1. Organization and operationsThe CompanyGenocea Biosciences, Inc. (the “Company”) is a biopharmaceutical company that was incorporated in Delaware on August 16, 2006 and has aprincipal place of business in Cambridge, Massachusetts. The Company seeks to discover and develop novel cancer vaccines through its AnTigen LeadAcquisition System ("ATLAS"TM) proprietary discovery platform. The ATLAS platform is designed to recall a patient's pre-existing CD4+ and CD8+ T cellimmune responses to their tumor to identify neoantigens and antigens for inclusion in vaccines that are designed to act through T cell (or cellular) immuneresponses. The Company believes that using ATLAS to identify neoantigens and antigens for inclusion in cancer vaccines could lead to more immunogenicand efficacious cancer vaccines.In September 2017, the Company announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines.Currently, all of the Company’s research programs and product candidates in active development are at the preclinical stage. The Company's most advancedprogram in active development is its preclinical immuno-oncology program, GEN-009, a neoantigen cancer vaccine. The GEN-009 program leveragesATLAS to identify patient neoantigens, or newly formed antigens unique to each patient, that are associated with that individual's tumor. The Company isalso exploring partnering opportunities in the development of cancer vaccines targeting tumor-associated antigens and a vaccine targeting cancers caused byEpstein-Barr Virus ("EBV").The Company has one non-active Phase 3-ready product candidate, GEN-003, an investigational immunotherapy for the treatment of genital herpes.In September 2017, the Company announced it was exploring strategic alternatives for GEN-003. Consequently, substantially all GEN-003 spending andactivities were ceased and the Company reduced its workforce by approximately 40 percent.The Company is devoting substantially all of its efforts to product research and development, initial market development, and raising capital. TheCompany has not generated any product revenue related to its primary business purpose to date and is subject to a number of risks similar to those of otherpreclinical stage companies, including dependence on key individuals, competition from other companies, the need and related uncertainty associated to thedevelopment of commercially viable products, and the need to obtain adequate additional financing to fund the development of its product candidates. TheCompany is also subject to a number of risks similar to other companies in the life sciences industry, including the uncertainty of success of its preclinicaland clinical trials, regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies,the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third parties, productliability, and dependence on key individuals.As of December 31, 2017, the Company had an accumulated deficit of approximately $264.2 million. The Company had cash and cash equivalentsof $12.3 million at December 31, 2017. In January 2018, the Company sold in concurrent public offerings (the "Concurrent Offerings") (i) 53,365,000 sharesof the Company’s common stock and accompanying warrants to purchase up to 26,682,500 shares of common stock and (ii) 1,635 shares of the Company’sSeries A convertible preferred stock, which are convertible into 1,635,000 shares of common stock and accompanying warrants to purchase up to 817,500shares of common stock for net combined proceeds of approximately $51.7 million, after deducting approximately $3.3 million in underwriting discountsand commissions, excluding offering costs payable by us. The Company expects that existing cash and cash equivalents along with the proceeds from theConcurrent Offerings are sufficient to support operating expenses and capital expenditure requirements for at least the next twelve months from the date offiling this Annual Report on Form 10-K.2. Summary of significant accounting policiesPrinciples of ConsolidationThe consolidated financial statements include the accounts of Genocea Biosciences, Inc., and a wholly-owned subsidiary. All inter-companyaccounts and transactions have been eliminated.Basis of presentation and use of estimatesF-7The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States ofAmerica (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accountingprinciples as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting StandardsBoard (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect theamounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, whichinclude, but are not limited to, estimates related to prepaid and accrued research and development expenses, stock-based compensation expense, incometaxes including the valuation allowance for deferred taxes and reported amounts of revenues and expenses during the reported period. The Company bases itsestimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actualresults may differ from those estimates or assumptions.Segment informationOperating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chiefoperating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company’schief operating decision maker view the Company’s operations and manage its business in one operating segment, which is the business of developing andcommercializing cancer vaccines. The Company operates in only one geographic segment.Cash, cash equivalents and investments The Company determines the appropriate classification of its investments at the time of purchase. All liquid investments with original maturities of90 days or less from the purchase date are considered to be cash equivalents. The Company’s current and non-current investments are comprised ofcertificates of deposit and government agency securities that are classified as available-for-sale in accordance with FASB ASC Topic 320, Investments—Debtand Equity Securities. The Company classifies investments available to fund current operations as current assets on its balance sheets. Investments areclassified as non-current assets on the balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and(ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in Accumulated other comprehensive loss on theCompany’s balance sheets. Realized gains and losses are determined using the specific identification method and are included as a component of Interestincome or Interest expense, respectively. There were no realized gains or losses recognized for the years ended December 31, 2017, 2016 and 2015. The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost andevidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the investment beforerecovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, the severity and the durationof the impairment and changes in value subsequent to period end. As of December 31, 2017, there were no investments with a fair value that was significantlylower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period.Concentrations of credit risk and off-balance sheet riskFinancial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and investments.The Company’s cash, cash equivalents and investments are held in accounts with financial institutions that management believes are creditworthy. TheCompany’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that theCompany believes minimizes the exposure to concentration of credit risk. These amounts at times may exceed federally insured limits. The Company has notexperienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financialinstruments with off-balance sheet risk of loss. Deferred financing costsOffering costs related to debt and equity financing primarily consist of direct and incremental external expenses. In accordance with ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of DebtF-8Issuance Costs (“ASU 2015-03”), the Company presents debt issuance costs related to a recognized debt liability in the balance sheet as a direct deduction ofthe carrying value of the debt liability, consistent with the accounting treatment of debt discounts. The amortization of deferred debt financing costs followsthe effective interest rate method.Offering costs related to registration statements and the initiation of the ATM are recorded as an asset and are reclassified to equity on a pro-ratabasis based upon the successful selling of common shares compared to the available limits in either equity program. The costs are reviewed for impairmentand will be recorded to expense if and when the Company determines that future equity offerings are not probable of occurring. At December 31, 2017 and2016, the Company had $571 thousand and $339 thousand of deferred offering costs, respectively, recorded as an Other non-current asset.Fair value of financial instrumentsThe Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used indetermining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures (“ASC 820”), established a hierarchy of inputs used inmeasuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs beused when available. Observable inputs are inputs that market participants would use in pricing the financial instrument based on market data obtained fromsources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants woulduse in pricing the financial instrument and are developed based on the best information available in the circumstances. The fair value hierarchy applies onlyto the valuation inputs used in determining the reported or disclosed fair value of the financial instruments and is not a measure of the investment creditquality. Fair value measurements are classified and disclosed in one of the following three categories:•Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the abilityto 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 inputsare 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 measurementand unobservable.To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair valuerequires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized inLevel 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair valuemeasurement.Financial instruments measured at fair value on a recurring basis include cash equivalents and investments (Note 3).An entity may elect to measure many financial instruments and certain other items at fair value at specified election dates. Subsequent unrealizedgains and losses on items for which the fair value option has been elected will be reported in net loss. The Company did not elect to measure any additionalfinancial instruments or other items at fair value. The Company is also required to disclose the fair value of financial instruments not carried at fair value. Thefair value of the Company’s long-term debt (Note 6) is determined using current applicable rates for similar instruments as of the balance sheet dates andassessment of the credit rating of the Company. The carrying value of the Company’s long-term debt approximates fair value because the Company’s interestrate yield is near current market rates. The Company’s long-term debt is considered a Level 3 liability within the fair value hierarchy.There have been no changes to the valuation methods utilized by the Company during the three years ended December 31, 2017. The Companyevaluates transfers between levels at the end of each reporting period. There were no transfers of financial instruments between levels during the years endedDecember 31, 2017, 2016 and 2015.Derivative InstrumentsThe Company occasionally issues financial instruments in which a derivative instrument is “embedded”. Upon issuing the financial instrument, theCompany assesses whether the economic characteristics of the embedded derivative are clearly and closely related to the economic characteristics of theremaining component of the financial instrument (i.e., the host contract) and whether a separate, non-embedded instrument with the same terms as theembedded instrument would meet the definition of a derivative instrument. When it is determined that (1) the embedded derivative possesses economiccharacteristics that are not clearly and closely related to the economic characteristics of the host contract and (2) a separate,F-9stand-alone instrument with the same terms would qualify as a derivative instrument, the embedded derivative is separated from the host contract and carriedat fair value with any changes in fair value recorded in current period earnings.In connection with the issuance of the 2014 Term Loan and the First Amendment (Note 6), the Company evaluated all features of the agreementnoting none that required bifurcation under FASB ASC Topic 815, Derivatives and Hedging (“ASC 815”).Property and equipmentProperty and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of therespective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost andaccumulated depreciation is removed from the accounts and any resulting gain or loss is included in the statements of operations and comprehensive loss.Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets, which are as follows:Asset Estimated useful lifeLaboratory equipment 5Furniture and office equipment 5Computer hardware and software 3-5 yearsLeasehold improvements Shorter of the useful life or remaining lease termDevelopment of Software for Internal UseThe Company accounts for the costs of software developed or obtained for internal use in accordance with ASC 350-40, Internal-Use Software.Costs of materials, consultants, payroll, and payroll-related costs for employees incurred in developing internal-use software are capitalized as incurred.These costs are included in Property and equipment, net. Costs incurred during the preliminary project and post-implementation stages are charged toexpense. Amortization is recorded using the straight-line method over the estimated useful lives of the respective asset which is five years.Impairment of long-lived assetsThe Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assetsmay not be recoverable. Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that theassets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the bookvalue of the assets exceed their fair value. The Company recognized $1.0 million of asset impairment losses in the year ended December 31, 2017 related tothe September 2017 announcement of its strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines. The Companyhad not recognized any impairment losses for the years ended December 31, 2016 and 2015.Revenue recognitionThe Company has generated revenue solely through research and development grants with private not-for-profit organizations and federal agenciesfor the development and commercialization of product candidates.Periodically, the Company receives grants from private not-for-profit organizations and federal agencies to conduct vaccine development research.Funds received in advance of services being performed are recorded as deferred revenue. Revenue under these grants is recognized as research services areperformed.In September 2014, the Company received $1.2 million in the form of a grant entered into with the Bill & Melinda Gates Foundation for theidentification of protective T-cell antigens for malaria vaccines. The grant provided for the continued expansion of the Company’s malaria antigen library toaid in the identification of novel protein antigens to facilitate the development of highly efficacious anti-infection malarial vaccines. Activities, and therelated grant revenue, were completed under this grant by March 2016. The Company recognized revenue under the agreement of $235 thousand and $640thousand for the years ended December 31, 2016 and 2015, respectively.Research and development expensesF-10Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employeecompensation costs, facilities and overhead, clinical study and related clinical manufacturing costs, regulatory and other related costs.Nonrefundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred andcapitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.Stock-based compensation expenseThe Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718,Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options andrestricted stock, to be recognized in the statements of operations and comprehensive loss based on their grant date fair values. Compensation expense relatedto awards to employees is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which isgenerally the vesting term. Share-based payments issued to non-employees are recorded at their fair values, and are periodically revalued as the equityinstruments vest and are recognized as expense over the related service period in accordance with the provisions of ASC 718 and FASB ASC Topic 505,Equity (“ASC 505”), and are expensed using an accelerated attribution model.The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjectiveassumptions, including (a) the expected volatility of the Company’s stock price, (b) the expected term of the award, (c) the risk-free interest rate, (d) expecteddividends and (e) the estimated fair value of the Company’s common stock on the measurement date. Due to the limited operating history of the Company asa public entity and a lack of company specific historical and implied volatility data, the Company has based its estimate of expected volatility on thehistorical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stockprice volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry,and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility datausing the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. TheCompany will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomesavailable. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options usingthe “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. Theexpected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securitieswith a maturity date commensurate with the expected term of the associated award. The Company has never paid, and does not expect to pay dividends in theforeseeable future.The Company early adopted ASU 2016-09, Compensation — Stock Compensation (Topic 718), as of June 30, 2016. In connection with the earlyadoption, the Company elected an accounting policy to record forfeitures as they occur. There was no financial statement impact upon adoption as theCompany had estimated a forfeiture rate of zero given that most option awards vest on a monthly basis. ASU 2016-09 also provides that companies no longerrecord excess tax benefits or certain tax deficiencies in additional paid-in capital Instead, all excess tax benefits and tax deficiencies are recorded as incometax expense or benefit in the Company's statement of operations and comprehensive loss. There was no financial statement impact of adopting this provisionof ASU 2016-09 as the Company is in a net operating loss position and all excess tax benefits that exist from options previously exercised require a fullvaluation allowance. As such, the adoption of this standard did not have a material impact on the financial statements. For the years ended December 31,2017 and 2016, the Company did not record an income statement benefit for excess tax benefits as a valuation allowance is also required on these amounts.Income taxesIncome taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an assetand liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and thetax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences areexpected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likelythan not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize thebenefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets.F-11The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Companyrecognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefitwill more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.As of December 31, 2017 and 2016, the Company does not have any significant uncertain tax positions. The Company’s policy is to recognize interestand/or penalties related to income tax matters in income tax expense.Earnings per shareThe Company computes basic and diluted earnings (loss) per share using a methodology that gives effect to the impact of outstanding participatingsecurities (the “two-class method”). For the three years ended December 31, 2017, there is no income allocation required under the two-class method ordilution attributed to weighted average shares outstanding in the calculation of diluted loss per share.Basic earnings (loss) per share is calculated by dividing net income (loss) by the weighted average shares outstanding during the period, withoutconsideration for common stock equivalents.Diluted earnings (loss) per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalentsoutstanding for the period, determined using the treasury-stock and if-converted methods. For purposes of the diluted net income (loss) per share calculation,preferred stock, stock options, unvested restricted stock, and warrants are considered to be common stock equivalents but have been excluded from thecalculation of diluted net income (loss) per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per sharewere the same for all periods presented.The following common stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for theperiods presented, due to their anti-dilutive effect (in thousands): Years ended December 31, 2017 2016 2015Stock options 4,129 3,807 2,723Restricted stock units 24 — —Warrants 78 78 78Outstanding ESPP — 73 144Total 4,231 3,958 2,945Comprehensive lossComprehensive loss consists of net loss and changes in equity during a period from transactions and other events and circumstances generated fromnon-owner sources. For all periods presented other comprehensive income (loss), if any, consists of unrealized gains and losses on the Company’sinvestments.F-12Recent accounting pronouncementsStandard Description Effect on the financial statementsASU 2014-09, Revenue fromContracts withCustomers (Topic 606) The standard will replace existing revenue recognition standardsand significantly expand the disclosure requirements for revenuearrangements. It may be adopted either retrospectively or on amodified retrospective basis to new contracts and existing contractswith remaining performance obligations as of the effective date. In July 2015, the FASB affirmed its proposal to defer the effectivedate of the new revenue standard for all entities by one year. As aresult, public business entities will be required to apply the newrevenue standard to annual reporting periods beginning afterDecember 15, 2017. The standard became effective for theCompany on January 1, 2018 (the first quarter of the 2018 fiscalyear).The Company does not currently have anyarrangements that would be impacted by the newstandard.ASU 2016-02, Leases (Topic 842) In February 2016, the FASB issued ASU 2016-02, which replacesthe existing lease accounting standards.The new standard requires a dual approach for lessee accountingunder which a lessee would account for leases as finance (alsoreferred to as capital) leases or operating leases. Both finance leasesand operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases thelessee would recognize interest expense and amortization of theright-of-use asset and for operating leases the lessee wouldrecognize straight-line total lease expense.ASU 2016-02 is effective for fiscal years, and interim periods withinthose years, beginning after December 15, 2018. The Company generally does not financepurchases of equipment but it does lease officeand lab facilities. The Company is in the processof evaluating the effect that this ASU will have onits consolidated financial statements and relateddisclosures.ASU 2016-18, Statement ofCash Flows (Topic 230):Restricted Cash In November 2016, the FASB issued ASU 2016-18, which requiresadditional disclosures related to restricted cash.The new standard requires that amounts generally described asrestricted cash and restricted cash equivalents be included withcash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement ofcash flows.ASU 2016-18 is effective for fiscal years, and interim periods withinthose years, beginning after December 15, 2017. The Company does not expect the adoption ofthis standard to have a material effect on itsconsolidated financial statements.3. Cash, cash equivalents and investmentsAs of December 31, 2017, cash and cash equivalents was comprised of funds in depositary and money market funds. As of December 31, 2016, cash,cash equivalents and investments was comprised of funds in depository, money market accounts, U.S treasury securities, and FDIC-insured certificates ofdeposit. The following table presents the cash equivalents and investments carried at fair value in accordance with the hierarchy defined in Note 2 (inthousands): F-13 Total Quoted pricesin activemarkets(Level 1) Significantotherobservableinputs(Level 2) Significantunobservableinputs(Level 3)December 31, 2017 Money market funds, included in cash equivalents$11,528 $11,528 $— $—Total$11,528 $11,528 $— $— December 31, 2016 Money market funds, included in cash equivalents$25,602 $25,602 $— $—Certificates of deposit, included in cash equivalents992 — 992 —Investments - U.S treasuries16,508 16,508 — —Investments - certificates of deposit19,429 — 19,429 —Total$62,531 $42,110 $20,421 $—Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reportingperiod, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including bothincome and market based approaches and observable market inputs to determine value. The Company validates the prices provided by its third party pricingservices by reviewing their pricing methods and obtaining market values from other pricing sources. After completing its validation procedures, theCompany did not adjust any fair value measurements provided by the pricing services as of December 31, 2017 and 2016. Cash equivalents and investments at December 31, 2016 consist of the following (in thousands):ContractualMaturity AmortizedCost UnrealizedGains UnrealizedLosses Fair ValueCash equivalents and investments U.S. Treasuries31-181 days $16,508 $— $— $16,508Certificates of deposit4-180 days 20,421 — — 20,421Total $36,929 $— $— $36,9294. Property and equipment, netProperty and equipment, net consist of the following (in thousands): December 31, 2017 2016Laboratory equipment$3,771 $4,894Furniture office equipment447 921Computer hardware315 317Leasehold improvements1,524 1,514Internally developed software1,970 1,390Total property and equipment8,027 9,036Accumulated depreciation(4,567) (4,165)Property and equipment, net$3,460 $4,871Depreciation expense was $1.2 million, $1.7 million and $1.1 million, for the years ended December 31, 2017, 2016 and 2015, respectively. Aportion of the Company's internally developed computer software was placed into service during 2016 and $0.1 million of amortization was recorded for theyear ended December 31, 2016. The remainder of the Company's internally developed computer software was placed into service during 2017 and $0.3million of amortization was recorded for the year ended December 31, 2017. No internally developed software was available to be placed into service and noamortization was recorded for the year ended December 31, 2015.F-145. Accrued expenses and other current liabilitiesAccrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2017 2016Payroll and employee-related costs$1,830 $2,090Restructuring costs44 —Research and development costs2,886 1,239Other current liabilities844 849Total$5,604 $4,1786. Long-term debt2014 Term Loan, First Amendment On November 20, 2014 (the "Closing Date"), the Company entered into a loan and security agreement (the “Loan Agreement”) with HerculesTechnology Growth Capital, Inc. (“Hercules”) which provided up to $27.0 million in debt financing in three separate tranches (the “2014 Term Loan”). Thefirst tranche of $17.0 million was available through June 30, 2015, of which $12.0 million was drawn down at loan inception for which approximately $9.8million of the proceeds were used to repay all outstanding indebtedness under the previously existing $10.0 million loan agreement. The option to drawdown the remaining $5.0 million under the first tranche expired unused on June 30, 2015. The second tranche of $5.0 million was subject to certaineligibility requirements which were achieved as of June 30, 2015 and the Company had the option to draw down the second tranche on or prior toDecember 15, 2015. The second tranche expired unused on December 15, 2015. The third tranche of $5.0 million was not eligible to draw as the Companydid not achieve positive results from its Phase 2a human challenge study of GEN-004.In December 2015, the Company amended the Loan Agreement (the "First Amendment") with Hercules. The First Amendment required the Companyto draw an additional $5.0 million and permits it to draw two additional $5.0 million tranches. One $5.0 million tranche was immediately available to drawthrough December 15, 2016 and a second $5.0 million tranche could have become available through December 15, 2016, subject to the Companydemonstrating sufficient evidence of continued clinical progression of its GEN-003 product and making favorable progress in applying its proprietarytechnology platform toward the development of novel immunotherapies with application in oncology. Both tranches expired unused at December 31, 2016,and $14.3 million was outstanding under the amended 2014 Term Loan at December 31, 2017.2014 Term LoanThe 2014 Term Loan had an original maturity of July 1, 2018. The eligibility requirements for the second tranche also contained an election for theCompany to extend the maturity date to January 1, 2019. During the second quarter of 2015, the Company elected to extend the maturity date of the 2014Term Loan. The maturity date of January 1, 2019 remained unchanged by the First Amendment.Each advance accrues interest at a floating rate per annum equal to the greater of (i) 7.25% or (ii) the sum of 7.25% plus the prime rate minus 5.0%.The 2014 Term Loan provided for interest-only payments until December 31, 2015, which was extended by the Company for a six-month period as theeligibility requirements for the second tranche were met during the second quarter of 2015. The First Amendment subsequently extended the interest onlyperiod through June 30, 2017. Thereafter, beginning July 1, 2017, principal and interest payments will be made monthly for 18 months with a payoffschedule based upon a 30-month amortization schedule, the original amortization term of the 2014 Term Loan. The remaining unpaid principal is due onJanuary 1, 2019.The 2014 Term Loan may be prepaid in whole or in part upon seven business days’ prior written notice to Hercules. Prepayments will be subject toa charge of 3.0% if an advance is prepaid within 12 months following the Closing Date, 2.0%, if an advance is prepaid between 12 and 24 months followingthe Closing Date, and 1.0% thereafter. Amounts outstanding at the time of an event of default shall be payable on demand and shall accrue interest at anadditional rate of 5.0% per annum on any outstanding amounts past due. The Company is also obligated to pay an end of term charge of 4.95% (the "End ofTerm Charge") of the balance drawn when the advances are repaid.F-15The 2014 Term Loan is secured by a lien on substantially all of the assets of the Company, other than intellectual property, provided that such lienon substantially all assets includes any rights to payments and proceeds from the sale, licensing or disposition of intellectual property. The Loan Agreementcontains non-financial covenants and representations, including a financial reporting covenant, and limitations on dividends, indebtedness, collateral,investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. There are no financial covenants.Under the provisions of the 2014 Term Loan, the Company has also entered into account control agreements ("ACAs") with Hercules and certain ofthe Company's financial institutions in which cash, cash equivalents, and investments are held. These ACAs grant Hercules a perfected first priority securityinterest in the subject accounts. The ACAs do not restrict the Company's ability to utilize cash, cash equivalents, or investments to fund operations andcapital expenditures unless there is an event of default and Hercules activates its rights under the ACAs.The Loan Agreement contains a material adverse effect ("Material Adverse Effect") provision that requires all material adverse effects to be reportedunder the financial reporting covenant. Loan advances are subject to a representation that no event that has had or could reasonably be expected to have aMaterial Adverse Effect has occurred and is continuing. Under the Loan Agreement, a Material Adverse Effect means a material adverse effect upon: (i) thebusiness, operations, properties, assets or condition (financial or otherwise) of the Company; or (ii) the ability of the Company to perform the securedobligations in accordance with the terms of the Loan Agreements, or the ability of agent or lender to enforce any of its rights or remedies with respect to thesecured obligations; or (iii) the collateral or agent’s liens on the collateral or the priority of such liens. Any event that has a Material Adverse Effect is anevent of default under the Loan Agreement and repayment of amounts due under the Loan Agreement may be accelerated by Hercules under the same termsas an event of default.Events of default under the Loan Agreement include failure to make any payments of principal or interest as due on any outstanding indebtedness,breach of any covenant, any false or misleading representations or warranties, insolvency or bankruptcy, any attachment or judgment on the Company’sassets of at least $100 thousand, or the occurrence of any material default of the Company involving indebtedness in excess of $100 thousand. If an event ofdefault occurs, repayment of all amounts due under the Loan Agreement may be accelerated by Hercules, including the applicable prepayment charge.The 2014 Term Loan is automatically redeemable upon a change in control whereas the Company must prepay the outstanding principal and anyaccrued and unpaid interest through the prepayment date including any unpaid agent’s and lender’s fees and expenses accrued to the date of the repaymentincluding the End of Term Charge and the applicable prepayment charge. If a change in control occurs, repayment of amounts due under the Loan Agreementmay be accelerated by Hercules. The Company believes acceleration of the repayment of amounts outstanding under the loan is remote, and therefore thedebt balance is classified according to the contractual payment terms at December 31, 2017.In connection with the 2014 Term Loan, the Company issued a common stock warrant to Hercules on November 20, 2014. The warrant is exercisablefor 73,725 shares of the Company’s common stock (equal to $607,500 divided by the exercise price of $8.24). The exercise price and the number of shares aresubject to adjustment upon a merger event, reclassification of the shares of common stock, subdivision or combination of the shares of common stock orcertain dividends payments. The warrant is exercisable until November 20, 2019 and will be exercised automatically on a net issuance basis if not exercisedprior to the expiration date and if the then-current fair market value of one share of common stock is greater than the exercise price then in effect. The warranthas been classified as equity for all periods it has been outstanding.Contemporaneously with the 2014 Term Loan, the Company also entered into an equity rights letter agreement on November 20, 2014 (the “EquityRights Letter Agreement”). Pursuant to the Equity Rights Letter Agreement, the Company issued to Hercules 223,463 shares of the Company’s CommonStock for an aggregate purchase price of approximately $2.0 million at a price per share equal to the closing price of the Company’s common stock asreported on The Nasdaq Global Market on November 19, 2014. The shares will be subject to resale limitations and may be resold only pursuant to aneffective registration statement or an exemption from registration.Additionally, under the Equity Rights Letter Agreement, Hercules has the right to participate in any one or more subsequent private placementequity financings of up to $2.0 million on the same terms and conditions as purchases by the other investors in each subsequent equity financing. The EquityRights Letter Agreement, and all rights and obligations thereunder, will terminate upon the earlier of (1) such time when Hercules has purchased $2.0 millionof subsequent equity financing securities in the aggregate and (2) the later of (a) the repayment of all indebtedness under the Loan Agreement and (b) theexpiration or termination of the exercise period for the warrant issued in connection with the Loan Agreement. The Company allocated $36 thousand offinancing costs to additional paid-in capital for issuance fees that were reimbursed to Hercules.F-16The Company incurred $0.3 million in debt financing costs related to the First Amendment which was recorded as a debt discount and will beamortized over the remaining loan term. In connection with the issuance of the 2014 Term Loan, the Company incurred $0.1 million of financing costs andalso reimbursed Hercules $0.2 million for debt financing costs which has been recorded as a debt discount and will be amortized over the remaining loanterm. The End of Term Charge is amortized ratably over the term loan period based upon the outstanding debt and the increase in the amount of End of TermCharge due to the additional borrowing from the First Amendment is being amortized from the First Amendment date through maturity. The debt discount isbeing amortized to interest expense over the life of the 2014 Term Loan using the effective interest method. At December 31, 2017, the 2014 Term Loanbears an effective interest rate of 10.2%.As of December 31, 2017 and 2016, the Company had outstanding borrowings under the 2014 Term Loan of $14.3 million and $17.0 million,respectively. Interest expense related to the 2014 Term Loan was $1.7 million, $1.7 million and $1.3 million for the years ended December 31, 2017, 2016and 2015, respectively.As of December 31, 2017, future principal payments, including the End of Term Charge, on the 2014 Term Loan are as follows (in thousands): December 31, 20172018$6,65920198,034Total$14,693In January 2018, the Company entered into an amendment to the Loan Agreement (the "Second Amendment") with Hercules. The SecondAmendment provides for a deferred payment period of the Company's outstanding principal balance for the three consecutive months commencing onFebruary 1, 2018 through and including April 1, 2018. During the deferred payment period the Company will continue to make monthly payments ofinterest. The Company initiated a process to restructure or refinance the debt facility with Hercules to better align repayment of the debt with its newcorporate strategy and anticipated clinical milestones. If this process is successful, the Company expects to be able to defer certain debt principal payments,thereby reducing expected significant cash payments in 2018 and 2019 relating to the Company's current debt facility with Hercules.7. WarrantsAs of December 31, 2017 and 2016, the Company had warrants outstanding that represent the right to acquire 77,603 shares of common stock, ofwhich 73,725 represented warrants issued to Hercules in relation to the 2014 Term Loan and 3,878 represented warrants to purchase common stock issued inperiods prior to the Company's initial public offering ("IPO").In accordance with ASC Topic No. 815, “Derivatives and Hedging” (Topic No. 815), the Company determined the common stock warrant issued toHercules to be equity classified.8. Commitments and contingenciesLease commitmentsIn February 2014, the Company signed an operating lease for office and laboratory space that commenced in March 2014 and was set to expire inFebruary 2017 (the "2014 Lease"). In May 2016, the Company entered into a lease amendment (the "2016 Lease") for office and laboratory space currentlyoccupied under the 2014 Lease. The 2016 Lease extends the 2014 Lease by an additional three years through February 2020.In June 2015, the Company signed a second operating lease for office space in the same building as the 2014 Lease, which was also set to expire inFebruary 2017 (the "2015 Lease"). In August 2016, the Company exercised a three-year renewal option extending the 2015 Lease to February 2020. Rentexpense for the years ended December 31, 2017, 2016 and 2015, was $1.5 million, $1.4 million and $1.2 million, respectively.The minimum future lease payments under both the 2016 Lease and the 2015 Lease are as follows (in thousands):F-17December 31, 20172018$1,60720191,6372020274Total$3,518At December 31, 2017 and 2016, the Company has an outstanding letter of credit of $316 thousand with a financial institution related to a securitydeposit for the 2016 Lease, which is secured by cash on deposit and expires on February 29, 2020. An additional unsecured deposit was required for the 2015Lease.Significant Contracts and AgreementsIn addition to lease commitments, the Company enters into contractual arrangements that obligate it to make payments to the contractualcounterparties upon the occurrence of future events. In the normal course of operations, the Company enters into license and other agreements and intends tocontinue to seek additional rights relating to compounds or technologies in connection with its discovery, manufacturing and development programs. Theseagreements may require payments to be made by the Company upon the occurrence of certain development milestones and certain commercializationmilestones for each distinct product covered by the licensed patents (in addition to certain royalties to be paid on marketed products or sublicense income)contingent upon the occurrence of future events that cannot be reasonably estimated.The Company relies on research institutions, contract research organizations, clinical investigators as well as clinical and commercial materialmanufacturers for its product candidates. Under the terms of these agreements, the Company is obligated to make milestone payments upon the achievementof manufacturing or clinical milestones defined in the contracts. In some cases, monthly service fees for project management services are charged over theduration of the arrangement. In addition, clinical and manufacturing contracts generally require reimbursement to suppliers for certain set-up, production,travel, and other related costs as they are incurred. In some manufacturing contracts, the Company also may be responsible for the payment of a reservationfee, which will equal a percentage of the expected production fees, to reserve manufacturing slots in the production timeframe. Generally, the Company isliable for actual effort expended by these organizations at any point in time during the contract through the notice period. To the extent amounts paid to asupplier exceed the actual efforts expended, the Company records a prepaid asset, and to the extent actual efforts expended exceed amounts billed or billableunder a contract, an accrual for the estimate of services rendered is recorded.In February 2014, the Company entered into a supply agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (“Fujifilm”) for themanufacture and supply of antigens for future GEN-003 clinical trials. Under the agreement, the Company was obligated to pay Fujifilm manufacturingmilestones, in addition to reimbursement of certain material production related costs. Additionally, the Company was responsible for the partial payment ofmanufacturing fees to reserve manufacturing slots in the production timeframe. In June and September 2016, the Company entered into new statements ofwork under the agreement with Fujifilm for the manufacture and supply of antigens for the Company's Phase 3 clinical trials for GEN-003. In September 2017,the Company notified Fujifilm to cease all manufacturing activities of antigens for GEN-003. Amounts recorded as of December 31, 2017 represent allliabilities for manufacturing services complete or in process prior to the notification date, materials purchased which cannot be re-used or re-purposed byFujifilm and charges for terminating services within a certain time frame of the anticipated start dates.The Company incurred expenses under this agreement of $3.6 million for the year ended December 31, 2017, of which $526 thousand are includedin Restructuring costs in the Consolidated Statements of Operations and Comprehensive Loss. The Company incurred expenses under this agreement of $4.7million and $4.2 million for the years ended December 31, 2016 and 2015, respectively.In January 2018, we entered into a License and Supply Agreement with Oncovir, Inc. (“Oncovir”). The Agreement relates to the manufacture andsupply of Hiltonol® (poly-ICLC) (“Hiltonol”), an immunomodulator and vaccine adjuvant. Hiltonol is the adjuvant component of GEN-009, ourinvestigational personal neoantigen cancer vaccine. Under this Agreement, we are obligated to pay Oncovir (i) an up-front payment in the mid-six figures inconsideration of the license granted to us and for the initial supply of Hiltonol for the planned GEN-009 Phase 1/2 trial, (ii) a supply price for Hiltonol in thelow-three figures per vial of Hiltonol for use in clinical trials or commercial use, (iii) a milestone payment in the low-six figures upon the achievement ofcertain clinical trial milestones for each Combination Product, (iv) a milestone payment in the mid-six figures upon the first marketing approval ofcommercial sales for each Combination Product in certain territories, and (v) tiered royalties in the low-single digits on a product-by-product basis based onthe net sales of Combination Products. WeF-18may terminate the Agreement upon a decision to discontinue the development of the Combination Product or upon a determination by us or an applicableregulatory authority that Hiltonol or Combination Product is not clinically safe or effective. The Agreement may also be terminated by either party due to amaterial uncured breach by the other party, or due to the other party’s bankruptcy, insolvency or dissolution.LitigationOn October 31, 2017, a putative class action complaint was filed in the U.S. District Court for the District of Massachusetts (the “District ofMassachusetts” or the "Court”), naming the Company, Chief Executive Officer William D. Clark, and Chief Financial Officer Jonathan Poole as defendants.The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 in connection with disclosures made in and subsequent to theCompany’s Quarterly Report on Form 10-Q for the period ending March 31, 2017, filed with the SEC on May 5, 2017, and the Company’s announcement ofa strategic shift to immuno-oncology on September 25, 2017. The plaintiff sought to represent a class of shareholders who purchased or otherwise acquiredthe Company’s securities between May 5, 2017 and September 25, 2017. The complaint sought unspecified damages and costs. On November 3, 2017,another purported Company shareholder filed a substantially identical complaint in the District of Massachusetts. On December 15, 2017, a purportedCompany shareholder filed a third complaint in the District of Massachusetts, substantially the same as the previous two, but alleging a class periodbeginning on August 4, 2016 and ending on September 25, 2017. The District of Massachusetts designated all three complaints as related, and entered anorder in each action recognizing that the defendants are not obligated to respond to the initial complaint filed in any of the three actions. Per the proceduresset forth by federal securities laws, applications for appointment of lead plaintiff(s) and lead counsel in the three actions were due to the Court on January 2,2018. Three applications for lead plaintiff and lead counsel were submitted to the Court on that date; one of the three movants subsequently withdrew theirapplication. The Court held a hearing on the two remaining motions for lead plaintiff(s) and lead counsel on January 31, 2018. The Court consolidated thethree actions into one case, under the docket number Civil Action No. 17-cv-12137-PBS, U.S. District Court (Mass.), and took the motions for lead plaintiff(s)and counsel under advisement. Counsel for both lead plaintiff movants told the Court that they intended to file an amended complaint in the consolidatedaction, if appointed. On February 12, 2018, the Court appointed the Genocea Investor Group (a group of five purported shareholders) as lead plaintiff, andappointed Scott+Scott LLP, Levi & Korsinsky LLP, and Block & Leviton as lead counsel. On February 14, 2018, the parties submitted a stipulationproposing a briefing schedule with the following deadlines: filing of an amended complaint by the lead plaintiffs and counsel due March 29, 2018; filing ofan answer or motion to dismiss by defendants on May 14, 2018; filing of any opposition by plaintiffs to a motion to dismiss on June 28, 2018; and filing ofany reply by defendants in support of a motion to dismiss on July 30, 2018.On January 31, 2018, a putative shareholder derivative action was filed in the U.S. District Court for the District of Delaware, naming certain of theCompany’s officers and directors as defendants, and naming the Company as a nominal defendant. The complaint alleges violations of the SecuritiesExchange Act of 1934 and Rule 14a-9 in connection with disclosures made in the Company’s Schedule 14A Proxy Statement, filed with the SEC on April 21,2017. The complaint also alleges claims for breach of fiduciary duty, unjust enrichment, and waste of corporate assets.The Company is unable at this time to determine whether the outcome of the litigation would have a material impact on its results of operations,financial condition or cash flows. The Company does not have contingency reserves established for any litigation liabilities.Refund of research and development expenseIn August 2009, the Company entered into an exclusive license and collaboration agreement (the “Novavax Agreement”) with Isconova AB, aSwedish company which subsequently was acquired by Novavax, Inc. ("Novavax"). Pursuant to the agreement, Novavax granted the Company a worldwide,sublicensable, exclusive license to two patent families, to import, make, have made, use, sell, offer for sale and otherwise exploit licensed vaccine productscontaining an adjuvant which incorporates or is developed from Matrix-A, Matrix-C and/or Matrix-M technology, in the fields of HSV and chlamydia.Matrix-M is the adjuvant used in GEN-003.The Novavax Agreement includes a research funding clause for which the Company made monthly payments to Novavax between August 2009 andMarch 2012 of approximately $1.6 million. All amounts of research funding provided were to be refunded by Novavax. After December 31, 2015, anyamounts remaining due from Novavax, including accrued interest, could be received in cash upon 30-day written notice provided by the Company. TheCompany provided this notice in January 2016.The Company provided the research funding solely to benefit the supply plan for the Matrix-M adjuvant to the point that a Phase 1 clinical trialcould be initiated. Because of the benefit received from the research funding payments, anF-19assessment of Novavax's financial ability to repay the research funding at the time of the payments, along with the duration of which amounts could beoutstanding, the Company concluded the initial research funding should be recorded as research and development expense at the time of payment. InFebruary 2016, upon receipt of the $1.6 million refund including accrued interest, the Company recorded a gain within operating expenses in theConsolidated Statements of Operations and Comprehensive Loss.9. Stockholders' equity (deficit) At December 31, 2017, the Company authorized 175,000,000 shares of common stock at $0.001 par value per share, of which 28,734,898 shares ofcommon stock were issued and outstanding.At-the-market equity offering programOn March 2, 2015, the Company entered into a Sales Agreement with Cowen and Company, LLC (the "Sales Agreement") to establish an at-the-market equity offering program (“ATM”) pursuant to which it was able to offer and sell up to $40.0 million of its common stock at prevailing market pricesfrom time to time. On May 8, 2015, the Sales Agreement was amended to increase the offering amount under the ATM to $50.0 million of its common stock.In January 2017, the Company sold 52 thousand shares and received $0.2 million in net proceeds after deducting commissions. In April 2016, the Companysold 136 thousand shares and received $0.8 million in net proceeds after deducting commissions. There were no sales under this program during the fiscalyear ended December 31, 2015.Restricted stockDuring 2013, a Company director exercised stock options and received 31,092 shares of common stock that were subject to a Stock Restriction andRepurchase Agreement with the Company. Under the terms of the agreement, shares of common stock issued are subject to a vesting schedule and unvestedshares are subject to repurchase by the Company. Vesting occurs periodically at specified time intervals and specified percentages. As of December 31, 2017,all shares of common stock were fully vested.At both December 31, 2017 and December 31, 2016, the Company had issued 35,964 shares of restricted common stock. At December 31, 2016,1,941 shares of nonvested restricted stock were subject to repurchase by the Company. These shares vested in 2017 and at December 31, 2017 there were noshares of restricted stock subject to repurchase by the Company.In May 2017, the Company granted an officer 47,620 units of Restricted Stock ("RSUs") in accordance with the 2014 Equity Incentive Plan (the"2014 Equity Plan") and subject to a Restricted Stock Unit Award Agreement with the Company. On the date of grant, 7,937 units of RSUs vestedimmediately, and another 23,810 units of RSUs will vest on the eighteen month anniversary of the grant date, subject to the continued employment of theofficer. The remaining 15,873 RSUs, which contained a performance condition of completing a material financing event on or before September 30, 2017,were canceled as the performance criterion was not achieved. As of December 31, 2017, 23,810 RSUs remain unvested.10. Stock and employee benefit plansThe Company’s board of directors adopted the 2014 Equity Plan, which was approved by its stockholders and became effective prior to thecommencement of the Company's IPO.The 2014 Equity Plan provides for the grant of incentive stock options, non-qualified stock options, restricted stock and other awards to keyemployees and directors of, and consultants and advisors to, the Company. The maximum number of shares of common stock that may be delivered insatisfaction of awards under the 2014 Equity Plan is 903,494 shares, plus 219,765 shares that were available for grant under the 2007 Equity Incentive Plan(the "2007 Equity Plan") on the date the 2014 Equity Plan was adopted. The 2014 Equity Plan provides that the number of shares available for issuance willautomatically increase annually on each January 1, from January 1, 2015 through January 1, 2024, in amount equal to the lesser of 4.0% of the outstandingshares of the Company’s outstanding common stock as of the close of business on the immediately preceding December 31 or the number of sharesdetermined the Company’s board of directors. On January 1, 2018, the total number of shares available for issuance under the 2014 Equity Plan increased by1,149,396 for shares under this provision.Outstanding option awards granted from the 2007 Equity Plan, at the time of the adoption of the 2014 Equity Plan, remain outstanding andeffective. The shares of common stock underlying awards that are cancelled, forfeited, repurchased,F-20expire or are otherwise terminated under the 2007 Equity Plan are added to the shares of common stock available for issuance under the 2014 Equity Plan. AtDecember 31, 2017, 5,274,992 option awards are permitted under the Company's equity plans and 1,114,067 awards remain available for future grants.Stock options issued to non-employees are accounted for using the fair value method of accounting, and are periodically revalued as the optionsvest, and are recognized as expense over the related service period. The total expense related to all non-employee options for the years ended December 31,2017, 2016 and 2015 was $338 thousand, $271 thousand and $263 thousand, respectively.Stock-Based Compensation ExpenseTotal stock-based compensation expense is recognized for stock options granted to employees and non-employees and has been reported in theCompany’s Statements of Operations as follows (in thousands): Years ended December 31, 2017 2016 2015Research and development $1,310 $1,568 $1,690General and administrative 2,924 2,579 2,158Total $4,234 $4,147 $3,848Stock OptionsThe following table summarizes stock option activity for employees and nonemployees (shares in thousands): Shares Weighted-AverageExercisePrice Weighted-AverageRemainingContractualTerm (years) AggregateIntrinsicValueOutstanding at December 31, 2016 3,807 $5.94 7.52 $2,441Granted 1,475 $4.74 Exercised (155) $2.95 Canceled (998) $6.52 Outstanding at December 31, 2017 4,129 $5.48 7.07 $—Exercisable at December 31, 2017 2,378 $5.98 6.05 $—Vested or expected to vest at December 31, 2017 4,129 $5.48 7.07 $—During the years ended December 31, 2017, 2016 and 2015, the Company granted stock options to purchase an aggregate of 1,474,800, 1,576,700and 715,262 shares of its common stock, respectively, with weighted-average grant date fair values of $3.16, $3.56 and $9.12, respectively.The total intrinsic value of options exercised was $442 thousand, $113 thousand and $1.0 million in the years ended December 31, 2017, 2016 and2015, respectively. As of December 31, 2017, there was $4.8 million of total unrecognized compensation cost, related to employee stock options grantedunder the Company’s equity plans.The total unrecognized compensation costs, related to non-employee stock options was $228 thousand, $269 thousand and $255 thousand for theyears ended December 31, 2017, 2016, and 2015, respectively.The Company expects to recognize that cost over a remaining weighted-average period of 2.38 years.The Company estimates the fair value of each employee stock award on the grant date using the Black-Scholes option-pricing model based on thefollowing assumptions:F-21 Years ended December 31, 2017 2016 2015Expected Volatility 74.6% - 90.1% 67.4% - 77.9% 68.5% - 85.3%Risk-free interest rate 1.85% - 2.18% 1.14% - 2.09% 1.56% - 1.94%Expected term (in years) 5.5 - 9.88 5.50 - 6.08 5.50 - 6.08Expected dividend yield 0% 0% 0%Performance-Based Stock OptionsThe Company granted stock options to certain employees, executive officers and consultants, which contain performance-based vesting criteria.Milestone events are specific to the Company’s corporate goals, which include, but are not limited to, certain clinical development milestones, businessdevelopment agreements and capital fundraising events. Stock-based compensation expense associated with these performance-based stock options isrecognized if the performance conditions are considered probable of being achieved, using management’s best estimates. During the years endedDecember 31, 2017, 2016 and 2015, the Company recorded no stock-based compensation expense related to the 56,336 performance-based common stockoptions that remain outstanding for which the probability of achievement was not deemed probable at both December 31, 2017 and 2016.Employee Stock Purchase PlanOn February 10, 2014, the Company’s board of directors adopted the 2014 Employee Stock Purchase Plan (the “2014 ESPP”). The 2014 ESPPauthorizes the initial issuance of up to a total of 200,776 shares of common stock to participating eligible employees. The 2014 ESPP provides for six-monthoption periods commencing on January 1 and ending June 30 and commencing July 1 and ending December 31 of each calendar year. The first offeringunder the 2014 ESPP began on July 1, 2014. For the year ended December 31, 2017, the Company incurred $121 thousand in stock-based compensationexpense and 73,461 shares were issued. For the year ended December 31, 2016, the Company incurred $155 thousand in stock-based compensation expenseand 70,774 shares were issued. For the year ended December 31, 2015, the Company incurred $113 thousand in stock-based compensation expense and40,912 shares were issued. There were 7 shares remaining for future issuance under the plan as of December 31, 2017.401(k) Savings planIn 2007, the Company established a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code (“401(k) Plan”). The401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annualcompensation on a pretax basis. Beginning January 1, 2015, the Company began making matching contributions to participants in this plan. The Companymade matching contributions to participants in this plan which totaled $224 thousand, $243 thousand and $174 thousand for the years ended December 31,2017, 2016 and 2015, respectively.11. Income taxesThe Tax Cuts and Jobs Act ("Tax Reform Act"), which was signed into law on December 22, 2017, significantly changes U.S. tax law by, amongother things, lowering corporate income tax rates, implementing a territorial tax systems and imposing a repatriation tax on deemed repatriated earnings offoreign subsidiaries. The Tax Reform Act permanently reduces the U.S. corporate income tax rate from a maximum of 35% to a flat 21% rate, effectiveJanuary 1, 2018.The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognizedfor the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and theirrespective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which thosetemporary differences are expected to reverse. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the Tax Reform Act,the Company revalued its ending deferred tax assets and liabilities at December 31, 2017. Due to the Company's full valuation allowance, no provisional taxexpense or benefit associated with the re-measurement was recognized in the Company's consolidated statement of operations and comprehensive loss for theyear ended December 31, 2017. However, the reduction of the U.S. federal corporate tax rate from 35% to 21% resulted in increases to the amounts reflectedin the “Change in valuation allowance” and "Change in tax rate" captions for the year ended December 31, 2017 in the Company’s tax reconciliation tablecompared to those amounts disclosed for the years ended December 31, 2016 and 2015. The change in the U.S. federal corporate tax rate, which is effectiveJanuary 1, 2018, is also reflected in the Company’s deferred tax table.F-22The Company has recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amountsin its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to, amongother things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, andactions the Company may take as a result of the Tax Reform Act, which could result in changes to the provisional tax impacts during 2018.For the years ended December 31, 2017 and 2016, the Company did not record a current or deferred income tax expense or benefit. The Company’slosses before income taxes consist solely of domestic losses. The significant components of the Company’s deferred tax assets are comprised of the following: December 31, 2017 2016Deferred tax assets: U.S and state net operating loss carryforwards$42,895 $52,829Capitalized R&D21,924 20,280Research and development credits8,582 6,422Stock-based compensation1,808 2,184Accrued expenses474 794Depreciation and amortization761 784Other temporary differences116 365Total deferred tax assets76,560 83,658Less valuation allowance(76,560) (83,658)Net deferred tax assets$— $—The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company’shistory of operating losses, the Company has concluded that it is more likely than not that the benefit of its deferred tax assets will not be realized.Accordingly, the Company has provided a full valuation allowance for deferred tax assets as of December 31, 2017 and 2016. The valuation allowancedecreased approximately $7.1 million during the year ended December 31, 2017 due primarily to the adjustment in the corporate tax rate from 34% to 21%enacted for 2018 partially offset by the generation of net operating losses. The valuation allowance increased approximately $21.0 million during the yearended December 31, 2016, due primarily to the Company's election to capitalize and amortize certain research and development expenses.A reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the consolidated financialstatements is as follows: Years ended December 31, 2017 2016 2015Federal income tax expense at statutory rate 34.0 % 34.0 % 34.0 %State income tax, net of federal benefit 5.1 % 5.0 % 4.6 %Permanent differences (1.2)% (1.5)% (2.1)%Research and development credit 2.9 % 2.5 % 1.9 %Change in tax rate (52.8)% 0.0 % 0.0 %Change in valuation allowance 12.5 % (40.0)% (38.4)%Other, net (0.5)% 0.0 % 0.0 %Effective tax rate 0.0 % 0.0 % 0.0 %As of December 31, 2017, 2016 and 2015, the Company had U.S. federal net operating loss carryforwards of approximately $160.6 million, $136.6million and $143.8 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2037. As ofDecember 31, 2017, 2016 and 2015, the Company also had U.S. state net operating loss carryforwards of approximately $145.1 million, $121.2 million and$128.5 million, respectively, which may be available to offset future income tax liabilities and expire at various dates through 2037. For the years endedDecember 31, 2017 and 2016, deductions related to the excess tax benefit from stock option exercises are recognized in the federal and state net operatingloss carryforwards as a component of the tax provision. For the year ended December 31, 2015,F-23approximately $2.8 million of excess tax benefits related to the exercise of stock options were included in the federal and state net operating losscarryforwards.As of December 31, 2017 and 2016, the Company had federal research and development tax credit carryforwards of approximately $6.1 million and$4.8 million, respectively, available to reduce future tax liabilities which expire at various dates through 2037. As of December 31, 2017 and 2016, theCompany had state research and development tax credit carryforwards of approximately $2.9 million and $2.5 million, respectively, available to reducefuture tax liabilities which expire at various dates through 2032.Under the provisions of the Internal Revenue Code of 1986, as amended (the "Code"), the net operating loss and tax credit carryforwards are subjectto review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may becomesubject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period inexcess of 50%, as defined under Sections 382 and 383 of the Code, respectively, as well as similar state provisions. This could limit the amount of taxattributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the valueof the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Companyhas completed several financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Code, orcould result in a change in control in the future.The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2017 and 2016, theCompany had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements ofoperations and comprehensive loss.For all years through December 31, 2017, the Company generated research credits but has not conducted a study to document the qualifiedactivities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed andany adjustment is known, no amounts are being presented as an uncertain tax position for these years. A full valuation allowance has been provided againstthe Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax assetestablished for the research and development credit carryforwards and the valuation allowance.The Company files income tax returns in the United States and various state jurisdictions. The federal and state income tax returns are generallysubject to tax examinations for the tax years ended December 31, 2013 through December 31, 2017. To the extent the Company has tax attributecarryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service, state or foreign taxauthorities to the extent utilized in a future period.12. Restructuring costsOn September 25, 2017, the Company announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines,including GEN-009. The Company also announced that it is exploring strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapyfor the treatment of genital herpes. Consequently, substantially all GEN-003 spending and activities were ceased and the Company reduced its workforce byapproximately 40 percent as of the quarter ended September 30, 2017. Pursuant to ASC 420, Exit or Disposal Cost Obligations, charges for employeeseverance, employee benefits, and contract terminations were recorded in the year ended December 31, 2017. Asset impairment charges, pursuant to ASC 360,Property, Plant, and Equipment, were also recorded in the year ended December 31, 2017 and primarily related to fixed assets specific to GEN-003 researchand development activities.The following table summarizes the impact of the September 2017 restructuring activities for the year ended December 31, 2017, along with the currentliability recorded in the balance sheet as of December 31, 2017 (in thousands):F-24 Charges incurred duringthe year ended December31, 2017 Amount paid throughDecember 31, 2017 Less non-cash chargesduring the year endedDecember 31, 2017 Remaining liability atDecember 31, 2017Employee severance, benefits and related costs$1,064 $(1,050) $— $14Contract terminations526 — — 526Asset impairments1,028 — (1,028) —Total$2,618 $(1,050) $(1,028) $540The Company expects to vacate certain leased space in early 2018 at which point it expects to record a liability for the remaining lease obligation lessan estimate of sublease income in accordance with ASC 420.13. Quarterly financial information (unaudited, in thousands, except per share data) Three Months Ended, March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017Revenue $— $— $— $—Operating expenses 13,376 14,998 16,496 10,385Net loss (13,735) (15,375) (16,868) (10,732)Net loss per share - basic and diluted $(0.48) $(0.54) $(0.59) $(0.37)Weighted-average number of common shares used incomputing net loss per share - basic and diluted 28,496 28,541 28,666 28,705 Three Months Ended, March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016Revenue $235 $— $— $—Operating expenses 9,664 10,704 12,430 15,682Net loss (9,751) (11,023) (12,765) (16,034)Net loss per share - basic and diluted $(0.35) $(0.39) $(0.45) $(0.56)Weighted-average number of common shares used incomputing net loss per share - basic and diluted 28,152 28,276 28,370 28,39414. Subsequent eventOn January 19, 2018, the Company sold in the Concurrent Offerings (i) 53,365,000 shares of the Company’s common stock, par value $0.001 per share,and accompanying Class A warrants to purchase up to 26,682,500 shares of common stock, at a combined price of $1.00 per share, for gross proceeds ofapproximately $53.4 million and (ii) 1,635 shares of the Company’s Series A convertible preferred stock, par value $0.001 per share, which are convertibleinto 1,635,000 shares of common stock and accompanying Class A warrants to purchase up to 817,500 shares of common stock, for gross proceeds ofapproximately $1.6 million. The Class A warrants (the “Warrants”) are exercisable for one share of common stock having an exercise price of $1.20 per share,subject to adjustment in certain circumstances. The shares of common stock and preferred stock are immediately separable from the Warrants and were issuedseparately.The underwriters partially exercised their option to purchase additional securities by purchasing 3,061,100 Warrants.Each share of preferred stock is convertible at any time at the option of the holder, provided that the holder will be prohibited from converting thepreferred stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99% of the totalnumber of shares of common stock then issued and outstanding. The preferred stock will rank pari passu on an as-converted to common stock basis with thecommon stock as to distributions of assets upon the Company’s liquidation, dissolution or winding up, whether voluntarily or involuntarily, or a“Fundamental Transaction,” as defined in the Certificate of Designation. Shares of preferred stock will generally have no voting rights, except as required bylaw and except that the consent of the holders of a majority of the outstanding preferred stock will be required to amend the terms of the preferred stock.The holder of the Warrants may exercise the Warrants at any time or from time to time during the period beginning on the date of issuance and expiringon the fifth-year anniversary of such issuance date. Notwithstanding the foregoing, the holder will be prohibited from exercising each Warrant into shares ofthe common stock if, as a result of such exercise, the holder, togetherF-25with its affiliates, would own more than 4.99% of the total number of shares of the common stock then issued and outstanding, provided that this limitationon exercise shall not be applicable to any holder, together with its affiliates, who owns 10.0% or more of the Company’s common stock immediately prior tothe exercise of each Warrant (without giving effect to any shares of common stock underlying each Warrant). A holder may increase or decrease thisbeneficial ownership limitation to an amount not to exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect tothe issuance of shares of common stock issuable upon exercise of each Warrant.F-26SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized on February 16, 2018. GENOCEA BIOSCIENCES, INC. By:/s/ William Clark William Clark President and Chief Executive OfficerPursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons on behalf of the registrant in thecapacities and on the dates indicated.Signature Title Date /s/ William Clark President and Chief Executive Officer and Director William Clark (Principal Executive Officer) February 16, 2018 /s/ Jonathan Poole Chief Financial Officer Jonathan Poole (Principal Financial Officer and Principal Accounting Officer) February 16, 2018 /s/ Kenneth Bate Kenneth Bate Director February 16, 2018 /s/ Ali Behbahani Ali Behbahani Director February 16, 2018 /s/ Katrine Bosley Katrine Bosley Director February 16, 2018 /s/ Ronald Cooper Ronald Cooper Director February 16, 2018 /s/ Michael Higgins Michael Higgins Director February 16, 2018 /s/ Howard Mayer Howard Mayer, M.D. Director February 16, 2018 /s/ George Siber George Siber, M.D. Director February 16, 2018ExhibitNumber Exhibit 3.1 Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s CurrentReport 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, FileNo. 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 Fourth Amended and Restated Registration Rights Agreement (incorporated by reference to Exhibit 4.5 to the Company’sRegistration Statement on Form S-1, File No. 333-193043, filed on December 23, 2013) 4.3 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 onNovember 21, 2014) 4.4 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated byreference to Exhibit 4.1 to the Company's Current Report on Form 8-K, File No. 001-36289 filed on January 19, 2018) 4.5* Form of Class A Warrant to Purchase Shares of Common Stock of Genocea Biosciences, Inc. 10.1 Form of Director Indemnification Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statementon Form S-1, File No. 333-193043, filed on December 23, 2013) 10.2+ 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 10.2 to the Company’s Form 10-Q, File No.001-36289, datedNovember 4, 2016) 10.3+ License and Collaboration Agreement between Genocea Biosciences, Inc. and Isconova AB, dated August 5, 2009, as amendedon March 19, 2010, June 18, 2010, August 17, 2010, October 19, 2011 and February 6, 2012 (incorporated by reference toExhibit 10.3 to the Company’s Form 10-Q, File No.001-36289, dated November 4, 2016 10.4+ Exclusive License Agreement for Escherichia Coli K12 to Deliver Protein to the Macrophage Cytosol between GenoceaBiosciences, Inc. and The Regents of the University of California, dated August 18, 2006 (incorporated by reference toExhibit 10.5 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.5 Lease, dated as of July 3, 2012 between TBCI, LLC and Genocea Biosciences, Inc. (incorporated by reference to Exhibit 10.8 tothe Company’s Registration Statement on Form S-1, File No. 333-193043, dated December 23, 2013) 10.6 Agreement Regarding Sublease, dated as of July 9, 2012, by TBCI, LLC, FoldRx Pharmaceuticals, Inc., Pfizer Inc. and GenoceaBiosciences, 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) 10.7† Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan, as amended on June 24, 2013 (incorporated byreference to Exhibit 10.10 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed on December 23,2013) 10.8† 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 RegistrationStatement on Form S-1, File No. 333-193043, filed on December 23, 2013) 10.9† 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, asamended on January 23, 2014) 10.10† Amended and Restated Employment Letter Agreement between Seth Hetherington, M.D. and Genocea Biosciences, Inc., datedJanuary 16, 2014 (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1, FileNo. 333-193043, as amended on January 23, 2014) ExhibitNumber Exhibit 10.11† Letter Agreement, dated April 7, 2014, between the Company and Jonathan Poole (incorporated by referenced to Exhibit 10.1 tothe Company’s Current Report on Form 8-K, File No. 001-36289, filed on April 8, 2014) 10.12† Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference to Exhibit 10.15 to the Company’s RegistrationStatement on Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.13† Genocea Biosciences, Inc. Cash Incentive Plan (incorporated by reference to Exhibit 10.16 to the Company’s RegistrationStatement on Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.14† Form of Nonstatutory Stock Option Granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity IncentivePlan (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) 10.15† 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 onDecember 23, 2013) 10.16† Form of Incentive Stock Option under the Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference toExhibit 10.22 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.17† Form of Nonstatutory Stock Option under the Genocea Biosciences, Inc. 2014 Equity Incentive Plan (incorporated by reference toExhibit 10.23 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.18† Restricted Stock Agreement between Genocea Biosciences, Inc. and Katrine Bosley, dated November 7, 2013 (incorporated byreference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amended onJanuary 13, 2014) 10.19† Genocea Biosciences, Inc. 2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.26 to the Company’sRegistration Statement on Form S-1, File No. 333-193043, as amended on January 23, 2014) 10.20† Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan toKatrine Bosley, dated May 13, 2013 (incorporated by reference to Exhibit 10.27 to the Company’s Registration Statement onForm S-1, File No. 333-193043, as amended on January 13, 2014) 10.21† Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan toKatrine Bosley, dated November 5, 2013 (incorporated by reference to Exhibit 10.28 to the Company’s Registration Statement onForm S-1, File No. 333-193043, as amended on January 13, 2014) 10.22+ Bioprocessing Services Agreement between the Company and FUJIFILM Diosynth Biotechnologies U.S.A., Inc. datedFebruary 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) 10.23 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 onNovember 21, 2014) 10.24 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 onNovember 21, 2014) 10.25† 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) ExhibitNumber Exhibit 10.26 Amendment No. 1 to Loan and Security Agreement between the Company and Hercules Technology Growth Capital, Inc., datedDecember 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) 10.27 Sublease Agreement between the Company and the Smithsonian Institution, dated June 15, 2015 (incorporated by reference toExhibit 10.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on June 19, 2015) 10.28 First Amendment to Lease, dated May 16, 2016, between 100 Discovery Park DE, LLC, a Delaware limited liability company (assuccessor in interest to TBCI, LLC, as Trustee of 100 Discovery Park Realty Trust) and Genocea Biosciences, Inc. (incorporatedby reference to Exhibit 10.30 to the Company’s Form 10-Q, filed on August 5, 2016, File No. 001-36289) 10.29†* Sixth Amendment to the Consulting Agreement between Genocea Biosciences, Inc. and George Siber, dated June 13, 2017 10.30* Amendment No. 2 to the Loan and Security Agreement between the Company and Hercules Technology Growth Capital, Inc.,dated January 19, 2018 10.31+* License and Supply Agreement, between the Company and Oncovir, Inc., dated January 26, 2018 21.1 List of Subsidiaries of the Company (incorporated by reference to Exhibit 21.1 to the Company's Form 10-K, filed on February 17,2016, File No. 001.36289) 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 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 beensubmitted separately to the Securities and Exchange Commission.Exhibit 4.5CLASS A WARRANT NO. 2018-[______] NUMBER OF SHARES: [_______]DATE OF ISSUANCE: January 19, 2018 (subject to adjustment hereunder)EXPIRATION DATE: January 18, 2023CLASS A WARRANT TO PURCHASE SHARESOF COMMON STOCK OFGENOCEA BIOSCIENCES, INC.This Class A Warrant (the “Warrant”) is issued by Genocea Biosciences, Inc., a Delaware corporation (the “Company”), to[________], or its registered assigns (including any successors or assigns, the “Holder”), and is subject to the terms and conditions setforth below. The Warrant is being issued pursuant to a Warrant Agreement between the Company and Computershare Inc., aDelaware corporation (“Computershare”) and its fully owned subsidiary Computershare Trust Company, N.A., a national bankingassociation (collectively with Computershare, the “Warrant Agent”).1.EXERCISE OF WARRANT.(a) Number and Exercise Price of Warrant Shares; Expiration Date. Subject to the terms and conditions set forth herein,the Holder is entitled to purchase from the Company up to [______] shares of the Company’s Common Stock, $0.001 par value pershare (the “Common Stock”) (as adjusted from time to time pursuant to the provisions of this Warrant) (the “Warrant Shares”), at apurchase price of $1.20 per share (the “Exercise Price”), on or before 5:00 p.m. New York City time on January 18, 2023 (the“Expiration Date”).(b) Method of Exercise. While this Warrant remains outstanding and exercisable in accordance with Section 1(a) above,the Holder may exercise this Warrant in whole or in part in accordance with Section 5 by either:(1) wire transfer to the Company or cashier’s check drawn on a United States bank made payable to the order ofthe Company, or(2) exercising of the right to credit the Exercise Price against the Fair Market Value (as defined below) of theWarrant Shares (as defined below) at the time of exercise (the “Net Exercise”) pursuant to Section 1(c).(c) Net Exercise. If the Company shall receive written notice from the Holder at the time of exercise of this Warrant thatthe Holder elects to Net Exercise the Warrant, the Company shall deliver to such Holder (without payment by the Holder of anyexercise price in cash) that number of Warrant Shares computed using the following formula:Where1 X =The number of Warrant Shares to be issued to the Holder.Y =The number of Warrant Shares purchasable under this Warrant or, if only a portion of the Warrant is beingexercised, the portion of the Warrant being cancelled (at the date of such calculation).A =The Fair Market Value of one share of Common Stock (at the date of such calculation).B =The Exercise Price (as adjusted to the date of such calculations).The “Fair Market Value” of one share of Common Stock shall mean (x) the last reported sale price and, if there are nosales, the last reported bid price, of the Common Stock on the last trading day prior to the date of exercise on the trading market onwhich the Common Stock is listed as reported by Bloomberg Financial Markets (or a comparable reporting service of nationalreputation selected by the Company and reasonably acceptable to the Holder if Bloomberg Financial Markets is not then reportingsales prices of the Common Stock) (collectively, “Bloomberg”), or (y) if the foregoing does not apply, the last sales price of suchsecurity in the over-the-counter market on the pink sheets by Pink Sheets LLC (formerly the National Quotation Bureau, Inc.) (the“pink sheets”) or bulletin board for such security as reported by Bloomberg, or if no sales price is so reported, the last bid price of theCommon Stock as reported by Bloomberg or (z) if the fair market value cannot be calculated on any of the foregoing bases, the fairmarket value determined by the Company’s Board of Directors in good faith.(d) Disputes. In the case of a dispute as to the determination of the Exercise Price or the arithmetic calculation of theWarrant Shares, the Company shall promptly issue to the Holder the number of Warrant Shares that are not disputed.(e) Deemed Exercise. In the event that immediately prior to the close of business on the Expiration Date, the Fair MarketValue of one share of Common Stock (as determined in accordance with Section 1(c) above) is greater than the then applicableExercise Price, this Warrant shall be deemed to be automatically exercised on a net exercise issue basis pursuant to Section 1(c) above,and the Company shall deliver the applicable number of shares of Common Stock to the Holder pursuant to the provisions of Section1(c) above and this Section 1(e).2. CERTAIN ADJUSTMENTS.(a)Adjustment of Number of Warrant Shares and Exercise Price. The number and kind of Warrant Sharespurchasable upon exercise of this Warrant and the Exercise Price shall be subject to adjustment from time to time as follows:(1) Subdivisions, Combinations and Other Issuances. If the Company shall at any time after the Date of Issuancebut prior to the Expiration Date subdivide its shares of capital stock of the same class as the Warrant Shares, by split-up or otherwise,or combine such shares of capital stock, or issue additional shares of capital stock as a dividend with respect to any shares of suchcapital stock, the number of Warrant Shares issuable on the exercise of this Warrant shall-2- forthwith be proportionately increased in the case of a subdivision or stock dividend, or proportionately decreased in the case of acombination. Appropriate adjustments shall also be made to the Exercise Price payable per share, but the aggregate Exercise Pricepayable for the total number of Warrant Shares purchasable under this Warrant (as adjusted) shall remain the same. Any adjustmentunder this Section 2(a)(1) shall become effective at the close of business on the date the subdivision or combination becomes effective,or as of the record date of such dividend, or in the event that no record date is fixed, upon the making of such dividend.(2) Reorganizations or Mergers. In case of any reclassification, capital reorganization or change in the capital stockof the Company (other than as a result of a subdivision, combination or stock dividend provided for in Section 2(a)(1) above andSection (d) below) that occurs after the Date of Issuance, then, as a condition of such reclassification, reorganization or change, lawfulprovision shall be made, and duly executed documents evidencing the same from the Company or its successor shall be delivered tothe Holder, so that the Holder shall thereafter have the right at any time prior to the expiration of this Warrant to purchase, at a totalprice equal to that payable upon the exercise of this Warrant, the kind and amount of shares of stock and/or other securities or property(including, if applicable, cash) receivable in connection with such reclassification, reorganization or change by a holder of the samenumber and type of securities as were purchasable as Warrant Shares by the Holder immediately prior to such reclassification,reorganization or change. In any such case, appropriate provisions shall be made with respect to the rights and interest of the Holder sothat the provisions hereof shall thereafter be applicable with respect to any shares of stock or other securities or property deliverableupon exercise hereof, and appropriate adjustments shall be made to the Exercise Price payable hereunder, provided the aggregateExercise Price shall remain the same (and, for the avoidance of doubt, this Warrant shall be exclusively exercisable for such shares ofstock and/or other securities or property from and after the consummation of such reclassification or other change in the capital stock ofthe Company).(3) Rights Upon Distribution of Assets. If the Company shall declare or make any dividend, other distribution of itsassets (or rights to acquire its assets) or evidences of its indebtedness to holders of shares of Common Stock generally (which dividendor other distribution has not already been given to the Holder with respect to the Warrant Shares), by way of return of capital orotherwise not addressed by this Section 2 above (including, without limitation, any distribution of cash, stock or other securities,property or options by way of a dividend, spin off, subdivision, reclassification, corporate rearrangement, scheme of arrangement orother similar transaction) (a “Distribution”), at any time after the issuance of this Warrant and prior to the Expiration Date, then, in eachsuch case the Holder shall be entitled (subject to the following proviso) to participate in such Distribution to the same extent that theHolder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon completeexercise of this Warrant (without regard to any limitations or restrictions on exercise of this Warrant, including, without limitation, theBeneficial Ownership Limitation) immediately before the date on which a record is taken for such Distribution, or, if no such record istaken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in suchDistribution; provided, however, that the Holder shall only be permitted to take delivery of such Distribution if and to the extent theHolder exercises some or all of the Warrant (the portion of delivery of the Distribution shall be based on-3- the pro rata portion of the Warrant Shares issuable upon the portion of the Warrant exercised as compared to the maximum number ofWarrant Shares issuable upon complete exercise of the Warrant (without regard to any limitations or restrictions on exercise of thisWarrant, including, without limitation, the Beneficial Ownership Limitation)), provided that, to the extent that the Warrant has not beenpartially or completely exercised at the time of such Distribution, such portion of the Distribution shall be held in abeyance for thebenefit of the Holder until the Holder has exercised the Warrant, at which time the Company shall issue to the Holder the pro-rataportion of such Distribution equivalent to that portion of this Warrant then exercised. Notwithstanding anything to the contrarycontained herein, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder and its affiliatesexceeding the Beneficial Ownership Limitation, if applicable pursuant to Section 5(c) herein, then the Holder shall not be entitled toparticipate in such Distribution to the extent of the Beneficial Ownership Limitation (and shall not be entitled to beneficial ownershipof such shares of Common Stock as a result of such Distribution (and beneficial ownership) to the extent of any such excess) and theportion of such Distribution shall be held in abeyance for the benefit of the Holder until such time or times, if ever, as its right theretowould not result in the Holder and its affiliates exceeding the Beneficial Ownership Limitation, at which time or times the Holder shallbe granted such Distribution (and any Distributions declared or made on such initial Distribution or on any subsequent Distributionheld similarly in abeyance) to the same extent as if there had been no such limitation).(b)Notice of Adjustment. When any adjustment is required to be made in the number or kind of shares purchasableupon exercise of the Warrant, or in the Exercise Price, the Company shall promptly notify the Holder of such event and of the numberof Warrant Shares or other securities or property thereafter purchasable upon exercise of this Warrant.(c)Calculations. No adjustment in the Exercise Price shall be required unless such adjustment would require anincrease or decrease of at least $0.01 in such price; provided, however, that any adjustment which by reason of this Section 2(c) is notrequired to be made shall be carried forward and taken into account in any subsequent adjustments under this Section 2. Allcalculations under this Section 2 shall be made by the Company in good faith and shall be made to the nearest cent or to the nearestone hundredth of a share, as applicable. No adjustment need be made for a change in the par value or no par value of the Company’sCommon Stock.(d)Treatment of Warrant upon an Acquisition.(1)In the event of an Acquisition (as defined below) prior to the Expiration Date (other than, for the purposes ofthis provision, an Acquisition consummated by way of an unsolicited third-party offer), the Company shall use its best efforts to ensurethat lawful and adequate provision shall be made whereby each Holder shall thereafter continue to have the right to subscribe for uponthe terms and conditions set forth herein in lieu of the Warrant Shares issuable upon exercise of the Warrants held by such Holder, suchnumber of shares, where the value of each new warrant to purchase one share in the surviving or acquiring entity (“Acquirer”) isdetermined in accordance with the Black-Scholes Option Pricing formula set forth in Appendix (A) hereto, that is equivalent to theaggregate value of the Warrants held by such Holder, where the value of each Warrant to-4- purchase one share of Common Stock in the Company is determined in accordance with the Black-Scholes Option Pricing formula setforth Appendix (B) hereto. Furthermore, the new warrants to purchase shares in the Acquirer referred to herein shall have the sameexpiration date as the Warrants, and shall have a strike price, KAcq, that is calculated in accordance with Appendix (A) hereto. For theavoidance of doubt, if the Acquirer surviving or acquiring entity, as the case may be, is a member of a consolidated group for financialreporting purposes, the “Acquirer” shall be deemed to be the parent of such consolidated group for purposes of this Section 2(d) andAppendix (A) hereto.(2)Moreover, appropriate provision shall be made with respect to the rights and interests of each Holder to theend that the provisions hereof (including, without limitation, provision for adjustment of the Exercise Price) shall thereafter beapplicable, as nearly equivalent as may be practicable in relation to any shares (or ADSs) thereafter deliverable upon the exercisethereof. The Company shall not effect any such Acquisition unless prior to or simultaneously with the consummation thereof thesuccessor corporation resulting from such consolidation or merger, or the corporation purchasing or otherwise acquiring such assets orother appropriate corporation or entity shall assume by written instrument, reasonably deemed by the Board of Directors of theCompany and the Holder to be satisfactory in form and substance, the obligation to deliver to the holder of the Warrants, at the lastaddress of such holder appearing on the books of the Company, such shares of stock, as, in accordance with the foregoing provisions,such holder may be entitled to purchase, and the other obligations under these Warrants. The provisions of this Section 2(d) shallsimilarly apply to successive Acquisitions.(3)If the Company, in spite of using its best efforts, is unable to cause these Warrants to continue in full forceand effect until the expiration of the Expiration Date in connection with any Acquisition, then the Company shall pay the Holders anamount per Warrant to purchase one share of Common Stock that is calculated in accordance with the Black-Scholes Option Pricingformula set forth in Appendix (B) hereto (the “Black-Scholes Value”). Such payment shall be made in cash in the event that theAcquisition results in the stockholders of the Company receiving cash from the Acquirer at the closing of the transaction, and shall bemade in shares of the Company (with the value of each share of Common Stock determined according to SCorp in Appendix (B)hereto) in the event that the Acquisition results in the stockholders of the Company receiving shares in the Acquirer or other entity atthe closing of the transaction. In the event that the stockholders of the Company receive both cash and shares at the closing of thetransaction, such payment to the Holders shall also be made in both cash and shares in the same proportion as the considerationreceived by the stockholders. Following any payment required pursuant to this Section 2(d)(3), the Warrant shall terminate, withoutpayment of any additional consideration therefor.(4)Notwithstanding the foregoing, in the event that as a result of the Acquisition the Warrants will beexercisable for anything other than shares or securities that are listed on a regulated market (within the meaning of the Markets inFinancial Instruments Directive (2004/39(EC))) or a United States national securities exchange, the Holder shall be entitled to demandto receive a cash payment in an amount equal to the Black-Scholes Value per Warrant (calculated in accordance with Appendix Battached hereto) contemporaneously with or promptly after the consummation of such Acquisition. Following any such demand, theWarrant shall-5- terminate, without payment of any consideration other than the Black-Scholes Value therefor, effective upon the payment of suchamount.(5)“Acquisition” means any of the following: (i) any sale, lease, license, transfer, conveyance or otherdisposition of all or substantially all of the assets of the Company; (ii) any reorganization, consolidation, merger, demerger or sale ofshares of the Company (including, without limitation, a public tender offer for the shares in the Company) where the holders of theCompany’s outstanding shares as of immediately before the transaction (or series of related transactions) beneficially own less than amajority by voting powers of the outstanding shares of the surviving or successor entity as of immediately after the transaction; or (iii)the acquisition by any “person” (together with his, her or its Affiliates) or “group” (within the meaning of Section 13(d) or 14(d) of theSecurities Exchange Act of 1934, as amended (the “Exchange Act”)) acquires, directly or indirectly, the beneficial ownership (as suchterm is defined in Rule 13d-3 promulgated under the Exchange Act) of outstanding shares of capital stock and/or other equity securitiesof the Company, in a single transaction or series of related transactions (including, without limitation, one or more tender offers orexchange offers), representing at least 50% of the voting power of or economic interests in the then outstanding shares of capital stockof the Company.3. NO STOCKHOLDER RIGHTS. Until the exercise of this Warrant, the Holder shall not have, nor exercise, any rights as astockholder of the Company (including without limitation the right to notification of stockholder meetings or the right to receive anynotice or other communication concerning the business and affairs of the Company), except as provided in Section 8 below.4. COVENANT TO PERFORM; NONCIRCUMVENTION. The Company hereby covenants and agrees that the Companywill at all times in good faith carry out all the provisions of this Warrant and will not, by amendment of its certificate of incorporation,bylaws or other organizational documents or through an Acquisition, dissolution, sale of assets or any other voluntary action, avoid orseek to avoid the observance or performance of any of the terms of this Warrant. Without limiting the generality of the foregoing, theCompany (i) shall not increase the par value of any shares of Common Stock receivable upon the exercise of this Warrant above theExercise Price then in effect, (ii) shall take such actions as may be necessary or appropriate in order that the Company may validly andlegally issue fully paid and nonassessable shares of Common Stock upon the exercise of this Warrant, and (iii) shall, so long as thisWarrant is outstanding, take action necessary to reserve and keep available out of its authorized and unissued shares of CommonStock, solely for the purpose of effecting the exercise of this Warrant, 100% of the number of shares of Common Stock issuable uponexercise of this Warrant then outstanding.5. MECHANICS OF EXERCISE.(a)Delivery of Warrant Shares Upon Exercise. This Warrant may be exercised by the Holder hereof upon thedelivery of a Notice of Exercise (the “Exercise Notice”) attached hereto as Exhibit A duly completed and executed on behalf of theHolder hereof, at the office of the Warrant Agent designated for such purpose together with this Warrant and payment in full of theExercise Price (unless the Holder has elected to Net Exercise) then in effect with respect to the number of-6- Warrant Shares as to which the Warrant is being exercised. This Warrant shall be deemed to have been exercised immediately prior tothe close of business on the date of its surrender for exercise as provided above, and the person entitled to receive the Warrant Sharesissuable upon such exercise shall be treated for all purposes as the holder of such shares of record as of the close of business on suchdate. The Holder shall be required to deliver the original Warrant in order to effect an exercise hereunder. Execution and delivery ofthe Exercise Notice with respect to less than all of the Warrant Shares have the same effect as cancellation of the original Warrant andissuance of a new Warrant evidencing the right to purchase the remaining number of Warrant Shares. On or before the second (2nd)business day following the date on which the Warrant Agent has duly received each of the Exercise Notice, this Warrant and theAggregate Exercise Price (or confirmation from the Company of the number of shares of Warrant Shares issuable in connection with aduly executed and delivered notice of Net Exercise), the Warrant Agent shall transmit by facsimile an acknowledgment of confirmationof receipt of the Exercise Notice to the Holder and the Company’s transfer agent (“Transfer Agent”). The Company shall deliver anyobjection to the Exercise Notice on or before the second Trading Day following the date on which the Company has received theExercise Notice. In the event of any discrepancy or dispute, the records of the Company shall be controlling and determinative in theabsence of manifest error. On or before the third (3rd) business day following the date on which the Warrant Agent has received theExercise Notice, this Warrant and the Aggregate Exercise Price (the “Share Delivery Date”), the Warrant Agent shall (X) provided thatthe Transfer Agent is participating in The Depository Trust Company (“DTC”) Fast Automated Securities Transfer Program, upon therequest of the Holder, credit such aggregate number of Warrant Shares to which the Holder is entitled pursuant to such exercise to theHolder’s or its designee’s balance account with DTC through its Deposit Withdrawal Agent Commission system, or (Y) if the TransferAgent is not participating in the DTC Fast Automated Securities Transfer Program, issue and dispatch by overnight courier to theaddress as specified in the Exercise Notice, a certificate, registered in the Company’s share register in the name of the Holder or itsdesignee, for the number of shares of Common Stock to which the Holder is entitled pursuant to such exercise. Upon delivery of theExercise Notice, this Warrant and the payment of the Aggregate Exercise Price (or a duly executed and delivered notice of NetExercise), the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares withrespect to which this Warrant has been exercised, irrespective of the date such Warrant Shares are credited to the Holder’s DTCaccount or the date of delivery of the certificates or book-entry position evidencing such Warrant Shares, as the case may be. TheCompany shall pay any and all taxes (other than taxes based upon the income of the Holder) which may be payable with respect to theissuance and delivery of Warrant Shares upon exercise of this Warrant; provided, that the Company shall not be required to pay anytax that may be payable in respect of any transfer involved in the issue and delivery of shares of Common Stock in any name otherthan that of the Holder, in either case with respect to any income or transfer tax due by the Holder with respect to such shares ofCommon Stock issued upon exercise of this Warrant.(b)Company’s Failure to Timely Deliver Securities. If the Company shall fail for any reason or for no reason to issueto the Holder by the Share Delivery Date in compliance with the terms of this Section 5, a certificate or book entry position for thenumber of shares of Common Stock to which the Holder is entitled and register such shares of Common Stock on the Company’sshare register or to credit the Holder’s balance account with DTC for such number of-7- shares of Common Stock to which the Holder is entitled upon the Holder’s exercise of this Warrant, and if on or after such trading daythe Holder purchases (in an open market transaction or otherwise) shares of Common Stock to deliver in satisfaction of a sale by theHolder of shares of Common Stock issuable upon such exercise that the Holder anticipated receiving from the Company (a “Buy-In”),then the Company shall, within three (3) business days after the Holder’s request and in the Holder’s discretion, either (i) pay cash tothe Holder in an amount equal to the Holder’s total purchase price (including brokerage commissions, if any) for the shares ofCommon Stock so purchased less the Exercise Price (the “Buy-In Price”), at which point the Company’s obligation to deliver suchcertificate or evidence of book entry position (and to issue such Warrant Shares) shall terminate, or (ii) promptly honor its obligation todeliver to the Holder a certificate or certificates or evidence of book entry position representing such Warrant Shares and pay cash tothe Holder in an amount equal to the excess (if any) of the Buy-In Price over the product of (A) such number of shares of CommonStock, times (B) the closing bid price on the date of exercise.(c) Holder’s Exercise Limitation. Notwithstanding anything to the contrary contained in this Warrant, this Warrant shall notbe exercisable by the Holder pursuant to Section 1 or otherwise, to the extent (but only to the extent) that after giving effect to suchissuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s affiliates, and any otherpersons acting as a group together with the Holder or any of the Holder’s affiliates (such Person, “Attribution Parties”)), wouldbeneficially own in excess of 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to theissuance of shares of Common Stock issuable upon exercise of this Warrant (the “Beneficial Ownership Limitation”); provided, thatnotwithstanding anything herein to the contrary, this limitation on exercise shall not be applicable to any person that beneficially owns10.0% or more of the Company’s outstanding Common Stock immediately prior to the exercise of this Warrant, but without givingeffect to any shares of Common Stock underlying this Warrant. Notwithstanding the forgoing, the Holder shall have the right toincrease or decrease the Beneficial Ownership Limitation to an amount not to exceed 9.99% of the number of shares of CommonStock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon exercise of this Warrant,with any increase to be effective only upon the Holder providing the Company with prior written notice of such increase, which shallbe effective 61 days after delivery of such notice to the Company. To the extent the above limitation applies, the determination ofwhether this Warrant shall be exercisable (vis-à-vis other convertible, exercisable or exchangeable securities owned by the Holder orany of its Attribution Parties) and of which such securities shall be exercisable (as among all such securities owned by the Holder orany of its Attribution Parties) shall, subject to such Beneficial Ownership Limitation, be determined by the Holder, and the Companyshall have no responsibility for determining the accuracy of the Holder’s determination. No prior inability to exercise this Warrantpursuant to this paragraph shall have any effect on the applicability of the provisions of this paragraph with respect to any subsequentdetermination of exercisability. For purposes of the calculation of the Beneficial Ownership Limitation, the aggregate number of sharesof Common Stock beneficially owned by the Holder and its Attribution Parties shall include the number of shares of Common Stockissuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of sharesof Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficiallyowned by the Holder-8- or any of its Attribution Parties and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of theCompany (including, without limitation, any other convertible notes or convertible preferred stock or warrants) subject to a limitationon conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its AttributionParties. Except as set forth in the preceding sentence, for purposes of this section, beneficial ownership shall be calculated inaccordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged bythe Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of theExchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. In addition, adetermination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Actand the rules and regulations promulgated thereunder. For purposes of this Section 5(c), in determining the number of outstandingshares of Common Stock, the Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) theCompany’s most recent periodic or annual report filed with the Securities and Exchange Commission, as the case may be, (B) a morerecent public announcement by the Company or (C) a more recent written notice by the Company or the Company’s transfer agentsetting forth the number of shares of Common Stock outstanding. In any case, the number of outstanding shares of Common Stockshall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holderor its Attribution Parties since the date as of which such number of outstanding shares of Common Stock was reported. The provisionsof this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 5(c)to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial OwnershipLimitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. Thelimitations contained in this paragraph shall apply to a successor holder of this Warrant. Upon the reasonable written request of theHolder, the Company shall within three (3) business days confirm orally or in writing to the Holder the number of shares of CommonStock then outstanding, including by virtue of any prior conversion or exercise of convertible or exercisable securities into CommonStock, including, without limitation, pursuant to this Warrant or securities issued pursuant to the Purchase Agreement.6. CERTIFICATE OF ADJUSTMENT. Whenever the Exercise Price or number or type of securities issuable upon exerciseof this Warrant is adjusted, as herein provided, the Company shall, at its expense, promptly deliver to the Holder and the WarrantAgent a certificate of an officer of the Company setting forth the nature of such adjustment and showing in detail the facts upon whichsuch adjustment is based.7. NOTICES.In the event of:(a)any taking by the Company of a record of the holders of any class of securities for the purpose of determining theholders thereof who are entitled to receive any dividend (other than a cash dividend payable out of earned surplus of the Company) orother distribution, or any-9- right to subscribe for, purchase or otherwise acquire any shares of stock of any class or any other securities or property, or to receiveany other right; or(b)any voluntary or involuntary dissolution, liquidation or winding-up of the Company or consummation of anAcquisition,then and in each such event the Company will promptly mail or cause to be delivered to the Warrant Agent and Holder (or apermitted transferee) a notice specifying (i) the date on which any such record is to be taken for the purpose of such dividend,distribution or right, and stating the amount and character of such dividend, distribution or right, and (ii) the date on which any suchdissolution, liquidation or winding-up is to take place, and the time, if any, as of which the holders of record of Common Stock (orother securities) shall be entitled to exchange their shares of Common Stock (or other securities) for securities or other propertydeliverable upon such dissolution, liquidation or winding-up. Such notice shall be delivered at least twenty (20) days prior to thedate therein specified.(c)Whenever any other notice is required to be given under this Warrant, unless otherwise provided herein, theCompany shall provide prompt written notice of all actions taken pursuant to this Warrant, including in reasonable detail a descriptionof such action and the reason therefore.8. REPLACEMENT OF WARRANTS. On receipt of evidence reasonably satisfactory to the Company and Warrant Agent ofthe loss, theft, destruction or mutilation of this Warrant and, in the case of any such loss, theft or destruction of this Warrant, ondelivery of an indemnity agreement reasonably satisfactory in form and amount to the Company and Warrant Agent or, in the case ofany such mutilation, on surrender and cancellation of such Warrant, the Company at its expense will execute and deliver, in lieuthereof, a new Warrant of like tenor.9. ISSUANCE OF NEW WARRANTS. Whenever the Company is required to issue a new Warrant pursuant to the terms ofthis Warrant, such new Warrant (i) shall be of like tenor with this Warrant, (ii) shall represent, as indicated on the face of such newWarrant, the right to purchase the Warrant Shares then underlying this Warrant (or in the case of a new Warrant being issued pursuantto Sections 8 or 9, the Warrant Shares designated by the Holder which, when added to the number of shares of Common Stockunderlying the other new Warrants issued in connection with such issuance, does not exceed the number of Warrant Shares thenunderlying this Warrant), (iii) shall have an issuance date, as indicated on the face of such new Warrant which is the same as theIssuance Date, and (iv) shall have the same rights and conditions as this Warrant.10. NO FRACTIONAL SHARES. No fractional Warrant Shares or scrip representing fractional shares will be issued uponexercise of this Warrant. In lieu of any fractional shares which would otherwise be issuable, the Company shall pay cash equal to theproduct of such fraction multiplied by the Fair Market Value of one Warrant Share.11. AMENDMENT AND WAIVER. Except as otherwise provided herein, the provisions of this Warrant may be amendedand the Company may take any action herein prohibited, or omit-10- to perform any act herein required to be performed by it, only if the Company has obtained the written consent of the Holder.12. TRADING DAYS. If the last or appointed day for the taking of any action or the expiration of any right required orgranted herein shall be other than a day on which the Common Stock is traded (which for the avoidance of doubt includes a Saturday,Sunday or a legal U.S. holiday) on the NASDAQ Global Market, or, if the NASDAQ Global Market is not the principal tradingmarket for the Common Stock or other such securities, as applicable, then on the principal securities exchange or securities market onwhich the Common Stock is then traded, then such action may be taken or such right may be exercised on the next succeeding day onwhich the Common Stock is so traded.13. TRANSFERS; EXCHANGES.(a)Subject to compliance with applicable federal and state securities laws and Section 7 hereof, this Warrant may betransferred by the Holder with respect to all of the Warrant Shares purchasable hereunder. For a transfer of this Warrant as an entiretyby Holder, upon surrender of this Warrant to the Warrant Agent, together with the Notice of Assignment in the form attached hereto asExhibit B duly completed and executed on behalf of the Holder, the Company shall issue a new Warrant of the same denomination tothe assignee. Upon surrender of this Warrant to the Warrant Agent, together with the Notice of Assignment in the form attached heretoas Exhibit B duly completed and executed on behalf of the Holder, for transfer of this Warrant with respect to a portion of the WarrantShares purchasable hereunder, the Company will forthwith issue and deliver upon the order of the Holder a new Warrant (inaccordance with Section 9), registered as the Holder may request, representing the right to purchase the number of Warrant Sharesbeing transferred by the Holder and, if less than the total number of Warrant Shares then underlying this Warrant is being transferred, anew Warrant (in accordance with Section 9) to the Holder representing the right to purchase the number of Warrant Shares not beingtransferred.(b)This Warrant is exchangeable, without expense, at the option of the Holder, upon presentation and surrenderhereof to the Warrant Agent for other warrants of different denominations entitling the holder thereof to purchase in the aggregate thesame number of shares of Common Stock purchasable hereunder. This Warrant may be combined with other warrants that carry thesame rights upon presentation hereof at the office of the Warrant Agent designated for such purpose together with a written noticespecifying the denominations in which new warrants are to be issued to the Holder and signed by the Holder hereof. The term“Warrants” as used herein includes any warrants into which this Warrant may be divided or exchanged.14. GOVERNING LAW; VENUE. All questions concerning the construction, validity, enforcement and interpretation of thisWarrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, withoutregard to the principles of conflicts of law thereof. With respect to any disputes arising out of or related to this Warrant, the partiesconsent to the exclusive jurisdiction of, and venue in, the state courts in the State of New York (or in the event of exclusive federaljurisdiction, the courts of the District of New York). Each party hereby irrevocably waives personal service of process and consents toprocess being served-11- in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence ofdelivery) to such party at the address in effect for notices to it under this Warrant and agrees that such service shall constitute good andsufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve processin any other manner permitted by law. EACH OF THE COMPANY AND THE HOLDER HEREBY IRREVOCABLYWAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIALBY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS WARRANT OR THETRANSACTIONS CONTEMPLATED HEREBY.15. DISPUTE RESOLUTION. In the case of a dispute as to the determination of the Exercise Price, the arithmetic calculationof the Warrant Shares or under Sections 2 or 6, the disputing party shall submit the disputed determinations or arithmetic calculations tothe other party. If the Holder and the Company are unable to agree upon such determination or calculation of the Exercise Price or theWarrant Shares within three (3) business days of such disputed determination or arithmetic calculation being submitted to the non-disputing party, then the Company shall, within two (2) business days submit the dispute to an independent, reputable accountant. TheCompany shall cause, at the expense of the prevailing party, the accountant to perform the determinations or calculations and notify theCompany and the Holder of the results no later than ten (10) business days from the time it receives the disputed determinations orcalculations. Such accountant’s determination or calculation shall be binding upon all parties absent demonstrable error.16. REMEDIES, OTHER OBLIGATIONS, BREACHES AND INJUNCTIVE RELIEF. The remedies provided in thisWarrant shall be cumulative and in addition to all other remedies available under this Warrant, at law or in equity (including a decree ofspecific performance and/or other injunctive relief), and nothing herein shall limit the right of the Holder to pursue actual damages forany failure by the Company to comply with the terms of this Warrant.17. CONSTRUCTION; HEADINGS. This Warrant shall be deemed to be jointly drafted by the Company and the Holder andshall not be construed against any person as the drafter hereof. The headings of this Warrant are for convenience of reference and shallnot form part of, or affect the interpretation of, this Warrant.18. SUCCESSORS AND ASSIGNS. Subject to applicable securities laws, this Warrant and the rights and obligationsevidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and thesuccessors and permitted assigns of the Holder. The provisions of this Warrant are intended to be for and the benefit of any Holderfrom time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.19. MISCELLANEOUS. All notices, requests, consents and other communications hereunder shall be in writing, shall be sentby confirmed electronic mail, or mailed by first-class registered or certified airmail, or nationally recognized overnight express courier,postage prepaid, and shall be deemed given when so sent in the case of electronic mail transmission, or when so received in the case ofmail or courier, and addressed as follows: (a) if to the Company, at Cambridge Discovery Park, 100 Acorn Park Drive, 5th Floor,Cambridge, MA 02140, attention of the Finance-12- Department, Attention: Finance Department; with a copy to (which shall not constitute notice) Ropes & Gray LLP, Prudential Tower,800 Boylston StreetBoston, MA 02199-3600, Attention: Marc Rubenstein and (b) if to the Holder, at such address or addresses (including copies tocounsel) as may have been furnished by the Holder to the Company in writing. The invalidity or unenforceability of any provisionhereof shall in no way affect the validity or enforceability of any other provisions.[Signature Page Follows]-13- IN WITNESS WHEREOF, this Common Stock Purchase Warrant is issued effective as of the date first set forth above.GENOCEA BIOSCIENCES, INC.By: Name: Title: SIGNATURE PAGE TOWARRANT NO. 2018-«WARRANT NO»EXHIBIT ANOTICE OF INTENT TO EXERCISE(To be signed only upon exercise of Warrant)To: Genocea Biosciences, Inc.The undersigned, the Holder of the attached Warrant, hereby irrevocably elects to exercise the purchase right represented bysuch Warrant for, and to purchase thereunder, __________________________ shares of Common Stock of Genocea Biosciences,Inc., a Delaware corporation (the “Company”), and (choose one)__________ herewith makes payment of USD ___________________________ thereofor__________ elects to Net Exercise the Warrant pursuant to Section 1(b)(2) thereof.The undersigned requests that the certificates or book entry position evidencing the shares to be acquired pursuant to suchexercise be issued in the name of, and delivered to __________________________________________, whose address is____________________________________________________________________________________________________.By its delivery of this Exercise Notice, the undersigned represents and warrants to the Company that in giving effect to theexercise evidenced hereby the Holder will not beneficially own in excess of the number of shares of Common Stock (as determined inaccordance with Section 13(d) of the Securities Exchange Act of 1934, as amended) permitted to be owned under Section 5(c) of theWarrant to which this notice relates.By its signature below the undersigned hereby represents and warrants that it is an “accredited investor” as defined in Rule501(a) of Regulation D promulgated under the Securities Act of 1933, as amended, and agrees to be bound by the terms andconditions of the attached Warrant as of the date hereof, including Section 7 thereof.DATED: (Signature must conform in allrespects to name of the Holderas specified on the face of theWarrant) «Holder»Address:  EXHIBIT BNOTICE OF ASSIGNMENT FORMFOR VALUE RECEIVED, «Holder» (the “Assignor”) hereby sells, assigns and transfers all of the rights of the undersignedAssignor under the attached Warrant with respect to the number of shares of common stock of Genocea Biosciences, Inc., a Delawarecorporation (the “Company”), covered thereby set forth below, to the following “Assignee” and, in connection with such transfer,represents and warrants to the Company that the transfer is in compliance with Section 7 of the Warrant and applicable federal andstate securities laws:NAME OF ASSIGNEEADDRESS Number of shares: Dated: Signature: ASSIGNEE ACKNOWLEDGMENTThe undersigned Assignee acknowledges that it has reviewed the attached Warrant and by its signature below it herebyrepresents and warrants that it is an “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the SecuritiesAct of 1933, as amended, and agrees to be bound by the terms and conditions of the Warrant as of the date hereof, including Section 7thereof.Signature: By: Its: Address: Appendix ABlack-Scholes Option Pricing formula to be used when calculating the value of each new warrant to purchase one share in theAcquirer shall be:CAcq = SAcqe-λ(TAcq-tAcq)N(d1) – KAcqe-r(TAcq-tAcq)N(d2), whereCAcq = value of each warrant to purchase one share in the AcquirerSAcq = price of Acquirer’s stock as determined by reference to the average of the closing prices on the securities exchange or Nasdaqover the 20-day period ending three trading days prior to the closing of the Acquisition described in Section 2(d) if the Acquirer’s stockis then traded on such exchange or system, or the average of the closing bid or sale prices (whichever is applicable) in the over-the-counter market over the 20-day period ending three trading days prior to the closing of the Acquisition if the Acquirer’s stock is thenactively traded in the over-the-counter market, or the then most recently completed financing if the Acquirer’s stock is not then tradedon a securities exchange or system or in the over-the-counter market.TAcq = expiration date of new warrants to purchase shares in the Acquirer = TCorp tAcq = date of issue of new warrants to purchase shares in the AcquirerTAcq-tAcq = time until warrant expiration, expressed in yearsσ = volatility = annualized standard deviation of daily log-returns (using a 262-day annualization factor) of the Acquirer’s stock priceon the securities exchange or Nasdaq over a 20-day trading period, determined by the Holders, that is within the 100-day tradingperiod ending on the trading day immediately after the public announcement of the Acquisition described in Section 2(d) if theAcquirer’s stock is then traded on such exchange or system, or the annualized standard deviation of daily-log returns (using a 262-dayannualization factor) of the closing bid or sale prices (whichever is applicable) in the over-the-counter market over a 20-day tradingperiod, determined by the Holder, that is within the 100-day trading period ending on the trading day immediately after the publicannouncement of the Acquisition if the Acquirer’s stock is then actively traded in the over-the-counter market, or 0.5 (or 50%) if theAcquirer’s stock is not then traded on a securities exchange or system or in the over-the-counter market. In no event will the volatilityvariable be more than 0.5 (or 50%).N = cumulative normal distribution functiond1 = (ln(SAcq/KAcq) + (r-λ+σ2/2)(TAcq-tAcq)) ÷ (σ√(TAcq-tAcq))ln = natural logarithmλ = dividend rate of the Acquirer for the most recent 12-month period at the time of closing of the Acquisition.KAcq = strike price of new warrants to purchase shares in the Acquirer = KCorp * (SAcq / SCorp)r = annual yield, as reported by Bloomberg at time tAcq, of the United States Treasury security measuring the nearest time TAcq d2 = d1- σ√(TAcq-tAcq)1 APPENDIX BBlack-Scholes Option Pricing formula to be used when calculating the value of each Warrant to purchase one share ofCommon Stock in the Company shall be:CCorp = SCorpe-λ(TCorp-tCorp)N(d1) – KCorpe-r(TCorp-tCorp)N(d2), whereCCorp = value of each Warrant to purchase one share of Common Stock in the CompanySCorp = price of Company stock as determined by reference to the average of the closing prices on Nasdaq over the 20-day periodending three trading days prior to the closing of the Acquisition described in Section 2(d) if the Company’s stock is then traded onNasdaq, or the average of the closing bid or sale prices (whichever is applicable) in the over-the-counter market over the 20-day periodending three (3) trading days prior to the closing of the Acquisition if the Company’s stock is then actively traded in the over-the-counter market, or on the AIM market, if the Company’s stock is not then traded on a securities exchange or system or in the over-the-counter market, or the most recently completed financing if the Company’s stock is not then traded on AIM.TCorp = expiration date of Warrants to purchase shares in the CompanytCorp = date of public announcement of transactionTCorp-tCorp = time until Warrant expiration, expressed in yearsσ = volatility = the annualized standard deviation of daily log-returns (using a 262-day annualization factor) of the Company’s stockprice on the securities exchange or Nasdaq over a 20-day trading period, determined by the Holders, that is within the 100-day tradingperiod ending on the trading day immediately after the public announcement of the Acquisition described in Section 2(d) if theCompany’s stock is then traded on such exchange or system, or the annualized standard deviation of daily-log returns (using a 262-dayannualization factor) of the closing bid or sale prices (whichever is applicable) in the over-the-counter market over a 20-day tradingperiod, determined by the Holder, that is within the 100-day trading period ending on the trading day immediately after the publicannouncement of the Acquisition if the Company’s stock is then actively traded in the over-the-counter market, or 0.5 (or 50%) if theCompany’s stock is not then traded on a securities exchange or system or in the over-the-counter market. In no event will the volatilityvariable be more than 0.5 (or 50%).N = cumulative normal distribution functiond1 = (ln(SCorp/KCorp) + (r-λ+σ2/2)(TCorp-tCorp)) ÷ (σ√(TCorp-tCorp))ln = natural logarithmλ = dividend rate of the Company for the most recent 12-month period at the time of closing of the Acquisition.KCorp = strike price of Warrantr = annual yield, as reported by Bloomberg at time tCorp, of the United States Treasury security measuring the nearest time TCorp d2 = d1- σ√(TCorp-tCorp)2 Exhibit 10.30 SECOND AMENDMENT TO LOAN AND SECURITY AGREEMENTTHIS SECOND AMENDMENT TO LOAN AND SECURITY AGREEMENT (this “Amendment”) is dated as ofJanuary 22, 2018 (the “Second Amendment Date”) is entered into by and among GENOCEA BIOSCIENCES, INC., a Delawarecorporation (“Borrower”), HERCULES CAPITAL, INC., a Maryland corporation (“HC”), in its capacity as administrative agentfor itself and Lender (in such capacity, “Agent”), the Lenders otherwise a party hereto from time to time including HC in its capacity asa Lender, and HERCULES CAPITAL FUNDING TRUST 2014-1(“2014 Trust”), assignee of HC (2014 Trust and HCcollectively, referred to as “Lender”).RECITALSA. Borrower, Lender and Agent entered into that certain Loan and Security Agreement, dated as of November 20, 2014, asamended by that certain First Amendment to Loan and Security Agreement, dated as of December 17, 2015 (as may be furtheramended, modified or restated from time to time, the “Loan Agreement”). Capitalized terms used herein without definition shall havethe same meanings given them in the Loan Agreement.B. Borrower has requested that the parties hereto amend the Loan Agreement as set forth herein.C. Borrower, Lender and Agent have agreed to amend the Loan Agreement upon the terms and conditions more fully setforth herein.AGREEMENTNOW, THEREFORE, the parties hereto agree as follows:1.AMENDMENTS. Subject to the satisfaction of the conditions set forth in Section 3 of this Amendment, the LoanAgreement is amended in the following respects:1.1 Section 1.1 (Definitions and Rules of Construction). The Loan Agreement is amended by inserting thefollowing new definitions to appear alphabetically in Section 1.1 thereof:“ “Deferred Payment” and “Deferred Payments” are defined in Section 2.1(d).“ “Equity Event” means confirmation by Agent, that Borrower has received, after January 1, 2018 but on or beforethe Second Amendment Date, unrestricted and unencumbered (including, not subject to any redemption, clawback,escrow or similar restriction or encumbrance) gross cash proceeds in the minimum amount of at least Fifty MillionDollars ($50,000,000.00) from the issuance and sale by Borrower of its equity securities.”“ “Second Amendment” means that certain Second Amendment to the Loan and Security Agreement by and betweenBorrower, Agent and Lender dated as of January 22, 2018.”“ “Second Amendment Date” is defined in the Second Amendment.”1.2 Section 2.1(d) (Payment). Section 2.1 is amended by inserting the following to new provision to appear as thesecond paragraph in subsection (d) thereof:Notwithstanding the foregoing, provided that no Event of Default has occurred or is continuing (after givingeffect to the Second Amendment), upon the occurrence of the Equity Event, the scheduled principal payments due onthe first (1st) Business Day of each month, for the three (3) consecutive months commencing on February 1, 2018through and including April 1, 2018 (each, a “Deferred Payment” and collectively, the “Deferred Payments”) shall bedeferred (not waived). Borrower shall continue to make monthly payments of interest as set forth herein. Commencingon May 1, 2018, and continuing on the first (1st) Business Day of each month thereafter, Borrower shall repay theaggregate Term Loan Advances, including the Deferred Payments, in equal monthly installments of principal andinterest (mortgage style) based upon an amortization schedule equal to thirty (30) consecutive months. The entireprincipal balance of the Term Loan Advances, including Deferred Payments and all accrued but unpaid interesthereunder, and all other Secured Obligations with respect to the Term Loan Advances, shall be due and payable onTerm Loan Maturity Date.2.BORROWER’S REPRESENTATIONS AND WARRANTIES. Borrower represents and warrants that:(a) Immediately upon giving effect to this Amendment (i) the representations and warranties contained in the LoanDocuments are true and correct in all material respects as of the date hereof (except to the extent such representations and warrantiesrelate to an earlier date, in which case they are true and correct as of such date), and (ii) no Event of Default has occurred and iscontinuing with respect to which Borrower has not been notified in writing by Lender.(b) The certificate of organization, operating agreement and other organizational documents of Borrower previouslydelivered to Lender remain true, accurate and complete and have not been amended, supplemented or restated and are and continue tobe in full force and effect.(c) The execution and delivery by Borrower of this Amendment and the performance by Borrower of all of itsagreements and obligations under the Loan Agreement and other Loan Documents, as amended by this Amendment, have been dulyauthorized by all necessary company action on the part of Borrower. With respect to Borrower, the execution and delivery byBorrower of this Amendment does not and will not require any registration with, consent or approval of, or notice to any Person(including any governmental authority).(d) This Amendment, the Loan Agreement and the other Loan Documents, as amended hereby, constitute the legal,valid and binding obligations of Borrower enforceable againstBorrower in accordance with their terms, except as enforceability is limited by bankruptcy, insolvency, reorganization, moratorium,general equitable principles or other laws relating to or affecting generally the enforcement of, creditors’ rights and except to the extentthat availability of the remedy of specific performance or injunctive relief is subject to the discretion of the court before which anyproceeding therefor may be brought.(e) Immediately after giving effect to this Amendment (i) no fact or condition exists that would (or would, with thepassage of time, the giving of notice, or both) constitute an Event of Default, and (ii) no event that has had or could reasonably beexpected to have a Material Adverse Effect has occurred and is continuing.3.EFFECTIVENESS. This Amendment shall become effective upon the satisfaction of all the following conditionsprecedent:3.1 Amendment. Borrower, Agent and Lender shall have duly executed and delivered to Lender (i) this Amendment,and (ii) all other documents and instruments reasonably required by Lender to effectuate the transactions contemplated hereby, in allcases in form and substance reasonably acceptable to Lender.3.2 Equity Event. Confirmation by Agent that the Equity Event has occurred.3.3 No Default. As of the Second Amendment Date, no fact or condition exists that would (or would, with thepassage of time, the giving of notice, or both) constitute an Event of Default.3.4 Fees and Expenses. Borrower shall have paid to Agent an amount equal to the documented out-of-pocket costsand expenses and reasonable attorneys’ fees and documented expenses that Lender and Agent have incurred in connection with thisAmendment.4.COUNTERPARTS. This Amendment may be signed in any number of counterparts (including by facsimile orother electronic transmission), with the same effect as if the signatures to each such counterpart were upon a single instrument. Allcounterparts shall be deemed an original of this Amendment.5.MISCELLANEOUS. Lender and Borrower agree that:5.1 THIS AMENDMENT AND ALL MATTERS RELATING THERETO OR ARISING THEREFROMSHALL BE GOVERNED BY, AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THESTATE OF CALIFORNIA, EXCLUDING CONFLICT OF LAWS PRINCIPLES THAT WOULD CAUSE THEAPPLICATION OF LAWS OF ANY OTHER JURISDICTION.5.2 This Amendment expresses the entire understanding of the parties with respect to the transactions contemplatedhereby. No prior negotiations or discussions shall limit, modify, or otherwise affect the provisions hereof, and no extrinsic evidencemay be introduced in any judicial or arbitration proceeding, if any, involving this Amendment.5.3 Any determination that any provision of this Amendment or any application hereof is invalid, illegal orunenforceable in any respect and in any instance shall not affect the validity, legality, or enforceability of such provision in any otherinstance, or the validity, legality or enforceability of any other provisions of this Amendment.5.4 The captions in this Amendment are for convenience of reference only and shall not define or limit the provisionshereof.[Signature page follows]IN WITNESS WHEREOF, the parties have duly authorized and caused this Amendment to be executed as of the SecondAmendment Date.BORROWER:GENOCEA BIOSCIENCES, INC.Signature: _/s/ Jonathan Poole_______Print Name: _Jonathan Poole _________Title: _Chief Financial Officer___AGENT:HERCULES CAPITAL, INC.Signature: _/s/ Jennifer Choe________Print Name: _Jennifer Choe ______ ___Title: _Assistant General Counsel_LENDER:HERCULES CAPITAL, INC.Signature: _/s/ Jennifer Choe________Print Name: _Jennifer Choe ______ ___Title: _Assistant General Counsel_HERCULES CAPITAL FUNDING TRUST 2014-1By: HERCULES CAPITAL, INC., its servicerSignature: _/s/ Jennifer Choe________Print Name: _Jennifer Choe ______ ___Title: _Assistant General Counsel_ Exhibit 10.31THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.LICENSE AND SUPPLY AGREEMENTby and betweenGENOCEA BIOSCIENCES, INC.andONCOVIR, INC.TABLE OF CONTENTSPage1.Definitions. 12.License and Supply ofProduct. 53.Up-Front Payment; InitialSupply. 64.Additional Orders andSupply of Product; Marketing Approval Milestone Payment. 75.DIRECT OR INDIRECTEARNED SALES ROYALTIES: 86.Terms and Conditions ofSale 97.ManufacturingSupport. 128.Regulatory Support. 159.Certain Representationsand Covenants. 1610.Indemnification,Insurance and Liability. 1711.Confidentiality ofAgreement12.Inventions andIntellectual Property 1913.Term andTermination 2014.Miscellaneous 22LICENSE AND SUPPLY AGREEMENTThis License and Supply Agreement (“Agreement”) is made effective as of January 26, 2018 (the “Effective Date”) by and betweenGENOCEA BIOSCIENCES, Inc. a Delaware corporation having its principal office at 100 Acorn Park Drive, Cambridge, MA02140 (“GENOCEA” or ‘COMPANY’), and ONCOVIR, Inc., a Delaware corporation having its principal office at 3203Cleveland Ave., NW, Washington, DC 20008 (“ONCOVIR”). Each of GENOCEA and ONCOVIR, are sometimes referred toherein individually as a “Party”, and collectively, as the “Parties.”WHEREAS, ONCOVIR owns and controls the Product (as defined below) which Product is currently manufactured [* * *]for ONCOVIR by [* * *] (hereafter referred to as the “Manufacturer”);WHEREAS, ONCOVIR owns and controls certain additional information, methods, know-how, formulas, compositions,plans, specifications, data (including, without limitation, regulatory, safety, efficacy and pharmacological data), manufacturingimprovements, trade secrets, Patents and other intellectual property, associated with development and manufacture of the Product;WHEREAS, ONCOVIR maintains two Drug Master Files (each, a “DMF”) and two INDs at the United States Food andDrug Administration (“FDA”) that includes manufacturing intellectual property for the Product plus additional toxicology,pharmacology and clinical safety and efficacy data relating to the Product; andWHEREAS; the Parties wish to define the terms under which ONCOVIR will supply and license to GENOCEA the Productfor the conduct of research, product development, clinical trials and commercialization in conjunction with GENOCEA’s vaccines andits pharmaceuticals in the Territory (as defined below).NOW THEREFORE, in consideration of the foregoing, and the mutual promises set forth herein, the adequacy andsufficiency of which are hereby acknowledged, the Parties hereto agree as follows:1.Definitions.1.1 “Act” means the United States Federal Food, Drug and Cosmetic Act, as amended to date and as may be furtheramended from time to time during the Term, and the regulations promulgated with respect thereto.1.2 “Affiliate” means, with respect to any Person, any other Person which directly or indirectly controls, is controlledby, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, ordirectly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or ifit directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person byany means whatsoever.1.3 “Applicable Law” means all laws, rules, regulations and guidelines within the United States of America and theEuropean Union, as applicable, (including, but not limited to, the Act and all regulations promulgated thereunder, including, butnot limited to, cGMP), as existing as of the Effective Date and as may be amended from time to time thereafter, that apply to theimport, export, research, development, manufacture, marketing, distribution and/or sale of Products in the USA or theperformance of either Party’s obligations under this Agreement.1.4 “Change of Control” means, with respect to ONCOVIR, (a) a merger or consolidation of ONCOVIR with a thirdparty which results in the voting securities of ONCOVIR outstanding immediately prior thereto ceasing to represent at least fiftypercent (50%) of the combined voting power of the surviving entity or its ultimate parent entity immediately after such merger orconsolidation, (b) a transaction or series of related transactions in which one or more third parties, together with its or theirAffiliates, becomes the owner of fifty percent (50%) or more of the combined voting power of ONCOVIR’s outstandingsecurities other than through issuances by ONCOVIR of securities of ONCOVIR in a bona fide financing transaction or series ofrelated bona fide financing transactions, or (c) the sale or other transfer to a third party of all or substantially all of ONCOVIR’sassets or all or substantially all of ONCOVIR’s business to which this Agreement relates.1.5 “Commercially Reasonable Efforts" means efforts and resources comparable to those undertaken bypharmaceutical/biotech companies to develop, market, supply, sell and distribute a product owned by it or to which it has rights,which is of similar overall market potential at a similar stage in its product lifecycle.1.6 “GENOCEA Technology” means any [* * *] of GENOCEA that GENOCEA wishes to use in combination withthe Product.1.7 “GAAP” means U.S. generally accepted accounting principles as in effect at the relevant time or for the relevantperiod applied on a consistent basis during the period involved.1.8 “cGMP” means the then-current good manufacturing practices as described in Applicable Law, including Parts 210and 211 of Title 21 of the United States Code of Federal Regulations FDA and European Medicine Agency, together with thelatest guidance documents pertaining to manufacturing, testing and quality control practice. To the extent any additionalmanufacturing practices are required to comply with applicable law, GENOCEA and ONCOVIR shall work together to satisfysuch requirements.1.9 “Combination Product” means any product or bundle of products consisting of a combination of GENOCEATechnology and the Product, whether administered together or separately as part of a given therapy, for any indication.Combination Product includes but is not limited to personalized cancer vaccines (“Personalized Vaccines”) and GENOCEAnon-personalized or off-the-shelf cancer vaccines (“Off-the-shelf Vaccines”). It is anticipated that Company’s first CombinationProduct will be Personalized Vaccines. Combination Product does not include Product administered alone or with other inactiveingredients or excipients or in controlled release formulations.1.10 “Effective Date” has the meaning set forth in the preamble.1.11 “Total Net Sales” Means the gross invoice price from the sale, lease or other transfer or disposition, other than bysublicense, of a Combination Product by the Company or any sublicensee or affiliate to third parties, less the followingdeductions, provided they actually pertain to the disposition of the particular Combination Product and, in the case of the itemsspecified in the immediately succeeding clauses are separately stated on the applicable invoice or are provided in a separateinvoice:(i) reasonable returns, allowances, refunds, and rebates actually paid, granted or accrued, (ii) trade, quantity, cash, andother discounts and any other reasonable adjustments actually allowed or granted, including, but not limited to, thosegranted on account of price adjustments (including retroactive price adjustments), billing errors, rejected goods,damaged or defective goods, or recalls, (iii) chargebacks, rebates, reimbursements or similar payments or adjustmentsgranted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions,pharmacy benefit management companies, health maintenance organizations or other health care organizations, or anygovernmental or regulatory authority or agency (including their purchasers and/or reimbursers), (iv) adjustments arisingfrom consumer discount programs, (v) customs or excise duties, tariffs, sales, consumption, value added, and othertaxes (except income taxes) or similar payments related to particular sales or shipments of the Combination Product asmay be considered reasonable and customary in the Industry, and (vi) freight, handling and insurance Notwithstandinganything herein to the contrary, the transfer of a Combination Product to an Affiliate, sublicensee, or other Third Party(i) in connection with the research, development or testing of a Combination Product, (ii) for purposes of distribution aspromotional samples or resale, or (iii) for indigent or similar public support or compassionate use programs shall not, inany case, be considered a sale of a Combination Product under this Agreement.Except as set forth in in Section 5.3, no deductions shall be made for any other costs or expenses, including, but notlimited to, payments due to third parties, royalties of any kind, commissions to independent sales agents or those on theCompany’s or a sublicensee’s or affiliate’s payroll or for the cost of collection.1.12 “ONCOVIR IP” means any and all ONCOVIR Proprietary Information, Patents, technical and regulatoryinformation, know-how and other rights which are related to the Product and are as of the Effective Date or at any time duringthe Term owned or controlled by ONCOVIR or any of its Affiliates.1.13 “ONCOVIR Proprietary Information” means any and all proprietary improvements, methods, know-how,formulas, compositions, plans, specifications, data (including, without limitation, regulatory, safety, efficacy and pharmacologicaldata) or other intellectual property of any kind, related to the formulation, manufacture, production or use of the Product.1.14 “Patents” shall mean those patents and patent applications listed on Appendix C attached hereto and anycontinuations, continuations in part, divisionals, provisionals, continued prosecution applications, substitutions, reissues,reexaminations, extensions, supplemental protection certificates, registrations, confirmations or renewals thereof.1.15 “Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association,joint venture, non-profit organization, pool, syndicate, sole proprietorship, unincorporated organization, university, governmentalauthority or any other form of entity not specifically listed herein.1.16 “Product” means ONCOVIR’s standalone immunomodulator and vaccine adjuvant, Poly-Inosinic-Poly-CytidylicAcid-polyLysine-Carboxymethylcellulose (poly-ICLC, Hiltonol®) as defined in ONCOVIR’s BB-DMF 14,302 and allimprovements thereto made after the Effective Date.1.17 “Purchase Orders” has the meaning set forth in Section 2.3.1.18 “Regulatory Authority” means any federal, state or local regulatory agency, department, bureau or othergovernmental entity, including, without limitation, the FDA, that is responsible for issuing approvals, licenses, registrations orauthorizations necessary for the production, use, storage, import, transport or sale of Product in its jurisdiction.1.19 “Regulatory Requirements” means all applicable approvals, licenses, registrations, cGMP requirements, therequirements stipulated in the International Convention on Harmonisation guidelines on quality, authorizations and all otherrequirements of each applicable Regulatory Authority in relation to the Product, including, but not limited to, each of theforegoing which is necessary for, or otherwise governs, the manufacture, packaging, labeling, handling, use, storage, import,export, transport, distribution or sale of Product.1.20 “Regulatory Standards” has the meaning set forth in Section 6.5.1.21 “Royalty Term” means the period that begins on the Effective Date and ends ten (10) years after the EffectiveDate or the date on which last Valid Claim of any of the Patents expires, whichever is longer.1.22 “Specifications” means the quality assurance and other requirements, procedures, guidelines and specifications forthe manufacturing, packaging, labelling, handling, dating and storage of the Product, each as set forth in the applicable DMF forsuch Product or as may be required pursuant to any Regulatory Requirements or Applicable Law, and further including thespecifications attached hereto as Appendix B and as may be amended from time to time as required by any RegulatoryRequirements, Applicable Law or by the mutual written agreement of the Parties.1.23 “Supply Interruption” will have the meaning set forth in Section 7.5.1.24 “Term” means the period that begins on the Effective Date and ends upon any expiration without renewal orearlier termination of this Agreement.1.25 “Territory” means any and all countries of the World.1.26 “Valid Claim” means any claim of an issued and unexpired Patent on a country by country basis within theONCOVIR IP where such claim has not been donated to the public, abandoned, disclaimed, revoked or held unpatentable,invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been admitted to be invalidor unenforceable through reissue, re-examination, disclaimer or otherwise.2. License and Supply of Product.2.1 License Grant. ONCOVIR grants to GENOCEA a non-exclusive, assignable (to the extent provided in Section14.2 below), royalty-bearing (to the extent provided in Section 5.1) license throughout the Territory, with the right to grantsublicenses through one tier, under the ONCOVIR IP in connection with the research, development, registration, use, sale,offering for sale, having sold, marketing, importation, or any other activities related to the research, development orcommercialization of any Combination Products, including the use of the Product in connection with any of the foregoing, butnot for manufacturing, use or sale of the Product alone or with inactive ingredients or excipients or in timed release formulations.The foregoing license shall remain in effect at all times during the Term.2.2 Supply of Products to GENOCEA. During the Term, GENOCEA shall purchase Product from ONCOVIR, andONCOVIR will supply Product to GENOCEA on the terms set forth in this Agreement, as requested by GENOCEA for use inconnection with the research, development, registration, use, sale, offering for sale, having sold, importation, manufacture,commercialization, and marketing of Combination Products.(a)Notwithstanding anything to the contrary set forth in this Agreement, GENOCEA shall not be required to purchaseany minimum quantity of Product from ONCOVIR.(b)In accordance with the provisions 14.2, if GENOCEA proposes to enter into a license to or development agreementwith a third party or an Affiliate of GENOCEA for research, development or commercialization of aCombination Product, then GENOCEA shall grant such third party or GENOCEA Affiliate, as the case maybe, the applicable sublicense rights and ensure that such sublicensee agrees to be bound in writing by theapplicable obligations hereunder with respect to the Product(c)The supplied Hiltonol® for clinical trial use for any Combination Product will be cGMP grade and meet US FDAand European EMA quality requirements for clinical trial use. To the extent any additional qualityrequirements are required to comply with applicable law, GENOCEA and ONCOVIR shall work together tosatisfy such requirements.(d)The supplied Hiltonol® for use in commercial production and sale of any Combination Product will be cGMP gradeand meet US FDA regulatory quality requirements for commercial product use, subject to the provisions ofsections 6 and 8, “Regulatory Support”.2.3 Purchase Orders and Lead Time. GENOCEA shall issue written purchase orders for Product (“PurchaseOrders”) for specific amounts of Product from ONCOVIR as GENOCEA may determine from time to time. ONCOVIR shallsupply such quantities of Product as are requested by GENOCEA, vialed in such amounts per vial and labeled as GENOCEAreasonably requests, and for which GENOCEA agrees to pay any reasonable added set-up charges incurred by ONCOVIR forany nonstandard vial types or sizes. Purchase Orders must provide for a lead time for manufacturing of not less than [* * *] fromthe date of the Purchase Order to the date of delivery of the Product ordered, unless stock Product is available that meetsGENOCEA’s specifications or as otherwise agreed to by ONCOVIR. ONCOVIR will use Commercially Reasonable Efforts tohave stock available or substantially reduce such lead time, will coordinate such efforts with GENOCEA, and will reduce suchlead time for Purchase Orders by GENOCEA as such reductions are achieved.3. Up-Front Payment; Initial Supply.3.1 Up-Front Payment. GENOCEA will pay ONCOVIR an upfront fee of [* * *], with [* * *] due [* * *] after theexecution of this Agreement and [* * *] within [* * *] thereafter. (the “Up-Front Payment”). The Up-Front Payment willconstitute consideration for the license granted to GENOCEA in Section 2, the Initial Supply (as defined below), and theregulatory support and manufacturing support services to be provided by ONCOVIR under Sections 7 and 8 below.3.2 Initial Supply of Product. In consideration of the Up-Front Payment, ONCOVIR will supply GENOCEA, within[* * *] after written request by GENOCEA and at no additional charge, with [* * *] vials of Product from its last manufacturingrun [* * *] (with each vial containing [* * *]. Concentration is [* * *]. In addition, in consideration of the Up-Front Payment,ONCOVIR will supply GENOCEA, at no additional charge, with [* * *] vials of Product (with each vial containing [* * *])from ONCOVIR’s next manufactured lot of Product (the “Initial Supply”), currently estimated for delivery in February 2018.4. Additional Orders and Supply of Product; Marketing Approval Milestone Payment.4.1 Purchase Orders and Payments. During the pre-clinical and clinical trial stage of each Combination Product, theCompany shall purchase from ONCOVIR, and ONCOVIR shall supply the Company, with such quantities of the Product foruse only in such Combination Product in a pre-clinical or clinical trial setting as are specified by the Company from time totime. Once the Company receives regulatory approval to market a Combination Product, the Company shall market and sellsuch Combination Product in accordance with Company’s marketing plans and strategy.The Company shall purchase from ONCOVIR, and ONCOVIR shall supply the Company with, all of the Company’srequirements for Product in such quantities of the Product as are specified by the Company from time to time, for use only insuch Combination Product.The Company shall provide periodic rolling forecasts to ONCOVIR regarding the Company’s anticipated needs for theProduct so that ONCOVIR can plan its production and supply Product to the Company in the quantities and on the deliverydates requested by the Company from time to time.4.2 After receipt of each Purchase Order, ONCOVIR shall issue to GENOCEA an invoice containing the total pricefor the quantities of Product set forth in the Purchase Order (at the pricing set forth in Section 4.3 or Section 4.4 below, asapplicable). ONCOVIR shall deliver the quantities of Product set forth in the Purchase Order to GENOCEA by the deliverydate specified by GENOCEA in such Purchase Order, provided that such delivery date is no sooner than the lead time set forthin Section 2.3 or otherwise agreed upon by ONCOVIR. Within [* * *], GENOCEA will make a payment to ONCOVIR of [** *] of the total price, with, [* * *]. For clarity, if ONCOVIR has Product in inventory for immediate delivery then [* * *].Payment(s) will be promptly refunded in the event of non-conformance with Specifications. Interest shall accrue on paymentsor refunds that are not paid when due at the rate of [* * *]4.3 Product Pricing for Research Use. The supply price that ONCOVIR will charge to GENOCEA for Product foruse in clinical trials and other research purposes shall be [* * *], and for which GENOCEA agrees to pay any reasonableadded set-up charges incurred by ONCOVIR. In addition, GENOCEA may request a reasonable amount of research grade(non-GMP) Product, if available, at a reduced price.4.4 Product Pricing for Commercial Use. Following marketing approval of the Combination Product, GENOCEAshall purchase from ONCOVIR, and ONCOVIR shall supply GENOCEA with such quantities of Product for use only in theCombination Product as are specified by GENOCEA from time to time. The initial cost of Product for GENOCEA afterregulatory approval of the applicable Combination Product shall be [* * *], and for which GENOCEA agrees to pay anyreasonable added set-up charges incurred by ONCOVIR.4.5 Price Changes: ONCOVIR may increase the sale price of the Product on no more than an annual basis, but suchincreases shall be limited to:(1) reasonable increases in ONCOVIR’s manufacturing costs, but in no event more than [* * *] perannum, supported by financial analysis or (2) as otherwise mutually agreed by the Company and ONCOVIR. The "BaseYear" is the year that ends [* * *] after the Effective Date.4.6 Milestone Payments. For each Combination Product the Company, its affiliates and/or sublicensees shall pay thefollowing milestone royalties within [* * *] of the following:(1) a non-refundable milestone royalty of [* * *] upon the [* * *]; and(2) a non-refundable milestone royalty of [* * *] upon the [* * *].Each of the foregoing Milestone Royalties shall be payable only once for each Combination Product.5. DIRECT OR INDIRECT EARNED SALES ROYALTIES:5.1 Royalties(a) [* * *] Combination Products. During the Royalty Term, GENOCEA shall make calendar-quarterly royaltypayments on annual Total Net Sales of each Combination Product by GENOCEA, its Affiliates and its sublicensees, ona product-by-product basis (worldwide) as follows:[* * *](b) Combination Products using [* * *]. During the Royalty Term, GENOCEA shall make calendar-quarterlyroyalty payments on annual Total Net Sales of each Combination Product by GENOCEA, its Affiliates and itssublicensees, on a product-by-product basis (worldwide) as follows:[* * *](c) For any other Combination Products except as outlined in 5(a) and 5(b) above, Royalties will be negotiated.5.1 Payment. GENOCEA will pay any royalties due ONCOVIR on a quarterly basis, within [* * *] after the end ofthe calendar quarter in which the Net Sales to which the royalties relate were received by GENOCEA, its Affiliates or itssublicensees.5.2 Third Party Offsets. ONCOVIR represents and warrants it has Patents, listed under Appendix C, giving itexclusivity and freedom to operate the licensed technology. If, at any time, Company discovers that Product infringes theintellectual property of a third party, as determined by a Court of competent jurisdiction, Company may, if it has not alreadydone so, negotiate with the owner of such intellectual property for a license. Should the license with the owner of suchintellectual property require the payment of royalties or other consideration to such owner, then the royalties otherwise payableunder this Agreement shall be reduced [* * *]; provided that in no event shall the royalty payable under this Agreement bereduced by more than [* * *].6. Terms and Conditions of Sale6.1 Notification of Inability to Fill Orders. ONCOVIR shall advise GENOCEA as soon as reasonably practicableof any inability of ONCOVIR to make full and timely delivery of Product ordered by GENOCEA.6.2 Delivery. All Product supplied under this Agreement shall be supplied to GENOCEA at ONCOVIR’s designatedmanufacturing or warehouse location and shall be shipped by a carrier selected by GENOCEA to such location as designatedby GENOCEA in the applicable Purchase Order. Title and risk of loss, delay and damage shall pass to GENOCEA upondelivery to GENOCEA’s carrier. At GENOCEA’s request ONCOVIR may arrange for shipping and insurance. ONCOVIRshall not ship any goods until GENOCEA confirms whether it desires to obtain insurance on such shipment, or waives suchright. All costs incurred by ONCOVIR in so doing shall be invoiced directly to, and upon receipt payable directly by,GENOCEA. ONCOVIR shall assist GENOCEA with shipping and insurance in such manner as GENOCEA reasonablyrequests. All Product will be packaged for shipment with commercial packaging generally suitable for shipment via land, air orsea, as applicable, in standardized containers in accordance with ONCOVIR’s standards and procedures. In the event of acarrier’s mis-delivery, ONCOVIR shall offer reasonable assistance to GENOCEA (at no additional cost) in dealing with thecarrier in tracing the shipment.6.3 Sales and Use Taxes. GENOCEA shall pay any duty, sales or use taxes or similar fees or costs that may apply tothe supply of Product hereunder. In the event ONCOVIR incurs any such duty, sales or use taxes or similar fees or costs infilling an order, such expenses may be invoiced separately and shall be payable upon receipt by GENOCEA. GENOCEA’sobligation to pay the taxes and other costs set forth above shall only apply to transfers of goods between ONCOVIR andGENOCEA designated facilities.6.4 Product Quality; Records; Retentions. All Product supplied hereunder will initially meet the Specifications andall applicable Regulatory Requirements of the Regulatory Authorities of the United States, (including, but not limited to, thoserelated to quality) with respect to clinical use of the Product in the United States (the “Regulatory Standards”). For clarity andsubject to Section 6.5, as of the Effective Date, the Product manufacturing process is not yet fully validated and Product maynot yet meet all Regulatory Requirements for commercial sale in the United States or other countries of the Territory.ONCOVIR shall maintain, and shall cause the Manufacturer and any other supplier to ONCOVIR to maintain, true andcomplete books, records, test and laboratory data, reports and other information accurately documenting the manufacture andsupply of the Product, including all information required to be maintained by Applicable Law. ONCOVIR shall maintain andstore samples of all Product released and supplied under this Agreement with a certificate of analysis for such period as may berequired by Applicable Law. If GENOCEA requests, ONCOVIR shall maintain such samples for a longer period atGENOCEA’s expense.6.5 Regulatory Approvals; Cooperation. ONCOVIR will cooperate with the Company to assist the Company inobtaining regulatory approval for any clinical trials of each Combination Product and marketing approval for commercial salesof such Combination Product, including, without limitation, providing Company the right to cross reference the Drug MasterFile.ONCOVIR shall provide the Company, at the Company’s request, with its materials, documents and support to assist theCompany in obtaining regulatory approval for any clinical trial related to a Combination Product. ONCOVIR will provide theCompany cross-reference authorization to its Poly-ICLC DMF and IND FDA filings. ONCOVIR will also provide all safetydocumentation and selected Product manufacturing information, including all available Product stability data, directly toCompany for its regulatory filings. The parties acknowledge that Product manufacturing process is not yet fully validated and the Product may not yet meet allFDA regulatory requirements for commercial sale in the United States or other countries of the Territory. However,ONCOVIR is currently planning a Product quality and regulatory strategy and other measures to supply the Product to theCompany in compliance with applicable regulatory Requirements of the regulatory authorities of the United States and theEuropean Union for conduct of phase III trials and for commercial sale, and as required by regulatory authorities for othercountries in the Territory to be agreed by the Company and ONCOVIR. ONCOVIR shall keep GENOCEA apprised of thestrategy.The Product shall have its manufacturing process validated to conduct phase III trials in the USA or Europe prior to Companybeing required to pay the milestone payment associated with such.Notwithstanding the above, certain of ONCOVIR’s manufacturing method details and batch records containing trade secretsand proprietary information shall not be released to the Company, its successors or assigns. However, ONCOVIR will provideinformation required for regulatory filings and will allow independent audit of its manufacturing facilities and all regulatorydocumentation, at the Company’s expense and subject to the manufacturer’s scheduling constraints. All such information shallbe treated as ONCOVIR Confidential Information.6.6 Certification of Quality and Quantity. ONCOVIR shall provide GENOCEA with a certificate stating that thequality and quantity of each batch of Product sold to GENOCEA conforms to the Specifications, the Regulatory Standards, theRegulatory Requirements (when applicable) and the GENOCEA Purchase Order requirements. ONCOVIR will provide toGENOCEA a written certificate of analysis with each delivery of Product.6.7 Implied Acceptance. Subject to Section 6.9, if within [* * *] of GENOCEA’s receipt of any quantity of Productfrom ONCOVIR, GENOCEA does not notify ONCOVIR that the relevant quantity does not comply with the Specifications,GENOCEA’s Purchase Order requirements, or the Regulatory Standards (or Regulatory Requirements, when applicable), andsubmit a sample of the non-compliant Product, that quantity shall be deemed to comply in all respects with the Specifications,GENOCEA’s Purchase Order requirements and the Regulatory Standards (or Regulatory Requirements, when applicable).6.8 Rejection. If GENOCEA notifies ONCOVIR (within the [* * *] period set forth in Section 6.7) of non-compliance of Product with the Specifications, GENOCEA’s Purchase Order requirements, or the Regulatory Standards (orRegulatory Requirements, when applicable), then ONCOVIR shall check the conformity to the Specifications, GENOCEA’sPurchase Order requirements, and Regulatory Standards (or Regulatory Requirements, when applicable) of such sample. Incase ONCOVIR confirms that the sample does not conform, then GENOCEA shall have properly rejected such shipment ofProduct, and GENOCEA shall at its option (i) receive a refund for any amounts already paid to ONCOVIR for the rejectedProduct (ii) request ONCOVIR deliver conforming Product; (iii) and/or receive a credit for any amounts already paid toONCOVIR for the rejected Product against the amount due for the next shipment of Product accepted by GENOCEA untilsuch credit shall have been fully utilized. At the request of ONCOVIR, GENOCEA shall either return or destroy the rejectedProduct, at the cost and expense of ONCOVIR. In case the opinions of GENOCEA and ONCOVIR, differ on the conformityor nonconformity of the product to Specifications, GENOCEA’s Purchase Order requirements or Regulatory Standards (orRegulatory Requirements, when applicable), the Parties shall meet in order to settle the difference amicably. If the differencecannot be settled amicably, it will be submitted to an independent expert, to be designated by both Parties, and any testingassociated therewith will be submitted to an independent laboratory, to be designated by both Parties. The opinion of theindependent expert shall be final. The cost of the independent expert and laboratory shall be borne by the losing Party.6.9 Product Recalls. Other than with regard to normal expiration of Product, in the event: (i) a regulatory authority orother national government authority of the United States or the European Union issues a request, directive or order that theProduct be recalled; (ii) a court of competent jurisdiction orders such a recall of the Product, or (iii) ONCOVIR or GENOCEAreasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shallcooperate in any governmental investigations surrounding the recall. ONCOVIR shall be responsible for replacing the quantityof Product that was recalled at no cost to GENOCEA. ONCOVIR shall use all commercially reasonable efforts to replacesuch Product as soon as practicable. In addition, ONCOVIR agrees that it shall be responsible for the administrative expensesof any Product recall. For purposes of this Agreement, the administrative expenses of recall shall include the expenses ofnotification and destruction or return of the recalled Product, and any costs associated with the delivery of replacement Productto Company, but shall not include cost of Combination Product or lost profits. 7. Manufacturing Support.7.1 Manufacturing Transparency. ONCOVIR shall use commercially reasonable efforts to provide GENOCEA withtransparency on the manufacture of Product and allow GENOCEA’s commercially reasonable manufacturing needs to influenceONCOVIR strategy and actions in the manufacturing process so that the manufacturing of Product will comply with theSpecifications, GENOCEA’s Purchase Order requirements or Regulatory Standards (or Regulatory Requirements, whenapplicable) applicable to the Product and any Combination Product in the U.S.A., European Union, and Canada.7.2 Manufacturing Specifications. ONCOVIR shall manufacture, or cause to be manufactured, Product under thisAgreement in compliance with all applicable Specifications, GENOCEA’s Purchase Order requirements, Regulatory Standardsand Regulatory Requirements and in accordance with the representations and warranties set forth in this Agreement.7.3 Inspection of Manufacturing Facilities. ONCOVIR shall permit GENOCEA, at GENOCEA’s sole expense, to visitManufacturer’s premises, upon ten (10) day’s prior notice, during normal working hours, for the purpose of inspecting themanufacturing processes and components used in the manufacture of Product to determine whether the Product is beingmanufactured in accordance with the Specifications, GENOCEA’s Purchase Order requirements and Regulatory Standards (orRegulatory Requirements, when applicable). The inspector shall be entitled to access to ONCOVIR Proprietary Information asrequired to certify the compliance or non-compliance of the Product and the Manufacturer to the Specifications, GENOCEA’sPurchase Order requirements, Regulatory Standards (or Regulatory Requirements, when applicable). If the inspector is notcovered by the confidentiality obligations of GENOCEA hereunder, the inspector shall be required to execute a confidentialityagreement on commercially reasonable terms acceptable to ONCOVIR (such acceptance not to be unreasonably withheld) beforereviewing any ONCOVIR Proprietary Information. The inspector shall not copy ONCOVIR Proprietary Information or removesuch from the Manufacturer’s premises. Subject to the foregoing, and to the extent necessary for regulatory compliance byGENOCEA and the safety of patients exposed to a Combination Product, the inspector may reveal to the Parties hereunder:(a) whether the manufacture of the Product complies with the requirements set forth herein or under Applicable Law; and (b) asummary and description of the type of non-compliance with the requirements set forth herein or under any Applicable Law. Inall cases, GENOCEA shall treat all non-public information subject to review or made available as a result of or in connectionwith this Section 7.3 as ONCOVIR Proprietary Information and shall cause its authorized agents to retain all such information inconfidence (subject to the following), and shall not use any such information, or cause or allow any such information to be used,for any purpose other than regulatory compliance or patient safety. 7.4 Change in Commercial Manufacturing. If ONCOVIR desires to make any changes or modifications to themanufacturing process of Product, except for an increase in lot size, ONCOVIR shall notify GENOCEA at least [* * *] prior toimplementing any such changes or modifications. Such notice shall specify in reasonable detail such proposed changes ormodifications and the reasons therefor. If requested by GENOCEA within [* * *] after receipt of such notice, ONCOVIR shallmeet with GENOCEA within [* * *] of GENOCEA’s request to discuss such proposed changes or modifications and thereasons therefor. ONCOVIR shall consider in good faith any comments or recommendation of GENOCEA with regard to suchchanges or modifications. ONCOVIR will submit promptly to the FDA and other applicable Regulatory Authorities anynecessary modifications to the applicable Drug Master File in order that GENOCEA can obtain any necessary approval for suchchange or modification from the FDA and other applicable Regulatory Authorities. ONCOVIR agrees that it will not implementany such change or modification until receipt of approval from the FDA and other applicable Regulatory Authorities, if priorapproval from the FDA is required. If FDA approval of such a change is required, ONCOVIR will continue to supplyGENOCEA with Product in conformity with then-existing conditions of the Product manufacturing process, until GENOCEAnotifies ONCOVIR that applicable FDA approvals have been received. Notwithstanding the foregoing, ONCOVIR shall notmake any changes to the manufacturing process of Product without the prior written consent of GENOCEA if said changeswould have an impact on GENOCEA’s development or sale of Combination Product or require GENOCEA to make changes toits IND or Protocols for ongoing clinical trials.7.5 Supply Interruption. Supply of the Product is subject to availability, but ONCOVIR shall use all CommerciallyReasonable Efforts to ensure supply. ONCOVIR shall take all steps to ensure clinical and commercial supply. ShouldONCOVIR or a manufacturer for ONCOVIR, at any time during clinical trial development or thereafter, have reason to believethat it will be unable to meet Company’s commercially reasonable Product requirements or delivery dates, or to supply Product inaccordance with a Purchase Order or otherwise meet its obligations under this Agreement (each a “Supply Interruption”),ONCOVIR shall promptly notify Company stating the reasons for the delay or failure to comply with the terms of theAgreement, the expected duration of the delay and the efforts ONCOVIR is taking to address the cause for the delay. AtCompany’s sole discretion ONCOVIR shall work collaboratively with Company to discuss and promptly resolve any suchSupply Interruption, which efforts shall include, but shall not be limited to: providing to the extent reasonably possible inaccordance with confidentiality provisions of this agreement, and at Company cost, access to ONCOVIR’s Manufacturer duringManufacturer’s regular business hours and ONCOVIR’s relevant facilities and personnel until the supply interruption is resolvedand ensuring that any remedial actions recommended by Company are considered in good faith and if accepted, promptlyimplemented. In addition to the rights set forth above, during any Supply Interruption, where ONCOVIR, its successors, orassigns, in breach of this agreement, unjustifiably refuse or are unable to submit a purchase order to resolve the SupplyInterruption for any reason, and such refusal or inability shall have continued for at least [* * *], then Company shall have theright at its sole discretion to [* * *].[* * *] However, ONCOVIR will provide information required for regulatory filings and will allow independent audit of itsmanufacturing facilities and all regulatory documentation, at the Company’s expense and subject to the manufacturer’sscheduling constraints. All such information shall be treated as ONCOVIR IP and Confidential Information. Notwithstanding the above, once the Supply Interruption ceases to be continuing and once ONCOVIR has re-establishedsupply, the supply, purchase and sale of PRODUCT under this Agreement shall resume under the direction of ONCOVIR.Company shall abandon its efforts to seek a future supply of PRODUCT separate from ONCOVIR.7.6 Second Source Manufacturer: ONCOVIR has identified [* * *] potential additional manufacturing sites forProduct, and within [* * *] of the effective date of this agreement, ONCOVIR will take all reasonably necessary steps to validateone such additional manufacturing sites capability to manufacture the Product (including, without limitation, in Bulk Product andFinished Dosage Form) (“Second Source Manufacturer”) that complies with all Applicable Laws and is qualified to manufacturethe Product in compliance with Regulatory Requirements. ONCOVIR will transfer its manufacturing method details and tradesecrets directly to the Second Source Manufacturer as necessary to enable production of Product in acceptable quality andquantity and provide such other assistance to assure an efficient and smooth transfer of the manufacturing processes for theProduct. Such information will be provided only to the Second Source Manufacturer and only under strict confidentiality.7.7 Reserve Supply of Product. Once ONCOVIR begins to supply commercial Product, thereafter GENOCEA shall atall times have in its possession an additional stock of Product that has not been combined with any drug, covering itsrequirements for Product that GENOCEA reasonably anticipates will be sufficient for at least [* * *].7.8 Force Majeure. Subject to compliance with Sections 4, 6, and 7 of this Agreement, ONCOVIR shall not be liable toGENOCEA for delay in supply of Product hereunder, if such failure or delay is due to Force Majeure. “Force Majeure” meansstrikes, labor disputes, riots, war, acts of God, invasion, fire, explosion, floods, delay of carrier, acts of government orgovernment or regulatory agencies or instrumentalities, and any other similar circumstances, provided that in each such case suchcause or circumstance must not have been foreseeable, and must have been beyond the control of ONCOVIR, the Manufactureror any of their respective suppliers to avoid or overcome.8. Regulatory Support.ONCOVIR has filed and maintains, and will continue to maintain, at its expense, a Drug Master File for the Product with theFDA, as well as other regulatory filings in other jurisdictions related to the Product (the “ONCOVIR Regulatory Files”).ONCOVIR shall provide GENOCEA, at GENOCEA’s request, with any and all materials, documents and support to assistGENOCEA in obtaining regulatory approval for any clinical trial or new drug application related to a Combination Product.ONCOVIR will provide cross-reference authorization to its Poly-ICLC DMF and IND FDA filings. ONCOVIR will alsoprovide all safety documentation and selected PRODUCT manufacturing information, including all available PRODUCTstability data, and associated forced degradation study reports to verify that analytical methods are stability indicating, directly toGENOCEA for its regulatory filings. ONCOVIR will provide such other information as may be requested or required byapplicable regulatory authorities. ONCOVIR will permit GENOCEA to inspect and review ONCOVIR’s manufacturingprocesses and plants per Section 7.3. Notwithstanding the above, certain of ONCOVIR’s manufacturing method details andtrade secrets and Proprietary information shall not be released to GENOCEA, its successors or assigns except in strictconfidentiality as required to satisfy Applicable Law, including Regulatory Requirements. However, ONCOVIR will allowindependent audit of such details and trade secrets, its manufacturing facilities and all regulatory documentation at such timesduring normal business hours as GENOCEA requests and using independent auditors selected by GENOCEA and reasonablyacceptable to ONCOVIR. All such information shall be treated as ONCOVIR Confidential Information. All such information isadditionally on file with FDA and ONCOVIR will provide GENOCEA authorization to cross-reference the entirety of thatrecord.9. Certain Representations and Covenants.9.1 Organization; Authorization. Each Party hereby represents and warrants to the other Party that: (a) it is acorporation duly organized, validly existing and in good standing under the laws of the governing body of its applicablejurisdiction of incorporation; (b) it has full right, power, and authority to execute and deliver this Agreement and to perform itsobligations pursuant to this Agreement and (c) this Agreement has been duly and validly authorized, executed, and delivered byit and constitutes its valid and binding obligation, enforceable in accordance with its terms.9.2 No Violation. Each Party represents and warrants to the other Party that the execution, delivery and performance ofthis Agreement by such Party, and the consummation of the transactions contemplated herein will not: (a) violate any provisionsof law, statute, rule, regulation or executive order to which such Party is subject; (b) violate any judgment, order, writ or decreeof any court applicable to such Party; or (c) result in a breach or conflict with any term, covenant, condition, or provision of theorganizational documents of such Party. Each Party to this Agreement represents and warrants that it has all permits,authorizations, and consents, whether of a governmental or regulatory agency, that are or may be required for the performance ofsuch Party’s services hereunder9.3 Certification of Ownership and Rights. ONCOVIR represents and warrants that it has full rights or title to anyand all Product supplied to GENOCEA under this Agreement, and that to its knowledge, GENOCEA’s use of the ONCOVIRIP or other materials associated with the Product and provided by ONCOVIR to supply the Product will not infringe ormisappropriate any third party’s patents or other intellectual property rights.9.4 Debarment. ONCOVIR represents and warrants that it is not debarred and has not and will not knowingly use inany capacity the services of any person debarred under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992or any comparable law of any foreign jurisdiction, as each may be amended from time to time.9.5 Adverse Event Reporting. Each Party shall notify the other Party promptly (but in no event later than [* * *] afterlearning of the occurrence of) of any serious unexpected adverse drug reactions related to any vaccine or drug containing theProduct, whether in clinical trials or commercial sales, any Product recall, regulatory safety or efficacy challenges or inquiriesrelating to any therapy that incorporates the Product or any adverse results of any regulatory inspection of any facility at whichthe Product is manufactured. Each Party shall promptly upon any other Party’s request provide, on a confidential basis, as suchParty’s Proprietary Information, such information relating to such event as such other Party may request.9.6 Product. ONCOVIR represents and warrants that: (a) the Product, when delivered to GENOCEA, will conform inall material respects to the Specifications, the Regulatory Standards, the Regulatory Requirements (when applicable) and all otherthe requirements of this Agreement; (b) no Product delivered pursuant to this Agreement will, at the time of such delivery, beadulterated or otherwise fail to comply with the Specifications or Applicable Laws and (c) the manufacturing facilities andmanufacturing activities conducted for the manufacture of the Product will, at the time of manufacture, comply with allSpecifications and Applicable Laws.9.7 Diligence. ONCOVIR will use its commercially reasonable efforts to supply GENOCEA all of its commerciallyreasonable requirements of the Product.10. Indemnification, Insurance and Liability.10.1 Indemnification of ONCOVIR. Subject to Section 10.2 below, GENOCEA shall indemnify, defend and holdharmless ONCOVIR and Manufacturer, its directors, officers, employees and agents (the “ONCOVIR Indemnitees”) from allLosses, as defined in Section 12.4 below, that they may suffer as a result of any claims, demands, actions or other proceedingsmade or instituted by any third party (each, a “Third Party Claim”) directly arising from GENOCEA’s use of the Product(including, without limitation, research, development, manufacture, marketing, sale or distribution of any Combination Product orCombination Product candidate), except to the extent arising from (i) the failure of ONCOVIR, Manufacturer or any of theirsubcontractors to manufacture Product in accordance with the Specifications, GENOCEA’s Purchase Order requirements or theRegulatory Standards or Regulatory Requirements (when applicable) or (ii) any other breach of this this Agreement byONCOVIR, or the negligence or willful misconduct of any of the ONCOVIR Indemnitees. If ONCOVIR intends to claimindemnification under this Section 10.1, ONCOVIR shall promptly notify GENOCEA in writing of the Third Party Claim, shallcooperate with GENOCEA in its control the defense of such Third Party Claim, and shall cooperate with GENOCEA in suchdefense.10.2 Indemnification of GENOCEA. ONCOVIR shall indemnify, defend and hold harmless GENOCEA, itsAffiliates and its and their respective directors, officers, employees, agents and licensees (the “GENOCEA Indemnitees”) fromand against all Losses that they may suffer as a result of any Third Party Claim arising from (i) the failure of ONCOVIR,Manufacturer or any of their subcontractors to manufacture Product in accordance with the Specifications, GENOCEA’sPurchase Order requirements or the Regulatory Standards or Regulatory Requirements (when applicable) or (ii) any other breachof this this Agreement by ONCOVIR, or the negligence or willful misconduct of any of the ONCOVIR Indemnitees. IfGENOCEA intends to claim indemnification under this Section 10.2, GENOCEA shall promptly notify ONCOVIR in writingof any Claim, shall cooperate with ONCOVIR in its control the defense of such Claim, and shall cooperate with ONCOVIR insuch defense.10.3 Insurance. ONCOVIR shall maintain liability insurance against claims made by patients or their representativesregarding the manufacture, sale, distribution or use of the Product. GENOCEA shall maintain sufficient liability insurance againstclaims made by patients or their representatives, regarding the manufacture, sale, distribution or use of the Combination Product.The Parties shall maintain such insurance in such amounts as are customary in the industry for similar activities during the Termof this Agreement and thereafter for so long as Combination Products administered to or used by patients may have adverseeffects and product liability claims may occur from the use of the Product. GENOCEA will notify ONCOVIR before thebeginning of each clinical trial for a candidate Combination Product and will specify the expected number of patients.10.4 Liability. Except with regard to 1) damages arising from the gross negligence, fraud, or willful misconduct of aParty, and 2) any duty to indemnify under Section 10.1, Section 10.2, or Section 12.4 for losses resulting from a third partyclaim; in no event shall either Party or any of their respective Affiliates be liable for special, punitive, indirect, incidental orconsequential damages or lost profits arising from or in connection with this Agreement, whether based on contract, tort, or anyother legal theory and irrespective of whether such party has been advised of the possibility of any such loss or damage.11. Confidentiality of Agreement. Each Party agrees that this Agreement and the information contained herein shall be treated asconfidential and further agrees not to disclose to any third party the content of this Agreement, except to the extent that such third partyis bound by confidentiality obligations with respect thereto; provided, however, that notwithstanding the foregoing, each Party maydisclose publicly this Agreement or its terms to the extent such Party determines that disclosure is required pursuant to applicablesecurities laws or regulations or exchange rules.11.1 Definition of Confidential Information. The term “Confidential Information” shall mean any and allinformation, data or know-how, whether technical or non-technical, oral or written, that is disclosed by one Party or its Affiliates(“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”), which the Receiving Party knows or has reason toknow is regarded as confidential by the Disclosing Party, including but not limited to, the Disclosing Party’s trade secrets, thestructure, composition and manufacturing requirements or processes of the Disclosing Party’s technology (including withoutlimitation, for ONCOVIR, the Product and for GENOCEA, GENOCEA Technology), marketing plans, techniques, processes,procedures and formulae. Notwithstanding the foregoing, Confidential Information of the Disclosing Party shall not includeinformation which the Receiving Party can establish by written documentation (a) to have been publicly known prior todisclosure of such information by the Disclosing Party to the Receiving Party, (b) to have become publicly known, without faulton the part of the Receiving Party, subsequent to disclosure of such information by the Disclosing Party to the Receiving Party,(c) to have been received by the Receiving Party at any time from a source, other than the Disclosing Party, rightfully havingpossession of and the right to disclose such information, (d) to have been otherwise known by the Receiving Party prior todisclosure of such information by the Disclosing Party to the Receiving Party, (e) to have been independently developed byemployees or agents of the Receiving Party without access to or use of such information disclosed by the Disclosing Party to theReceiving Party, or (f) is approved in writing by the Disclosing Party for release by the Receiving Party.11.2 Non-Disclosure and Non-Use. During the Term and for [* * *] thereafter, the Receiving Party shall (i) treatConfidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) not disclosesuch Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, and (iii) not use suchConfidential Information other than for fulfilling its obligations or exercising its rights under this Agreement. Each Party shallnotify the other promptly upon discovery of any unauthorized use or disclosure of the other Party’s Confidential Information.11.3 Required Disclosures. The confidentiality obligations contained in this Section 11 shall not apply to the extent thatthe Confidential Information (i) is required to be disclosed by the Receiving Party to comply with Applicable Law, rule orregulation (including stock exchange rules) or a court or administrative order or to defend or prosecute litigation providing theReceiving Party furnishes prompt notice (to the extent such notice is feasible) to the Disclosing Party and takes reasonable andlawful action to avoid and/or minimize the extent of such disclosure or (ii) is required to be to disclosed to any governmentalagency for purposes of obtaining approval to test or market a Combination Product, provided that the Receiving Party shallprovide written notice thereof to the Disclosing Party (to the extent such notice is feasible) and takes reasonable and lawful actionto seek confidential treatment thereof.11.4 Use of Names. Unless otherwise required by law, neither Party shall use the name of the other Party, or anyAffiliate of such other Party, in any press release or other public disclosure without the prior written consent of such other Partyexcept as required to comply with applicable law, rule or regulation (including stock exchange rules) or a court or administrativeorder or to defend or prosecute litigation11.5 Reverse Engineering Prohibited. The Company will not reverse engineer, disassemble, or use any other meansto reverse-engineer Poly-ICLC or any Hiltonol®-containing drug product. The Company will not seek to make or have made orotherwise to obtain Poly-ICLC or any chemical variant of Poly-ICLC for the purpose, or with the effect, of avoiding itsobligations to make payments to ONCOVIR under the License & Supply Agreement.12. Inventions and Intellectual Property12.1 Pre-existing Rights: Company agrees that all right, title and interest in and to the Product and information,patents, patent applications and other intellectual property pertaining to Poly-ICLC manufacture and use that are provided byONCOVIR to Company under this Agreement will remain with ONCOVIR. Company acknowledges that this Agreementmay not be construed as a grant by ONCOVIR of a license or any other right or interest beyond those expressly set forthherein. ONCOVIR agrees that all right, title and interest in Company’s background technology, antigens, actual and potentialproducts, and information provided by the Company shall remain with the Company.12.2 GENOCEA Data. Data generated as a result of preclinical and clinical testing being conducted by or on behalfof GENOCEA shall be the sole property of GENOCEA. However, GENOCEA shall make any such data related toONCOVIR’s Product, and particularly data relating to patient safety, available to ONCOVIR for its regulatory filings.12.3 Costs. Each Party shall be responsible for all costs associated with the prosecution and maintenance of its ownintellectual property. If ONCOVIR decides to abandon any Intellectual Property relevant to the Product, then GENOCEA shallhave the right, but not obligation, to take over the ownership, prosecution and maintenance of such patents.12.4 Indemnification. ONCOVIR will indemnify and hold harmless GENOCEA, its affiliates and licensees, and eachof their respective directors, officers, agents and employees, from and against any damages, judgments, liabilities, penalties,losses, costs, and expenses, including, but not limited to, reasonable attorney’s fees, (collectively, the “Losses”) incurred inconnection with any third party claim that (i) ONCOVIR’s Product infringes any intellectual property right; (ii) arising out ofONCOVIR’s manufacture and delivery of Product; or (iii) breach of any term of this Agreement, except insofar as such Lossesresult from GENOCEA’s gross negligence or willful misconduct, but only in proportion to and to the extent that such Losses arecaused by or result from the negligent or intentional acts or omissions of ONCOVIR, its officers agents or employees.GENOCEA shall notify ONCOVIR promptly of GENOCEA’s receipt of notice of any claim, proceeding or investigation forwhich indemnification may be sought. Notwithstanding the foregoing, the failure to give notice shall not impact GENOCEA’sright to indemnity under this Section unless ONCOVIR has been prejudiced by such failure. ONCOVIR shall have the right, butnot the obligation, to control the defense of any claim for which GENOCEA is seeking indemnification, provided ONCOVIRwill not settle any such claim without GENOCEA’s prior written consent unless such settlement fully releases GENOCEAwithout any admission of fault or wrong-doing on GENOCEA’s part. The indemnification set forth in this Section 12 shallinclude amounts paid in settlement; provided, however, that no such settlement shall be entered into by GENOCEA withoutONCOVIR’s consent.13. Term and Termination13.1 Term. The term of this Agreement shall commence on the Effective Date and shall terminate upon terminationby a Party in accordance with Section 13.2 or Section 13.3. Upon expiration of the Royalty Term, the licenses granted hereinto GENOCEA shall become perpetual, fully paid and royalty free.13.2 Termination. A Party may terminate this Agreement immediately in the event of and in accordance with thefollowing:(a) the other Party defaults in the performance of any of its (1) obligations to pay money or (2) material obligationsunder this Agreement not involving the payment of money and in either such case fails to cure any non-monetary default,including without limitation, failure to supply, within [* * *] after written notice thereof, or cure any monetary default within [** *] after written notice thereof from the other Party;(b) the other Party shall become bankrupt, file for a voluntary or involuntary petition for bankruptcy, becomeinsolvent, make an assignment for the benefit of creditors, default in respect of any material indebtedness, admit its inability inwriting to pay its debts as they become due, or generally fail to meet its obligations as they become due;(c) the other Party shall dissolve, wind-up, or cease conducting its operations generally or ceases to conduct thebusiness of supplying Product(d) Genocea may terminate upon decision by GENOCEA to discontinue development of a Combination Product; or(e) Genocea may terminate upon finding by GENOCEA or an applicable Regulatory Authority that the Product orCombination Product is not clinically safe or effective.If either Party terminates this Agreement, the Parties shall be responsible for their respective obligations and payment orcompletion of all Purchase Orders existing as of the date of such termination.13.3 Wind-Down. For a period of [* * *] after the effective date of termination of this Agreement, if such terminationoccurs after regulatory approval of a Combination Product, GENOCEA and its Affiliates and sublicensees shall be entitled to sellany of the Product remaining in inventory, provided that such sales and related activities shall be subject to the terms andconditions of this Agreement, including the royalty provisions of this Agreement. In the event of any early termination of thisAgreement, GENOCEA may continue and complete any ongoing clinical trials involving the Product and ONCOVIR shallcontinue to supply the Product for such purpose in accordance with terms and conditions of this Agreement as necessary tocontinue and complete such clinical trials. In the event of any early termination of this Agreement, the Parties will work togetherin good faith to determine and implement such additional, reasonable wind-down procedures with respect to the Product andCombination Products and related activities ongoing at the time of such termination.13.4 Survival. Any expiration termination hereof shall not impair any rights or discharge any obligations that accrued to theParties as of the effective date of such expiration or termination. The following provisions shall survive any expiration ortermination of this Agreement Sections 5, 6.5 (last two sentences), 8, 9.5, 10, 11, 12, 13.4, 13.5 and 14.14. Miscellaneous14.1 Notices. Any consent, notice or report required or permitted to be given or made under this Agreement by one ofthe Parties to the other shall be in writing and addressed to such other Party at its address indicated below, or to such otheraddress as the addressee shall have last furnished in writing to the addressor in accordance with this notice provision, and shall beeffective upon documented receipt by the addressee, if sent by express courier, or at the time of successful transmission if sent byfax, or be deemed to be effective on the fifth (5th) business day following the date of mailing if mailed registered or certified mail,return receipt requested.If to GENOCEA: GENOCEA Biosciences, Inc.100 Acorn Park DriveCambridge, MA, 02140.Attn: Legal AffairsIf to ONCOVIR: ONCOVIR, Inc.3203 Cleveland Ave, NWWashington, DC 20008Attn: Andres M. Salazar, CEOFax: 202-248-232414.2 Assignment. Neither Party shall be entitled to assign this Agreement without prior written permission from theother Party, which permission shall not be unreasonably withheld; provided, however, that notwithstanding the foregoing, aParty may assign this Agreement without any obligation to obtain the other Party’s prior written permission: (i) to any of itsAffiliates or (ii) in connection with any merger, sale or other transfer of all or substantially all assets, sale of equity interests orother change of control transaction involving such Party (or, in the case of GENOCEA, involving any product or products towhich this Agreement relates). In case of a succession the successor shall execute and deliver to ONCOVIR or GENOCEA asthe case may be, an instrument in form, scope and substance agreeing to be bound by and to perform all its predecessor’sobligations under this Agreement.14.3 Bankruptcy. All rights and licenses granted under or pursuant to any clause of this Agreement are and willotherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), asamended (the “Bankruptcy Code”) or any comparable, applicable law outside the United States (“Insolvency Law”), licenses ofrights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code. ONCOVIR agrees that GENOCEA, aslicensee of such rights under this Agreement, (a) shall be entitled to retain all rights and licenses granted to GENOCEA underthis Agreement, (b) shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or any otherprovisions of Insolvency Law that provide similar protection for “intellectual property.” Any agreement supplemental hereto willbe deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code.14.4 Governing Law. This Agreement, and any disputes arising from or related to this Agreement, shall be governed andinterpreted in all respects in accordance with the laws of the State of Delaware, without reference to choice of law rules.14.5 Independent Contractor. Each Party hereby acknowledges that the Parties shall be independent contractors and thatthis Agreement between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have theauthority to make any statements, representations or commitments of any kind, or to take any action which would be binding onthe other Party.14.6 Waivers. This Agreement may be amended, supplemented, or otherwise modified only by means of a writteninstrument signed by both Parties. No term or provision hereof will be considered waived by either Party, and no breach excusedby either Party, unless such waiver or consent is in writing signed on behalf of the Party against whom the waiver is asserted. Noconsent by either Party to, or waiver of, a breach by either Party, whether express or implied, will constitute consent to, waiverof, or excuse of any other, different, or subsequent breach by either Party.14.1 Entire Agreement. This Agreement constitutes the entire agreement between the Parties relating to this subjectmatter and supersedes all prior or simultaneous representations, discussions, negotiations, and agreements, whether written ororal, including, without limitation, the Prior Agreements as listed in Appendix A.14.2 Severability. In the event that any provision of this Agreement shall be held invalid or unenforceable for any reason,such invalidity or unenforceability shall not affect any other provision of this Agreement. The Parties shall consult one anotherand use reasonable efforts to agree upon a valid and enforceable provision that is a reasonable substitute for the invalid orunenforceable provision.14.3 Counterparts. This Agreement may be executed simultaneously in two or more counterparts, and by the Parties onseparate counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the sameinstrument.[Signature Page Next Page]IN WITNESS WHEREOF, the Parties have caused their authorized representatives to execute this License and SupplyAgreement on the date first above written.ONCOVIR, INC.By: /s/ Andres M. Salazar, MD Date: January 24, 2018 Name: Dr. Andres M. Salazar, MDTitle: Chairman, President and Chief Executive OfficerGENOCEA BIOSCIENCES, INC.By: /s/ William Clark Date: January 29, 2018Name: Chip ClarkTitle: Chief Executive OfficerAPPENDIX APRIOR AGREEMENTSMTA dated February 4, 2017APPENDIX BPRODUCT SPECIFICATIONSAnalysisLimitsTest Method [* * *][* * *]For Informational Purposes Only:[* * *][* * *][* * *]APPENDIX CPATENTSApplicationFiledTitleStatus[* * *][* * *][* * *][* * *] APPENDIX DPOTENTIAL SECOND SOURCE MANUFACTURERS[* * *]- i - Exhibit 10.29GENOCEA BIOSCIENCES, INC.SIXTH AMENDMENT TO CONSULTING AGREEMENTThis Sixth Amendment to Consulting Agreement (the “Amendment”) is made as of the 13th day of June, 2017 (the“Amendment Date”) by and between Genocea Biosciences, Inc., a Delaware corporation (the “Company”) and George Siber (the“Consultant”). Capitalized terms used herein but not otherwise defined shall have the meanings given to such terms in the ConsultingAgreement (as defined below).WHEREAS, the Company and the Consultant are parties to that certain Consulting Agreement, dated as of May 16, 2007, asamended on June 30, 2009, December 16, 2010, June 15, 2011, June 5, 2013 and June 15, 2015 (the “Consulting Agreement”);WHEREAS, the term of the Consulting Agreement currently expires on June 17, 2017;WHEREAS, the Consulting Agreement may be amended by written agreement signed by the Company and the Consultant;andWHEREAS, the Company and the Consultant desire to amend the Consulting Agreement as set forth herein.NOW, THEREFORE, in consideration of the mutual covenants set forth herein, and for other good and valuableconsideration, the receipt and sufficiency of which are acknowledged, the undersigned agree to amend the Consulting Agreement asfollows:1.Term. As of the Amendment Date, the term of the Consulting Agreement is extended until June 17, 2019.2. Compensation. As of the Amendment Date, Section 2(A) of Exhibit A shall be amended and replaced in its entirety asfollows:“(A) Throughout the term of this Agreement the Company will pay Consultant a fee of $9,833 per month inconsideration for rendering the Services. All such payments will be made monthly within ten days after the close of thecalendar month.”3. Miscellaneous.(a) Continuation of Agreement. Except as amended hereby, the Consulting Agreement shall remain in full force andeffect.(b) Entire Agreement. The Consulting Agreement, as amended hereby, constitutes the entire agreement betweenConsultant and the Company with regard to the subject matter hereof. The Consulting Agreement, as amended hereby, is the complete,final, and exclusive embodiment of their agreement with regard to the subject matter thereof and supersedes any prior oral discussionsor written communications and agreements.1(c) Severability. Whenever possible, each provision of the Consulting Agreement, as amended hereby, will beinterpreted in such manner as to be effective and valid under applicable law, but if any provision of the Consulting Agreement, asamended hereby, is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, suchinvalidity, illegality or unenforceability will not affect any other provision or any other jurisdiction, but the Consulting Agreement, asamended hereby, and will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceableprovisions had never been contained in the Consulting Agreement or this Amendment.(d) Governing Law. This Amendment shall be governed by and construed in accordance with the laws of theCommonwealth of Massachusetts, without regard to conflicts of law principles thereof.(e) Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed anoriginal, but all of which together shall constitute one and the same instrument. This Amendment may also be executed and deliveredby facsimile signature and in two or more counterparts, each of which shall be deemed an original, but all of which together shallconstitute one and the same instrument.[Remainder of page intentionally left blank.]IN WITNESS WHEREOF, the parties have executed this Fifth Amendment to Consulting Agreement as of the date firstwritten above.COMPANY/s/ William ClarkName: William ClarkTitle: President and Chief ExecutiveOfficerCONSULTANT/s/ George SiberName: George Siber2Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1)Registration Statement (Form S-8 No. 333-194021) pertaining to the Amended and Restated 2007 Equity Incentive Plan and 2014 Equity IncentivePlan 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-3 No. 333-203981) of Genocea Biosciences, Inc., and(4)Registration Statement (Form S-8 No. 333-216183) pertaining to the 2014 Equity Incentive Plan of Genocea Biosciences, Inc.;of our report dated February 16, 2018, with respect to the consolidated financial statements of Genocea Biosciences, Inc. included in this Annual Report(Form 10-K) of Genocea Biosciences, Inc. for the year ended December 31, 2017. /s/ Ernst & Young LLPBoston, MassachusettsFebruary 16, 2018Exhibit 31.1CERTIFICATION PURSUANT TOSECURITIES EXCHANGE ACT RULES 13a-14 and 15d-14AS ADOPTED PURSUANT TOSECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, William D. Clark, Chief Executive Officer, certify that: 1. I have reviewed this Annual Report on Form 10-K of Genocea Biosciences, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financialcondition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in ExchangeAct Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrantand have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; b) Designed such internal control over financial, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordancewith generally accepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlover financial reporting. /s/ WILLIAM D. CLARK William D. Clark President & Chief Executive Officer Date:February 16, 2018Exhibit 31.2CERTIFICATION PURSUANT TOSECURITIES EXCHANGE ACT RULES 13a-14 and 15d-14AS ADOPTED PURSUANT TOSECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Jonathan Poole, Chief Financial Officer, certify that: 1. I have reviewed this Annual Report on Form 10-K of Genocea Biosciences, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financialcondition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in ExchangeAct Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrantand have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; b) Designed such internal control over financial, or caused such internal control over financial reporting to be designed under our supervision, toprovide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordancewith generally accepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlover financial reporting. /s/ JONATHAN POOLE Jonathan Poole Chief Financial Officer Date:February 16, 2018Exhibit 32.1CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 10-K of Genocea Biosciences, Inc. (the “Company”) for the period ended December 31, 2017 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), I, the undersigned, William D. Clark, as the President & Chief Executive Officer ofthe Company, do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the bestof my knowledge: (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ WILLIAM D. CLARK William D. Clark* President &Chief Executive Officer Date:February 16, 2018____________________________________ * A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request. The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350,Chapter 63 of Title 18, United States Code) and is not being filed as part of the Form 10-K or as a separate disclosure document.Exhibit 32.2CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 10-K of Genocea Biosciences, Inc. (the “Company”) for the period ended December 31, 2017 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), I, the undersigned, Jonathan Poole, as the Chief Financial Officer of the Company, dohereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge: (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ JONATHAN POOLE Jonathan Poole* Chief Financial Officer Date:February 16, 2018 ____________________________________*A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnishedto the Securities and Exchange Commission or its staff upon request. The foregoing certification is being furnished solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350,Chapter 63 of Title 18, United States Code) and is not being filed as part of the Form 10-K or as a separate disclosure document.

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