| ● | Following the submission of the clinical trial application (IND equivalent) for HB-400, a Hepatitis B therapeutic, in 2022, HOOKIPA expects the first patient to be dosed in a Phase 1 clinical trial during 2023. |
Upcoming Milestones
| ● | First patient enrolled in HB-300 Phase 1 study (prostate cancer) expected in the first quarter of 2023 |
| ● | Phase 2 HB-200 data in combination with pembrolizumab in the first- and second-line setting for HPV16+ head and neck cancer expected in the first half of 2023 |
| ● | Randomized Phase 2 HB-200 study in combination with pembrolizumab in the first-line setting for HPV16+ head and neck cancer expected to launch in 2023 (Fast Track designation) |
| ● | Phase 2 HB-101 data for the prevention of Cytomegalovirus (CMV) in kidney transplant recipients expected in the first half of 2023 |
| ● | HB-400 Hepatitis B therapeutic (Gilead-led): first patient dosed 2023 |
Third Quarter 2022 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2022 was $100.7 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.
HOOKIPA’s cash position as of September 30, 2022 does not include a $25.0 million upfront payment that the Company is entitled to receive under the strategic collaboration and licensing agreement signed with Roche in October 2022 and up to $30.0 million from the issuance of common stock that Gilead is required to purchase at the discretion of the Company pursuant to the terms of a stock purchase agreement signed in February 2022
Revenue: Revenue was $2.2 million for the three months ended September 30, 2022, compared to $3.9 million for the three months ended September 30, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead as Hookipa neared completion of HBV program assets in preparation for Gilead to progress with a Phase 1 clinical trial. The main parts of the $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022, remained recorded as deferred revenue to be recognized in future accounting periods.
Research and Development Expenses: HOOKIPA’s research and development expenses were $18.3 million for the three months ended September 30, 2022, compared to $20.7 million for the three months ended September 30, 2021. The decrease for the three months ended September 30, 2022, compared to the three months ended September 30, 2021, was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs, a decrease in laboratory consumables, and a decrease in personnel-related expenses including stock-based compensation that was partially offset by an increase in training and recruitment expenses..
General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2022, were $4.9 million, compared to $4.3 million for the three months ended September 30, 2021. The increase was primarily due to an increase in professional and consulting fees and an increase in training and recruitment expenses that was partially offset by a decrease in personnel-related expenses and a decrease in other expenses. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, 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 $18.3 million for the three months ended September 30, 2022, compared to a net loss of $20.0 million for the three months ended September 30, 2021. This decrease was primarily due to a decrease in research and development expenses.
