Genocea Biosciences Inc
Annual Report 2019

Plain-text annual report

UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549FORM 10-Kx ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2019ORo 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 of incorporation or organization) (I.R.S. Employer Identification No.)100 Acorn Park Drive, Cambridge, MA 02140(Address of principal executive offices) (Zip Code)(617) 876-8191(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Title of each class Trading symbol Name of each exchange on which registeredCommon Stock, $0.001 par value GNCA Nasdaq Capital MarketSecurities registered pursuant to Section12(g) of the Act: NoneIndicate 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 whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 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.Large accelerated filero Accelerated filerxNon-accelerated filero Smaller reporting companyx Emerging growth companyoIf 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. oIndicate 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 Capital Market on June 30, 2019, the last business day of the registrant’s most recently completed second quarter, was: $73,983,101.The number of shares outstanding of the registrant’s common stock as of February 11, 2020 was 27,643,773.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Registrant’s definitive proxy statement related to its 2020 annual meeting of stockholders to be filed subsequently are incorporated by reference into Part III ofthis report. TABLE OF CONTENTSPART I Item 1.Business4Item 1A.Risk Factors16Item 1B.Unresolved Staff Comments41Item 2.Properties41Item 3.Legal Proceedings41Item 4.Mine Safety Disclosures41 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities42Item 6.Selected Financial Data43Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations43Item 7A.Quantitative and Qualitative Disclosures About Market Risk49Item 8.Financial Statements and Supplementary Data49Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure49Item 9A.Controls and Procedures49Item 9B.Other Information50 PART III Item 10.Directors, Executive Officers and Corporate Governance52Item 11.Executive and Director Compensation52Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters52Item 13.Certain Relationships and Related Transactions, and Director Independence52Item 14.Principal Accountant Fees and Services52 PART IV Item 15.Exhibits and Financial Schedules53Item 16.Form 10-K Summary532FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements areneither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future ofour 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 theseterms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifyingwords.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 conduct clinical trials for GEN-009, to continue preclinical studies and file aninvestigational new drug (“IND”) for GEN-011, to continue preclinical studies for our other product candidates and to continue our investments inimmuno-oncology;•our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need foradditional financing;•the timing of, and our ability to, obtain and maintain regulatory approvals for our productcandidates;•the potential benefits of strategic partnership agreements and our ability to enter into strategic partnershiparrangements;•our intellectual propertyposition;•the rate and degree of market acceptance and clinical utility of any approved productcandidate;•our ability to quickly and efficiently identify and develop product candidates;and•our commercialization, marketing and manufacturing capabilities andstrategy.We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue relianceon our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-lookingstatements we make. We have included important factors in the cautionary statements included in this Annual Report on Form 10-K, particularly in the “RiskFactors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-lookingstatements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or collaborations orstrategic 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 completely andwith the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-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 seeks to discover and develop novel cancer immunotherapies using our ATLASTM proprietary discoveryplatform. The ATLAS platform profiles each patient's CD4+ and CD8+ T cell immune responses to every potential target or "antigen" in that patient's tumor. Webelieve that this approach optimizes antigen selection for immunotherapies such as cancer vaccines and cellular therapies by identifying the antigens to which thepatient can respond. Consequently, we believe that ATLAS could lead to more immunogenic and efficacious cancer immunotherapies.Our most advanced program is GEN-009, a personalized neoantigen cancer vaccine, for which we are conducting a Phase 1/2a clinical trial. The GEN-009 programuses ATLAS to identify neoantigens, or immunogenic tumor mutations unique to each patient, for inclusion in each patient's GEN-009 vaccine. We are alsoadvancing GEN-011, a neoantigen-specific adoptive T cell therapy program that also relies on ATLAS. We expect to file an IND application for GEN-011 in thesecond quarter of 2020.ATLAS PlatformHarnessing and directing the T cell arm of the immune system to kill tumor cells is increasingly viewed as having potential in the treatment of manycancers. This approach has been effective against hematologic malignancies and, more recently, certain solid tumors. Vaccines or cellular therapies employing thisapproach must target specific differences from normal tissue present in a tumor, such as antigens arising from genetic mutations. However, the discovery ofoptimal antigens for such immunotherapies has been particularly challenging for two reasons. First, the genetic diversity of human T cell responses means thateffective antigens vary from person to person. Second, the number of candidate antigens can be very large, with up to thousands of candidates per patient in somecancers. An effective antigen selection system must therefore account both for each patient's tumor and for their T cell repertoire.ATLAS achieves effective antigen selection by employing components of the T cell arm of the human immune system from each patient. Using ATLAS,we measure each patient's T cell responses to a comprehensive set of candidate neoantigens, tumor-associated antigens and tumor-associated viral antigens fortheir own cancer, allowing us to select those targets associated with the anti-tumor T cell responses that may kill that individual's cancer. We believe that ATLASrepresents the most comprehensive and accurate system for antigen discovery. Further, we believe ATLAS identifies a novel candidate antigen profile, that ofinhibitory T cell responses. Previously, all candidate antigens were thought either to be targets of effective anti-tumor responses (stimulatory), or irrelevant.However, using ATLAS, we have identified inhibitory antigens we call Inhibigenstm, which are shown to promote tumor progression in preclinical studies. Wehave also discovered that an antigen can be stimulatory in one patient and inhibitory in another, reinforcing the importance of selecting each patient's potentiallyimmunogenic antigens.The ATLAS portfolio comprises three patent families. The first two families comprise issued U.S. patents, with patent terms until at least 2031 and 2030,respectively, as well as granted foreign patents and pending U.S. and foreign applications. The third family is directed to ATLAS-based methods for cancerdiagnosis, prognosis and patient selection, as well as related compositions. This patent family currently comprises pending applications in eleven foreignjurisdictions and a pending U.S. application. Patents issuing from these applications are expected to have a patent term until at least March 2038. Our Immuno-Oncology ProgramsOur cancer immunotherapies include a vaccine that is designed to educate T cells to recognize and attack specific cancer targets, and a cellular therapyintended to introduce T cells that have been educated to attack these targets. We believe that neoantigen vaccines could be used in combination with existingtreatment approaches for cancer to potentially direct and enhance an individual’s T cell response to his or her cancer, thereby potentially effecting better clinicaloutcomes. We also believe that isolating and expanding T cell populations targeting specific neoantigens through adoptive cell therapy could provide meaningfulclinical benefit.The following describes our active immuno-oncology programs in development:4Our lead program, GEN-009, is an adjuvanted neoantigen peptide vaccine candidate. Using ATLAS to identify specific neoantigens, we thenmanufacture a personalized vaccine for each patient using only those neoantigens determined by ATLAS to be stimulatory to that patient's anti-tumor immuneresponses. We are currently conducting a Phase 1/2a clinical trial for GEN-009 across a range of solid tumor types:•Part A of the trial is assessing the safety and immunogenicity of GEN-009 as monotherapy in certain cancer patients with no evidence of disease;and•Part B of the trial, for which we have commenced dosing patients, is designed to assess the safety, immunogenicity, and preliminary antitumor activity ofGEN-009 in combination with ICI therapy in patients with advanced or metastatic tumors.Throughout 2019, we presented data from Part A of the clinical trial. In the data from the eight dosed patients that, we believe, confirms the potentialantigen selection advantages of ATLAS:•100% of patients had measurable CD4+ and CD8+ T cell responses to their GEN-009vaccine;•Responses were detected against 99% of the administered vaccine neoantigens (N=88 administered antigens), a response rate in excess of that which hasbeen reported previously in response to candidate neoantigen vaccines;•GEN-009 elicited CD8+ T cell responses ex vivo, which is a measure of T cell effector function, for 41% of vaccine neoantigens and CD4+ T cellresponses to 51% of neoantigens;•GEN-009 elicited broad immune responses using an in vitro stimulation assay, which is a measure of central memory responses, with 87% of neoantigenseliciting a CD4+ response and 57% of neoantigens eliciting a CD8+ response;•GEN-009 was well tolerated, with no dose-limiting toxicities observed;and•Through January 31, 2020, we are not aware of any disease recurrence in any of the vaccinatedpatients.As with any open label study, we may slow or pause enrollment to evaluate a smaller set of patients in an effort to assure that a preliminary clinical signalis seen. We anticipate reporting these preliminary clinical results for our GEN-009 Part B clinical trial in the second or third quarter of 2020. Based upon thisevaluation, we will consider whether it is appropriate to continue the study.We also are advancing GEN-011, an adoptive T cell therapy specific for neoantigens identified by ATLAS. Adoptive T cell therapies such as tumorinfiltrating lymphocyte ("TIL") therapy offers an alternative treatment in solid tumors. TIL therapy, which relies on extracting TILs from each patient's solidtumor, non-specifically expanding them ex vivo, and reinfusing them into the cancer patient, has demonstrated measurable and sustainable tumor shrinkage inpatients who failed immune checkpoint inhibitor ("ICI") therapy in mid-stage clinical studies. GEN-011 extracts and specifically expands ATLAS-identifiedneoantigen-specific T cells from each patient's peripheral blood rather than their tumor (as is done for TIL generation). We believe GEN-011 could providepotency, efficacy, and ease of manufacturing benefits over TIL therapy. We expect to file an IND application for GEN-011 with the U.S. Food and DrugAdministration ("FDA") in the second quarter of 2020, with preliminary clinical results anticipated in the first half of 2021.5We also continue to explore additional program opportunities. We continue to evaluate GEN-010, our vaccine candidate employing next-generationantigen delivery technology, which we may advance to provide an opportunity for better immunogenicity and/or efficiency of vaccine production. In addition, weare using ATLAS to pursue discovery of novel candidate antigens for non-personalized cancer immunotherapies. Such programs could target shared neoantigens,non-mutated tumor-associated antigens, cancers of viral origin such as cancers driven by Epstein-Barr virus infection and Inhibigenstm.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 and cellular therapy expertise provide us with competitiveadvantages, we face potential competition from many different sources, including larger and better-funded pharmaceutical companies. Not only must we competewith other immuno-oncology companies but any products that we may commercialize will have to compete with existing therapies and new therapies that maybecome available in the future.There are several companies attempting to develop new neoantigen cancer vaccines, including BioNTech SE, CureVac AG, Genentech, Inc., GritstoneOncology Inc., Merck & Co., Inc., Moderna Inc., Nouscom, and Vaccibody AS. We believe that GEN-009 has advantages against each of these product candidatesbased on the potential power of the ATLAS platform to comprehensively identify for each cancer patient the neoantigens to which such patient has a pre-existingimmune response. We believe that selecting neoantigens for personal cancer vaccines using ATLAS will lead to more effective vaccines. However, there can be noassurance that one or more of these companies or other companies will not achieve similar or superior clinical results in the future as compared to GEN-009 or thatour future clinical trials will be successful.Similarly, there are other companies attempting to develop cellular therapies targeted towards neoantigens, either through transferring T cells that havebeen transduced with T cell Receptors ("TCR") that recognize tumor antigens, or T cells that have been enriched from tumors in a non-specific way (tumorinfiltrating lymphocytes), or T cells from the peripheral blood that have been expanded on multiple tumor-specific antigens. These include Achilles TherapeuticsLtd., Adaptive Biotechnologies Corp., BioNTech SE, Cellular Biomedicine Group Inc., Eutilex Co., Ltd., Gilead Sciences, Inc., Iovance Biotherapeutics Inc.,Marker Therapeutics, Inc., Oncotherapy Science Inc., PACT Pharma Inc., and Ziopharm Oncology Inc. We believe that Genocea’s ATLAS true neoantigenselection will lead to better targeted and more effective cell therapy; 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 as compared to GEN-011, 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 do andgreater experience in the discovery and development of product candidates, obtaining FDA, and other regulatory approvals of vaccines and the commercializationof those vaccines or cell therapies. Accordingly, our competitors may be more successful than us in obtaining approval for vaccines and cell therapies andachieving widespread market acceptance. Our competitors’ vaccines or cell therapies may be more effective, or more effectively marketed and sold, than any wemay commercialize and may render our products 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 and establishingclinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available. We expectany vaccines or cell therapies that we develop and commercialize to compete based on, 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, havefewer or less severe side effects, are more convenient, or are less expensive than any products that we may develop. Our competitors also may obtain FDA or otherregulatory approval for their products more rapidly than we may obtain approval for our products, which could result in our competitors establishing a strongmarket 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 payorsseeking to encourage the use of generic products.Intellectual Property6We strive to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to our business, includingseeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. We also rely on trade secrets relating to ourproprietary technology platform and on know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain ourproprietary position in the vaccine and cell therapy fields. We additionally rely on regulatory protection afforded through data exclusivity, market exclusivity, andpatent term extensions where available. Still further, we utilize trademark protection for our company name, and expect to do so for products and/or services asthey are marketed.Our commercial success may depend in part on our ability to obtain and maintain patent and other proprietary protection for commercially importanttechnology, inventions and know-how related to our business; defend and enforce our patents; preserve the confidentiality of our trade secrets; and operate withoutinfringing the valid enforceable patents and proprietary rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell orimporting our products may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. Withrespect to both licensed and company-owned intellectual property, we cannot be sure that patents will be granted with respect to any of our pending patentapplications 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 any patents that may begranted 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 and cell therapy products. The term of individual patents depends upon the legal term of the patents in the countriesin which they 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 UnitedStates, a patent’s term may be lengthened by patent term adjustment ("Patent Term Adjustment"), which compensates a patentee for administrative delays by theUnited States Patent and Trademark 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 a UnitedStates patent as compensation for the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up tofive years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review. A patentterm extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to anapproved drug may be extended. Moreover, a patent can only be extended once, and thus, if a single patent is applicable to multiple products, it can only beextended based on one product. Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approveddrug. When possible, depending upon the length of clinical trials and other factors involved in the filing of a biologics license application ("BLA"), we expect toapply 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 three patent families, currently comprising five issued U.S. patents. We hold an exclusive license fromPresident and Fellows of Harvard College ("Harvard") to the first patent family, which covers methods related to the ATLAS discovery platform, includingdiscovery of antigens expressed in neoplastic cells. This first patent family includes U.S. Patents 9,051,564 and 9,920,314, an allowed U.S. application, and patentsgranted in Europe, Canada, and Australia. The granted foreign patents in this family are expected to expire in 2027. U.S. Patents 9,051,564 and 9,920,314 includePatent Term Adjustments and extend until December 2031 and June 2028, respectively. We wholly own a second patent family, which is specifically directed tothe ATLAS platform as utilized by us, including for discovery of cancer- or tumor-related antigens. This second patent family includes U.S. Patents 8,313,894,9,045,791, and 9,873,870, an allowed U.S. patent application, a pending U.S. patent application, issued patents in Europe, Canada, and Australia, and a pendingapplication in Europe. The granted foreign patents in this family have a patent term until July 2029. U.S. Patents 8,313,894 and 9,045,791 have terms that includePatent Term Adjustments and extend until August 2030 and August 2029, respectively. U.S. Patent 9,873,870 has a term that extends until July 2029. We whollyown the third patent family, which is directed to methods for cancer diagnosis, prognosis, and patient selection, as well as related compositions. This third familycurrently comprises pending applications in eleven foreign jurisdictions and a pending U.S. application. We wholly own three further patent families, eachcomprising a pending PCT application, claiming first priority to provisional applications filed in late 2018. These PCT applications are directed to ATLAS-basedmethods for further selection of cancer- or tumor-related antigens, and for redirecting immune responses and re-educating T cells.7License AgreementsHarvard UniversityWe have an exclusive license agreement with Harvard University (“Harvard”), granting us an exclusive, worldwide, royalty-bearing, sublicensablelicense to three patent families, to develop, make, have made, use, market, offer for sale, sell, have sold and import licensed products and to perform licensedservices related to the ATLAS discovery platform. We are also obligated to pay Harvard milestone payments up to $1.6 million in the aggregate upon theachievement of certain development and regulatory milestones. As of December 31, 2019, we have paid $0.3 million in aggregate milestone payments. We areobligated under this license agreement to use commercially reasonable efforts to develop, market and sell licensed products in compliance with an agreed upondevelopment plan. In addition, we are obligated to achieve specified development milestones and in the event we are unable to meet our development milestonesfor any type of product or service, absent any reasonable proposed extension or amendment thereof, Harvard has the right, depending on the type of product orservice, to terminate this agreement with respect to such products or to convert the license to a non-exclusive, non-sublicensable license with respect to suchproducts and services.Upon commercialization of our products covered by the licensed patent rights or discovered using the licensed methods, we are obligated to pay Harvardroyalties on the net sales of such products and services sold by us, our affiliates, and our sublicensees. This royalty varies depending on the type of product orservice but is in the low single digits. The sales-based royalty due by our sublicensees is the greater of the applicable royalty rate or a percentage in the high singledigits or the low double digits of the royalties we receive from such sublicensee, depending on the type of product. Based on the type of commercialized product orservice, royalties are payable until the expiration of the last-to-expire valid claim under the licensed patent rights or for a period of 10 years from first commercialsale of such product or service. The royalties payable to Harvard are subject to reduction, capped at a specified percentage, for any third-party payments required tobe made. 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 the license thatincludes the sublicense. This license agreement with Harvard will expire on a product-by-product or service-by-service and country-by-country basis until the expiration of thelast-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 similar circumstances; or ifwe challenge the validity of any patents licensed to us.Oncovir License and Supply AgreementIn 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 in connectionwith the research, development, use, sale, manufacture, commercialization and marketing of products combining Hiltonol with our technology (the “CombinationProduct”). Hiltonol is the adjuvant component of GEN-009, which will consist of synthetic long peptides or neoantigens identified using our proprietary ATLASplatform, formulated with Hiltonol. 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 notthe use of Hiltonol for manufacturing or the use or sale of Hiltonol alone. The license will become perpetual, fully paid-up, and royalty-free on the later of January25, 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 low to mid six figure milestone payments upon the achievement of certain clinical trial milestonesfor each Combination Product and the first marketing approval for each Combination Product in certain territories as well as tiered royalties in the low-single digitson 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 either party dueto a material uncured breach by the other party, or due to the other party’s bankruptcy, insolvency, or dissolution.Trade Secrets8We may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to protect. We seek to protect ourproprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. Wealso seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronicsecurity of our information technology systems. While we have confidence in these individuals, organizations, and systems, agreements or security measures maybe breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discoveredby competitors. To the extent that our consultants, contractors, or collaborators use intellectual property owned by others in their work for us, disputes may arise asto the rights in related or resulting know-how and inventions.Government RegulationBiological products such as vaccines and adoptive cell therapies are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("FD&C Act")and the Public Health Service Act ("PHS Act"), and other federal, state, local and foreign statutes and regulations. Both the FD&C and PHS Acts and theircorresponding regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution,reporting, advertising and other promotional practices involving biological products. Clinical testing of biological products is subject to FDA review beforeinitiation. In addition, FDA approval must be obtained before marketing of biological products. The process of obtaining regulatory review and approval and thesubsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resourcesand we 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 process:•completion of nonclinical laboratory tests and animal studies according to good laboratory practices ("GLP") and applicable requirements for thehumane 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 maybegin;•performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices("GCP") and any additional requirements for the protection of human research subjects and their health information, to establish the safety andefficacy of the proposed biological product for its intended use, including approval by an independent Institutional Review 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 of nonclinicaltesting 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, qualityand purity and, if applicable, the FDA’s current good tissue practices ("GTP") for the use of human cellular and tissue products;•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 theBLA.Before testing any biological product candidate in humans, the product candidate enters the preclinical study stage. Preclinical studies, also referred to asnonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety andactivity 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 available clinicaldata or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical studies may continue even after the IND is submitted. The INDautomatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that 30-day time period. In sucha case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA also may impose clinical9holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance. If the FDA imposes a clinical hold,studies may not recommence without FDA authorization and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of anIND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such 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 other things,the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety, includingstopping rules that assure a clinical trial will be stopped if certain adverse events ("AEs") should occur. Each protocol and any amendments to the protocol must besubmitted to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the GCPrequirements, including the requirement that all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an IRB,at or servicing 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 anticipated benefits. TheIRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and mustmonitor 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 product may be too inherentlytoxic 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 preliminarily evaluate theefficacy 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 patient population atgeographically dispersed clinical trial sites. These clinical studies are intended to establish the overall risk/benefit ratio of the product and provide anadequate 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 clinical studiesare 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 and clinicaltrial investigators. Annual progress reports detailing the results of the clinical studies must be submitted to the FDA. Written IND safety reports must be promptlysubmitted to the FDA and the investigators for serious and unexpected AEs, any findings from other studies, tests in laboratory animals or in vitro testing thatsuggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocolor investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies forreporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after thesponsor’s initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any 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 various grounds, including a finding that theresearch subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at itsinstitution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the biological product has been associated with unexpectedserious harm to patients. Sponsors of all controlled clinical trials, except for Phase 1 trials, are required to submit certain clinical trial information for inclusion inthe 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 the physicalcharacteristics of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with GMP requirements.To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHS Act emphasizes the importance of manufacturing controlfor products whose attributes10cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among otherthings, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriatepackaging must be selected and tested, and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptabledeterioration 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 the biologicalproduct. The BLA must include results of product development, laboratory and animal studies, human studies, information on the manufacture and composition ofthe product, proposed labeling and other relevant information. In addition, under the Pediatric Research Equity Act, a BLA or supplement to a BLA must containdata to assess the safety and effectiveness of the biological product for the claimed indications in all relevant pediatric subpopulations and to support dosing andadministration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partialwaivers. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, evenif filed, that any approval will be granted on a timely basis, if at all, 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. PDUFA also imposes annual program fees based on each approved biologic. Fee waivers or reductions are available in certain circumstances,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 agency accepts itfor filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additionalinformation. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDAaccepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA. The FDA reviews the BLA todetermine, among other things, whether the proposed product is safe and potent, or effective, for its intended use, and has an acceptable purity profile, and whetherthe 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 or efficacy to an advisory committee,typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved andunder what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when makingdecisions. During the biological product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy ("REMS"), is necessaryto assure the safe use of the biological product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS; the FDA will notapprove 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 the productwithin required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials wereconducted in compliance with IND study requirements and GCP requirements. To assure GMP, GTP and GCP compliance, an applicant must incur significantexpenditure 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 regulatory criteria forapproval and deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the samedata. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter that usually describes all of the specificdeficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiringadditional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant might take to place the application in acondition for approval. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies 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 the form ofa REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinicaltrials, designed11to further assess a biological product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have beencommercialized.United States Fraud and Abuse, Transparency and Privacy LawsIn the United States, our business activities are subject to numerous other federal, state and local laws designed to, for example, prevent fraud and abuse;promote transparency in interactions with others in the healthcare industry; protect the privacy of individual information; ensure integrity of research or protecthuman subjects involved in research. These laws are enforced by various federal and state enforcement authorities, including but not limited to, the United StatesDepartment of Justice, and individual United States Attorney offices within the Department of Justice, the United States Department of Health and HumanServices ("HHS"), HHS’ various divisions, including but not limited to, the Centers for Medicare & Medicaid Services ("CMS"), the Office of Inspector General,the Office for Human Research Protections, and the Office of Research Integrity, and other state and 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 the futurereceive regulatory and marketing approval. Anti-kickback laws generally prohibit a pharmaceutical manufacturer from soliciting, offering, receiving, or payingany remuneration to generate business, including the purchase, prescription or use of a particular drug. False claims laws generally prohibit anyone fromknowingly and willingly presenting, or causing to be presented, any claims for payment for reimbursed drugs or services to third party payors (including Medicareand Medicaid) that are false or fraudulent. Although the specific provisions of these laws 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 suchlaws.Laws and regulations have been enacted by the federal government and various states to regulate the sales and marketing practices of pharmaceuticalmanufacturers with marketed products. The laws and regulations generally limit financial interactions between manufacturers and health care providers; requiremanufacturers to adopt certain compliance standards and/or require disclosure to the government and public of such interactions. Many of these laws andregulations contain ambiguous requirements or require administrative guidance for implementation. Given the lack of clarity in laws and their implementation, anyfuture activities (if we obtain approval and/or reimbursement from federal healthcare programs for our product candidates) could be subject to challenge.We may be subject to privacy and security laws in the various jurisdictions in which we operate, obtain or store personally identifiable information.Numerous U.S. federal and state laws govern the collection, use, disclosure and storage of personal information. Various foreign countries also have, or aredeveloping, laws governing the collection, use, disclosure and storage of personal information. Globally, there has been an increasing focus on privacy and dataprotection issues that may affect our business. See “Risk Factors - Risks Related to Our Business and Industry”.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 be subject topenalties, including, without limitation, civil, criminal, and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participationin Medicare, Medicaid and other federal health care programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment orrestructuring 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 and adequatereimbursement for such products from third-party payors, such as government health care programs, private health insurers, and managed care organizations.Patients who are provided vaccinations, and providers providing vaccinations, generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Sales of any approved vaccines will therefore depend substantially, both domestically and abroad, on the extent to which the costs of our approvedvaccines will be paid by third-party payors. These third-party payors are increasingly challenging the prices charged for medical products and services andimposing controls to manage costs. The containment of health care costs has become a priority of federal and state governments and the prices of drugs have been afocus in this effort. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions onreimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictivepolicies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Third-party payors may limit coverage to specificproducts on an approved list or formulary, which might not include all of the FDA-approved products for a particular indication. In addition, there is significantuncertainty regarding the reimbursement status of newly approved health care products. Third-party payors are increasingly examining the medical necessity andcost-effectiveness of medical products12and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost-effectivenessof our products. If third-party payors do not consider our products to be cost-effective compared to other therapies, the payors may not cover our products afterapproval 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.Within the United States, if we obtain appropriate approval in the future to market any of our current product candidates, we may seek coverage for thoseproducts under Medicaid, Medicare, and the 340B drug pricing programs. These programs are administered by various federal and state agencies and provideprescription drug benefits to individuals who are age 65 and over, low income, or disabled or allow healthcare providers that serve vulnerable populations topurchase prescription drugs at discounted prices. In the future, we may also seek to sell any approved product candidates to government purchasers. In order toobtain coverage for our products under government benefit programs, or to sell products to government purchasers, we may be required to track and report pricesfor our products, offer discounts to certain purchasers, or pay rebates on certain utilization.In the United States, federal and state governments continue to propose and pass legislation designed to reform delivery of, or payment for, health care,which include initiatives to reduce the cost of healthcare. For example, in March 2010, the United States Congress enacted the Patient Protection and AffordableCare Act and the Health Care and Education Reconciliation Act (the "Healthcare Reform Act") which expanded health care coverage through Medicaid expansionand the implementation of the individual mandate for health insurance coverage and which included changes to the coverage and reimbursement of drug productsunder government healthcare programs. Under the Trump administration, there have been ongoing efforts to modify or repeal all or certain provisions of theHealthcare Reform Act. For example, tax reform legislation was enacted at the end of 2017 that eliminates the tax penalty for individuals who do not maintainsufficient health insurance coverage beginning in 2019 (the so-called “individual mandate”). In a May 2018 report, the Congressional Budget Office estimated that,compared to 2018, the number of uninsured will increase by 3 million in 2019 and 6 million in 2028, in part due to the elimination of the individual mandate. TheHealthcare Reform Act has also been subject to judicial challenge. In December 2018, a federal district court judge, in a challenge brought by a number of stateattorneys general, found the Healthcare Reform Act unconstitutional in its entirety because, once Congress repealed the individual mandate provision, there wasno longer a basis to rely on Congressional taxing authority to support enactment of the law. In December 2019, a federal appeals court agreed that the individualmandate provision was unconstitutional, but remanded the case back to the district court to assess more carefully whether any provisions of the Healthcare ReformAct were severable and could survive. Pending action by the district court and resolution of any appeals, which could take some time, the Healthcare Reform Act isstill operational in all respects.There have been other reform initiatives under the Trump Administration, including initiatives focused on drug pricing. For example, in May of 2018,President Trump and the Secretary of the Department of Health and Human Services released a “blueprint” to lower prescription drug prices and out-of-pocketcosts. Certain proposals in the blueprint, and related drug pricing measures proposed since the blueprint, could cause significant operational and reimbursementchanges for the pharmaceutical industry. As another example, legislation passed in 2019 revised how certain prices reported by manufacturers under the MedicaidDrug Rebate Program are calculated, a revision that the Congressional Budget Office has estimated will save the federal government approximately $3 billion inthe next ten years.There have also been other efforts by government officials or legislators to implement measures to regulate prices or payment for pharmaceuticalproducts, including legislation on drug importation. Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposalsto address the perceived high cost of pharmaceuticals. There have been recent state legislative efforts to address drug costs, which generally have focused onincreasing 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. We cannot,however, predict the ultimate content, timing, or effect of any changes to the Healthcare Reform Act or other federal and state reform efforts. There is no assurancethat 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, reimbursement andhealth care payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. Pricing ofprescription pharmaceuticals is subject to governmental control in many countries. Pricing negotiations with governmental authorities can extend well beyond thereceipt of regulatory marketing approval for a product and may require us to conduct a clinical trial that compares the cost effectiveness of our product candidatesor products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in our commercialization efforts. Third-partypayors are challenging the prices charged for medical products and services, and many third-party payors limit reimbursement for newly-approved health careproducts. Recent budgetary pressures in many European Union countries are also causing governments to consider or implement various cost-containmentmeasures, such as price freezes, increased price cuts and13rebates. If budget pressures continue, governments may implement additional cost-containment measures. Cost-control initiatives could decrease the price wemight establish for products that we may develop or sell, which would result in lower product revenues or royalties payable to us. There can be no assurance thatany country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for anyof 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 sales anddistribution of our product candidates. Whether or not we obtain FDA approval for a product candidate, we must obtain approval from the comparable regulatoryauthorities of foreign countries or economic areas, such as the European Union, before we may commence clinical trials or market products in those countries orareas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place toplace, and the time may be longer or shorter than that required for FDA approval.Certain countries outside of the United States have a process that requires the submission of a clinical trial application ("CTA") much like an IND prior tothe commencement of human clinical trials. In Europe, for example, a CTA must be submitted to the competent national health authority and to independent ethicscommittees in each country in which a company intends to conduct clinical trials. Once the CTA is approved in accordance with a country’s requirements, clinicaltrial development may proceed in that country. In all cases, the clinical trials must be conducted in accordance with GCPs and other applicable regulatoryrequirements.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 orphan medicines,and optional for other medicines which are highly innovative. Under the centralized procedure, a marketing application is submitted to the European MedicinesAgency where it will be evaluated by the Committee for Medicinal Products for Human Use and a favorable opinion typically results in the grant by the EuropeanCommission of a single marketing authorization that is valid for all European Union member states within 67 days of receipt of the opinion. The initial marketingauthorization is valid for five years, but once renewed is usually valid for an unlimited period. The decentralized procedure provides 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 thedecentralized approval procedure, an applicant submits an application, or dossier, and related materials to the reference member state and concerned memberstates. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report andrelated materials. If a member state does not recognize the marketing authorization, the disputed points are eventually referred to the European Commission, whosedecision is binding on all member states. In light of the United Kingdom’s vote in 2016 to leave the European Union, the so-called Brexit vote, there may bechanges forthcoming in the scope of the centralized approval procedure as the terms of that exit are negotiated between the United Kingdom and the EuropeanUnion.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.Information about our Executive OfficersThe following table sets forth the name, age and position of each of our executive officers as of February 13, 2020.Name Age PositionWilliam Clark 51 President and Chief Executive OfficerGirish Aakalu, Ph.D. 45 Chief Business OfficerThomas Davis, M.D. 56 Chief Medical OfficerDiantha Duvall 48 Chief Financial OfficerJessica Baker Flechtner, Ph.D. 48 Chief Scientific OfficerNarinder Singh 48 Senior Vice President, Pharmaceutical Sciences and Manufacturing14William "Chip" Clark. Chip has served as our President and Chief Executive Officer since February 2011 after serving as our Chief Business Officer from August2010 to February 2011. Chip has also served on our board of directors since February 2011. Prior to joining Genocea, he served as Chief Business Officer atVanda Pharmaceuticals, a biopharmaceutical company he co-founded in 2004. While at Vanda, he led the company’s strategic and business development activitiesand played a central role in raising more than $400 million through business development deals and equity financings. Prior to Vanda, Chip was a principal at CareCapital, a venture capital firm investing in biopharmaceutical companies, after serving in a variety of commercial and strategic roles at SmithKline Beecham (nowGlaxoSmithKline). Chip holds a B.A. from Harvard University and an M.B.A. from The Wharton School at the University of Pennsylvania.Girish Aakalu, Ph.D. Girish joined Genocea in December 2018 as Chief Business Officer. In this role, he leads Genocea’s business development efforts. His broadskill set spans business development, corporate and R&D strategy, product portfolio management, commercial planning, and alliance management. Prior to joiningGenocea, Girish was employed by the Ipsen Group, from May 2015 until December 2018, where he was most recently Vice President: Global Head of ExternalInnovation, and Pfizer, Inc., from October 2007 until May 2015, where he held the title of Executive Director: Head of Strategy, Innovation & Operations forPfizer’s External R&D Innovation team prior to his departure. His previous roles also include business development and oncology pipeline market planningpositions at Genentech, Inc. and life science consulting experience at L.E.K Consulting. He received a B.A. in Biophysics with General and Departmental Honorsfrom Johns Hopkins University, a Ph.D. in Cellular and Molecular Neurobiology following an M.S. in Biology from the California Institute of Technology and hascompleted executive education in Corporate Governance at Northwestern University - Kellogg School of Management.Thomas Davis, M.D. Tom joined Genocea in October 2018 as Chief Medical Officer with over 20 years of academic and industry experience in immuno-oncologyand cancer drug development. Most recently, he served as Chief Medical Officer of Gadeta B.V., a Dutch cell therapy company pursuing novel cancer targets fromOctober 2017 to April 2018, where he steered a novel cell therapy technology into first-in human clinical studies. Prior to Gadeta B.V., he served as Chief MedicalOfficer of Celldex from 2006 to 2017, where he led all aspects of clinical and regulatory development including strategy, tactics, and execution. While at Celldex,Tom actively built and oversaw Clinical Science, Medical Affairs, Safety, Clinical Operations, Statistics, Regulatory Affairs, and Project Management, managedcollaborations with large global pharmaceutical partners, and participated in investor relations activities. He also served as Chief Medical Officer at GenVec and asSenior Director of Clinical Science at Medarex.Prior to joining the industry, Tom supervised clinical efforts at the Cancer Therapy Evaluation Program (CTEP) ofthe National Cancer Institute (NCI), and worked on the development of rituximab and idiotype vaccines at Stanford University. Dr. Davis received his B.A. inBiophysics from Johns Hopkins, his M.S. in Physiology and his M.D. from Georgetown University, and completed a fellowship in medical oncology at StanfordUniversity.Diantha Duvall. Diantha joined Genocea in March 2019 as the Chief Financial Officer. Prior to her appointment with Genocea, Ms. Duvall was Vice President,Controller and Chief Accounting Officer at Bioverativ, Inc. from February 2017 to January 2019. Prior to that, she worked at Biogen Inc., serving as GlobalCommercial Controller from February 2016 to January 2017, and U.S. Commercial Controller from February 2015 to January 2016. She also held a number ofpositions at Merck and Co. from May 2009 to January 2015. Her experiences at Merck spanned roles in venture investment, business development, joint ventures,and alliances, as well as operational controls and technical accounting. She also has extensive experience in SEC reporting, Sarbanes Oxley compliance,transaction support and risk management, having held multiple health industries positions within PricewaterhouseCoopers from 1996 to 2009. Ms. Duvall has aMaster of Science in Accounting and Master of Business Administration from Northeastern University and a Bachelor of Arts from Colby College.Jessica Baker Flechtner, Ph.D. Jess joined Genocea in 2007, soon after the company was founded, and has held multiple scientific roles since joining Genocea.She has served as our Chief Scientific Officer since February 2016, Senior Vice President of Research from February 2014 to January 2016, and Vice President ofResearch from January 2010 to February 2014. From 2007 to February 2014, she held various roles of increasing seniority at Genocea. Prior to joining Genocea,Dr. Flechtner was an Immunology Consultant at BioVest International, Inc. from June 2006 to March 2007, where she guided the development of assays toevaluate the success of the company’s autologous Follicular (Non-Hodgkin’s) Lymphoma vaccine in patients. As a researcher at Mojave Therapeutics, Inc., orMojave, and Antigenics Inc. (now Agenus), which acquired Mojave’s intellectual property, from 2001 to 2005, Dr. Flechtner developed protein and peptide-basedvaccines and immunotherapies for cancer, infectious disease, autoimmunity and allergy. She is an inventor on various pending or issued patents and has multiplepeer-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 Cornell Women,and Women in Bio.Narinder Singh. Narinder joined Genocea in March 2018 as Senior Vice President, Pharmaceutical Sciences and Manufacturing. In this role, Narinder manages themanufacturing process development and manufacturing of Genocea’s products. Narinder has15extensive experience in process development, scale-up, technical operations, and manufacturing supply chain of biopharmaceuticals. Prior to joining Genocea,Narinder served as Vice President of Drug Product Development and Manufacturing at Momenta Pharmaceuticals from July 2015 to March 2018, responsible forprocess development and manufacturing of drug products for Momenta’s biosimilars and novel product portfolio. Prior to Momenta, Narinder served as Director,Drug Product Technology at Amgen from June 2007 to July 2015, responsible for process development, commercialization, manufacturing and new technologydevelopment for drug products development of Amgen’s biologics-based portfolio. He began his career at Amgen functioning in various junior technical roles,beginning in 1997. Narinder received an Integrated B.Tech/M.Tech. in Biochemical Engineering and Biotechnology from the Indian Institute of Technology,Delhi in 1995, an M.S. in Chemical Engineering from the University of Houston, and an M.B.A. from UCLA Anderson School of Management.EmployeesAs of December 31, 2019, we had 59 full-time employees, of which 46 were engaged in research and development and 13 were engaged in finance, legal,business development, human resources, facilities, information technology or other general and administrative functions. None of our employees is represented bya labor union or covered by a collective bargaining agreement and we have not experienced any work stoppages. We consider our relations with our employees tobe good.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, 5thFloor, 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 reasonably practicablefollowing the time they are filed with, or furnished to, the Securities and Exchange Commission ("SEC"). The SEC also maintains an Internet website that containsreports, proxy and information statements, and other information regarding issuers, including the Company, that file electronically with the SEC. The public canobtain any documents that we file with the SEC at http://www.sec.gov. References to our website address do not constitute incorporation by reference of theinformation contained on the website, and the information contained on the website is not part of this document.Item 1A. Risk FactorsRisks Related to Our Financial Position and Need for Additional CapitalWe require additional financing to execute our operating plan and continue to operate as a going concern.Our audited financial statements for the year ended December 31, 2019 have been prepared assuming we will continue to operate as a going concern, butwe believe that our continuing operating losses raise substantial doubt about our ability to continue as such. We plan to continue to fund our operations throughpublic or private equity offerings, strategic transactions, proceeds from sales of our common stock under our at-the-market equity offering program, our equity lineof credit or by other means. However, adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise capital whenneeded, or on attractive terms, we may be forced to implement further cost reduction strategies, including ceasing development of GEN-009, GEN-011, and/orother product candidates and other corporate activities.We have incurred significant losses since our founding in 2006 and anticipate that we will continue to incur significant losses for the foreseeable future andmay never achieve or maintain profitability.We are a clinical-stage biotechnology company, and we have not yet generated significant revenues. We have incurred net losses each year since ourinception, including net losses of $39.0 million and $27.8 million for the years ended December 31, 2019 and 2018, respectively. As of December 31, 2019, we hadan accumulated deficit of approximately $331.0 million. To date, we have not commercialized any products or generated any revenues from the sale of productsand do not know whether or when we will generate product revenues or become profitable. To date, we have financed our operations primarily through multiplepublic equity offerings, private placements of our common and preferred stock and debt arrangements.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 our16future expenditures and our ability to obtain funding through equity offerings or strategic transactions. We have not completed pivotal clinical studies for anyproduct candidate, and it will be several years, if ever, before we have a product candidate ready for commercialization. Even if we obtain regulatory approval tomarket a product candidate, our future revenues will depend upon the size of any markets in which our product candidates have received approval, our ability toachieve 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:•continue clinical trials for GEN-009, our most advanced productcandidate;•initiate non-clinical, clinical or other studies for GEN-011 and our other productcandidates;•manufacture material for clinical trials and for commercialsale;•seek regulatory approvals for any product candidates that successfully complete clinicaltrials;•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketingapproval;•seek to discover and develop additional productcandidates;•acquire or in-license other product candidates andtechnologies;•make royalty, milestone or other payments under any in-licenseagreements;•maintain, protect and expand our intellectual propertyportfolio;•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 that 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 expectations ofsecurities analysts or investors, which could cause our stock price to decline. To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. This willrequire us to be successful in a range of challenging activities, including completing non-clinical studies and clinical trials of our product candidates, discoveringadditional product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling any products for which we mayobtain regulatory approval. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, maynever 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 the timing oramount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the FDA or the European Medicines Agency to performstudies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates, ourexpenses 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 all or partof 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, 2019, our cash and cash equivalents were $40.1 million. We believe that we will continue to expend substantial resources for theforeseeable future developing GEN-009, GEN-011 and any other neoantigen cancer vaccine product candidates. These expenditures will include costs associatedwith research and development, potentially acquiring new technologies, potentially obtaining regulatory approvals and manufacturing products, as well asmarketing and selling products approved for sale, if any. In addition, other unanticipated costs may arise. Because the outcome of our planned and anticipatedclinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the17development and commercialization of our product candidates. Furthermore, because of the significant expense associated with conducting clinical trials, wecannot be certain we will have sufficient capital to complete such trials for a given product candidate. Our future capital requirements depend on many factors, including:•the timing and costs of our planned clinical trials for GEN-009 and GEN-011;•the progress, timing, and costs of manufacturing GEN-009 and GEN-011 for planned clinicaltrials;•the outcome, timing, and costs of seeking regulatory approvals, including an IND application for GEN-011;•the initiation, progress, timing, costs, and results of preclinical studies and clinical trials for our other product candidates and potential productcandidates;•the terms and timing of any future collaborations, grants, licensing, consulting, or other arrangements that we mayestablish;•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, defenseand enforcement of any patents or other intellectual property rights, including milestone payments, royalty payments and patent prosecution fees that weare obligated to pay pursuant to our license agreements;•the costs of preparing, filing, and prosecuting patent applications, maintaining and protecting our intellectual property rights, and defending againstintellectual property related claims;•the extent to which we in-license or acquire other products andtechnologies;•the receipt of marketingapproval;•the costs of commercialization activities for GEN-009 and GEN-011 and other product candidates, if we receive marketing approval, including the costsand timing of establishing product sales, marketing, distribution, and manufacturing capabilities; and•revenue received from commercial sales of our productcandidates.Based on our current operating plan, we believe that our existing cash and cash equivalents are sufficient to support our operating expenses and capitalexpenditure requirements into the first quarter of 2021. Our operating plan may change as a result of many factors currently unknown to us, and we may need additional funds sooner than planned. In addition,we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or futureoperating plans. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to uswhen needed, we would be required to delay, limit, reduce or terminate non-clinical studies, clinical trials or other development activities for one or more of ourproduct candidates or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary tocommercialize our product candidates.We cannot be certain that we will be successful in advancing GEN-009 or GEN-011 through clinical development, obtaining regulatory approval for eitherproduct candidate, or commercializing either product candidate or any of our future product candidates.At this time, GEN-009 is our most advanced product candidate and our future revenues, if any, will depend highly on the successful clinical progress,approval, and commercialization of GEN-009. In addition to GEN-009, we also are advancing preclinical work on GEN-011, for which we expect to file an INDwith the FDA in the second quarter of 2020. GEN-009, GEN-011 and any future product candidate will require substantial clinical development, testing andregulatory approval before we are permitted to commence commercialization. This process can take many years and will require the expenditure of substantialresources and we expect it will require that we obtain substantial additional funding.We are currently conducting our GEN-009 Part B clinical trial. As with any open label study, we may slow or pause enrollment to evaluate a smaller setof patients in an effort to assure that a preliminary clinical signal is seen. We anticipate reporting these preliminary clinical results for our GEN-009 Part B clinicaltrial in the second or third quarter of 2020. Based upon this evaluation, we will consider whether it is appropriate to continue the study. A decision to stop the studywould result in a delay in the clinical progress, approval and commercialization of GEN-009.18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 equity offeringsand strategic transactions. In January 2018, we raised additional net proceeds of approximately $51.7 million through concurrent public offerings of our commonstock and warrants exercisable for shares of our common stock and preferred stock and warrants exercisable for shares of our common stock (the "ConcurrentOfferings"). In February 2019, we raised additional net proceeds of approximately $13.8 million through private placement. In June 2019, we raised additional netproceeds of approximately $38.4 million through an underwritten public offering of our common stock and warrants exercisable for shares of our common stock.In October 2019, we entered into an agreement (the "Purchase Agreement") with Lincoln Park Capital ("LPC") from which we raised additional net proceeds of$2.5 million, and we have the right, at our sole discretion, to sell up to an additional $27.5 million of our common stock based on prevailing market prices of ourcommon stock at the time of each sale. The Purchase Agreement limits our sales of shares of common stock to LPC to 5,227,323 shares of common stock,representing 19.99% of the shares of common stock outstanding on the date of the Purchase Agreement. The Purchase Agreement also prohibits us from directingLPC to purchase any shares of common stock if those shares, when aggregated with all other shares of our common stock then beneficially owned by LPC and itsaffiliates, would result in LPC and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding shares ofour common stock. We have also periodically sold shares under our at-the-market equity offering program with Cowen and Company, LLC (the "ATM"). To theextent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may includeliquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenantslimiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additionalfunds through strategic partnerships with third parties, we may have to relinquish valuable rights to our technologies or product candidates, future revenue streams,research programs 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 wouldbe required to delay, limit, reduce or terminate our product development or commercialization efforts for GEN-009, GEN-011, or our other product candidates.Our stockholders will experience substantial additional dilution if shares of our preferred stock are converted into, or outstanding warrants are exercised for,common stock.As of February 11, 2020 there were 1,635 shares of our Series A convertible preferred stock outstanding, which are convertible, without payment ofadditional consideration, into 204,375 shares of our common stock. As of February 11, 2020, there were 5,122,183 shares of common stock issuable upon theexercise of warrants, having a weighted average exercise price of $7.66 per share, and 1,310,927 shares of common stock issuable upon the exercise of stockoptions outstanding, having a weighted average exercise price of $11.72 per share. The conversion of the outstanding shares of our Series A convertible preferredstock into, or exercise of outstanding options or warrants for, common stock would be substantially dilutive to existing stockholders. Any dilution or potentialdilution may cause our stockholders to sell their shares, which may contribute to a downward movement in the stock price of our common stock.SEC regulations limit the amount of funds we may raise during any 12-month period pursuant to our shelf registration statement on Form S-3. Our public float was less than $75 million within 60 days of filing of this Annual Report on Form 10-K. As a result, under General Instruction I.B.6 toForm S-3, the amount of funds we can raise through primary public offerings of securities, including through our ATM, in any 12-month period using ourregistration statement on Form S-3 is limited to one-third of the aggregate market value of the voting and non-voting common equity held by our non-affiliates.We are subject to this limitation until such time as our public float exceeds $75 million. If we are required to file a new registration statement on another form, wemay incur additional costs and be subject to delays due to review by the SEC.Risks Related to Clinical Development, Regulatory Review and Approval of Our Product CandidatesWe are substantially dependent on the success of the clinical development of GEN-009, our only product candidate currently in active clinical trials. 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. We are now currently investing a significant portion of our efforts and financial resources in the development of the GEN-009, a neoantigen cancervaccine which is currently in a Phase 1/2a clinical trial. Our ability to generate product revenue depends heavily on the success of clinical trials for GEN-009 andthe successful development and commercialization of GEN-009. The successful development and commercialization of GEN-009 will depend on several factors,including the following:19•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 thirdparties;•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 our business,results of operations and financial condition. Because our active product candidate is in an early stage of clinical development, there is a high risk of failure, and we may never succeed in developingmarketable products or generating product revenue. We are currently conducting our GEN-009 Phase 1/2a clinical trial. We anticipate reporting the preliminary clinical results for our GEN-009 Part Bclinical trial in the second or third quarter of 2020. Based upon this evaluation, we will consider whether it is appropriate to continue the study. A decision to stopthe study would result in a delay in the clinical progress, approval and commercialization of GEN-009. Even if the results are successful, such results may not bereplicated in later and larger clinical trials. Among other reasons for the potential failure of earlier, smaller clinical trials to be replicated in later, larger clinicaltrials is the fact that manufacturing scale up is necessary to prepare for Phase 3 development and commercialization. Our product candidates may require complexmanufacturing processes and scaling up these processes can cause changes in the product that may not be apparent until the product is further tested during Phase3 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 clinical endpointswith statistical significance or if there are safety concerns or AEs associated with our product candidates, we may be prevented or delayed in obtaining marketingapproval for our product candidates. Alternatively, even if we obtain regulatory approval, that approval may be for indications or patient populations that are not asbroad as intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. We may also be required toperform additional or unanticipated clinical trials to obtain approval or be subject to additional post-marketing testing requirements to maintain regulatoryapproval. In addition, regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in the form of a modified riskevaluation and mitigation strategy. 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 through extensivenon-clinical studies and clinical trials that the product candidate is safe and effective for use in each target indication. Clinical trials are expensive, time-consumingand uncertain as to outcome. We may gain regulatory approval for GEN-009, GEN-011 or our other current or potential future clinical and non-clinical productcandidates in some but not all of the territories available or some but not all of the target indications, resulting in limited commercial opportunity for our productcandidates, or we may never 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 studies becauseof negative publicity from AEs in the biotechnology industries or for other reasons, including competitive clinical trials for similar patient populations, the timelinefor recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed or prevented. These delays could result inincreased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination 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 achieve diversity in astudy, to complete our clinical trials in a timely manner. Patient enrollment is affected by factors including: 20•severity of the disease under investigation;•design of the study protocol;•size of the patientpopulation;•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 prospectivepatients;•availability of competing therapies and clinical trials;•efforts to facilitate timely enrollment in clinicaltrials;•patient referral practices of physicians;and•ability to monitor patients adequately during and aftertreatment.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, limitor 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 clinical trial inany 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 contract research organizations ("CROs") andphysicians;•different standards for the conduct of clinical trials;•our inability to locate qualified local consultants, physicians andpartners;•the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation ofpharmaceutical and biotechnology products and treatment; and•the acceptability of data obtained from studies conducted outside the United States to the FDA in support of aBLA.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 be unable toobtain, 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 can occurat any stage of testing. Events that may prevent successful or timely completion of clinical development include:•delays caused by us or third parties in conducting clinical trials for GEN-009;•delays by us in reaching a consensus with regulatory agencies on trial design, including the IND for GEN-011;•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 trialsite;•imposition of a clinical hold by regulatory agencies or an IRB for any reason, including safety concerns raised by other clinical trials of similarvaccines that may reflect an unacceptable risk with GEN-009 or GEN-011 or after an inspection of clinical operations or trial sites;21•failure to perform in accordance with the FDA’s good clinical practices ("GCPs") or applicable regulatory guidelines in othercountries;•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 completedosing;•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 clinicalprotocols.Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete a clinical trial. We cannot give anyassurance 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 not able tosuccessfully initiate and complete subsequent clinical trials, we will not be able to obtain regulatory approval and will not be able to commercialize our productcandidates. Our active product candidate, GEN-009, GEN-011 and our future potential product candidates arising out of our immuno-oncology program, are or will bebased 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 for vaccines,immunotherapies and medical treatments, and our future success is highly dependent on the successful development of T cell immunotherapies in general, and ouractive development product and current and future product candidates in particular. Consequently, it may be difficult for us to predict the time and cost of productdevelopment. Unforeseen problems with the T cell approach to vaccines and immunotherapies may prevent further development or approval of our current andfuture product candidates. There can be no assurance that any development problems we or others researching T cell vaccines and immunotherapies mayexperience in the future will not cause significant delays or unanticipated costs, or that such development problems can be solved. Because of the novelty of thisapproach, there may be unknown safety risks associated with the vaccines and immunotherapies that we develop. Regulatory agencies such as the FDA mayrequire us to conduct extensive safety testing prior to approval to demonstrate a low risk of rare and severe AEs caused by the vaccines and immunotherapies. Ifapproved, the novel mechanism of action of the vaccines may adversely affect physician and patient perception and uptake of our products.Our product candidates are uniquely manufactured for each patient and we may encounter difficulties in production, particularly with respect to scaling ourmanufacturing capabilities. If we or any of the third-party manufacturers with whom we contract encounter these types of difficulties, our ability to provideour product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain acommercially viable cost structure. Some of our third-party manufacturers are located outside the U.S., and we may encounter disruption in clinical materialsupplies due to logistics, as well as risk of adverse regulatory action due to local regulatory oversight.We custom design and manufacture our product candidates. Manufacturing unique lots of these product candidates is susceptible to product loss or failuredue to issues with:•logistics associated with the collection of a patient’s tumor orblood;•batch-specific manufacturing failures or issues that arise due to the uniqueness of each patient-specific batch that may not have beenforeseen;•quality control testing failures;•unexpected failures of batches placed onstability;•novel assays, cell selection or other components within our manufacturingprocesses;•significant costs associated with individualized manufacturing that may adversely affect our ability to continuedevelopment; •successful and timely manufacture and release of the patient-specific batch;•shipment issues encountered during transport of the batch to the site of patient care;and•our reliance on single-sourcesuppliers. 22As certain of our product candidates are manufactured for each individual patient, we will be required to maintain a chain of identity with respect to eachpatient’s sample, sequence data derived from such sample, analyze results of such patient’s immunologic profile, and the custom manufactured product for eachpatient. Maintaining such a chain of identity is difficult and complex, and failure to do so could result in product mix-up, adverse patient outcomes, loss of product,or regulatory action, including withdrawal of any approved products from the market. Further, as our product candidates are developed through early-stage clinicalstudies to later-stage clinical trials towards approval and commercialization, we expect that multiple aspects of the complicated collection, analysis, manufactureand delivery processes will be modified in an effort to optimize processes and results. These changes may not achieve the intended objectives, and any of thesechanges could cause our product candidates to perform differently than we expect, potentially affecting the results of clinical trials. Novel vaccine adjuvants, including those in our GEN-009 product candidate, may pose an increased safety risk to patients. Adjuvants are compounds that are added to vaccine antigens to enhance the activation of the immune system and improve the immune response andefficacy of vaccines. Development of vaccines with novel adjuvants requires evaluation in larger numbers of patients prior to approval than would be typical fortherapeutic drugs. Guidelines for evaluation of vaccines with novel adjuvants have been established by the FDA and other regulatory bodies and expertcommittees. Our product candidates, including GEN-009, may include one or more novel adjuvants. Any neoantigen cancer vaccine, because of the presence of anadjuvant, may have side effects considered 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 requirements foradditional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. In addition, in many countries outside the UnitedStates, 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 to charge for ourvaccine is also subject to approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by oneforeign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval processmay include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not beable 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 result insignificant additional expense. Additionally, our product candidates, including our active development product, GEN-009, GEN-011 and any other potentialfuture immunotherapy product candidates, if approved, could be subject to labeling and other restrictions, and we may be subject to penalties if we fail tocomply 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 the productmay be marketed or to conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, andsurveillance to monitor the safety and efficacy of the vaccine or immunotherapy potentially over many years. In addition, if the FDA approves any of our productcandidates, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion and recordkeeping for the product will besubject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports,registration, as well as continued compliance with current good manufacturing practice (cGMP) and GCP, for any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with an approved product, including AEs of unanticipated severity or frequency, or with manufacturingoperations 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 mandatory productrecalls;•fines, warning letters, or holds on clinical trials;•refusal by the FDA to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of productlicense approvals;23•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 received forour product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative 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 new requirements or policies, or notable to maintain regulatory compliance, we may lose any marketing approval that may have been obtained and we may not achieve or sustain profitability, whichwould adversely affect our business.Risks Related to Our Reliance on Third Parties We rely on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates, including our active clinicaldevelopment product, GEN-009, GEN-011 and any other future product candidates, and if they do not properly and successfully perform their obligations tous, we may not be able to obtain regulatory approvals for our product candidates. We rely, and intend to continue to rely on, on third party CROs and other third parties to assist in managing, monitoring and otherwise carrying out ourGEN-009 and GEN-011 clinical trials. We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutionsand clinical investigators, to conduct our clinical trials. We compete with many other companies for the resources of these third parties. The third parties on whomwe rely generally may terminate their engagements at any time and having to enter into alternative arrangements would delay development and commercializationof our product 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 that therights, integrity and confidentiality of trial participants are protected. Although we rely on third parties to conduct our clinical trials, we are responsible for ensuringthat 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 to clinicaltrial protocols or to regulatory requirements, or if they otherwise fail to comply with clinical trial protocols or meet expected deadlines, the clinical trials of ourproduct candidates may not meet regulatory requirements. If clinical trials do not meet regulatory requirements or if these third parties need to be replaced, non-clinical development activities or clinical trials may be extended, delayed, suspended or terminated. If any of these events occur, we may not be able to obtainregulatory 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 additional lossesand 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 and GEN-011. We have also relied on third party suppliers and manufacturers tomanufacture and supply vaccines for other 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 activities will reduce our control over these activities but will not relieve us ofour responsibility to ensure compliance with all required regulations regarding manufacturing.24 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 reasonableterms;•reduced control as a result of using third party manufacturers for all aspects of manufacturing activities, including regulatory compliance andquality assurance;•termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging tous;•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 commercialize futureproducts. 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. Our failure, orthe failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines,injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operatingrestrictions 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 not currentlyhave arrangements in place for redundant supply or a second source for GEN-009 and GEN-011. If our current contract manufacturers cannot perform as agreed,we may be required to replace such manufacturers. Although we believe that there are several potential alternative manufacturers who could manufacture ourproduct 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 a manufacturingfacility for our products, we may experience delays in product development, clinical trials, regulatory approval and commercial distribution. 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 of ourproduct candidates in the volumes that will be necessary to support large-scale clinical trials or commercial sales. Efforts to establish these capabilities may notmeet 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-partymanufacturers must also receive FDA approval before they can produce clinical material or commercial products. Our products may be in competition with otherproducts for access to these facilities and may be subject to delays in manufacture if third-parties give other products greater priority. We may not be able to enterinto any necessary third-party manufacturing arrangements on acceptable terms, or on a timely basis. In addition, we may have to enter into technical25transfer agreements and share our know-how with the third-party manufacturers, which can 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. Becauseof contractual restraints and the limited number of third-party manufacturers with the expertise, required regulatory approvals and facilities to manufacture ourbulk vaccines on a commercial-scale, replacement of a manufacturer may be expensive and time-consuming and may cause interruptions in the production of ourvaccine. A third-party manufacturer may also encounter difficulties in production. These problems may include:•difficulties with production costs, scale-up andyields;•unavailability of raw materials andsupplies;•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, including potentiallywith major biotechnology or pharmaceutical companies. We face significant competition in seeking appropriate partners for our product candidates, and thenegotiation process is time-consuming and complex. In order for us to successfully partner our product candidates, potential partners must view these productcandidates as economically valuable in markets they determine to be attractive in light of the terms that we are seeking and other available products for licensing byother companies. Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree upon may not be favorable to us, and we maynot be able to maintain such strategic partnerships if, for example, development or approval of a product is delayed or sales of an approved product aredisappointing. Any delay in entering into strategic partnership agreements related to our product candidates could delay the development and commercialization ofour 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 these agreements.Furthermore, our strategic partners will likely negotiate for certain rights to control decisions regarding the development and commercialization of our productcandidates, 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 expertise which we donot have and for which we have not budgeted. This could negatively affect the development of any unpartnered product candidate.In addition, we are currently seeking to establish strategic partnerships with companies with adjuvant and delivery technologies for our neoantigen cancervaccine candidates. If we are unable to successfully enter into these partnerships, our ability to develop our neoantigen cancer vaccine candidates may be adverselyaffected. Risks Related to Our Intellectual Property 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 our markets. We rely upon a combination of patents, patent applications, know-how and confidentiality agreements to protect the intellectual property related to ourplatform technology and product candidates. The patent position of biotechnology companies is generally uncertain because it involves complex legal and factualconsiderations. The standards applied by the United States26Patent and Trademark Office ("U.S. PTO") and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is nouniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology patents. The patent applications that we own orin-license may fail to result in issued patents with claims that cover our discovery platform or product candidates in the United States or in other countries. There isno assurance that all potentially relevant prior art relating to our patents and patent applications or those of our licensors has been found, and prior art that we havenot disclosed could be used by a third party to invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents dosuccessfully issue and even if such patents cover our discovery platform or product candidates, third parties may challenge their validity, enforceability or scope,which may result in such patents being narrowed or invalidated. Furthermore, even if they are unchallenged, our patents and patent applications, or those of ourlicensors, may not adequately protect our platform technology, provide exclusivity for our product candidates, prevent others from designing around our patentswith similar products, or prevent others from operating in jurisdictions in which we did not pursue patent protection. Any of these outcomes could impair ourability to prevent competition from 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 of protectionis threatened, or if they fail to provide meaningful exclusivity for our product candidates or ATLAS discovery platform, it could dissuade companies fromcollaborating 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 licensorshave filed several patent applications covering aspects of our product candidates. We cannot offer any assurances about which, if any, patents will be issued, thebreadth of any such patents or whether any issued patents will be found invalid and unenforceable or will be challenged by third parties. Any successful oppositionto these patent applications, or patents that may issue from them, or to any other patent applications or patents owned by or licensed to us, could deprive us ofrights necessary for the successful commercialization of any product candidate that we may develop. Since patent applications in the United States and most othercountries are confidential for a period of time after filing, and some remain so until issued, we cannot be certain that we or our licensors were the first to file apatent 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 to invent isentitled 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 United States transitionedto 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 priorsystem or current one, third parties are allowed to submit prior art prior to the issuance of a patent. Furthermore, both the U.S. and foreign patent systems permitthird parties or, in some cases, the patent authorities themselves, to initiate proceedings challenging the scope and / or validity of issued patents, including forexample, opposition, derivation, reexamination, inter partes review or interference proceedings. An adverse determination against our or our licensor's patentrights in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, which could adversely affect our competitiveposition 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 the date it isfiled. Various extensions of patent term may be available in particular countries, however in all circumstances the life of a patent, and the protection it affords, hasa limited term. If we encounter delays in obtaining regulatory approvals, the period of time during which we could market a product under patent protection couldbe reduced. We expect to seek extensions of patent terms where these are available in any countries where we are prosecuting patents. Such possible extensionsinclude those permitted under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States, which permits a patent term extension ofup to five years to cover an FDA-approved product. However, the applicable authorities, including the FDA in the United States, and any equivalent regulatoryauthority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or maygrant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials byreferencing our clinical and non-clinical data, and then may be able to launch their product earlier than might otherwise be the case.Filing, prosecuting and enforcing patents on our platform or product candidates in all countries throughout the world would be prohibitively expensive,and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In addition, the laws ofsome foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not beable to prevent third parties from infringing our patents in all countries outside the United States, or from selling or importing products that infringe our patents inand into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to developtheir own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that inthe United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to preventthem from competing. 27Any loss of, or failure to obtain, patent protection could have a material adverse impact on our business. We may be unable to prevent competitors fromentering 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 parties maychallenge the validity or enforceability of those rights. To counter infringement or unauthorized use, or to defend against other challenges, litigation may benecessary to enforce or defend our intellectual property rights, to protect our trade secrets and/or to determine the validity and scope of our own intellectualproperty rights or the proprietary rights of others. Such litigation can be expensive and time consuming. Many of our current and potential competitors have theability to dedicate substantially greater resources to litigate intellectual property rights than we can. Accordingly, despite our efforts, we may not be able to preventthird parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs and diversion of management resources,which could harm our business and financial results. In addition, in contested proceedings, a court or agency may decide that a patent owned by or licensed to us isinvalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology inquestion. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpretednarrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of ourconfidential 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 our licensors’proprietary technologies without infringing the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside theUnited States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits,interferences, oppositions, reexamination, and inter partes review proceedings before the U.S. PTO and corresponding foreign patent offices. Numerous U.S. andforeign issued patents and pending patent applications owned by third parties exist in the fields in which we are developing and may develop our productcandidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may be subjectto 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 patent applicationswith claims for example to materials, formulations, methods of manufacture, methods of analysis, and/or methods for treatment related to the use or manufacture ofour 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 remain confidential untilpatents issue. Except for the preceding exceptions, patent applications in the United States and elsewhere are generally published only after a waiting period ofapproximately 18 months after the earliest filing. Therefore, patent applications covering our platform technology or our products or product candidates couldhave been filed by others without our knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be lateramended in a manner that could cover our platform technologies, our products or product candidates and/or the use, analysis, and/or manufacture of our productcandidates. If any third-party patents were held by a court of competent jurisdiction to cover aspects of our materials, formulations, methods of manufacture, methodsof analysis, and/or methods for treatment, the holders of any such patents would be able to block our ability to develop and commercialize the applicable productcandidate until such patent expired or unless we obtain a license. Such licenses may not be available on acceptable terms, if at all. Even if we were able to obtain alicense, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be preventedfrom commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, weare 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 costly andtime 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 our management team,distracting them from the pursuit of other company business. In the event of a successful claim of infringement against us, we may have to pay substantial28damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses fromthird 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 our productcandidates, and we may be required to pay damages. During the course of any patent or other intellectual property litigation, there could be public announcementsof the results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements asnegative, the perceived value of our products, programs, or intellectual property could be diminished. Accordingly, the market price of our common stock maydecline. 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 intellectual property. 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 - License Agreements” for a description of our in-license agreement with Harvard and Oncovir. These and other licenses may notprovide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop orcommercialize our technology and product candidates in the future. It is possible that we may be unable to obtain additional licenses at a reasonable cost or onreasonable terms, if at all. As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territoriesincluded 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 orlicense replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop orcommercialize the affected product candidates, which could harm our business significantly. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty andother obligations on us. For example, in our existing license agreements, and we expect in our future agreements, patent prosecution of our licensed technologymay be controlled by the licensor, and we may be required to reimburse the licensor for their costs of patent prosecution. If our licensors fail to obtain and maintainpatent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual property or our exclusivity withrespect to those rights, and our competitors could market competing products covered by the intellectual property. Further, in our license agreements we may beresponsible for bringing any actions against any third party for infringing the patents we have licensed. If there is any conflict, dispute, disagreement or issue ofnon-performance between us and our licensing partners regarding our rights or obligations under the license agreements, including any such conflict, dispute ordisagreement arising from our failure to satisfy payment obligations under any such agreement, we may owe damages, our licensor may have a right to terminatethe affected license, and our ability to utilize the affected intellectual property in our drug discovery and development efforts, and our ability to enter intocollaboration or marketing agreements for an affected product candidate, may be adversely affected. For example, disputes may arise regarding intellectualproperty subject to a licensing agreement, including the scope of rights granted under the license agreement and other interpretation-related issues; the extent towhich our technology infringes the intellectual property of the licensor that is not subject to the licensing agreement; the sublicensing of patent and other rightsunder any collaborative development relationships; our diligence obligations under the license agreement and what activities satisfy those diligence obligations;the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;and the priority of invention of patented technology. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain ourcurrent licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.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 patentable or thatwe may elect not to patent, processes for which patents are difficult to enforce and any other elements of our platform technology and discovery and developmentprocesses that involve proprietary know-how, information or technology that is not covered by patents. We seek to protect our proprietary technology andprocesses, in part, by entering into confidentiality agreements with our employees, consultants, and outside scientific advisors, contractors and collaborators.Although we use reasonable efforts to protect our know-how, our employees, consultants, contractors, or outside scientific advisors might intentionally orinadvertently disclose our know-how information to competitors. In addition, competitors may otherwise gain access to our know-how or independently developsubstantially equivalent information and techniques.29 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 or unauthorizeddisclosure 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, GEN-011 or any other products that we may develop or acquire in the future, the product may notgain market 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, includingany 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 to trynew 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 governmentauthorities;•relative convenience and ease ofadministration;•the prevalence and severity of adverse sideeffects;•the effectiveness of our sales and marketing efforts;and•the restrictions on the use of our products together with other medications, ifany.Market acceptance is critical to our ability to generate significant revenue. Any product candidate, if approved and commercialized, may be accepted inonly 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 to generate significantrevenue 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 and whenthey are approved. We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achievecommercial 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, recruitingand training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which werecruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred thesecommercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and 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 marketingpersonnel;•the inability of sales personnel to obtain access tophysicians;•the lack of adequate numbers of physicians to prescribe any futureproducts;•the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies withmore extensive product lines; and30•unforeseen costs and expenses associated with creating an independent sales and marketingorganization.If we are unable to establish our own sales, marketing and distribution capabilities, and instead enter into arrangements with third parties to perform theseservices, 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 we developourselves. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may beunable 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 the necessaryresources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on ourown 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 to sellour products profitably. Market acceptance and sales of any approved products will depend significantly on the availability of adequate coverage and reimbursement from third-party payors and may be affected by existing and future health care reform measures. Third-party payors, such as government health care programs, private healthinsurers and managed care organizations, decide for which drugs they will provide coverage and establish reimbursement levels. Coverage and reimbursementdecisions by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:•a covered benefit under its healthplan;•safe, effective and medicallynecessary;•appropriate for the specificpatient;•cost-effective; and•neither experimental norinvestigational.Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. Coverage and reimbursement can vary significantly from payor to payor. As a result, obtaining coverage and reimbursement approval for a productfrom each government and other third-party payor may require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products toeach payor separately, with no assurance that we will be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. We cannotbe sure that coverage or adequate reimbursement will be available for any of our product candidates. Also, we cannot be sure that coverage determinations orreimbursement amounts will not reduce the demand for or require us to lower the price of or provide discounts on, our products. If reimbursement is not availableor is available 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, significant uncertaintyexists as to whether and how much third-party payors will reimburse patients for their use of newly approved drugs, which in turn will put pressure on the pricingof 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 price ceilingson specific products and therapies. In some countries, particularly member states of the European Union, the pricing of prescription pharmaceuticals is subject togovernmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for aproduct. In addition, there can be considerable pressure by governments and other stakeholders on coverage, prices and reimbursement levels, including as part ofcost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continueafter coverage and reimbursement has been obtained. Reference pricing used by various European Union member states and parallel distribution, or arbitragebetween 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 thatcompare the cost-effectiveness of our product candidates to other available vaccines in order to obtain or maintain coverage, reimbursement or pricing approval.Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publicationand other countries. There can be no assurance that our vaccine candidates will be considered cost-effective by third-party payors, that an adequate level ofreimbursement will be available or that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our products profitably. Ifreimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.31 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 and mayadversely 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 by changesin health care spending and policy in the United States and abroad. We operate in a highly regulated industry and new laws or judicial decisions, or newinterpretations of existing laws or decisions, related to health care availability, the method of delivery or payment for health care products and services couldnegatively impact our business, operations and financial condition. There is significant interest in promoting health care reform, as evidenced by the enactment inthe United States of the Healthcare Reform Act, as well as by the ongoing efforts to eliminate or significantly modify the Healthcare Reform Act. For example,recent tax reform legislation eliminated the tax penalty for individuals who do not maintain sufficient health insurance coverage. See “Business- GovernmentRegulation-Reimbursement”. It is likely that federal and state legislatures within the United States as well as foreign governments will continue to consider changesto existing health care legislation.We cannot predict the ultimate content, timing or effect of any changes to the Healthcare Reform Act or other federal and state reform efforts within theUnited States or 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 or reducecosts of health care may adversely affect:•the demand for any drug products for which we may obtain regulatoryapproval;•our ability to set a price that we believe is fair for ourproducts;•our ability to obtain coverage and reimbursement approval for aproduct;•our ability to generate revenues and achieve or maintain profitability;and•the level of taxes that we are required topay.In addition, other broader legislative changes have been adopted that could have an adverse effect upon, and could prevent, our products’ or productcandidates’ commercial success. The Budget Control Act of 2011, as amended, or the Budget Control Act, includes provisions intended to reduce the federaldeficit, including reductions in Medicare payments to providers through 2029. Any significant spending reductions affecting Medicare, Medicaid, or other publiclyfunded or subsidized health programs, or any significant taxes or fees imposed as part of any broader deficit reduction effort or legislative replacement to theBudget Control Act, or otherwise, could have an adverse impact on our anticipated product revenues.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 andcommercialize new products with superior efficacy, convenience, tolerability and safety. In many cases, the products that we commercialize will compete withexisting, market-leading products.Other companies that are seeking to identify antigens for the development of vaccines and T cell receptor therapies using predictive tools include AchillesTherapeutics Ltd., Adaptive Biotechnologies Corp., BioNTech SE, Cellular Biomedicine Group Inc., Eutilex Co., Ltd., Genentech, Inc., Gilead Sciences, Inc.,Gritstone Oncology Inc., Iovance Biotherapeutics Inc., Marker Therapeutics, Inc., Merck & Co., Inc., Moderna Inc., Oncotherapy Science Inc., PACT Pharma Inc.,Vaccibody AS and Ziopharm Oncology Inc. Many of our potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources thanwe do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, including recruiting patients, obtaining regulatory approvals,recruiting patients and in manufacturing pharmaceutical products. In particular, these companies have greater experience and expertise in securing governmentcontracts and grants to support their research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products,manufacturing such products on a broad scale and marketing approved products. These companies also have significantly greater research and marketingcapabilities than we do and may also have products that have been approved or are in late stages of development and have collaborative arrangements in our targetmarkets with leading companies and research institutions.32Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds thatcould make the product that we develop obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDAapproval or discovering, developing and commercializing products before we do. In addition, any new product that competes with an approved product mustdemonstrate compelling advantages in efficacy, convenience, tolerability, and safety to overcome price competition and to be commercially successful. If we arenot able to compete effectively 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 commercial potential. Undesirable side effects caused by our products or even competing products in development that utilize a common mechanism of action could cause us orregulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities andpotential product liability claims. Serious AEs deemed to be caused by our product candidates could have a material AE on the development of our productcandidates and our business as a whole. We do not yet have any information 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, a number ofpotentially significant negative consequences could result, including:•our clinical trials may be put onhold;•we may be unable to obtain regulatory approval for our vaccinecandidates;•regulatory authorities may withdraw approvals of ourvaccines;•regulatory authorities may require additional warnings on thelabel;•a medication guide outlining the risks of such side effects for distribution to patients may berequired;•we could be sued and held liable for harm caused to patients;and•our reputation maysuffer.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 April 2018, we entered into an amended and restated loan and security agreement with Hercules Capital, Inc. (f/k/a Hercules Technology GrowthCapital, Inc.) (“Hercules”), which was subsequently amended in November 2019 (as amended, the "2018 Term Loan"). The 2018 Term Loan provides up to $14.0million of debt financing. The 2018 Term Loan has interest only payments through December 31, 2020. Thereafter, we are obligated to make payments that willinclude equal installments of principal and interest through the maturity date of May 2021. At December 31, 2019, $13.4 million was outstanding under the 2018Term Loan, as amended. All obligations under the 2018 Term Loan are secured by substantially all of our existing property and assets, excluding our intellectual property and in-licensed technology. This indebtedness may create additional financing risk for us, particularly if our business or prevailing financial market conditions are notconducive to paying off or refinancing our outstanding debt obligations at maturity. This indebtedness could also have important negative consequences, includingthe fact that:•we will need to repay our indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance ouroperations, our research and development efforts and other general corporate activities; and•our failure to comply with the restrictive covenants in the 2018 Term Loan could result in an event of default that, if not cured or waived, would accelerateour obligation to repay this indebtedness, and Hercules could seek to enforce its security interest in the assets securing such indebtedness.33To the extent that 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 do notmake scheduled payments when due, or otherwise materially breach or experience an event of default under the 2018 Term Loan Hercules could accelerateour total loan obligation or enforce its security interest against us. Failure to satisfy our current and future debt obligations under the 2018 Term Loan could result in an event of default. In addition, other events, includingcertain events that are not entirely in our control, such as the occurrence of a material adverse event on our business, could cause an event of default to occur. As aresult of the occurrence of an event of default, Hercules could accelerate all of the amounts due. In the event of an acceleration of amounts due under the 2018Term Loan we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness. In addition, Hercules could seek toenforce its security interests in the assets securing such indebtedness. If we are unable to pay amounts due to Hercules upon acceleration of the 2018 Term Loan orif Hercules enforces its security interest against our assets securing our indebtedness to Hercules, our ability to continue to operate our business may bejeopardized. We are subject to certain restrictive covenants which, if breached, could result in the acceleration of our debt under the 2018 Term Loan and have a materialadverse effect on our business and prospects. The 2018 Term Loan imposes operating and other restrictions on us. Such restrictions will affect, and in many respects limit or prohibit, our ability andthe ability of any future subsidiary to, among other things:•dispose of certainassets;•change our lines ofbusiness;•engage in mergers or consolidations;•incur additional indebtedness;•create liens on assets;•pay dividends and make distributions or repurchase our capital stock;and•engage in certain transactions withaffiliates.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 breach any ofthese restrictive covenants, Hercules could accelerate our indebtedness under the 2018 Term Loan or enforce its security interest against our assets, either of whichwould 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, Girish Aakalu,Ph.D., our Chief Business Officer, Tom Davis, M.D., our Chief Medical Officer, Diantha Duvall, our Chief Financial Officer, Jessica Flechtner, Ph.D., our ChiefScientific Officer, and Narinder Singh, our Senior Vice President of Pharmaceutical Sciences and Manufacturing. The loss of the services of any of these personscould impede the achievement of our research, development and commercialization objectives. We have employment agreements with each of these members ofsenior management. Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success. The loss of theservices of our executive officers or other key employees could impede the achievement of our research, development and commercialization objectives andseriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and maytake an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfullydevelop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retainor motivate these key personnel on acceptable terms, based on the status of our clinical development programs and the competition among numerouspharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel fromuniversities and research institutions. In34addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development andcommercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisorycontracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue ourgrowth strategy will be limited.Our employees, independent contractors, principal investigators, consultants, commercial partners, and vendors may engage in misconduct or other improperactivities, 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 the laws ofthe FDA and similar foreign regulatory bodies; to provide true, complete and accurate information to the FDA and similar foreign regulatory bodies; to complywith manufacturing standards we have established; to comply with federal, state and foreign health care fraud and abuse laws and regulations; to report financialinformation or data accurately; or to disclose unauthorized activities to us. In particular, the promotion, sale and marketing of health care items and services, as wellas 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, structuringand commission(s), certain customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use ofinformation obtained in the course of patient recruitment for clinical trials. It is not always possible to identify and deter such misconduct, and the precautions wetake to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmentalinvestigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us,and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition ofcivil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid and other federalhealth care programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any ofwhich 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 we willneed 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 compete effectivelywill depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts and clinical trialseffectively and hire, train and integrate additional management, administrative and, if necessary, sales and marketing personnel. We may not be able to accomplishthese 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 during producttesting, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure towarn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts.If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of ourproduct candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome,liability claims may result in:•decreased demand for any product candidates or products that we maydevelop;•injury to our reputation and significant negative mediaattention;•withdrawal of clinical trial participants;•significant costs to defend the relatedlitigations;35•a diversion of management’s time and ourresources;•substantial monetary awards to trial participants or patients;•product recalls, withdrawals, or labeling, marketing or promotionalrestrictions;•loss of revenue;•the inability to commercialize any product candidates that we may develop;and•a decline in our stockprice.Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent orinhibit the commercialization of products we develop. We currently carry product liability insurance covering our clinical trials in the amount of $5.0 million in theaggregate. Although we maintain product liability insurance, any claim that may be brought against us could result in a court judgment or settlement in an amountthat is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have variousexclusions, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiatedin a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to paysuch 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, state andlocal laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of these materials. We cannoteliminate the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials. Inthe event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could beheld liable for any resulting damages and any such liability could exceed our assets and resources. We are uninsured for third-party contamination injury.Our failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity andcould negatively affect our operating results and business.We are subject to data protection laws and regulations that address privacy and data security. The legislative and regulatory landscape for data protectioncontinues to evolve, and in recent years there has been an increasing focus on privacy and data security issues. In the United States, numerous federal and statelaws and regulations, including state data breach notification laws, state health information privacy laws and federal and state consumer protection laws govern thecollection, use, disclosure and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could resultin government enforcement actions, which could include civil or criminal penalties, private litigation and/or adverse publicity and could negatively affect ouroperating results and business. In addition, we may obtain health information from third parties (e.g., healthcare providers who prescribe our products) that aresubject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health InformationTechnology for Economic and Clinical Health Act (collectively, “HIPAA”). While we are not a “covered entity” or “business associate” subject directly toregulation under HIPAA, HIPAA’s criminal provisions can apply to entities other than “covered entities” or “business associates” in certain circumstances.Accordingly. we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information from a HIPAA-coveredentity in a manner that is not authorized or permitted.The collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation (“GDPR”)which came into effect in May 2018. This regulation imposes several requirements relating to the consent of the individuals to whom the personal data relates, theinformation provided to the individuals, notification of data processing obligations to the competent national data protection authorities and the security andconfidentiality of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States. Failure tocomply with the requirements of the GDPR and the related national data protection laws of the European Union Member States may result in significant fines andother administrative penalties. In the United States, several state legislatures are considering enacting new data privacy legislation. One example of such legislationthat has already been passed is the California Consumer Privacy Act (“CCPA”), which takes effect on January 1, 2020. The CCPA gives California consumers(defined to include all California residents) certain rights, including the right to receive certain details regarding the processing of their data by covered companies,the right to request deletion of their data, and the right to opt out of sales of their data. The CCPA additionally imposes several obligations on covered companies toprovide notice to California consumers regarding their data processing activities. The36CCPA provides for imposition of substantial fines on companies that violate the law and also confers a private right of action on data subjects to seek statutory oractual damages for breaches of their personal information.Significant disruptions of information technology systems or security breaches could adversely affect our business.We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of business,we collect, store and transmit large amounts of confidential information (including, among other things, trade secrets or other intellectual property, proprietarybusiness information and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidentialinformation. We also have outsourced elements of our operations to third parties, and as a result we manage a number of third-party vendors who may or couldhave access to our confidential information. The size and complexity of our information technology systems, and those of third-party vendors with whom wecontract, and the large amounts of confidential information stored on those systems, make such systems vulnerable to service interruptions or to security breachesfrom inadvertent or intentional actions by our employees, consultants, third-party vendors, and/or business partners, or from cyber-attacks by malicious thirdparties. Cyber-attacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect. Cyber-attacks could includethe deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten theconfidentiality, integrity and availability of information. Cyber-attacks could also include phishing attempts or e-mail fraud to cause payments or information to betransmitted to an unintended recipient.Significant disruptions of our information technology systems, or those of our third-party vendors, or security breaches could adversely affect ourbusiness operations and/or result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidentialinformation, including, among other things, trade secrets or other intellectual property, proprietary business information and personal information, and could resultin financial, legal, business and reputational harm to us. For example, any such event that leads to unauthorized access, use or disclosure of personal information,including personal information regarding our patients or employees, could harm our reputation, require us to comply with federal and/or state breach notificationlaws and foreign law equivalents, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information.Security breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type describedabove. While we have implemented security measures to protect our information technology systems and infrastructure, there can be no assurance that suchmeasures will prevent service interruptions or security breaches that could adversely affect our business. Risks Related to Our Common Stock Our largest stockholder, New Enterprise Associates (“NEA”), could exert significant influence over us and could limit your ability to influence the outcome ofkey 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 ofJanuary 31, 2020. 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 adverse toyour interests. The concentration of ownership of our capital stock may have the effect of delaying, preventing or deterring a change of control of our company,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 adversely affect themarket 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 common stockwill trade. It is possible that in one or more future periods our results of operations may be below the expectations of public market analysts and investors and, as aresult 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, including securitiesclass 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.37As a result of this volatility, our stockholders could incur substantial losses. The market price for our common stock may be influenced by many factors, including:•the success of competitive products ortechnologies;•results of clinical trials of our productcandidates;•the timing of the release of results of our clinicaltrials;•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 proprietaryrights;•the results of our efforts to discover, develop, acquire or in-license additional product candidates orproducts;•actual or anticipated fluctuations in our financial condition and operatingresults;•publication of research reports by securities analysts about us or our competitors or ourindustry;•our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to themarket;•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 ourindustry;•fluctuations in the valuation of companies perceived by investors to be comparable tous;•sales of our common stock by us, our insiders or our otherstockholders;•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 civilunrest;•natural disasters and othercalamities;•changes in market conditions for biopharmaceutical stocks; and•changes in general market and economicconditions.In addition, the stock market has recently experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and other lifesciences 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.Further, any future lawsuits or litigation could result in substantial costs and divert our management's attention and resources and could also require us tomake substantial payments to satisfy judgments or to settle litigation.Failure to comply with The Nasdaq Capital Market continued listing requirements may result in our common stock being delisted from The Nasdaq CapitalMarket.If our stock price falls below $1.00 per share, we may not continue to qualify for continued listing on The Nasdaq Capital Market or The Nasdaq GlobalMarket. To maintain listing, we are required, among other things, to maintain a minimum closing bid price of $1.00 per share. If the closing bid price of ourcommon stock is below $1.00 per share for 30 consecutive business days, we will receive a deficiency notice from Nasdaq advising us that we have a certainperiod of time, typically 180 days, to regain compliance by maintaining a minimum closing bid price of at least $1.00 for at least ten consecutive business days,although Nasdaq could require a longer period.38On June 15, 2018, we received a written notification from Nasdaq's Listing Qualifications Department that we had failed to comply with Nasdaq ListingRule 5450(a)(1) because the bid price for our common stock over a period of 30 consecutive business days prior to such date had closed below the minimum $1.00per share requirement for continued listing. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were afforded an initial period of 180 calendar days, oruntil December 12, 2018, to regain compliance with Rule 5450(a)(1). We determined that we would not be in compliance with Rule 5450(a)(1) by December 12,2018, and on November 19, 2018, submitted an application to transfer our common stock from listing on the Nasdaq Global Market to the Nasdaq Capital Market.Doing so allowed us to become eligible for an additional 180 day compliance period provided for companies listed on the Nasdaq Capital Market, provided that wemet the continued listing requirements for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with theexception of the minimum bid price requirement, and provided written notice of our intention to cure the deficiency during the second compliance period byeffecting a reverse stock split, if necessary. In accordance with the original notification, we indicated in our transfer application that we met all of the othercontinuing listing requirements for the Nasdaq Capital Market, with the exception of the bid price requirement, and provided written notice of our intention to curethe deficiency during the second compliance period by effecting a reverse stock split, if necessary. On December 13, 2018, we received notice from Nasdaq thatwe were granted an additional 180 calendar days, or until June 11, 2019, to regain compliance with the minimum $1.00 bid price per share requirement of theNasdaq listing rules. Accordingly, at the opening of business on December 17, 2018, the listing of the shares of our common stock was transferred from theNasdaq Global Market to the Nasdaq Capital Market. Our common stock continues to trade under the symbol "GNCA."On May 22, 2019, we effected a reverse stock split of our issued and outstanding common stock, par value $0.001, at a ratio of one-for-eight. As such,prior to June 10, 2019 the bid price of our common stock closed at or above $1.00 per share for a minimum of 10 consecutive business days, and Nasdaq providedwritten notice that we achieved compliance with the Nasdaq listing rules. Even though we did regain compliance with minimum closing bid price of $1.00 pershare by June 10, 2019, there is no guarantee that we will remain in compliance thereafter. The delisting of our common stock would significantly affect the abilityof investors to trade our common stock and negatively impact the liquidity and price of our common stock. In addition, the delisting of our common stock couldmaterially adversely impact our ability to raise capital on acceptable terms or at all. Delisting from Nasdaq could also have other negative results, including thepotential loss of confidence by our current or prospective third-party providers and collaboration partners, the loss of institutional investor interest, and fewerlicensing and partnering opportunities.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 effect onour stock price. We cannot assure you that any material weaknesses or significant deficiencies in our internal control over financial reporting will not be identified in thefuture. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in additionalmaterial weaknesses or significant deficiencies, cause us to fail to meet our periodic reporting obligations or result in material misstatements in our financialstatements. Any such failure could also adversely affect the results of periodic management evaluations regarding the effectiveness of our internal control overfinancial reporting. The existence of a material weakness or significant deficiency could result in errors in our financial statements that could result in a restatementof financial statements, cause us to fail to meet our reporting obligations and cause investors to lose confidence in our reported financial information, leading to adecline 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. In addition, our administrative staff are required to performadditional tasks. We invest resources to comply with evolving laws, regulations and standards, and this investment could result in increased general andadministrative expenses and may divert management’s time and attention from product development activities. If our efforts to comply with new laws, regulationsand standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legalproceedings against us and our business may be harmed. Due to the recent changes in the shareholder class action landscape, director and officer liability insurancehas been more expensive. If this trend continues we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. Thesefactors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee andcompensation committee, and qualified executive officers. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting. Any failureto develop or maintain effective controls could adversely affect the results of periodic management evaluations. In the event that we are not able to demonstratecompliance with the Sarbanes-Oxley Act, that our internal control39over financial reporting is perceived as inadequate, or that we are unable to produce timely or accurate financial statements, investors may lose confidence in ouroperating results and the price of our ordinary shares could decline. In addition, if we are unable to continue to meet these requirements, we may not be able toremain 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 to certifyfinancial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of our internal control overfinancial reporting commencing with our second annual report. This assessment must include the disclosure of any material weaknesses in our internal control overfinancial reporting identified by our management or our independent registered public accounting firm. To achieve compliance with Section 404 within theprescribed period, we engage in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In thisregard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document theadequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls arefunctioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, thereis a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required bySection 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in thereliability 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 investors might bewilling to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directorsis responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace orremove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions:•authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting,liquidation, dividend and other rights superior to our common stock;•create a classified board of directors whose members serve staggered three-yearterms;•specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, our chiefexecutive officer or our president;•prohibit stockholder action by writtenconsent;•establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposednominations of persons for election to our board of directors;•provide that our directors may be removed only forcause;•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 ofdirectors;•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. Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, whichprohibits 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 the date of thetransaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. 40Any provision of our amended and restated certificate of incorporation, our amended and restated by-laws or Delaware law that has the effect of delayingor deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock and could also affectthe 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” issubject 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 or preferredstock, 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 notbe able to utilize a material portion of our NOLs. Furthermore, our ability to utilize our NOLs is conditioned upon our attaining profitability and generating U.S.federal taxable income. We have incurred net losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable 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 exclusive forumfor certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicialforum 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 of afiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (3) any action asserting a claim against us arising pursuant toany provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated by-laws or (4) anyother action asserting a claim against us that is governed by the internal affairs doctrine. Any person or entity purchasing or otherwise acquiring any interest inshares of our capital stock shall be deemed to have notice of and to have consented to the provisions of our amended and restated certificate of incorporationdescribed above. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us orour directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees. Alternatively, if a court wereto find these provisions of our amended and restated certificate of incorporation inapplicable to, or unenforceable in respect of, one or more of the specified typesof actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our businessand 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 of gainfor 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 dividends toholders of our common stock in the foreseeable future. Instead, we plan to retain any earnings to maintain and expand our operations. In addition, our ability to paycash dividends is currently prohibited by the terms of our debt financing arrangement, and any future debt financing arrangement may contain terms prohibiting orlimiting the amount of dividends that may be declared or paid on our common stock. Accordingly, investors must rely on sales of their common stock after priceappreciation, which may never occur, as the only way to realize any return on their investment. As a result, investors seeking cash dividends should not purchaseour common stock.Item 1B. Unresolved Staff CommentsNone.Item 2. PropertiesOur principal executive office is located at 100 Acorn Park Drive, 5th floor, Cambridge, Massachusetts 02140. We have two leases at this address, and inaggregate, we occupy approximately 34,200 square feet of laboratory and office space. In March 2020, we will occupy an additional 22,440 square feet oflaboratory and office space. The lease for just office space expires in February 2020, while the lease for laboratory and office space expires in February 2025. Webelieve that our existing facilities are sufficient for our present operations, but that in the near future our existing facility space will need to be expanded to meetthe demands of our future lab operations or we will have to move into a new facility.Item 3. Legal ProceedingsIn the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating tointellectual property, commercial arrangements and other matters. We do not believe we are currently party to any pending legal action, arbitration proceeding orgovernmental proceeding, the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a materialadverse effect on our business or operating results. We are not a party to any material proceedings in which any director, member of senior management or affiliateof ours is either a party adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.Item 4. Mine Safety DisclosuresNot applicable.41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 Capital Market under the symbol “GNCA” since December 17, 2018. Prior to that, ourcommon stock had been publicly traded on The Nasdaq Global Market since February 5, 2014.HoldersAs of February 11, 2020, there were approximately 14 holders of record of our common stock. This number does not include beneficial owners whose sharesare 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.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, 2019.Plan category Number of securitiesto be issued upon exercise ofoutstanding stock options andwarrants Weighted-average exerciseprice of outstanding optionsand warrants Number of securitiesremaining available forfuture issuance underequity compensation plans Equity compensation plans approved by securityholders (1) 6,445,288 $8.48 245,430(2)(1) Includes information regarding our Amended and Restated 2014 Equity Incentive Plan.(2) Does not include 1,098,116 shares added to the Amended and Restated 2014 Equity Incentive Plan under the evergreen provision on January 1, 2020.42Item 6. Selected Financial DataNot applicable.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 our financial statements andrelated notes appearing in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in thisAnnual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward-lookingstatements 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 onForm 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the followingdiscussion and analysis.OverviewWe are a biopharmaceutical company that seeks to discover and develop novel cancer immunotherapies using our ATLASTM proprietary discoveryplatform. The ATLAS platform profiles each patient's CD4+ and CD8+ T cell immune responses to every potential target or "antigen" in that patient's tumor. Webelieve that this approach optimizes antigen selection for immunotherapies such as cancer vaccines and cellular therapies by identifying the antigens to which thepatient can respond. Consequently, we believe that ATLAS could lead to more immunogenic and efficacious cancer immunotherapies.Our most advanced program is GEN-009, a personalized neoantigen cancer vaccine, for which we are conducting a Phase 1/2a clinical trial. The GEN-009 programuses ATLAS to identify neoantigens, or immunogenic tumor mutations unique to each patient, for inclusion in each patient's GEN-009 vaccine. We are alsoadvancing GEN-011, a neoantigen-specific adoptive T cell therapy program that also relies on ATLAS. We expect to file an IND application for GEN-011 in thesecond quarter of 2020.Financing and business operationsWe commenced business operations in August 2006. To date, our operations have been limited to organizing and staffing our company, acquiring anddeveloping our proprietary ATLAS technology, identifying potential product candidates, and undertaking preclinical studies and clinical trials for our productcandidates. We have not generated any product revenue and do not expect to do so for the foreseeable future. We have financed our operations primarily throughthe issuance of our equity securities, debt financings, and amounts received through grants. As of December 31, 2019, we had received an aggregate of $399.3million in gross proceeds from the issuance of equity securities and gross proceeds from debt facilities and an aggregate of $7.9 million from grants. AtDecember 31, 2019, our cash and cash equivalents were $40.1 million. Since inception, we have incurred significant operating losses. Our net losses were $39.0 million and $27.8 million for the years ended December 31,2019 and 2018, respectively, and our accumulated deficit was $331.0 million as of December 31, 2019. We expect to incur significant expenses and increasingoperating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year. We will need to generate significantrevenue to achieve profitability, and we may never do so.In October 2019, we entered into a purchase agreement with LPC pursuant to which LPC purchased $2.5 million of our common stock at a purchase priceof $2.587 per share. In addition, for a period of 30 months, we have the right, at our sole discretion, to sell up to an additional $27.5 million of our common stock(subject to certain ownership limitations) based on prevailing market prices of our common stock at the time of each sale. In consideration for entering into thepurchase agreement, we issued 289,966 shares of our common stock to LPC as a commitment fee.In June 2019, we completed an underwritten public offering in which we sold 10.5 million shares of our common stock at a price of $3.50 per share, forgross proceeds of approximately $36.8 million. This underwritten public offering also included an overallotment option for the underwriters for 1.6 million shares,which they exercised in full on June 26, 2019. This generated additional gross proceeds of $5.5 million. We incurred approximately $3.9 million of offering-relatedexpenses, resulting in total net proceeds of $38.4 million. In February 2019, we completed a private placement financing transaction in which we issued shares of our common stock, pre-funded warrant topurchase shares of our common stock, and warrants to purchase shares of our common stock for gross cash proceeds of approximately $15.0 million. We incurred$1.2 million of offering-related expenses, resulting in total net proceeds of $13.8 million.43In January 2018, we completed two underwritten public offerings in which we issued common stock, warrants, and preferred shares for net proceeds ofapproximately $51.7 million.As reflected in our consolidated financial statements, we used cash to fund operating activities of $37.7 million for the year ended December 31, 2019 andhad $40.1 million available in cash and cash equivalents at December 31, 2019. In addition, we had an accumulated deficit of $331.0 million and anticipate that wewill continue to incur significant operating losses for the foreseeable future as we continue to develop our product candidates. Until such time, if ever, as weattempt to generate substantial product revenue and achieve profitability, we expect to finance our cash needs through a combination of equity offerings, strategictransactions, proceeds from sale of our common stock under our at-the-market equity offering program, and other sources of funding. If we are unable to raiseadditional funds when needed, we may be required to implement further cost reduction strategies, including ceasing development of GEN-009, GEN-011, andother corporate programs and activities. These factors, combined with our forecast of cash required to fund operations for a period of at least one year from thedate of issuance of these consolidated financial statements, raise substantial doubt about our ability to continue as a going concern.We believe that our cash and cash equivalents at December 31, 2019 are sufficient to support our operating expenses and capital expenditure requirementsinto the first quarter of 2021.Costs related to clinical trials can be unpredictable and there can be no guarantee that our current balances of cash and cash equivalents combined withproceeds received from other sources, will be sufficient to fund our trials or operations through this period. These funds will not be sufficient to enable us toconduct pivotal clinical trials for, seek marketing approval for, or commercially launch GEN-009, GEN-011 or any other product candidate. Accordingly, we willbe required to obtain further funding through public or private equity offerings, collaboration and licensing arrangements, or other sources. Adequate additionalfinancing may not be available to us on acceptable terms, or at all, which could result in a decision to pause or delay development or advancement of clinical trialsfor one or more of our product candidates. Similarly, we may decide to pause or delay development or advancement of clinical trials for one or more of our productcandidates if we believe that such development or advancement is imprudent or impractical.Financial OverviewResearch and development expenses Research and development expenses consist primarily of costs incurred to advance our preclinical and clinical candidates, which include:•salaries and relatedexpenses;•expenses incurred under agreements with contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), consultants,and other vendors that conduct our clinical trials and preclinical activities;•costs of acquiring, developing, and manufacturing clinical trial materials and lab supplies;and•facility costs, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, andother supplies. We expense internal research and development costs to operations as incurred. Nonrefundable advance payments for goods and services that will be usedin future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when thepayment is made. The following table identifies research and development expenses for our product candidates as follows (in thousands): Years ended December 31, Increase 2019 2018 (Decrease)Phase 1/2a programs $16,462 $6,234 $10,228Discovery and pre-IND 7,141 14,888 (7,747)Other research and development 3,349 4,087 (738)Total research and development $26,952 $25,209 $1,743Phase 1/2a programs are Phase 1 or Phase 2 development activities. Discovery and pre-IND includes costs incurred to support our discovery research andtranslational science efforts up to the initiation of Phase 1 development. Other research and44development includes costs that are not specifically allocated to active product candidates, including facilities costs, depreciation expense, and other costs. General and administrative expenses General and administrative expenses consist primarily of salaries and related expenses for personnel in executive and other administrative functions.Other general and administrative expenses include facility costs, and professional fees associated with consulting, corporate and intellectual property legalexpenses, and accounting services. Other income (expense)Other income (expense) consists of the change in warrant liability, interest expense, net of interest income, and other expense for miscellaneous items,such as the transaction expenses.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 consolidated financial statements, whichhave been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). The preparation of consolidated financial statements inconformity with GAAP requires us to make estimates and judgments that affect the amounts of assets, liabilities and expenses reported in the consolidatedfinancial statements and accompanying notes. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base ourestimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Theseestimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.Actual results may differ materially from those estimates or assumptions.While our significant accounting policies are described in more detail in Note 2. Summary of significant accounting policies appearing in Item 8 in thisAnnual Report on Form 10-K, we believe the following accounting policies are the most critical to aid you in fully understanding and evaluating our reportedfinancial results and affect the more significant judgments and estimates that we use in the preparation of our consolidated financial statements.Research and Development ExpensesAs part of the process of preparing our consolidated financial statements, we are required to estimate our research and development expenses. Thisprocess involves a thorough review of open contracts and purchase orders and an evaluation by internal personnel to identify services received that have beenperformed for us and estimating the associated cost incurred for these services for which we have not yet been invoiced or otherwise notified of the actual cost. Themajority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accruedresearch and development expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at thattime. We periodically confirm the accuracy of our estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued researchand development expenses include fees paid to CROs in connection with clinical trials, CMOs with respect to preclinical 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 conduct clinical trialson our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Paymentsunder some of these contracts depend on factors such as the successful enrollment of patients and the completion of required data submission. In recording servicefees, we make estimates based upon the time period over which services will be performed or other observable and measurable progress points as defined in thecontracts, such as number of patients enrolled, number of sites, or extent of services performed in each period. The calculated amount of service fee expense iscompared to the actual payments made pursuant to the contract's billing schedule to determine the resulting prepaid or accrual position. If our estimates of thestatus 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 anyparticular period. To date, there has been no material differences from our estimates to the amount incurred.Warrants to Purchase Redeemable SecuritiesWe have recorded the warrants issued in a 2018 public offering to purchase redeemable securities (the "2018 Public Offering Warrants") as a liability onour balance sheets. As the 2018 Public Offering Warrants are liability-classified, we remeasure the fair value of the 2018 Public Offering Warrants at eachreporting date. We calculated the estimated fair value of the 2018 Public45Offering Warrants using a Monte Carlo simulation. The Monte Carlo simulation requires the input of assumptions, including our stock price, the volatility of ourstock price, remaining term in years, expected dividend yield, and risk-free rate. In addition, the valuation model considers our probability of being acquired duringeach annual period within the 2018 Public Offering Warrant term, as an acquisition event can potentially impact the settlement of the 2018 Public OfferingWarrants. Changes to the assumptions used in determining the fair value of the 2018 Public Offering Warrants could result in materially different fair values of the2018 Public Offering Warrants.Results of OperationsComparison of the Years Ended December 31, 2019 and December 31, 2018 Years Ended December 31, Increase(in thousands) 2019 2018 (Decrease)Operating expenses: Research and development $26,952 $25,209 $1,743General and administrative 12,037 14,309 (2,272)Total operating expenses 38,989 39,518 (529)Loss from operations (38,989) (39,518) (529)Other income (expense): Change in fair value of warrant 986 14,757 (13,771)Interest expense, net (946) (1,021) (75)Other expense (1) (2,029) (2,028)Total other income 39 11,707 (11,668)Net loss $(38,950) $(27,811) $11,139 Research and development expensesResearch and development expenses increased $1.7 million to $27.0 million for the year ended December 31, 2019 from $25.2 million for the year endedDecember 31, 2018. The increase was due largely to increased external manufacturing costs of approximately $2.2 million, increased headcount-related costs ofapproximately $0.6 million, and increased clinical costs of approximately $0.3 million, offset by decreased consulting and professional services costs ofapproximately $1.3 million.We expect that our overall research and development expenses will increase due to our continued development of our clinical operations and our supplychain capabilities for our GEN-009 program. We also expect to incur costs related to the preparation and submission of an investigational new drug ("IND")application and subsequent initiation of a clinical trial for the advancement of GEN-011.General and administrative expenses General and administrative expense decreased approximately $2.3 million to $12.0 million for the year ended December 31, 2019 from $14.3 million forthe year ended December 31, 2018. The decrease was primarily due to reduced legal costs of approximately $2.2 million. In 2018, the Company incurredsignificant legal fees related to shareholder litigation, which was settled in 2019.We anticipate that our general and administrative expenses will increase in the future to support the expected growth in our business, expand ouroperations and organizational capabilities. Additionally, if and when we believe regulatory approval of our first product candidate appears likely, we anticipate thatwe will increase costs in preparation for commercial launch.Change in fair value of warrantsChange in fair value of warrants reflects the non-cash change in the fair value of the 2018 Public Offering Warrants, which were recorded at their fairvalue on the date of issuance and are remeasured as of any warrant exercise date and at the end of each reporting period. The decrease in income is attributed to asmaller decrease in our stock price than that in the prior year.Interest expense, net46Interest expense, net, consists primarily of interest expense on our long-term debt facilities, offset by interest earned on our cash equivalents.Other income (expense)Other income (expense) decreased $2.0 million for the year ended December 31, 2019, as compared to the year ended December 31, 2018. For the yearended December 31, 2018, other expense included $2.2 million of transaction costs allocated to the warrants related to the 2018 Public Offering Warrants.Liquidity and Capital ResourcesOverviewSince our inception in 2006, we have funded operations primarily through proceeds from public issuances of common stock, our long-term debt and theprivate placement of our common stock.As of December 31, 2019, we had approximately $40.1 million in cash and cash equivalents.In April 2018, we entered into an amended and restated loan and security agreement with Hercules Capital, Inc. ("Hercules"), which was subsequentlyamended in November 2019 (as amended, the "2018 Term Loan"). The 2018 Term Loan provides a $14.0 million term loan. The 2018 Term Loan will mature onMay 1, 2021 and accrues interest at a floating rate per annum equal to the greater of (i) 8.00% or (ii) the sum of 3.00% plus the prime rate. The 2018 Term Loanprovides for interest-only payments until January 1, 2021. Thereafter, payments will include equal installments of principal and interest through maturity. The2018 Term Loan may be prepaid subject to a prepayment charge. We are also obligated to pay an end of term charge of $1.0 million at maturity. As ofDecember 31, 2019, the Company had outstanding borrowings of $13.4 million.In October 2019, we entered into a purchase agreement with LPC pursuant to which LPC purchased $2.5 million of our common stock at a purchase priceof $2.587 per share. In addition, for a period of 30 months, we have the right, at our sole discretion, to sell up to an additional $27.5 million of our common stockbased on prevailing market prices of our common stock at the time of each sale. In consideration for entering into the purchase agreement, we issued 289,966shares of our common stock to LPC as a commitment fee. The purchase agreement limits our sales of shares of common stock to LPC to 5,227,323 shares ofcommon stock, representing 19.99% of the shares of common stock outstanding on the date of the purchase agreement. The purchase agreement also prohibits usfrom directing LPC to purchase any shares of common stock if those shares, when aggregated with all other shares of our common stock then beneficially ownedby LPC and its affiliates, would result in LPC and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then totaloutstanding shares of our common stock.In June 2019, we entered into an underwriting agreement relating to the underwritten public offering of 10,500,000 shares of our common stock, parvalue $0.001 per share, at a price to the public of $3.50 per share, for gross proceeds of approximately $36.8 million (the “2019 Public Offering”). We also grantedthe underwriters an option to purchase up to an additional 1,575,000 shares of common stock (“Overallotment Option”). In June 2019, the underwriters exercisedthis option in full. We received approximately $5.5 million in gross proceeds from the underwriter’s exercise of the Overallotment Option. In connection with the2019 Public Offering, inclusive of the Overallotment Option, we incurred approximately $3.9 million of offering-related expenses, resulting in total net proceeds of$38.4 million.In February 2019, we completed a private placement financing transaction (the “Private Placement”). We issued 3,199,998 shares (the “Shares”) ofcommon stock, prefunded warrants (the “Pre-Funded Warrants”) to purchase 531,250 shares of common stock (the “Pre-Funded Warrant Shares”), and warrants(the “Private Placement Warrants”) to purchase up to 932,812 shares of common stock (the “Warrant Shares”). The Shares, Pre-Funded Warrants and PrivatePlacement Warrants (collectively, the “Units”) were sold at a purchase price of $4.02 per Unit. We received net cash proceeds of approximately $13.8 million forthe purchase of the Shares, Pre-Funded Warrant Shares and Warrant Shares.Cash FlowsThe following table summarizes our sources and uses of cash for the years ended December 31, 2019 and 2018 (in thousands):47 Years ended December 31, Increase 2019 2018 (Decrease)Net cash used in operating activities $(37,734) $(41,235) $(3,501)Net cash used in investing activities (1,087) (131) 956Net cash provided by financing activities 52,901 55,455 (2,554)Net increase in cash and cash equivalents $14,080 $14,089 $(9)Operating ActivitiesNet cash used in operations decreased $3.5 million to $37.7 million for the year ended December 31, 2019 from $41.2 million for the year endedDecember 31, 2018. The decrease in net cash used was due to favorable changes in working capital attributable to accounts payable and accrued expenses.Investing ActivitiesNet cash used in investing activities increased $1.0 million to $1.1 million of cash used in investing activities for the year ended December 31, 2019compared to $0.1 million of cash used in investing activities for the year ended December 31, 2018. The increase in cash used in investing activities was due toincreased purchases of property and equipment.Financing ActivitiesNet cash provided by financing activities decreased $2.6 million to $52.9 million for the year ended December 31, 2019 from $55.5 million of cashprovided by financing activities for the year ended December 31, 2018. In 2018, we generated net proceeds of $51.7 million from a 2018 public offering ofcommon stock and warrants and we generated net proceeds of $2.9 million from the sale of shares of common stock issued pursuant to our ATM facility, whereasin 2019, the Private Placement generated net proceeds of $13.8 million, the 2019 Public Offering generated net proceeds of $38.4 million, and the transactionspursuant to the purchase agreement with LPC generated net proceeds of $2.5 million. During the years ended December 31, 2019 and 2018, we made payments of$1.9 million and $0.5 million on our long term debt.Operating Capital RequirementsOur primary uses of capital are for compensation and related expenses, manufacturing costs for preclinical and clinical materials, third party clinical trialservices, laboratory and related supplies, legal and other regulatory expenses, and general overhead costs. We expect these costs will continue to be the primaryoperating capital requirements for the near future.We expect that our existing cash and cash equivalents are sufficient to support our operations into the first quarter of 2021. As reflected in theconsolidated financial statements, we had available cash and cash equivalents of $40.1 million at December 31, 2019. In addition, we had cash used in operatingactivities of $37.7 million for the year ended December 31, 2019. These factors, combined with our forecast of cash required to fund operations for a period of atleast one year from the date of issuance of these financial statements, raise substantial doubt about our ability to continue as a going concern. We have based ourprojections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than weexpect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unableto estimate the exact amount of our operating capital requirements. Our future funding requirements 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 clinicaltrials;•the outcome, timing, and costs of seeking regulatory approvals, including an IND application for GEN-011;•the initiation, progress, timing, costs, and results of preclinical studies and clinical trials for our other product candidates and potential productcandidates;•the terms and timing of any future collaborations, grants, licensing, consulting, or other arrangements that we mayestablish;•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, including48milestone payments, royalty payments, and patent prosecution fees that we are obligated to pay pursuant to our license agreements;•the costs of preparing, filing, and prosecuting patent applications, maintaining and protecting our intellectual property rights, and defending againstintellectual property related claims;•the extent to which we in-license or acquire other products andtechnologies;•the receipt of marketingapproval;•the costs of commercialization activities for GEN-009 and other product candidates, if we receive marketing approval, including the costs and timingof establishing product sales, marketing, distribution, and manufacturing capabilities; and•revenue received from commercial sales of our productcandidates.We will need to obtain substantial additional funding in order to complete clinical trials and receive regulatory approval for GEN-009, GEN-011 and ourother product candidates. To the extent that we raise additional capital through the sale of our common stock, convertible securities, or other equity securities, theownership interests of our existing stockholders may be materially diluted and the terms of these securities could include liquidation or other preferences thatcould adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased fixed payment obligations and mayinvolve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures,or declaring dividends, that could adversely affect our ability to conduct our business. If we are unable to raise capital when needed or on attractive terms, wecould be forced to significantly delay, scale back, or discontinue the development of GEN-009, GEN-011 or our other product candidates, seek collaborators at anearlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, and relinquish or license, potentially onunfavorable terms, our rights to GEN-009, GEN-011 or our other product candidates that we otherwise would seek to develop or commercialize ourselves.Off-Balance Sheet ArrangementsWe do not have any off-balance sheet arrangements.Item 7A. Qualitative and Quantitative Disclosures About Market RiskWe had cash and cash equivalents of approximately $40.1 million as of December 31, 2019. The primary objectives of our investment activities are topreserve principal, provide liquidity and maximize income without significantly increasing risk. Our primary exposure to market risk relates to fluctuations ininterest rates, which are affected by changes in the general level of U.S. interest rates. Given the short-term nature of our cash and cash equivalents, we believe thata sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operations. We do not ownany derivative financial instruments.We do not believe that our cash, cash equivalents and marketable securities have significant risk of default or illiquidity. While we believe our cash andcash equivalents do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes inmarket value. In addition, we maintain significant amounts of cash, cash equivalents and marketable securities at one or more financial institutions that are inexcess of federally insured limits.Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation had a material effect on our results ofoperations during the year ended December 31, 2019.Item 8. Financial Statements and Supplementary DataOur consolidated financial statements, together with the report of our independent registered public accounting firm, appear beginning on page F-1 of thisAnnual Report on Form 10-K.Item 9. Changes in and Disagreements with Accountants on 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 or submitunder the Securities and Exchange Act of 1934 (the "Exchange Act") is (1) recorded, processed, summarized, and reported within the time periods specified in theSEC’s rules and forms, and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, toallow timely decisions regarding required disclosure.Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controlsand procedures as of December 31, 2019 (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls andprocedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily appliesits judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer haveconcluded, based upon the evaluation described above that, as of December 31, 2019, our disclosure controls and procedures were effective at the reasonable-assurance level.49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 over financialreporting 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 Chief Executive Officerand our Chief Financial Officer, and effected by our board of directors, management, and other personnel, to provide reasonable assurance regarding the reliabilityof our financial 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 ofassets;(2)provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP,and that receipts and expenditures are being made only in accordance with the authorizations of management and directors; and(3)provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that couldhave a material effect on our financial statements.Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted anevaluation of the effectiveness of our internal control over financial reporting based on the framework provided in Internal Control - Integrated Framework (2013)issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"). Based on this evaluation, our management concluded that ourinternal control over financial reporting was effective as of December 31, 2019.Changes in Internal Control Over Financial ReportingDuring the quarter ended December 31, 2019, 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 InformationOn February 12, 2020, our board of directors (the “Board”) elected Gisela M. Schwab, M.D., age 63, to the Board as an independent director, effectiveFebruary 14, 2020. Ms. Schwab will be a Class II director of the Company and will be nominated for re-election at the annual meeting of our stockholders to beheld in 2022.Dr. Schwab has served as President, Product Development and Medical Affairs and Chief Medical Officer of Exelixis, Inc. (“Exelixis”) since February2016. Previously she served as Executive Vice President and Chief Medical Officer of Exelixis from January 2008 to February 2016 and as Senior Vice Presidentand Chief Medical Officer of Exelixis from September 2006 to January 2008. From 2002 to 2006, she held the position of Senior Vice President and ChiefMedical Officer at Abgenix, Inc. (“Abgenix”), a human antibody-based drug development company. She also served as Vice President, Clinical Development, atAbgenix from 1999 to 2001. Prior to working at Abgenix, from 1992 to 1999, she held positions of increasing responsibility at Amgen Inc., most recently asDirector of Clinical Research and Hematology/Oncology Therapeutic Area Team Leader. From August 2011 through July 2014, Dr. Schwab served as a memberof the board of directors of Topotarget A/S, a publicly-held biopharmaceutical company. Since June 2012 she has served as a member of the board of directors ofCellerant Therapeutics, Inc. a privately-held biopharmaceutical company and since March 2015, she has served as a member of the board of directors of NordicNanovector A.S., a Norwegian biotechnology company. She received her Doctor of Medicine degree from the University of Heidelberg, trained at the Universityof Erlangen-Nuremberg and the National Cancer Institute and is board certified in internal medicine and hematology and oncology. We believe that Dr. Schwab’sscientific expertise, which includes advancing product candidates through development and regulatory approval to commercial launch, qualifies her to serve as amember of our Board.Dr. Schwab will receive compensation for her service as a director in accordance with our non-employee director compensation policy, including anannual director fee of $35,000. Pursuant to our non-employee director compensation policy and our Amended and Restated 2014 Equity Incentive Plan and non-qualified stock option award agreement, Dr. Schwab will receive an award of stock options to purchase 9,375 shares of our common stock on February 14, 2020.In accordance with our customary practice, we have entered into an indemnification agreement with Dr. Schwab, which requires us to indemnify heragainst certain liabilities that may arise in connection with her status or service as a director. The indemnification agreement also provides for an advancement ofexpenses incurred by Dr. Schwab in connection with any proceeding50relating to her status as a director. The foregoing description is qualified in its entirety by the full text of the form of indemnification agreement, which was filedwith the Securities and Exchange Commission as Exhibit 10.1 to our Registration Statement on Form S-1 (Registration No. 333-197247), and which isincorporated herein by reference.There is no arrangement or understanding between Dr. Schwab and any other person pursuant to which Dr. Schwab was selected as a director. Other thanas described above, there are no transactions involving Dr. Schwab requiring disclosure under Item 404(a) of Regulation S-K of the Securities and ExchangeCommission.51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—Information about ourExecutive Officers,” the information required to be furnished pursuant to this item is incorporated herein by reference to our definitive proxy statement for the2020 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 statement for the 2020 Annual Meeting ofStockholders.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 statement for the 2020 Annual Meeting ofStockholders.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 statement for the 2020 Annual Meeting ofStockholders.Item 14. Principal Accountant Fees and ServicesThe information required by this Item 14 is incorporated herein by reference from our definitive proxy statement for the 2020 Annual Meeting ofStockholders.52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, 2019 and 2018Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2019 and 2018Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2019 and 2018Consolidated Statements of Cash Flows for each of the years ended December 31, 2019 and 2018Notes 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 or notesthereto.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 such listingis incorporated herein by reference.53Genocea Biosciences, Inc.Index to Financial Statements PagesReport of Independent Registered Public Accounting FirmF-2Consolidated Balance Sheets as of December 31, 2019 and 2018F-3Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2019 and 2018F-4Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2019 and 2018F-5Consolidated Statements of Cash Flows for each of the years ended December 31, 2019 and 2018F-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, 2019 and 2018, the relatedconsolidated statements of operations and comprehensive loss, stockholders’ equity (deficit) and cash flows for the years ended December 31, 2019 and 2018, andthe related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, theconsolidated financial position of the Company at December 31, 2019 and 2018, and the consolidated results of its operations and its cash flows for the yearsended December 31, 2019 and 2018, in conformity with U.S. generally accepted accounting principles.Adoption of New Accounting StandardsAs discussed in Note 2 to the consolidated financial statements, the Company changed its method of accounting for leases as a result of the adoption of AccountingStandards Update (ASU) No. 2016-02, Leases (Topic 842), and the related amendments effective January 1, 2019.The Company's Ability to Continue as a Going ConcernThe accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 tothe financial statements, the Company has suffered recurring losses from operations, has a working capital deficiency, and has stated that substantial doubt existsabout the Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans regarding thesematters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are requiredto be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities andExchange 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, nor werewe engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal controlover financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial 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 performingprocedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overallpresentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion./s/ Ernst & Young LLPWe have served as the Company’s auditor since 2009Boston, MassachusettsFebruary 13, 2020F-2Genocea Biosciences, Inc.Consolidated Balance Sheets(In thousands, except per share data) December 31, 2019 December 31, 2018Assets Current assets: Cash and cash equivalents$40,127 $26,361Prepaid expenses and other current assets1,457 696Total current assets41,584 27,057Property and equipment, net2,617 2,582Right of use assets6,306 —Restricted cash631 316Other non-current assets1,473 1,160Total assets$52,611 $31,115 Liabilities and stockholders’ equity Current liabilities: Accounts payable$553 $1,659Accrued expenses and other current liabilities4,611 3,816Lease liabilities1,117 —Current portion of long-term debt— 5,257Total current liabilities6,281 10,732Non-current liabilities: Long-term debt, net of current portion13,407 9,565Warrant liability2,486 3,472Lease liabilities, net of current portion5,395 —Other non-current liabilities— 11Total liabilities27,569 23,780Commitments and contingencies (Note 6) Stockholders’ equity: Preferred stock, $0.001 par value; (shares authorized of 25,000,000 at December 31, 2019 and 2018; 1,635 shares issued andoutstanding at December 31, 2019 and 2018)701 701Common stock, $0.001 par value; (shares authorized of 85,000,000 and 250,000,000 at December 31, 2019 and 2018;27,452,900 shares issued and outstanding at December 31, 2019 and 10,846,397 shares issued and outstanding at December 31,2018)27 11Additional paid-in capital355,268 298,627Accumulated deficit(330,954) (292,004)Total stockholders’ equity25,042 7,335Total liabilities and stockholders’ equity$52,611 $31,115See 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, 2019 2018Operating expenses: Research and development$26,952 $25,209General and administrative12,037 14,309Total operating expenses38,989 39,518Loss from operations(38,989) (39,518)Other income (expense): Change in fair value of warrant986 14,757Interest expense, net(946) (1,021)Other expense(1) (2,029)Total other income39 11,707Net loss$(38,950) $(27,811) Comprehensive loss$(38,950) $(27,811)Net loss per share - basic and diluted$(1.89) $(2.69)Weighted-average number of common shares used in computing net loss per share20,644 10,321See accompanying notes to consolidated financial statements.F-4Genocea Biosciences, Inc.Consolidated Statements of Stockholders’ Equity (Deficit)(In thousands) Preferred Additional Total Common Shares Shares Paid-In Accumulated Stockholders’ Shares Amount Amount Capital Deficit Equity (Deficit)Balance at December 31, 20173,592 $3 $— $258,140 $(264,193) $(6,050)Issuance of common stock, net7,230 8 701 38,077 — 38,786Issuance of common Stock; ESPP purchase25 — — 67 — 67Stock-based compensation expense— — — 2,153 — 2,153Issuance of warrants in connection with debt modification— — — 190 — 190Net loss— — — — (27,811) (27,811)Balance at December 31, 201810,847 $11 $701 $298,627 $(292,004) $7,335Issuance of common stock, net16,530 16 — 54,653 — 54,669Issuance of common stock; ESPP purchase71 — — 130 — 130Exercise of stock options5 — — 21 — 21Stock-based compensation expense— — — 1,837 — 1,837Net loss— — — — (38,950) (38,950)Balance at December 31, 201927,453 $27 $701 $355,268 $(330,954) $25,042See accompanying notes to consolidated financial statements.F-5Genocea Biosciences, Inc.Consolidated Statements of Cash Flows(In thousands) Years Ended December 31, 2019 2018Operating activities Net loss$(38,950) $(27,811)Adjustments to reconcile net loss to net cash used in operating activities Depreciation and amortization1,097 1,088Stock-based compensation1,837 2,153Allocation of proceeds to transaction expenses— 2,115Change in fair value of warrant liability(986) (14,757)Gain on sale of equipment(29) (78)Write-off of deferred financing fees110 355Non-cash interest expense504 643Changes in operating assets and liabilities Prepaid expenses and other current assets(803) 53Right of use assets, net of lease liabilities206 —Other non-current assets(423) (989)Accounts payable(1,106) (2,103)Accrued expenses and other liabilities809 (1,904)Net cash used in operating activities(37,734) (41,235)Investing activities Purchases of property and equipment(1,135) (241)Proceeds from sale of equipment48 110Net cash used in investing activities(1,087) (131)Financing activities Proceeds from equity offerings, net of issuance costs54,669 55,458Payment of deferred financing costs— (127)Proceeds from long-term debt— 592Repayment of long-term debt(1,919) (535)Proceeds from exercise of stock options21 —Proceeds from the issuance of common stock under ESPP130 67Net cash provided by financing activities52,901 55,455Net increase in cash, cash equivalents and restricted cash$14,080 $14,089Cash, cash equivalents and restricted cash at beginning of period26,678 12,589Cash, cash equivalents and restricted cash at end of period$40,758 $26,678Non-cash financing activities and supplemental cash flow information Cash paid in connection with operating lease liabilities$1,637 $—Cash paid for interest$1,103 $1,074Warrants issued in connection with debt modification$— $190See 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 a principalplace of business in Cambridge, Massachusetts. The Company seeks to discover and develop novel cancer immunotherapies using its ATLASTM proprietarydiscovery platform. The ATLAS platform profiles each patient's CD4+ and CD8+ T cell immune responses to every potential target or "antigen" in that patient'stumor. The Company believes that this approach optimizes antigen selection for immunotherapies such as cancer vaccines and cellular therapies. Consequently, theCompany believes that ATLAS could lead to more immunogenic and efficacious cancer immunotherapies.The Company’s most advanced program is GEN-009, a personalized neoantigen cancer vaccine, for which it is conducting a Phase 1/2a clinical trial. TheGEN-009 program uses ATLAS to identify neoantigens, or immunogenic tumor mutations unique to each patient, for inclusion in each patient's GEN-009 vaccine.The Company is also advancing GEN-011, a neoantigen-specific adoptive T cell therapy program that also relies on ATLAS, and is targeting an IND filing forGEN-011 in the second quarter of 2020.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 and uncertainties common tocompanies in the biotech and pharmaceutical industry, including, but not limited to, the risks associated with the uncertainty of success of its preclinical andclinical trials; the challenges associated with gaining regulatory approval of product candidates; the risks associated with commercializing pharmaceuticalproducts, if approved for marketing and sale; the potential for development by third parties of new technological innovations that may compete with theCompany’s products; the dependence on key personnel; the challenges of protecting proprietary technology; the need to comply with government regulations; thehigh costs of drug development; compliance with government regulations, competition from companies with greater financial, technological and other resources;and the uncertainty of being able to secure additional capital when needed to fund operations.Accounting Standards Update ("ASU"), 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40), also referred to as AccountingStandards Codification ("ASC") 205-40 (“ASC 205-40”), requires the Company to evaluate whether conditions and/or events raise substantial doubt about itsability to meet its future financial obligations as they become due within one year after the financial statements are issued. As of December 31, 2019, the Companyhad an accumulated deficit of $331.0 million and anticipates that it will continue to incur significant operating losses for the foreseeable future as it continues todevelop its product candidates. Until such time, if ever, as the Company can generate substantial product revenue and achieve profitability, the Company expectsto finance its cash needs through a combination of equity offerings, strategic transactions, and other sources of funding. If the Company is unable to raiseadditional funds when needed, the Company may be required to implement further cost reduction strategies, including ceasing development of GEN-009, GEN-011, and other corporate programs and activities.As reflected in the consolidated financial statements, the Company had available cash and cash equivalents of $40.1 million at December 31, 2019. Inaddition, the Company had cash used in operating activities of $37.7 million for the year ended December 31, 2019. These factors, combined with the Company’sforecast of cash required to fund operations for a period of at least one year from the date of issuance of these consolidated financial statements, raise substantialdoubt about the Company’s ability to continue as a going concern.The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets andsatisfaction of liabilities in the ordinary course of business. The consolidated financial statements do not include any adjustments relating to the recoverability andclassification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.Effective May 22, 2019, the Company effected a reverse stock split of its issued and outstanding common stock, par value $0.001, at a ratio of one-for-eight, and decreased the number of authorized shares of common stock from 250,000,000 shares to 85,000,000 shares. The share and per share informationpresented in these financial statements and related notes have been retroactively adjusted to reflect the one-for-eight reverse stock split.F-72. Summary of significant accounting policiesThe following is a summary of significant accounting policies followed in the preparation of these financial statements. Basis of presentation and principles of consolidationThe accompanying consolidated financial statements include those accounts of the Company and a wholly-owned subsidiary after elimination of allintercompany accounts and transactions. The Company operates as one segment, which is discovering, researching, developing and commercializing novel cancerimmunotherapies.Use of estimatesThe preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amountsreported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are notlimited to, estimates related to clinical trial accruals, estimates related to prepaid and accrued research and development expenses, stock-based compensationexpense, and warrants to purchase redeemable securities. The Company bases its estimates on historical experience and other market-specific or other relevantassumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.Cash and cash equivalents The Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months from date ofpurchase to be cash equivalents. The carrying values of money market funds approximate fair value due to their short-term maturities.Prepaid research and developmentCash advances paid by the Company prior to receipt of preclinical or clinical material and preclinical and clinical trial services are recorded as prepaidresearch and development costs. The prepayments are applied against future research and development costs. The Company expects the carrying value of prepaidresearch and development costs to be fully realized.Property and equipmentProperty and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respectiveassets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulateddepreciation is removed from the accounts and any resulting gain or loss is included in the statements of operations and comprehensive loss. Depreciation isrecorded 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 (“ASC350-40”). 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 on the consolidated balance sheet. Costs incurred during the preliminary project and post-implementationstages are charged to expense. Amortization is recorded using the straight-line method over the estimated useful lives of the respective asset which is three to fiveyears.Impairment of long-lived assetsF-8The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets maynot be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventualdisposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written down to theirestimated fair values. Long-lived assets to be disposed are reported at the lower of the carrying amount or fair value less cost to sell. The Company recognized noasset impairment losses in the years ended December 31, 2019 and 2018.Deferred financing costsOffering costs primarily consist of direct and incremental expenses incurred related to debt and equity financing in accordance with ASU 2015-03,Interest-Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). The Company presents debt issuancecosts related to a recognized debt liability in the balance sheet as a direct deduction of the carrying value of the debt liability, consistent with the accountingtreatment of debt discounts in accordance with ASU 2015-03. The amortization of deferred debt financing costs follows the effective interest rate method.Fair value of financial instrumentsThe Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchyas described in the accounting standards for fair value measurements.•Level 1—Fair values are determined by utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Companyhas the ability to access;•Level 2—Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observableinputs such as interest rates, yield curves and foreign currency spot rates; and•Level 3—Prices or valuations that require inputs that are both significant to the fair value measurement andunobservable.The Company's financial assets consist of cash equivalents and the Company's financial liabilities consist of a warrant liability.The fair value of the Company’s cash equivalents is determined using quoted prices in active markets. The Company's cash equivalents consist of moneymarket funds that are classified as Level 1.The fair value of the Company’s warrant liability is determined using a Monte Carlo simulation. See Note 9. Warrants for assumptions used andmethodologies utilized in calculating the estimated fair value. The Company’s warrant liability is classified as Level 3.LeasesAt the inception of the contract, the Company determines if an arrangement is a lease and has a lease term greater than 12 months. A lease qualifies as afinance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the endof the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of theremaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leasedasset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All otherleases are recorded as operating leases. All leases that are concluded to be in accordance with ASU No. 2018-11, Leases (Topic 842): Targeted Improvements areincluded in lease right-of-use (“ROU”) assets and lease liabilities in the consolidated balance sheets.ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to makelease payments arising from the lease. Lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of leasepayments over the lease term. As most of the Company's leases do not provide an implicit rate, the Company uses an estimate of its incremental borrowing ratebased on the information available at the lease commencement date in determining the present value of lease payments. The Company uses the implicit rate whenreadily determinable. The operating lease ROU asset is reduced by deferred lease payments and unamortized lease incentives. The Company's lease terms mayinclude options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for fixed lease payments onoperating leases are recognized over the expected term on a straight-line basis, while lease expense for fixed lease payments on financing leases are recognizedusing the effective interestF-9method over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately. The non-leasecomponents generally consist of common area maintenance that is expensed as incurred.Research and development expensesResearch and development costs are expensed as incurred. The Company has entered into various research and development contracts with researchinstitutions and other companies. Nonrefundable advanced payments for goods or services to be received in the future for use in research and developmentactivities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed or when the goodshave been received rather than when the payment is made. When evaluating the adequacy of the related accrued liabilities, the Company analyzes progress of thestudies and/or services performed, including the phase or completion of events, invoices received and contracted costs.Stock-based compensation expenseThe Company accounts for its stock-based compensation to employees in accordance with ASC 718, Compensation-Stock Compensation and adjusts theamounts recorded each period to reflect actual forfeitures.Effective January 1, 2019, the Company recognizes stock-based compensation expense for stock-based awards, including grants of stock options andrestricted stock, made to non-employee consultants based on the estimated fair value on the date of grant, over the requisite service period. Through December 31,2018, the Company recognized stock-based compensation expense for stock-based awards granted to non-employee consultants based on the fair value of theawards on each date on which the awards vest. Stock-based compensation expense was recognized over the vesting period, provided that services were rendered bysuch non-employee consultants during that time. At the end of each financial reporting period, the fair value of unvested options was re-measured using the then-current fair value of the common stock of the Company and updated assumptions in the Black-Scholes option-pricing model.For awards that vest or begin vesting upon achievement of a performance condition, the Company recognizes stock-based compensation expense whenachievement of the performance condition is deemed probable using an accelerated attribution model over the implicit service period. Certain of the Company’sawards that contain performance conditions also require the Company to estimate the number of awards that will vest, which the Company estimates when theperformance condition is deemed probable of achievement.Income taxesThe Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for theestimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respectivetax basis. Deferred tax assets and liabilities are measured using the enacted tax rates in effect for the year in which these temporary differences are expected torecovered or settled. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred taxassets will not be realized.Basic and diluted net loss per shareBasic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding for the period. For periods inwhich the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, because dilutive common shares are not assumed tohave been issued if their effect is antidilutive. The Company reported a net loss for the years ended December 31, 2019 and 2018.New Accounting PronouncementsThe following new accounting pronouncements were adopted by the Company on January 1, 2019:In February 2016, the FASB issued ASU No. 2016-02, Leases, which replaced existing guidance in ASC 840, “Leases”, and in July 2018, the FASBissued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. The new standard establishes a ROU that requires a lessee to recognize a ROU asset andlease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting thepattern and classification of expense recognition in the income statement. The adoption of ASC 842 resulted in the Company recognizing ROU assets and relatedoperating lease liabilities of $1.7 million and $1.8 million, respectively, in the consolidated balance sheet as of January 1, 2019. The Company used the modifiedretrospective method of adoption, with January 1, 2019 as the effective date of initial application.F-10The Company elected the short-term lease recognition exemption for all leases that qualify. The Company also elected the package of practical expedients forleases that commenced prior to January 1, 2019, allowing it not to reassess (i) whether any expired or existing contracts contain leases, (ii) the lease classificationfor any expired or existing leases and (iii) the initial indirect costs for any existing leases.In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share Based Payment Accounting. The new standard largely aligns theaccounting for share-based payment awards issued to employees and nonemployees by expanding the scope of ASC 718 to apply to nonemployee share-basedtransactions, as long as the transaction is not effectively a form of financing. The Company adopted the provisions of ASU No. 2018-17 effective January 1, 2019,which did not have a material impact on the Company's consolidated financial statements for the year ended December 31, 2019.The following new accounting pronouncements have been issued but are not yet effective as of December 31, 2019:In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types offinancial instruments, including trade receivables and available-for-sale debt securities. The new standard is effective beginning January 1, 2020. Based on thecomposition of the Company's investment portfolio, which includes only money market funds, and the insignificance of the Company's other financial assets,current market conditions, and historical credit loss activity, the Company does not expect the adoption of this standard to have a material impact on theconsolidated financial position and results of operations and related disclosures.In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the DisclosureRequirements for Fair Value Measurement. The new standard requires public entities to disclose certain new information and modifies some disclosurerequirements. The new standard is effective beginning January 1, 2020. The Company does not expect that the adoption of this standard will have a materialimpact on its disclosures.In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting forImplementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 requires a customer in a cloud computingarrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification 350-40 to determine whichimplementation costs to defer and recognize as an asset. The new standard is effective beginning January 1, 2020. The Company does not expect that the adoptionof this standard will have a material impact on its consolidated financial position and results of operations and related disclosures.3. Fair value of financial instruments The following table sets forth the Company's assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2019 and 2018(in thousands): Total Quoted prices in activemarkets(Level 1) Significant otherobservable inputs(Level 2) Significantunobservable inputs(Level 3)December 31, 2019 Assets Cash equivalents39,971 39,971 — —Total assets$39,971 $39,971 $— $— Liabilities Warrant liability2,486 — — 2,486Total liabilities$2,486 $— $— $2,486 December 31, 2018 Assets Cash equivalents24,651 24,651 — —Total assets$24,651 $24,651 $— $— Liabilities Warrant liability3,472 — — 3,472Total liabilities$3,472 $— $— $3,472F-11The following table reflects the change in the Company’s Level 3 warrant liability (in thousands): Warrant liabilityBalance at Issuance (January 2018) $18,231Change in fair value (14,757)Warrants exercised (2)Balance at December 31, 2018 $3,472Change in fair value (986)Balance at December 31, 2019 $2,4864. Property and equipment, netProperty and equipment, net consist of the following (in thousands): December 31, 2019 2018Laboratory equipment$4,125 $3,761Internally developed software2,547 1,970Leasehold improvements1,524 1,524Furniture and office equipment456 447Computer hardware338 338Internally developed software in progress97 —Total property and equipment9,087 8,040Accumulated depreciation and amortization(6,470) (5,458)Property and equipment, net$2,617 $2,582Depreciation expense was $0.7 million for both the years ended December 31, 2019 and 2018, respectively. Amortization related to the Company'sinternally developed software was $0.4 million for both the years ended December 31, 2019 and 2018, respectively.F-125. Accrued expenses and other current liabilitiesAccrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2019 2018Payroll and employee-related costs$2,245 $2,147Research and development costs1,607 759Other current liabilities759 910Total$4,611 $3,8166. Commitments and contingenciesOperating LeasesAs of January 1, 2019, the Company has entered into two lease agreements for two floors of lab and office space in a multi-tenant building in Cambridge,Massachusetts. In March 2019, the Company entered into a sublease agreement for a portion of office space lease through February 2020. Since the Company retained itsobligations under the sublease, it did not adjust the lease liability, however the sublease is being reflected as a reduction of lease expense.In May 2019, the Company entered into a lease extension for office and lab space through February 2025. As a result of the lease term extension, theCompany recognized an increase in the ROU assets of $5.4 million and associated lease liabilities of $5.3 million. The associated lease obligation for the extensionis included in the Company’s ROU assets and associated lease liabilities as of December 31, 2019. The Company has the option to extend the lease terms for anadditional five years, which is not included in the Company's ROU assets and associated lease liabilities as of December 31, 2019. In July 2019, the Company exercised an option for additional office and lab space from March 2020 through February 2025. As the Company does nothave the right to use or control the office space, the Company has not included the associated lease obligation in its determination of ROU assets and associatedlease liabilities as of December 31, 2019. The Company's lease obligation associated with the additional lab and office space is $7.2 million and will be reflected asa lease liability upon it's right to use the office space in March 2020.For the year ended December 31, 2019, lease expense, net of sublease income, was $1.5 million.The weighted average remaining lease term and weighted average discount rate of the Company's operating leases are as follows: December 31, 2019Weighted average remaining lease term in years 5.12Weighted average discount rate 8.27%Finance LeaseIn December 2019, the Company entered into an agreement to lease lab equipment for a term of 15 months. The Company determined that the agreementqualifies as a finance lease based on the criteria that the Company holds the option to purchase the asset and is reasonably certain to exercise at the end of the leaseterm. The ROU asset and lease liability were calculated using an incremental borrowing rate of 7.95%. Lease payments on this lease begin in January 2020.F-13The following table summarizes the presentation in the Company's consolidated balance sheets:Leases (in thousands) Classification December 31, 2019Assets Operating Lease right-of-use asset $6,156Finance Lease right-of-use asset 150Total leased assets $6,306Liabilities Current Operating Lease liabilities $990 Finance Lease liabilities 127Non-current Operating Lease liabilities, net of current portion 5,373 Finance Lease liabilities, net of current portion 22Total lease liabilities $6,512The minimum lease payments related to the Company's operating leases in accordance with ASC 842 as of December 31, 2019 were as follows (inthousands):Operating Leases Finance Leases Total2020$1,477 $134 $1,61120211,473 23 1,49620221,511 — 1,51120231,548 — 1,5482024 and thereafter1,853 — 1,853 Total lease payments$7,862 $157 $8,019Less imputed interest(1,500) (7) (1,507) Total$6,362 $150 $6,512The following information is disclosed in accordance with ASC 840, which was applicable until the adoption of ASC 842 as of January 1, 2019. As ofDecember 31, 2018, future minimum commitments under the Company's operating leases with initial terms of more than one year were as follows (in thousands): Total Lease Commitments2019 $1,6372020 274Total $1,911For the year ended December 31, 2018, under ASC 840, the Company paid $1.5 million in rent expense.At December 31, 2019 and 2018, the Company has an outstanding letter of credit of $0.6 million and $0.3 million, respectively, with a financialinstitution related to a security deposit for the office and lab space lease. The amount is secured by cash on deposit and expires on February 28, 2025.Contractual obligations The Company has entered into certain agreements with various contract research organizations ("CROs") and contract manufacturing organizations("CMOs"), which generally include cancellation clauses.F-14Harvard University License Agreement The Company has an exclusive license agreement with Harvard University (“Harvard”), granting the Company 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 to performlicensed services related to the ATLAS discovery platform. The Company is also obligated to pay Harvard milestone payments up to $1.6 million in the aggregateupon the achievement of certain development and regulatory milestones. As of December 31, 2019, the Company has paid $0.3 million in aggregate milestonepayments. The Company is obligated under this license agreement to use commercially reasonable efforts to develop, market and sell licensed products incompliance with an agreed upon development plan. In addition, the Company is obligated to achieve specified development milestones and in the event theCompany is unable to meet its development 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.Upon commercialization of our products covered by the licensed patent rights or discovered using the licensed methods, the Company is obligated to payHarvard royalties on the net sales of such products and services sold by the Company, the Company's affiliates, and the Company's sublicensees. This royaltyvaries depending on the type of product or service but is in the low single digits. The sales-based royalty due by the Company’s sublicensees is the greater of theapplicable royalty rate or a percentage in the high single digits or the low double digits of the royalties the Company receives from such sublicensee, depending onthe type of product. Based on the type of commercialized product or service, royalties are payable until the expiration of the last-to-expire valid claim under thelicensed patent rights or for a period of 10 years from first commercial sale of such product or service. The royalties payable to Harvard are subject to reduction,capped at a specified percentage, for any third-party payments required to be made. In addition to the royalty payments, if the Company receives any additionalrevenue (cash or non-cash) under any sublicense, the Company must pay Harvard a percentage of such revenue, excluding certain categories of payments, varyingfrom the low single digits to up to the low double digits depending on the scope of the license that includes the sublicense. This license agreement with Harvard will expire on a product-by-product or service-by-service and country-by-country basis until the expiration of thelast-to-expire valid claim under the licensed patent rights. The Company may terminate the agreement at any time by giving Harvard advance written notice.Harvard may also terminate the agreement in the event of a material breach by the Company that remains uncured; in the event of our insolvency, bankruptcy, orsimilar circumstances; or if the Company challenges the validity of any patents licensed to us.Oncovir License and Supply AgreementIn January 2018, the Company entered into a License and Supply Agreement with Oncovir, Inc. (“Oncovir”). The agreement provides the terms andconditions under which Oncovir will manufacture and supply an immunomodulator and vaccine adjuvant, Hiltonol® (poly-ICLC) (“Hiltonol”), to the Company foruse in connection with the research, development, use, sale, manufacture, commercialization and marketing of products combining Hiltonol with the Company'stechnology (the “Combination Product”). Hiltonol is the adjuvant component of GEN-009, which will consist of synthetic long peptides or neoantigens identifiedusing the Company's proprietary ATLAS platform, formulated with Hiltonol. Oncovir granted the Company a non-exclusive, assignable, royalty-bearing worldwide license, with the right to grant sublicenses through one tier, tocertain of Oncovir’s intellectual property in connection with the research, development, or commercialization of Combination Products, including the use ofHiltonol, but not the use of Hiltonol for manufacturing or the use or sale of Hiltonol alone. The license will become perpetual, fully paid-up, and royalty-free onthe later of January 25, 2028 or the date on which the last valid claim of any patent licensed to the Company under the agreement expires.Under this agreement, the Company is obligated to pay Oncovir low to mid six figure milestone payments upon the achievement of certain clinical trialmilestones for each Combination Product and the first marketing approval for each Combination Product in certain territories, as well as tiered royalties in the low-single digits on a product-by-product basis based on the net sales of Combination Products. The Company may terminate the agreement upon a decision to discontinue the development of the Combination Product or upon a determination by theCompany or an applicable regulatory authority that Hiltonol or a Combination Product is not clinically safe or effective. The agreement may also be terminated byeither party due to a material uncured breach by the other party, or due to the other party’s bankruptcy, insolvency, or dissolution.F-157. Long-term debt In April 2018, the Company entered into an amended and restated loan and security agreement with Hercules Capital, Inc. ("Hercules"), which wassubsequently amended in November 2019 (as amended, the "2018 Term Loan"). The 2018 Term Loan provides a $14.0 million term loan. The 2018 Term Loanmatures on May 1, 2021 and accrues interest at a floating rate per annum equal to the greater of (i) 8.00%, or (ii) the sum of 3.00% plus the prime rate. The 2018Term Loan provides for interest-only payments until January 1, 2021. Thereafter, payments will include equal installments of principal and interest throughmaturity. The 2018 Term Loan may be prepaid subject to a prepayment charge. The Company is obligated to pay an end of term charge of $1.0 million at maturity.The Company evaluated the November 2019 amendment to the 2018 Term Loan and concluded that it was a modification pursuant to ASC 470-50, Debt (Topic470).The 2018 Term Loan is secured by a lien on substantially all assets of the Company, other than intellectual property. Hercules has a perfected first-priority security interest in certain cash, cash equivalents and investment accounts. The 2018 Term Loan contains non-financial covenants, representations and aMaterial Adverse Effect provision. There are no financial covenants. A "Material Adverse Effect" means a material adverse effect upon: (i) the business,operations, properties, assets or condition (financial or otherwise) of the Company; (ii) the ability of the Company to perform the secured obligations in accordancewith the terms of the loan documents, or the ability of agent or lender to enforce any of its rights or remedies with respect to the secured obligations; or (iii) thecollateral or agent’s liens on the collateral or the priority of such liens. Any event that has a Material Adverse Effect or would reasonably be expected to have aMaterial Adverse Effect is an event of default under the Loan Agreement and repayment of amounts due under the Loan Agreement may be accelerated byHercules under the same terms as an event of default. As of December 31, 2019, the Company was in compliance with all covenants of the 2018 Term Loan. The2018 Term Loan is automatically redeemable upon a change in control. The Company believes acceleration of the repayment of amounts outstanding under theloan is remote, and therefore, the debt balance is classified according to the contractual payment terms at December 31, 2019.In connection with a previously issued term loan in 2014 the Company issued common stock warrants to Hercules which expired unexercised inNovember 2019. In connection with the 2018 Term Loan, the Company issued common stock warrants to Hercules (the “Hercules Warrant”). See Note 9.Warrants.As of December 31, 2019 and 2018, the Company had outstanding borrowings of $13.4 million and $14.8 million, respectively. During the years endedDecember 31, 2019 and 2018, the Company made payments of $1.9 million and $0.5 million on its long term debt. Interest expense was $1.6 million and $1.7million for the years ended December 31, 2019 and 2018, respectively.Future principal payments, including the End of Term Charges, are as follows (in thousands): December 31, 20192020$—202113,960Total$13,9608. Stockholders' equity2019 Public OfferingIn June 2019, the Company entered into an underwriting agreement relating to the public offering of 10,500,000 shares of the Company’s common stock,par value $0.001 per share, at a price of $3.50 per share, for gross proceeds of approximately $36.8 million (the “2019 Public Offering”). The Company alsogranted the underwriters an option to purchase up to an additional 1,575,000 shares of common stock (“Overallotment Option”). On June 26, 2019, theunderwriters exercised this option in full. The Company received approximately $5.5 million in gross proceeds from the underwriter’s exercise of theOverallotment Option. In connection with the 2019 Public Offering, inclusive of the Overallotment Option, the Company received net proceeds of $38.4 million.Private PlacementIn February 2019, the Company completed a private placement financing transaction (the “Private Placement”). The Company issued 3,199,998 shares ofcommon stock, prefunded warrants (the “Pre-Funded Warrants”) to purchase 531,250 shares of common stock (the “Pre-Funded Warrant Shares”), and warrants(the “Private Placement Warrants”) to purchase up to 932,812 shares of common stock (the “Warrant Shares”). The Shares, Pre-Funded Warrants and PrivatePlacement Warrants (collectively, the “Units”) were sold at a purchase price of $4.02 per Unit. The Company received net cash proceeds of approximately $13.8million for the purchase of the Shares, Pre-Funded Warrant Shares and Warrant Shares. See Note 9. Warrants.F-16The Company had the option to issue additional shares of common stock in a second closing (the “Second Closing”) for gross proceeds of up to $24.2million. The occurrence of the Second Closing was conditioned on top-line results from Part A of the Company's Phase 1/2a clinical trial for GEN-009 and adecision by the Company's board of directors to proceed with the Second Closing. In June 2019, the Company announced top-line results from this trial but electednot to proceed with the Second Closing. In lieu of the Second Closing, the Company proceeded with the 2019 Public Offering.2018 Public OfferingIn January 2018, the Company entered into two underwriting agreements, the first relating to the public offering of 6,670,625 shares of the Company’scommon stock, par value $0.001 per share, and accompanying warrants to purchase up to 3,335,313 shares of common stock (“2018 Public Offering Warrants”), ata combined price of $8.00 per share, for gross proceeds of approximately $53.4 million (the “2018 Common Stock Offering”) and the second relating to the publicoffering of 1,635 shares of the Company’s Series A convertible preferred stock ("Preferred Stock"), par value $0.001 per share, which are convertible into 204,375shares of common stock, and accompanying warrants to purchase up to 102,188 shares of common stock for gross proceeds of approximately $1.6 million (the“Preferred Stock Offering,” and together with the 2018 Common Stock Offering, the “January 2018 Financing”). The Company received approximately $1.0million in gross proceeds and issued 119,718 shares of common stock and warrants to purchase up to 179,757 shares of common stock from the underwriters'exercise of their overallotment option.Preferred StockEach share of preferred stock is convertible into 125 shares of common stock, subject to certain adjustments upon stock dividends and stock splits. Theholders of preferred stock shall be entitled to receive dividends in the same form as dividends actually paid on shares of common stock when, as and if suchdividends are declared by the Board of Directors and paid on shares of the common stock, on an as-if-converted-to-common stock basis.Issuance costsIn connection with the January 2018 Financing, the Company incurred approximately $4.0 million of issuance costs. The Company allocatedapproximately $2.6 million of the issuance costs to the common and preferred stock within additional paid-in capital and immediately expensed approximately$1.4 million of the issuance costs allocated to the liability classified 2018 Public Offering Warrants.WarrantsSee Note 9. Warrants.HerculesIn connection with the 2018 Loan Agreement with Hercules, the Company also entered into an amendment to the November 2014 equity rights letteragreement (the “Amended Equity Rights Letter Agreement”). Hercules has the right to participate in any one or more subsequent private placement equityfinancings of up to $2.0 million on the same terms and conditions as purchases by the other investors in each subsequent equity financing. The Amended EquityRights Letter Agreement will terminate upon the earlier of (1) such time when Hercules has purchased $2.0 million of subsequent equity financing securities in theaggregate, and (2) the later of (a) the repayment of all indebtedness under the 2018 Term Loan, or (b) the expiration or termination of the exercise period for theHercules Warrant. See Note 9. Warrants.Agreement with Lincoln Park CapitalIn October 2019, the Company entered into a purchase agreement with Lincoln Park Capital (“LPC”) pursuant to which LPC purchased shares of theCompany's common stock at a purchase price of $2.587 per share and received net proceeds of approximately $2.5 million. In addition, for a period of thirtymonths, the Company has the right, at its sole discretion, to sell up to an additional $27.5 million of the Company's common stock based on prevailing marketprices of its common stock at the time of each sale. In consideration for entering into the purchase agreement, the Company issued 289,966 shares of its commonstock to LPC as a commitment fee. The purchase agreement limits our sales of shares of common stock to LPC to 5,227,323 shares of common stock, representing19.99% of the shares of common stock outstanding on the date of the purchase agreement. The purchase agreement also prohibits us from directing LPC topurchase any shares of common stock if those shares, when aggregated with all other shares of our common stock then beneficially owned by LPC and itsaffiliates, would result in LPC and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding shares ofour common stock. The Company determined that the right to sell additional shares represents a freestanding put option that meets the criteriaF-17of a derivative pursuant to ASC 815 Derivatives and Hedging, but has a fair value of zero, and therefore no additional accounting was required.At-the-market equity offering programIn 2015, the Company entered into an agreement, as amended, with Cowen and Company, LLC to establish an at-the-market equity offering program(“ATM”) pursuant to which it was able to offer and sell shares of its common stock at prevailing market prices from time to time. Through December 31, 2019, theCompany has sold an aggregate of 463,887 shares under the ATM and received approximately $4.0 million in net proceeds.9. WarrantsAs of December 31, 2019, the Company had the following potentially issuable shares of common stock related to unexercised warrants outstanding: Shares Exercise price Expiration date ClassificationHercules Warrant 41,177 $6.80 Q2 2023 Equity2018 Public Offering Warrants 3,616,944 $9.60 Q1 2023 LiabilityPrivate Placement Warrants 932,812 $4.52 Q1 2024 EquityPre-Funded Warrants 531,250 $0.08 Q1 2039 Equity 5,122,183 Hercules WarrantThe exercise price and the number of shares are subject to adjustment upon a merger event, reclassification of the shares of common stock, subdivision orcombination of the shares of common stock or certain dividends payments. The Company determined that the Hercules Warrant should be equity classified inaccordance with ASC 480, Distinguishing Liabilities from Equity ("ASC 480") for all periods presented.2018 Public Offering WarrantsThe exercise price and the number of shares are subject to adjustment upon a merger event, reclassification of the shares of common stock, subdivision orcombination of the shares of common stock or certain dividends payments. In the event of an “Acquisition,” defined generally to include a merger or consolidationresulting in the sale of 50% or more of the voting securities of the Company, the sale of all, or substantially all, of the assets or voting securities of the Company, orother change of control transaction, as defined in the 2018 Public Offering Warrants, the Company will be obligated to use its best efforts to ensure that the holdersof the 2018 Public Offering Warrants receive new warrants from the surviving or acquiring entity (the “Acquirer”). The new warrants to purchase shares in theAcquirer shall have the same expiration date as the 2018 Public Offering Warrants and a strike price that is based on the proportion of the value of the Acquirer’sstock to the Company’s common stock. If the Company is unable, despite its best efforts, to cause the Acquirer to issue new warrants in the Acquisition asdescribed above, then, if the Company’s stockholders are to receive cash in the Acquisition, the Company will settle the 2018 Public Offering Warrants in cash andif the Company’s stockholders are to receive stock in the Acquisition, the Company will issue shares of its common stock to each Warrant holder.The Company determined that the 2018 Public Offering Warrants should be liability classified in accordance with ASC 480. As the 2018 Public OfferingWarrants are liability-classified, the Company remeasures the fair value at each reporting date. The Company initially recorded the 2018 Public Offering Warrantsat their estimated fair value of approximately $18.2 million. In connection with the Company's remeasurement of the 2018 Public Offering Warrants to fair value,the Company recorded income of $1.0 million and $14.8 million for the years ended December 31, 2019 and 2018, respectively. The fair value of the warrantliability is approximately $2.5 million and $3.5 million as of December 31, 2019 and 2018, respectively.F-18The following table details the assumptions used in the Monte Carlo simulation models used to estimate the fair value of the Warrant Liability as ofDecember 31, 2019 and 2018, respectively: December 31, 2019 December 31, 2018Stock Price $2.07 $2.32Volatility 50.0% - 116.6% 50.0% - 111.3%Remaining term (years) 3.1 4.1Expected dividend yield —% —%Risk-free rate 1.6% 2.4% - 2.5%Range of annual acquisition event probability 20.0% 0.0% - 30.0%Private Placement and Prefunded WarrantsThe exercise price of the warrants is subject to appropriate adjustment in the event of stock dividends, subdivisions, stock splits, stock combinations,reclassifications, reorganizations or a change of control affecting our common stock. The Company determined that the Private Placement Warrants and the Pre-Funded Warrants should be equity classified in accordance with ASC 480 for the period ended December 31, 2019. The Company also determined that the Pre-Funded Warrants should be included in the determination of basic earnings per share in accordance with ASC 260, Earnings per Share.10. Stock and employee benefit plansThe Company issues stock options with service conditions, which are generally the vesting of the awards. The Company has also issued stock optionsthat vest upon the satisfaction of certain performance conditions.The 2014 Equity Incentive Plan ("2014 Equity Plan"), which was subsequently amended and restated in June 2018, provides for the grant of incentivestock options, non-qualified stock options, restricted stock, and other awards to key employees and directors of, and consultants and advisors to, the Company. The2014 Equity Plan, as amended, provides that the number of shares available for issuance will automatically increase annually on each January 1, in amount equal tothe lesser of 4.0% of the outstanding shares of the Company’s outstanding common stock as of the close of business on the immediately preceding December 31 orthe number of shares determined the Company’s board of directors. On January 1, 2020, the total number of shares available for issuance under the 2014 EquityPlan, as amended. increased by 1,098,116 for shares under this provision.At December 31, 2019, 1,568,535 option awards are reserved for issuance under the Company's equity plans and 245,430 awards remain available forfuture grants.Determining the Fair Value of Stock OptionsThe Company measures the fair value of stock options with service-based and performance-based vesting criteria to employees, consultants and directorson the date of grant using the Black-Scholes option pricing model.The Company does not have sufficient history to support a calculation of volatility and expected term using only its historical data. As such, the Companyhas used a weighted-average volatility considering the Company’s own volatility since its initial public offering and the volatilities of several guideline companies.For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading history, and stage of life cycle. The assumeddividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The average expected life was determined according tothe “simplified method” as described in SAB 110, which is the mid-point between the vesting date and the end of the contractual term. The risk-free interest rate isdetermined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant.The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows: Years ended December 31, 2019 2018Expected volatility 79.7% 78.6%Risk-free interest rate 2.3% 2.8%Expected term (in years) 6.0 6.0Expected dividend yield 0% 0%F-19The following table summarizes stock option activity for employees and non-employees (shares in thousands): Shares Weighted-AverageExercise Price Weighted-AverageRemainingContractualTerm (years) AggregateIntrinsic ValueOutstanding at December 31, 2018 893 $18.79 Granted 679 $4.36 Exercised (5) $4.32 Canceled (244) $17.64 Outstanding at December 31, 2019 1,323 $11.65 8.0 $—Exercisable at December 31, 2019 522 $20.09 6.6 $—During the years ended December 31, 2019 and 2018, the Company granted stock options to purchase an aggregate of 678,710 and 657,375 shares of itscommon stock, respectively, with weighted-average grant date fair values of $4.36 and $6.96, respectively.As of December 31, 2019, there was $3.0 million of total unrecognized compensation cost, related to employee and non-employee stock options grantedunder the Company’s equity plans. The Company expects to recognize that cost over a remaining weighted-average period of 2.65 years.Stock-based compensation expenseTotal stock-based compensation expense is recognized for stock options and restricted stock granted to employees and non-employees and has beenreported in the Company’s consolidated statements of operations as follows (in thousands): Years ended December 31, 2019 2018Research and development $725 $620General and administrative 1,112 1,533Total $1,837 $2,153Employee Stock Purchase PlanIn February 2014, the Company’s board of directors adopted the 2014 Employee Stock Purchase Plan (the “2014 ESPP”), which was subsequentlyamended in June 2018. The 2014 ESPP, as amended, authorizes the issuance of up to 337,597 shares of common stock to participating eligible employees. The2014 ESPP, as amended, provides for six-month option periods commencing on January 1 and ending June 30, and commencing July 1 and ending December 31 ofeach calendar year. The Company issued 71,118 and 23,417 shares under the 2014 ESPP, as amended, for the years ended December 31, 2019 and 2018,respectively. As of December 31, 2019, there were 217,985 shares remaining for future issuance under the plan.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 Company madematching contributions to participants in this plan which totaled $0.2 million and $0.1 million for the years ended December 31, 2019 and 2018, respectively.F-2011. Net loss per shareBasic and diluted net loss per share was calculated as follows for the years ended December 31, 2019 and 2018: Years ended December 31, 2019 2018Basic net loss per share: Numerator: Net loss (in thousands) $(38,950) $(27,811)Denominator: Weighted average common stock outstanding - basic (in thousands) 20,644 10,321 Dilutive effect of shares of common stock equivalents resulting from common stock options and restricted stock units — — Weighted average common stock outstanding - diluted 20,644 10,321Net loss per share - basic and diluted $(1.89) $(2.69)The following common stock equivalents outstanding as of December 31, 2019 and 2018, presented on an as converted basis, were excluded from thecalculation of net loss per share for the periods presented, due to their anti-dilutive effect (in thousands): Years ended December 31, 2019 2018Stock options 1,323 893Warrants 4,591 3,668Total 5,914 4,561Stock options that are outstanding and contain performance-based vesting criteria for which the performance conditions have not been met are excludedfrom the calculation of common stock equivalents outstanding.12. Income taxesFor the years ended December 31, 2019 and 2018, 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:F-21 December 31, 2019 2018Deferred tax assets: U.S. and state net operating loss carryforwards$56,906 $49,614Capitalized R&D28,427 25,366Research and development credits11,717 10,445Lease liability1,779 —Stock-based compensation1,053 1,989Depreciation and amortization545 640Accrued expenses507 450Other temporary differences38 85Total deferred tax assets100,972 88,589Less valuation allowance(99,249) (88,589)Deferred tax assets less valuation allowance$1,723 $— Deferred tax liabilities: ROU asset$(1,723) $—Total deferred tax liabilities(1,723) —Net deferred tax assets (deferred tax liabilities)$— $—The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company’s historyof 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, theCompany has provided a full valuation allowance for deferred tax assets as of December 31, 2019 and 2018. The valuation allowance increased approximately$10.7 million during the year ended December 31, 2019 due primarily to the generation of net operating losses.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, 2019 2018Federal income tax expense at statutory rate 21.0 % 21.0 %State income tax, net of federal benefit 6.3 % 8.9 %Permanent differences 0.0 % 9.0 %Research and development credit 3.3 % 6.7 %Change in valuation allowance (27.4)% (43.1)%Other, net (3.2)% (2.5)%Effective tax rate 0.0 % 0.0 %As of December 31, 2019 and 2018, the Company had U.S. federal net operating loss carryforwards of approximately $211.5 million and $184.8 million,respectively, which may be available to offset future income tax liabilities and expire at various dates through 2038. The federal net operating losses generated intax years after December 31, 2017 can be carried forward indefinitely. As of December 31, 2019 and 2018, the Company also had U.S. state net operating losscarryforwards of approximately $197.7 million and $171.1 million, respectively, which may be available to offset future income tax liabilities and expire atvarious dates through 2039.As of December 31, 2019 and 2018, the Company had federal research and development tax credit carryforwards of approximately $8.9 million and $7.8million, respectively, available to reduce future tax liabilities which expire at various dates through 2039. As of December 31, 2019 and 2018, the Company hadstate research and development tax credit carryforwards of approximately $3.5 million and $3.2 million, respectively, available to reduce future tax liabilitieswhich expire at various dates through 2034.Under the provisions of the Internal Revenue Code of 1986, as amended (the "Code"), the net operating loss and tax credit carryforwards are subject toreview and possible adjustment by the Internal Revenue Service and state tax authorities. NetF-22operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest ofsignificant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Code, respectively, as well as similar stateprovisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annuallimitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect thelimitation in future years. The Company has completed several financings since its inception which may have resulted in a change in control as defined by Sections382 and 383 of the Code, or could 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, 2019 and 2018, theCompany had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operationsand comprehensive loss.For all years through December 31, 2019, the Company generated research credits but has not conducted a study to document the qualified activities. Thisstudy may result in an adjustment to the Company’s research and development credit carryforwards. However, until a study is completed and any adjustment isknown, no amounts are being presented as an uncertain tax position for these years. A full valuation allowance has been provided against the Company’s researchand development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the researchand development credit carryforwards and the valuation allowance.The Company files income tax returns in the United States and the Commonwealth of Massachusetts. The federal and state income tax returns aregenerally subject to tax examinations for the tax years ended December 31, 2015 through December 31, 2019. 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.13. Quarterly financial information (unaudited, in thousands, except per share data) Three Months Ended, March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019Operating expenses $9,477 10,066 9,584 9,862Net income (loss) (15,567) (6,495) (7,532) (9,356)Net loss per share - basic and diluted $(1.22) $(0.42) $(0.28) $(0.34)Weighted-average number of common shares used in computingnet loss per share - basic and diluted 12,713 15,344 26,681 27,620 Three Months Ended, March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018Operating expenses $10,384 9,788 10,460 $8,886Net loss (15,890) (4,438) (7,833) 350Net loss per share - basic and diluted $(1.78) $(0.42) $(0.72) $0.03Weighted-average number of common shares used incomputing net loss per share - basic and diluted 8,905 10,693 10,829 10,847F-23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 13, 2020. 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 the capacitiesand on the dates indicated.Signature Title Date /s/ William Clark President and Chief Executive Officer and Director William Clark (Principal Executive Officer) February 13, 2020 /s/ Diantha Duvall Chief Financial Officer Diantha Duvall (Principal Financial Officer and Principal Accounting Officer) February 13, 2020 /s/ Kenneth Bate Kenneth Bate Director February 13, 2020 /s/ Ali Behbahani Ali Behbahani Director February 13, 2020 /s/ Katrine Bosley Katrine Bosley Director February 13, 2020 /s/ Ronald Cooper Ronald Cooper Director February 13, 2020 /s/ Michael Higgins Michael Higgins Director February 13, 2020 /s/ Howard Mayer Howard Mayer, M.D. Director February 13, 2020 /s/ George Siber George Siber, M.D. Director February 13, 2020ExhibitNumber Exhibit 3.1 Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Reporton Form 8-K, File No. 001-36289, filed on February 12, 2014) 3.2 Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to theCompany’s Current Report on Form 8-K, File No. 001-36289, filed on June 25, 2018) 3.3 Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to theCompany’s Current Report on Form 8-K, File No. 001-36289, filed on May 21, 2019) 3.4 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’s RegistrationStatement on Form S-1, File No. 333-193043, filed on December 23, 2013) 4.3 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by referenceto Exhibit 4.1 to the Company's Current Report on Form 8-K, File No. 001-36289 filed on January 19, 2018) 4.4 Form of Class A Warrant to Purchase Shares of Common Stock of Genocea Biosciences, Inc. (incorporated by reference to Exhibit4.5 to the Company's Annual Report on Form 8-K, File No. 001-36289, filed on February 16, 2018) 4.5 Warrant Agreement between the Company and Hercules Capital, Inc., dated April 24, 2018 (incorporated by reference to Exhibit 4.1to the Company's Current Report on Form 8-K, File No. 001-36289, filed on April 30, 2018) 4.6 Form of Pre-Funded Warrant to Purchase Shares of Common Stock of Genocea Biosciences, Inc. (incorporated by reference toExhibit 4.1 to the Company's Form 8-K, File No. 001-36289, filed on February 12, 2019) 4.7 Form of Class B Warrant to Purchase Shares of Common Stock of Genocea Biosciences, Inc. (incorporated by reference to Exhibit4.8 to the Company's Annual Report on Form 10-K, File No. 001-36289, filed on February 28, 2019) 4.8* Description of the Registrant's Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934. 10.1 Form of Director Indemnification Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement onForm 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, datedNovember 19, 2012 10.3 Lease, dated as of July 3, 2012 between TBCI, LLC and Genocea Biosciences, Inc. (incorporated by reference to Exhibit 10.8 to theCompany’s Registration Statement on Form S-1, File No. 333-193043, dated December 23, 2013) 10.4 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) 10.5† 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) 10.6† Amended and Restated Employment Letter Agreement between William Clark and Genocea Biosciences, Inc., dated January 16, 2014(incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-1, File No. 333-193043, as amendedon January 23, 2014) ExhibitNumber Exhibit 10.7† Genocea Biosciences, Inc. Amended and Restated 2014 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to theCompany's Current Report on Form 8-K, File No. 001-36289, filed on June 25, 2018) 10.8† Genocea Biosciences, Inc. Cash Incentive Plan (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statementon Form S-1, File No. 333-193043, as amended on January 13, 2014) 10.9† Form of Nonstatutory Stock Option Granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan(incorporated by reference to Exhibit 10.20 to the Company’s Registration Statement on Form S-1, File No. 333-193043, filed onDecember 23, 2013) 10.10† 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) 10.11† 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) 10.12† 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) 10.13† Genocea Biosciences, Inc. 2014 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 10.2 to theCompany’s Current Report on Form 8-K, File No. 001-36289, filed on June 25, 2018) 10.14† Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan to KatrineBosley, dated May 13, 2013 (incorporated by reference to Exhibit 10.27 to the Company’s Registration Statement on Form S-1, FileNo. 333-193043, as amended on January 13, 2014) 10.15† Nonstatutory Stock Option granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan to KatrineBosley, dated November 5, 2013 (incorporated by reference to Exhibit 10.28 to the Company’s Registration Statement on Form S-1,File No. 333-193043, as amended on January 13, 2014) 10.16 Equity Rights Letter Agreement between the Company and Hercules Technology Growth Capital, Inc., dated November 20, 2014(incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on November 21,2014) 10.17 Sublease Agreement between the Company and the Smithsonian Institution, dated June 15, 2015 (incorporated by reference to Exhibit10.2 to the Company’s Current Report on Form 8-K, File No. 001-36289, filed on June 19, 2015) 10.18 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. (incorporated byreference to Exhibit 10.30 to the Company’s Form 10-Q, filed on August 5, 2016, File No. 001-36289) 10.19+ License and Supply Agreement, between the Company and Oncovir, Inc., dated January 26, 2018 (incorporated by reference toExhibit 10.32 to the Company's Annual Report on Form 10-K, File No. 001-36289, filed on February 16, 2018). 10.20+ Amended and Restated Loan and Security Agreement between the Company, the several banks and other financial institutions orentities from time to time parties thereto and Hercules Capital, Inc., dated April 24, 2018 (incorporated by reference to Exhibit 10.4 tothe Company's Quarterly Report on Form 10-Q, File No. 001-36289, filed on August 3, 2018) 10.21 Amendment to Equity Rights Letter Agreement between the Company, Hercules Capital, Inc. (f/k/a Hercules Technology GrowthCapital, Inc.), dated April 24, 2018 (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K, File No.001-36289, filed on April 30, 2018) ExhibitNumber Exhibit 10.22 First Amendment to Amended and Restated Loan and Security Agreement between the Company, the several banks and otherfinancial institutions or entities from time to time parties thereto and Hercules Capital, Inc., dated November 14, 2019 (incorporated byreference to Exhibit 10.1 to the Company's Current Report on Form 8-K, File No. 001-36289, filed on November 19, 2019) 10.23* Second Amendment to the Lease, dated May 1, 2019, between 100 Discovery Park DE, LLC, a Delaware limited liability company(as successor in interest to TBCI, LLC, as Trustee of 100 Discovery Park Realty Trust) and Genocea Biosciences, Inc. 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 Principal 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 Principal 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 compensatoryplan.+Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been submittedseparately to the Securities and Exchange Commission.++Portions of this exhibit (indicated by asterisks) have been omitted because the Registrant has determined they are not material and would likely causecompetitive harm to the Registrant if publicly disclosed.DESCRIPTION OF THE REGISTRANT’S SECURITIESREGISTERED PURSUANT TO SECTION 12 OF THE SECURITIESEXCHANGE ACT OF 1934As of December 31, 2019, Genocea Biosciences Inc. (“Genocea,” “we,” “our,” or “us”) has one class of securities registeredunder Section 12 of the Securities Exchange Act of 1934, as amended: our common stock, $0.001 par value per share.DESCRIPTION OF CAPITAL STOCKThe following summary of the terms of our capital stock is based upon our fifth amended and restated certificate of incorporation,as amended (the “Certificate of Incorporation”), and our amended and restated bylaws (the “Bylaws”). The summary is notcomplete, and is qualified by reference to our Certificate of Incorporation and our Bylaws, which are filed as exhibits to this AnnualReport on Form 10-K and are incorporated by reference herein. We encourage you to read our Certificate of Incorporation, ourBylaws, and the applicable provisions of the Delaware General Corporation Law for additional information.Authorized Shares of Capital StockOur authorized capital stock consists of 85,000,000 shares of our common stock, par value $0.001 per share,and 25,000,000 shares of our preferred stock, par value $0.001 per share. As of January 31, 2020, we had 27,643,773 shares of ourcommon stock issued and outstanding and 1,635 shares of our preferred stock issued and outstanding.ListingOur common stock is listed and principally traded on The Nasdaq Capital Market under the symbol “GNCA.”Voting RightsEach holder of shares of our common stock is entitled to one (1) vote for each share held of record by such holder on theapplicable record date on all matters submitted to a vote of shareholders. Pursuant to our Certificate of Incorporation, shareholdersdo not have the right to vote cumulatively.Dividend Rights. Subject to preferences that may apply to shares of preferred stock outstanding at the time, holders of outstanding shares ofcommon stock are entitled to receive dividends out of assets legally available at the times and in the amounts as the board ofdirectors may from time to time determine.Conversion or Redemption Rights. Our common stock is neither convertible nor redeemable.Liquidation Rights. Upon our liquidation, dissolution or winding up, the holders of our common stock are entitled to receive pro rata our assetswhich are legally available for distribution, after payment of all debts and other liabilities and the satisfaction of any liquidationpreference granted to the holders of any then-outstanding shares of preferred stock.Rights and Preferences. Holders of common stock have no preemptive, conversion or subscription rights and there are no redemption or sinking fundprovisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to,and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate in thefuture.Transfer Agent and RegistrarThe transfer agent and registrar for our common stock is Computershare Trust Company, N.A. The transfer agent andregistrar’s address is 144 Fernwood Ave, Edison, New Jersey 08837.WarrantsAs of January 31, 2020, we had the following warrants outstanding:•warrants exercisable for an aggregate of 3,616,944 shares of our common stock at an exercise price of $9.60 per share thatexpire on January 18, 2023 and may be exercised at any time and from time to time, in whole or in part.•warrants exercisable for an aggregate of 41,177 shares of our common stock at an exercise price of $6.80 per share thatexpire on April 24, 2023 and may be exercised at any time and from time to time, in whole or in part.•warrants exercisable for an aggregate of 932,812 shares of our common stock at an exercise price of $4.52 per share thatexpire on February 14, 2024 and may be exercised at any time and from time to time, in whole or in part.•warrants exercisable for an aggregate of 531,250 shares of our common stock for which the aggregate exercise price waspartially paid by the holders of the warrants on or prior to the date of issuance, which warrants expire on February 14, 2039and may be exercised at any time and from time to time, in whole or in part, by payment of the remaining aggregate exerciseprice. Each of the foregoing warrants have a net exercise provision under which their holders may, in lieu of payment of the exerciseprice in cash, surrender the warrant and receive a net amount of shares based on the fair market value of our stock at the time ofexercise of the warrants after deduction of the aggregate exercise price. These warrants contain provisions for adjustment of theexercise price and number of shares issuable upon the exercise of warrants in the event of certain stock dividends, stock splits,reorganizations, reclassifications and consolidations.Except for the right to participate in certain dividends and distributions and as otherwise provided in the warrants or by virtueof such holder’s ownership of our common stock, the holders of the warrants do not have the rights or privileges of holders of ourcommon stock, including any voting rights, until they exercise their warrants.Our warrant agent is Computershare Trust Company, N.A.Anti-Takeover Effects of Our Certificate of Incorporation and Our By-LawsOur Certificate of Incorporation and Bylaws contain certain provisions that are intended to enhance the likelihood ofcontinuity and stability in the composition of the board of directors and which may have the effect of delaying, deferring orpreventing a future takeover or change in control of the company unless such takeover or change in control is approved by the boardof directors.These provisions include:Classified Board. Our Certificate of Incorporation provides that our board of directors is divided into three classes ofdirectors, with the classes as nearly equal in number as possible. As a result, approximately one-third of our board of directors willbe elected each year. The classification of directors will have the effect of making it more difficult for stockholders to change thecomposition of our board. Our Certificate of Incorporation also provides that, subject to any rights of holders of preferred stock toelect additional directors under specified circumstances, the number of directors will be fixed exclusively pursuant to a resolutionadopted by our board of directors.Action by Written Consent; Special Meetings of Stockholders. Our Certificate of Incorporation provides that stockholderaction can be taken only at an annual or special meeting of stockholders and cannot be taken by written consent in lieu of a meeting.Our Certificate of Incorporation and Bylaws also provide that, except as otherwise required by law, special meetings of thestockholders can be called only by or at the direction of the board of directors pursuant to a resolution adopted by a majority of thetotal number of directors. Except as described above, stockholders are not be permitted to call a special meeting or to require theboard of directors to call a special meeting.Removal of Directors. Our Certificate of Incorporation provides that our directors may be removed only for cause by theaffirmative vote of at least 75% of the voting power of our outstanding shares of capital stock, voting together as a single class. Thisrequirement of a supermajority vote to remove directors could enable a minority of our stockholders to prevent a change in thecomposition of our board.Advance Notice Procedures. Our Bylaws establish an advance notice procedure for stockholder proposals to be broughtbefore an annual meeting of our stockholders, including proposed nominations of persons for election to the board of directors.Stockholders at an annual meeting are only be able to consider proposals or nominations specified in the notice of meeting orbrought before the meeting by or at the direction of the board of directors or by a stockholder who was a stockholder of record onthe record date for the meeting, who is entitled to vote at the meeting and who has given our Secretary timely written notice, inproper form, of the stockholder’s intention to bring that business before the meeting. Although the Bylaws do not give the board ofdirectors the power to approve or disapprove stockholder nominations of candidates or proposals regarding other business to beconducted at a special or annual meeting, the by-laws may have the effect of precluding the conduct of certain business at a meetingif the proper procedures are not followed or may discourage or deter a potential acquirer from conducting a solicitation of proxies toelect its own slate of directors or otherwise attempting to obtain control of the company.Super Majority Approval Requirements. The Delaware General Corporation Law generally provides that the affirmativevote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s certificate of incorporation orbylaws, unless either a corporation’s certificate of incorporation or bylaws requires a greater percentage. Our Certificate ofIncorporation and Bylaws provide that the affirmative vote of holders of at least 75% of the total votes eligible to be cast in theelection of directors is required to amend, alter, change or repeal the by-laws. This requirement of a supermajority vote to approveamendments to our by-laws could enable a minority of our stockholders to exercise veto power over any such amendments.Authorized but Unissued Shares. Our authorized but unissued shares of common stock and preferred stock are available forfuture issuance without stockholder approval. These additional shares may be utilized for a variety of corporate purposes, includingfuture public offerings to raise additional capital, corporate acquisitions and employee benefit plans. The existence of authorized butunissued shares of common stock and preferred stock could render more difficult or discourage an attempt to obtain control of amajority of our common stock by means of a proxy contest, tender offer, merger or otherwise.Exclusive Forum. Our Certificate of Incorporation provides that, subject to limited exceptions, the state or federal courtslocated in the State of Delaware are the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf,(ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or ourstockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General CorporationLaw, our Certificate of Incorporation or our Bylaws, or (iv) any other action asserting a claim against us that is governed by theinternal affairs doctrine. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock shall bedeemed to have notice of and to have consented to the provisions of our Certificate of Incorporation described above. Although webelieve these provisions benefit us by providing increased consistency in the application of Delaware law for the specified types ofactions and proceedings, the provisions may have the effect of discouraging lawsuits against our directors and officers. Theenforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legalproceedings, and it is possible that, in connection with one or more actions or proceedings described above, a court could find thechoice of forum provisions contained in our Certificate of Incorporation to be inapplicable or unenforceable.Section 203 of the Delaware General Corporation LawWe are subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits apublicly-held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-yearperiod following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in aprescribed manner. A “business combination” includes, among other things, a merger, asset or stock sale or other transactionresulting in a financial benefit to the interested stockholder. An “interested stockholder” is a person who, together with affiliates andassociates, owns, or did own within three years prior to the determination of interested stockholder status, 15% or more of thecorporation's voting stock.Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfiesone of the following conditions: before the stockholder became interested, the board of directors approved either the businesscombination or the transaction which resulted in the stockholder becoming an interested stockholder; upon consummation of thetransaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% ofthe voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining thevoting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances;or at or after the time the stockholder became interested, the business combination was approved by the board of directors of thecorporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of theoutstanding voting stock which is not owned by the interested stockholder.A Delaware corporation may “opt out” of these provisions with an express provision in its original certificate of incorporationor an express provision in its certificate of incorporation or by-laws resulting from a stockholders' amendment approved by at least amajority of the outstanding voting shares. We have not opted out of these provisions. As a result, mergers or other takeover orchange in control attempts of us may be discouraged or prevented.EXHIBIT 10.2 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEENOMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO GENOCEABIOSCIENCES, INC. IF PUBLICLY DISCLOSED. AMENDED AND RESTATED LICENSE AGREEMENTThis Amended and Restated License Agreement (“Agreement”) is entered into as of this 19th day of November, 2012 (the“Amended and Restated Effective Date”), by and between Genocea Biosciences, Inc., a company formed under the laws of the Stateof Delaware, having a place of business at Cambridge Discovery Park, 100 Acorn Park Drive, 5th Floor, Cambridge, MA 02140(“Licensee”) and President and Fellows of Harvard College, an educational and charitable corporation existing under the laws andthe constitution of the Commonwealth of Massachusetts, having a place of business at Holyoke Center, Suite 727, 1350Massachusetts Avenue, Cambridge, Massachusetts 02138 (“Harvard”).WHEREAS, Harvard is the owner of the Patent Rights and Harvard Technology Transfer Materials (as defined below) andhas the right to grant licenses thereunder; andWHEREAS, Harvard desires to have products developed and commercialized under such patent rights and materials tobenefit the public; andWHEREAS, Licensee has represented to Harvard, in order to induce Harvard to enter into this Agreement, that Licenseeshall commit itself to commercially reasonable efforts to develop and commercialize products based on the Patent Rights andHarvard Technology Transfer Materials;WHEREAS, Harvard and Licensee previously entered into that certain License Agreement, dated November 30, 2007 (the“Original Effective Date”), pursuant to which Licensee obtained a license under the Patent Rights and Harvard Technology TransferMaterials (the “Original Agreement”); andWHEREAS, the parties now desire to modify their arrangements under the Original Agreement, all on the terms andconditions set forth herein.NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:80198190_10. Amendment and Restatement.Licensee and Harvard hereby agree that, effective as of the Amended and Restated Effective Date, the Original Agreement ishereby amended and restated in its entirety as set forth in this Agreement, and the Original Agreement shall be of no further force oreffect from and after the Amended and Restated Effective Date, except as expressly provided herein, provided, that nothing in thisAgreement shall affect the rights and obligations of the parties under the Original Agreement with respect to periods prior to theAmended and Restated Effective Date, all of which shall survive in accordance with their terms. 1.Definitions. Whenever used in this Agreement with an initial capital letter, the terms defined in this Article 1, whether used in thesingular or the plural, shall have the meanings specified below.1.1 “Affiliate” shall mean, with respect to an entity, any person, organization or entity controlling, controlled by or undercommon control with, such entity. For purposes of this definition only, “control” of another person, organization or entity shall meanthe possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of suchperson, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting theforegoing, control shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%)or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly orindirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization orother entity. The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of theUnited States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), andthat in such cases such lower percentage shall be substituted in the preceding sentence.1.2 “Calendar Quarter” shall mean each of the periods of three (3) consecutive calendar months ending on March 31, June30, September 30 and December 31, for so long as this Agreement is in effect.1.3 “Development Milestones” shall mean the development and commercialization milestones set forth in Exhibit 1.3hereto, as such milestones may be adjusted pursuant to Section 3.4.-2-80198190_11.4 “Development Plan” shall mean the plan for the development and commercialization of Licensed Products attachedhereto as Exhibit 1.4, as such plan may be adjusted from lime to time pursuant to Section 3.2.1.5 “Direct Development Costs” shall mean the costs incurred, on a cash basis, by Licensee with respect to thedevelopment of Licensed Products in accordance with the Development Plan, such as:1.5.1 Costs for development activities conducted to procure data necessary for regulatory filings to obtain marketingapproval from a Regulatory Authority, including, but not limited to, research, formulation development and testing, clinicaldevelopment activities, data management, toxicology and planning and execution of clinical trials;1.5.2 costs for regulatory filings necessary to obtain marketing approval from a Regulatory Authority;1.5.3 insurance premiums paid for commercial insurance to the extent such insurance directly relates to developmentactivities conducted pursuant to the Development Plan (i.e., if insurance covers risks other than risks related to development of theLicensed Product, then only an appropriate portion of such premiums shall be included); and1.5.4 capital expenditures to the extent directly attributable to the development of Licensed Products.1.5.5 the fully burdened costs of labor for the percentage of the individuals’ time spent on such developmentactivities.To the extent a cost is associated with activities in addition to development of Licensed Products then only the appropriateportion of such costs devoted to the development of Licensed Products shall be included as Direct Development Costs.1.6 “FDA” shall mean the United States Food and Drug Administration.1.7 “Harvard Technology Transfer Materials” shall mean the protocols and other materials listed in Exhibit 1.7 hereto, assuch Exhibit may be supplemented and updated from time to time by mutual written agreement of the parties. Effective upon eachsuch agreement by the parties, Exhibit 1.7 shall be amended automatically to include any such additional protocols and othermaterials. Within thirty (30) days after the Original Effective Date, Harvard shall deliver the initial set of Harvard TechnologyTransfer Materials to Licensee.-3-80198190_11.8 “IND” shall mean an investigational new drug application, clinical study application, clinical trial exemption or similarapplication or submission for approval to conduct human clinical investigations filed with a Regulatory Authority.1.9 “Infringed Patent” shall mean (a) an issued and unexpired patent that has not been abandoned, held invalid, revoked,held or rendered unenforceable or lost through an interference proceeding, and (b) a pending claim of a pending patent applicationthat (i) has been asserted and continues to be prosecuted in good faith, (ii) has not been abandoned or finally rejected without thepossibility of appeal or refiling, and (iii) has not been pending for more than five (5) years; which in either case would be infringedby the identification, discovery, development, manufacture, use or sale of a Licensed Product.1.10 “Initiation” or “Initiate” shall mean, with respect to a Phase I Clinical Trial, a Phase II Clinical Trial or a Phase IIIClinical Trial, the administration of the first dose to the first patient in such clinical trial.1.11 “Licensed Method” shall mean any method, the practice of which would, but for the grant of rights hereunder, infringea Valid Claim (in the case of a Valid Claim that has not yet issued, assuming that such Valid Claim has issued).1.12 “Licensed Product” shall mean any Type I Licensed Product or any Type II Licensed Product. 1.13 “Licensed Services” shall mean any service provided for or on behalf of a third party on a fee-for-service basis that entailsthe practice of a Licensed Method.1.14 “Net Sales” shall mean the gross amount invoiced by or on behalf of Licensee, its Affiliates and Sublicensees (in eachcase, the “Invoicing Entity”) on sales, leases or other transfers of Licensed Products, less the following to the extent applicable onsuch sales, leases or other transfers of Licensed Products and not previously deducted from the gross invoice price: (a) customarytrade, quantity or cash discounts to the extent actually allowed and taken; (b) amounts actually repaid or credited by reason ofrejection or return of any previously sold, leased or otherwise transferred Licensed Products; (c) customer freight charges that arepaid by or on behalf of the Invoicing Entity; and (d) to the extent separately stated on purchase orders, invoices or other documentsof sale, any sales, value added or similar taxes, custom duties or other similar governmental charges levied directly on theproduction, sale, transportation, delivery or use of a Licensed Product that are paid by or on behalf of the Invoicing Entity, but notincluding any tax levied with respect to income; provided that:1.14.1 in the event that an Invoicing Entity receives non-cash consideration for any Licensed Products or in the caseof transactions not at arm’s length with a non-Affiliate of Invoicing-4-80198190_1Entity, Net Sales shall be calculated based on the fair market value of such consideration or transaction, assuming an arm’s lengthtransaction made in the ordinary course of business; and1.14.2 sales of Licensed Products by an Invoicing Entity to its Affiliate or Sublicensee for resale by such Affiliate orSublicensee shall not be deemed Net Sales. Instead, Net Sales shall be determined based on the gross amount invoiced by suchAffiliate or Sublicensee on resale of Licensed Products to a third party purchaser.Notwithstanding the foregoing, the following shall not be included in Net Sales: (1) Licensed Products provided byLicensee, its Affiliates or Sublicensees for administration to patients enrolled in clinical trials or distributed through a not-for-profitfoundation at no charge to eligible patients provided that Licensee, its Affiliates, or Sublicensees receive no consideration from suchclinical trials or not-for-profit foundation for such use of Licensed Products and (2) Licensed Products used as samples to promoteadditional Net Sales, in amounts consistent with normal business practices of Licensee, its Affiliates or Sublicensees, provided thatLicensee, its Affiliates, or Sublicensees receive no consideration for such samples.Further, Net Sales shall be adjusted as follows:In the event a Licensed Product is [* * *] as defined below, Net Sales of the [* * *], where [* * *]. If, in a specific country,the relevant Licensed Product is [* * *] in such country. As used above, the term [* * *] means [* * *]. Without limiting any of theforegoing, Net Sales shall be determined in accordance with normally accepted accounting principles, such as GAAP, IFRS orsimilar accounting principles, on a basis consistent with the audited consolidated financial statements of Licensee, its Affiliates, orits Sublicensees, as applicable. 1.15 “Non-Royalty Sublicense Income” shall mean any payments or other consideration that Licensee or any of its Affiliatesreceives in connection with a Sublicense, other than royalties based on Net Sales or Service Income or the receipt of a portion ofprofits derived from the sale of Licensed Products or the performance of Licensed Services. In the event that Licensee or anAffiliate of Licensee receives non-cash consideration in connection with a Sublicense or in the case of transactions not at arm’slength, Non-Royalty Sublicense Income shall be calculated based on the fair market value of such consideration or transaction, atthe time of the transaction, assuming an arm’s length transaction made in the ordinary course of business. Non-Royalty SublicenseIncome shall not include (a) amounts received from a Sublicensee that are committed to cover future industry standard, fullyburdened costs to be incurred by Licensee or any of its Affiliates in the performance of research and development activities to beperformed by Licensee or any of its Affiliates under a Sublicense agreement in connection with a Licensed Product or a productexpected to become a Licensed Product, (b) equity investments in Licensee to the extent such payment reflects the fair market valueof such securities, (c) amounts received from a Sublicensee in connection with a bona fide, fully repayable, market rate loan made bySublicensee to Licensee, (d) the attributed value of any cross-license granted by a Sublicensee to-5-80198190_1Licensee to the extent such cross-license provides Licensee with freedom to operate with respect to a Licensed Product or a productexpected to become a Licensed Product (but not excluding any consideration actually received from such Sublicensee on account ofsuch cross-license), (e) payments made to reimburse Licensee for any amounts paid by it to Harvard under Section 6.2 of thisAgreement or (1) payments made to reimburse Licensee for the costs of Licensee’s full time equivalents who market and promoteLicensed Products and Licensed Services and sell Licensed Products, which reflect the fair market value of such services and aresubstantiated by any report delivered by Licensee to any such Sublicensee to claim such reimbursement.1.16 “Patent Rights” shall mean, in each case to the extent owned and controlled by Harvard: (a) the patent applicationslisted on Exhibit 1.15; (b) any patent or patent application that claims priority to and is a divisional, continuation, reissue, renewal,reexamination, substitution or extension of any patent application identified in (a); (c) any patents issuing on any patent applicationidentified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of acontinuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matterspecifically described in, at least one of the patents or patent applications identified in (a), (b) or (c); and (e) any foreign counterpart(including PCTs) of any patent or patent application identified in (a), (b) or (c) or of the claims identified in (d).1.17 “Phase I Clinical Trial” shall mean a clinical trial in any country involving the initial introduction of an investigationalnew drug into humans, typically designed to determine the metabolism and pharmacologic actions of the drug in humans, the sideeffects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the United States, “Phase IClinical Trial” means a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21(a). 1.18 “Phase II Clinical Trial” shall mean a human clinical trial in any country conducted to evaluate the effectiveness of adrug for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine thecommon short-term side effects and risks associated with the drug. In the United States, “Phase II Clinical Trial” means a humanclinical trial that satisfies the requirements of 21 C.F.R. § 312.21(b).1.19 “Phase III Clinical Trial” shall mean a human clinical trial in any country, whether controlled or uncontrolled, that isperformed after preliminary evidence suggesting effectiveness of the drug under evaluation has been obtained, and intended togather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the-6-80198190_1drug and to provide an adequate basis for physician labeling. In the United Slates, “Phase III Clinical Trial means a human clinicaltrial that satisfies the requirements of 21 C.F.R. § 312.21(c).1.20 “Regulatory Authority” shall mean any applicable government regulatory authority involved in granting approvals forthe manufacturing and/ marketing of a Licensed Product, including, in the United States, the FDA.1.21 “Service Income” shall mean the gross amount invoiced by or on behalf of an Invoicing Entity (as defined in Section1.14) for the performance of Licensed Services; provided that:1.21.1 in any performance of Licensed Services by an Invoicing Entity for its Affiliate, Service Income shall be equalto the fair market value of the Licensed Services performed, assuming an arm’s length transaction made in the ordinary course ofbusiness; and1.21.2 in the event that an Invoicing Entity received non-case consideration for any Licensed Services or in the caseof transactions not at arm’s length with a non-Affiliate of Invoicing Entity, Service Income shall be calculated based on the fairmarket value of such consideration or transaction, assuming an arm’s length transaction made in the ordinary course of business.1.22 “Sublicense” shall mean: (a) any right granted, license given or agreement entered into by Licensee to or with any otherperson or entity (or by a Sublicensee to or with a further Sublicensee in accordance with Section 2.3.2.4), under or with respect to orauthorizing any use of any of the Patent Rights, or otherwise authorizing the development, manufacture, marketing, distribution, useand/or sale of Licensed Products or the performance of Licensed Services; or (b) any option or other right granted by Licensee toany other person or entity (or by a Sublicensee to or with a further Sublicensee in accordance with Section 2.3.2.4) to negotiate for orreceive any of the rights described under clause (a), including in connection with a standstill agreement; in each case regardless ofwhether such grant of rights, license given or agreement entered into is referred to or is described as a sublicense.1.23 “Sublicensee” shall mean any person or entity granted a Sublicense, other than an Affiliate. 1.24 “Third Party Proposed Product” shall mean a Type II Licensed Product for vaccination against or treatment of anorganism or disease for which Licensee is not developing or commercializing a Licensed Product.-7-80198190_11.25 “Type I Licensed Product” shall mean any product, the manufacture, use, sale, marketing or importation of whichfalls within the scope of a Valid Claim in the country in which it is manufactured, used, sold, marketed or imported.1.26 “Type II Licensed Product” shall mean any product that is not a Type I Licensed Product, but is identified ordiscovered through the use of a Licensed Method.1.27 “Valid Claim” shall mean: (a) a claim of an issued and unexpired patent within the Patent Rights that has not been (i) heldpermanently revoked, unenforceable, unpatentable or invalid by a decision of a court or governmental body of competentjurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer orotherwise, (iii) abandoned or (iv) lost through an interference proceeding; or (b) a pending claim of a pending patent applicationwithin the Patent Rights that (i) has been asserted and continues to be prosecuted in good faith, (ii) has not been abandoned or finallyrejected without the possibility of appeal or refiling, and (iii) has not been pending for more than five (5) years from the date ofissuance of the first substantive patent office action considering the patentability of such claim by the applicable patent office insuch country (at which time such pending claim shall cease to be a Valid Claim for purposes of this Agreement unless and untilsuch claim becomes a claim of an issued patent). 2.License Grants.2.1 Licenses.2.1.1 Exclusive License. Subject to the terms and conditions set forth in this Agreement, Harvard hereby grants toLicensee an exclusive, worldwide, royalty-bearing license, sublicensable solely in accordance with Sections 2.2 and 2.3, under thePatent Rights solely (a) to identify, discover, develop, make, have made, use, market, offer for sale, sell, have sold and import TypeI and Type II Licensed Products and (b) to perform Licensed Services; provided, however, that:2.1.1.1 Harvard shall retain the right to make and use Type I and Type II Licensed Products, and to grantlicenses to other not-for-profit research organizations the right to make and use Type I Licensed Products, for internal research,teaching and other educational purposes and not for the purpose of commercial manufacture, distribution or provision of services fora fee; and2.1.1.2 the United States federal government shall retain rights in the Patent Rights pursuant to 35 U.S.C. §§200-212 and 37 C.F.R. § 401 et seq., and any right granted in this-8-80198190_1Agreement greater than that permitted under 35 U.S.C. §§ 200-212 or 37 C.F.R. § 401 et seq. shall be subject to modification as maybe required to conform to the provisions of those statutes and regulations.2.1.2 Non-Exclusive License. Subject to the terms and conditions set forth in this Agreement, Harvard hereby grantsto Licensee a non-exclusive, worldwide, license under its rights in and to the Harvard Technology Transfer Materials solely for usein identifying, discovering, developing, making, having made, using, marketing, offering for sale, selling, having sold andimporting any Type I Licensed Product or Type II Licensed Product. Notwithstanding anything contained herein or in any otheragreement to the contrary, ownership of inventions discovered or invented using the Harvard Technology Transfer Materials shallfollow inventorship and inventorship shall be determined in accordance with United States patent law; provided, however, thatLicensee’s ownership of any such discovery or invention shall not affect its obligations under this Agreement, including itsobligations under Section 4.5.2.2.2 Sublicenses to Affiliates. The licenses granted to Licensee under Section 2.1 shall include the right to have some or all ofLicensee’s rights or obligations under this Agreement performed or exercised by one or more of Licensee’s Affiliates (for so longeach such Affiliate remains an Affiliate of Licensee), provided that:2.2.1 no such Affiliate shall be entitled to grant, directly or indirectly, to any third party any right of whatever natureunder, or with respect to, or permitting any use or exploitation of, any of the Patent Rights or the Harvard Technology TransferMaterials, including any right to develop, manufacture, market or sell Licensed Products or to practice Licensed Methods unlessLicensee has assigned the rights under this Agreement to such Affiliate pursuant to Section 11.12 because, in such event, suchAffiliate will be the Licensee under this Agreement; and2.2.2 any act or omission taken or made by an Affiliate of Licensee under this Agreement shall be deemed an act oromission by Licensee under this Agreement.2.3 Other Sublicenses.2.3.1 Sublicense Grant. Licensee shall be entitled to grant Sublicenses to Sublicensees under the license grantedpursuant to Section 2.1.1 subject to the terms of this Section 2.3. Any such Sublicense shall be on terms and conditions incompliance with and not inconsistent with the terms of this Agreement. Such Sublicenses shall only be made for consideration andin bona-fide arm’s length transactions.2.3.2 Sublicense Agreements. Sublicenses under this Section 2.3 shall be granted only pursuant to writtenagreements, which shall be subject to and consistent with the terms and-9-80198190_1conditions of this Agreement. Such Sublicense agreements shall contain, among other things, provisions to the following effect: 2.3.2.1 all provisions necessary to ensure Licensee’s ability to comply with Licensee’s obligation under or not violate theprovisions of Sections 4.4, 4.5, 4.6, 5.1, 5.3, 5.4, 8.1 and 11.1;2.3.2.2 a section substantially the same as Article 9 (Indemnification), which also shall state that theIndemnitees (as defined in Section 9.1) are intended third party beneficiaries of such Sublicense agreement for the purpose ofenforcing such indemnification;2.3.2.3 in the event of termination of the license set forth in Section 2.1.1 above (in whole or in part (e.g.,termination of the license as to a Licensed Product or in a particular country)), any existing Sublicense shall terminate to the extentof such terminated license; provided, however, that, for each Sublicensee, upon termination of the license, if the Sublicensee is notthen in breach of the Sublicense agreement such that Licensee would have the right to terminate such Sublicense agreement, suchSublicensee shall have the right to obtain a license from Harvard on the same terms and conditions as set forth herein, which shallnot impose any representations, warranties, obligations or liabilities on Harvard that are not included in this Agreement, providedthat (a) the scope of the license granted directly by Harvard to such Sublicensee shall be coextensive with the scope of the licensegranted by Licensee to such Sublicensee, (b) if the Sublicense granted to such Sublicensee was non-exclusive, such Sublicensee shallnot have the right to participate in the prosecution or enforcement of the Patent Rights under the license granted to it directly byHarvard and (c) if there are more than one Sublicensee, each Sublicensee that is granted a direct license shall be responsible for apro rata share of the reimbursement due under Section 6.2.3 of this Agreement (based on the number of direct licenses under thePatent Rights in effect on the date of reimbursement);2.3.2.4 the Sublicensee shall only be entitled to sublicense its rights under such Sublicense agreement on theterms set forth in this Section 2.3; and2.3.2.5 the Sublicensee shall not be entitled to assign the Sublicense agreement without the prior writtenconsent of Harvard, except that Sublicensee may assign the Sublicense agreement to a successor in connection with the merger,consolidation or sale of all or substantially all of its assets or that portion of its business to which the Sublicense agreement relates;provided, however, that any permitted assignee agrees in writing in a manner reasonably satisfactory to Harvard to be bound by theterms of such Sublicense agreement.2.3.3 Delivery of Sublicense Agreement. Licensee shall furnish Harvard with a fully executed copy, redacted withrespect to matters not relevant to Harvard’s interests, of any such-10-80198190_1Sublicense agreement or further Sublicense agreement under Section 2.3.2.4, promptly after its execution. Harvard shall keep allsuch Sublicense agreements and their terms confidential and shall use them solely for the purpose of monitoring Licensee’s andSublicensees’ compliance with their obligations hereunder and enforcing Harvard’s rights under this Agreement. 2.3.4 Breach by Sublicensee. During the term of this Agreement, Licensee shall be responsible for any breach of a Sublicenseagreement by a Sublicensee (or further Sublicense agreement under Section 2.3.2.4) that results in a material breach of thisAgreement. Licensee may elect (a) to cure such breach in accordance with Section 10.2.3.1 of this Agreement or (b) to enforce itsrights by terminating such Sublicense agreement in accordance with the terms thereof. Licensee shall indemnify Harvard for, andhold it harmless from, any and all damages or losses caused to Harvard as a result of any such breach by a Sublicensee or furtherSublicensee.2.4 Improvements. In the future event that Harvard owns and controls patents and/or patent applications (a) for which oneof the inventors is Dr. Darren Higgins or Dr. Michael Starnbach, (b) that are not Patent Rights and (c) that include claims that aredominated by any Valid Claims, Licensee may notify Harvard in writing that it wishes to obtain a license under such patents and/orpatent applications solely with respect to those claims that are dominated by such Valid Claims. Harvard will grant Licensee alicense under such claims by amending this Agreement to include such claims in the definition of Patent Rights if (i) Harvard is not,at the time of its receipt of Licensee’s notice, subject to any legal or pre-existing contractual obligations or restraints that wouldprevent it from granting the requested license and (ii) the inventor(s) do(es) not reasonably object to the grant of the requestedlicense. Licensee shall not be required to pay any additional upfront consideration for such license, except for a license issuance feeto be agreed upon by the parties. The other financial terms of this Agreement (e.g., maintenance fees, milestone payments, royaltypayments and payments on account of Non-Royalty Sublicense Income) will apply to the requested license.2.5 [†].2.6 No Other Grant of Rights. Except as expressly provided in this Agreement, nothing in this Agreement shall beconstrued to confer any ownership interest, license or other rights upon Licensee by implication, estoppel or otherwise as to anytechnology, intellectual property rights, products or biological materials of Harvard or any other entity, regardless of whether suchtechnology, intellectual property rights, products or biological materials are dominant, subordinate or otherwise related to any PatentRights. 3.Development and Commercialization.-11-80198190_13.1 Diligence. Licensee shall use commercially reasonable efforts and shall cause its Sublicensees to use commercially reasonableefforts: (a) to develop Licensed Products in accordance with the Development Plan; (b) to introduce Licensed Products into thecommercial market; and (c) to market Licensed Products following such introduction into the market. In addition, Licensee, by itselfor through its Affiliates or Sublicensees, also shall achieve each of the Development Milestones referenced in the then-currentversion of Exhibit 1.3 within the time periods specified therein. Harvard’s right to take any action against Licensee in connectionwith a failure to achieve any such Development Milestones shall be limited to those rights set forth in Section 3.4 or, if and to theextent applicable, Section 10.2.3. The parties acknowledge and agree that if Licensee, by itself or through its Affiliates orSublicensees, meets its obligations in the preceding sentence then Licensee will be deemed to have also met its developmentobligations under (a) above.3.2 Modification of Development Plan. Licensee may modify the then applicable Development Plan from time to time toimprove Licensee’s ability to meet the Development Milestones.3.3 Reporting. Within sixty (60) days after the end of each calendar year. Licensee shall furnish Harvard with a writtenreport summarizing its, its Affiliates’ and its Sublicensees’ efforts during the prior year to develop and commercialize LicensedProducts, including without limitation: (a) research and development activities; (b) commercialization efforts; and (c) marketingefforts. Each report shall contain a description of Licensee’s efforts in compliance with its obligations under Section 3.1, and adiscussion of intended efforts for the then current year. Together with each report. Licensee shall provide Harvard with a copy of thethen current Development Plan.3.4 Failure. If Licensee believes that it will not achieve one or more Development Milestones with respect to LicensedProducts, it may notify Harvard in writing in advance of the relevant deadline. Licensee shall include with such notice anexplanation of the reasons for such failure, a proposal for extending and/or amending the relevant milestone(s), and a detailedwritten plan for promptly achieving such extended and/or amended milestone(s). If Licensee does not provide Harvard with areasonable explanation of its failure to meet the relevant Development Milestone(s) (and lack of finances shall not constitutereasonable basis for such failure) or does not provide Harvard with a reasonable proposed extension and/or amendment, Harvardmay notify Licensee in writing of Licensee’s failure to meet the relevant Development Milestone(s) and, in such event, shall allowLicensee ninety (90) days to cure such failure. Subject to the last sentence of this section, Licensee’s failure to cure within suchninety (90) day period shall constitute a material breach of this Agreement (a ‘‘Development Breach”) entitling Harvard to proceedsolely under this Section 3.4. In the event of a Development Breach where the relevant Development Milestone pertains to-12-80198190_1a Type I Licensed Product, Harvard shall have the right, in lieu of its rights under Section 10.2.3, to terminate the licenses granted inthis Agreement only as they apply to Type I Licensed Products. In the event Licensee (a) commits a Development Breach withrespect to two Type II Licensed Products or (b) commits a Development Breach with respect to one Type II Licensed Product afteralready having committed a Development Breach with respect to a Type I Licensed Product, Harvard shall have the right, in lieu ofits rights under Section 10.2.3, only to convert the license granted in Section 2.1.1 as it applies to Type II Licensed Products andLicensed Services into a non-exclusive, non-transferable, worldwide license (without the right to sublicense). Notwithstanding theforegoing, if Licensee does provide Harvard with an explanation of its failure to meet the relevant Development Milestone(s) and aproposed extension and/or amendment that is reasonably acceptable to Harvard, Exhibit 1.3 shall be amended automatically toincorporate such extension and/or amendment, as applicable. For clarity, if and only if Licensee fails to achieve a DevelopmentMilestone and does not avail itself of any aspect of the procedure set forth in this Section 3.4 (e.g., by failing to notify Harvard inaccordance with the first sentence of this Section 3.4), such failure to achieve the Development Milestone shall be a material breachthat entitles Harvard to proceed under Section 10.2.3. 4.Consideration for Grant of License4.1 Equity.4.1.1 Grant. As partial consideration for the licenses granted hereunder, within thirty (30) days after the OriginalEffective Date, Licensee shall issue to Harvard such amount of common stock of Licensee that constitutes [* * *] of the outstandingcommon stock of Licensee, on a Fully Diluted Basis, after giving effect to such issuance (the “Shares”). “Fully Diluted Basis” shallmean, as of the Original Effective Date, the number of shares of common stock of Licensee then outstanding (assuming conversionof all outstanding stock other than common stock into common stock) plus the number of shares of common stock of Licenseeissuable upon exercise or conversion of then outstanding convertible securities, options, rights or warrants of Licensee (which shallbe determined without regard to whether such securities arc then vested, exercisable or convertible). Harvard acknowledges that allcertificates representing the shares described in this Section may bear customary securities legends requiring compliance with theSecurities Act of 1933 and related slate securities laws upon any transfer of such shares.4.1.2 Representations and Warranties. Licensee hereby represents and warrants to Harvard that:-13-80198190_14.1.2.1 the capitalization table attached hereto as Exhibit 4.1.2.1 (the “Cap Table”) sets forth all of theoutstanding capital stock of Licensee on a Fully-Diluted Basis as of the Original Effective Date;4.1.2.2 other than as set forth in the Cap Table, as of the Original Effective Date, there were no outstandingshares of capital stock, convertible securities, outstanding warrants, options or other rights to subscribe for, purchase or acquire fromLicensee any capital stock of Licensee and there were no contracts or binding commitments providing for the issuance of, or thegranting of rights to acquire, any capital stock of Licensee or under which Licensee was obligated to issue any of its securities; and4.1.2.3 the Shares, when issued pursuant to the terms of the Original Agreement, became, upon such issuance,duly authorized, validly issued, fully paid and nonassessable.4.2 License Fee. As partial consideration for the licenses granted hereunder, Licensee shall pay Harvard a non-refundablelicense fee of [* * *] within thirty (30) days after the Original Effective Date. The license fee paid under this Section 4.2 shall becreditable against any amount that is payable to Harvard under Section 4.6 on account of an upfront sublicense fee or milestonepayment paid by a Sublicensee to Licensee.4.3 License Maintenance Fees. As partial consideration for the licenses granted hereunder, Licensee shall pay Harvard non-refundable annual license maintenance fees as follows:4.3.1 [* * *] due and payable on the first anniversary of the Original Effective Date;4.3.2 [* * *] due and payable on the second anniversary of the Original Effective Date;4.3.3 [* * *] due and payable on the third anniversary of the Original Effective Date; and4.3.4 [* * *] for Type I Licensed Products and [* * *] for Type II Licensed Products due and payable on the fourthanniversary of the Original Effective Date and on each subsequent anniversary of the Original Effective Date during the Term.Each license maintenance fee paid under this Section 4.3 shall be creditable against the royalties that are payable to Harvard underSection 4.5.4.4 Milestones.-14-80198190_14.4.1 As partial consideration for the licenses granted hereunder, Licensee shall pay Harvard the following milestonepayments as specified in Section 4.4.2, regardless of whether such milestone is achieved by Licensee, its Affiliate or a Sublicensee:4.4.1.1 [* * *] upon [* * *] with respect to the first Type I Licensed Product;4.4.1.2 [* * *] upon [* * *] with respect to the first Type I Licensed Product;4.4.1.3 [* * *] upon [* * *] with respect to the first Type I Licensed Product; and4.4.1.4 [* * *] upon the [* * *] with respect to the first Type I Licensed Product.With respect to the first three (3) Type II Licensed Products to achieve a milestone set forth above, Licensee shall pay Harvard thirtythree percent (33%) of the amount due with respect to a Type I Licensed Product for meeting the same milestone. With respect toeach subsequent Type II Licensed Product to achieve such milestone, Licensee shall pay Harvard sixteen and one half percent(16.5%) of the amount due with respect to a Type I Licensed Product for meeting the same milestone.4.4.2 Licensee shall notify Harvard in writing within thirty (30) days following the achievement of each milestonedescribed in Section 4.4.1, and shall make the appropriate milestone payment within thirty (30) days after the achievement of suchmilestone.4.4.3 The milestones set forth in Section 4.4 are intended to be successive. In the event that a Licensed Product is notrequired to undergo the testing or other event associated with a particular milestone (“Skipped Milestone”), such Skipped Milestoneshall be deemed to have been achieved upon the achievement by such Licensed Product of the next successive milestone (“AchievedMilestone”). Subject to Section 4.4.2, payment for any Skipped Milestone that is owed in accordance with the provisions of thisSection 4.4.3 shall be due within thirty (30) days after the achievement of the Achieved Milestone.4.4.4 Each milestone payment made under this Section 4.4 shall be creditable against any amount that is payable toHarvard under Section 4.6 on account of any amount paid by a Sublicensee to Licensee for upfront or milestone payments.4.5 Royalties.-15-80198190_14.5.1 Type I Licensed Products. As partial consideration for the license granted under Section 2.1.1, Licensee shallpay Harvard an amount equal to the following percentages of Net Sales with respect to Type I Licensed Products and of ServiceIncome:4.5.1.1 for Net Sales and Service Income by Licensee and its Affiliates, [* * *] of such Net Sales and ServiceIncome: and4.5.1.2 for Net Sales and Service Income by a Sublicensee, the greater of (a) [* * *] of such Net Sales andService Income and (b) [* * *] of royalties payable by such Sublicensee to Licensee on account of such Net Sales and ServiceIncome.4.5.2 Type II Licensed Products. As partial consideration for the license granted under Section 2.1.2, Licensee shallpay Harvard an amount equal to the following percentages of Net Sales with respect to Type II Licensed Products:4.5.2.1 for Net Sales by Licensee and its Affiliates, [* * *] of such Net Sales; and4.5.2.2 for Net Sales by a Sublicensee, the greater of (a) [* * *] of such Net Sales and (b) [* * *] of royaltiespayable by such Sublicensee to Licensee on account of such Net Sales.Such royalties shall be payable under this Agreement on aLicensed Product by Licensed Product and country by country basis until [* * *] have passed since the date of [* * *] in each suchcountry.4.5.3 Third Party Royalty Set Off. In the event that Licensee or a Sublicensee is required to obtain a license from athird party to an Infringed Patent in order to identify, discover, develop, manufacture, use or sell a Type I or Type II LicensedProduct, and Licensee or a Sublicensee obtains such a license after arm’s length negotiations, Licensee may offset [* * *] of anyroyalties paid under such third party license with respect to sales of Type I or Type II Licensed Products against the royaltypayments that are due to Harvard pursuant to Section 4.5.1 or 4.5.2 with respect to sales of such Type I or Type II Licensed Productin such country. Notwithstanding the above, (a) the royalty payments to Harvard with respect to a Licensed Product that is thesubject of an offset under this Section 4.5.3 may not be reduced by more than [* * *] of the amount otherwise due with respect tosuch Type I or Type II Licensed Product, (b) the offset that Licensee is entitled to make against royalty payments due to Harvardmay not be greater than any offset that Licensee or a Sublicensee, as applicable, is entitled to make against royalty payments due to athird party licensee on account of royalty payments made under or by virtue of this Agreement and (c) in the event that a Sublicenseeis required to obtain a license from a third party as described above, the percentage offset that Licensee is entitled to make againstroyalty payments due to Harvard with respect to Net-16-80198190_1Sales by such Sublicensee may not be greater than any percentage offset that such Sublicensee actually makes against royaltypayments due to Licensee with respect to such Net Sales.4.5.4 Bad Debt. If, after exercising good faith, commercially reasonable collection efforts, Licensee is unable tocollect any amount related to the sale, lease or other transfer of Licensed Products and/or related to the performance of LicensedServices for which it has previously paid royalties hereunder, Licensee shall be entitled to deduct any royalty previously paid withrespect to such uncollected amount from the royalty payment due by Licensee in the next Calendar Quarter, which deduction shallbe set forth in the corresponding report under Section 5.1 below. If, at any time after such deduction Licensee does collect any ofsuch amounts, such collected amounts shall be included as Net Sales or Service Income in the Calendar Quarter in which they arecollected and Licensee shall pay Harvard royalties thereon accordingly.4.6 Non-Royalty Sublicense Income. As partial consideration for the licenses granted hereunder. Licensee shall payHarvard an amount equal to [* * *] of all Non-Royalty Sublicense Income. Notwithstanding the foregoing, if a Sublicense is part ofa transaction in which [* * *] to be attributed to the Sublicense as part of the overall transaction. In such event, the amount payableto Harvard under this Section 4.6 with respect to Non-Royalty Sublicense Income received in connection with such transaction shallbe determined by the following equation:(x)(y) [* * *] = Awhere:(x) is the [* * *];(y) is the [* * *]; and A is the amount to be paid to Harvard.4.7 No Multiple Payments. Only a single royalty shall be due and payable by Licensee under this Agreement with respect to aLicensed Product or Licensed Service regardless of whether the Licensed Product or Licensed Service is covered by more than oneValid Claim. 5.Reports; Payments; Records.5.1 Reports and Payments.5.1.1 Reports. Within sixty (60) days after the conclusion of each Calendar Quarter commencing with the firstCalendar Quarter in which Net Sales or Service Income are generated or Non-Royalty Sublicense Income is received, Licensee shalldeliver to Harvard a report containing-17-80198190_1the following information (in each instance, with a Licensed Product-by-Licensed Product and Licensed Service-by-LicensedService breakdown):5.1.1.1 the number of units of Licensed Products sold, leased or otherwise transferred by Licensee, its Affiliates and Sublicenseesfor the applicable Calendar Quarter (with a breakdown by type of Licensed Products - i.e., Type I Licensed Products and Type IILicensed Products);5.1.1.2 the gross amount invoiced for Licensed Products sold, leased or otherwise transferred by Licensee, itsAffiliates and Sublicensees during the applicable Calendar Quarter (with a breakdown by type of Licensed Products) and LicensedServices performed;5.1.1.3 a calculation of Net Sales and Service Income for the applicable Calendar Quarter, including anitemized listing of applicable deductions;5.1.1.4 a detailed accounting of all Non-Royalty Sublicense Income received during the applicable Calendar Quarter and amountsreceived from Sublicenses that Licensee excluded from Non-Royalty Sublicense Income pursuant to Section 1.14 (a) - (f); and5.1.1.5 the total amount payable to Harvard in U.S. Dollars in Net Sales, Service Income, and Non-RoyaltySublicense Income for the applicable Calendar Quarter, together with the exchange rates used for conversion.Each such report shall be certified on behalf of Licensee by its Chief Financial Officer, President or Chief Executive Officeras true, correct and complete in all material respects. If no amounts are due to Harvard for a particular Calendar Quarter, the reportshall so state.5.1.2 Payment. Within sixty (60) days after the end of each Calendar Quarter. Licensee shall pay Harvard allamounts due with respect to Net Sales, Service Income, and Non- Royalty Sublicense Income for the applicable Calendar Quarter. 5.2 Payment Currency. All payments due under this Agreement shall be payable in U.S. Dollars. Conversion of foreigncurrency to U.S. Dollars shall be made at the conversion rate existing in the United States (as reported in the Wall Street Journal) onthe last working day of the applicable Calendar Quarter. Such payments shall be without deduction of exchange, collection or othercharges.5.3 Records. Licensee shall maintain, and shall cause its Affiliates and Sublicensees to maintain, complete and accuraterecords of Licensed Products that are made, used or sold and Licensed Services that are performed under this Agreement, anyamounts payable to Harvard in-18-80198190_1relation to such Licensed Products and Licensed Services, and all Non-Royalty Sublicense Income received by Licensee, whichrecords shall contain sufficient information to permit Harvard to confirm the accuracy of any reports or notifications delivered toHarvard under Section 5.1. Licensee, its Affiliates and/or its Sublicensees, as applicable, shall retain such records relating to a givenCalendar Quarter for at least five (5) years after the conclusion of that Calendar Quarter, during which time Harvard shall have theright, at its expense, to cause an independent, certified public accountant to inspect such records during normal business hours forthe sole purpose of verifying any reports and payments delivered under this Agreement. Such accountant shall not disclose toHarvard any information other than information relating to the accuracy of reports and payments delivered under this Agreement.The parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of theaudit. In the event that any audit performed under this Section 5.3 reveals an underpayment in excess of five percent (5%) in anycalendar year, the audited entity shall bear the full cost of such audit. Harvard may exercise its rights under this Section 5.3 onlyonce every year per audited entity and only with reasonable prior notice to the audited entity.5.4 Late Payments. Any payments by Licensee that are not paid on or before the date such payments are due under thisAgreement shall bear interest at the lower of (a) one and one half percent (1.5%) per month and (b) the maximum rate allowed bylaw. Interest shall accrue beginning on the first day following the due date for payment and shall be compounded quarterly.Payment of such interest by Licensee shall not limit, in any way. Harvard’s right to exercise any other remedies Harvard may haveas a consequence of the lateness of any payment.5.5 Payment Method. Each payment due to Harvard under this Agreement shall be paid by check or wire transfer of funds toHarvard’s account in accordance with written instructions provided by Harvard. If made by wire transfer, such payments shall bemarked so as to refer to this Agreement.5.6 Withholding and Similar Taxes. All amounts to be paid to Harvard pursuant to this Agreement shall be withoutdeduction of exchange, collection, or other charges, and, specifically, without deduction of withholding or similar taxes or othergovernment imposed fees or taxes, except as permitted in the definition of Net Sales. 6.Intellectual Property. 6.1 Title. The entire right, title and interest in the Patent Rights and Harvard Technology Transfer Materials shall be ownedsolely by Harvard.-19-80198190_16.2 Patent Filing, Prosecution and Maintenance.6.2.1 Patent Rights. Harvard shall be responsible for the preparation, filing, prosecution, protection and maintenanceof and, subject to Licensee meeting its payment obligations under Section 6.2.3, shall prepare, file, prosecute, protect and maintainall Patent Rights, using patent counsel reasonably acceptable to Licensee. With respect to Patent Rights, Harvard shall: (a) useindependent patent counsel reasonably acceptable to Licensee and instruct such patent counsel to furnish the Licensee with copies ofall correspondence relating to the Patent Rights from the United States Patent and Trademark Office (USPTO) and any other patentoffice, as well as copies of all proposed responses to such correspondence in time for Licensee to review and comment on suchresponse; (b) give Licensee an opportunity to review’ the text of each patent application before filing; (c) consult with Licensee withrespect thereto; (d) supply Licensee with a copy of the application as filed, together with notice of its filing date and serial number;(e) keep Licensee advised of the status of actual and prospective patent filings; and (f) provide advance copies of any papers relatedto the filing, prosecution, protection and maintenance of such patent filings. Harvard shall give Licensee the opportunity to providecomments on and make requests of Harvard concerning the preparation, filing, prosecution, protection and maintenance of thePatent Rights, and shall consider such comments and requests in good faith.6.2.2 Past Expenses. Within thirty (30) days after its receipt of an invoice from Harvard, Licensee shall reimburseHarvard for all documented, out-of-pocket expenses incurred by Harvard through the end of the last full Calendar Quarter before theOriginal Effective Date (the “Past Expense Period”) with respect to the preparation, filing, prosecution, protection and maintenanceof the Patent Rights.6.2.3 Future Expenses. Subject to Section 6.2.4 below, within thirty (30) days after its receipt of each invoice fromHarvard, Licensee shall reimburse Harvard for all documented, out-of-pocket expenses inclined by Harvard pursuant to Section6.2.1, including those incurred between the end of the Past Expense Period and the Original Effective Date.6.2.4 Abandonment. Should Licensee decide that it does not wish to pay for the preparation, filing, prosecution,protection or maintenance of any Patent Rights in a country (“Abandoned Patent Rights”), Licensee shall provide Harvard withprompt written notice of such election. Ninety (90) days after receipt of such notice by Harvard, Licensee shall be released from itsobligation to reimburse Harvard for the expenses incurred thereafter as to such Abandoned Patent Rights. In the event of Licensee’sabandonment of any Patent Rights, Harvard may terminate (at any time upon written notice) the license granted to Licenseehereunder with respect to such Abandoned Patent Rights. In such case, Licensee will have no rights whatsoever to exploit suchAbandoned Patent Rights and the claims of such Abandoned Patent Rights shall cease to constitute-20-80198190_1Valid Claims. Harvard shall then be free, without further notice or obligation to Licensee, to grant rights in and to such AbandonedPatent Rights to third parties.6.2.5 Small Entity Designation. If Licensee, its Affiliates, any Sublicensee and/or any holder of an option to obtain aSublicense does not qualify, or at any point during the term of this Agreement ceases to qualify, as an entity entitled to pay lesserfees as provided by the USPTO (i.e., a “small entity”) or the patent office of any other country. Licensee shall so notify Harvardimmediately, in order to enable Harvard to comply with regulations regarding payment of fees with respect to Patent Rights.6.2.6 Marking. Licensee, its Affiliates and Sublicensees shall mark all Licensed Products sold or otherwise disposedof in such a manner as to conform with the patent laws and practice of the country to which such products arc shipped or in whichsuch products are sold. 7.Enforcement of Patent Rights.7.1 Notice. In the event either party becomes aware of any possible or actual infringement of any Patent Rights relating toLicensed Products or a Licensed Service that are not solely within the scope of rights granted to a third party under Section 2.5 (an“Infringement”), that party shall promptly notify the other party and provide it with details regarding such Infringement.7.2 Suit by Licensee. Licensee shall have the first right, but not the obligation, to take action in the prosecution, preventionor termination of any Infringement. Before Licensee commences an action with respect to any Infringement, Licensee shall considerin good faith the views of Harvard and potential effects on the public interest in making its decision whether to sue. Should Licenseeelect to bring suit against an infringer, Licensee shall keep Harvard reasonably informed of the progress of the action and shall giveHarvard a reasonable opportunity in advance to consult with Licensee and offer its views about major decisions affecting thelitigation. Licensee shall give careful consideration to those views, but shall have the right to control the action; provided, however,that if Licensee fails to defend in good faith the validity and/or enforceability of the Patent Rights in the action or, or if Licensee’slicense to a Valid Claim in the suit terminates, Harvard may elect to take control of the action pursuant to Section 7.3. ShouldLicensee elect to bring suit against an infringer and Harvard is joined as party plaintiff in any such suit, Harvard shall have the rightto approve the counsel selected by Licensee to represent Licensee and Harvard, such approval not to be unreasonably withheld. Theexpenses of such suit or suits that Licensee elects to bring, including any expenses of Harvard reasonably incurred in conjunctionwith the prosecution of such suits or the settlement thereof, shall be paid for entirely by Licensee and Licensee shall hold Harvardfree, clear and harmless from and against any and all costs of such litigation, including attorney’s fees.-21-80198190_1Licensee shall not compromise or settle such litigation without the prior written consent of Harvard, which consent shall not beunreasonably withheld or delayed. In the event Licensee exercises its right to sue pursuant to this Section 7.2, it shall first reimburseitself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, includingreasonable attorney’s fees, necessarily incurred in the prosecution of any such suit. If, after such reimbursement, any funds shallremain from said recovery, then Harvard shall receive an amount equal to twenty percent (20%) of such funds and the remainingeighty percent (80%) of such funds shall be retained by Licensee.7.3 Suit by Harvard. If Licensee does not lake action in the prosecution, prevention, or termination of any Infringementpursuant to Section 7.2 above, and has not commenced negotiations with the infringer for the discontinuance of said Infringement,within ninety (90) days after receipt of notice to Licensee by Harvard of the existence of an Infringement, Harvard may elect to doso. Should Harvard elect to bring suit against an infringer and Licensee is joined as party plaintiff in any such suit, Licensee shallhave the right to approve the counsel selected by Harvard to represent Harvard, such approval not to be unreasonably withheld. Theexpenses of such suit or suits that Harvard elects to bring, including any expenses of Licensee reasonably incurred in conjunctionwith the prosecution of such suits or the settlement thereof, shall be paid for entirely by Harvard and Harvard shall hold Licenseefree, clear and harmless from and against any and all costs of such litigation, including attorney’s fees. Harvard shall notcompromise or settle such litigation without the prior written consent of Licensee, which consent shall not be unreasonably withheldor delayed. In the event Harvard exercises its right to sue pursuant to this Section 7.3, it shall first reimburse itself out of any sumsrecovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorney’sfees, necessarily incurred in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from saidrecovery, then Licensee shall receive an amount equal to twenty percent (20%) of such funds and the remaining eighty percent(80%) of such funds shall be retained by Harvard.7.4 Own Counsel. Each party shall always have the right to be represented by counsel of its own selection and at its ownexpense in any suit instituted under this Article 7 by the other party for Infringement.7.5 Cooperation. Each party agrees to cooperate fully in any action under this Article 7 that is controlled by the other party,provided that the controlling party reimburses the cooperating party promptly for any costs and expenses incurred by thecooperating party in connection with providing such assistance.7.6 Standing. If a party lacks standing and the other party has standing to bring any such suit, action or proceeding, thensuch other party shall do so at the request of and at the expense of-22-80198190_1the requesting party. If either party determines that it is necessary or desirable for another party to join any such suit, action orproceeding, the other party shall execute all papers and perform such other acts as may be reasonably required in the circumstances.7.7 Declaratory Judgment. If a declaratory judgment action is brought naming Licensee and/or any of its Affiliates orSublicensees as a defendant and alleging invalidity or unenforceability of any claims within the Patent Rights, Licensee shallpromptly notify Harvard in writing and Harvard may elect, upon written notice to Licensee within thirty (30) days after Harvardreceives notice of the commencement of such action, to take over the sole defense of the invalidity or unenforceability aspect of theaction at its own expense and shall reasonably consider all comments of Licensee concerning such action. 8.Warranties; Limitation of Liability.8.1 Compliance with Law. Licensee represents and warrants that it will comply, and will ensure that its Affiliates andSublicensees comply, with all local, state, and international laws and regulations relating to the development, manufacture, use, saleand importation of Licensed Products and the performance of Licensed Services. Without limiting the foregoing, Licenseerepresents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees comply, with all United States exportcontrol laws and regulations.8.2 No Warranty.8.2.1 NOTHING CONTAINED HEREIN SHALL BE DEEMED TO BE A WARRANTY BY HARVARD THATIT CAN OR WILL BE ABLE TO OBTAIN PATENTS ON PATENT APPLICATIONS INCLUDED IN THE PATENT RIGHTS,OR THAT ANY OF THE PATENT RIGHTS WILL AFFORD ADEQUATE OR COMMERCIALLY WORTHWHILEPROTECTION.8.2.2 HARVARD MAKES NO REPRESENTATION THAT THE PRACTICE OF THE PATENT RIGHTS OR USEOF THE HARVARD TECHNOLOGY TRANSFER MATERIALS OR THE DEVELOPMENT, MANUFACTURE, USE, SALEOR IMPORTATION OF ANY LICENSED PRODUCT OR THE PRACTICE OF ANY LICENSED METHOD, OR ANYELEMENT THEREOF, WILL NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY THIRD PARTY.8.2.3 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKESANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, PATENTS, GOODS, SERVICES, RIGHTS OR OTHERSUBJECT MATTER-23-80198190_1OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR APARTICULAR PURPOSE AND NONINFRINGEMENT WI TH RESPECT TO ANY AND ALL OF THE FOREGOING.8.3 Limitation of Liability.8.3.1 Except with respect to Licensee’s indemnification obligations under Article 9, neither party will be liable to theother with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitabletheory for (a) any indirect, incidental, consequential or punitive damages or lost profits or (b) cost of procurement of substitutegoods, technology or services. 8.3.2 Harvard’s aggregate liability for all damages of any kind arising out of or relating to this Agreement or itssubject matter shall not exceed the amounts paid to Harvard under this Agreement. 9.Indemnification.9.1 Indemnity.9.1.1 Licensee shall indemnify, defend and hold harmless Harvard and its current or former directors, governingboard members, trustees, officers, faculty, medical and professional staff, employees, students, and agents and their respectivesuccessors, heirs and assigns (collectively, the “Indemnitees”) from and against any claim, liability, cost, expense, damage,deficiency, loss or obligation or any kind or nature (including, without limitation, reasonable attorney’s fees and other costs andexpenses of litigation) by or owed to a third party (collectively, “Claims”), based upon, arising out of, (a) practice by Licensee, itsAffiliates and Sublicensees of the Patent Rights or (b) the development, manufacture, distribution, sale or use of Licensed Productsor the performance of Licensed Services, including without limitation any cause of action relating to product liability concerningany product, process, or service made, used or sold pursuant to any right or license granted under this Agreement; provided,however, that the above indemnification shall not apply to any Claim to the extent that it is directly attributable to the grossnegligence or intentional misconduct of any Indemnitee.9.1.2 Licensee shall, at its own expense, provide attorneys reasonably acceptable to Harvard to defend against anyactions brought or filed against any Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or notsuch actions are rightfully brought. Any Indemnitee seeking indemnification hereunder shall promptly notify Licensee of suchClaim;-24-80198190_1provided, however, that failure to so notify Licensee will relieve Licensee from liability for indemnification only if and to the extentLicensee did not otherwise promptly learn of such Claim and such failure results in additional costs, expenses or liability of Licenseeor the inability to defend any such Claim under Section 9.1. The Indemnitees shall provide Licensee, at Licensee’s expense, withreasonable assistance and full information with respect to such Claim and give Licensee sole control of the defense or settlement ofany Claim for which Licensee acknowledges full responsibility under this Section 9.1; provided, however, that (a) Licensee shall notsettle any such Claim which will adversely impact Harvard’s interest in the Patent Rights, admit any liability on the part of anIndemnitee or impose any obligations on any Indemnitee without the prior written consent of Harvard, which consent shall not beunreasonably withheld, and (b) any Indemnitee shall have the right to retain its own counsel, at the expense of Licensee, ifrepresentation of such Indemnitee by the counsel retained by Licensee would be inappropriate because of actual or potentialdifferences in the interests of such Indemnitee and any other party represented by such counsel. Notwithstanding the foregoing, inno event shall Licensee be required to pay the expenses of more than one counsel for the Indemnitees in addition to counsel retainedby Licensee. Licensee agrees to keep Harvard informed of the progress in the defense and disposition of such claim, suit or actionand to consult with Harvard with regard to any proposed settlement. Notwithstanding the foregoing, Licensee shall have noobligations for any Claim if the Indemnitee seeking indemnification makes any admission, settlement or other communicationregarding such Claim without the prior written consent of Licensee, in its sole discretion.9.2 Insurance.9.2.1 Beginning at the time any Licensed Product is being commercially distributed or sold (other than for thepurpose of obtaining regulatory approvals) or any Licensed Service is being performed by Licensee, or by an Affiliate, Sublicenseeor agent of Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance inamounts not less than $5,000,000 per incident and $5,000,000 annual aggregate and naming the Indemnitees as additional insureds.During clinical trials of any such Licensed Product, Licensee shall, at its sole cost and expense, procure and maintain commercialgeneral liability insurance in amounts not less than $3,000,000 per incident and $3,000,000 annual aggregate, naming theIndemnitees as additional insureds. Such commercial general liability insurance shall provide: (a) product liability coverage and (b)broad form contractual liability coverage for Licensee’s indemnification under this Agreement.9.2.2 If Licensee elects to self-insure all or part of the limits described above in Section 9.2.1 (including deductiblesor retentions which are in excess of $250,000 annual aggregate) such self-insurance program must be acceptable to Harvard and theRisk Management Foundation-25-80198190_1of the Harvard Medical Institutions, Inc. in their commercially reasonable discretion. The minimum amounts of insurance coveragerequired shall not be construed to create a limit o! Licensee’s liability with respect to its indemnification under this Agreement.9.2.3 Licensee shall provide Harvard with written evidence of such insurance upon request of Harvard. Licensee shallprovide Harvard with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in suchinsurance; if Licensee does not obtain replacement insurance providing comparable coverage within thirty (30) days after suchnotice, Harvard shall have the right to terminate this Agreement effective at the end of such thirty (30) day period without notice orany additional waiting periods.9.2.4 Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of thisAgreement during: (a) the period that any Licensed Product is being commercially distributed or sold or any Licensed Service isbeing performed by Licensee, or an Affiliate, Sublicensee or agent of Licensee; and (b) a reasonable period after the period referredto in (a) above which in no event shall be less than five (5) years. 10.Term and Termination.10.1 Term. The term of this Agreement shall commence on the Original Effective Date and, unless earlier terminated asprovided in this Article 10, shall continue in full force and effect on a Licensed Product by Licensed Product, Licensed Service byLicensed Service and country by country basis until the expiration of the last to expire Valid Claim.10.2 Termination.10.2.1 Termination Without Cause. Licensee may terminate this Agreement upon ninety (90) days prior writtennotice to Harvard, as to Type I or Type II Licensed Products, or as to both. All rights and licenses granted herein shall survive suchtermination as to the type of Licensed Product that is not terminated. In the event of a termination with respect to Type II LicensedProducts, Licensee’s obligations under Sections 4.4, 4.5.2, 4.6 and Articles 5 and 9 shall survive such termination with respect toType II Licensed Products that were identified or discovered through the use of a Licensed Method, which use was made prior tosuch termination.10.2.2 Termination for Patent Challenge. Harvard may terminate this Agreement immediately, as to Type I or TypeII Licensed Products or both, upon written notice to Licensee if Licensee commences an action in which it challenges the validity,enforceability or scope of any of the Patent Rights. All rights and licenses granted herein shall survive such termination as to theLicensed Product that is not terminated.-26-80198190_110.2.3 Termination for Default.10.2.3.1 Subject to Section 3.4, in the event that cither party commits a material breach of its obligationsunder this Agreement and fails to cure that breach within ninety (90) days after receiving written notice thereof, the other party mayterminate this Agreement in its entirety immediately upon written notice to the party in breach; provided, however, that in the eventthat Licensee has materially breached its obligations under this Agreement (such as a failure to achieve an applicable DevelopmentMilestone without availing itself of any aspect of the procedure set forth in Section 3.4) solely with respect any given Type ILicensed Product and not with respect to any Type II Licensed Products, then Harvard shall consider in good faith, but in its solediscretion, terminating only the rights and licenses granted herein with respect to Type I Licensed Products, and either leaving as isor converting to non-exclusive the rights and licenses granted herein with respect to Type II Licensed Products and LicensedServices.10.2.3.2 If Licensee defaults in its obligations under Section 9.2 to procure and maintain insurance or, ifLicensee has in any event failed to comply with the notice requirements contained therein, then Harvard may terminate thisAgreement immediately without notice or additional waiting period.10.2.4 Bankruptcy. Harvard may terminate this Agreement upon notice to Licensee if Licensee becomes judiciallydeclared insolvent, is adjudged bankrupt, applies for judicial or extra judicial settlement with its creditors, makes an assignment forthe benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by reasonof its insolvency, or in the event an involuntary bankruptcy action is filed against Licensee and not dismissed within ninety (90)days, or if the other party becomes the subject of liquidation or dissolution proceedings or otherwise discontinues business.10.3 Effect of Termination.10.3.1 Termination of Rights. Upon termination of this Agreement in whole or in part by either party pursuant toany of the provisions of Sections 3.4 or 10.2: (a) the rights and licenses granted to Licensee under Article 2 with respect to theterminated Licensed Products and/or Licensed Services, as applicable, shall terminate and, in the event that the Agreement isterminated in whole, all rights in and to and under the Patent Rights shall revert to Harvard; and (b) any existing agreements thatcontain a Sublicense with respect to the terminated Licensed Products shall terminate to the extent of such Sublicense; provided,however, that, for each Sublicensee, upon termination of the Sublicense agreement with such Sublicensee, if the Sublicensee is notthen in breach of its Sublicense agreement with Licensee such that Licensee would have the right to terminate such Sublicense, suchSublicensee shall have the right to obtain a license from Harvard-27-80198190_1on the same terms and conditions as set forth herein, which shall not impose any representations, warranties, obligations or liabilitieson Harvard that arc not included in this Agreement provided that (a) the scope of the license granted directly by Harvard to suchSublicensee shall be co-extensive with the scope of the license granted by Licensee to such Sublicensee, (b) if the Sublicense grantedto such Sublicensee was non-exclusive, such Sublicensee shall not have the right to participate in the prosecution or enforcement ofthe Patent Rights under the license granted to it directly by Harvard and (c) if there are more than one Sublicensee, each Sublicenseethat is granted a direct license shall be responsible for a pro rata share of the reimbursement due under Section 6.2.3 of thisAgreement (based on the number of direct licenses under the Patent Rights in effect on the date of reimbursement).10.3.2 Accruing Obligations. Termination or expiration of this Agreement shall not relieve the parties of obligationsaccruing prior to such termination or expiration, including obligations to pay amounts accruing hereunder up to the date oftermination or expiration. After the date of termination or expiration (except in the case of termination by Harvard pursuant toSection 10.2.2, 10.2.3 or 10.2.4), Licensee, its Affiliates and Sublicensees (a) may sell Licensed Products then in stock and (b) maycomplete the production of Licensed Products then in the process of production and sell the same; provided that, in the case of both(a) and (b), Licensee shall pay the applicable royalties and payments to Harvard in accordance with Article 4, provide reports andaudit rights to Harvard pursuant to Article 5 and maintain insurance in accordance with the requirements of Section 9.2.10.4 Survival. The parties’ respective rights, obligations and duties under Articles 5, 9 and 10 and Section 4.5.2, as well asany rights, obligations and duties which by their nature extend beyond the expiration or termination of this Agreement, shall surviveany expiration or termination of this Agreement. In addition, Licensee’s obligations under Section 4.6 with respect to Sublicensesgranted prior to termination of the Agreement shall survive termination. 11.Miscellaneous.11.1 Preference for United States Industry. During the period of exclusivity of this license in the United States, Licenseeshall comply with 37 C.F.R. § 401.14(i) or any successor rule or regulation. Upon Licensee’s request. Harvard agrees to makereasonable efforts to assist Licensee in obtaining a waiver of the requirements imposed by such rules or regulations.11.2 Security Interest. If Licensee enters into any agreement under which Licensee grants to or otherwise creates in anythird party a security interest in this Agreement or any of the rights granted to Licensee herein (“Security Agreement”), and thereoccurs a default under the terms of-28-80198190_1such Security Agreement, if such default is not cured within any applicable cure period that may be provided under such SecurityAgreement, and any such third party takes any action under the Security Agreement to take title to the secured property, such actionshall be deemed a default under this Agreement and be subject to the terms of Section 10.2.3.11.3 Use of Name. Licensee shall not, and shall ensure that its Affiliates and Sublicensees shall not, use the name or insigniaof Harvard or the name of any of Harvard officers, faculty, other researchers or students, or any adaptation of such names, in anyadvertising, promotional or sales literature, including without limitation any press release or any document employed to obtainfunds, without the prior written approval of Harvard. This restriction shall not apply to any information required by law to bedisclosed to any governmental entity.11.4 Entire Agreement. This Agreement is the sole agreement with respect to the subject matter hereof and except asexpressly set forth herein, supersedes all other agreements and understandings between the parties with respect to the same.11.5 Notices. Unless otherwise specifically provided, all notices required or permitted by this Agreement shall be in writingand may be delivered personally, or may be sent by facsimile, overnight delivery or certified mail, return receipt requested, to thefollowing addresses, unless the parties arc subsequently notified of any change of address in accordance with this Section 11.5: If to Licensee: Genocea Biosciences, Inc. Cambridge Discovery Park 100 Acorn Park Drive, 5th FloorCambridge, Massachusetts 02140 Attn: President If to Harvard: Office of Technology Development Harvard University Holyoke Center 727 1350 Massachusetts Avenue Cambridge, Massachusetts 02138Attn.: Chief Technology Development Officer Any notice shall be deemed to have been received as follows: (a) by personal delivery, upon receipt; (b) by facsimile orovernight delivery, one business day after transmission or dispatch; (c) by certified mail, as evidenced by the return receipt. If noticeis sent by facsimile, a confirming copy of the same shall be sent by mail to (lie same address.-29-80198190_111.6 Governing Law and Jurisdiction. This Agreement will be governed by, and construed in accordance with, thesubstantive laws of the Commonwealth of Massachusetts, without giving effect to any choice or conflict of law provision, exceptthat questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patentshall have been granted. Any action, suit or other proceeding arising under or relating to this Agreement (a “Suit”) shall be broughtin a court of competent jurisdiction in the Commonwealth of Massachusetts, and the Parties hereby consent to the sole jurisdictionof the state and federal courts sitting in the Commonwealth of Massachusetts. Each party agrees not to raise any objection at anytime to the laying or maintaining of the venue of any Suit in any of the specified courts, irrevocably waives any claim that Suit hasbeen brought in any inconvenient forum and further irrevocably waives the right to object, with respect to any Suit, that such courtdoes not have any jurisdiction over such party.11.7 Binding Effect. This Agreement shall be binding upon and inure to the benefit of the parties and their respective legalrepresentatives, successors and permitted assigns.11.8 Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of thisAgreement.11.9 Counterparts. The parties may execute this Agreement in two or more counterparts, each of which shall be deemed anoriginal.11.10 Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms maybe waived, only by a written instrument executed by each party or, in the case of waiver, by the party waiving compliance. Thedelay or failure of either party at any time or times to require performance of any provisions hereof shall in no manner affect therights at a later time to enforce the same. No waiver by either party of any condition or of the breach of any term contained in thisAgreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as a further orcontinuing waiver of any such condition or of the breach of such term or any other term of this Agreement.11.11 No Agency or Partnership. Nothing contained in this Agreement shall give either party the right to bind the other, orbe deemed to constitute either party as agent for or partner of the other or any third party.11.12 Assignment and Successors. This Agreement may not be assigned by either party without the consent of the other,which consent shall not be unreasonably withheld, except that each party may, without such consent, assign this Agreement and therights, obligations and interests of such party to any of its Affiliates, to any purchaser of all or substantially all of its assets or the-30-80198190_1portion of its business to which the subject matter of this Agreement relates, or to any successor corporation resulting from anymerger or consolidation of such party with or into such corporation; provided, in each case, that the assignee agrees in writing to bebound by the terms of this Agreement. Any assignment purported or attempted to be made in violation of the terms of this Section11.12 shall be null and void and of no legal effect.11.13 Force Majeure. Neither party will be responsible for delays resulting from causes beyond the reasonable control ofsuch party, including, without limitation, fire, explosion, flood, war, strike, or riot, provided that the nonperforming party usescommercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under thisAgreement with reasonable dispatch whenever such causes are removed.11.14 Interpretation. Each party hereto acknowledges and agrees that: (a) it and/or its counsel reviewed and negotiated theterms and provisions of this Agreement and has contributed to its revision; (b) the rule of construction to the effect that anyambiguities are resolved against the drafting party shall not be employed in the interpretation of this Agreement; and (c) the termsand provisions of this Agreement shall be construed fairly as to both parties hereto and not in favor of or against either party,regardless of which party was generally responsible for the preparation of this Agreement.11.15 Severability. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competentjurisdiction or is deemed unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected. [Signature Page Follows]-31-80198190_1IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as ofthe date first written above. President and Fellows of Harvard College Genocea Biosciences, Inc. By: /s/ Cristin L. Rothfuss___________ By: /s/ Chip Clark _________ Name: Cristin L. Rothfuss ___________ Name: Chip Clark _______________ Title: Director of Technology Transactions - Office ofTechnology Development - Harvard University Title: President and CEO _____ -32-80198190_1SECOND AMENDMENT OF LEASETHIS SECOND AMENDMENT OF LEASE (this “Amendment”) is made as of the 1st day of May, 2019, by 100 DiscoveryPark DE, LLC, a Delaware limited liability company (as successor in interest to TBCI, LLC, as Trustee of 100 Discovery ParkRealty Trust) (“Landlord”), and Genocea Biosciences, Inc., a Delaware corporation (“Tenant”).RecitalsA. Landlord and Tenant are parties to a Lease dated as of July 3, 2012, as amended by that First Amendment of Leasedated May 16, 2016 (as amended, the “Lease”) pursuant to which Landlord has leased to Tenant 23,666 leasable square feet of spaceon the fifth floor and a portion of the ground floor (the “Existing Premises”) of the building located at and commonly known asBuilding 100, Cambridge Discovery Park, Cambridge, Massachusetts. All capitalized terms used in this Amendment which aredefined in the Lease and not otherwise defined in this Amendment shall have the meanings given in the Lease.B. Landlord and Tenant desire to amend the Lease to: (i) extend the Lease Term for five (5) years beyond February 29,2020, to February 28, 2025; (ii) expand the Existing Premises by providing for the addition of an agreed upon 22,442 leasablesquare feet of space, as depicted on Exhibit C hereto (the “Expansion Premises”), as of the Expansion Date (as defined below); and(iii) make certain other changes to the Lease, on and subject to the terms and conditions set forth below.Statement of AmendmentFor good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenanthereby agree as follows:1.Extension of Term. The term of the Lease is extended for five (5) years beyond February 29, 2020 (“ExtensionDate”) to February 28, 2025.2. Expansion of Existing Premises. The Expansion Premises shall be added to the Existing Premises as of the date thatLandlord delivers possession of the Expansion Premises to Tenant free of all tenants or other occupants and otherwise in thecondition set forth in Section 3 of this Amendment (the “Expansion Date”), which date is anticipated to occur on March 1, 2020. Allterms and provisions of the Lease, as amended hereby, shall apply to Tenant’s leasing of the Expansion Premises from and after theExpansion Date. Notwithstanding the foregoing, Landlord shall use commercially reasonable efforts to deliver the ExpansionPremises to Tenant in the condition required by the prior sentence on or before the date that is ninety (90) days after the existingtenant of the Expansion Premises vacates the Expansion Premises and the lease between Landlord and such tenant with respect tothe Expansion Premises has been terminated. Notwithstanding the foregoing, if (a) Landlord is unable to deliver possession of theExpansion Premises to Tenant in such condition on or before June 1, 2020, or (b) the Smithsonian institution AstrophysicalObservatory (“Smithsonian”) exercises its right of first offer to lease the Expansion Premises, which Landlord agrees to offer toSmithsonian within ten (10) days after the date hereof,80333389_1and which, under the terms of its lease with Landlord, Smithsonian is required to exercise in writing within ten (10) business daysafter its receipt of Landlord’s offer and if not timely exercised is deemed waived, the Expansion Premises shall not be added to theExisting Premises and the terms of this Amendment related to the Expansion Premises shall be null and void and have no furtherforce or effect (the “Expansion Rescission”). Landlord shall notify Tenant in writing within two (2) business days after Smithsonianexercises or waives (or is deemed to have waived) its right of first offer.3. Condition of Expansion Premises. Tenant hereby acknowledges and agrees that, with the exception of Landlord’sobligation to deliver the Expansion Premises to Tenant on the Expansion Date in compliance with all applicable LegalRequirements, with ail base building systems serving the Expansion Premises in good working order and condition and with thewindows watertight, decommissioned in compliance with applicable Legal Requirement, so as to clean and remove any biomedicalmaterial or waste or any other Hazardous Materials handled by the previous tenant, and otherwise in so-called “broom cleancondition” free of all tenants, occupants and personal property and the trade fixtures of the prior tenant of the Expansion Premises,(a) the Expansion Premises are being leased by Tenant in their condition as of the Expansion Date, “as-is,” without representation orwarranty by Landlord, and (b) Landlord will not have any obligation to make any alterations or improvements to the ExpansionPremises.4. Expansion Termination Option. Tenant shall have the one time right to elect to terminate the Lease with respect to theExpansion Premises (the “Expansion Termination Option”) by written notice to Landlord on or before July 31, 2019. Upon timelyexercise of the Expansion Termination Option in accordance with this Section, then the Expansion Premises shall not be added tothe Existing Premises on the Expansion Date, and the terms of this Amendment related to the Expansion Premises shall be null andvoid and have no further force or effect. If Tenant fails to exercise the Expansion Termination Option strictly in accordance with thisSection, then the Expansion Termination Option shall automatically lapse and Tenant shall have no further right to terminate theLease with respect to the Expansion Premises.5. Tenant’s Building Share and Tenant’s Project Share. Provided that neither the Expansion Rescission occurred nor is theExpansion Termination Option exercised in accordance with this Amendment, as of the Expansion Date, Tenant’s Building Shareshall be 35.85% (46,108/128,601) and Tenant’s Project Share shall be 13.95% (46,108/330,457).6. Security Deposit. Provided that Tenant does not exercise the Expansion Termination Option and the ExpansionRescission has not yet occurred, Tenant shall deposit on or before August 1, 2019, an additional $315,546.68 (the “AdditionalSecurity Deposit”) with the Landlord as an additional security deposit for the Expansion Premises in the form of cash or letter ofcredit, to be held in accordance with Section 2.5 of the Lease. Additionally, in the event that the Expansion Rescission thereafteroccurs, Landlord shall promptly return the Additional Security Deposit to Tenant no later than thirty (30) days immediatelyfollowing the Expansion Rescission.7. Specific Amendments of Lease. In furtherance of the above provisions of this Amendment, the Lease is amended asfollows, as of the date of this Amendment, unless otherwise expressly stated:280333389_1a.Item 5. Item 5 of the Summary of Basic Terms of the Lease is deleted in its entirety and replaced with thefollowing:“5. Lease Term: From March 1, 2014 through February 28, 2025.”b.Item 8. Effective as of the Extension Date, Item 8 of the Summary of Basic Terms of the Lease is deleted inits entirety and replaced with the following:“Tenant’s Parking Allocation” means 1.5 parking spaces per 1,000 leasable square feet of the Premises, whichspaces shall be allocated and available to Tenant throughout the Lease Term in Parking Garage A.c.Item 9. Item 9 of the Summary of Basic Terms of the Lease is amended by adding the following at the end ofthe chart showing Base Rent:“Base Rent for the Existing Premises (23,666 s.f.)PERIODANNUAL RATEMONTHLY RATEPSF RATEMarch 1, 2020 - February 28, 2021$1,443,626.00$120,302.17$61.00March 1, 2021 - February 28, 2022$1,479,834.98$123,319.58$62.53March 1, 2022 - February 28, 2023$1,516,753.94$126,396.16$64.09March 1, 2023 - February 29, 2024$1,554,619.54$129,551.63$65.69March 1, 2024 - February 28, 2025$1,593,431.78$132,785.98$67.33”d.Definitions. The definition of “Lease Term” in Article I of the Lease is deleted in its entirety and thefollowing is respectively substituted in place thereof:“Lease Term” means the period beginning at 12:01 a.m. on March 1, 2014 and ending at 11:59 p.m. onFebruary 28, 2025.”e.Lease Term. Section 2.4 of the Lease is deleted in its entirety and replaced with the following:“Section 2.4. Lease Term: The Lease Term shall commence at 12:01 A.M. on March 1, 2014 and shall end at11:59 P.M. on February 28, 2025.”8. Additional Specific Amendments of Lease if neither the Expansion Rescission occurs nor the Expansion TerminationOption is exercised. In furtherance of the above provisions of this Amendment and provided that neither the Expansion Rescissionoccurred nor is the Expansion Termination Option exercised in accordance with this Amendment, the Lease is amended as followsas of the Expansion Date:380333389_1a.Item 3A. Item 3A of the Summary of Basic Terms of the Lease is deleted in its entirety and replaced with thefollowing:“3A. Premises: All of the leasable space on the fifth floor (the “Existing Premises”) and the sixth floor (the“Expansion Premises”) of the Building, as depicted on Exhibit C, and storage rooms on the first floor of theBuilding, as depicted on Exhibit C-1. The Building and the Other Buildings which are currently part of theProject are depicted on Exhibit B.b.Item 3D. Item 3D of the Summary of Basic Terms of the Lease is deleted in its entirety and replaced with thefollowing:“3D. Leasable Square Footage of the Premises (which includes a proportionate share of the Floor Area of theCommon Areas of the Building, as provided for in this Lease): An agreed upon 46,108 leasable square feet.”c.Item 7. Item 7 of the Summary of Basic Terms of the Lease is deleted in its entirety and replaced with thefollowing:“7. “Security Deposit”: $631,093.36, in the form of cash or letter of credit.”d.Item 9. Item 9 of the Summary of Basic Terms of the Lease is amended by adding the following at the endthereof:“Base Rent for the Expansion Premises (22.442 s.f.)PERIODANNUAL RATEMONTHLY RATEPSF RATEExpansion Date - February 28, 2021$1,368,962.00$114,080.17$61.00March 1,2021 - February 28, 2022$1,403,298.26$116,941.52$62.53March 1, 2022 - February 28, 2023$1,438,307.78$119,858.98$64.09March 1, 2023 - February 29, 2024$1,474,214.98$122,851.25$65.69March 1, 2024 - February 28, 2025$1,511,019.86$125,918.32$67.33”e.Exhibit C and Exhibit C-1. Exhibit C and Exhibit C-1 to the Lease are deleted and Exhibit C and Exhibit C-1attached to this Amendment are substituted in place thereof.9. Allowance. Landlord will provide an amount up to $25.00 per leasable square foot of the Existing Premises and theExpansion Premises (provided neither the Expansion Rescission occurs nor the Expansion Termination Option is exercised) (the“Additional Allowance”) to or for the benefit of Tenant to pay or reimburse Tenant for costs of designing and constructingalterations and improvements to either the Existing Premises and/or the Expansion Premises (provided neither the ExpansionRescission occurs nor the Expansion Termination Option is exercised), including permits, architectural and engineering costs (butexcluding costs for Tenant’s equipment, furniture, trade fixtures and personal property) performed by or on behalf of Tenant fromand after the date480333389_1of this Amendment (the “Additional Tenant Improvements”). The Additional Allowance shall be $1,152,700 ($25.00 X 46,108),provided, however; that (i) if either the Expansion Rescission occurs or the Expansion Termination Option is exercised, theAdditional Allowance shall be $591,650.00 ($25.00 X 23,666), and (ii) until the Expansion Date occurs, the Additional Allowanceshall not exceed $591,650.00 ($25.00 X 23,666). Tenant shall have the right to allocate the Additional Allowance to either theExpansion Premises (provided neither the Expansion Rescission occurs nor the Expansion Termination Option is exercised) or theExisting Premises, or both. Tenant’s construction of the Additional Tenant improvements will be performed by contractors approvedby Landlord, and pursuant to plans and specifications approved by Landlord in accordance with and otherwise, subject to theprovisions of Section 7.5 of the Lease; provided, also, that within thirty (30) days of being invoiced therefor, Tenant will reimburseLandlord for the costs incurred by Landlord to review, inspect and/or approve, as applicable, any such plans or specifications orconstruction. Disbursement of the Additional Allowance to or at the direction of Tenant shall be conditioned on the subjectAdditional Tenant Improvements having been performed in accordance with the provisions of this Amendment and the Lease, andshall be subject to Landlord’s receipt of a request for payment in form and with backup reasonably satisfactory to Landlord,including but not limited to such certifications, lien waivers and other documents from Tenant, Tenant’s contractor and Tenant’sarchitect as Landlord may reasonably require. Landlord may inspect the subject Additional Tenant Improvements as a condition tomaking any requested disbursement of the Additional Allowance to confirm the status of such Additional Tenant improvements andthat such Additional Tenant Improvements have been performed in accordance with the provisions of this Amendment and theLease, in the event that the cost of any such Additional Tenant Improvements exceeds the amount of the Additional Allowance,Tenant shall be entirely responsible for such excess. Any portion of the Additional Allowance for which Tenant has not qualified fordisbursement within twelve (12) months after the first to occur of (i) the Expansion Rescission, or (ii) the Expansion Date for workrelated to the Expansion Premises, shall be forfeited by Tenant.10. Extension Option.(a) Extension Term. Provided that (i) an Event of Default does not exist as of the commencement of the ExtensionTerm (as defined below) or as of the date of Landlord’s receipt of the Extension Notice (as defined below), (ii) neither theExpansion Rescission occurred nor the Expansion Termination Option is exercised in accordance with this Amendment and(iii) Tenant has not assigned the Lease (excluding an assignment to a Permitted Transferee) or subleased more than fifty percent(50%) of the Premises (excluding a sublease to a Permitted Transferee), Tenant shall have the right to extend the Lease Term for one(1) period of five (5) years (the “Extension Term”) by giving Landlord written notice of extension (the “Extension Notice”), whichnotice must be received by Landlord not earlier than 18 months, nor later than 12 months, prior to the then-expiration date of theLease Term, if such extension becomes effective, the Lease Term shall be automatically extended upon the same terms andconditions as are applicable to the current Lease Term, except that (x) Base Rent for the Extension Term shall be as set forth insubsection (b) below, and (y) there shall be no further right to extend or renew the Lease Term beyond the Extension Term. Theright of extension provided under this section is personal to Genocea Biosciences, Inc. (or any of its Permitted Transferees) and isnot exercisable by any subtenant or assignee permitted under this Lease.580333389_1(b) Base Rent for Extension Term.(i) The Base Rent per square foot for the Extension Term will be the then fair market rent per square foot forthe Premises (the “Market Rent”), determined in accordance with this subsection (b); provided, that, in no event shall the Base Rentfor the Extension Term be less than the Base Rent in effect during the twelve (12) months immediately preceding the ExtensionTerm. For a period of thirty (30) days after Tenant gives to Landlord the Extension Notice (such period being called the“Negotiation Period”‘). Landlord and Tenant shall negotiate in good faith to attempt to agree upon the Market Rent, and, in thecourse of such negotiations, each party may from time to time submit modified proposals to the other. If the parties agree upon theMarket Rent prior to the determination of the arbitrator pursuant to subsection (b)(ii) below, whether such agreement is reachedduring or after the Negotiation Period, the Market Rent shall be as so agreed.(ii) If the parties are unable to agree upon the Market Rent within the Negotiation Period, then each partyshall, upon selection of an arbitrator pursuant to subsection (b)(iii) below, simultaneously submit to the arbitrator for bindingarbitration a proposal as to the Market Rent. The Market Rent shall be determined as of the commencement of the Extension Termat the then current arms- length negotiated base rents being charged for comparable space in comparable buildings located in themarket area of the Building, taking into consideration all relevant factors. The Market Rent may include escalations at various pointsduring the Extension Term. The arbitrator shall not have the right to modify any provision of the Lease except Base Rent. Withinthirty (30) days after both parties have submitted such proposals to the arbitrator, the arbitrator shall select one of the proposals asmore closely approximating the Market Rent appropriate for the Extension Term, and, unless the parties have then agreed upon theMarket Rent, the proposed Market Rent set forth in such proposal selected by the arbitrator shall be deemed to be the Market Rent.(iii) if the parties are unable to agree upon the Market Rent within the Negotiation Period, then the partiesshall, within fifteen (15) days after the end of the Negotiation Period (such fifteen (15) day period being herein called the “SelectionPeriod”), attempt to agree upon an arbitrator to whom to submit the determination of Market Rent for binding arbitration pursuant tosubsection (b)(ii) above, if the parties are unable to agree upon an arbitrator within the Selection Period, then, at the end of theSelection Period, each party shall select an arbitrator and, within fifteen (15) days after the end of the Selection Period, thearbitrators shall agree upon an arbitrator to whom the determination of Market Rent shall be submitted for binding arbitrationpursuant to subsection (b)(ii) above. If such arbitrators are unable to agree promptly upon an arbitrator, an arbitrator shall beselected by the American Arbitration Association. Any arbitrator selected by either party, by the arbitrators selected by the parties orby the American Arbitration Association shall be independent of both parties and shall have such experience, either as a licensed realestate broker or as an appraiser for at least ten years in the market area of the Building, Massachusetts, as would qualify sucharbitrator as an expert with respect to leasing terms in the market area of the Building. Such arbitrator shall make the determinationrequired pursuant to subsection (b)(ii) within thirty (30) days after selection. The parties shall share equally the fees and expenses ofthe arbitrator to whom the determination of Market Rent is submitted. Landlord and Tenant shall each pay the fee of the arbitratorselected by it.680333389_111. Brokers. Each of Landlord and Tenant represents to the other that it has not dealt with any person in connection withthis Amendment other than officers or employees of Landlord and Jones Lang LaSalle. Tenant shall indemnify and save Landlordharmless from and against all claims, liabilities, costs and expenses incurred as a result of any breach of the foregoing representationby Tenant. Landlord shall indemnify and save Tenant harmless from and against all claims, liabilities, costs and expenses incurred asa result of any breach of the foregoing representation by Landlord. Landlord shall be solely responsible for the brokeragecommission owing to Jones Lang LaSalle in connection with this Amendment in accordance with a separate agreement.12. Inconsistencies: Continuing Effect of Lease. To the extent that the provisions of this Amendment are inconsistent withthe provisions of the Lease, the provisions of this Amendment will control and the Lease will be deemed to be amended hereby.Except as amended by this Amendment, the provisions of the Lease remain in full force and effect.13. Multiple Counterparts. This Amendment may be executed in multiple counterparts, each of which will be an original,but all of which, taken together, will constitute one and the same Amendment.[SIGNATURE PAGE FOLLOWS]780333389_1IN WITNESS WHEREOF, Landlord and Tenant have executed this Amendment as of the date first set forth above.LANDLORD:100 DISCOVERY PARK DE, LLC By: /s/ Robert A. SchlagerName: Robert A. SchlagerTitle: Vice PresidentTENANT:GENOCEA BIOSCIENCES, INC. By: /s/ Derek MeisnerName: Derek MeisnerTitle: SVP, General Counsel80333389_1EXHIBIT CBUILDING FLOOR PLAN (FIFTH FLOOR)80333389_1EXHIBIT C CONT’D.BUILDING FLOOR PLAN (SIXTH FLOOR)EXHIBIT C-1BUILDING FLOOR PLAN (FIRST FLOOR)1080333389_1Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1)Registration Statements (Form S-3 Nos. 333-225086, 333-230577) of Genocea Biosciences,Inc.(2)Registration Statements (Form S-8 Nos. 333-230062, 333-223129, 333-216183, 333-209576, 333-202333 and 333-197127) pertaining to the Amendedand Restated 2014 Equity Incentive Plan of Genocea Biosciences, Inc.,(3)Registration Statement (Form S-8 No. 333-226655) pertaining to the Amended and Restated 2014 Equity Incentive Plan, 2014 Employee StockPurchase Plan, as amended, and common stock issuable pursuant to Narinderjeet Singh Inducement Stock Option Agreement of Genocea Biosciences,Inc.,(4)Registration Statement (Form S-8 No. 333-194021) pertaining to the Amended and Restated 2007 Equity Incentive Plan and 2014 Equity Incentive Planof Genocea Biosciences, Inc., andof our report dated February 13, 2020, 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, 2019. /s/ Ernst & Young LLPBoston, MassachusettsFebruary 13, 2020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, President and Chief Executive Officer and Director, 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 the statementsmade, 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 Exchange ActRules 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 registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly duringthe 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, to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generallyaccepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness ofthe disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sauditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likelyto adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. /s/ WILLIAM D. CLARK William D. Clark President and Chief Executive Officer and Director (Principal Executive Officer)Date:February 13, 2020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, Diantha Duvall, Chief Financial Officer (Principal Financial and Accounting 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 the statementsmade, 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 Exchange ActRules 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 registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly duringthe 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, to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generallyaccepted accounting principles; c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness ofthe disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’sinternal control over financial reporting; and 5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’sauditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likelyto adversely affect the registrant’s ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. /s/ DIANTHA DUVALL Diantha Duvall Chief Financial Officer (Principal Financial and Accounting Officer)Date:February 13, 2020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, 2019 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), I, the undersigned, William D. Clark, as the President and Chief Executive Officer andDirector of the 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 thebest 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/ WILLIAM D. CLARK William D. Clark* President and Chief Executive Officer and Director Date:February 13, 2020____________________________________ * 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 furnished to theSecurities 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, Chapter63 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, 2019 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), I, the undersigned, Diantha Duvall, 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/ DIANTHA DUVALL Diantha Duvall* Chief Financial Officer (Principal Financial and Accounting Officer)Date:February 13, 2020 ____________________________________*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 furnished to theSecurities 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, Chapter63 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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