On November 14, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, "HOOKIPA", the "Company"), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, reported financial results for the third quarter ended September 30, 2024 and provided recent business highlights, including an update on the progress of the lead clinical program, eseba-vec (Press release, Hookipa Pharma, NOV 14, 2024, View Source [SID1234648399]).

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"HOOKIPA made excellent progress across each program in our pipeline in the third quarter," said Malte Peters, MD, Chief Executive Officer of HOOKIPA. "We advanced the development of eseba-vec for HPV16+ head and neck squamous cell carcinoma (HNSCC), through the start of an investigator initiated study in the new clinical setting of adjuvant care, and presented continued positive, updated data from our Phase 2 study in first-line recurrent/metastatic disease as a late breaking abstract at SITC (Free SITC Whitepaper) 2024. In parallel, we have made significant progress with our review of the business strategy and operations, having implemented a number of initiatives to optimize spending and ensure prioritization of resources."

Recent Developments

Oncology

Eseba-vec: Pivotal-trial ready immunotherapy for human papilloma virus type 16 positive (HPV16+) cancers, including head and neck squamous cell carcinoma (HNSCC) and oropharyngeal squamous cell carcinoma (OPSCC). HOOKIPA owns all rights to this program

● Enrollment completed in the Phase 2 H200-001 study for eseba-vec in combination with pembrolizumab in HPV+ HNSCC with 68 patients enrolled as of October 2024.
● First Patients Dosed in Phase 2 Adjuvant Therapy IIT with MSKCC: On October 30, 2024, HOOKIPA announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) dosed the first patients in an investigator initiated trial (IIT) evaluating eseba-vec in patients with minimal residual disease positive (MRD+) HPV-16+ driven, locally advanced HNSCC, following treatment for curative intent. The study could pave the way to broaden the eseba-vec HNSCC opportunity into adjuvant care.
● Updated Phase 2 Data Presented as SITC (Free SITC Whitepaper) 2024 Late-Breaker: On November 9, 2024, HOOKIPA’s clinical collaborator, Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at MSKCC, presented a late-breaking poster at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024). The presentation provided updated results, including data from additional patients enrolled in the Phase 2 trial evaluating eseba-vec plus pembrolizumab as 1L treatment of recurring/metastatic HPV16+ HNSCC in patients with PD-L1 CPS levels of greater than or equal to 20. Eseba-vec treatment resulted in continued, durable clinical responses and antigen-specific T cell responses.

HB-700: The HB-700 program is a novel Phase 1-ready immunotherapy for KRAS-mutated cancers, including pancreatic, colorectal and lung cancer. The investigational therapy was designed to target the most prevalent KRAS mutations of these cancers in a single therapy. HOOKIPA owns all rights to this program and the Investigational New Drug Application (IND) received FDA clearance in April 2024.

● Presentation of Strong Preclinical Dataset: On September 25, 2024, HOOKIPA presented the preclinical proof-of-concept dataset for HB-700 at the 6th Annual RAS-Targeted Drug Development Summit. The dataset demonstrated that HB-700 induced target-specific CD8+ T cells and target cell killing in several different animal and translational models.

Infectious Diseases

HOOKIPA is advancing two independent anti-viral programs (HB-400 for HBV and HB-500 for HIV-1) through a collaboration and license agreement with Gilead Sciences, Inc. (Gilead).

HB-400: An investigational therapeutic vaccine for the treatment of chronic hepatitis B (CHB).

● Enrollment Completed in Phase 1a/1b Clinical Trial: The vaccine is being evaluated in a Phase 1a/1b clinical trial (NCT05770895) in 83 subjects to assess the safety and immune response induced by HB400 in healthy participants and in participants with CHB on oral antiviral therapy

HB-500: An investigational therapeutic vaccine for the treatment of human immunodeficiency virus-1 (HIV-1).

● Ongoing Phase 1b Clinical Trial: The vaccine is being evaluated in a Phase 1b clinical trial (NCT06430905) to assess the safety and magnitude of cellular immune response against HIV-1 induced by HB-500 in people living with HIV who are taking anti-retroviral treatment. Under the collaboration agreement with Gilead, HOOKIPA received a $5 million milestone payment associated with dosing of the first subject in this trial in July 2024.

Corporate and Financial Updates

Corporate Highlights

● Board of Director Changes: On August 30, 2024, Director Julie O’Neill was appointed to be Non-Executive Chair of the Company’s Board of Directors, succeeding Jan van de Winkel, who decided to step down from the Board due to increased time commitments from other executive responsibilities. Tim Reilly also stepped down from the Board to dedicate more time to his other professional responsibilities. HOOKIPA is grateful for the years of service each Director dedicated to the Company.

● Leadership Changes: On July 22, 2024, the Board of Directors appointed Malte Peters, MD, as Chief Executive Officer and Terry Coelho as Executive Vice President and Chief Financial Officer to lead the Company through its next phase of development and to realize the significant opportunity of HOOKIPA’s pipeline.

● Board Appointment: On July 22, 2024, Sean Cassidy was appointed to the Board of Directors. Mr. Cassidy serves as the chair of the Audit Committee and as a member of the Compensation and the Nominating and Corporate Governance Committees.

● Reverse Split: On July 9, 2024, the Company effected a reverse stock split of the outstanding shares of its common stock on a one-for-ten (1:10) basis. The reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

Financial Highlights: Milestone Payments

● Gilead: In July, HOOKIPA received a $5.0 million milestone payment under its collaboration and license agreement with Gilead. The success-based milestone payment was achieved in connection with the dosing of the first subject in the Phase 1b clinical trial of HB-500 for the treatment of HIV-1, initiated on July 1, 2024.

Third Quarter 2024 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2024 was $60.0 million compared to $117.5 million as of December 31, 2023. The decrease was primarily attributable to cash used in operating activities, partially offset by cash received relating to milestone achievements under our collaboration agreements with Roche and Gilead.Revenue: Revenue was $4.7 million for the three months ended September 30, 2024, compared to $6.9 million for the same period in 2023. The decrease was primarily due to lower partnering revenues as a result of the termination of the Roche collaboration agreement.

Research and Development Expenses: HOOKIPA’s research and development expenses were $15.6 million for the three months ended September 30, 2024, compared to $24.6 million for the same period in 2023. The primary changes in research and development expenses were lower personnel-related and laboratory-related expenses, as well as lower manufacturing and research expenses, resulting from the pause in development activities related to HB-300 announced in January 2024, partially offset by higher clinical study expenses for the eseba-vec program.

General and Administrative Expenses: General and administrative expenses amounted to $6.7 million for the three months ended September 30, 2024, compared to $4.9 million for the same period in 2023. The primary drivers of the increase in general and administrative expenses were an increase in personnel-related expenses and an increase in professional and consulting fees incurred in connection with management transitions during the third quarter of 2024.

Restructuring Expenses: Restructuring expenses amounted to $0.9 million for the three months ended September 30, 2024, and resulted from severance and other personnel costs as well as professional fees related to a reduction in workforce and related activities conducted in the third quarter of 2024.

Impairment Expenses: Impairment expenses amounted to $0.2 million for the three months ended September 30, 2024, and resulted from write-downs related to laboratory equipment.

Net Loss: HOOKIPA’s net loss was $13.8 million for the three months ended September 30, 2024, compared to a net loss of $19.1 million for the same period in 2023.