HanAll Biopharma Q3 2024 Financial Results and Business Update

HanAll Biopharma Co., Ltd., a global biopharmaceutical company based in Rockville, Maryland and Seoul, South Korea, has announced its financial results for the third quarter of 2024 along with significant business updates. HanAll reported a total revenue of 36.8 billion KRW for the third quarter, marking an 11.7% increase compared to the same period last year. The company also recorded an operating profit of 430 million KRW. Pharmaceutical sales were robust, contributing 34 billion KRW to the total revenue, driven by strong sales of key products.

In the third quarter, HanAll's anti-FcRn assets showed promise as leading treatments for various autoimmune diseases, most notably Graves' Disease. The company is currently conducting a Phase 2b trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Phase 3 trials for generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED). The topline results for these studies are expected in the first quarter and first half of 2025, respectively.

HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed a Phase 1 study of HL192 in healthy subjects. The results of this study are anticipated in November 2024.

Sean Jeong, MD, MBA, CEO of HanAll Biopharma, highlighted the company's focus on growth and commitment to research and development. He stated that HanAll aims to expand its competitive edge by specializing in key products and strengthening its R&D capabilities.

HanAll’s pipeline includes several noteworthy programs:

1. **Batoclimab (HL161BKN)**: This fully human antibody targets FcRn and is designed to treat IgG-mediated autoimmune diseases. Phase 3 studies for gMG and TED are ongoing, with results expected in the first quarter and first half of 2025. Batoclimab has shown positive results in a Phase 2a study for Graves' Disease, achieving a 76% response rate in patients not adequately controlled on antithyroid drugs.

2. **HL161ANS (IMVT-1402)**: Another fully human antibody targeting FcRn, designed to reduce IgG levels while minimizing interference with albumin recycling. Plans are underway to initiate several studies for IMVT-1402 across various indications, with registrational studies expected before the end of the first quarter of 2025.

3. **Tanfanercept (HL036)**: This novel therapy for ophthalmic diseases, including dry eye disease (DED), inhibits TNF and is currently in Phase 3 trials. The VELOS-4 study aims to assess the efficacy and safety of tanfanercept, with topline results expected in 2026.

4. **HL192 (ATH-399A)**: Developed in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, this candidate targets Nurr1 for the treatment of neurodegenerative diseases like Parkinson's Disease. The Phase 1 study has been completed, with results expected in November 2024.

5. **Oncology Programs**: HanAll has decided to discontinue its monoclonal antibody programs targeting TIM-3 and TIGIT following recent data outcomes and decisions from other global companies. The company is exploring new oncology targets for future development.

HanAll Biopharma, with a presence in Korea, the USA, Japan, and Indonesia, has been active for over 50 years, focusing on endocrine, circulatory, and urologic diseases. The company has recently expanded its focus to include immunology, oncology, neurology, and ophthalmology. Its lead pipeline assets include HL161 (batoclimab) and HL161ANS (IMVT-1402), both targeting autoimmune diseases, and HL036 (tanfanercept) for dry eye disease. HL192 (ATH-399A) is in development for Parkinson's Disease, with Phase 1 results expected soon.