On May 9, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and recent business highlights for the first quarter of 2024 (Press release, Hookipa Biotech, MAY 9, 2024, View Source [SID1234642992]).
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"The first quarter was about focus at HOOKIPA. We are embarking on a pivotal trial for HB-200 in combination with pembrolizumab and made important decisions to align our organization for late-stage clinical trial execution. We also added to the depth of our executive team with a new Chief Development Officer, Mark Winderlich, who brings crucial experience to help us execute on our clinical development strategy," said Joern Aldag, Chief Executive Officer of HOOKIPA. "We have made great progress and have an FDA-aligned pivotal Phase 2/3 trial design that is patient-centric and we believe has a high probability of success. Our path forward is clear, and the team is excited to take a major step on our path to deliver better outcomes for patients."
Business Highlights and Recent Developments
Oncology
HOOKIPA is preparing to start a seamless pivotal Phase 2/3 trial of HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting.
The Phase 2/3 trial design and protocol are based on alignment with the FDA following the Company’s Type C meeting.
EMA granted PRIME designation to the investigational product HB-200 in combination with pembrolizumab. PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. Eligibility and approval are based on preliminary clinical evidence and indicate that the drug candidate may offer substantial improvement over existing therapies.
The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. HB-200 was accepted for an oral abstract presentation at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab.
The HB-700 program is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers. The Company received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700 for the treatment of KRAS-mutated cancers. Effective April 25, 2024, HOOKIPA regained full control of the associated intellectual property portfolio and has full collaboration and licensing rights for this program.
Infectious Disease
HB-400 is currently being evaluated in a Phase 1 trial and is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. (Gilead). Gilead is solely responsible for further development and commercialization of the HBV product candidate.
HB-500 is an investigational therapeutic vaccine for the treatment of human immunodeficiency virus (HIV), also partnered with Gilead. HOOKIPA received FDA clearance of its IND application in the fourth quarter of 2023 and expects to initiate a Phase 1 clinical trial of HB-500 in people with HIV in the second quarter of 2024. Under the collaboration agreement with Gilead, HOOKIPA is eligible for a milestone payment upon dosing the first patient in this trial.
Corporate and Financial Updates
Corporate Highlights
On January 29, 2024, HOOKIPA provided an update on its business priorities and oncology partnership programs. The Company announced that it will focus its resources in two strategic areas: (1) the clinical development of a randomized trial for its HB-200 program and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and HIV.
Mark Winderlich, Ph.D., joined the Company on April 1, 2024, as Chief Development Officer to lead HOOKIPA’s clinical research and development organization.
Financial Highlights
HOOKIPA received a final $10.0 million milestone payment under its now-terminated HB-700 collaboration agreement with Roche. The success-based milestone payment was achieved in connection with HOOKIPA’s submission of an IND application for HB-700 for the treatment of KRAS mutated tumors.
Total revenues of $36.6 million, mainly driven by the recognition of previously received upfront and milestone payments under the now-terminated Roche collaboration, as well as the recent HB-700 milestone achievement, led to a profitable first quarter of 2024.
Anticipated Catalysts & Milestones
Program Indication Upcoming Anticipated Catalysts
Oncology Programs
HB-200 HPV16+ HNSCC
Additional Phase 2 first-line data for HB-200 in combination with pembrolizumab (ASCO 2024)
Pivotal study start (4Q 2024)
HB-700 KRAS
Publication of preclinical data (ASCO 2024)
Infectious Disease Programs: Gilead-Partnered
HB-400 HBV
Gilead-led: Phase 1b actively enrolling
Next milestone: Initiation of Phase 2
(timing determined by Gilead)
HB-500 HIV
Initiation of Phase 1 trial; first patient dosed and associated milestone payment (2Q 2024)
First Quarter 2024 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of March 31, 2024 was $93.0 million compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities.
Revenue: Revenue was $36.6 million for the three months ended March 31, 2024, compared to $3.2 million for the same period in 2023. The increase was primarily due to higher partial revenue recognition under the Roche collaboration as a result of the termination of the agreement, leading to accelerated recognition of the upfront and milestone payments that were initially recorded as deferred revenue.
Research and Development Expenses: HOOKIPA’s research and development expenses were $20.2 million for the three months ended March 31, 2024, compared to $20.9 million for the same period in 2023. The primary drivers of the decrease in research and development expenses were lower personnel-related and laboratory-related expenses, partially offset by higher clinical study expenses for the HB-200 program.
General and Administrative Expenses: General and administrative expenses amounted to $4.1 million for the three months ended March 31, 2024, compared to $4.9 million for the same period in 2023. The primary driver of the decrease in general and administrative expenses was a decrease in personnel-related expenses.
Restructuring Expenses: Restructuring expenses amounted to $1.3 million for the three months ended March 31, 2024, and resulted from severance and other personnel costs as well as consulting costs associated with the Company’s restructuring plan announced in January 2024.
Net Income (Loss): HOOKIPA’s net income was $14.4 million for the three months ended March 31, 2024, compared to a net loss of $19.7 million for the same period in 2023. This increase was primarily due to the accelerated recognition of upfront and milestone payments under the Roche collaboration.