HOOKIPA Pharma (HOOK) Q2 2024 earnings summary

Executive summary

• HOOKIPA is a clinical-stage biopharma focused on arenavirus-based immunotherapeutics, prioritizing oncology and infectious disease programs.

• Strategic refocus in Q2 2024 led to workforce reduction (~30%) and discontinuation of GMP facility project.

• Reported best-in-class Phase 2 data for eseba-vec in HPV16+ head and neck cancer at ASCO 2024, supporting ongoing and future pivotal trials.

• Eseba-vec (HPV16+ head and neck cancer) and Gilead-partnered HBV/HIV programs are current development priorities.

• Leadership changes in July 2024: new CEO, CFO, and Board member appointed, with severance for outgoing executives.

Financial highlights

• Revenue for Q2 2024 was $1.3M, down from $2.7M in Q2 2023; six-month revenue rose to $37.9M from $5.9M due to accelerated recognition from Roche contract termination.

• Net loss was $19.1M for Q2 2024 and $4.7M for the six months ended June 30, 2024, compared to $18.0M and $37.7M in the prior year periods.

• Cash, cash equivalents, and restricted cash totaled $77.4M as of June 30, 2024, down from $117.5M at year-end 2023.

• Research and development expenses were $19.7M in Q2 2024, flat year-over-year; six-month R&D was $39.9M, slightly down from $40.6M.

• Received $10M milestone from Roche in April and $5M from Gilead in July 2024.

Outlook and guidance

• Substantial doubt exists regarding ability to continue as a going concern for at least 12 months; additional funding is required.

• Plans to initiate AVALON-1 Phase 2/3 trial for eseba-vec in Q4 2024; regulatory alignment with FDA and EMA PRIME designation achieved.

• HB-700 program for KRAS-mutated cancers regained full rights and cleared IND; partnering options under evaluation.

• HB-400 (HBV) Phase 1b enrollment to complete and Phase 2 start timing to be determined by Gilead.

• Ongoing pursuit of capital through equity, debt, grants, or collaborations; $50M ATM program established with Jefferies in August 2024.