• 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. and SEOUL, South Korea, April 30, 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 first quarter 2024 and provided business updates.

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.

"We are pleased to end the first quarter with solid performance, driven by our anti-FcRn assets and our momentum of innovations." said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. "As we continue to advance our clinical programs and explore new opportunities, we remain confident that we are well-positioned for continued growth and success in the global market," he added.

First 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, 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.
• 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.

• 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.

• 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.

• HanAll Biopharma and Daewoong Pharmaceutical plan to initiate the Phase 3 VELOS-4 study in the first half of 2024.
• 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).
• 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).

• 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.

• 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 

• 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.
• 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.
• 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 

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.