- 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 (ERATM) 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. 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
- 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.
- Topline data from the Phase 3 study in generalized Myasthenia
Gravis (gMG) is also anticipated in the first quarter of 2025.
- 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.
- 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.
- 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
- 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.
- 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)
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).
- 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
|
(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.
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SOURCE HanAll Biopharma