HanAll Biopharma Q2 2024 Financial Results and Business Update

HanAll Biopharma Co., Ltd., a global biopharmaceutical company, announced its financial results for the second quarter of 2024, reporting total revenue of 31.6 billion KRW. Despite this, the company faced an operating loss of 3.1 billion KRW, attributed to the absence of milestone revenues from its licensed partner. Nevertheless, sales revenue increased by 5.4% from the previous year, reaching 28.1 billion KRW, driven by the strong performance of key products.

In terms of business developments, HanAll has strengthened its collaboration with Turn Biotechnologies by signing an exclusive licensing agreement. This partnership aims to explore the potential of transient epigenetic reprogramming using Yamanaka factors, specifically targeting ophthalmic and otic diseases.

HanAll also reported significant progress in its clinical development programs. The company completed a Phase 1 first-in-human study of HL192 (ATH-399A) for Parkinson's Disease, with results expected in the latter half of 2024. Additionally, HanAll initiated the Phase 3 VELOS-4 study, which investigates tanfanercept for the treatment of dry eye disease (DED), with topline results anticipated in 2026.

In the realm of autoimmune diseases, HanAll continues to advance its anti-FcRn assets. The development program for HL161ANS (IMVT-1402) is making headway, with the potential for new studies to begin by the first quarter of 2025. Concurrently, top-line results from the ongoing Phase 2b study on batoclimab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and the Phase 3 study in generalized Myasthenia Gravis (gMG) are expected in the first quarter of 2025. The resubmission of the Biologics License Application (BLA) in China for gMG marks a pivotal milestone, bringing batoclimab closer to commercialization.

Moreover, a total of 10 additional studies are planned for HL161ANS (IMVT-1402), with initial studies expected to commence by the first quarter of 2025. The remaining indications are slated to start by the first quarter of 2026.

CEO of HanAll Biopharma, Sean Jeong, M.D., MBA, highlighted the progress in R&D, particularly the completion of the HL192 Phase 1 study in Parkinson's Disease, the initiation of the VELOS-4 Phase 3 study for dry eye disease, and the establishment of a licensing agreement with Turn Biotechnologies. Jeong emphasized the company's commitment to sustaining its investment in R&D through enhanced operational efficiency.

HanAll's public pipeline development update includes a comprehensive overview of its research, detailing compounds, targeted indications, and developmental phases. Noteworthy programs include:

AUTOIMMUNE DISEASES PROGRAMS

- Batoclimab (HL161BKN): A novel, fully human, subcutaneously administered antibody targeting FcRn, designed to selectively bind to FcRn and reduce harmful IgG antibodies. Batoclimab is being developed for multiple autoimmune diseases, with ongoing studies in Graves' disease, generalized Myasthenia Gravis (gMG), and Thyroid Eye Disease (TED).

- HL161ANS (IMVT-1402): Another fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG. Immunovant plans to initiate 4 to 5 potentially registrational studies by the first quarter of 2025, targeting a total of 10 indications by the first quarter of 2026.

OPHTHALMIC DISEASE PROGRAM

- Tanfanercept (HL036): A novel topical protein therapy for dry eye disease (DED), inhibiting TNF to reduce ocular inflammation. The Phase 3 VELOS-4 study is underway, with results expected in 2026.

NEUROLOGY PROGRAM

- HL192 (ATH-399A): A candidate targeting Nurr1 for the treatment of neurodegenerative diseases, including Parkinson's Disease. The Phase 1 study has been completed, with results expected in the second half of 2024.

ONCOLOGY PROGRAMS

- HL187 and HL186: Monoclonal antibodies targeting TIGIT and TIM-3, respectively. These are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

HanAll Biopharma remains dedicated to discovering and developing innovative medicines to address severe unmet medical needs, operating globally with a focus on immunology, oncology, neurology, and ophthalmology.

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