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ROCKVILLE, Md. and SEOUL, South Korea, July 26, 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 the second quarter of 2024 and provided business updates.
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 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 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 FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies
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
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
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).
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.
FINANCIAL HIGHLIGHTS (CONSOLIDATED) Key Highlights |
|||
(KRW in billion) |
Q2 2024 |
Q2 2023 |
% change |
Sales |
31.6 |
41.4 |
-23.7 % |
Gross Profit |
15.9 |
27.2 |
-41.6 % |
Selling, marketing and administrative expenses |
12.6 |
11.3 |
+11.2 % |
Research and development expenses |
6.4 |
7.8 |
-18.0 % |
Operating income |
(3.1) |
8.1 |
N/A |
Net Income |
(3.3) |
7.3 |
N/A |
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 update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.