HOOKIPA Pharma Q1 2024 Financial Results and Business Highlights

HOOKIPA Pharma Inc., based in New York and Vienna, has announced significant financial results and progress in its recent business initiatives for the first quarter of 2024. The company, which focuses on developing innovative immunotherapies using its proprietary arenavirus platform, is advancing towards key clinical trials and expanding its executive team.

The first quarter of 2024 marked a period of strategic focus for HOOKIPA as it prepares for a pivotal Phase 2/3 trial for HB-200 in combination with pembrolizumab. This trial, designed for patients with HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC), aligns with feedback from the U.S. Food and Drug Administration (FDA). CEO Joern Aldag expressed confidence in the trial's design and its potential to improve patient outcomes, highlighting the addition of Mark Winderlich as Chief Development Officer to strengthen the company's clinical development capabilities.

The HB-200 program received a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), which aims to expedite the development and review process based on promising early clinical data. The company plans to enroll the first patient in this trial by the fourth quarter of 2024 and will present data from approximately 40 patients at the ASCO 2024 Annual Meeting.

In addition to oncology, HOOKIPA is making strides in its HB-700 program, an investigational therapy targeting KRAS-mutated cancers. The FDA has cleared the company's Investigational New Drug (IND) application for HB-700, enabling further development of this promising treatment for cancers such as lung, pancreatic, and colon cancer. HOOKIPA has regained full control of the program's intellectual property and collaboration rights as of April 25, 2024.

In the infectious disease sector, HOOKIPA continues its collaboration with Gilead Sciences, Inc. on two key programs. The HB-400 program, designed for hepatitis B virus (HBV), is currently in Phase 1 trials under Gilead's lead. Meanwhile, the HB-500 program, a potential therapeutic vaccine for human immunodeficiency virus (HIV), received FDA clearance for its IND application in late 2023. HOOKIPA expects to begin a Phase 1 clinical trial for HB-500 in the second quarter of 2024, with a milestone payment due upon dosing the first patient.

Financially, HOOKIPA reported total revenues of $36.6 million for the first quarter of 2024, a significant increase from $3.2 million in the same period of 2023. This boost was primarily due to the recognition of previously received upfront and milestone payments from their Roche collaboration, which has since been terminated. Consequently, the company reported a net income of $14.4 million for the first quarter of 2024, compared to a net loss of $19.7 million for the same period in the previous year.

The company's research and development expenses were slightly lower at $20.2 million, down from $20.9 million in the first quarter of 2023, mainly due to reduced personnel and laboratory costs offset by higher clinical study expenses for the HB-200 program. General and administrative expenses also saw a decrease, amounting to $4.1 million compared to $4.9 million previously, attributed to lowered personnel-related expenses.

HOOKIPA's cash, cash equivalents, and restricted cash totaled $93.0 million as of March 31, 2024, down from $117.5 million at the end of 2023, reflecting cash used in operating activities.

In summary, HOOKIPA is progressing well in its clinical trials and strategic collaborations, showing promising financial health and potential for substantial advancements in both oncology and infectious disease therapies.