Business Description

Overview We are a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on our proprietary arenavirus platform that is designed to target and amplify T cell and immune responses to fight diseases. Our replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. We believe that our technologies can meaningfully leverage the human immune system therapeutic purposes by inducing CD8+ T cell response levels previously not achieved by other immune therapy approaches. We are building a proprietary immuno-oncology pipeline utilizing our replicating technology. Our oncology portfolio targets oncoviral cancer antigens and next-generation antigens and includes two primary programs in development: ● HB-700 is a novel, next-generation multi-KRAS mutant-targeting, investigational immunotherapy for the treatment of KRAS mutated cancers, including lung, colorectal and pancreatic cancers, which received Investigational New Drug Application (“IND”) clearance from the Food and Drug Administration (“FDA”) in April 2024 and is Phase 1 ready. ● Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent in clinical development for the treatment of Human Papillomavirus 16-positive (“HPV16+”) head and neck cancers with enrollment completed in a Phase 1/2 clinical trial. Further clinical development activities were paused as of November 2024. We also have a third oncology program, HB-300, targeting self-antigens for the treatment of prostate cancer, which the Company paused further development in January 2024, to conserve capital and ensure pipeline success and operational efficiency. Additionally, we are developing infectious disease therapies in partnership with other companies. Our Hepatitis B (“HBV”) program, HB-400, and our Human Immunodeficiency Virus (“HIV”) program, HB-500, are being developed in a partnership with Gilead. Both programs are in Phase 1 clinical development. Significant Recent Events Restructuring Plan On November 18, 2024, we approved a plan to continue to improve our cost structure and operating efficiency, which includes a reduction in our workforce by approximately 80% of our then-current employee base (the “Restructuring Plan”). The Company began the implementation of the Restructuring Plan in the fourth quarter of 2024 and expects the Restructuring Plan to be substantially completed by the end of the first half of 2025. The Restructuring Plan includes the closing and consolidation of office and laboratories in Vienna, Austria, does not include social plan or severance payments and it is planned that the affected employees will continue to work throughout their termination period. In connection with the Restructuring Plan, in an effort to rebalance our cost structure in alignment with our strategic refocus and development of the oncology portfolio, we also announced that we would pause clinical development in our eseba-vec program for the treatment of HPV16+ head and neck cancers, including an early 6 Table of Contents termination of the Phase 1/2 clinical trial for the treatment of HPV16+ cancers. The early termination of our Phase 1/2 clinical trial for the treatment of HPV16+ was not due to lack of efficacy or adverse safety profiles. While we will continue to seek partnering opportunities for the eseba-vec program, we will focus primarily on progressing the Phase 1-ready HB-700 program for the treatment of KRAS mutant cancers and our Gilead-partnered programs. Research Incentives Receivables We participate in a research incentive program provided by the Austrian government under which we are entitled to reimbursement of a percentage of qualifying research and development expenses and capital expenditures incurred in Austria. In February 2025, we received a payment of $19.8 million related to the research incentive program including the receivable of $17.3 million from Austrian research incentive program for the years 2022 and 2023. Potential Combination of Poolbeg Pharma plc and HOOKIPA On January 2, 2025, we and Poolbeg Pharma plc (“Poolbeg”) released an announcement pursuant to Rule 2.4 of the U.K.…