HOOK HOOKIPA Pharma Inc.

15.1
-0.1  -1%
Previous Close 15.2
Open 15.18
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Drug Stage Catalyst Date
HB-201 and HB-202 (alone and double)
Treatment-refractory HPV16+ cancers
Phase 1/2
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HB-101
Cytomegalovirus (CMV)
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Latest News

  1. NEW YORK and VIENNA, Austria, May 03, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that it will release first quarter 2021 financial results before the market opens on Wednesday, May 12, 2021.

    The Company will not be conducting a conference call in conjunction with this earnings release.

    About HOOKIPA
    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce…

    NEW YORK and VIENNA, Austria, May 03, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that it will release first quarter 2021 financial results before the market opens on Wednesday, May 12, 2021.

    The Company will not be conducting a conference call in conjunction with this earnings release.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

    HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

    HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    For further information, please contact: 
    MediaInvestors
    Nina WaibelMatt Beck
    Senior Director - CommunicationsExecutive Director - Investor Relations



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  2. NEW YORK and VIENNA, Austria, April 29, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA's management team will participate and present at the following upcoming virtual investor conferences:

    • 7th Annual Truist Securities Life Sciences Summit, May 4 – 5, 2021
      Fireside Chat: May 4, 1:50pm ET
    • Bank of America 2021 Health Care Conference, May 10 – 13, 2021
      Presentation: May 13, 1:15pm ET
    • Morgan Stanley Virtual Asia Healthcare Conference, May 13 - 14, 2021

    • RBC Capital Markets Global Healthcare Conference, May 18 - 20, 2021
      Fireside Chat: May 18, 9:45am ET

    The live audio webcasts of the fireside chats…

    NEW YORK and VIENNA, Austria, April 29, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA's management team will participate and present at the following upcoming virtual investor conferences:

    • 7th Annual Truist Securities Life Sciences Summit, May 4 – 5, 2021

      Fireside Chat: May 4, 1:50pm ET
    • Bank of America 2021 Health Care Conference, May 10 – 13, 2021

      Presentation: May 13, 1:15pm ET
    • Morgan Stanley Virtual Asia Healthcare Conference, May 13 - 14, 2021



    • RBC Capital Markets Global Healthcare Conference, May 18 - 20, 2021

      Fireside Chat: May 18, 9:45am ET

    The live audio webcasts of the fireside chats and presentation will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

    HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

    HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    For further information, please contact:

    MediaInvestors
    Nina WaibelMatt Beck
    Senior Director - CommunicationsExecutive Director - Investor Relations



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  3. NEW YORK and VIENNA, Austria, April 14, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA's management team will participate and host 1:1 meetings at the virtual Kempen Life Science Conference, taking place April 21, 2021.

    Additional information will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events.

    About HOOKIPA
    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's…

    NEW YORK and VIENNA, Austria, April 14, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that HOOKIPA's management team will participate and host 1:1 meetings at the virtual Kempen Life Science Conference, taking place April 21, 2021.

    Additional information will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

    HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

    HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    For further information, please contact:

    Media Investors
    Nina Waibel Matt Beck
    Senior Director - Communications Executive Director - Investor Relations
       



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    • Preliminary data demonstrate a robust increase in HPV16+-specific T cells, including up to 8% of circulating CD8+ T cells, after one dose of HB-201 or HB-202

    • Early data on HB-201 monotherapy show an increase in interferon-gamma and other immune stimulatory cytokines after a single dose, highlighting immune system activation

    • Late-breaker data at AACR Annual Meeting reinforce promising anti-tumor activity reported in 2020 and underscore the potential of HOOKIPA's novel arenavirus platform to deliver transformational cancer therapies

    NEW YORK and VIENNA, Austria, April 10, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today…

    • Preliminary data demonstrate a robust increase in HPV16+-specific T cells, including up to 8% of circulating CD8+ T cells, after one dose of HB-201 or HB-202



    • Early data on HB-201 monotherapy show an increase in interferon-gamma and other immune stimulatory cytokines after a single dose, highlighting immune system activation



    • Late-breaker data at AACR Annual Meeting reinforce promising anti-tumor activity reported in 2020 and underscore the potential of HOOKIPA's novel arenavirus platform to deliver transformational cancer therapies

    NEW YORK and VIENNA, Austria, April 10, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, to treat Human Papillomavirus 16-positive (HPV16+) cancers. The results are from an ongoing Phase 1/2 study (NCT04180215) currently investigating HB-201 as a single-vector therapy and HB-201 and HB-202 as an alternating two-vector therapy for the treatment of advanced metastatic HPV16+ cancers. The data were presented today at a late-breaker poster session at the virtual American Association for Cancer Research Annual Meeting.

    "We're excited to see the quantity and quality of a targeted immune response, particularly the directly measured increase in HPV16+-specific CD8+ T cells, generated by a single dose of our lead oncology candidates, HB-201 or HB-202. As we are still exploring optimal dosing, these early responses are particularly encouraging," said Joern Aldag, Chief Executive Officer of HOOKIPA. "We believe our novel arenavirus platform has the potential to introduce a new class of immunotherapeutics that could considerably advance how physicians care for people with HPV16+ cancers. Building on the early clinical results reported on HB-201 in December, we look forward to additional data read-outs from our first clinical oncology program in the coming months."

    Preliminary data showed a strong antigen-specific T cell response after one dose of HB-201 or HB-202, based on direct Enzyme-Linked ImmunoSpot (ELISpot) T cell analysis. (ELISpot is used to quantify antigen-specific T cells in the blood.) All 5 patients who received a single dose of HB-201 or HB-202 had a strong induction of T cells specific to HPV16+ cancer 2 weeks after administration. An up to 250-fold increase in antigen-specific T cells was observed 2 weeks after a single dose of HB-201 in 4 patients. One patient who received a single dose of HB-202 showed a 150-fold increase in antigen-specific T cells 2 weeks after administration. Importantly, the results are based on direct ELISpot without ex vivo expansion of T cells, underscoring the magnitude of T cell response generated by one dose of HB-201 or HB-202. (Ex vivo expansion is often used to amplify responses so that they are more easily measured.) The data are derived from dose level 2 of ongoing dose escalation, and the recommended Phase 2 doses for HB-201 and HB-202 have not been reached.

    In addition, analysis of the antigen-specific T cell response showed an increase in CD8+ T cells specific to HPV16+ cancer after a single dose of HB-201 (baseline 0% to 2.8% two weeks later) and HB-202 (baseline 0% to 8.1% two weeks later). These data were assessed using intracellular cytokine staining (ICS) followed by flow cytometry, which differentiates antigen-specific CD8+ T cells (cytotoxic/killer T cells) from antigen-specific CD4+ T cells (helper T cells). Of note, the HPV16+ cancer patients included in this analysis had negligible levels of antigen-specific CD8+ T cells prior to treatment with HB-201 or HB-202.

    Other preliminary immunogenicity data highlight immune system activation following a single dose of HB-201. Blood samples from 12 patients were assessed across 13 timepoints for levels of 30 different cytokines and chemokines, which play critical roles in activating an immune response. At the time of data cut-off, baseline and day 4 samples were available for 9 of the 12 patients. The analysis showed that, 4 days after a single dose of HB-201, interferon-gamma levels increased in 90% of patients, and an increase in other immune stimulatory cytokines and chemokines was observed. These data comprise an early sign of natural killer (NK) cell and/or T cell activation by HB-201.

    "Treatment options are limited for people with metastatic HPV16+ cancers, and the likelihood for long-term survival is low," said Dmitriy Zamarin, MD, PhD, Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study. "We don't often see this robust and high-quality immune response, particularly in antigen-specific CD8+ T cells, from a single dose and without any combination therapy. I'm excited to see how these early immunogenicity data may translate to clinical outcomes in the future."

    These preliminary immunogenicity data reinforce the promising anti-tumor activity reported from this trial in December 2020 and are consistent with recently published preclinical data, which showed that intravenous HB-201 administration induced single digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeding 50% of the circulating T cell pool. As the HB-201/HB-202 clinical trial is ongoing, HOOKIPA expects to present additional translational and clinical data at upcoming medical conferences in 2021. The company anticipates these data to further inform the HPV program, as well as other earlier stage programs in its oncology pipeline, including therapeutics for prostate cancer, as it seeks to deliver transformational therapies through induction of antigen-specific CD8+ T cells. The poster and audio review are available at https://ir.hookipapharma.com/events/event-details/aacr-annual-meeting-2021.

    About HB-201/HB-202

    HB-201 and HB-202 are HOOKIPA's lead oncology candidates engineered with the company's proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (LCMV for HB-201 and PICV for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone.

    About the trial

    This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ cancers. The primary endpoint of the Phase 1 is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1 and immunogenicity.

    The trial is evaluating HB-201 as a single-vector monotherapy, as an alternating two-vector therapy with HB-202, and in combination with a PD-1 inhibitor. Participants receive HB-201/HB-202 intravenously or, for patients with an accessible lesion, the first dose can be delivered via intratumoral injection followed by intravenous dosing. Dosing every three weeks and every two weeks is being explored, as well as different dose levels. HOOKIPA expects to share interim clinical data on the HB-201/202 therapy in mid-2021.

    About Human Papillomavirus

    Human Papillomavirus, or HPV, is estimated to cause about 5 percent of the worldwide burden of cancers. This includes approximately 99 percent of cases in cervical, up to 60 percent of head and neck, 70 percent of vaginal and 88 percent of anal cancers.

    The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.



    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

    HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

    HOOKIPA's non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    Forward Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises, the impact of COVID-19 on the enrollment of patients and timing of clinical results for HB-101 and other programs, and other matters that could affect the sufficiency of existing cash to fund operations and HOOKIPA's ability to achieve the milestones under the agreement with Gilead. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA's annual report on Form 10-K for the financial year ended December 31, 2020 which is available on the Security and Exchange Commission's website at www.sec.gov and HOOKIPA's website at www.hookipapharma.com.

    Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.

    For further information, please contact:

    Media  Investors
    Nina Waibel  Matt Beck
    Senior Director - Communications   Executive Director - Investor Relations
       
       
    Media enquiries  
    Instinctif Partners  
       
    +44 (0)20 7457 2020  


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    • Proprietary arenavirus immunotherapeutics platform demonstrated promising clinical activity with interim data from lead oncology and infectious disease candidates

    • Follow-on offering strengthened cash basis with $143 million available at year-end to support progression of Human Papillomavirus 16-positive (HPV16+) cancer and Cytomegalovirus (CMV) programs and pipeline expansion
    • HOOKIPA on track to report additional clinical data on efficacy and T cell response in 2021 for HB-201 and HB-202

    NEW YORK and VIENNA, Austria, March 18, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and provided…

    • Proprietary arenavirus immunotherapeutics platform demonstrated promising clinical activity with interim data from lead oncology and infectious disease candidates



    • Follow-on offering strengthened cash basis with $143 million available at year-end to support progression of Human Papillomavirus 16-positive (HPV16+) cancer and Cytomegalovirus (CMV) programs and pipeline expansion
    • HOOKIPA on track to report additional clinical data on efficacy and T cell response in 2021 for HB-201 and HB-202

    NEW YORK and VIENNA, Austria, March 18, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ:HOOK, ‘HOOKIPA'))), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and provided a corporate update for the fourth quarter and full year 2020.

    "Despite the global pandemic, 2020 was a break-out year for HOOKIPA, a testament to the strength of our novel scientific platform and our dedicated team. We reported compelling, early clinical data with both our replicating and non-replicating technologies in oncology and infectious diseases, respectively, and advanced the HBV and HIV cures towards the clinic in our strategic collaboration with Gilead Sciences. With the appointment of Jean-Charles Soria, M.D., Ph.D., we added a globally recognized oncology expert to our board to help guide our clinical development progress," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Our strong year-end cash balance of $143 million positions us well to advance our CMV and HPV16+ cancer programs and to expand our pipeline. Given the strength of the interim data reported in 2020, we are excited about the further potential of our platform and additional read-outs this year, particularly from our HB-201/HB-202 two-vector alternating immunotherapy, which has the potential to deliver even greater immune response than HB-201 alone."

    R&D Pipeline Update and Clinical Progress

    Oncology Portfolio (HB-201 and HB-202)

    • Clinical proof of concept achieved with HB-201. In December, interim Phase 1 data on HB-201 for the treatment of advanced HPV16+ cancers showed promising anti-tumor activity and favorable tolerability as a monotherapy, i.e. without any additional combination product. Data demonstrated responses and stable disease in head and neck cancer patients who failed prior standard of care therapy, platinum therapy, PD(L)1 inhibitor, or both. By targeting an antigen common to HPV16+, HB-201 has the potential to be a tumor-agnostic therapy for all HPV16+ cancers. These early-stage data establish proof of concept for HOOKIPA's replicating single-vector immunotherapy in oncology. Dose escalation and dose frequency continue to be evaluated in the ongoing Phase 1/2 trial, with the next data read-out anticipated by mid-2021. HPV is estimated to cause 5% of the worldwide cancer burden, the majority of which is HPV16+.
    • First patient dosed with HB-202. HOOKIPA expanded its Phase 1/2 HB-201 clinical trial to include evaluation of HB-201/HB-202, an alternating two-vector therapy. Following clearance of the IND by the Food and Drug Administration in June 2020, the first patient was dosed with HB-202 in October 2020. Preclinical data show that adding an additional arenaviral vector to achieve alternating two-vector therapy can enhance the immune response. Initial data read-out is anticipated by mid-2021.
    • OncoImmunology published HB-201 pre-clinical data demonstrating high immunogenicity. In September, pre-clinical data on HB-201 in HPV16+ models were published in OncoImmunology. Specifically, intravenous administration of HB-201 elicited a robust expansion of antigen-specific CD8+ T cell responses. In the HPV16+ tumor model, HB-201 showed significantly delayed tumor growth or complete tumor clearance with prolonged survival.  
    • Pre-clinical data highlighting the potential of alternating two-vector cancer therapeutics published in Cell Reports Medicine. The March 2021 issue of Cell Reports Medicine featured pre-clinical data showing that alternating, intravenous administration of two replicating arenaviral vectors induced tumor-specific responses exceeding 50% of circulating CD8 T cells. In addition, the two-vector approach resulted in tumor cures and long-term immunity in a pre-clinical setting. HOOKIPA is currently evaluating the alternating two-vector therapy in its ongoing HB-201/HB-202 clinical trial, with initial data read-out anticipated by mid-2021.

    Infectious Disease Portfolio (HB-101)

    • Clinical proof of concept achieved with HB-101. In November, interim Phase 2 data were released for patients who received a three-dose CMV vaccination with HB-101 prior to a kidney organ transplantation. These interim results showed a reduction in CMV viremia, reduction in antiviral use, and no CMV disease in the CMV-negative kidney transplant recipients as compared to placebo. Strong CMV-neutralizing antibody responses and a favorable tolerability profile were also observed. HOOKIPA believes that these interim data establish proof of concept for HB-101, a potential first-in-class vaccine candidate, which uses HOOKIPA's non-replicating technology. HOOKIPA expects to conclude enrollment of the ongoing Phase 2 trial in mid-2021 and to report additional data in the second half of 2021. 
    • Scientific validation with Phase 1 HB-101 data publication in The Journal of Infectious Diseases. In April, Phase 1 safety and immunogenicity data on HB-101 were published in The Journal of Infectious Diseases. The trial concluded that the CMV vaccine candidate was well-tolerated and induced strong neutralizing antibody and T cell immune responses against CMV in healthy adult volunteers.

    Strategic Collaborations

    • Gilead Sciences collaboration for Hepatitis B Virus and HIV therapeutic vaccines advances. HOOKIPA's collaboration with Gilead aims to develop immunotherapy candidates for functional cures of Hepatitis B Virus and HIV in combination therapies. Significant progress was made in the collaboration during 2020. In the fourth quarter, another pre-clinical milestone was triggered in the HIV program, bringing the total revenue recorded from the Gilead collaboration in 2020 to $19.6 million. Gilead agreed to reserve manufacturing capacity and expanded resources to support future clinical trials.

    Corporate Highlights

    • Balance sheet strengthened with $80.9m financing. Following the positive data read-outs in both the oncology and infectious disease programs, HOOKIPA completed a successful follow-on offering to close the year with a cash balance of $143.2 million. Funding will support advancement of the HPV16+ and CMV programs and an expansion of the overall pipeline.
    • Board of Directors adds expertise in late-stage oncology clinical development. In October, HOOKIPA welcomed Professor Jean-Charles Soria, M.D., Ph.D., Director General of the Gustave Roussy Cancer Center in Paris, as a Board Director. Dr. Soria is a globally recognized physician-scientist who brings deep oncology, immunotherapy and clinical development expertise to the Board.
    • Strong management through COVID-19 uncertainty. Despite the challenges of the pandemic, HOOKIPA's team was able to continue to deliver effectively on our corporate goals. HOOKIPA quickly pivoted early on to maintain its laboratory and manufacturing operations with appropriate safety precautions, while other employees were able to maintain productivity via remote work. HOOKIPA continues to monitor the impact of the ongoing pandemic on its overall operations.

    Upcoming Milestones

    • Translational data from the HB-201 program in Q2 2021
    • Additional HB-201 and initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021
    • Additional HB-101 CMV Phase 2 efficacy data in H2 2021
    • Advancing HB-300 towards IND for the treatment of metastatic prostate cancer
    • HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies

    Fourth Quarter and Full Year 2020 Financial Results

    Cash Position: HOOKIPA's cash, cash equivalents and restricted cash as of December 31, 2020 was $143.2 million compared to $113.6 million as of December 31, 2019. The increase was primarily attributable to $75.0 million in net proceeds from the issuance of common stock and convertible preferred stock in a follow-on financing in December 2020, offset by cash used in operating activities.

    Revenue was $5.2 million for the three months ended December 31, 2020, and $19.6 million for the year ended December 31, 2020 compared to $3.6 million for the three months ended December 31, 2019 and $11.9 million for the year ended December 31, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead and the partial recognition of a milestone payment we received from Gilead in February 2020.

    Research and Development Expenses: HOOKIPA's research and development expenses were $15.7 million for the three months ended December 31, 2020, and $54.8 million for the year ended December 31, 2020 compared to $11.2 million for the three months ended December 31, 2019, and $46.3 million for the year ended December 31, 2019.

    The primary driver of the increase in research and development expenses by $8.5 million compared to 2019 was an increase in internal research and development expenses, partially offset by a decrease in direct research and development expenses.

    Internal research and development expenses increased primarily due to higher personnel expenses, including stock based compensation and an increase in facility related expenses. The decrease in direct expenses was primarily due to a decrease in research and development service expenses, along with a decrease in manufacturing and quality control expenses and a decrease of other direct research and development expenses, partially offset by an increase in clinical trial expenses and an increase in laboratory expenses.

    General and Administrative Expenses: General and administrative expenses amounted to $4.7 million for the three months ended December 31, 2020 and $18.1 million for the for the year ended December 31, 2020 compared to $5.7 million for the three months ended December 31, 2019, and $16.7 million for the year ended December 31, 2019. The increase was mainly due to the growth in personnel related expenses as well as costs associated with ongoing business activities and costs to operate as a public company, partially offset by a decrease in professional and consulting fees.

    Net Loss: HOOKIPA's net loss was $12.5 million for the three months ended December 31, 2020 and $44.1 million for the year ended December 31, 2020 compared to a net loss of $10.2 million for the three months ended December 31, 2019 and $43.0 million for the year ended December 31, 2019. This increase was due to an increase in research and development expenses, mainly driven by the progression of HOOKIPA's oncology programs, and an increase in general and administrative expenses to operate as a public company.

    Conference call: HOOKIPA will host a conference call and live webcast at 8:30 am EDT to discuss its financial results. Please register here to access the conference call. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA's website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event.

    About HOOKIPA

    HOOKIPA Pharma Inc. (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that reprograms the body's immune system.

    HOOKIPA's proprietary arenavirus-based technologies, non-replicating and replicating, induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA's viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy not used in combination, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.

    HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers in a Phase 1/2 clinical trial.

    HOOKIPA's non-replicating prophylactic Cytomegalovirus vaccine candidate, HB-101, is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic hepatitis B infections.

    Find out more about HOOKIPA online at www.hookipapharma.com.

    HOOKIPA Forward Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises, the impact of COVID-19 on the enrollment of patients and timing of clinical results for HB-101 and other programs, and other matters that could affect the sufficiency of existing cash to fund operations and HOOKIPA's ability to achieve the milestones under the agreement with Gilead. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA's quarterly report on Form 10-K for the quarter ended December 31, 2020 which is available on the Security and Exchange Commission's website at www.sec.gov and HOOKIPA's website at www.hookipapharma.com.

    Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.



    HOOKIPA Pharma Inc.

    Consolidated Statements of Operations (Unaudited)

    (In thousands, except share and per share data)

                
     Three months ended December 31,  Year ended December 31, 
     2020     2019     2020     2019 
    Revenue from collaboration and licensing$5,163  $3,618  $19,584  $11,942 
    Operating expenses:               
    Research and development (15,688)  (11,179)  (54,787)  (46,312)
    General and administrative (4,669)  (5,664)  (18,082)  (16,715)
    Total operating expenses (20,357)  (16,843)  (72,869)  (63,027)
    Loss from operations (15,194)  (13,225)  (53,285)  (51,085)
    Total interest, other income and taxes, net 2,719   2,981   9,203   8,048 
    Net loss$(12,475) $(10,244) $(44,082) $(43,037)
    Net loss per share — basic and diluted (0.46)  (0.40)  (1.69)  (2.41)
                    



    Condensed Balance Sheets (Unaudited)

    (In thousands)

          
     As of    As of
     December 31,  December 31, 
     2020 2019
    Cash, cash equivalents and restricted cash$143,177 $113,575
    Total assets 187,817  143,745
    Total liabilities 31,694  25,846
    Total stockholders' equity 156,123  117,899
          



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    Senior Director - CommunicationsExecutive Director - Investor Relations
      
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    Instinctif Partners 
      
    +44 (0)20 7457 2020 


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