1. Pro-tumor effects detected as early as four days after Inhibigen administration

    Insights into Inhibigen biology may yield new therapeutic targets to address immunotherapy resistance

    CAMBRIDGE, Mass., April 10, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new insights into Inhibigen™-associated responses and continues to underscore the detrimental impact of their inclusion in cancer immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2021 from April 10-15. The findings – powered by Genocea's proprietary ATLAS™ platform – further validate previous research…

    Pro-tumor effects detected as early as four days after Inhibigen administration

    Insights into Inhibigen biology may yield new therapeutic targets to address immunotherapy resistance

    CAMBRIDGE, Mass., April 10, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new insights into Inhibigen™-associated responses and continues to underscore the detrimental impact of their inclusion in cancer immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2021 from April 10-15. The findings – powered by Genocea's proprietary ATLAS™ platform – further validate previous research presented at SITC 2020 and published in Cancer Discovery, together revealing that the presence of an Inhibigen (antigen uniquely identifiable by ATLAS as dampening anti-tumor immune responses) in an otherwise protective immunotherapy can completely reverse the therapy's intended anti-tumor responses.

    The new data show that therapeutic vaccination of tumor-bearing mice with a single Inhibigen caused their tumors to hyperprogress, in contrast to a vaccine containing stimulatory antigens that protected them against tumor growth. The combination of this single Inhibigen with the otherwise-protective vaccine abrogated vaccine efficacy and returned tumor growth to levels of unvaccinated mice. The Inhibigen-associated effects included dampening of T cell immune responses as early as four days after a single dose, and a reversal of the infiltration of both lymphoid and myeloid populations into the tumor microenvironment. These data suggest that Inhibigen-specific responses not only dampen systemic immunity, but also revert tumor microenvironments to an immune-cold state – a feature of early-stage tumor growth.

    "Our data add to a growing body of preclinical and clinical evidence confirming that Inhibigens are not innocent bystanders, but rather they can reverse the beneficial effects of cancer immunotherapies," said Hanna Starobinets, a scientist at Genocea and lead presenter at the AACR meeting. "While Genocea continues to exclude Inhibigens from its immunotherapy candidates, ongoing studies aim to further allow us to understand and overcome immunotherapy resistance."

    Genocea previously demonstrated that Inhibigen vaccination could stifle immune responses to other antigens co-formulated in a vaccine, and that the effect could not be reversed through combination therapy with immune checkpoint inhibitors (ICI). Moreover, early data from ATLAS profiling of T cell responses in patients with cancer showed that the relative proportion of Inhibigen- and neoantigen-specific responses prior to treatment appeared to predict clinical efficacy of subsequent ICI therapy.

    "While we avoid Inhibigens in our current immunotherapy candidates, our preclinical work is focused on understanding the mechanisms of Inhibigen-associated immune suppression so that we may ultimately develop new treatments that can revert the phenotype in the context of immuno-oncology and perhaps even drive the phenotype in other contexts, such as autoimmune diseases," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "This important nuance – the possibility for Inhibigens to be used for therapeutic benefit – is one that we look forward to exploring further as we continue to gain insights into their underlying biology and function."

    AACR POSTER SESSION CATEGORY: Inflammation, Immunity, and Cancer

    TRACK: Immunology, Clinical Research Excluding Trials

    Poster 1762

    Title: Inhibigens™ subvert otherwise-efficacious cancer vaccines and immunotherapies in conjunction with alterations in the tumor microenvironment

    Presenter: Hanna Starobinets, Ph.D., Genocea Biosciences, Cambridge, MA

    Date: April 10, 2021

    Time: 8:30 a.m. – 11:59 p.m. EDT

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy using neoantigen-targeted peripheral cells for which we are commencing a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in identifying meaningful therapies. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-009, GEN-011 and research updates within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2020 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:Media Contact:
    Dan FerrySarah O'Connell
    617-430-7576 
     



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  2. CAMBRIDGE, Mass., April 06, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13th at 2:15 P.M. ET.

    A live webcast of the presentation will be available "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer…

    CAMBRIDGE, Mass., April 06, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13th at 2:15 P.M. ET.

    A live webcast of the presentation will be available "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our proprietary ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy using neoantigen-targeted peripheral cells for which we are commencing a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in identifying meaningful therapies. To learn more, please visit https://www.genocea.com.

    Investor Contact:

    Dan Ferry

    617-430-7576



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  3. CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, 2021. A webcast of the on-demand presentation will be available on the investor section of the Genocea website at http://ir.genocea.com, beginning on Tuesday, March 9, 2021 at 7:00 A.M. ET.

    Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer…

    CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, 2021. A webcast of the on-demand presentation will be available on the investor section of the Genocea website at http://ir.genocea.com, beginning on Tuesday, March 9, 2021 at 7:00 A.M. ET.

    Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our proprietary ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy using neoantigen-targeted peripheral cells for which we are commencing a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in identifying meaningful therapies. To learn more, please visit https://www.genocea.com.

    Investor Contact:

    Dan Ferry

    617-430-7576

     



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  4. GEN-011 and GEN-009 clinical trials continue to advance

    ATLASTMstimulatory antigen and inhibitory antigen (InhibigenTM) identification profiled in Cancer Discovery

    Announcing SARS-CoV-2 T cell antigen discovery program

    Conference call today at 8:30 a.m. E.T.

    CAMBRIDGE, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today provided a business update for the fourth quarter ended December 31, 2020 and other recent significant developments.

    "We are extremely pleased to make progress across multiple fronts by using ATLAS' unique ability to find the most relevant targets of T cell responses," said Chip Clark, Genocea President…

    GEN-011 and GEN-009 clinical trials continue to advance

    ATLASTM stimulatory antigen and inhibitory antigen (InhibigenTM) identification profiled in Cancer Discovery

    Announcing SARS-CoV-2 T cell antigen discovery program

    Conference call today at 8:30 a.m. E.T.

    CAMBRIDGE, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today provided a business update for the fourth quarter ended December 31, 2020 and other recent significant developments.

    "We are extremely pleased to make progress across multiple fronts by using ATLAS' unique ability to find the most relevant targets of T cell responses," said Chip Clark, Genocea President and Chief Executive Officer. "As we advance GEN-009 and GEN-011, our scientific team continues to refine and explore the implications of our pioneering antigen discovery work in multiple disease settings. Included in this is the work we have underway to identify antigens of T cell responses to SARS-CoV-2 (COVID-19), which may prove pivotal to stemming the course of this deadly virus. We are looking forward to continuing this momentum in 2021."

    Clinical updates

    GEN-011 Phase 1/2a clinical trial (TITAN trial)

    • GEN-011 is a neoantigen-targeted peripheral T cell therapy (NPT therapy) in development to treat checkpoint inhibitor-refractory patients. Our phase 1/2a study, the TITAN trial, is designed to explore safety, biomarkers of activity and anti-tumor efficacy. Genocea has initiated the first two of multiple planned clinical sites and is accruing patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.

    GEN-009 Phase 1/2a clinical trial

    • At the 2020 Society for Immunotherapy of Cancer (SITC) annual meeting in November, the Company shared expanded clinical and immunogenicity findings for GEN-009, its adjuvanted peptide neoantigen vaccine. Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume and achieved independent RECIST responses post-GEN-009 dosing, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Within the CPI-resistant population, five of seven patients appear to have stabilized disease lasting up to seven months. GEN-009 elicited strong anti-tumor CD4+ and CD8+ T cell responses. Genocea expects to provide additional clinical and immunogenicity data from these patients in Q2.

    Research updates

    Publication in Cancer Discovery

    • In January, Genocea's paper, "An empirical antigen selection method identifies neoantigens that either elicit broad anti-tumor T cell responses or drive tumor growth," was published in Cancer Discovery. The paper confirms that ATLAS zeroes in on tumor mutations that are either neoantigens that activate anti-tumor responses or inhibitory antigens (Inhibigens) that are targets of pro-tumor responses, in both CD8+ (killer) and CD4+ (helper) T cells. This breakthrough potentially improves neoantigen immunotherapies by ensuring they both target the right neoantigens and exclude Inhibigens.

    SARS-CoV-2 T cell antigen discovery program

    • Genocea has a research program to identify conserved antigens of protective T cell responses to SARS-CoV-2. This builds on earlier Genocea work in infectious disease, in which it demonstrated – across multiple pathogens – that novel antigens of protective T cell responses are often not immunodominant antigens of antibody responses. If true with SARS-CoV-2, this would suggest that vaccines focusing on the Spike protein may have limited long-term utility against emergent hyper-virulent strains. As part of this program, Genocea has entered into a collaboration with the University of Massachusetts Medical School's Dr. Robert Finberg, Distinguished Professor of Medicine and leading infectious diseases expert. Pairing ATLAS with Dr. Finberg's expertise in infectious diseases may enable a better understanding of the role of T cells, including responses to Inhibigens, in the severity and duration of symptoms.

    Collaboration with the University of Minnesota

    • Genocea and the University of Minnesota's Dr. Ingunn Stromnes, an expert on immuno-oncology and T cell engineering, entered into a collaboration to explore Inhibigen biology and develop TCRs targeting Genocea's proprietary shared neoantigens.

    Other business updates

    Strengthened executive leadership team

    • Genocea appointed Raymond D. Stapleton, Jr., Ph.D. as Executive Vice President of Pharmaceutical Sciences and Manufacturing. Ray brings 20+ years of industry experience having led technical, quality and manufacturing operations at commercial and clinical stage biopharmaceutical companies.

    Financial and other updates

    Fourth quarter 2020 financial results

    • Cash position: As of December 31, 2020, cash and cash equivalents were $79.8 million compared to $40.1 million as of December 31, 2019.
    • Research and Development (R&D) expenses: R&D expenses were $7.8 million for the quarter ended December 31, 2020, compared to $6.8 million for the same period in 2019.
    • General and Administrative (G&A) expenses: G&A expenses were $3.9 million for the quarter ended December 31, 2020, compared to $3.0 million for the same period in 2019.
    • Net loss: Net loss was $15.0 million for the quarter ended December 31, 2020, compared to $9.4 million for the same period in 2019.

    Guidance

    • Genocea's operating plan extends its cash runway to the end of 2022.

    February investor conferences

    • Genocea will participate in the LifeSci Advisors Precision Oncology Day on Wednesday, February 17 at 11:30 a.m. ET. Genocea will also participate in the SVB Leerink Global Healthcare conference on Thursday, February 25 at 10 a.m. ET. Details of the presentations can be found at https://ir.genocea.com/events-presentations.

    Conference Call

    Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5767897. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our proprietary ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS uniquely zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, InhibigensTM, that drive pro-tumor immune responses. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy using neoantigen-targeted peripheral cells for which we are commencing a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in identifying meaningful therapies. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-009, GEN-011 and research updates within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576





    (Tables to follow)

    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

    (In thousands)

      December 31, 2020 December 31, 2019
         
    Cash and cash equivalents $79,769  $40,127 
    Property and equipment, net 5,123  2,617 
    Right of use assets 9,308  6,306 
    Other assets 4,293  3,561 
    Total assets $98,493  $52,611 
         
    Accounts payable and accrued expenses $7,878  $5,164 
    Deferred revenue 1,641   
    Debt, current and long-term 13,862  13,407 
    Warrant liabilities 56,118  2,486 
    Lease liabilities 10,012  6,512 
    Total liabilities 89,511  27,569 
    Stockholders' equity 8,982  25,042 
    Total liabilities and stockholders' equity $98,493  $52,611 





    GENOCEA BIOSCIENCES, INC.


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (In thousands, except per share data)

     Three Months Ended

    December 31,
     Year Ended

    December 31,
     2020 2019 2020 2019
    License revenue$   $   $1,359   $  
            
    Operating expenses:       
    Research and development7,837   6,817   33,960   26,952  
    General and administrative3,877   3,045   14,388   12,037  
    Total operating expenses11,714   9,862   48,348   38,989  
    Loss from operations(11,714)  (9,862)  (46,989)  (38,989) 
    Other income (expense)(3,271)  506   3,275   39  
    Net loss$(14,985)  $(9,356)  $(43,714)  $(38,950) 
            
    Net loss per share:       
    Basic$(0.23)  $(0.34)  $(0.98)  $(1.89) 
    Diluted$(0.18)  $(0.34)  $(1.11)  $(1.89) 
    Weighted-average number of shares used in computing net loss per share:       
    Basic64,625   27,620   44,436   20,644  
    Diluted66,954   27,620   46,553   20,644  


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  5. CAMBRIDGE, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its fourth quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, February 11th at 8:30 a.m. ET.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5767897. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-presentations

    A webcast replay will be available on the Genocea website beginning approximately…

    CAMBRIDGE, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its fourth quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, February 11th at 8:30 a.m. ET.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5767897. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-presentations

    A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     



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  6. Study validates ATLAS bioassay for developing patient-specific cancer immunotherapies by including neoantigens
    of anti-tumor T cell responses and excluding Inhibigens™, or neoantigens of pro-tumor T cell responses

    CAMBRIDGE, Mass., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced a milestone publication in Cancer Discovery, a journal of the American Association for Cancer Research. The paper, titled, "An empirical antigen selection method identifies neoantigens that either elicit broad anti-tumor T cell responses or drive tumor growth," builds on years of preclinical research and clinical experience. It shows that ATLAS

    Study validates ATLAS bioassay for developing patient-specific cancer immunotherapies by including neoantigens

    of anti-tumor T cell responses and excluding Inhibigens™, or neoantigens of pro-tumor T cell responses

    CAMBRIDGE, Mass., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced a milestone publication in Cancer Discovery, a journal of the American Association for Cancer Research. The paper, titled, "An empirical antigen selection method identifies neoantigens that either elicit broad anti-tumor T cell responses or drive tumor growth," builds on years of preclinical research and clinical experience. It shows that ATLAS zeroes in on tumor mutations that are either neoantigens that activate anti-tumor responses or inhibitory antigens (Inhibigens) that are targets of pro-tumor responses, in both CD8+ (killer) and CD4+ (helper) T cells. This breakthrough improves neoantigen immunotherapies by potentially ensuring they are targeting the right neoantigens and excluding Inhibigens.

    ATLAS profiling of neoantigen-specific T cell responses in a cohort of lung cancer patients revealed three critical observations. First, many of these tumor-specific helper and killer T cells were inhibitory and shut off neighboring beneficial T cell responses. Second, none of the common features used for in silico predictions, currently in use for identifying neoantigens for vaccine or cell therapy targeting, accurately identify either Inhibigens or neoantigens. Third, patients have existing T cell responses to a much greater proportion of neoantigens than previously reported by others using epitope prediction algorithms.

    Preclinical results demonstrate the biological relevance of Inhibigens. In the B16F10 mouse melanoma model, T cell responses to Inhibigens stifle protective anti-tumor immune responses in vivo. ATLAS-identified Inhibigens on their own, or more importantly, when combined in an otherwise protective vaccine formulation and administered to tumor-bearing mice, led to tumor growth that was comparable to, or in some cases surpassed, tumor growth in control animals. In contrast, when an ATLAS-identified anti-tumor neoantigen was added to the same formulation, tumor growth was either significantly delayed or completely abrogated, an effect that was durable and protected animals upon tumor re-challenge.

    "To effectively treat cancer patients with neoantigen-targeted therapies, it is essential to identify the correct tumor antigens, both presented by the tumor and recognized by the immune system, against which to direct T cell responses," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "Our research in both humans and mice has consistently shown that Inhibigens are negatively associated with responses to tumor immunotherapy and must be excluded from treatments because of their tendency to completely undermine efficacy. In this way, Genocea's ATLAS platform is proving to be an invaluable tool in identifying what does – and what does not – belong in an immunotherapy."

    More evidence of the relevance of ATLAS is emerging from Genocea's GEN-009 neoantigen vaccine Phase1/2a trial evaluating its safety, immunogenicity and efficacy. The study authors found that participants immunized with GEN-009 generated broad CD4+ and CD8+ T cell responses to 99% of the vaccinated peptide neoantigens. Importantly, CD8+ killer T cell responses were measurable directly from the blood without any requirement for specialized amplification in the laboratory – a remarkable and unprecedented result based on peer-reviewed neoantigen vaccine clinical trial publications to date.

    "Our ongoing Phase 1/2a study evaluates the GEN-009 vaccine in combination with standard-of-care immunotherapy regimens," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "The ability to selectively elicit a T cell response against relevant personalized targets, those presented by the tumor and recognized by the T cells, while avoiding specific suppression of immunity by Inhibigens, is a novel and fundamental concept that can drive the development of safer and more effective vaccines and cell therapies for patients. The results to date suggest that GEN-011, a personalized cell therapy targeting up to 30 neoantigens, should have broad and potent anti-tumor effects in the ongoing phase 1 TITAN™ study."

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens, Inhibigens™, that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements related to the use of ATLAS-based insights to potentially identify both the right targets and Inhibigens to advance programs. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     



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  7. CAMBRIDGE, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will participate in a fireside chat at B. Riley Securities' Virtual Oncology Investor Conference on January 21, 2021 from 11:00 am – 11:30 am Eastern Time. A live webcast of the fireside chat will be available on the Genocea website at http://ir.genocea.com. This event will also remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique…

    CAMBRIDGE, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will participate in a fireside chat at B. Riley Securities' Virtual Oncology Investor Conference on January 21, 2021 from 11:00 am – 11:30 am Eastern Time. A live webcast of the fireside chat will be available on the Genocea website at http://ir.genocea.com. This event will also remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens, Inhibigens™, that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Investor Contact:

    Dan Ferry

    617-430-7576



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  8. CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect Conference being held from January 11 – 14, 2021. A webcast of the on-demand presentation will be available on the investor section of the Genocea website at http://ir.genocea.com, beginning on Monday, January 11, 2021.

    Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by…

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect Conference being held from January 11 – 14, 2021. A webcast of the on-demand presentation will be available on the investor section of the Genocea website at http://ir.genocea.com, beginning on Monday, January 11, 2021.

    Following the conclusion of the conference, the presentation will remain archived on the Genocea website for approximately 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576



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  9. CAMBRIDGE, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18th at 8:40 a.m. ET.

    A live webcast of the presentation can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. A replay of the webcast will be archived for 90 days following the presentation.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies…

    CAMBRIDGE, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18th at 8:40 a.m. ET.

    A live webcast of the presentation can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. A replay of the webcast will be archived for 90 days following the presentation.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  10. Novel clinical and durable immune response patterns suggest addition of GEN-009 may offer additive clinical benefit in combination with PD-1-based therapies

    GEN-011, a neoantigen-targeted peripheral T cell ("NPT") product, addresses several critical adoptive T cell therapy challenges

    ATLASTM-identified Inhibigens decrease anti-tumor T cell responses, cannot be overcome by powerful checkpoint blockade immunotherapy

    CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented four posters that collectively validate the company's unique and differentiated approach to identifying clinically meaningful immunotherapy…

    Novel clinical and durable immune response patterns suggest addition of GEN-009 may offer additive clinical benefit in combination with PD-1-based therapies

    GEN-011, a neoantigen-targeted peripheral T cell ("NPT") product, addresses several critical adoptive T cell therapy challenges

    ATLASTM-identified Inhibigens decrease anti-tumor T cell responses, cannot be overcome by powerful checkpoint blockade immunotherapy

    CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented four posters that collectively validate the company's unique and differentiated approach to identifying clinically meaningful immunotherapy targets at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting taking place virtually November 9th – 14th.

    GEN-009

    In follow up to data shared at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the company shared expanded clinical and immunogenicity findings from Part B of its ongoing GEN-009 Phase 1/2a trial, which evaluates GEN-009, Genocea's neoantigen vaccine, in combination with PD-1 inhibitors in advanced cancers. Posters 390 and 413 outline the clinical and immune responses elicited by GEN-009 in 16 checkpoint inhibitor (CPI) therapy sensitive and resistant patients. Poster 413 was a highly scored abstract selected for a "Poster Walk."

    Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Within the CPI-resistant population, five of seven patients appear to have stabilized disease lasting up to seven months. GEN-009 elicited strong anti-tumor immune responses with both CD4+ and CD8+ T cell responses observed at day 50 post-vaccination and with peak ex vivo responses occurring Day 92. Early data from two patients tested so far show a complete absence of circulating tumor DNA by day 50, which is consistent with a vaccine clinical effect. There was also emerging evidence of epitope spreading in patients who successfully responded to therapy. GEN-009 was safe and well tolerated.

    "We are highly encouraged by the response patterns observed in this clinical cohort, which are a novel signal that further support the possibility that GEN-009 administration can significantly decrease tumor burden in certain patients" said Thomas Davis, M.D., Chief Medical Officer of Genocea. "Augmenting the breadth of immune response against relevant cancer specific targets through GEN-009 can deepen CPI response in patients with advanced disease. We will continue to monitor these patients to measure the GEN-009 impact on longer-term disease stabilization. While we await these data, we do not intend to dose additional patients. We believe the cumulative GEN-009 data set establishes a differentiated clinical profile based on superior neoantigen selection and also provides a strong foundation for GEN-011, which also utilizes ATLAS selected targets to generate a potent cell therapy."

    Inhibigens

    One distinguishing feature of Genocea's proprietary ATLAS technology is its ability not only to identify the stimulatory neoantigens to include in GEN-009 and GEN-011, but also to reveal Inhibigens – peptides that elicit T cell responses with the capacity to compromise anti-tumor immunity. Poster 526 delves further into the biology of Inhibigen-specific responses and reveals important insights that add to the company's growing body of knowledge beyond data previously shared at the AACR Virtual Annual Meeting II. Findings in mice and humans confirmed the presence of Inhibigens in nearly every sample screened, and mouse data show the abrogation of anti-tumor activity in response to otherwise protective vaccines is associated with decreased CD4+ and CD8+ T cell, macrophage and dendritic cell infiltration into tumors. This outcome may be attributed to abolished cytokine activity in response to tumor-specific vaccine antigens. The data also show that vaccination with an Inhibigen renders CPI co-administration ineffective.

    "Our understanding of Inhibigens' mechanism of action and their translational relevance will be critical as we advance Genocea's vaccine and adoptive T cell therapy products through the clinic," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "Immunotherapies targeting PD-1 and CTLA-4 have become standard of care across multiple cancer indications with remarkable yet variable effects. Learning more about Inhibigen biology may be critical to improving standard-of-care treatments for patients. We believe that Inhibigens must be identified and excluded from the rational design of immunotherapies, including GEN-011, the company's NPT product."

    GEN-011

    Poster 149 highlights important advantages of GEN-011 over TIL and TCR-T therapies. GEN-011 has been developed with 100% manufacturing success at clinical scale via PLANET™, a process designed to deliver billions of NPTs for every patient. The 16 PLANET runs conducted to date have confirmed GEN-011 comprises over 98% of highly functional, non-exhausted T cells with a mean neoantigen breadth of response nearing 90% of intended targets. In contrast, recent reported data from TIL products showed responses to less than 10% of intended neoantigens. GEN-011 NPTs have an unparalleled breadth of neoantigen coverage, targeting up to 30 relevant antigens. The drug product also avoids pro-tumor Inhibigens that may hinder clinical responses and the PLANET process does not require extra surgery or viable tumor.

    "I am pleased by the body of work shared today," said Chip Clark, President and Chief Executive Officer of Genocea. "Our proprietary ATLAS platform has played an integral role in the development of GEN-009 and GEN-011, and we remain eager to continue using ATLAS-based insights to identify both the right targets and Inhibigens to advance these programs in 2021 and beyond."

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements related to the possibility that GEN-009 administration can significantly decrease tumor burden in certain patients and the use of ATLAS-based insights to potentially identify both the right targets and Inhibigens to advance programs in 2021 and beyond. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  11. CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host an investor call with a live Q&A on Monday, November 9th at 8:30 a.m. EST to provide additional details on the clinical and immune response data from the remaining GEN-009 Part B patients to be shared at the 35th Annual Meeting of The Society for Immunotherapy of Cancer (SITC 2020) taking place virtually November 9th – 14th.

    Genocea's Chief Executive Officer Chip Clark, Chief Medical Officer Thomas Davis, M.D. and Chief Scientific Officer, Jessica Flechtner, will provide additional context around the following GEN-009 poster presentations:

    Abstract Number: 390

    CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host an investor call with a live Q&A on Monday, November 9th at 8:30 a.m. EST to provide additional details on the clinical and immune response data from the remaining GEN-009 Part B patients to be shared at the 35th Annual Meeting of The Society for Immunotherapy of Cancer (SITC 2020) taking place virtually November 9th – 14th.

    Genocea's Chief Executive Officer Chip Clark, Chief Medical Officer Thomas Davis, M.D. and Chief Scientific Officer, Jessica Flechtner, will provide additional context around the following GEN-009 poster presentations:

    Abstract Number: 390

    Title: Emerging safety and activity data from GEN-009-101: A phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 checkpoint inhibitors (CPI) in advanced solid tumors

    Abstract Number: 413

    Title: GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors

    Interested participants may access the conference call by dialing 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and referring to conference ID number 13712664. To ask a question during the live Q&A, please submit your question to . For those who are unable to listen in during the event, a replay of the call will be available here.

    Genocea's GEN-009 posters (along with posters highlighting Inhibigen™ data and the neoantigen cell therapy GEN-011) will become available to registered attendees through the SITC virtual meeting platform at 8 a.m. EST on Monday, November 9th. Poster presentations with accompanying video will also be simultaneously posted to "Events and Presentations" tab of the investor relations section of the Genocea website.

    Webcast & Conference Call Information

    A live webcast of the investor call can also be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. A replay of the webcast will be archived for 30 days following the presentation.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  12. Initiated GEN-011 Phase1/2a clinical trial

    Presented positive follow-up GEN-009 Part B data at ESMO Virtual Congress 2020 demonstrating potential added benefit to PD-1 inhibitor therapy

    Closed financing with net proceeds of $74.5 million

    Upcoming presentations at SITC 2020 Virtual Conference on GEN-009, InhibigensTM and GEN-011

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the third quarter ended September 30, 2020.

    GEN-011 Phase 1/2a clinical trial initiation
    Genocea recently announced the…

    Initiated GEN-011 Phase1/2a clinical trial

    Presented positive follow-up GEN-009 Part B data at ESMO Virtual Congress 2020 demonstrating potential added benefit to PD-1 inhibitor therapy

    Closed financing with net proceeds of $74.5 million

    Upcoming presentations at SITC 2020 Virtual Conference on GEN-009, InhibigensTM and GEN-011

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the third quarter ended September 30, 2020.

    GEN-011 Phase 1/2a clinical trial initiation

    Genocea recently announced the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) Application for GEN-011, an adoptive neoantigen T cell therapy designed to improve upon the limitations of TIL and TCR therapies. The company initiated a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy to evaluate safety, T cell proliferation and persistence as well as clinical activity. Genocea plans to enroll up to 24 patients across several tumor types in the trial.

    Scientific and clinical presentations: ESMO Congress, upcoming SITC meeting and conference call

    Genocea presented clinical response and immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The incremental follow-up findings demonstrated tumor reductions or stable outcomes for all five patients, suggesting GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100% of patients demonstrated immune responses to ATLAS™-identified neoantigens.

    Genocea will report additional clinical and immunogenicity data from the remaining GEN-009 Part B patients during the 2020 virtual Society for Immunotherapy of Cancer (SITC) annual meeting from November 9-14. The company will also provide a detailed introduction to GEN-011 and will share new insights on the utility of ATLAS-identified Inhibigens to inform future immunotherapy development.

    Genocea will host a conference call on Monday, November 9 at 8:30 a.m. EST to discuss the new GEN-009 clinical and immunogenicity data reported at SITC.

    Private placement

    In July, Genocea completed a private placement with $74.5 million in net proceeds. The proceeds will be used to fund continued development of GEN-009, GEN-011 and ATLAS.

    "In the third quarter, our team achieved important clinical, scientific and financial progress. We provided what we believe to be differentiated immunogenicity and efficacy data from an initial look at our GEN-009 Part B clinical trial and secured critical fresh capital", said Chip Clark, president and chief executive officer Genocea. "Using these proceeds to advance GEN-011 into the clinic and to further our investigation into ATLAS and its applications represents an exciting opportunity."

    Third Quarter 2020 Financial Results

    • Cash position: As of September 30, 2020, cash and cash equivalents were $87.6 million versus $40.1 million as of December 31, 2019.
    • Research and Development (R&D) expenses: R&D expenses were $7.5 million for the quarter ended September 30, 2020, compared to $6.8 million for the same period in 2019.
    • General and Administrative (G&A) expenses: G&A expenses were $3.6 million for the quarter ended September 30, 2020, compared to $2.8 million for the same period in 2019.
    • Net loss: Net loss was $4.6 million for the quarter ended September 30, 2020, compared to $7.5 million for the same period in 2019.

    Guidance

    Genocea expects that its existing cash and cash equivalents are sufficient to support its operations to mid-2022.

    Conference Call

    Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we are commencing a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576



    (Tables to follow)



    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

    (In thousands)

      September 30, 2020 December 31, 2019
         
    Cash and cash equivalents $87,625  $40,127 
    Right of use assets 10,737  6,306 
    Other assets 7,836  6,178 
    Total assets $106,198  $52,611 
         
    Accounts payable and accrued expenses $6,351  $5,164 
    Deferred revenue 1,641   
    Debt, current and long-term 13,743  13,407 
    Warrant liabilities 53,237  2,486 
    Lease liabilities 11,021  6,512 
    Total liabilities 85,993  27,569 
    Stockholders' equity 20,205  25,042 
    Total liabilities and stockholders' equity $106,198  $52,611 





    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (In thousands, except per share data)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
    License revenue$453  $  $1,359  $ 
            
    Operating expenses:       
    Research and development7,548  6,826  26,123  20,135 
    General and administrative3,644  2,758  10,511  8,992 
    Total operating expenses11,192  9,584  36,634  29,127 
    Loss from operations(10,739) (9,584) (35,275) (29,127)
    Other income (expense)6,184  2,052  6,546  (467)
    Net loss$(4,555) $(7,532) $(28,729) $(29,594)
            
    Net loss per share:       
    Basic$(0.08) $(0.28) $(0.76) $(1.62)
    Diluted$(0.26) $(0.28) $(1.01) $(1.62)
    Weighted-average number of shares used in computing net loss per share:       
    Basic55,492  26,681  37,657  18,297 
    Diluted61,130  26,681  39,550  18,297 

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  13. CAMBRIDGE, Mass., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its third quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, October 29th at 8:30 a.m. EDT.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations.

    A webcast replay will be available on the Genocea website beginning approximately…

    CAMBRIDGE, Mass., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its third quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, October 29th at 8:30 a.m. EDT.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations.

    A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we are commencing a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

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  14. Will showcase clinical and immune responses from the ongoing GEN-009 Phase 1/2a trial

    Will provide a detailed introduction to GEN-011, an adoptive T cell therapy designed to improve upon the limitations of TIL and TCR therapies

    Will share new insights on the utility of InhibigensTM as identified by ATLASTM to inform immunotherapy development

    CAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the titles and times of its presentations at the upcoming 35th Annual Meeting of The Society for Immunotherapy of Cancer (SITC 2020) taking place virtually November 9th – 14th.

    The following posters will be…

    Will showcase clinical and immune responses from the ongoing GEN-009 Phase 1/2a trial

    Will provide a detailed introduction to GEN-011, an adoptive T cell therapy designed to improve upon the limitations of TIL and TCR therapies

    Will share new insights on the utility of InhibigensTM as identified by ATLASTM to inform immunotherapy development

    CAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the titles and times of its presentations at the upcoming 35th Annual Meeting of The Society for Immunotherapy of Cancer (SITC 2020) taking place virtually November 9th – 14th.

    The following posters will be available on Monday, November 9 at 8 a.m. ET:

    Abstract Number: 390

    Title: Emerging safety and activity data from GEN-009-101: A phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 checkpoint inhibitors (CPI) in advanced solid tumors

    Abstract Number: 413

    Title: GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors

    Abstract Number: 149

    Title: GEN-011: An ATLAS™-guided peripheral-blood derived neoantigen-specific T cell therapy designed to improve on TIL approaches

    Abstract Number: 526

    Title: InhibigenTM-specific responses suppress anti-tumor immunity and promote tumor growth

    Per SITC policy, full abstracts are embargoed until 8 a.m. ET on November 9, 2020.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

    Primary Logo

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  15. CAMBRIDGE, Mass., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) Application for GEN-011, an adoptive T cell therapy targeting neoantigens and designed to improve upon the limitations of TIL and TCR therapies. The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.

    "GEN-011 builds on the power of our ATLAS™ platform, as…

    CAMBRIDGE, Mass., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) Application for GEN-011, an adoptive T cell therapy targeting neoantigens and designed to improve upon the limitations of TIL and TCR therapies. The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.

    "GEN-011 builds on the power of our ATLAS™ platform, as demonstrated in our GEN-009 clinical trial, to identify the relevant neoantigens which drive robust anti-tumor T cell responses in patients, regardless of HLA type," said Chip Clark, President and Chief Executive Officer of Genocea. "Using a patient's peripheral T cells, already programmed to kill cancer cells with relevant neoantigens, enables this non-engineered therapy to rapidly scale. We therefore believe GEN-011 may eventually offer efficacy, accessibility and cost advantages to patients and providers."

    Genocea plans to enroll up to 24 patients across several tumor types in the Phase 1/2 trial. In one cohort, patients will receive multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion. In the other cohort, patients will receive a single GEN-011 dose after lymphodepletion and a high dose of IL-2.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we are commencing a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  16. Step-down responses to GEN-009, with 3 objective responses (2 PR, 1 CR) in the first 5 patients, suggests added benefit to PD-1 inhibitor therapy

    100% of patients have immune responses to ATLAS-identified neoantigens

    CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    ESMO E-POSTER PRESENTATION:
    Poster 1028P 
    Title: Preliminary results of a pilot trial of GEN-009, a neoantigen vaccine

    Step-down responses to GEN-009, with 3 objective responses (2 PR, 1 CR) in the first 5 patients, suggests added benefit to PD-1 inhibitor therapy

    100% of patients have immune responses to ATLAS-identified neoantigens

    CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

    ESMO E-POSTER PRESENTATION:

    Poster 1028P 

    Title: Preliminary results of a pilot trial of GEN-009, a neoantigen vaccine containing immunogenic tumor specific neoantigens, in combination with PD-1 inhibitors in advanced cancers

    Date: September 17, 2020

    Time: at 9:00 a.m. CEST (3:00 a.m. EDT)

    Link to the poster: https://www.esmo.org/meetings/esmo-virtual-congress-2020/registration?hit=ehp

    The results build on the Part B findings shared previously, which evaluated the preliminary immunogenicity and efficacy of GEN-009 in combination with standard-of-care checkpoint inhibitor-based regimens (CPI) in an initial cohort of five patients with advanced solid tumors. All five patients received GEN-009 approximately four months following the start of CPI treatment.

    New follow-up scans, ranging from 91-233 days post-vaccination, confirm the previously disclosed findings, with tumor reduction or stable outcomes for all five patients, including three RECIST-criteria changes in tumor size (2 PR, 1 CR) after vaccination and likely attributable to GEN-009. The new results continue to suggest GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100 percent of patients had neoantigen-specific responses elicited by vaccination, in some cases with evidence of epitope spread. No significant adverse side effects were reported, with only mild symptoms associated with the vaccine adjuvant.

    "The step-down response curves represent a promising and previously unobserved pattern of tumor response that warrants further investigation," said Maura Gillison, M.D., Ph.D., Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. "It will be important to continue our assessment of GEN-009's specific contribution to the clinical effects seen to date. We look forward to validating these results in a broader cohort to support our hypothesis that inclusion of GEN-009 in CPI regimens may lead to beneficial outcomes for patients with hard-to-treat solid cancers."

    "Our findings, which show that RECIST responses were maintained for at least three months in three of the five patients evaluated, underscore the potential of GEN-009 to boost CPI regimens in hard to treat patients," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "We believe that the path forward to designing better immunotherapies is powered by ATLAS. These results build further confidence that we are indeed targeting relevant tumor antigens for inclusion in our GEN-009 vaccine."

    The company expects to share additional immunogenicity and clinical data from the remaining 10 Part B patients later this year.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

    Primary Logo

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  17. CAMBRIDGE, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that the company will present incremental follow-up data, including additional tumor scan results and detailed immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2 a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. Genocea expects to share similar clinical and immunogenicity data from the remaining 10 Part B patients later this year.

    Conferences Details:
    Event:  European Society for Medical Oncology (ESMO) Virtual Congress 2020
    Format:  Poster 1028P and Abstract

    CAMBRIDGE, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that the company will present incremental follow-up data, including additional tumor scan results and detailed immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2 a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. Genocea expects to share similar clinical and immunogenicity data from the remaining 10 Part B patients later this year.

    Conferences Details:
    Event:  European Society for Medical Oncology (ESMO) Virtual Congress 2020
    Format:  Poster 1028P and Abstract #3549; Preliminary results of a pilot trial of GEN-009, a neoantigen vaccine containing immunogenic tumor specific neoantigens, in combination with PD-1 inhibitors in advanced cancers
    Date:  Thursday, September 17TH
    Time:  9:00 a.m. CEST (3.00 a.m. ET)
        
    In addition, Chip Clark, president and chief executive officer, will present via webcast corporate overviews at the virtual Baird Global Healthcare Conference and the virtual H.C. Wainwright 22nd Annual Global Investment Conference.

        
    Conferences Details:

    Event:   Baird Global Healthcare Conference 2020 (virtual)
    Format:  Presentation
    Date:  Thursday, September 10TH
    Time:  4:20 p.m. ET
        
    Event:  H.C. Wainwright 22nd Annual Global Investment Conference (virtual)
    Format:  Presentation
    Date:  Tuesday, September 15TH
    Time:  1:30 p.m. ET

    Live webcasts of these presentations can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Replays of the webcasts will be archived for 90 days following the conferences.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

    Primary Logo

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  18. Webcast/conference call scheduled today, July 30th at 8:00 a.m. EDT

    Three of five patients achieved separate RECIST responses after GEN-009 administration

    GEN-009 elicited antigen-specific CD4+ and CD8+ T cell responses in 100% of treated patients

    CAMBRIDGE, Mass., July 30, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present initial clinical data today on the first five patients from Part B of the ongoing Phase 1/2a study, which explores the combination of Genocea's neoantigen vaccine, GEN-009 and checkpoint inhibitor-based regimens (CPI) in advanced solid tumors. The webcast and presentation will feature Dr. Maura L. Gillison…

    Webcast/conference call scheduled today, July 30th at 8:00 a.m. EDT

    Three of five patients achieved separate RECIST responses after GEN-009 administration

    GEN-009 elicited antigen-specific CD4+ and CD8+ T cell responses in 100% of treated patients

    CAMBRIDGE, Mass., July 30, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present initial clinical data today on the first five patients from Part B of the ongoing Phase 1/2a study, which explores the combination of Genocea's neoantigen vaccine, GEN-009 and checkpoint inhibitor-based regimens (CPI) in advanced solid tumors. The webcast and presentation will feature Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center.

    The trial combines GEN-009 with a Standard of Care (SOC) CPI-based regimen approximately four months after the SOC CPI-based regimen is started. The preliminary findings from the first five patients show three achieving independent RECIST responses starting from the first GEN-009 dose. These responses show an acceleration of shrinkage beyond that of the CPI regimen, creating a novel response plot that supports the effect being attributable to the addition of GEN-009. One such patient achieved a complete response ("CR"), while two demonstrated partial responses ("PR"). Overall, two of the first five patients achieved CRs and three experienced PRs.

    These results are corroborated by the patients' immune responses. Neoantigen-specific CD4+ and CD8+ T cell responses were detected in 100% of patients, with all patients responding to multiple vaccinated antigens. Early comparison of T cell responses post-checkpoint (pre-vaccination) and post-vaccination show that T cell responses are specific to GEN-009 and not augmented by checkpoint blockade.

    "We are incredibly encouraged by these initial results," said Dr. Gillison. "The breadth and magnitude of immune responses validate the complete and partial responses observed in the five patients evaluated. We believe incorporating GEN-009 into standard-of-care immunotherapy regimens may help boost the effectiveness of immune checkpoint inhibitor therapy in patients with advanced disease."

    "We are very pleased this initial data set continues to validate antigen selection using our proprietary ATLAS™ platform," said Chip Clark, President and Chief Executive Officer, Genocea. "We look forward both to reporting data from approximately ten additional patients this fall and to initiating the clinical trial for the neoantigen cell therapy GEN-011, which should similarly benefit from ATLAS to drive anti-tumor responses through T cells targeting the right neoantigens in checkpoint-refractory patients."

    Webcast & Conference Call Information

    Interested participants may access the call by clicking here. For those who are unable to listen in during the event, a replay of the call will be available here.

    A replay of the webcast will be archived for 30 days following the presentation by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

    Primary Logo

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  19. Upcoming GEN-009 data update planned for July 30th at 8 a.m. EDT
    Filed IND application for GEN-011 and is working with the FDA to provide additional information
    Private Placement with Leading Life Science Investment Funds

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., July 23, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the second quarter ended June 30, 2020. Genocea had an active and productive second quarter, demonstrating important progress across the Company:

    GEN-009

    • On July 30, 2020, the Company plans to present initial clinical data on the first 5 patients from Part…

    Upcoming GEN-009 data update planned for July 30th at 8 a.m. EDT

    Filed IND application for GEN-011 and is working with the FDA to provide additional information

    Private Placement with Leading Life Science Investment Funds

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., July 23, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the second quarter ended June 30, 2020. Genocea had an active and productive second quarter, demonstrating important progress across the Company:

    GEN-009

    • On July 30, 2020, the Company plans to present initial clinical data on the first 5 patients from Part B with Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. Part B of the study is exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.
    • Presented long-term follow-up data from Part A of the ongoing Phase 1/2a clinical trial at ASCO20 Virtual Scientific Program that evaluates eight participants for duration of immune responses and clinical outcomes.
      • Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up.
      • ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 1 year after the last vaccination.

    GEN-011

    • Hosted a virtual KOL symposium introducing GEN-011 – a neoantigen cell therapy that uses peripheral blood T cells and is powered by ATLAS™ to target the right tumor neoantigens. The event featured commentary from Dr. Eric Tran, Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute and members of the Genocea management team on GEN-011 as a new category of T cell therapy designed to improve on current limitations of TIL therapy.
    • Filed an Investigational New Drug (IND) application to initiate a Phase 1/2a clinical study of GEN-011 evaluating patient safety, T cell proliferation and persistence, and clinical activity. The trial expects to enroll up to 24 patients and will assess GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The Company has received verbal notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its review of the Company's IND for GEN-011. In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA's position in the near future and plans to work with the FDA to resolve their questions as quickly as possible.

    Private Placement

    • On July 22, 2020 the Company entered into a private placement led by an undisclosed leading U.S. public investment fund specializing in life sciences as well as certain existing and new investors providing for the purchase of up to approximately $80 million of its common stock and warrants to purchase shares of Genocea common stock (before deducting fees to the placement agent and other offering expenses payable by Genocea). Genocea will offer 21.4 million shares of common stock and 12.2 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant purchased by an investor. The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $2.25 per share and will have a 4-year term. The closing of the private placement is expected to occur on or about July 24, 2020, subject to customary closing conditions.

    Shionogi Material Transfer Agreement ("MTA")

    • Entered into an MTA and exclusive license option with Shionogi & Co., Ltd. ("Shionogi") to develop a novel HSV-2 vaccine using Genocea's proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. As part of this agreement, the Company received $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi's option, terms of the license are expected to include an upfront payment, regulatory and sales milestones, as well as tiered royalties. Final terms of the license agreement will be based on results of the MTA evaluation and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product.

    Inhibigens

    • Presented preclinical data at the AACR Virtual Annual Meeting II that furthers understanding of inhibitory antigen (InhibigenTM) function and builds on previous research demonstrating that the presence of an Inhibigen in an otherwise protective immunotherapy can be detrimental to anti-tumor responses.
      • Inhibigens were found to alter the tumor microenvironment and drive tumor hyperprogression and also abolished both global and tumor antigen-specific T cell activity to beneficial anti-tumor antigens.
      • Findings suggest that Inhibigens must be identified and excluded from the rational design of cancer immunotherapies to achieve more favorable patient outcomes.

    "We continue to advance our clinical programs for patients living with cancer," said Chip Clark, President and Chief Executive Officer, Genocea. "I am pleased by our ability to remain on track during these uncertain times, meeting our highest priority milestones and working to deliver on the promise of developing effective immunotherapies through our unique and differentiated approach."

    Second Quarter 2020 Financial Results

    • Cash position: As of June 30, 2020, cash and cash equivalents were $22.1 million versus $40.1 million as of December 31, 2019.
    • Research and Development (R&D) expenses: R&D expenses were $8.6 million for the quarter ended June 30, 2020, compared to $6.8 million for the same period in 2019.
    • General and Administrative (G&A) expenses: G&A expenses were $3.5 million for the quarter ended June 30, 2020, compared to $3.2 million for the same period in 2019.
    • Net loss: Net loss was $11.3 million for the quarter ended June 30, 2020, compared to $6.5 million for the same period in 2019.

    Guidance

    Genocea expects that its existing cash and cash equivalents inclusive of the private placement proceeds are sufficient to support its operations to mid-2022.

    Conference Call

    Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8894505. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    GEN-009 Clinical Update Registration

    Genocea will present a clinical update on GEN-009 on Thursday, July 30 at 8 a.m. EDT. Interested participants may access this event by registering here.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

    (Tables to follow)

    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

    (In thousands)

      June 30, 2020 December 31, 2019
         
    Cash and cash equivalents $22,108  $40,127 
    Right of use assets 11,265  6,306 
    Other assets 7,143  6,178 
    Total assets $40,516  $52,611 
         
    Debt, current and long-term $13,627  $13,407 
    Accounts payable and accrued expenses 4,749  5,164 
    Deferred revenue 1,094   
    Lease liabilities 11,526  6,512 
    Warrant liability 1,483  2,486 
    Total liabilities 32,479  27,569 
    Stockholders' equity 8,037  25,042 
    Total liabilities and stockholders' equity $40,516  $52,611 



    GENOCEA BIOSCIENCES, INC.


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (In thousands, except per share data)

     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
     2020 2019 2020 2019
    License revenue$906  $  $906  $ 
            
    Operating expenses:       
    Research and development8,587  6,849  18,574  13,309 
    General and administrative3,480  3,217  6,868  6,234 
    Total operating expenses12,067  10,066  25,442  19,543 
    Loss from operations(11,161) (10,066) (24,536) (19,543)
    Other (expense) income(160) 3,571  362  (2,519)
    Net loss$(11,321) $(6,495) $(24,174) $(22,062)
            
    Net loss per share - basic and diluted$(0.39) $(0.42) $(0.84) $(1.57)
    Weighted-average number of common shares used in computing net loss per share29,142  15,344  28,642  14,035 

     

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  20. CAMBRIDGE, Mass., July 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today announced that it has entered into a private placement led by an undisclosed leading U.S. public investment fund specializing in life sciences as well as certain existing and new investors providing for the purchase of up to approximately $80 million of its common stock and warrants to purchase shares of Genocea common stock (before deducting fees to the placement agent and other offering expenses payable by Genocea). Genocea will offer 21.4 million shares of common stock and 12.2 million pre-funded warrants to purchase common stock, along with accompanying warrants to…

    CAMBRIDGE, Mass., July 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today announced that it has entered into a private placement led by an undisclosed leading U.S. public investment fund specializing in life sciences as well as certain existing and new investors providing for the purchase of up to approximately $80 million of its common stock and warrants to purchase shares of Genocea common stock (before deducting fees to the placement agent and other offering expenses payable by Genocea). Genocea will offer 21.4 million shares of common stock and 12.2 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant purchased by an investor. The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $2.25 per share and will have a 4-year term. The closing of the private placement is expected to occur on or about July 24, 2020, subject to customary closing conditions.

    Genocea intends to use the net proceeds from this private placement to fund continued clinical and program development of its neoantigen vaccine GEN-009 and its neoantigen cell therapy GEN-011, as well as for working capital and other general corporate purposes.

    Stifel is acting as sole placement agent for the private placement.  Brookline Capital Markets, a division of Arcadia Securities, LLC is serving as financial advisor to the Company in connection with the private placement.

    The securities sold in the offering have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Genocea has agreed to file a resale registration statement with the Securities and Exchange Commission (the "SEC") within 30 days of the closing of the offering for purposes of registering the resale of the shares of common stock issued or issuable in connection with the offering.

    This notice is issued pursuant to Rule 135c under the Securities Act and does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial.

    Genocea Forward-Looking Statement

    This press release includes forward-looking statements, including statements relating to immunogenicity-related clinical trial results, the proposed offering terms and the use of the net proceeds therefrom, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  21. CAMBRIDGE, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced updates to its clinical programs, the neoantigen vaccine GEN-009 and the neoantigen cell therapy, GEN-011. 

    GEN-009

    On July 30, 2020, the Company will share initial clinical data on the first 5 patients from Part B of the ongoing Phase 1/2a clinical trial exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.  The lead investigator, Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, will present.

    GEN-011

    In…

    CAMBRIDGE, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced updates to its clinical programs, the neoantigen vaccine GEN-009 and the neoantigen cell therapy, GEN-011. 

    GEN-009

    On July 30, 2020, the Company will share initial clinical data on the first 5 patients from Part B of the ongoing Phase 1/2a clinical trial exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.  The lead investigator, Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, will present.

    GEN-011

    In June 2020, the Company submitted the IND to support the initiation of a Phase 1/2 clinical trial and the 30-day FDA review period has just ended.  The Company has received verbal notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its review of the Company's Investigational New Drug Application (IND) for GEN-011.  In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA's position in the near future and will work with the FDA to resolve their questions as quickly as possible.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

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  22. CAMBRIDGE, Mass., July 16, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its second quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, July 23rd at 8:30 a.m. EDT.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8894505. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay will be available on the Genocea website beginning approximately…

    CAMBRIDGE, Mass., July 16, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its second quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, July 23rd at 8:30 a.m. EDT.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8894505. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood and expect preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  23. Inhibigens (inhibitory antigens) are detrimental an otherwise protective immunotherapy

    Inhibigens alter the tumor microenvironment and drive tumor hyperprogression

    Inhibigens abolish both global and tumor antigen-specific T cell activity

    CAMBRIDGE, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new and important insights into the biology and behavior of inhibitory neoantigens (Inhibigens™)  at the American Association for Cancer Research (AACR) Virtual Annual Meeting II from June 22-24. The findings build on previous research presented at SITC 2019 which demonstrated that the…

    Inhibigens (inhibitory antigens) are detrimental an otherwise protective immunotherapy

    Inhibigens alter the tumor microenvironment and drive tumor hyperprogression

    Inhibigens abolish both global and tumor antigen-specific T cell activity

    CAMBRIDGE, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new and important insights into the biology and behavior of inhibitory neoantigens (Inhibigens™)  at the American Association for Cancer Research (AACR) Virtual Annual Meeting II from June 22-24. The findings build on previous research presented at SITC 2019 which demonstrated that the presence of an Inhibigen in an otherwise protective immunotherapy can completely reverse anti-tumor responses.

    In the preclinical study, pro-tumor Inhibigen effects were found to be correlated with an increasingly immune-suppressive tumor microenvironment (TME), including reduced TILs and enhanced expression of T cell exhaustion markers. Vaccination of tumor-bearing mice with a formulation containing an inhibigen impaired both tumor antigen specific and nonspecific T cell function by blocking their ability to secrete cytokines and kill tumor cells – an effect that abolished T cell responses to beneficial anti-tumor antigens.

    "This observed downregulation of anti-tumor cytokine responses could be detrimental to cancer immunotherapies," said Victoria DeVault, a Genocea research scientist and lead presenter of the results to be shared at AACR. "Thanks to insights gleaned from our unique ATLAS platform, we are beginning to understand why immunization with Inhibigens leads to a defective immune response and why proper T cell engagement against the right targets is critical to producing an effective vaccination."

    In addition, the poster presentation revealed that immunization with Inhibigens led to a reduction in T cell receptor (TCR) expression of tumor-specific T cells, which further hindered T cell function and activity needed to produce a robust immune response. The analysis also demonstrated that the Inhibigen-specific responses are not mediated by regulatory T cells – a subset of T cells known to suppress immune responses.

    "Taken together, the results add to the growing body of evidence that Inhibigens must be identified and excluded from the rational design of cancer immunotherapies," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "ATLAS allows us to pinpoint the underlying potential reasons why such treatments fail in patients. Armed with this critical knowledge, we can design better and smarter personalized vaccines and cell therapies for more favorable patient outcomes."

    AACR POSTER SESSION TITLE: Immune Response to Therapies 2  

    Abstract 7039 / Poster 6680

    Title: Inclusion of inhibitory neoantigens can abolish efficacy of otherwise protective therapeutic anti-tumor vaccines.

    Presenter: Victoria DeVault, Ph.D., Genocea Biosciences, Cambridge, MA

    Date: June 22, 2020

    Time: 9:00 a.m. – 6:00 p.m. EDT

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial with preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

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  24. CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021.

    Powered by ATLAS™, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike…

    CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021.

    Powered by ATLAS™, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike TILs, GEN-011 does not require extra surgery or collection of viable tumor samples and uses peripheral blood in a rapidly scalable manufacturing process. This may enable access to a broader population of patients with advanced cancers, and may result in a cost of therapy that is favorable compared to TIL-based approaches. GEN-011 may also offer lasting clinical efficacy by targeting up to 30 relevant neoantigens with CD4+ and CD8+ memory T cells and avoiding pro-tumor Inhibigens™ that may be detrimental to clinical response.  

    "In only 18 months the Genocea team took GEN-011 from whiteboard to IND filing," said Chip Clark, President and Chief Executive Officer of Genocea. "We look forward to sharing data from yet another program demonstrating that targets matter."

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial with preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  25. Data show immune responses occur rapidly after only two vaccinations and can be sustained for more than one year

    Part B is exploring the vaccine's ability to reduce tumor size beyond the standard-of-care therapy alone

    CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate. Data will be shared by Roger Cohen, M.D., University of Pennsylvania Abramson Cancer Center, during a video poster presentation (Abstract #3107) at the virtual 2020 American Society…

    Data show immune responses occur rapidly after only two vaccinations and can be sustained for more than one year

    Part B is exploring the vaccine's ability to reduce tumor size beyond the standard-of-care therapy alone

    CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate. Data will be shared by Roger Cohen, M.D., University of Pennsylvania Abramson Cancer Center, during a video poster presentation (Abstract #3107) at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020 from 8:00 – 11:00 am EDT.

    ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
    Abstract 3107

    Title: GEN-009, a neoantigen vaccine containing ATLAS-selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.

    The analysis evaluates eight patients from Part A of the trial who were vaccinated with GEN-009 as adjuvant therapy, focusing on the onset and duration of induced immunity and clinical outcomes. Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year. All patients received dosing as planned, with five doses given over a six-month period with immune responses occurring rapidly after only two vaccinations. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant. In addition, there are several notable patient outcomes:

    • Prior to the GEN-009 trial, one patient diagnosed with melanoma (low PDL-1) had progressed after treatment with a PD-1 antibody, an experimental vaccine and a CTLA-4 inhibitor. After GEN-009, the patient continues in remission for more than 12 months.
    • A patient diagnosed with squamous cell cancer of the head and neck had experienced successively shorter remissions but is now exceeding previous remissions and approaching nine months progression free with GEN-009.

    "The fact that seven of eight patients continue without progression is encouraging. The vaccine has been well tolerated with only mild injection site reactions. Vaccinated patients have generated both CD4+ and CD8+ ex vivo immune responses with immunogenicity manifested to 99% of the vaccinated antigens," said Dr. Cohen.

    Both CD8+ and CD4+ responses were measured in both ex vivo and in vitro assays and were detected as early as day 29 extending as far as 12 months.

    The Part B trial continues with patients diagnosed with advanced disease who are receiving GEN-009 in combination with standard of care regimens, including immune checkpoint inhibitors. This cohort will explore the vaccine's ability to reduce tumor size beyond the standard of care therapy alone.

    "Together, these data suggest that ATLAS-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "We look forward to advancing the GEN-009 Phase 1/2a Part B trial and reporting those results, and additional Part A results, later in 2020."

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  26. CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced it has entered into a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd. to develop a novel HSV-2 vaccine using Genocea's proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. 

    Under the terms of the agreement, Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi's option, terms of the license are expected to include an upfront payment, regulatory and sales milestones…

    CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced it has entered into a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd. to develop a novel HSV-2 vaccine using Genocea's proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. 

    Under the terms of the agreement, Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi's option, terms of the license are expected to include an upfront payment, regulatory and sales milestones, as well as tiered royalties. Final terms of the license agreement will be based on results of the MTA evaluation and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product.

    "The HSV-2 antigens were identified by our proprietary ATLASTM platform. This agreement with Shionogi further validates our ATLAS technology to identify clinically relevant and best-in-class antigens across a range of illnesses, including infectious diseases and cancer. We are incredibly pleased to support Shionogi's efforts to develop a novel vaccine for the millions of people seeking more effective treatment options for their genital herpes disease," said Chip Clark, President and Chief Executive Officer, Genocea.

    "The agreement with Genocea is an important step forward in our ability to discover leading vaccines and therapies that address infectious diseases with high unmet medical need – a core research area of ongoing interest for Shionogi. We are committed to helping genital herpes patients better control outbreaks and preventing further epidemic spread of the virus," said Dr. Ryuichi Kiyama, Senior Executive Officer, Executive Vice President, Pharmaceutical Research Division, Shionogi & Co., Ltd.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    About Shionogi & Co., Ltd.
    Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and wellbeing of the patients we serve." Shionogi's research and development currently targets two therapeutic areas: infectious diseases, and pain/CNS disorders.

    For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic diseases and oncology/immunology.

    Contributing to the health and QOL of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp/en/

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  27. Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up

    ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination

    CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate at the virtual 2020 American Society for Clinical Oncology (ASCO) Annual Meeting from May 29-31.

    The analysis evaluates…

    Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up

    ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination

    CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate at the virtual 2020 American Society for Clinical Oncology (ASCO) Annual Meeting from May 29-31.

    The analysis evaluates eight patients from Part A of the trial who were vaccinated with GEN-009 as adjuvant therapy, focusing on the onset and duration of induced immunity and clinical outcomes. Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year. All patients received dosing as planned with five doses given over a six-month period. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant.

    GEN-009 vaccination also generated immune responses across 99% of neoantigen targets while avoiding inhibitory peptides also known as Inhibigens™, or antigens that drive inhibitory T cell responses. Both CD8+ and CD4+ responses were measured in both ex vivo and in vitro assays, and were detected as early as day 29 extending as far out as 12 months.

    "I am pleased to see early and durable immune responses and favorable patient outcomes in Part A of the GEN-009 trial," said Roger Cohen, M.D., Associate Director of Clinical Research, Abramson Cancer Center. "While we can't assess the specific contribution of the vaccine in the adjuvant setting in this mixed population, the progression-free survival, safety and immunogenicity results support the role that GEN-009 could play in the therapy of multiple tumor types."

    "We are very pleased to find that these patients have done so well with GEN-009 vaccination. The breadth and durability of immune response as well as the clinical outcomes strengthen our excitement to see the effects of combination therapy in patients with measurable tumors," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "We are eager to elaborate further on our latest GEN-009 findings at the upcoming ASCO meeting and look forward to sharing additional data from Part B of this study on the benefits of the vaccine in patients receiving immune checkpoint inhibitors later this year."

    ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
    Abstract 3107

    Title: GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.

    Presenter: Roger B. Cohen, M.D., University of Pennsylvania Abramson Cancer Center
    Date: May 29, 2020
    Time: 8:00 – 11:00 a.m. EDT

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

     

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  28. CAMBRIDGE, Mass., May 12, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, hosted a KOL symposium today with Dr. Eric Tran, Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute reflecting on the T cell therapy landscape, while Genocea provided an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy.

    Genocea introduced data showing that GEN-011 embraces the advantages of TIL therapy while improving on its limitations. Using Genocea's proprietary ATLAS™ platform, GEN-011 targets the right tumor neoantigens. Genocea has also established a robust, scalable manufacturing process, PLANET™, using…

    CAMBRIDGE, Mass., May 12, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, hosted a KOL symposium today with Dr. Eric Tran, Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute reflecting on the T cell therapy landscape, while Genocea provided an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy.

    Genocea introduced data showing that GEN-011 embraces the advantages of TIL therapy while improving on its limitations. Using Genocea's proprietary ATLAS™ platform, GEN-011 targets the right tumor neoantigens. Genocea has also established a robust, scalable manufacturing process, PLANET™, using peripheral blood T cells to ensure greater activity and durability for larger patient populations. Highlights include:

    GEN-011 Advantages over TIL Therapy

    • Unparalleled breadth of neoantigen coverage, targeting up to 30 relevant neoantigens with CD4+ and CD8+ memory T cells to overcome non-tumor specific "passenger" T cells that can expand during TIL manufacturing
    • Avoids pro-tumor Inhibigens™ that may be detrimental to clinical response, which TIL therapy cannot avoid
    • No extra surgery or viable tumor required
    • Billions of neoantigen-specific T cells with proven cytolytic capacity derived from peripheral blood
      ο 89% of intended neoantigen targets are addressed with GEN-011 T cells compared with fewer than 10% in recently reported TIL data
    • Non-exhausted cells with potential for superior activity and persistence

    "In GEN-011, Genocea is creating a transformative ATLAS-enabled, peripheral blood-derived T cell therapy," said Chip Clark, Genocea's President and Chief Executive Officer. "We believe the next-generation of T cell therapies should build on the successes that TIL-based approaches have shown to date, while realizing the opportunity to develop options for more patients living with cancer. We are eager to advance GEN-011, with an IND filing within Q2 and initial clinical data in the first half of 2021."

    KOL Symposium Webcast Replay
    A replay of the KOL symposium webcast and presentation can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com.   

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  29. CAMBRIDGE, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy – on Tuesday, May 12th at 12:00 p.m. EDT.

    Genocea will highlight GEN-011 as a potential best-in-class adoptive T cell therapy designed to improve upon the current limitations of TIL therapy. Genocea will also outline the robust, scalable manufacturing process - PLANET™ - to simplify and expand cancer patient access to treatment.

    The event will also feature Eric Tran…

    CAMBRIDGE, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy – on Tuesday, May 12th at 12:00 p.m. EDT.

    Genocea will highlight GEN-011 as a potential best-in-class adoptive T cell therapy designed to improve upon the current limitations of TIL therapy. Genocea will also outline the robust, scalable manufacturing process - PLANET™ - to simplify and expand cancer patient access to treatment.

    The event will also feature Eric Tran, Ph.D., Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute, who will review the evolution of TIL and TCR solid tumor treatment approaches as part of ongoing efforts to improve patient outcomes for hard-to-address cancers.

    KOL Symposium Webcast & Conference Call Information
    A live webcast of the KOL symposium can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Interested participants may also access the KOL symposium by dialing (323) 794-2597 (domestic) or (323) 701-0218 (international) and referring to conference ID number 6118728. To ask a question during the live Q&A, please submit your question to .

    For those who are unable to join during the event, a replay of the webcast will be available here.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  30. CAMBRIDGE, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy – on Tuesday, May 12th at 12:00 p.m. EDT.

    Genocea management will highlight the potential for GEN-011 to become a best-in-class adoptive T cell therapy. GEN-011 was designed to improve upon TIL therapy. Using the company's proprietary ATLASTM platform to select neoantigens and T cells derived from peripheral blood, Genocea believes GEN-011 may deliver greater efficacy…

    CAMBRIDGE, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy – on Tuesday, May 12th at 12:00 p.m. EDT.

    Genocea management will highlight the potential for GEN-011 to become a best-in-class adoptive T cell therapy. GEN-011 was designed to improve upon TIL therapy. Using the company's proprietary ATLASTM platform to select neoantigens and T cells derived from peripheral blood, Genocea believes GEN-011 may deliver greater efficacy through more active and longer-lasting T cells specific for the tumor than possible through other approaches.  Genocea has also established a robust, scalable manufacturing process to simplify and expand cancer patient access to therapy.

    The event will also feature Eric Tran, Ph.D., Assistant Member at the Earle A. Chiles Research Institute in the Providence Cancer Institute, who was previously involved in the seminal research at the National Cancer Institute (NCI) that initially demonstrated the promise of TIL therapy targeting cancer mutations. Dr. Tran's presentation will review the evolution of TIL and TCR solid tumor treatment approaches as part of ongoing efforts to improve patient outcomes for hard-to-address cancers.

    "Through GEN-011, Genocea is creating an entirely new category of T cell therapy," said Chip Clark, President and Chief Executive Officer, Genocea. "We are eager to advance GEN-011 with an IND filing in Q2 and initial clinical data in the first half of 2021."

    Webcast & Conference Call Information
    Interested participants may access the conference call by dialing (323) 794-2597 (domestic) or (323) 701-0218 (international) and referring to conference ID number 6118728. For those who are unable to listen in during the event, a replay of the call will be available here.

    A live webcast of the KOL event can also be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com.  To ask a question during the live Q&A, please submit your question to . A replay of the webcast will be archived for 30 days following the presentation.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  31. Clinical stage programs GEN-009 and GEN-011 continue to advance
    Anticipate GEN-011 IND filing in Q2
    Expect GEN-009 Phase 1/2a Part B readout in Q3
    GEN-011 Virtual Symposium planned for May 12th

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the first quarter ended March 31, 2020.

    Genocea remains on track with its two differentiated clinical stage programs - GEN-009 (neoantigen vaccine) and GEN-011 (neoantigen cell therapy). The GEN-009 phase 1/2a clinical trial has reached sufficient enrollment for Part B of the study, which…

    Clinical stage programs GEN-009 and GEN-011 continue to advance
    Anticipate GEN-011 IND filing in Q2
    Expect GEN-009 Phase 1/2a Part B readout in Q3
    GEN-011 Virtual Symposium planned for May 12th

    Conference call today at 8:30 a.m. EDT

    CAMBRIDGE, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today reported its operating and financial results for the first quarter ended March 31, 2020.

    Genocea remains on track with its two differentiated clinical stage programs - GEN-009 (neoantigen vaccine) and GEN-011 (neoantigen cell therapy). The GEN-009 phase 1/2a clinical trial has reached sufficient enrollment for Part B of the study, which evaluates GEN-009 in combination with standard-of-care ICI therapy. The company anticipates preliminary clinical results in Q3 2020. Genocea also intends to file an Investigational New Drug Application (IND) for GEN-011 later this quarter with preliminary clinical results expected in 1H 2021.

    Genocea will host a GEN-011 virtual symposium on May 12th at 12 p.m. EDT with Eric Tran, PhD, who generated transformational data showing the potential of TIL therapy as a National Cancer Institute (NCI) fellow. Dr. Tran will provide a brief overview of the current T cell therapy landscape - including the evolution of adoptive cell therapy and the need for new approaches to improve patient outcomes. Genocea will provide an in-depth profile of GEN-011 - a potential best-in-class adoptive T cell therapy -targeting an unprecedented breadth of relevant neoantigens, avoiding unwanted expansion of deleterious T cells and employing peripheral blood in a rapidly scalable manufacturing process to treat large cancer patient populations.

    "Over the last quarter, we have conducted our GEN-009 clinical program and prepared GEN-011 for IND filing as planned," said Chip Clark, President and Chief Executive Officer, Genocea. "We remain focused on the opportunity to create life-changing medicines for cancer patients during these uncertain and challenging times."

    First Quarter 2020 Financial Results

    • Cash position: As of March 31, 2020, cash and cash equivalents were $26.5 million versus $40.1 million as of December 31, 2019.
    • Research and Development (R&D) expenses: R&D expenses were $10.0 million for the quarter ended March 31, 2020, compared to $6.5 million for the same period in 2019.
    • General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended March 31, 2020, compared to $3.0 million for the same period in 2019.
    • Net loss: Net loss was $12.9 million for the quarter ended March 31, 2020, compared to $15.6 million for the same period in 2019.

    Guidance
    Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.

    Conference Call
    Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 4855738. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

    (Tables to follow)


    GENOCEA BIOSCIENCES, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
    (In thousands)

        March 31, 2020   December 31, 2019
             
    Cash and cash equivalents   $ 26,509     $ 40,127  
    Other assets   18,683     12,484  
    Total assets   $ 45,192     $ 52,611  
             
    Debt, current and long-term   $ 13,515     $ 13,407  
    Accounts payable, accrued expenses and other liabilities   16,959     11,676  
    Warrant liability   1,705     2,486  
    Total liabilities   32,179     27,569  
    Stockholders' equity   13,013     25,042  
    Total liabilities and stockholders' equity   $ 45,192     $ 52,611  


    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
    (In thousands, except per share data)

      Three Months Ended
    March 31,
      2020   2019
    Operating expenses:      
    Research and development $ 9,987     $ 6,460  
    General and administrative 3,388     3,017  
    Total operating expenses 13,375     9,477  
    Loss from operations (13,375 )   (9,477 )
    Other income (expense) 522     (6,090 )
    Net loss $ (12,853 )   $ (15,567 )
           
    Net loss per share - basic and diluted $ (0.46 )   $ (1.22 )
    Weighted-average number of common shares used in computing net loss per share 28,141     12,713  

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  32. CAMBRIDGE, Mass., April 23, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its first quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, April 30th at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 4855738. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay will be available on the Genocea website beginning approximately…

    CAMBRIDGE, Mass., April 23, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will host its first quarter 2020 financial results and corporate update conference call and live audio webcast on Thursday, April 30th at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 4855738. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    Additionally, Genocea will host a virtual KOL symposium with a live Q&A providing a brief review of the current T cell therapy landscape – including the evolution of TIL and TCR therapy utility, and the need for new approaches to better patient outcomes – on Tuesday, May 12th at 12 p.m. EDT. Members of the Genocea management team will also provide an overview of the development of GEN-011, a potential best-in-class solid tumor adoptive T cell therapy. More details will follow on accessing the virtual KOL symposium.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in Q2/Q3 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  33. CAMBRIDGE, Mass., April 08, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the 19th Annual Needham Virtual Healthcare Conference on Wednesday, April 15th at 9:20 a.m. EDT.

    A live webcast of the presentation can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Replays of the webcasts will be archived for 90 days following the conferences.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies…

    CAMBRIDGE, Mass., April 08, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Chip Clark, president and chief executive officer, will present a corporate overview at the 19th Annual Needham Virtual Healthcare Conference on Wednesday, April 15th at 9:20 a.m. EDT.

    A live webcast of the presentation can be accessed by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at http://ir.genocea.com. Replays of the webcasts will be archived for 90 days following the conferences.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in Q2/Q3 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  34. UNITED STATES
    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549
    SCHEDULE 14A
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    UNITED STATES
    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549
    SCHEDULE 14A
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    Definitive Additional Materials
    o
     
    Soliciting Material under §240.14a-12
     
     
     
    Genocea Biosciences, Inc.
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    1



    Genocea Biosciences, Inc.
    100 Acorn Park Drive,
    Cambridge, MA 02140

    NOTICE OF ANNUAL MEETING OF STOCKHOLDERS

    The 2020 Annual Meeting of Stockholders of Genocea Biosciences, Inc. (the "Company" or "Genocea") will be held on June 1, 2020, at 9:00 a.m. EST. We have adopted a virtual format for our Annual Meeting to provide a consistent experience to all stockholders regardless of location. We will provide a live webcast of the Annual Meeting at www.virtualshareholdermeeting.com/GNCA2020. The meeting will be held for the following purposes:

    1. To elect Mr. William Clark, Mr. Ronald Cooper and Dr. George Siber as Class III directors, each for a three-year term;

    2. To approve an amendment to the Company’s restated certificate of incorporation to provide for an increase in the total number of shares of common stock that the Company is authorized to issue from 85,000,000 shares to 170,000,000 shares;

    3. To approve an amendment to the Genocea Biosciences, Inc. Amended and Restated 2014 Equity Incentive Plan to increase the number of shares of the Company's common stock reserved for issuance thereunder by 2,800,000 shares, to increase the individual non-employee director share limit contained in the plan and to remove the other individual participant limits contained in the plan;

    4. To approve, on an advisory basis, the compensation paid to our named executive officers;

    5. To approve, on an advisory basis, the frequency of future advisory votes on the compensation paid to our named executive officers;

    6. To ratify the appointment of Ernst & Young LLP as the independent registered public accounting firm for the Company for the fiscal year ending December 31, 2020; and

    7. To consider and act upon any other matters that properly come before the Annual Meeting or any adjournment or postponement thereof.

    Each outstanding share of the Company's common stock (NASDAQ:GNCA) entitles the holder of record at the close of business on April 6, 2020, to receive notice of and to vote at the Annual Meeting or any adjournment or postponement of the Annual Meeting.

    Due to the ongoing public health impact of the coronavirus outbreak (COVID-19) and to support the health and well-being of our directors, employees and stockholders, our Annual Meeting will be a completely virtual meeting of stockholders, which will be conducted via live webcast. You will be able to attend the Annual Meeting online and submit your questions during the meeting by visiting www.virtualshareholdermeeting.com/GNCA2020. You will also be able to vote your shares electronically at the Annual Meeting. Details regarding how to attend the meeting online are more fully described in the Notice of Meeting and proxy statement.

    WHETHER OR NOT YOU EXPECT TO ATTEND THE ANNUAL MEETING, WE URGE YOU TO VOTE YOUR SHARES BY FOLLOWING THE INSTRUCTIONS TO THE IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS THAT YOU PREVIOUSLY RECEIVED AND SUBMIT YOUR PROXY BY INTERNET, TELEPHONE, OR BY SIGNING, DATING AND RETURNING THE PROXY CARD INCLUDED IN THESE MATERIALS. IF YOU CHOOSE TO ATTEND THE ANNUAL MEETING, YOU MAY STILL VOTE YOUR SHARES, EVEN THOUGH YOU HAVE PREVIOUSLY VOTED OR RETURNED YOUR PROXY BY ANY OF THE METHODS DESCRIBED IN OUR PROXY STATEMENT. IF YOUR SHARES ARE HELD IN A BANK OR BROKERAGE ACCOUNT, PLEASE REFER TO THE MATERIALS PROVIDED BY YOUR BANK OR BROKER FOR VOTING INSTRUCTIONS.

    ALL STOCKHOLDERS ARE EXTENDED AN INVITATION TO ATTEND THE ANNUAL MEETING.


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    By Order of the Board of Directors
     
     
    chipssignaturea04.jpg
     
     
    William Clark
     
     
    President and Chief Executive Officer
     
     
    [ ], 2020

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    Genocea Biosciences, Inc.
    100 Acorn Park Drive,
    Cambridge, MA 02140
     
    PROXY STATEMENT FOR ANNUAL MEETING OF STOCKHOLDERS
    To Be Held On June 1, 2020 at 9:00 am EST

    This proxy statement (the “Proxy Statement”), along with the accompanying Notice of 2020 Annual Meeting of Stockholders, contains information about the Annual Meeting, including any adjournments or postponements of the Annual Meeting. We are holding the Annual Meeting as a virtual meeting at 9:00 a.m. EST, at www.virtualshareholdermeeting.com/GNCA2020.

    On or about April 16, 2020, we made available this Proxy Statement and the attached Notice of 2020 Annual Meeting of Stockholders to all stockholders entitled to vote at the Annual Meeting, and we began sending the proxy card and the Important Notice Regarding the Availability of Proxy Materials to all stockholders entitled to vote at the Annual Meeting. Although not part of this Proxy Statement, we have also made available with this Proxy Statement our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Annual Report”), which includes our financial statements for the fiscal year ended December 31, 2019.

    IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE STOCKHOLDER MEETING TO BE HELD ON June 1, 2020

    This Proxy Statement and our Annual Report are available for viewing, printing and downloading at www.proxyvote.com. To view these materials, please have your 16-digit control number(s) available that appears on your proxy card.

    Additionally, you can find a copy of our Annual Report on the website of the Securities and Exchange Commission (“SEC”) at www.sec.gov, or in the “Financials & Filings - Annual Reports and Proxies” tab of the “Investors” section of our website at www.genocea.com. You may also obtain a printed copy of our Annual Report, free of charge, by sending a written request to: Genocea Biosciences, Inc., 100 Acorn Park Drive, Cambridge, Massachusetts 02140, Attention: Secretary. Exhibits, if any, will be provided upon written request and payment of an appropriate processing fee.

    GENERAL INFORMATION

    When are this Proxy Statement and the accompanying material scheduled to be sent to stockholders?

    On or about [ ], 2020, we began sending the Important Notice Regarding the Availability of Proxy Materials to all stockholders entitled to vote at the Annual Meeting.

    Who is soliciting my vote?

    The Board of Directors of the Company is soliciting your vote for the 2020 Annual Meeting of Stockholders.

    When is the record date for the Annual Meeting?

    The Company's Board of Directors has fixed the record date for the Annual Meeting as of the close of business on April 6, 2020.

    Meeting Information
    We will hold the Annual Meeting exclusively online via a live audio webcast at www.virtualshareholdermeeting.com/GNCA2020 at 9:00 a.m. EST on June 1, 2020, unless adjourned or postponed. There is no physical location for the Annual Meeting. Directions for accessing the virtual Annual Meeting can be found under the Investors section of our website at www.genocea.com.

    Why a virtual Annual Meeting?

    Due to the ongoing public health impact of the coronavirus outbreak (COVID-19) and to support the health and well-being of our directors, employees and stockholders, we are relying on the latest technology to host a virtual Annual Meeting. Stockholders will be able to attend the Annual Meeting online and submit questions by visiting www.virtualshareholdermeeting.com/GNCA2020. Stockholders will also be able to vote their shares electronically during the Annual Meeting.

    How do I attend the Annual Meeting?


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    Our Annual Meeting will begin promptly at 9:00 a.m. EST in a virtual meeting format at www.virtualshareholdermeeting.com/GNCA2020. To participate in the Annual Meeting, you will need the 16-digit control number included in your Notice or on the instructions that accompanied your proxy materials. The meeting webcast will begin promptly at 9:00 a.m. EST. We encourage you to access the meeting prior to the start time. Online check-in will start shortly before the meeting, and you should allow ample time for the check-in procedures. Instructions should also be provided on the voting instruction card provided by your bank or brokerage firm. If you lose your 16-digit control number, you may join the Annual Meeting as a “Guest,” but you will not be able to vote, ask questions or access the list of stockholders as of the Record Date.

    What if During the Check-In Time or During the Annual Meeting I have Technical Difficulties or Trouble Accessing the Virtual Meeting Website?

    We will have technicians ready to assist you with any technical difficulties you may have accessing the virtual meeting website. If you encounter any difficulties accessing the virtual meeting website during the check-in or meeting time, please call the technical support number that will be posted on the Annual Meeting log-in page.

    How many votes can be cast by all stockholders?

    A total of [ ] shares of common stock of the Company were outstanding on April 6, 2020 and are entitled to be voted at the Annual Meeting. Each share of common stock is entitled to one vote on each matter.

    How do I vote?

    If you are a stockholder of record and your shares are registered directly in your name, you may vote:

    By Internet. Access the website at www.proxyvote.com and follow the instructions provided on the Important Notice Regarding Availability of Proxy Materials on the proxy card. Your shares will be voted in accordance with your instructions. You must specify how you want your shares voted, or your Internet vote cannot be completed and you will receive an error message.

    By Telephone. Call 1-800-690-6903 toll-free and follow the instructions on the enclosed proxy card. Your shares will be voted in accordance with your instructions. You must specify how you want your shares voted, or your telephone vote cannot be completed.

    By Mail. Complete and mail the enclosed proxy card to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY, 11717 in the enclosed postage prepaid envelope. Your proxy will be voted in accordance with your instructions. If you sign and return the enclosed proxy but do not specify how you want your shares voted, they will be voted (i) FOR the election as directors of the nominees named herein to the Company's Board of Directors, (ii) FOR approval of the amendment to our restated certificate of incorporation to increase the number of shares of common stock authorized for issuance from 85,000,000 shares to 170,000,000 shares; (iii) FOR approval of the amendment to the Genocea Biosciences, Inc. Amended and Restated 2014 Equity Incentive Plan to increase the number of shares reserved for issuance thereunder by 2,800,000 shares, to increase the individual non-employee director share limit contained in the plan and to remove the other individual participant limits contained in this plan; (iv) FOR approval of the advisory vote on the compensation paid to our named executive officers; (v) FOR approval of the advisory vote on an annual frequency for future advisory votes on the compensation paid to our named executive officers; (vi) FOR the ratification of Ernst & Young LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2020, and (vii) will be voted according to the discretion of the proxy holder named in the proxy card upon any other business that may properly be brought before the Annual Meeting and at all adjournments and postponements thereof.

    At the Annual Meeting. The Annual Meeting will be held entirely online. To participate in the Annual Meeting, you will need the 16-digit control number included in your Notice or on the instructions that accompanied your proxy materials. The meeting webcast will being promptly at 9:00 a.m. EST. We encourage you to access the meeting prior to the start time. Online check-in will start shortly before the meeting, and you should allow ample time for the check-in procedures. Instructions should also be provided on the voting instruction form provided by your bank, broker or other nominee. If you lose your 16-digit control number, you may join the Annual Meeting as a “Guest,” but you will not be able to vote, ask questions or access the list of stockholders as of the Record Date.
     
    If your shares of common stock are held in street name (held for your account by a broker or other nominee):


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    By Internet or By Telephone. You will receive instructions from your broker or other nominee if you are permitted to vote by Internet or telephone.

    By Mail. You will receive instructions from your broker or other nominee explaining how to vote your shares.

    At the Annual Meeting. The Annual Meeting will be held entirely online. To participate in the Annual Meeting, you will need the 16-digit control number included in your Notice or on the instructions that accompanied your proxy materials. The meeting webcast will begin promptly at 9:00 a.m. EST. We encourage you to access the meeting prior to the start time. Online check-in will start shortly before the meeting, and you should allow ample time for the check-in procedures. Instructions should also be provided on the voting instruction form provided by your bank, broker or other nominee. If you lose your 16-digit control number, you may join the Annual Meeting as a “Guest,” but you will not be able to vote, ask questions or access the list of stockholders as of the Record Date.

    Management, members of our board and representatives of Ernst & Young LLP are expected to attend the Annual Meeting and be available to respond to questions from shareholders.

    What are the Board's recommendations on how to vote my shares?
     
    The Board of Directors recommends a vote:
     
    Proposal 1: FOR ALL election of the three Class III directors.

    Proposal 2: FOR approving the amendment to our restated certificate of incorporation to provide for an increase in the total number of shares of common stock that the Company is authorized to issue from 85,000,000 shares to 170,000,000 shares.

    Proposal 3: FOR approving the amendment to the Genocea Biosciences, Inc. Amended and Restated 2014 Equity Incentive Plan to increase the number of shares reserved for issuance thereunder by 2,800,000 shares, to increase the individual non-employee director share limit contained in the plan and to remove the other individual participant limits contained in this plan.

    Proposal 4: FOR approving, on an advisory basis, the compensation paid to our named executive officers.

    Proposal 5: FOR approving, on an advisory basis, an annual frequency for the advisory vote on the compensation paid to our named executive officers.

    Proposal 6: FOR ratification of the appointment of Ernst & Young LLP as the Company's independent registered public accounting firm for the fiscal year 2020.

    Who pays the cost for soliciting proxies?

    Genocea will bear the cost of solicitation of proxies. This includes the charges and expenses of brokerage firms and others for forwarding solicitation material to beneficial owners of our outstanding common stock as well as support for hosting of the virtual Annual Meeting. Genocea may solicit proxies by mail, personal interview, telephone, or via the Internet through its officers, directors and other management employees, who will receive no additional compensation for their services.

    Can I change my vote?

    You may revoke your proxy at any time before it is voted by notifying the Secretary in writing, by returning a signed proxy with a later date, by transmitting a subsequent vote over the Internet or by telephone prior to the close of the Internet voting facility or the telephone voting facility, or by attending the Annual Meeting online. If your stock is held in street name, you must contact your broker or nominee for instructions as to how to change your vote.

    How is a quorum reached?

    The presence, online or by proxy, of holders of at least a majority of the total number of outstanding shares entitled to vote is necessary to constitute a quorum for the transaction of business at the Annual Meeting. Abstentions and "broker non-votes" (i.e., shares represented at the Annual Meeting held by brokers, bankers or other nominees as to which instructions have not been received from the beneficial owners or persons entitled to vote such shares and, with respect to one or more but not all issues,

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    such brokers or nominees do not have discretionary voting power to vote such shares), if any, will be counted for purposes of determining whether a quorum is present for the transaction of business at the Annual Meeting.

    What vote is required to approve each item?

    Directors are elected by a plurality of votes cast (Proposal 1). A vote to withhold or a broker non-vote will have no direct effect on the outcome. The affirmative vote of a majority of the shares of common stock outstanding and entitled to vote is necessary for the approval of the amendment to our restated certificate of incorporation (Proposal 2). A majority of votes cast is necessary for the approval of the amendment to the Genocea Biosciences, Inc. Amended and Restated 2014 Equity Incentive Plan (Proposal 3). Because approval of the compensation paid to our named executive officers (Proposal 4) and the frequency of future advisory votes on the compensation paid to our named executive officers (Proposal 5) are advisory votes there is no “required” vote. We will consider a majority of votes cast to be approval for each of these proposals. A majority of votes cast is necessary for ratification of the selection of Ernst & Young LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2020 (Proposal 6). A vote to abstain will have no direct effect on the outcome.

    If there are insufficient votes to approve these proposals, your proxy may be voted by the persons named in the proxy card to adjourn the Annual Meeting in order to solicit additional proxies in favor of the approval of such proposals. If the Annual Meeting is adjourned or postponed for any purpose, at any subsequent reconvening of the Annual Meeting, your proxy will be voted in the same manner as it would have been voted at the original convening of the Annual Meeting unless you withdraw or revoke your proxy.

    Could other matters be decided at the Annual Meeting?

    Genocea does not know of any other matters that may be presented for action at the Annual Meeting. Should any other business come before the Annual Meeting, the persons named on the enclosed proxy will have discretionary authority to vote the shares represented by such proxies in accordance with their best judgment. If you hold shares through a broker, bank or other nominee as described above, they will not be able to vote your shares on any other business that comes before the Annual Meeting unless they receive instructions from you with respect to such matter.

    What happens if the Annual Meeting is postponed or adjourned?

    Your proxy may be voted at the postponed or adjourned Annual Meeting. You will still be able to change your proxy until it is voted.

    What does it mean if I receive more than one proxy card or voting instruction form?

    It means that you have multiple accounts at the transfer agent or with brokers. Please complete and return all proxy cards or voting instruction forms to ensure that all of your shares are voted.

    Who should I call if I have any additional questions?

    If you hold your shares directly, please call Diantha Duvall, Secretary, at 617-876-8191. If your shares are held in street name, please contact the telephone number provided on your voting instruction form or contact your broker or nominee holder directly.


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    PROPOSAL NO. 1—ELECTION OF DIRECTORS

    In accordance with the Company's restated certificate of incorporation and amended and restated by-laws, the Board of Directors is divided into three classes of approximately equal size. The members of each class are elected to serve a three-year term with the term of office of each class ending in successive years. William Clark, Ronald Cooper and George Siber are the Class III directors whose terms expire at the Annual Meeting. Mr. Clark, Mr. Cooper and Dr. Siber have all been nominated for and have agreed to stand for re-election to the Board of Directors to serve as a Class III director of the Company until the 2023 annual meeting of stockholders and until his successor is duly elected.

    It is intended that, unless you give contrary instructions, shares represented by proxies will be voted for the election of the three nominees listed above as director nominees. Genocea has no reason to believe that any nominee will be unable to serve. In the event that one or more nominees is unexpectedly not available to serve, proxies may be voted for another person nominated as a substitute by the Board of Directors, or the Board of Directors may reduce the number of directors to be elected at the Annual Meeting. Information relating to each nominee for election as director and for each continuing director, including his or her period of service as a director of Genocea, principal occupation and other biographical material, is shown below.

    THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE
    FOR
    ALL OF THESE NOMINEES FOR CLASS III DIRECTOR
    (PROPOSAL 1 ON YOUR PROXY CARD)

    DIRECTOR BIOGRAPHIES

    Below sets forth information concerning our directors as of March 1, 2020. The biographical description of each director includes the specific experience, qualifications, attributes and skills that the Board of Directors would expect to consider if it were making a conclusion currently as to whether such person should serve as a director.

    CLASS III DIRECTOR NOMINEES

    William "Chip" Clark, age 51, is a Class III director who has served on our Board of Directors and as our President and Chief Executive Officer since February 2011. Previously, he served as our Chief Business Officer from August 2010 to February 2011. Mr. Clark has served on our Board of Directors since February 2011. Prior to joining our Company, he served as Chief Business Officer at Vanda Pharmaceuticals, Inc. ("Vanda"), a biopharmaceutical company that he co-founded in 2004. While at Vanda, he led the company’s strategic and business development activities, and played a central role in multiple public and private financings. Prior to Vanda, Mr. Clark was a principal at Care Capital, LLC, a venture capital firm investing in biopharmaceutical companies, after serving in a variety of strategic and commercial roles at SmithKline Beecham (now GlaxoSmithKline). Mr. Clark holds a B.A. from Harvard University and an M.B.A. from The Wharton School at the University of Pennsylvania. We believe that Mr. Clark’s operational and historical experience with our Company gained from serving as our Chief Executive Officer, President and member of our Board of Directors, combined with his prior experience at Vanda and in the venture capital industry focusing on biopharmaceutical companies, qualifies him to serve as a member of our Board of Directors.

    Ronald Cooper, age 57, is a Class III director who has served as a member of our Board of Directors since June 2016. Mr. Cooper is President and CEO of Albireo Pharma ("Albireo"), a position that he was appointed to in June 2015. Mr. Cooper is a life sciences leader with a track record of growing and rejuvenating businesses, brands and organizations in the U.S. and Europe, ranging from entrepreneurial and resource-constrained, up to sales exceeding $4.5 billion. Prior to Albireo, Mr. Cooper was with Bristol-Myers Squibb ("BMS") for over 25 years working in five different countries and holding positions of increasing responsibility in sales, marketing and general management, culminating in President of Europe. In Europe, Mr. Cooper was responsible for over 30 countries with sales exceeding $4.5 billion. While at BMS, Mr. Cooper was directly associated with several product successes, including Abilify®, Avapro®, Atripla®, Eliquis®, Orencia®, Pravachol®, Plavix®, Reyataz®, Sustiva®, Sprycel® and Yervoy®. Mr. Cooper has successfully completed over a dozen business development deals including the creation of the first single tablet HIV/AIDS regimen partnership. Mr. Cooper is a graduate of St. Francis Xavier University in Canada. We believe that Mr. Cooper’s experience in the pharmaceutical industry, along with his background as an executive officer of a public company, qualifies him to serve as a member of our Board of Directors.

    George Siber, M.D., age 75, is a Class III director who has served as a member of our Board of Directors since 2007. From 1996 to 2007, Dr. Siber served as Executive Vice President and Chief Scientific Officer of Wyeth Vaccines ("Wyeth"). While at Wyeth, Dr. Siber oversaw the development and approval of multiple widely-used childhood vaccines, including: Prevnar, a pneumococcal vaccine which has achieved multibillion dollar revenues; Acel-Imune, an acellular pertussis vaccine; and Meningitec, a meningococcal meningitis vaccine. Prior to Wyeth, Dr. Siber was Director of the Massachusetts Public Health Biologic Laboratories

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    and a Harvard Medical School Associate Professor of Medicine at Dana Farber Cancer Institute. During this time, Dr. Siber led the research and manufacturing of multiple vaccines and immune globulins including Respigam, a human immune globulin against respiratory syncytial virus. Since 2007, Dr. Siber has served on the boards of directors of several vaccine companies, including Crucell, Selecta Biosciences, Vedantra Pharmaceuticals and Affinivax Inc., and as a consultant or scientific advisory board member of ClearPath Vaccines Company, of which he is currently the Chief Scientific Officer, PaxVax, Vaxess Technologies, Inc., the Bill & Melinda Gates Foundation, PATH, the Wellcome Trust, the European Commission (on vaccinations), the National Institutes of Health, or NIH, and the Korean FDA. Dr. Siber serves as a member of the Board of Trustees of the International Vaccine Institute. Dr. Siber holds an M.D. degree from McGill University in Canada, received post-doctoral training in Internal Medicine at Rush-Presbyterian Hospital in Chicago and Beth Israel Hospital in Boston and Infectious Disease and vaccinology training at Children’s Hospital and Beth Israel Hospital, Harvard Medical School Boston. We believe that Dr. Siber’s experience in life sciences, vaccine industries and his experience overseeing the development of multiple vaccines qualifies him to serve as a member of our Board of Directors.

    DIRECTORS NOT STANDING FOR ELECTION AT THE ANNUAL MEETING

    Kenneth Bate, age 69, is a Class I director who has served as a member of our Board of Directors since September 2014 and our chair since December 2018. Mr. Bate has served as an independent consultant in the biotechnology field since 2012. From 2009 to 2012, Mr. Bate served as President and Chief Executive Officer of Archemix, Inc., a privately-held biotechnology company. From 2006 to 2009, Mr. Bate served in various positions at NitroMed, Inc., a pharmaceutical company, most recently as President and Chief Executive Officer. From 2002 to 2005, Mr. Bate served as Chief Financial Officer of Millennium Pharmaceuticals Inc., where he headed the commercial organization. Prior to joining Millennium Pharmaceuticals Inc., Mr. Bate co-founded JSB Partners, LLC, a banking and advisory services firm for biopharmaceutical and life sciences companies. From 1990 to 1996, he was with Biogen Inc., a biotechnology company, first as their Chief Financial Officer, and then as head of the commercial organization responsible for launching the multiple sclerosis business. Mr. Bate is currently a director of AVEO Pharmaceuticals, Catabasis Pharmaceuticals, Epizyme Inc., and Madrigal Pharmaceuticals. He holds a B.A. from Williams College and an M.B.A. from The Wharton School of the University of Pennsylvania. We believe that Mr. Bate’s experience as a chief executive officer of multiple biotechnology companies, as well as his experience as a director of other companies, qualifies him to serve as a member of our Board of Directors.

    Ali Behbahani, M.D., age 43, is a Class I director who has served as a member of our Board of Directors since February 2018. Since 2007, Dr. Behbahani has served in various positions on the healthcare team at New England Associates, most recently as General Partner. The healthcare team specializes in investments in the biopharmaceutical and medical device sectors. He is also currently a member of the board of directors of CRISPR Therapeutics, Adaptimmune and Nevro Corp. He has previously worked as a consultant in business development at The Medicines Company and held positions as a Venture Associate at Morgan Stanley Venture Partners from 2000 to 2002 and as a Healthcare Investment Banking Analyst at Lehman Brothers from 1998 to 2000. Dr. Behbahani conducted basic science research in the fields of viral fusion inhibition and structural proteomics at the National Institutes of Health and at Duke University. He holds an M.D. degree from The University of Pennsylvania School of Medicine and an M.B.A. from The University of Pennsylvania Wharton School. We believe Dr. Behbahani’s experience in the biopharmaceutical industry, as well as his experience as a member on the boards of directors of multiple companies in the industry, qualifies him to serve as a member of our Board of Directors.

    Katrine Bosley, age 51, is a Class II director who has served as a member of our Board of Directors since March 2013 and as our chair from August 2013 until December 2018. Ms. Bosley served as the Chief Executive Officer of Editas Medicine Inc. ("Editas") from June 2014 through February 2019. Prior to Editas, Ms. Bosley was the Entrepreneur-in-Residence at The Broad Institute from September 2013 to May 2014. She served as Chief Executive Officer of Avila Therapeutics Inc. ("Avila"), from May 2009 to March 2012, when Avila was acquired by Celgene Corporation. Before Avila, she was Vice President, Strategic Operations at Adnexus Therapeutics Inc. ("Adnexus"), a BMS Company, and was Vice President, Business Development at Adnexus before that. She joined Adnexus from Biogen Idec where she held roles in business development, commercial operations, and portfolio strategy in the United States and Europe. In addition to serving as a director of our Company, Ms. Bosley currently serves as a director of Galapagos NV and Massachusetts Eye and Ear. She also is a member of the BIO Governing Board and Chair of the Emerging Companies Section of the Board. Ms. Bosley graduated from Cornell University with a B.A. in Biology. We believe that Ms. Bosley’s experience as a chief executive officer of a biotechnology company and her breadth of experience in creating strategic and business development value qualifies her to serve as a member of our Board of Directors.

    Michael Higgins, age 57, is a Class II director who has served as a member of our Board of Directors since February 2015. In January 2015, Mr. Higgins joined Polaris Partners as an Entrepreneur-in-Residence.  Prior to joining Polaris Partners, Mr. Higgins served as Chief Operating Officer and Chief Financial Officer at Ironwood Pharmaceuticals ("Ironwood") from 2003 through 2014, playing a key role in Ironwood’s evolution from a privately-funded discovery organization through its initial public offering and the launch of its first commercial product.  Under his leadership, Ironwood was able to raise more than one billion

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    dollars to help support the development of the business during that period.  Prior to his work at Ironwood, from 1997 through 2003, Mr. Higgins worked at Genzyme Corporation ("Genzyme") in a variety of leadership roles including Vice President, Corporate Finance and Vice President, Business Development.  While at Genzyme, he was involved with multiple businesses including the Cell Therapy, Gene Therapy, and Orphan Disease business units.  Previously, Mr. Higgins served as Chief Financial Officer of Procept, Inc., from 1992 to 1997, and led the company through its initial public offering. Mr. Higgins currently serves as a director of Pulmatrix, Inc. and Voyager Therapeutics. Mr. Higgins began his pharmaceutical career as a sales representative for Schering-Plough Corporation in 1986.  Mr. Higgins earned his B.S. from Cornell University and holds an M.B.A. from the Amos Tuck School of Business at Dartmouth College. We believe that Mr. Higgins' financial and business expertise, including his diversified background as an executive officer in public pharmaceutical companies, qualifies him to serve as a member of our Board of Directors.

    Howard Mayer, M.D., age 57, is a Class I director who has served as a member of our Board of Directors since March 2017. Dr. Mayer is Executive Vice President, Head of R&D at Ipsen since December 2019. Previous to that, Dr. Mayer was Senior Vice President and Chief Medical Officer at Shire Plc ("Shire"). Dr. Mayer joined Shire in 2012 and was responsible for global clinical development across hematology, immunology, oncology, genetic diseases, GI/metabolic, neuroscience and ophthalmology therapeutic areas. From 2009 to 2012 he served as Chief Medical Officer at EMD Serono, a division of Merck KGaA. Prior to that, he held a variety of global roles at Pfizer Inc. ("Pfizer"), including Head of Clinical Development and Medical Affairs for Virology/Infectious Diseases. Prior to joining Pfizer, he served as Director of Infectious Diseases Clinical Research at BMS for five years. Dr. Mayer obtained his B.A. from the University of Pennsylvania and his M.D. from Albert Einstein College of Medicine in New York, which was followed by an internship and residency at Mount Sinai Hospital and an Infectious Diseases fellowship at Harvard Medical School. Since 2011 he has served on the board of Autism Speaks in New England. In 2011 and 2017, he was honored by PharmaVoice as one of the 100 Most Inspiring People in the Life Sciences Industry. We believe that Dr. Mayer's scientific expertise, which includes clinical development experiences in both infectious disease and oncology, qualifies him to serve as a member of our Board of Directors.

    Gisela Schwab, M.D., age 63, is a Class II director who was appointed to serve as a member of our Board of Directors in February 2020. Dr. Schwab has served as President, Product Development and Medical Affairs and Chief Medical Officer of Exelixis, Inc. (“Exelixis”) since February 2016. Previously, she served as Executive Vice President and Chief Medical Officer of Exelixis from January 2008 to February 2016 and as Senior Vice President and Chief Medical Officer of Exelixis from September 2006 to January 2008. From 2002 to 2006, she held the position of Senior Vice President and Chief Medical Officer at Abgenix, Inc. (“Abgenix”), a human antibody-based drug development company. She also served as Vice President, Clinical Development, at Abgenix from 1999 to 2001. Prior to working at Abgenix, from 1992 to 1999, she held positions of increasing responsibility at Amgen Inc., most recently as Director of Clinical Research and Hematology/Oncology Therapeutic Area Team Leader. From August 2011 through July 2014, Dr. Schwab served as a member of 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 of Cellerant Therapeutics, Inc. a privately-held biopharmaceutical company and since March 2015, she has served as a member of the board of directors of Nordic Nanovector A.S., a Norwegian biotechnology company. She received her Doctor of Medicine degree from the University of Heidelberg, trained at the University of Erlangen-Nuremberg and the National Cancer Institute and is board certified in internal medicine and hematology and oncology. We believe that Dr. Schwab’s scientific expertise, which includes advancing product candidates through development and regulatory approval to commercial launch, qualifies her to serve as a member of our Board of Directors.

    BOARD OF DIRECTORS AND ITS COMMITTEES

    The following table describes which directors serve on each of the committees of the Board of Directors as of March 1, 2020.

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     committeecomposition.jpg

    8



    THE BOARD OF DIRECTORS AND ITS COMMITTEES

    Director Independence

    As required by the listing standards of The Nasdaq Capital Market ("Nasdaq"), the Board of Directors has affirmatively determined, upon the recommendation of the Nominating and Corporate Governance Committee, that each of our directors (other than William Clark, our President and Chief Executive Officer) is independent. To make this determination, our Board of Directors reviews all relevant transactions or relationships between each director and Genocea, its senior management and its independent registered public accounting firm. During this review, the Board of Directors considers whether there are any transactions or relationships between directors or any member of their immediate family (or any entity of which a director or an immediate family member is an executive officer, general partner or significant equity holder) and members of our senior management or their affiliates. The Board of Directors consults with Genocea's outside corporate counsel to ensure that the Board of Directors' determinations are consistent with all relevant securities and other laws and regulations regarding the definition of "independent," including those set forth in pertinent Nasdaq listing standards, as in effect from time to time.

    Board Meetings and Attendance

    The Board of Directors held nine meetings during the year ended December 31, 2019. Each of the directors attended at least 75% of the meetings of the Board of Directors and the committees of the Board of Directors on which he or she served during the year ended December 31, 2019 (in each case, which were held during the period for which he or she was a director and/or a member of the applicable committee). Each director who is up for election at an annual meeting of stockholders or who has a term that continues after such annual meeting is expected to attend the Annual Meeting. All but one of our then existing directors on the Board of Directors attended our 2019 annual meeting.

    Board Committees

    The Board of Directors has standing Audit, Compensation and Nominating and Corporate Governance Committees, each of which is comprised solely of independent directors, and is described more fully below. The charters for the Audit, Compensation and Nominating and Corporate Governance Committees are all available on our website (http://ir.genocea.com/) under "Investors" at "Governance".

    Audit Committee

    Our Audit Committee is composed of Mr. Bate, Mr. Cooper, and Mr. Higgins, with Mr. Higgins serving as chair of the committee. Our Board of Directors has determined, upon the recommendation of the Nominating and Corporate Governance Committee, that each member of the Audit Committee meets the independence requirements of Rule 10A-3 under the Exchange Act of 1934, as amended (the “Exchange Act”) and the applicable listing standards of Nasdaq. Our Board of Directors has determined that each of Mr. Bate, Mr. Cooper, and Mr. Higgins is an “audit committee financial expert” within the meaning of the SEC regulations and applicable listing standards of Nasdaq. Our Audit Committee operates pursuant to a written charter and it reviews and assesses the adequacy of its charter annually.

    The Audit Committee’s responsibilities include:

    appointing, approving the compensation of, and assessing the qualifications, performance and independence of our independent registered public accounting firm by considering (i) evaluations of our independent registered public accounting firm by our management and internal auditors, (ii) our independent registered public accounting firm’s effectiveness of communications and working with the Audit Committee and our management and internal auditors, (iii) the length of time our independent registered public accounting firm has served as our independent auditors, (iv) the quality and depth of our independent registered public accounting firm’s expertise and experience in the biotech and life sciences industries in light of the breadth, complexity and global reach of our business and (v) the advisability and potential impact of selecting a different independent registered public accounting firm;
    pre-approving audit and permissible non-audit services, and the terms of such services, to be provided by our independent registered public accounting firm;
    reviewing the internal audit plan with the independent registered public accounting firm and members of management responsible for preparing our financial statements;

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    reviewing and discussing with management and the independent registered public accounting firm our annual and quarterly financial statements and related disclosures as well as critical accounting policies and practices used by us;
    reviewing the adequacy of our internal control over financial reporting;
    establishing policies and procedures for the receipt and retention of accounting-related complaints and concerns;
    recommending, based upon the Audit Committee’s review and discussions with management and the Company's independent registered public accounting firm, whether our audited financial statements shall be included in our Annual Report;
    monitoring our compliance with legal and regulatory requirements as they relate to our financial statements and accounting matters;
    preparing the Audit Committee report required by the rules of the SEC to be included in our annual proxy statement;
    viewing all related party transactions for potential conflict of interest situations and approving all such transactions; and
    reviewing and discussing with management and our independent registered public accounting firm our earnings releases and scripts.
    All audit and non-audit services to be provided to us by our independent registered public accounting firm must be approved in advance by the Audit Committee. During the year ended December 31, 2019, the Audit Committee met four times. The report of the Audit Committee is included in this Proxy Statement under "Audit Committee Report".

    Compensation Committee

    Our Compensation Committee is composed of Mr. Bate, Dr. Behbahani, and Dr. Mayer, with Mr. Bate serving as chair of the committee. The Board of Directors has determined, upon the recommendation of the Nominating and Corporate Governance Committee, that each member of the Compensation Committee is "independent" within the meaning of the rules and regulations of Nasdaq and the SEC. In addition, each member is a "non-employee director" within the meaning of the SEC rules. Our Compensation Committee operates pursuant to a written charter and it reviews and assesses the adequacy of its charter periodically.

    The Compensation Committee’s responsibilities include:

    annually reviewing and recommending to the Board of Directors for approval the corporate goals and objectives relevant to the compensation of our Chief Executive Officer;
    evaluating the performance of our Chief Executive Officer in light of such corporate goals and objectives and recommending to the Board of Directors for approval the compensation of our Chief Executive Officer;
    reviewing and approving the compensation of our other executive officers;
    appointing, compensating and overseeing the work of any compensation consultant, legal counsel or other advisor retained by the Compensation Committee;
    conducting the independence assessment outlined in Nasdaq rules with respect to any compensation consultant, legal counsel or other advisor retained by the Compensation Committee;
    annually reviewing and reassessing the adequacy of the committee charter in accordance with the listing requirements of Nasdaq;
    reviewing and establishing our overall management compensation philosophy and policy;
    overseeing and administering our equity compensation and other incentive compensation programs;
    reviewing and approving our equity and incentive policies and procedures for the grant of equity-based awards and approving the grant of such equity-based awards;
    reviewing and making recommendations to the Board of Directors with respect to director compensation; and

    10



    if applicable, producing the compensation committee report to be included in our annual proxy statement and/or Annual Report.
    During the year ended December 31, 2019, the Compensation Committee met three times.

    Nominating and Corporate Governance Committee

    Our Nominating and Corporate Governance Committee is composed of Ms. Bosley, Mr. Cooper, and Dr. Siber, with Ms. Bosley serving as chair of the committee. Our Board of Directors has determined that each member of the Nominating and Corporate Governance Committee is "independent" within the meaning of the rules and regulations of Nasdaq. Our Nominating and Corporate Governance Committee operates pursuant to a written charter and it reviews and assesses the adequacy of its charter periodically.

    The Nominating and Corporate Governance Committee’s responsibilities include:

    developing and recommending to the Board of Directors criteria for board and committee membership;
    establishing procedures for identifying and evaluating Board of Director candidates, including nominees recommended by stockholders;
    identifying individuals qualified to become members of the Board of Directors;
    recommending to the Board of Directors the persons to be nominated for election as directors and to each of the Board of Directors’ committees;
    developing and recommending to the Board of Directors a set of corporate governance principles;
    articulating to each director what is expected, including reference to the corporate governance principles and directors’ duties and responsibilities;
    reviewing and recommending to the Board of Directors practices and policies with respect to directors;
    reviewing and recommending to the Board of Directors the functions, duties and compositions of the committees of the Board of Directors;
    reviewing and assessing the adequacy of the committee charter and submitting any changes to the Board of Directors for approval;
    considering and reporting to the Board of Directors any questions of possible conflicts of interest of Board of Directors members;
    providing for new director orientation and continuing education for existing directors on a periodic basis;
    performing an evaluation of the performance of the committee; and
    overseeing the evaluation of the Board of Directors and management.
    The Nominating and Corporate Governance Committee does not set specific, minimum qualifications that nominees must meet in order to be recommended to the Board of Directors, but rather believes that each nominee should be evaluated based on his or her individual merits, taking into account the needs of Genocea and the composition of the Board of Directors. Additionally, neither the Nominating and Corporate Governance Committee nor the Board of Directors has a specific policy with regard to the consideration of diversity in identifying director nominees; however, both may consider the diversity of background and experience of a director nominee in the context of the overall composition of the Board of Directors at that time, such as diversity of knowledge, skills, experience, geographic location, age, gender, and ethnicity. Members of the Nominating and Corporate Governance Committee discuss and evaluate possible candidates in detail and suggest individuals to explore in more depth.

    The Nominating and Corporate Governance Committee will consider candidates recommended by stockholders. Candidates recommended by stockholders are given appropriate consideration in the same manner as other candidates.

    During the year ended December 31, 2019, the Nominating and Corporate Governance Committee met five times.

    Board of Directors Leadership Structure


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    Mr. Bate has served as the chair of our Board of Directors since December 2018. The independent members of the Board of Directors have periodically reviewed the Board of Directors' leadership structure and have determined that Genocea and our stockholders are well served with this structure.

    The chair of the Board of Directors provides leadership to the Board of Directors and works with the Board of Directors to define its activities and the calendar for fulfillment of its responsibilities. The chair of the Board of Directors approves the meeting agendas after input from the Board of Directors and management, facilitates communication among directors and presides at meetings of our Board of Directors and stockholders.

    The Board of Directors' Role in Risk Oversight

    The Board of Directors plays an important role in risk oversight through direct decision-making authority with respect to significant matters as well as through the oversight of management by the Board of Directors and its committees. In particular, the Board of Directors administers its risk oversight function through (1) the review and discussion of regular periodic reports by the Board of Directors and its committees on topics relating to the risks that we face, (2) the required approval by the Board of Directors (or a committee of the Board of Directors) of significant transactions and other decisions, (3) the direct oversight of specific areas of our business by the Audit, Compensation and Nominating and Corporate Governance Committees, and (4) regular periodic reports from our independent registered public accounting firm and other outside consultants regarding various areas of potential risk, including, among others, those relating to our internal control over financial reporting and executive compensation. The Board of Directors also relies on management to bring significant matters impacting our Company to the attention of the Board of Directors.

    Pursuant to the Audit Committee's charter, the Audit Committee is responsible for reviewing and discussing with management and the independent registered public accounting firm our system of internal controls, our critical accounting practices, and policies relating to risk assessment and management. As part of this process, the Audit Committee discusses our major financial risk exposures and steps that management has taken to monitor and control such exposure. In addition, the Audit Committee has established procedures for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls or auditing matters, and the confidential, anonymous submissions by employees of concerns regarding questionable accounting or accounting matters.

    Because of the role of the Board of Directors and the Audit Committee in risk oversight, the Board of Directors believes that any leadership structure that it adopts must allow it to effectively oversee the management of the risks relating to our operations. The Board of Directors acknowledges that there are different leadership structures that could allow it to effectively oversee the management of the risks relating to the Company's operations and believes its current leadership structure enables it to effectively provide oversight with respect to such risks.

    Compensation Consultant

    As a part of determining compensation for our named executive officers, the Compensation Committee engaged Pay Governance LLC (“Pay Governance”) as its independent compensation consultant for 2019. As its independent compensation consultant, Pay Governance provided analysis and recommendations to the Compensation Committee regarding:

    trends with respect to executive and director compensation;
    the development of a peer group used for compensation-related purposes;
    forms and levels of compensation for executive officers and directors;
    stock utilization and related metrics;
    employment and separation agreements with our executive officers; and
    the risk profile of our compensation programs.

    When requested, consultants from Pay Governance attended meetings of the Compensation Committee, including executive sessions in which executive compensation matters were discussed. During 2019, Pay Governance reported to the Compensation Committee and not to management, although Pay Governance met with management for purposes of gathering information for its analyses and recommendations.

    Although the Board of Directors and the Compensation Committee considers the advice and recommendations of Pay Governance (or any other compensation consultant it might engage in the future) as related to our executive compensation program, the Board of Directors and the Compensation Committee ultimately make their own decisions about the compensation arrangements for our executive officers.


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    In determining whether to engage Pay Governance, the Compensation Committee considered the independence of Pay Governance, taking into consideration relevant factors, including the absence of other services provided to the Company by Pay Governance, the amount of fees the Company paid to Pay Governance as a percentage of Pay Governance's total revenues, the policies and procedures of Pay Governance that are designed to prevent conflicts of interest, any business or personal relationship of the individual compensation advisors employed by Pay Governance with any executive officer of the Company, any business or personal relationship of the individual compensation advisors employed by Pay Governance with any member of the Compensation Committee, and any stock of the Company owned by Pay Governance or the individual compensation advisors employed by Pay Governance (the “Independence Factors”). The Compensation Committee has determined, based on its analysis in light of all relevant factors, including the Independence Factors listed above, that the work of Pay Governance and the individual compensation advisors employed by Pay Governance as compensation consultants to the Compensation Committee did not create any conflicts of interest, and that Pay Governance was independent under the independence standards set forth in the Nasdaq listing standards promulgated pursuant to Section 10C of the Exchange Act.

    Non-Employee Director Compensation Policy

    Our Board of Directors adopted a non-employee director compensation policy that is designed to enable us to attract and retain, on a long-term basis, highly-qualified non-employee directors. Under the policy, as it may be amended from time to time, all non-employee directors will be paid cash compensation as set forth in the table below. Cash fees are prorated for partial years of service. In addition, we reimburse our non-employee directors for reasonable travel expenses in connection with their service.

     
    Annual Cash Fees
    Board of Directors:
     
    All non-employee members
    $
    35,000

    Additional retainer for chair
    $
    40,000

    Audit Committee:
     
    Members
    $
    7,500

    Additional retainer for chair
    $
    7,500

    Compensation Committee:
     
    Members
    $
    5,000

    Additional retainer for chair
    $
    5,000

    Nominating and Corporate Governance Committee:
     
    Members
    $
    3,500

    Additional retainer for chair
    $
    3,500


    Under our non-employee director compensation policy, each non-employee director who is initially appointed or elected to our Board of Directors is eligible to be granted options to purchase 9,375 shares of our common stock under the Genocea Biosciences Inc. Amended and Restated 2014 Equity Incentive Plan ("2014 Equity Plan") at the time of his or her initial appointment or election to our Board of Directors. These options vest annually in equal installments over a three-year period, generally subject to the non-employee director's continued service. In addition, each continuing non-employee director is eligible to be granted options to purchase 5,625 shares of our common stock under our 2014 Equity Plan on an annual basis, which vest in full on the first anniversary of the grant date, generally subject to the non-employee director's continued service through such date. These annual option grants are made on the date of the Company’s annual meeting of stockholders for the relevant year or as soon thereafter as is reasonably practicable.

    We did not make any changes to our non-employee director compensation policy for 2019, except the number of shares of our common stock subject to option grants was proportionately adjusted to reflect our eight-to-one reverse stock split in May 2019.

    Director Agreements

    Dr. Siber

    The Company was previously party to a consulting agreement with Dr. Siber that provided for a monthly consulting fee of $9,833 per month for consulting services performed by Dr. Siber related to strategic scientific and business development.


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    The term of the consulting agreement expired on July 17, 2019. Under the consulting agreement, Dr. Siber agreed not to solicit our employees, contractors and customers for a period of 12 months following the termination of the consulting agreement and is subject to covenants relating to the use and disclosure of confidential information and the assignment of inventions.

    Director Compensation

    The following table sets forth information concerning the compensation earned by our non-employee directors during 2019. All of our non-employee directors were compensated for service on our Board of Directors under our non-employee director compensation policy. Dr. Siber received additional compensation under his consulting agreement, as described above, prior to its expiration. Mr. Clark receives no additional compensation for his service as a director, and, consequently, is not included in this table. The compensation received by Mr. Clark as our President and Chief Executive Officer for 2019 is set forth in the “Summary Compensation Table” under the section “Executive Compensation”.

    Name
     
    Fees earned or
    paid in cash
    ($)(1)
     
    Option
    awards
    ($)(2)(3)
     
    Total
    ($)
    Kenneth Bate
     
    92,500

     
    20,588

     
    113,088

    Ali Behbahani, M.D. (4)
     
    42,637

     
    20,588

     
    63,225

    Katrine Bosley
     
    42,000

     
    20,588

     
    62,588

    Ronald Cooper
     
    46,000

     
    20,588

     
    66,588

    Michael Higgins
     
    50,000

     
    20,588

     
    70,588

    Howard Mayer, M.D.
     
    40,000

     
    20,588

     
    60,588

    George Siber, M.D. (4)
     
    109,179

     
    20,588

     
    129,767

    _________________________
    (1)
    Amounts represent annual director fees and, in the case of Dr. Siber, include consulting fees, for services rendered, as described above. Consulting fees paid to Dr. Siber were paid in equal monthly installments through July 2019, totaling $68,333. All other director fees were paid quarterly in arrears.
    (2)
    As of December 31, 2019, our directors held the following aggregate number of options to purchase shares of our common stock: Mr. Bate held options to purchase 16,892 shares of our common stock, Dr. Behbahani held options to purchase 15,000 shares of our common stock, Ms. Bosley held options to purchase 20,252 shares of our common stock, Mr. Cooper held options to purchase 16,250 shares of our common stock, Mr. Higgins held options to purchase 16,261 shares of our common stock, Dr. Mayer held options to purchase 14,375 shares of our common stock, and Dr. Siber held options to purchase 25,676 shares of our common stock.
    (3)
    Amounts in the table represent the aggregate grant date fair value of options to purchase shares of our common stock granted during 2019. All of our non-employee directors were granted options to purchase 5,625 shares of our common stock in 2019, which options will vest in full on the one-year anniversary of their respective date of grant, generally subject to the non-employee director's continued service. These grant date fair value amounts were computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation (“ASC 718”), excluding the effect of estimated forfeitures. Assumptions used in the calculation of these amounts are included in Note 10 to our financial statements included in our Annual Report.
    (4)
    In addition to annual director fees paid with respect to 2019 services, amounts include payments related to director services rendered in 2018 for which payment was not made until 2019.

    AUDIT COMMITTEE REPORT

    The Audit Committee reviewed the Genocea audited financial statements for the year ended December 31, 2019 and discussed these statements with management and Ernst & Young LLP, the Company's independent registered public accounting firm. Genocea management is responsible for the preparation of the Company's financial statements and for maintaining an adequate system of disclosure controls and procedures and internal control over financial reporting for that purpose. Ernst & Young LLP is responsible for expressing an opinion on the conformity of the audited financial statements with generally accepted accounting principles, discussing their judgments as to the quality, not just the acceptability, of the Company's accounting principles and such other matters as are required to be discussed with the Audit Committee under generally accepted auditing standards. The Audit Committee is responsible for providing independent, objective oversight of the Company's accounting functions and internal controls.


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    The Audit Committee also received from, and discussed with, Ernst & Young LLP all communications required under the standards of the Public Company Accounting Oversight Board (the "PCAOB"), including the matters required to be discussed by Ernst & Young LLP with the Audit Committee, including the matters to be discussed by the PCAOB and the SEC.

    Ernst & Young LLP also provided the Audit Committee with the written disclosures and the letter required under the PCAOB, which requires that independent registered public accounting firms annually disclose in writing all relationships that in their professional opinion may reasonably be thought to bear on independence, to confirm their perceived independence and engage in a discussion of independence. The Audit Committee reviewed this disclosure and discussed with Ernst & Young LLP their independence from Genocea.

    Based on its discussions with management and our independent registered public accounting firm, and its review of the representations and information provided by management and our independent registered public accounting firm, the Audit Committee recommended to the Board of Directors that the audited financial statements be included in the Genocea Annual Report on Form 10-K for the year ended December 31, 2019, for filing with the SEC.

    Respectfully submitted by the


    Audit Committee,

    Michael Higgins, Chair
    Kenneth Bate
    Ronald Cooper

    15



    PROPOSAL NO. 2—TO APPROVE AN AMENDMENT TO OUR RESTATED CERTIFICATE OF INCORPORATION TO PROVIDE FOR AN INCREASE IN THE TOTAL NUMBER OF SHARES OF COMMON STOCK THAT THE COMPANY IS AUTHORIZED TO ISSUE FROM 85,000,000 SHARES TO 170,000,000 SHARES

    General

    Stockholders are being asked to approve an amendment to our restated certificate of incorporation, in the form attached hereto as Appendix A (the “Charter Amendment”). The Charter Amendment increases the number of authorized shares of common stock from eighty-five million (85,000,000) shares to one hundred and seventy million (170,000,000) shares. On April 2, 2020, the Board of Directors approved the Charter Amendment, subject to stockholder approval, and directed that the Charter Amendment be submitted to a vote of the Company’s stockholders at this Annual Meeting. The Board of Directors has determined that the Charter Amendment is in the best interests of the Company and its stockholders and recommends approval by the stockholders.

    The current restated certificate of incorporation, as amended (the “Current Charter”) authorizes the issuance of up to 85,000,000 shares of common stock, par value of $0.001 per share. As of the close of business on March 31, 2020, 27,643,773 shares of common stock were outstanding. In addition, as of the close of business on March 31, 2020, the Company had 1,289,995 shares of common stock subject to outstanding awards granted under our 2014 Equity Plan, 1,251,700 shares of common stock reserved for issuance under our 2014 Equity Plan (determined without giving effect to the increase in shares contemplated by Proposal No. 3 below and without giving effect to the plan's evergreen provision), 100,032 shares of common stock subject to outstanding stock options granted under the Company’s Amended and Restated 2007 Equity Incentive Plan ("2007 Equity Plan"), 217,966 shares of common stock reserved for issuance under the Company’s 2014 Employee Stock Purchase Plan ("2014 ESPP"), 25,000 shares of common stock subject to outstanding stock options granted as inducement awards, 5,122,183 shares reserved for issuance upon the exercise of outstanding warrants (with a weighted average exercise price of $7.66 as of March 31, 2020), and 204,375 shares reserved for issuance upon conversion of Series A preferred stock. This means that as of March 31, 2020, the Company had just 1,251,635 shares of common stock available for corporate purposes, including, among other things, the issuance of stock options and stock splits by way of dividend. The Current Charter also authorizes the issuance of 25,000,000 shares of preferred stock, with only 1,635 shares of preferred stock issued and outstanding as of March 31, 2020. The Charter Amendment will not increase or otherwise affect the Company’s authorized preferred stock or otherwise affect any other provisions of the Current Charter.

    Purpose of the Charter Amendment

    The Board of Directors believes it is in the best interest of the Company to increase the number of authorized shares of common stock in order to give the Company greater flexibility in considering and planning for future potential business needs.

    With the exception of the Company’s routine practice of granting stock options to employees and directors, the Company has no current specific plan, commitment, arrangement, understanding, or agreement regarding the issuance of the additional shares of common stock resulting from the proposed increase in authorized shares. The additional shares of common stock will be available for issuance by the Board of Directors for various corporate purposes, including but not limited to, grants under employee stock plans, financings, potential strategic transactions, including mergers, acquisitions, strategic partnerships, joint ventures, divestitures, business combinations, stock splits, stock dividends, as well as other general corporate transactions.

    Having this additional authorized common stock available for future use will allow the Company to issue additional shares of common stock without the expense and delay of arranging a special meeting of stockholders.

    Possible Effects of the Charter Amendment and Additional Anti-takeover Consideration

    If the Charter Amendment is approved, the additional authorized shares would be available for issuance at the discretion of the Board of Directors and without further stockholder approval, except as may be required by law or the rules of Nasdaq. The additional shares of authorized common stock would have the same rights and privileges as the shares of common stock currently issued and outstanding. The adoption of the Charter Amendment would not have any immediate dilutive effect on the proportionate voting power or other rights of existing stockholders. Shares of common stock issued otherwise than for a stock split may decrease existing stockholders’ percentage equity ownership and, depending on the price at which they are issued, could be dilutive to the voting rights of existing stockholders and have a negative effect on the market price of the common stock. The common stock carries no preemptive rights to purchase additional shares of common stock.

    The Company cannot provide assurances that any such transactions will be consummated on favorable terms or at all, that they will enhance stockholder value or that they will not adversely affect the Company’s business or the trading price of our stock.


    16



    The Company has not proposed the increase in the number of authorized shares of common stock with the intention of using the additional authorized shares for anti-takeover purposes, but the Company would be able to use the additional shares to oppose a hostile takeover attempt or delay or prevent changes in control or management of the Company. For example, without further stockholder approval, the Board of Directors could sell shares of common stock in a private transaction to purchasers who would oppose a takeover or favor the current Board of Directors. Although this proposal to increase the authorized number of shares of common stock has been prompted by business and financial considerations and not by the threat of any known or threatened hostile takeover attempt, stockholders should be aware that approval of this proposal could facilitate future efforts by the Company to oppose changes in control of the Company and perpetuate the Company’s management, including transactions in which the stockholders might otherwise receive a premium for their shares over then current market prices.

    If the Company’s stockholders approve the Charter Amendment, the Board of directors will have authority to file with the Secretary of State of Delaware the Charter Amendment. The Charter Amendment will become effective on the date it is filed. The Board of Directors reserves the right to abandon or delay the filing of the Charter Amendment even if it is approved by our stockholders. The Charter Amendment is attached to this proxy statement as Appendix A.

    Neither Delaware law, the Current Charter, nor the Company’s amended and restated by-laws provides for appraisal or other similar rights for dissenting stockholders in connection with this proposal. Accordingly, the Company’s stockholders will have no right to dissent and obtain payment for their shares.

    The affirmative vote of a majority of the outstanding shares of common stock is required to approve the Amended Charter. Accordingly, abstentions and broker non-votes will have the effect of a negative vote.


    THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE
    FOR
    THE APPROVAL OF THE AMENDMENT TO OUR RESTATED CERTIFICATE OF INCORPORATION TO PROVIDE FOR AN INCREASE IN THE TOTAL NUMBER OF SHARES OF COMMON STOCK THAT THE COMPANY IS AUTHORIZED TO ISSUE FROM 85,000,000 SHARES TO 170,000,000 SHARES

    (PROPOSAL 2 ON YOUR PROXY CARD)


    17




    PROPOSAL NO. 3—TO APPROVE AN AMENDMENT TO THE GENOCEA BIOSCIENCES, INC. AMENDED AND RESTATED 2014 EQUITY INCENTIVE PLAN TO INCREASE THE NUMBER OF SHARES RESERVED FOR ISSUANCE BY 2,800,000 SHARES, TO INCREASE THE INDIVIDUAL NON-EMPLOYEE DIRECTOR SHARE LIMIT AND TO REMOVE THE INDIVIDUAL OTHER PARTICIPANT LIMITS CONTAINED IN THIS PLAN

    Our 2014 Equity Plan was originally approved by our Board of Directors and our stockholders prior to the effectiveness of our IPO in 2014 and was subsequently amended and restated in 2018. Our Board of Directors is asking our stockholders to approve an amendment to our 2014 Equity Plan to (i) increase by 2,800,000 shares the number of shares of our common stock reserved for issuance thereunder, (ii) increase the maximum number of shares of our common stock subject to awards that may be granted to our non-employee directors in any calendar year (subject to an aggregate dollar cap that has not been amended) and (iii) eliminate the limits on the maximum number of shares of our common stock subject to awards that may be granted to our employees in any calendar year. Other than these proposed changes, the amendment does not make any other changes to our 2014 Equity Plan.

    Our Board of Directors approved the amendment to our 2014 Equity Plan, subject to stockholder approval, to replenish the shares available to us for the grant of equity awards. We have historically granted equity awards to our employees, including our executive officers, almost exclusively in the form of stock options. Nearly all of our outstanding stock options are significantly underwater, with a weighted average exercise price of $11.28 per share. The closing price of our common stock on the Nasdaq was $1.72 per share on March 31, 2020. As a result, our Board of Directors believes that our currently outstanding equity awards are not an effective tool to retain and motivate our employees, including our executive officers, and, with the significant decrease in our stock price since the share pool was determined, the shares remaining available for issuance are not sufficient to permit us to deliver the value necessary to do so. Our Board of Directors believes that the effective use of long-term equity compensation is vital to our ability to achieve strong performance in the future and that our continued success depends, in large part, on our ability to attract, retain and motivate key employees with relevant experience and critical skills in the highly-competitive market for employee talent in which we operate. Further, the use of long-term equity compensation allows us to preserve our cash resources, which is especially important in light of the challenging global economic conditions and uncertainty that we and other companies are currently facing.

    For the reasons stated above, our Board of Directors has determined that it is in the best interests of the Company and its stockholders to approve this proposal. Our Board of Directors has approved the amendment to our 2014 Equity Plan, subject to stockholder approval, and recommends that stockholders vote in favor of this proposal at the Annual Meeting. Stockholder approval of this proposal requires the affirmative vote of a majority of the outstanding shares of common stock that are present in person or by proxy and entitled to vote on the proposal at the Annual Meeting.

    If stockholders approve this proposal, the amendment to our 2014 Equity Plan will become effective as of the date of stockholder approval. If stockholders do not approve this proposal, the amendment to our 2014 Equity Plan will not become effective and our 2014 Equity Plan will continue to be administered in its current form. In addition, if stockholders do not approve this proposal, certain awards that were granted contingent upon obtaining stockholder approval of this proposal, as described in more detail under "New Plan Benefits" below, will be automatically forfeited.

    Reasons for Voting for the Proposal

    Long-Term Equity is a Key Component of our Compensation Programs

    Delivering competitive equity compensation to our management team and our other key employees is essential to attracting and retaining the quality of talent required for us to achieve our operating and strategic objectives. We compete for this talent with a significant number of biotechnology, pharmaceutical and other life sciences companies in Massachusetts that offer generous equity compensation programs. Attracting and retaining key talent is very much in the interest of our stockholders.
    Equity awards incentivize our employees to manage our business as owners, aligning their interests with those of our stockholders. Equity awards, the value of which depends on our stock performance and which generally require continued service over time before any value can be realized, help achieve these objectives and are a key element of our compensation programs.
    Equity awards allow us to provide market competitive compensation while preserving our cash resources. We believe that, for investors, a combination of equity and cash compensation optimizes the Company’s valuation and properly incentivizes executives and key employees by linking their pay to Company performance.

    Additional Shares are Required for Future Grants and Retention of Key Employees


    18



    If we do not obtain approval to increase the available pool, it will negatively impact our ability to attract and retain quality talent, reward performance and provide market competitive compensation.

    Consider Unique Factors to Genocea

    The weighted average exercise price of our outstanding options as of December 31, 2019 was $11.65, which is significantly higher than the $1.72 closing price of the Company’s common stock on the Nasdaq on March 31, 2020. Because our outstanding options are significantly underwater, additional equity awards are necessary to properly incentivize and deliver competitive equity compensation to our management team and other key employees.

    We are Committed to the Effective Utilization of Shares

    Our Compensation Committee has engaged Pay Governance, an independent compensation consulting firm, to assist it in evaluating matters associated with competitive equity compensation practices, underwater stock options, the reduced value of prior awards and in structuring a compensation program designed to optimize our share utilization.
    We have maintained an annual burn rate within competitive biotechnology company market ranges in the last three fiscal years of 2.5%, 6.1% and 5.3% in 2019, 2018, and 2017, respectively, and plans to continue granting market competitive equity awards in future years.
    Our overhang (outstanding awards and shares available for future grant, excluding the proposed share increase of 2,800,000 shares), as of March 31, 2020, was 9.6% of stock outstanding.

    We Require Additional Shares to Meet our Forecasted Needs

    We granted equity awards in the form of options and restricted stock units with respect to 1,527,586 shares in April 2020, including equity awards with respect to 538,365 shares that are subject to stockholder approval of this proposal. A portion of these equity awards were granted in the form of restricted stock units, which we believe will be a more effective tool to retain and motivate our employees than awards consisting solely of stock options. We anticipate granting additional awards in the form of options and restricted stock units in 2020 in order to conserve our cash resources and to retain and motivate our employees. As a result, our Board of Directors, based on the recommendation of our Compensation Committee, concluded that it was necessary to increase the number of shares available for issuance under our 2014 Equity Plan.

    The Individual Participant Limits in our 2014 Equity Plan are no longer necessary and the Non-Employee Director Limits do not appropriately reflect our Capitalization or the Value of our Shares

    Because, as a result of a change in law, the inclusion of individual participant limits under our 2014 Equity Plan no longer are required for certain tax purposes, our Board of Directors concluded that these individual participant limits were no longer necessary and eliminated such limits from the plan. The annual limitation on shares that may be granted to our non-employee directors under our 2014 Equity Plan, however, will remain in effect. Our Board of Directors has concluded that such limitation should be increased , subject to the same aggregate dollar cap that currently applies, due to the decrease in the market value of our common stock from when our 2014 Equity Plan was last approved. Following this increase, no non-employee director may be granted awards with respect to more than 50,000 shares of our common stock (or, if less, awards having a grant date fair value of $1 million) in respect of his or her service as a director. This limit does not apply to any award granted pursuant to a director’s election to receive shares of our common stock in lieu of cash fees.

    Additional information regarding our equity compensation plans

    As of March 31, 2020, 1,251,700 shares remain available for issuance under our 2014 Equity Plan (not taking into account the April 2020 equity awards described above). The table below includes aggregate information regarding awards outstanding under our 2014 Equity Plan, the number of shares available for future awards under our 2014 Equity Plan, and the proposed number of shares that would be available for issuance under our 2014 Equity Plan if this proposal is approved by our stockholders. The table below does not include the future effect, in 2021 and beyond, of the evergreen provision of our 2014 Equity Plan, which would remain in effect in accordance with the current terms of our 2014 Equity Plan if stockholders approve this proposal.

    19



     
     
    Number of shares (1)
     
    As a percentage of stock outstanding (as of March 31, 2020)
    Outstanding stock options under our 2007 Equity Plan and our 2014 Equity Plan(2)
     
    1,344,746

     
    4.9
    %
    Total shares subject to outstanding awards under our 2007 Equity Plan and our 2014 Equity Plan(2)
     
    1,390,016

     
    5.0
    %
    Total shares available for future awards under our 2014 Equity Plan(3)
     
    1,251,700

     
    4.5
    %
    Proposed additional shares to be available for future awards under our 2014 Equity Plan(4)
     
    2,800,000

     
    10.1
    %
    Total shares outstanding under existing equity awards under our 2007 Equity Plan and our 2014 Equity Plan and proposed to be available for issuance under our 2014 Equity Plan (3)
     
    5,441,716

     
    19.7
    %
     
     
     
     
     
    Total shares subject to outstanding options under our 2014 ESPP (5)
     
    35,296

     
    0.1
    %
    Total shares available for future options under our 2014 ESPP
     
    182,670

     
    0.7
    %
    Total shares outstanding under existing options and available for issuance under our 2014 ESPP (5)
     
    217,966

     
    0.8
    %
    Total shares subject to outstanding options granted under inducement awards (6)
     
    25,000

     
    0.1
    %
    Total
     
    5,684,682

     
    20.6
    %

    (1)     The number of shares of our common stock listed in this column (and in the narrative disclosure in this proposal) have been proportionately adjusted to reflect our eight-to-one reverse stock split in May 2019. Outstanding equity awards and total shares available under the respective plans listed in the table are, in each case, as of March 31, 2020.
    (2)    Does not include the 1,527,586 shares of our common stock that are subject to equity awards granted in April 2020 in the form of options and restricted stock units, including equity awards with respect to 538,365 shares of our common stock that are subject to stockholder approval of this proposal.
    (3)     Does not include the future effect, in 2021 and beyond, of the evergreen provision of our 2014 Equity Plan.
    (4)     Share counting provisions, including adjustments to the number of shares available under our 2014 Equity Incentive Plan, are described below under “Authorized Shares” and “Certain Transactions; Certain Adjustments”.
    (5)    Outstanding options under our 2014 ESPP are estimated based on the rate of payroll deductions and the closing price of our common stock on March 31, 2020.
    (6)    Represents options to purchase shares of common stock granted as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4).

    A summary of the material features of our 2014 Equity Plan, as proposed to be amended, is below. The following summary is qualified in its entirety by reference to our Amended and Restated 2014 Equity Plan, a copy of which is set forth as Appendix B.

    Material Features of the 2014 Equity Plan

    Administration

    Our 2014 Equity Plan is administered by our Compensation Committee. Our Compensation Committee has the authority to, among other things, interpret our 2014 Equity Plan, determine eligibility for and grant awards, determine, modify or waive the terms and conditions of any awards, determine the form of settlement of awards (whether in cash, shares of our common stock or other property), prescribe forms, rules and procedures relating to the plan, and otherwise do all things necessary or appropriate to carry out the purposes of our 2014 Equity Plan. Our Compensation Committee's determinations under our 2014 Equity Plan are conclusive and binding. Our Compensation Committee may delegate its authority under our 2014 Equity Plan to the extent permitted by applicable law. References in this summary to our Compensation Committee refer to our Compensation Committee and its applicable delegates.

    Eligibility


    20



    Our key employees, directors, consultants and advisors are eligible to participate in our 2014 Equity Plan. As of March 31, 2020, we estimate that approximately 70 employees, 8 non-employee directors, 10 consultants and 4 advisors would be eligible to participate in our 2014 Equity Plan.

    Authorized Shares

    Subject to adjustment, as described below, the maximum number of shares of our common stock that may be delivered in satisfaction of awards under our 2014 Equity Plan as of March 31, 2020 is 2,541,695 shares, of which 1,251,700 shares remained available for grant as of March 31, 2020. If this proposal is approved by our stockholders, an additional 2,800,000 shares will become available under our 2014 Equity Plan. The number of shares of our common stock available for issuance under our 2014 Equity Plan will be automatically increased annually on each January 1st, through January 1, 2024, in an amount equal to the lesser of 4% of outstanding shares of our common stock as of the close of business on the immediately preceding December 31st or the number of shares determined by our Board of Directors. Subject to adjustment, as described below, no more than 1,125,000 shares of our common stock may be delivered in satisfaction of incentive stock options, or ISOs, awarded under our 2014 Equity Plan.

    The shares of our common stock to be issued under our 2014 Equity Plan may be authorized but unissued shares of our common stock or previously issued shares of our common stock acquired by us. Any shares of our common stock underlying awards that are settled in cash, expire or become unexercisable without having been exercised or that are forfeited or repurchased by us will again be available for issuance under our 2014 Equity Plan. In addition, the number of shares of our common stock delivered in satisfaction of awards will be determined net of shares of our common stock withheld by us in payment of the exercise price of an award or in satisfaction of tax withholding requirements with respect to an award.

    The closing price of our common stock as reported on Nasdaq on March 31, 2020 was $1.72 per share.

    Non-Employee Director Limits

    A participant who is a non-employee director on our Board of Directors may not receive awards in any calendar year with respect to the lesser of (A) 50,000 shares of our common stock, or (B) shares of our common stock having an aggregate grant date fair value in excess of $1 million (such limit does not apply to any award granted pursuant to a director’s election to receive shares of our common stock in lieu of cash fees).

    Types of Awards

    Our 2014 Equity Plan provides for awards of stock options, SARs, restricted stock, unrestricted stock, stock units, performance awards and other awards convertible into or otherwise based on shares of our common stock. Eligibility for stock options intended to be ISOs is limited to our employees. Dividend equivalents may also be provided in connection with an award under our 2014 Equity Plan.

    Stock options and SARs. The exercise price of a stock option, and the base value against which a SAR is to be measured, may not be less than the fair market value (or, in the case of an ISO granted to a ten percent stockholder, 110% of the fair market value) of shares of our common stock on the date of grant. Our Compensation Committee will determine the time or times at which stock options or SARs become exercisable and the terms on which such awards remain exercisable.

    Restricted and unrestricted stock. A restricted stock award is an award of shares of our common stock subject to forfeiture restrictions, while an unrestricted stock award is not subject to such restrictions.

    Stock units. A stock unit award is an award denominated in shares of our common stock that entitles the participant to receive shares of our common stock or cash measured by the value of the shares of our common stock in the future. The delivery of shares of our common stock or cash under a stock unit may be subject to the satisfaction of performance conditions or other vesting conditions.

    Performance awards. A performance award is an award the vesting, settlement or exercisability of which is subject to the satisfaction of specified performance criteria.

    Other awards. Other awards are awards that are convertible into or otherwise based on shares of our common stock.

    Vesting; Termination of Employment or Service


    21



    Our Compensation Committee has the authority to determine the vesting schedule applicable to each award, and to accelerate the vesting or exercisability of any award. Our Compensation Committee will determine the effect of termination of employment or service on an award. Unless otherwise provided by our Compensation Committee, upon a termination of a participant's employment or service, all unvested stock options and SARs then held by the participant will terminate and all other unvested awards will be forfeited and all vested stock options and SARs then held by the participant will remain outstanding for three months following such termination, or one year in the case of death, or, in each case, until the applicable expiration date, if earlier. All stock options and SARs held by a participant immediately prior to the participant's termination of employment or service will immediately terminate if such termination is for cause, as defined in our 2014 Equity Plan, or occurs in circumstances that would have constituted grounds for the participant's employment or service to be terminated for cause.

    Non-Transferability of Awards

    Awards under our 2014 Equity Plan may not be transferred other than by the laws of descent and distribution, unless, for awards other than ISOs, otherwise provided by our Compensation Committee.

    Recovery of Compensation

    Our Compensation Committee may cancel, rescind, withhold or otherwise limit or restrict any award at any time under our 2014 Equity Plan if the participant is not in compliance with the provisions of our 2014 Equity Plan or any award thereunder or if the participant breaches any agreement with our company with respect to non-competition, non-solicitation or confidentiality. Our Compensation Committee also may recover any award or payments or gain in respect of any award under our 2014 Equity Plan in accordance with any applicable company recoupment policy or as otherwise required by applicable law or applicable stock exchange listing standards.

    Certain Transactions; Certain Adjustments

    In the event of a consolidation, merger or similar transaction or series of related transactions, including a sale or other disposition of shares of our common stock, in which our company is not the surviving corporation or that results in the acquisition of all or substantially all of our then outstanding shares of common stock by a single person or entity or by a group of persons and/or entities acting in concert, a sale of all or substantially all of our assets or our dissolution or liquidation (any of the foregoing, a “covered transaction”), our Compensation Committee may, among other things, provide for the continuation or assumption of outstanding awards, for new grants in substitution of outstanding awards, for the accelerated vesting or delivery of shares under awards or for a cash-out of outstanding awards, in each case, on such terms and with such restrictions as it deems appropriate. Except as our Compensation Committee may otherwise determine, awards not assumed in connection with such a transaction will terminate automatically and, in the case of outstanding restricted stock, will be forfeited automatically, upon the consummation of a covered transaction.

    In the event of a stock dividend, stock split or combination of shares, including a reverse stock split, recapitalization or other change in our capital structure that constitutes an equity restructuring within the meaning of FASB ASC 718, our Compensation Committee will make appropriate adjustments to the maximum number of shares of our common stock that may be delivered under, and the ISO and individual share limits included in, our 2014 Equity Plan, and will also make appropriate adjustments to the number and kind of shares or securities subject to awards, the exercise prices of such awards or any other terms of awards affected by such change. Our Compensation Committee may also make the types of adjustments described above to take into account distributions and other events other than those listed above if it determines that such adjustments are appropriate to avoid distortion in the operation of our 2014 Equity Plan.

    Amendment; Termination

    Our Compensation Committee may amend our 2014 Equity Plan or outstanding awards, or terminate our 2014 Equity Plan as to future grants of awards, except that our Compensation Committee will not be able to alter the terms of an award if it would affect materially and adversely a participant's rights under the award without the participant's consent (unless expressly provided in our 2014 Equity Plan or the right to alter the terms of an award was expressly reserved by our Compensation Committee at the time the award was granted). Stockholder approval will be required for any amendment to our 2014 Equity Plan to the extent such approval is required by law, including applicable stock exchange requirements.

    Certain Federal Income Tax Consequences


    22



    This following is a summary of certain U.S. federal income tax consequences associated with awards granted under our 2014 Equity Plan. The summary does not purport to cover federal employment tax or other U.S. federal tax consequences that may be associated with our 2014 Equity Plan, nor does it cover state, local or non-U.S. taxes.

    Stock Options (other than ISOs)

    In general, a participant has no taxable income upon the grant of a stock option that is not intended to be an ISO (an “NSO”) but realizes income in connection with the exercise of the NSO in an amount equal to the excess (at the time of exercise) of the fair market value of the shares acquired upon exercise over the exercise price. A corresponding deduction is generally available to the Company, subject to the limitations of the Code. Upon a subsequent sale or exchange of the shares, any recognized gain or loss is treated as a capital gain or loss for which the Company is not entitled to a deduction.

    ISOs

    In general, a participant realizes no taxable income upon the grant or exercise of an ISO. However, the exercise of an ISO may result in an alternative minimum tax liability to the participant. With some exceptions, a disposition of shares acquired upon exercise of an ISO within two years from the date of grant or within one year after exercise produces ordinary income to the participant (and generally a deduction to the Company) equal to the value of the shares at the time of exercise less the exercise price. Any additional gain recognized in the disposition is treated as a capital gain for which the Company is not entitled to a deduction. If the participant does not dispose of the shares until after the expiration of these one and two-year holding periods, any gain or loss recognized upon a subsequent sale of shares acquired upon exercise of an ISO is treated as a long-term capital gain or loss for which the Company is not entitled to a deduction.

    SARs

    The grant of a SAR does not itself result in taxable income, nor does taxable income result merely because a SAR becomes exercisable. In general, a participant who exercises a SAR for shares of stock or receives payment in cancellation of a SAR will have ordinary income equal to the amount of any cash and the fair market value of any stock received. A corresponding deduction is generally available to the Company, subject to the limitations of the Code.

    Restricted Stock Awards

    A participant who is awarded or purchases shares subject to a substantial risk of forfeiture generally does not have income until the risk of forfeiture lapses. When the risk of forfeiture lapses, the participant has ordinary income equal to the excess of the fair market value of the shares at that time over the purchase price, if any, and a corresponding deduction is generally available to the Company. However, a participant may make an election under Section 83(b) of the Code to be taxed on restricted stock when it is acquired rather than later, when the substantial risk of forfeiture lapses. A participant who makes an effective 83(b) election will realize ordinary income equal to the fair market value of the shares as of the time of acquisition less any price paid for the shares. A corresponding deduction will generally be available to the Company, subject to the limitations of the Code. If a participant makes an effective 83(b) election, no additional income results by reason of the lapsing of the restrictions.

    For purposes of determining capital gain or loss on a sale of shares awarded under our 2014 Equity Plan, the holding period in the shares begins when the participant recognizes taxable income with respect to the transfer. The participant’s tax basis in the shares equals the amount paid for the shares plus any income realized with respect to the transfer. However, if a participant makes an effective 83(b) election and later forfeits the shares, the tax loss realized as a result of the forfeiture is limited to the excess of what the participant paid for the shares (if anything) over the amount (if any) realized in connection with the forfeiture.

    Unrestricted Stock Awards

    A participant who purchases or is awarded unrestricted stock generally has ordinary income equal to the excess of the fair market value of the shares at that time over the purchase price, if any, and a corresponding deduction is generally available to the Company, subject to the limitations of the Code.

    Restricted Stock Units

    The grant of a restricted stock unit does not itself generally result in taxable income. Instead, the participant is taxed upon vesting and settlement (and a corresponding deduction is generally available to the Company, subject to the limitations of the Code), unless he or she has made a proper election to defer receipt of the shares (or cash if the award is cash settled) under Section 409A

    23



    of the Code. If the shares delivered are restricted for tax purposes, the participant will instead be subject to the rules described above for restricted stock.

    New Plan Benefits

    Because future awards under our 2014 Equity Plan will be granted in the discretion of our Board of Directors or our Compensation Committee, the type, number, recipients, and other terms of such awards cannot be determined at this time. The following table sets forth the awards that were granted to our named executive officers, our current executive officers as a group, our current non-employee directors as a group, and our other employees (who are not executive officers) as a group in April 2020 that are subject to stockholder approval of this proposal.

    Name and Position
     
    Number of Options
     
    Number of Restricted Stock Units
    William Clark, President and Chief Executive Officer
     
    106,688

     
    27,344

    Girish Aakalu, Ph.D., Chief Business Officer

     
    24,938

     
    6,623

    Thomas Davis, M.D., Chief Medical Officer
     
    24,938

     
    6,623

    Executive Group
     
    244,502

     
    63,943

    Non-Executive Director Group
     

     

    Non-Executive Officer Employee Group
     
    127,969

     
    101,951


    Equity Compensation Plan Information

    The following table provides information as of December 31, 2019 about our common stock that may be issued upon the exercise of options, warrants, and rights under our existing equity compensation plans. The number of shares of our common stock and the exercise prices listed in the table below have been proportionally adjusted to account for our eight-to-one reverse stock split in May 2019.
    Plan Category
     
    Number of Securities to
    be Issued Upon Exercise
    of Outstanding Options and Rights
     
    Weighted-Average
    Exercise Price of
    Outstanding Options and Rights
     
    Number of Securities
    Remaining Available for
    Future Issuance Under
    Equity Compensation
    Plans
     
     
     
     
     
     
     
    Equity compensation plans approved by security holders (1)
     
    1,298,105

     
    $
    11.69

     
    245,430

    Equity compensation plans not approved by security holders (2)
     
    25,000

     
    $
    9.68

     

    Total
     
    1,323,105

     
    $
    11.65

     
    245,430


    (1)
    Represents options to purchase shares of our common stock that were granted under the Genocea Biosciences, Inc. Amended and Restated 2007 Equity Incentive Plan and our 2014 Equity Plan and were outstanding on December 31, 2019.
    (2)
    Represents options to purchase shares of our common stock granted as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4) that were outstanding on December 31, 2019.

    THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE
    FOR
    THE APPROVAL OF THE AMENDMENT TO THE AMENDED AND RESTATED GENOCEA BIOSCIENCES, INC. 2014 EQUITY INCENTIVE PLAN
    (PROPOSAL 3 ON YOUR PROXY CARD)


    24



    PROPOSAL NO. 4TO APPROVE, ON AN ADVISORY BASIS, OF THE COMPENSATION PAID TO OUR NAMED EXECUTIVE OFFICERS

    We are seeking your advisory vote, as required by Section 14A of the Exchange Act, to approve the compensation paid to our named executive officers for 2019, as described in the “Executive Compensation” section of this proxy statement. Because your vote is advisory, it will not be binding on our Compensation Committee or our Board of Directors. However, our Compensation Committee and our Board of Directors will review the voting results and take them into consideration when making future decisions regarding executive compensation.

    The Board of Directors unanimously recommends that stockholders vote in favor of the following resolution:

    “RESOLVED, that the compensation paid to the named executive officers of Genocea Biosciences, Inc., as disclosed pursuant to the compensation disclosure rules of the Securities and Exchange Commission, including the Summary Compensation Table and the related narrative disclosure included the “Executive Compensation” section of this proxy statement, is hereby APPROVED.”

    Vote Required

    Although the vote we are asking you to cast is non-binding, our Compensation Committee and our Board of Directors value the views of our stockholders and will consider the outcome of the vote when determining future compensation arrangements for our named executive officers. The resolution will be approved, on an advisory basis, if the votes cast FOR exceed the votes cast AGAINST the proposal. Abstentions and broker non-votes will have no effect on the voting of this proposal. We expect to hold an advisory vote to approve the compensation of our named executive officers annually until the next vote on the advisory frequency of such advisory votes, which will occur no later than our 2026 annual meeting of stockholders.

    THE BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT YOU VOTE
    FOR
    THE APPROVAL, ON AN ADVISORY BASIS, OF THE COMPENSATION PAID TO OUR NAMED EXECUTIVE OFFICERS


    (PROPOSAL 4 ON YOUR PROXY CARD)


    25



    EXECUTIVE COMPENSATION

    This section describes the compensation awarded or paid to, or earned by, our named executive officers for 2019. Our named executive officers for 2019 are:

    William Clark, our President and Chief Executive Officer;
    Girish Aakalu, Ph.D., our Chief Business Officer; and
    Thomas Davis, M.D., our Chief Medical Officer.
    Compensation Philosophy and Objectives

    Our executive compensation program is designed to: 
     
    attract, motivate and retain qualified and talented executives; 
    be fair, reasonable and market competitive; 
    provide a strong link between performance and pay, and reward performance; 
    be flexible to support our long-term growth strategy; 
    align the incentives of our executive officers with our corporate strategies and business objectives and the long-term interests of our stockholders; and
    promote long-term equity ownership by our executives. 

    To achieve these objectives, each year, our Compensation Committee considers a variety of factors in assessing the competitiveness of our executive compensation program and the individual compensation of each of our executive officers, including our named executive officers. These factors include the executive officer’s experience and individual performance, the Company’s performance as a whole, and data from compensation surveys, as well as compensation paid at companies in our peer group, as described below, cost of living increases and general industry conditions. Our Compensation Committee does not assign any specific weighting to any one factor when making compensation decisions. In furtherance of our pay-for-performance philosophy, actual compensation paid to our executive officers is correlated to the achievement of corporate goals, our stock price and individual performance.   

    Market Benchmarks and Competitive Analysis

    In making compensation decisions, our Compensation Committee reviews publicly available compensation data and survey data provided by its compensation consultant, Pay Governance, from a group of publicly traded, national and regional companies in the biopharmaceutical and biotechnology industries. Our Compensation Committee establishes our peer group, based on the recommendation of its compensation consultant, based on the following criteria: 

    companies whose scientific stage of development (R&D expense) and market capitalization are similar, though not necessarily identical, to ours; 
    companies with similar executive positions to ours; 
    companies against which we believe we compete for executive talent; and 
    public companies based in the United States whose compensation and financial data are available in proxy statements or through widely available compensation surveys.  

    Our Compensation Committee, working with its compensation consultant, reviews the companies in our peer group annually, based on agreed criteria regarding which companies should be included in the peer group, and makes adjustments as necessary to ensure the peer group continues to properly reflect the market in which we compete for talented executives. The peer group consisted of the following companies from November 2018 until November 2019.

    2018 Peer Group


    26



     
     
     
    Advaxis, Inc.
     
    Infinity Pharmaceuticals, Inc.
    aTyrPharma, Inc.
     
    Leap Therapeutics, Inc.
    Calithera Biosciences, Inc. 
     
    Merrimack Pharmaceuticals, Inc.
    Catabasis Pharmaceuticals, Inc.
     
    Mersana Therapeutics, Inc.
    Celldex Therapeutics, Inc.
     
    Neon Therapeutics, Inc.
    Cidara Therapeutics, Inc.  
     
    OncoMed Pharmaceuticals, Inc.
    Dicerna Pharmaceuticals, Inc.
     
    OncoSec Medical Incorporated
    Gritstone Oncology, Inc. 
     
    Spring Bank Pharmaceuticals
    Idera Pharmaceuticals, Inc.
     
    Tetraphase Pharmaceuticals, Inc.

    Based on the criteria listed above, in November 2019, our Compensation Committee approved an updated peer group consisting of the following companies:
     
     
     
    Advaxis, Inc.
     
    Infinity Pharmaceuticals, Inc.
    aTyrPharma, Inc.
     
    Jounce Therapeutics, Inc.
    Calithera Biosciences, Inc. 
     
    Leap Therapeutics, Inc.
    Catabasis Pharmaceuticals, Inc.
     
    Mersana Therapeutics, Inc.
    Celldex Therapeutics, Inc.
     
    Neon Therapeutics, Inc.
    Cidara Therapeutics, Inc.  
     
    OncoSec Medical Incorporated
    Cue Biopharma, Inc.
     
    Pieris Pharmaceuticals, Inc.
    Gritstone Oncology, Inc. 
     
    Spring Bank Pharmaceuticals
    Idera Pharmaceuticals, Inc.
     
    Surface Oncology, Inc.

    Certain companies included in our 2018 peer group were removed from our 2019 peer group because they were acquired or went through a significant reorganization or their market capitalization was no longer determined to be comparable to ours. Certain companies were added to our peer group in 2019 because they aligned with our scientific stage of development.

    We believe that the data from our Peer Group provides us with appropriate compensation benchmarks for evaluating the compensation of our executive officers. Notwithstanding the similarities of the companies in our Peer Group to us, due to the nature of our business, we compete for executive talent with many public companies that are larger and more established than we are, or that possess greater resources than we do, and with smaller private companies that may be able to offer greater equity compensation potential, as well as with prestigious academic and non-profit institutions. Our Compensation Committee takes these factors into account in assessing executive compensation and also reviews survey data to form a broader market perspective on compensation in the market. 
     
    Our Compensation Committee evaluates our executive compensation program with the goal of setting total compensation at levels that align with a total rewards strategy appropriate for our size and stage of development and achieve the objectives of our executive compensation program, as described above. Our Compensation Committee generally targets base salaries, annual bonuses, and annual equity awards for our executive officers around the market median for our peer group, with variability in actual payments based on corporate and individual performance. Our Compensation Committee may consider other factors, including market factors; the experience level of the executive; his or her total responsibilities; the executive’s contributions in helping to achieve established corporate goals; and overall contributions and performance, in determining variations to this general practice in making recommendations to our Board of Directors. 

    Key Performance Factors in Determining Executive Compensation 
     
    Because the biopharmaceutical industry is characterized by a very long product development cycle, including a lengthy R&D period and a rigorous regulatory approval process, including the requirements for multiple phases of human testing and the need to meet a significant number of other government requirements, many of the traditional financial performance metrics, such as product sales, revenues and profits, used to evaluate successful performance are inappropriate for a biopharmaceutical company with a continued development focus, such as Genocea. Instead, the specific performance our Compensation Committee considers when evaluating the compensation of our named executive officers include: 


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    key R&D achievements 
    initiation and progress of clinical trials for our product candidates; 
    expansion of our manufacturing and other operation capabilities; 
    achievement of regulatory milestones; 
    new business initiatives including financings; and 
    our progress in building out key functions and managing our growth while maintaining a high-performing organization and culture.  
     
    Annual corporate goals are proposed by our senior leadership team at the beginning of each year and approved by our Board of Directors. During the first quarter of each year, our Compensation Committee, with the input of the senior leadership team, evaluates our corporate performance for the prior year against the corporate goals set for that year, and, taking into account other corporate achievements and developments, recommends a corporate performance rating to be approved by our Board of Directors. For 2019, our Compensation Committee approved a corporate performance rating of 95% based on our corporate performance, as further described below under “Elements of Executive Compensation - Annual Cash Bonuses”. Our Compensation Committee, with the input of our Chief Executive Officer, also evaluates the individual performance of our executive officers (other than our Chief Executive Officer) against their individual goals for the year. For 2019, the Compensation Committee approved an individual performance rating of 100% for all of our executive officers. Our Compensation Committee and our Board of Directors also evaluate the performance of our Chief Executive Officer each year, although 100% of his annual bonus is based on the achievement of our corporate goals.

    During or before the first quarter of each year, our Compensation Committee typically evaluates compensation levels for such year for our executive officers, including the amount of each executive officer’s base salary, target annual bonus and annual equity awards, taking into consideration the compensation paid by members of our peer group, our prior year’s overall corporate performance against the established corporate goals, as well as each individual executive officer’s contributions to achievement of such corporate goals, individual performance and the other factors described above, in making compensation recommendations to our Board of Directors. Our Board of Directors considers these recommendations in determining the compensation for our executive officers for the applicable year.

    Elements of Executive Compensation

    The compensation of our named executive officers consists of base salary, annual cash bonuses and equity awards, as well as employee benefits that are made available to our salaried employees generally. Our named executives are also entitled to compensation and benefits upon certain terminations of employment, including following a change of control transaction, as described under "Employment Letter Agreements" below.

    Base Salaries.  Base salaries for our named executive officers are reviewed annually by our Compensation Committee and are set by our Board of Directors. When making its base salary recommendations to our Board of Directors, our Compensation Committee takes the factors described above into account, but does not assign any specific weighting to any one factor. Our Board of Directors determines each named executive officer’s base salary after reviewing the Compensation Committee’s recommendation with respect to such salaries. In 2019, on the recommendation of our Compensation Committee, our Board of Directors approved an increase of 3.5% to the base salary for Mr. Clark (to $535,613 per year) and Dr. Davis (to $439,875 per year). Dr. Aakalu's base salary of $385,000 per year was set when his employment began on December 6, 2018 and was not increased in 2019.

    Annual Cash Bonuses.  Our annual cash bonus program promotes and rewards the achievement of key strategic business goals and individual performance goals. For 2019, the target annual bonus as a percentage of base salary was 50% for Mr. Clark and 40% for each of Dr. Aakalu and Dr. Davis. In the case of Mr. Clark, 100% of his annual bonus was based on the achievement of pre-established corporate performance goals and, in the case of Dr. Aakalu and Dr. Davis, their respective annual bonuses were based on the achievement of pre-established corporate performance goals and pre-established individual performance goals.

    At the beginning of 2019, our Compensation Committee established the corporate performance goals for 2019 and the weighting for each goal. These corporate performance goals included key strategic and financial goals related to business development collaborations and financings, cash management, the development and commencement of certain clinical and commercial programs, and other strategic objectives related to our clinical pipeline. Also, at the beginning of 2019, Mr. Clark, working with Dr. Aakalu and Dr. Davis, established individual performance goals for each of Dr. Aakalu and Dr. Davis and their weightings. These goals included, to the extent applicable to the executive, objectives related to oversight of clinical activities for compliance with laws, developing and conducting clinical programs and studies, research and development, managing studies

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    according to schedule and within budgets, business and corporate development and demonstrating leadership with respect to direct reports.

    In February 2020, our Compensation Committee met to review and consider the level of corporate and individual performance goals that were achieved for purposes of making its recommendation to our Board of Directors regarding the amount of the annual cash bonus earned by our named executive officers for 2019. The Compensation Committee reviewed and evaluated our corporate performance against the pre-established corporate performance goals for 2019, taking into consideration Mr. Clark’s evaluation of our performance. With respect to the individual performance goals applicable to Dr. Aakalu and Dr. Davis, our Compensation Committee also considered Mr. Clark’s determination that Dr. Aakalu and Dr. Davis had each achieved 100% of such individual performance goals. After reviewing the achievement of our 2019 corporate performance goals, and after considering Mr. Clark’s determination regarding the level of achievement of the individual performance goals for Dr. Aakalu and Dr. Davis, our Compensation Committee recommended, and our Board of Directors approved, a 95% level of achievement of corporate performance goals and a 100% level of achievement of Dr. Aakalu's and Dr. Davis' individual goals. As a result, our Board of Directors approved an annual cash bonus of $241,695 for Mr. Clark, $146,300 for Dr. Aakalu, and $167,153 for Dr. Davis for 2019.

    Equity Awards.  Our named executive officers have each been granted stock options, including options intended to qualify as incentive stock options. Stock option awards serve to align the interests of our named executive officers with our stockholders because no value is created unless the value of our common stock appreciates after grant. Stock option awards also encourage retention through the use of time-based vesting conditions. We have from time to time in the past also granted stock options that are subject to performance-based vesting conditions, thereby incentivizing the achievement of key strategic goals.

    In February 2019, Mr. Clark, Dr. Aakalu and Dr. Davis were each granted options to purchase 93,751, 37,500, and 37,500 shares, respectively, of our common stock under our 2014 Equity Plan. These stock options vest in equal monthly installments over the 48 months following the date of grant, generally subject to the executive's continued employment. Pursuant to each named executive officer's employment letter agreement, stock options held by the executive would vest automatically upon certain terminations of employment following a change of control. See “Employment Letter Agreements” below for additional details about each individual's agreement.

    Benefits.  We provide modest benefits to all of our salaried employees, including our executive officers, which are limited to participation in our 401(k) plan, our employee stock purchase plan, and our health and welfare benefit plans.

    Employment Letter Agreements.  We have entered into employment letter agreements with Mr. Clark, Dr. Aakalu and Dr. Davis that include severance and change of control protections. Mr. Clark and Dr. Davis are also subject to restrictive covenants covering noncompetition, non-solicitation and confidentiality. See “Employment Letter Agreements” below for additional details about these agreements.

    Summary Compensation Table

    The following table sets forth information about compensation earned, awarded or paid to our named executive officers for 2019 and, for Mr. Clark, 2018. Dr. Aakalu and Dr. Davis were not named executive officers for 2018, and, as a result, their 2018 compensation is not included in the table below.
    Name and principal position
     
    Year
     
    Salary
    ($)(1)
     
    Bonus
    ($)(2)
     
    Option
    awards
    ($)(3)
     
    Nonequity incentive
    plan compensation
    ($)(4)
     
    All other compensation
    ($)(5)
     
    Total
    ($)
    William Clark,
     
    2019
     
    532,594

     
     
     
    282,272

     
    241,695

     
    6,435

     
    1,062,996

    President and Chief Executive Officer
     
    2018
     
    514,583

     
     
     
    583,459

     
    207,000

     
    5,984

     
    1,311,026

    Girish Aakalu, Ph.D.,
       Chief Business Officer
     
    2019
     
    385,000

     
    150,000

     
    112,908

     
    146,300

     
    3,850

     
    798,058

    Thomas Davis, M.D.,
       Chief Medical Officer
     
    2019
     
    437,396

     
     
     
    112,908

     
    167,153

     
    32,201

     
    749,658

    _________________________
    (1)
    Salaries include amounts contributed by the named executive officer to our 401(k) plan.
    (2)
    The amount shown reflects a signing bonus paid to Dr. Aakalu in 2019 in connection with his commencement of employment with us in December 2018.

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    (3)
    Amounts shown reflect the aggregate grant date fair value of options to purchase shares of our common stock granted in the applicable year, computed in accordance with ASC 718, excluding the effect of estimated forfeitures. Assumptions used in the calculation of these amounts are included in Note 10 to our consolidated financial statements included in our Annual Report.
    (4)
    Amounts shown for Dr. Aakalu and Dr. Davis reflect the annual cash bonuses paid to them for 2019 that were earned based on the achievement of Company and individual performance goals, and, in the case of Mr. Clark, the amounts shown reflect the annual cash bonuses paid to him for the applicable year based solely on the achievement of Company performance goals.
    (5)
    Amounts shown reflect employer matching contributions under our 401(k) plan for all of our named executive officers. For Dr. Davis, the 2019 amount shown includes a 10-month housing reimbursement of $26,430.
    Outstanding Equity Awards at Fiscal Year-End

    The following table sets forth information regarding equity awards held by our named executive officers as of December 31, 2019.
     
     
    Option Awards
    Name
     
    Number of
    securities underlying
    unexercised options (#) exercisable
     
    Number of securities
    underlying unexercised
    options (#) unexercisable
     
    Equity incentive
    plan awards: number of securities
    underlying unexercised
    unearned options (#)
     
    Option Exercise
    Price ($)(5)
     
    Option Expiration
    Date (6)
    William Clark
     
    3,090

    (1)
     

     
     

     
     
    $
    22.88

     
    12/17/2020
     
     

     
     

     
     
    4,976

    (2)
     
    $
    22.88

     
    12/17/2020
     
     
    42,571

    (1)
     

     
     

     
     
    $
    16.16

     
    2/17/2021
     
     
    10,209

    (3)
     

     
     

     
     
    $
    27.60

     
    7/25/2023
     
     
    16,701

    (4)
     

     
     

     
     
    $
    27.60

     
    7/25/2023
     
     
    17,251

    (1)
     

     
     

     
     
    $
    72.64

     
    2/26/2025
     
     
    34,501

    (1)
     
    1,500

    (1)
     

     
     
    $
    24.72

     
    2/2/2026
     
     
    25,500

    (1)
     
    10,500

    (1)
     

     
     
    $
    37.36

     
    2/28/2027
     
     
    49,501

    (1)
     
    58,501

    (1)
     

     
     
    $
    7.84

     
    2/8/2028
     
     
    17,656

    (1)
     
    74,220

    (1)
     
     
     
     
    $
    4.32

     
    2/7/2029
    Tom Davis, M.D.
     
    18,229

    (3)
     
    44,272

    (3)
     

     
     
    $
    6.32