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HanAll Biopharma Reports Q1 2024 Financial Results and Provides Business Update

Delivered solid performance to start 2024, with record-breaking first quarter revenue of 34.1 billion KRW. Strong sales momentum continued from key products, funding investments in ongoing R&D programs. Phase 3 VELOS-4 study of tanfanercept in dry eye disease expected to be initiated in the second quarter, alongside the expected initial data release from the Phase 2b study of batoclimab in CIDP, projected to occur either in the second or third quarter. Top-line results from HL192 (ATH-399A) Phase 1 study for Parkinson's Disease expected in the second half of 2024. ROCKVILLE, Md. and SEOUL, South Korea, April 30, 2024 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for first quarter 2024 and provided business updates. HanAll Biopharma achieved 18.4 percent revenue growth in the first quarter compared to the same period last year, recording a revenue of 34.1 billion Korean Won (KRW), driven by continued strong sales across key products. The operation income recorded 0.1 billion KRW. Advancements in R&D programs continued, with HL161ANS (IMVT-1402), a second-generation antibody targeting IgG-mediated autoimmune diseases, securing a joint patent in the U.S. from the United States Patent and Trademark Office (USPTO). Additionally, initial data readouts from batoclimab Phase 2b study in Chronic inflammatory demyelinating polyneuropathy (CIDP) are anticipated in mid-2024. Preparation for the Phase 3 VELOS-4 study in dry eye disease continued throughout the first quarter, with plans to initiate the VELOS-4 study in the second quarter. The HL192 (ATH-399A) Phase 1 study for Parkinson's Disease (PD) progressed in the first quarter 2024 and top-line results are expected in the second half of 2024. "We are pleased to end the first quarter with solid performance, driven by our anti-FcRn assets and our momentum of innovations." said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. "As we continue to advance our clinical programs and explore new opportunities, we remain confident that we are well-positioned for continued growth and success in the global market," he added. First Quarter 2024 BUSINESS UPDATEPipeline Development Highlights A comprehensive update of HanAll's public pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phases. AUTOIMMUNE DISEASES PROGRAMSBatoclimab (HL161BKN) A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies. Immunovant, a member of the Roivant group of companies, HanAll's licensed partner in the United States and Europe, is advancing the Phase 2b clinical trial in Chronic inflammatory demyelinating polyneuropathy (CIDP), aiming to attain initial results from period 1 in the second or third quarter of 2024. The top-line data from the Phase 3 study in gMG and Thyroid eye disease (TED) are anticipated in the second half of 2024 and the first half of 2025, respectively. Harbour BioMed, which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in their respective region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma) is a licensed partner in China. They intend to resubmit the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024, incorporating ...