HanAll Biopharma Reports Q2 2024 Financial Results and Provi..
- HanAll records revenue of 36.8 billion KRW in the third quarter, with an operating profit of 430 million KRW.
- Results for the Phase 1 study in healthy subjects for HL192 (ATH-399A), a novel compound targeting Parkinson’s Disease, are expected in November 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 third quarter of 2024 and provided businesss.
HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical
sales reached 34 billion KRW
from robust sales of key products.
Additionally, HanAll, in collaboration with
NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study
of HL192 in healthy subjects. Results for the HL192 Phase 1 study are
anticipated in November of this year.
“This past quarter, HanAll’s focus and
agile execution have positioned us for significant growth while allowing us to
continue our R&D efforts through strategic, value enhancing cost
optimization. Looking ahead, we are committed to expanding our competitive
advantage by specializing in key products and strengthening our R&D
capabilities as we strive to realize our highest potential as a global company,”
said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.
Third Quarter 2024 BUSINESS
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
- 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. Phase 3 studies
in gMG and TED are advancing, with topline results expected in the first
quarter of 2025 and first half of 2025, respectively.
- Immunovant reported positive results from
the Phase 2a study of batoclimab in Graves’ Disease. The study demonstrated
that a higher dose of batoclimab achieved a 76% response rate in patients who
were not adequately controlled on antithyroid drugs (ATDs) by 12 weeks of
treatment. The ATD-free response rate for these patients at the same time point
was 56%.
- Immunovant is progressing with subject enrollment
in the ongoing Phase 2b study for Chronic Inflammatory Demyelinating
Polyneuropathy (CIDP). The data obtained from this study will also be utilized
to refine the study design for a potential registrational program for IMVT-1402
in CIDP. Initial results from the first period of the Phase 2b study are
anticipated in the first quarter of 2025.
- 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), resubmitted the Biologics License
Application (BLA) for batoclimab to the National Medical Products
Administration (NMPA) in June 2024, which was accepted by the NMPA in July
2024. The BLA incorporated additional long-term safety data from the Phase
3 study in gMG which 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
a pivotal study in Graves’ Disease (GD) leveraging findings from the batoclimab
Phase 2a study in GD data. The results from the previous study indicate a
significant correlation between the reduction of IgG levels and clinical
outcomes, underscoring the potential of HL161ANS/IMVT-1402 as a best-in-class
treatment option for patients with GD.
- Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the conclusion of the first quarter of 2025. Additionally, the company plans to commence studies for IMVT-1402 across a total of up to 10 indications (in the aggregate) by the end of the first quarter of 2026. The company is also 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.
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
- HanAll
Biopharma and Daewoong Pharmaceutical are conducting the Phase 3 VELOS-4 study to
evaluate the efficacy and safety of tanfanercept in dry eye disease. The
topline results for the study are expected in 2026.
- 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.
- 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)
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 decided to discontinue its monoclonal antibody
programs targeting TIM-3 and TIGIT, following the recent data outcomes and
decisions from other global companies to cease their programs. HanAll is
exploring the potential for developing a new asset for a different oncology target.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) |
Q3 2024 |
Q3 2023 |
% change |
Sales |
36.8 |
33 |
11.7% |
Gross Profit |
19.8 |
17.5 |
13.1% |
Selling, marketing and administrative expenses |
13.4 |
12.9 |
3.8% |
Research and development expenses |
5.9 |
4.6 |
28.3% |
Operating income |
0.4 |
0.09 |
377.8% |
Net Income |
0.2 |
0.3 |
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), another anti-FcRn antibody from HanAll, is being evaluated in multiple indications including GD.
Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a 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, with results to be announced in November 2024.
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
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results may differ materially from those predicted by the forward-looking
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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
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