HanAll Biopharma Reports Third Quarter 2023 Financial Results and Provides a Business Update

• Sales recorded KRW 33 billion in Q3 2023, an 11 percent increase from the same period in 2022, due to the sustained growth of major products.
• 'HL161ANS', HanAll's second anti-FcRn antibody, demonstrated best-in-class potential through the initial outcome of Phase 1 study.
• 'HL192', a Nurr1 activator co-developed for Parkinson's Disease (PD) by NurrOn, Daewoong, and HanAll, started the first-in-human study.
• HanAll continues to invest in R&D supported by the strong financial performance.

ROCKVILLE, Md. and SEOUL, South Korea, Oct. 26, 2023 /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 third quarter and provided business updates.

HanAll ended the quarter with a revenue of 33 billion Korean won (KRW), an 11 percent increase year-on-year, mainly driven by two-digit growth from key pharmaceutical products. The net profit recorded was 300 million KRW, with an operation income of 100 million KRW.

"The third quarter marked a significant milestone. Our second anti-FcRn asset, HL161ANS (IMVT-1402), demonstrated a favorable safety and efficacy profile from the initial phase 1 Single Ascending Dose (SAD) and 300 mg subcutaneous MAD study, indicating it may be a potentially best-in-class anti-FcRn antibody for the treatment of IgG-mediated autoimmune diseases. We have also successfully initiated a Phase 1 clinical study for HL192 (ATH-399A) in collaboration with our partners to evaluate its potential as a treatment for Parkinson's disease," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

"In the fourth quarter, we anticipate the Phase 2 initial results for batoclimab in Grave's disease as well as additional MAD study results for HL161ANS 600 mg. We also plan to finalize the next Phase 3 study design for tanfanercept in dry eye disease before the end of 2023. We stay dedicated to our mission to humbly serve our patients by continuing to evolve ourselves into a global innovative biopharmaceutical company," he added.

THIRD 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 FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies.

• Harbour BioMed, a licensed partner in China, announced the official acceptance of the Biologics License Application (BLA) of batoclimab for the treatment of generalized myasthenia gravis (gMG) in June 2023. This application was based on a positive topline result from the Phase 3 clinical trial in March 2023.
• Immunovant, another licensed partner in United States and Europe, is actively engaged in the development of a FcRn inhibitor in four autoimmune indications: Grave's disease (GD), Chronic inflammatory demyelinating polyneuropathy (CIDP), gMG and Thyroid eye disease (TED). Anticipated milestones include the initial Phase 2 results for GD in the fourth quarter of 2023 and the initial data from Phase 2b clinical trials for CIDP in the first half of 2024. The top-line results from the gMG Phase 3 study are expected in the second half of 2024, with top-line data from the Phase 3 clinical study at TED expected in the first half of 2025.
• HanAll and Immunovant initiated a Phase 3 clinical study of batoclimab in gMG in Japan while preparing to initiate a Phase 3 study in TED.

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.

• Immunovant announced favorable initial HL161ANS (Immunovant project designation: IMVT-1402) Phase 1 SAD and 300 mg MAD results in September 2023. In the MAD portion of the study, HL161ANS achieved a 63% lgG reduction from the baseline after four weekly doses of 300 mg subcutaneous administration. No decrease in serum albumin below baseline and no increase in LDL-cholesterol level above baseline were observed. Overall, HL161ANS demonstrated a consistent reduction in lgG level with potency similar to or greater than that of batoclimab, without significant reduction from baseline of serum albumin levels and without significant increase in LDL-cholesterol levels observed at any timepoint measured (all p's > 0.05). Additional data from the MAD 600 mg cohort is expected in the fourth quarter of 2023.

OPHTHALMIC DISEASE PROGRAM

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

• HanAll Biopharma and Daewoong Pharmaceutical conducted an in-depth medical advisory board meeting to discuss the completed Phase 3 VELOS-3 study data and the planned Phase 3 VELOS-4 study design of tanfanercept ophthalmic solution for the treatment of DED. HanAll and Daewoong intend to discuss the VELOS-4 study design and development plan with the FDA within the second half of 2023, with plans to begin the next study in the year of 2024.
• The completed Phase 3 VELOS-3 study 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 subjects treated with tanfanercept compared to vehicle assessed at week 8 (p=0.002). Additionally, the proportion of subjects whose Schirmer test improved from baseline by at least 10 mm, as assessed at week 8, was statistically significant (p=0.011) in the tanfanercept arm (13%) relative to the vehicle arm (4%). It is notable that per the FDA's 2020 Draft Guidance on Dry Eye Drug Development, measurement of a statistically significant difference between the percentage of patients achieving at least a 10 mm increase in Schirmer test is an acceptable primary efficacy endpoint option. Another DED approval pathway option which the FDA has published would include demonstrating both an objective prespecified sign of dry eye but additionally requires at least one subjective prespecified symptom of dry eye. This second pathway often involves a greater degree of complexity, requiring additional studies to be conducted.

NEUROLOGY PROGRAM

HL192 (ATH-399A)

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).

• HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals initiated a Phase 1 clinical trial of HL192, which is being developed for the treatment of PD. This Phase 1 Study evaluates the safety, tolerability, and pharmacokinetics of both single and multiple doses of orally administered HL192 in healthy subjects. The initial 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.

• HanAll is currently progressing with the pre-clinical study of HL187 (anti-TIGIT), while assessing the potential of HL186 (anti-TIM-3) under the strategic portfolio review.

FINANCIAL HIGHLIGHTS (CONSOLIDATED) 

Key Highlights 

Sales recorded 33 billion KRW for the three-month period ending on September 30, 2023, an 11 percent increase from the three months ended September 30, 2022. The increase was primarily due to strong pharmaceutical sales, including 'Normix', 'Eligard', and 'BioTop'.

Research and development expenses were 4.6 billion KRW for the three-month period ending on September 30, 2023, up by 6 percent compared to the same period in 2022.

Net income was 300 million KRW for the three-month period ending on September 30, 2023, compared to 700 million KRW for the three months ended September 30, 2022.

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with 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 for 50 years.

HanAll has also expanded its focus in recent years 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-alpha inhibitor protein, is under development in Phase 3 clinical studies in the US 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.