On August 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the second quarter of 2021 (Press release, Hookipa Biotech, AUG 12, 2021, View Source [SID1234586380]).
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"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 (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper), 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) (Free AACR Whitepaper) (‘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) (Free ASCO Whitepaper) (‘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 June 30, 2021, compared to $11.6 million for the three months ended June 30, 2020.
The primary drivers of the increase in direct research expenses were an increase in manufacturing and quality control expenses of $1.6 million, and an increase in clinical operations expenses of $1.4 million, along with a general increase in other direct research and development expenses and laboratory expenses of $2.4 million. These expenses were mainly due to the progress in our HB-201 and HB-202 clinical trial, in particular for monitoring and testing activities, and manufacturing and quality control work in preparation of a further extension of the trial. Manufacturing and quality control expenses were also driven by the progress towards clinical development in our Gilead-partnered programs.
Internal research and development expenses increased by $2.6 million, mainly due to our increased research and development headcount.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $5.1 million, compared to $4.3 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel-related expenses, partially offset by a decrease in professional and consulting fees. The increase in personnel-related expenses resulted from a growth in headcount along with increased salaries in our general and administrative functions, and increased stock compensation expenses.
Net Loss: HOOKIPA’s net loss was $17.2 million for the three months ended June 30, 2021, compared to a net loss of $7.1 million for the three months ended June 30, 2020. This increase was due to an increase in research and development expenses, an increase in general and administrative expenses, a decrease in revenues from collaboration and licensing and a decrease in other income, partially offset by an increase in grant income.