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- HanAll reports strong financial performance with second quarter total revenue of 31.6 billion KRW, driven by the strong sales from the key products.

- HanAll expands collaboration with Turn Biotechnologies through an exclusive licensing agreement for Epigenetic Reprogramming of Aging (ERA^TM) technology, targeting ophthalmic and otic diseases.

- Progress in clinical development programs continued including the completion of Phase 1 study for HL192 (ATH-399A) in Parkinson’s Disease, with results expected in the second half of 2024 and initiation of VELOS-4 Phase 3 study on tanfanercept for Dry Eye Disease.

Rockville, MD, Seoul, KR - July 26, 2024 

HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the second quarter of 2024 and provided businesss.

HanAll ended the second quarter with total revenue of 31.6 billion KRW and an operating loss of 3.1 billion KRW. Sales revenue reached 28.1 billion KRW, reflecting a 5.4% increase from the same period in 2023, bolstered by robust sales of key products. The overall profitability for the second quarter turned to a loss due to the absence of milestone revenues from the licensed partner.

Within the past quarter, HanAll strengthened its relationship with Turn Biotechnologies, a company founded on licensed technologies from Stanford, culminating in an exclusive licensing agreement to explore the potential of transient epigenetic reprogramming with the use of Yamanaka factors for ophthalmic and otic diseases.

HanAll also completed a Phase 1 first in human study of HL192 (ATH-399A) targeting Parkinson’s Disease, with results anticipated in the second half of 2024.

HanAll's research and development efforts have achieved significant progress with the initiation of the Phase 3 VELOS-4 study investigating tanfanercept for dry eye disease (DED), with the topline results expected in 2026.

Progress in anti-FcRn assets continued, with the potential advancement of HL161ANS (IMVT-1402)’s development program. Top-line results are anticipated from the ongoing batoclimab Phase 2b study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Phase 3 study in generalized Myasthenia Gravis (gMG) in the first quarter of 2025. Additionally, the resubmission of the Biologics License Application (BLA) in China for gMG marked a significant milestone, bringing batoclimab one step closer to commercialization.

A total of 10 additional studies are being planned for HL161ANS (IMVT-1402). The initiation of studies for the first 4 to 5 potentially registrational studies is slated to begin by the first quarter of 2025. The remaining indications are slated to be initiated by the first quarter of 2026.

“HanAll made a meaningful progress in our R&D in the second quarter, including the completion of the HL192 Phase 1 study in PD, the initiation of the VELOS-4 Phase 3 study for dry eye, and the establishment of a licensing agreement with Turn.bio to develop medicines for age-related diseases. We will sustain our investment in R&D through enhancing efficiency of our operations," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

Second Quarter 2024 BUSINESS UPDATE

Pipeline Development Highlights

A comprehensive of HanAll’s public pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phases.

AUTOIMMUNE DISEASES PROGRAMS

Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases, batoclimab is designed toively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies

l  Immunovant, a member of the Roivant group of companies as well as HanAll's licensed partner in the United States and Europe, is making progress across four autoimmune indications. Results from the batoclimab study in Graves’ disease are expected in fall of 2024 from Immunovant. Phase 3 studies in gMG and TED are advancing.

l  Topline data from the Phase 3 study in generalized Myasthenia Gravis (gMG) is also anticipated in the first quarter of 2025.

l  Progress continues in the Phase 3 study for Thyroid Eye Disease (TED), with the top-line results also projected in the first half of 2025.

l  Regarding the ongoing Phase 2b Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) study, Immunovant has decided to extend the duration of the study in order to optimize the study design for IMVT-1402 in CIDP. Following this decision, initial results from period 1 of the Phase 2b study in CIDP are expected in the first quarter of 2025.

l  Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), has resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024. The BLA incorporated supplementary long-term safety data from the Phase 3 study in gMG, concluded in June 2023.

HL161ANS (IMVT-1402)

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions, while minimizing interference with albumin recycling

·        Immunovant plans to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the end of first quarter of 2025, following a recent Type B meeting with the FDA (Food and Drug Administration). The company plans to initiate studies on IMVT-1402 in a total of 10 indications before the end of the first quarter of 2026.

·        Immunovant is exploring initiating a registrational development in gMG with IMVT-1402.

·        Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab. This process involves extending the duration of Phase 2b study in batoclimab in CIDP and incorporating learnings from the previous studies.

·        Immunovant also plans to provide an overview of the development program for HL161ANS/IMVT-1402 in Grave’s disease (GD) in the second half of 2024.

OPHTHALMIC DISEASE PROGRAM

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation

l  HanAll Biopharma and Daewoong Pharmaceutical initiated the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye. The topline results for the VELOS-4 study is expected in 2026.

l  The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group.

l  The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval.

NEUROLOGY PROGRAM

HL192 (ATH-399A)

A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School’s Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

l  The Phase 1 study of HL192, being jointly developed by HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals, has completed dosing with the results expected in the second half of 2024.

ONCOLOGY PROGRAMS

HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

·        HanAll is continuing with the pre-clinical development of the HL187 (anti-TIGIT) asset and plans to evaluate the further development of HL186 (anti-TIM-3) based on the strategic portfolio review.

FINANCIAL HIGHLIGHTS (CONSOLIDATED) 

Key Highlights 

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years.

HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD). HL161ANS (IMVT-1402), an anti-FcRn antibody targeting multiple indications, is being evaluated in a Phase clinical study (healthy volunteers).

Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease.

HL192 (ATH-399A), a Nurr1 activator targeting Parkinson’s Disease, has completed a Phase 1 study in healthy volunteers.

For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

Disclaimer Statement 

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.