HanAll Biopharma Invests in Interon to Seek Collaboration Op..
- Delivered solid performance to start 2024, with record-breaking first quarter revenue of 34.1 billion KRW. Strong sales momentum continued from key products, funding investments in ongoing R&D programs.
- Phase 3 VELOS-4 study of tanfanercept in dry eye disease expected to be initiated in the second quarter, alongside the expected initial data release from the Phase 2b study of batoclimab in CIDP, projected to occur either in the second or third quarter.
- Top-line results from HL192 (ATH-399A) Phase 1 study for Parkinson’s Disease expected in the second half of 2024.
Rockville, MD, Seoul, KR – April 30, 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 first quarter 2024 and provided businesss.
HanAll
Biopharma achieved 18.4 percent revenue growth in the first quarter compared to
the same period last year, recording a revenue of 34.1 billion Korean Won (KRW),
driven by continued strong sales across key products. The operation income recorded
0.1 billion KRW.
Advancements
in R&D programs continued, with HL161ANS (IMVT-1402), a second-generation
antibody targeting IgG-mediated autoimmune diseases, securing a joint patent in
the U.S. from the United States Patent and Trademark Office (USPTO). Additionally,
initial data readouts from batoclimab Phase 2b study in Chronic inflammatory
demyelinating polyneuropathy (CIDP) are anticipated in mid-2024.
Preparation
for the Phase 3 VELOS-4 study in dry eye disease continued throughout the first
quarter, with plans to initiate the VELOS-4 study in the second quarter.
The HL192 (ATH-399A) Phase 1 study for Parkinson’s
Disease (PD) progressed in the first quarter 2024 and top-line results are
expected in the second half of 2024.
First 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, HanAll's licensed partner in the
United States and Europe, is advancing the Phase 2b clinical trial in Chronic
inflammatory demyelinating polyneuropathy (CIDP), aiming to attain initial
results from period 1 in the second or third quarter of 2024. The top-line data
from the Phase 3 study in gMG and Thyroid eye disease (TED) are anticipated in
the second half of 2024 and the first half of 2025, respectively.
l Harbour
BioMed, which transferred exclusive rights to develop, manufacture, and
commercialize batoclimab in their respective region to CSPC NBP Pharmaceuticals
Co., Ltd. (NBP Pharma) is a licensed partner in China. They intend to resubmit
the Biologics License Application (BLA) for batoclimab to the National Medical
Products Administration (NMPA) in the first half of 2024, incorporating
supplementary long-term safety data. The BLA submission for batoclimab for the
treatment of gMG was initiated in June 2023, following positive topline results
obtained from a Phase 3 clinical trial.
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
has been granted joint U.S Patent No. 11,926,669 (referred to as the ‘669
patent) by the United States Patent and Trademark Office for HL161ANS (IMVT-1402).
The patent encompasses claims related to the composition of matter for the
binding sequence of IMVT-1402 to FcRn, methods of using the antibody for
treating autoimmune diseases, and manufacturing methods. The ‘669 patent is set
to expire on June 23, 2043, without considering any potential extension period.
HL161ANS
demonstrated potentially best-in-class profile in the previous Phase 1 clinical
trial in healthy adults, showing deep lgG reduction similar to batoclimab but
with no or minimal changes in serum albumin and LDL-cholesterol level.
l Immunovant
plans to commence 4-5 potentially registrational programs for IMVT-1402 by 2025
and plans to initiate trials in 10 indications for IMVT-1402 by 2026, including
the potentially registrational programs.
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 plan to initiate the Phase 3 VELOS-4
study in the first half of 2024.
l The
concluded Phase 3 VELOS-3 study revealed a significant improvement in the
unanesthetized Schirmer test, a secondary efficacy endpoint measuring changes
in tear volume from baseline in individuals treated with tanfanercept 0.25%
compared to the vehicle. Tanfanercept demonstrated a highly statistically significant
outcome at the assessment period of week 8 (p=0.002).
l Furthermore,
a noteworthy proportion of participants in the tanfanercept group (13%)
exhibited a Schirmer test improvement of at least 10 mm from baseline at week
8, which was also statistically significant (p=0.011) compared to the vehicle
group (4%). The FDA 2020 Draft Guidance on Dry Eye Drug Development lists the
proportion of subjects with a minimum 10 mm increase in the Schirmer test as an
acceptable primary efficacy endpoint. An alternative approval pathway outlined
by the FDA includes demonstrating a statistically significant difference in an
objective predefined sign of dry eye and at least on subjective predefined
symptom of dry eye.
NEUROLOGY PROGRAM
HL192 (ATH-399A)
A pipeline candidate from NurrOn
Pharmaceuticals (originating from Harvard Medical School’s Molecular
Neurobiology Laboratory) 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 Biopharma, Daewoong
Pharmaceutical, and NurrOn Pharmaceuticals are progressing with the Phase 1
clinical trial of HL192 in healthy participants. The results from the Phase 1
clinical trial of HL192 are expected in the second half of 2024.
ONCOLOGY PROGRAMS
HL187/ HL186
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.
l HanAll is currently advancing the pre-clinical
examination of HL187 (anti-TIGIT) and concurrently evaluating the prospects of
HL186 (anti-TIM-3) as part of the ongoing strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights
(KRW in billion) |
Q1 2024 |
Q1 2023 |
% change |
Sales |
34.1 |
28.8 |
18.4% |
Gross Profit |
18.6 |
15.7 |
18.4% |
Selling, marketing and administrative
expenses |
13.2 |
11.5 |
14.5% |
Research and development expenses |
5.3 |
5.9 |
-10.8% |
Operating income |
0.1 |
(1.7) |
N/A |
Net Income |
(0.3) |
(1.3) |
N/A |
l Sales generated 34.1 billion
KRW in the first quarter of 2024, recording an 18.4 percent increase compared
to the first quarter of 2023.
l R&D expenses, reported as 5.3
billion KRW for the three-month period ending on March 31, 2024, were down by 10.8
percent compared to the same period in 2023.
l
Operating
income
was 100 million KRW for the
three-month period ending on March 31, 2024.
About HanAll Biopharma
HanAll Biopharma (KRX: 009420.KS) is a
global biopharmaceutical company with a presence 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 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. 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 generalized myasthenia
gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating
polyneuropathy (CIDP), and Graves’ disease (GD). Another main 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. HL161ANS, an anti-FcRn antibody targeting
multiple indications, and HL192 (ATH-399A), a Nurr1 activator currently
targeting Parkinson’s Disease, are also being evaluated in Phase 1 clinical
studies (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
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announcement include statements that are, or may be deemed to be,
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its 2024 business and financial outlook and related plans; the therapeutic
potential of its product candidates; the intended results of its strategy and
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