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l  Sales recorded KRW 41.4 billion, a 58 percent increase from the same period in 2022, due to sustained robust growth of major products in addition to milestone revenues from the progress in clinical programs of batoclimab.

l  Multiple clinical development milestones have been reached, including the announcement of the VELOS-3 top-line result and the submission of a BLA for batoclimab in China.

l  The collaborations to develop disease-modifying medicines with the potential to become treatments for neurodegenerative diseases continued in the second quarter.

Rockville, MD, Seoul, KR – July 28, 2023  

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 and provided business updates.

HanAll ended the quarter with total revenue of 41.4 billion won, an increase of 58 percent compared to the same period last year, and an operating profit of 8.1 billion won. Net profit recorded 7.3 billion won due to the continued growth of its pharmaceutical products and milestone revenues from the licensed partner.

"We are pleased to announce another successful quarter with strong sales growth and significant advancements in clinical developments. We achieved a meaningful result from the tanfanercept Phase 3 study for dry eye disease, while batoclimab progressed another step further towards commercialization in China. Our commitment to innovation is evident by portfolio expansion and fruitful collaborations in the neurodegenerative domain," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"In the second half 2023, we anticipate the initiation of a Phase 1 clinical study on Parkinson's disease (PD), along with the initial results from the anti-FcRn assets batoclimab in Grave’s disease and Phase 1 study of HL161ANS. In addition, we anticipate finalizing the next Phase 3 clinical study design for tanfanercept this year. These upcoming milestones exemplify our dedication to advancing innovative medicines, and we will continue to push the boundaries of science and steadfastly pursue our mission to improve patient outcomes," he added.

SECOND QUARTER 2023 BUSINESS UPDATE  

Pipeline Development Highlights 

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

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 to selectively bind to and inhibit FcRn, which plays a role in recycling IgG, thus may reduce harmful IgG antibodies.

l  Harbour BioMed, a licensed partner of HanAll in China, announced the official acceptance of the Biologics License Application (BLA) for batoclimab for the treatment of generalized myasthenia gravis (gMG) in June 2023, based on the positive topline result from the Phase 3 clinical trial in early March this year. The data from the Phase 3 clinical trial met the primary efficacy endpoint as well as key secondary endpoints with a favorable profile. Batoclimab received the ‘Breakthrough Therapy Certificate’ from NMPA in 2021.

l  Another licensed partner, Immunovant, located in the U.S. and Europe, is currently carrying out global Phase 3 trials on batoclimab in both gMG and TED. The initial results from the Phase 2 trial evaluating batoclimab in Grave’s disease (GD), is expected in the fourth quarter of 2023. The company expects initial results from the pivotal Phase 2b trial of CIDP in the first half of 2024.

l  HanAll is progressing towards the initiation of a Phase 3 clinical study of batoclimab in gMG in Japan this year. Additionally, HanAll is exploring options for developing batoclimab for TED and chronic inflammatory demyelinating polyneuropathy (CIDP) in Japan.

HL161ANS

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.

l  Immunovant is progressing a Phase 1 clinical trial of HL161ANS, a new FcRn inhibitor (Immunovatnt project designation: IMVT-1402), in New Zealand to evaluate the safety, pharmacokinetics, and pharmacodynamics profile in healthy patients. The Initial data readout for single-ascending dose (SAD) cohorts is expected in third quarter of 2023, and multi-ascending dose (MAD) cohorts are expected in the fourth quarter of 2023. Immunovant also received IND clearance for HL161ANS from the U.S. Food and Drug Administration (FDA) in the second quarter of 2023.

OPHTHALMIC DISEASE PROGRAMS

Tanfanercept (HL036)

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

l  HanAll Biopharma and Daewoong Pharmaceutical announced the top-line results from the Phase 3 VELOS-3 trial evaluating tanfanercept ophthalmic solution for the treatment of DED in May 2023. The Phase 3 VELOS-3 did not demonstrate statistical significance in either of the primary outcome measures of improvement in central corneal staining score (CCSS) or improvement in Eye Dryness Score (EDS) assessed at week 8 in subjects with moderate to severe DED. However, the solution demonstrated a highly statistically significant improvement in the secondary efficacy endpoint of the unanesthesized Schirmer test evaluating the change in tear volume from baseline in patients treated with tanfanercept compared to the vehicle arm assessed at week 8. HanAll and Daewoong plan to finalize the next study design within the second half of 2023 and intend to discuss VELOS-3 data and future plans with the FDA, with plans to begin the next study in the first half of 2024.

l  Previous notices reflected a significant improvement of p < 0.001 in the secondary efficacy endpoint of unanesthesized Schirmer testing to quantify change from baseline in tear volume in tanfanercept treatment arm relative to vehicle arm assessed at week 8 as well as a statistically different rate of the proportion of subjects whose Schirmer test improved from baseline by 10mm or greater at week 8 in tanfanercept arm (15%) relative to vehicle arm (4%), p < 0.001. Further analyses have revealed an update to those percentages and to the p-values, although there are no interpretation changes. The secondary efficacy endpoint of unanesthesized Schirmer testing to quantify the change from baseline in tear volume in tanfanercept treatment arm relative to vehicle arm assessed at week 8 demonstrated a significant improvement (p = 0.002). Additionally, the proportion of subjects whose Schirmer test improved from baseline by 10mm or greater as assessed at week 8 was statistically significant (p = 0.011) in the tanfanercept arm (13%) relative to the vehicle arm (4%).

l  Harbour BioMed, a licensed partner of HanAll in China, is discussing further development plans for tanfanercept in China.

ONCOLOGY PROGRAMS

HL187/ HL186

Monoclonal antibodies that respectively target T cell immunoreceptors with immunoglobulin (Ig) and ITIM (Immunoreceptor tyrosine-based inhibitory moti)} domains (TIGIT) and T cell Ig and mucin domain-3 (TIM-3) are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments

l  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.  

NEUROLOGY PROGRAMS

HL192

A pipeline candidate originated from NurrOn Pharmaceuticals that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD) 

l  HanAll entered into joint clinical development with NurrOn Pharmaceuticals and Daewoong Pharmaceutical to develop NurrOn’s leading asset HL192 (NurrOn project designation: ATH-399A) which will be evaluated in an array of neurodegenerative diseases with the primary area of focus targeting PD. The Phase 1 clinical study of HL192 in healthy participants is expected to be initiated this year.

FINANCIAL HIGHLIGHTS (CONSOLIDATED) 

Key Highlights 

Sales recorded 41.4 billion won in the second quarter of 2023, a 58 percent increase compared to the second quarter of 2022. Strong sales growth from pharmaceuticals continued from major products sold under the names of Biotop, Eligard, and Normix, with Biotop recording sales growth of 70% compared to the same period last year.

Research and development expenses for the second quarter ended June 30, 2023, were 7.8 billion won, up 111 percent from 3.7 billion won for the three months ended June 30, 2022.

Net income for the three months ended June 30, 2023, recorded 7.3 billion won, due to an increase in milestone revenue and pharmaceutical sales.

About HanAll Biopharma Co., Ltd.

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presences in Korea, the USA, Japan, and Indonesia, with a 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 areas ranging from endocrine, circulatory, and urologic diseases for 50 years.

HanAll has also expanded its focus to ophthalmology, immunology, oncology, and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, 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 myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF-alpha inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. 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 2023 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 update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.