GNCA Genocea Biosciences Inc.

2.98
-0.32  -10%
Previous Close 3.3
Open 3.23
52 Week Low 1.1
52 Week High 5.75
Market Cap $159,485,079
Shares 53,518,483
Float 42,867,600
Enterprise Value $111,082,666
Volume 423,308
Av. Daily Volume 684,581
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Upcoming Catalysts

Drug Stage Catalyst Date
GEN-009
Various cancers
Phase 1/2
Phase 1/2
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GEN-011
Various tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GEN-004
Universal vaccine candidate against pneumococcus
Phase 2
Phase 2
Topline data did not meet endpoints - September 2015

Latest News

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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