HOOKIPA Pharma Reports Second Quarter 2022 Financial Results and Corporate Updates
- HB-200 Phase 1 data presented at ASCO met all endpoints in heavily pre-treated head and neck cancer patients; Phase 2 study underway
- US Food and Drug Administration accepted HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer; Drug Master File accepted to support future regulatory submissions
NEW YORK and VIENNA, Austria, Aug. 11, 2022 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, today reported financial results for the second quarter of 2022 and Company updates.
“We continued to observe validation of our novel arenaviral platform in the second quarter with key Phase 1 data presented at ASCO for HB-200 in head and neck cancer and our plans to move forward with the Phase 2 program,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “We have expanded our clinical portfolio with the concurrent FDA acceptance of our investigational new drug application for HB-300 in prostate cancer and our Drug Master File. The Drug Master File is significant as it supports the implementation of our platform approach, facilitating reduced cycle time between preclinical studies and clinical entry of our pipeline projects across various cancer types.”
HOOKIPA Portfolio Highlights
- In July, HOOKIPA announced that the US FDA accepted HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer. A Drug Master File was also accepted, facilitating reduced cycle time between completion of preclinical studies and clinical entry of HOOKIPA’s pipeline projects.
- In June, HOOKIPA announced positive Phase 1 data and Phase 2 plans for HB-200 for the treatment of advanced head and neck cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting. Alternating 2-vector therapy showed superior antigen-specific T cell responses, more robust anti-tumor activity and similar tolerability vs. single-vector therapy. The Phase 2 trial will proceed with alternating 2-vector therapy alone and in combination with pembrolizumab, which will help inform the randomized Phase 2 trial planned to start in the first half of 2023.
- In June, HOOKIPA presented preclinical data on its novel arenaviral HIV therapeutic vaccines. The data were presented at the Keystone Symposium and highlighted robust and high-quality immune responses following administration of arenaviral therapeutic vaccines in a preclinical setting. Alternating 2-vector therapy induced greater immune response than single-vector therapy, translating to a significant reduction in viral load.
- In April, new data were announced at the American Association for Cancer Research (AACR) Annual Meeting showing HOOKIPA’s arenaviral immunotherapies induced potent T cell responses in novel combinations and against tumor self-antigens. Preclinical data also expanded evidence on arenaviral immunotherapy targeting self-antigens, reinforcing the scientific approach for the HB-300 program in prostate cancer.
HOOKIPA Leadership Updates
- In May, HOOKIPA announced the promotion of Christine D. Baker to Chief Operating Officer. Baker was previously Chief Business Officer for HOOKIPA.
- In June, HOOKIPA announced several executive leadership changes. Igor Matushansky, Chief Medical Officer and Global Head of Research and Development transitioned to Chair of HOOKIPA’s Scientific Advisory Board. Katia Schlienger, Senior Vice President and Head of Immuno-oncology was promoted to Executive Vice President, Clinical Development. Roman Necina, Chief Technology Officer, was appointed to the newly created role of Chief Development Officer.
Upcoming Anticipated Milestones
- Phase 2 HB-200 data in combination with pembrolizumab in HPV16+ head and neck cancer:
- First-line initial data expected in the second half of 2022
- Second-line initial data expected in the second half of 2022
- Randomized Phase 2 HB-200 study in combination with pembrolizumab in first-line for HPV16+ HNSCC: First half of 2023 (Fast Track designation)
- Hepatitis B therapeutic IND: 2022 (Gilead-led)
- Prostate cancer First Patient Enrolled expected in first quarter of 2023
Second Quarter 2022 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2022 was $118.9 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement and the follow-on financing in March 2022, partly offset by cash used in operating activities.
Revenue was $2.7 million for the three months ended June 30, 2022, compared to $5.4 million for the three months ended June 30, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead. The $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022 largely remained recorded as deferred revenue to be recognized in future accounting periods.
Research and Development Expenses: HOOKIPA’s research and development expenses were $16.1 million for the three months ended June 30, 2022, compared to $19.6 million for the three months ended June 30, 2021. The decrease for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs, a decrease in personnel-related expenses including stock-based compensation, and a decrease in laboratory consumables that was partially offset by an increase in professional and consulting fees and an increase in training and recruitment expenses.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2022 were $5.0 million, compared to $5.1 million for the three months ended June 30, 2021. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in other expenses that was partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses and the conversion of a portion of the base salaries of the Company’s executive team for the six months ended June 30, 2022 into common stock with a fair value below the conversion rate, that was partially offset by a growth in headcount along with increased salaries in our general and administrative functions.
Net Loss: HOOKIPA’s net loss was $16.4 million for the three months ended June 30, 2022 compared to a net loss of $17.2 million for the three months ended June 30, 2021. This decrease was primarily due to a decrease in research and development expenses.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.
Find out more about HOOKIPA online at www.hookipapharma.com.