Earnings release
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HOOKIPA PHARMA HOOKIPA Pharma Reports Second Quarter 2021 Financial Results and Recent Highlights August 12 , 2021 • Phase 1 HB - 200 data recognized at premier oncology meetings , highlighting potential of novel arenaviral platform to deliver a new class of immunotherapeutics • HOOKIPA on track to report comprehensive data from oncology and infectious disease programs in the second half of 2021 NEW YORK and VIENNA , Austria , Aug. 12 , 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 business highlights for the second quarter of 2021 . " During the second quarter , we gained considerable momentum in highlighting the promise of our novel arenaviral platform to redefine success in cancer immunotherapy . Our HB - 200 program in advanced Human Papillomavirus 16 - positive ( ' HPV16 + ' ) cancers was featured prominently at both AACR and ASCO , with compelling tumor antigen - specific T cell responses and tumor control that replicate pre - clinical results , " said Joern Aldag , Chief Executive Officer at HOOKIPA . " We are focused on advancing our oncology and infectious disease programs through the second half of the year , as we aim to deliver first - in - class arenaviral immunotherapies that induce potent , targeted immune responses to fight or prevent serious disease . " Quarter Highlights • At the virtual American Association for Cancer Research ( AACR ' ) Annual Meeting in April 2021 , HOOKIPA presented positive preliminary Phase 1 immunogenicity data for HB - 200 for the treatment of advanced HPV16 + cancers . These data demonstrated a robust increase in HPV16 + -specific T cells , including an increase of up to 8 % of antigen - specific circulating CD8 + T cells , after one dose of HB - 201 or HB - 202 . Early HB - 201 monotherapy data also highlighted immune system activation of increasing interferon - gamma and other immune stimulatory cytokines with a single dose . • In June , HOOKIPA reported positive Phase 1 data from the ongoing Phase 1/2 study of HB - 200 for the treatment of advanced HPV16 + cancers . The clinical data , presented as an oral presentation at the American Society of Clinical Oncology ( ASCO ' ) Annual Meeting , showed HB - 200 is highly immunogenic , inducing unprecedented levels of activated , tumor antigen - specific CD8 + T cells ( an average of 6 percent and up to 40 percent of the T cell pool ) . In addition , HB - 201 monotherapy showed an 18 percent overall response rate and median progression - free survival of 3.45 months in heavily pre - treated head and neck cancer patients who progressed on standard of care , including checkpoint inhibitors . • HOOKIPA completed enrollment in the Phase 2 clinical trial of its prophylactic Cytomegalovirus ( CMV ' ) , vaccine candidate , HB - 101 ; the last patient was enrolled in June 2021. We expect to report additional safety , immunogenicity , and efficacy data from evaluable patients in the second half of 2021 , with final top - line data readout in the first half of 2023. The protocol requires a 12 - month follow up after transplantation , which is typically two to three months after enrollment . • Jean - Charles Soria resigned as a Non - Executive Director of HOOKIPA's Board of Directors to avoid any conflicts of interest following a decision to join Amgen as senior vice president and lead of the oncology therapeutic area . Upcoming Milestones • Additional HB - 201 / HB - 202 Phase 1/2 data in HPV16 + cancers and recommended Phase 2 dose for the HB - 200 program in the fourth quarter of 2021 • HB - 101 CMV Phase 2 data in the second half of 2021 Advancing our HB - 300 program to IND for the treatment of metastatic prostate cancer • HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies ● Second Quarter 2021 Financial Results Cash Position : HOOKIPA's cash , cash equivalents and restricted cash as of June 30 , 2021 was $ 102.9 million compared to $ 143.2 million as of December 31 , 2020. The decrease was primarily attributable to cash used in operating activities . Revenue was $ 5.4 million for the three months ended June 30 , 2021 , and $ 6.7 million for the three months ended June 30 , 2020. The decrease was primarily due to receipt of a $ 1.0 million milestone payment under the Gilead collaboration during this time period in 2020 , but not in 2021 . Research and Development Expenses : HOOKIPA's research and development expenses were $ 19.6 million for the three months ended