HOOKIPA Pharma Q2 2024 Financial Results and Business Highlights

HOOKIPA Pharma Inc., a biopharmaceutical firm focusing on innovative immunotherapies, reported significant updates for the second quarter of 2024. The company, which uses its proprietary arenavirus platform to develop treatments, showcased notable progress in both leadership and clinical development.

New Leadership Appointments:
In mid-2024, HOOKIPA appointed Malte Peters as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer. Peters expressed optimism about the company’s future, emphasizing the robustness of HOOKIPA's pipeline and the dedication of its team. Coelho highlighted a focus on clinical execution and operational excellence, aiming to ensure the company’s financial health aligns with its ambitious goals.

Positive Clinical and Regulatory Reports for the Lead Product Candidate, HB-200 (eseba-vec):
One of HOOKIPA's primary advancements is with their lead product candidate, eseba-vec. At the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, HOOKIPA presented best-in-class Phase 2 data for eseba-vec combined with pembrolizumab. This treatment is designed for patients with HPV16+ head and neck cancer, demonstrating significant promise and generating momentum among clinical investigators.

Regulatory Progress:
HOOKIPA announced alignment with the U.S. Food and Drug Administration (FDA) on the design and protocol for the AVALON-1 Phase 2/3 pivotal trial. This trial will assess eseba-vec in combination with pembrolizumab for first-line treatment of HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC). The company is set to initiate this trial in Q4 2024. Furthermore, the European Medicines Agency (EMA) granted PRIME designation for eseba-vec in treating patients with HPV16+ recurrent or metastatic PD-L1 CPS ≥ 20 OPSCC.

New IND Clearance in Oncology:
The FDA also cleared HOOKIPA's Investigational New Drug (IND) application for HB-700, a novel therapy targeting KRAS-mutated cancers. This treatment addresses mutations responsible for major cancers like lung and pancreatic cancer. Preclinical data showcased at the ASCO 2024 Annual Meeting indicated that HB-700 effectively induced KRAS mutation-specific T cell responses in transgenic mice.

Initiation of HIV Study with Partner, Gilead:
In collaboration with Gilead Sciences, HOOKIPA dosed the first patient in a Phase 1b clinical trial of HB-500, an investigational therapeutic vaccine for HIV. This milestone resulted in a $5 million payment from Gilead under their collaboration agreement. The partnership also focuses on developing HB-400 for chronic hepatitis B (HBV), with Gilead overseeing its further development and commercialization.

Corporate and Financial Updates:
HOOKIPA executed a one-for-ten reverse stock split in July 2024 to comply with Nasdaq's minimum bid price requirements. Financially, the company reported a decrease in revenue to $1.3 million for Q2 2024 from $2.7 million in the same period the previous year, primarily due to the termination of its collaboration with Roche. Research and development expenses remained stable at $19.7 million, with a focus on clinical study expenses for eseba-vec. General and administrative expenses saw a decrease, attributed to lower personnel and consulting fees. The net loss for the quarter was $19.1 million, slightly higher than the $18.0 million for the same period in 2023.

Looking ahead, HOOKIPA has crucial objectives, including starting the pivotal AVALON-1 study of eseba-vec and advancing their collaborative projects with Gilead. With strong leadership and a strategic focus on innovative therapies, HOOKIPA aims to make significant strides in improving treatments for cancer and infectious diseases.