Nurron Pharmaceuticals, Inc.

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. 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 ([email protected], [email protected]). 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. SOURCE HanAll Biopharma

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 ([email protected], [email protected]). 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. SOURCE HanAll Biopharma

Full-year 2023 net revenue reaches 135 billion KRW, driven by strong sales growth. R&D momentum persisted with promising developments in anti-FcRn antibodies HL161ANS and batoclimab, positioning them as potentially best-in-class treatments for lgG-mediated autoimmune diseases. Anticipates the initiation of tanfanercept Phase 3 VELOS-4 study in dry eye disease in the first half of 2024 and top-line data results from HL192 Phase 1 study for Parkinson's Disease in the second half of 2024. ROCKVILLE, Md. and SEOUL, South Korea, March 21, 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 2023 and provided business updates. HanAll delivered a strong full-year performance, with a 23 percent increase in sales compared to 2022, demonstrating continued innovation momentum through multiple meaningful data readouts for anti-FcRn assets and the dry eye disease program. Total revenues for 2023 were 135 billion Korean won (KRW), mainly driven by strong sales growth from key products. Operating income for the year recorded 2.2 billion KRW. "2023 marked a significant milestone as we celebrated our 50th anniversary. We have delivered record-high sales performance, with continued advancements in our R&D programs by adding the Parkinson's disease program, completing the VELOS-3 study in dry eye, and securing meaningful outcomes from the Phase 1 study of HL161ANS, our second anti-FcRn asset," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. "As we anticipate further advancements in 2024, including the VELOS-4 study in dry eye and additional data readouts from the anti-FcRn assets and Parkinson's program, we will continue to focus our efforts to serve patients," he added. Full-Year 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 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, HanAll's licensed partner in the United States and Europe, has reported positive initial results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of batoclimab in patients with Graves' disease. The study demonstrated that batoclimab achieved response rates exceeding 50% in patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. Treatment response is defined as normalization of T3 and T4 hormone levels without increasing ATD dose. Consistent with studies of batoclimab in other indications, the subcutaneous administration of 680 mg batoclimab showed an impressive reduction of up to 87% in IgG levels, with a mean IgG reduction of 81% after 12 weeks of treatment. Batoclimab was generally well tolerated with no new safety signals identified from the initial data set. Immunovant plans to assess the development of the second anti-FcRn, 'HL161ANS (IMVT-1402)', for Graves' disease, with details expected to be unveiled later in 2024. Harbour BioMed, a licensed partner in China, provided updates on the progress of the Biologics License Application (BLA) submission for batoclimab, intended for the treatment of generalized myasthenia gravis (gMG). In line with the clinical study protocol, the company is currently in the extension period of the Phase 3 clinical trial to gather additional long-term safety data. Harbour BioMed plans to include the supplementary long-term safety data and aims to re-submit the BLA for batoclimab to the National Medical Products Administration (NMPA) in the first half of 2024. BLA submission for batoclimab for the treatment of gMG was made in June 2023, prompted by a positive topline result obtained from the Phase 3 clinical trial. HanAll and Immunovant are progressing a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan. Clinical trial notification (CTN) was approved to initiate a Phase 3 clinical study of batoclimab in thyroid eye disease (TED) in Japan. 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 positive initial Phase 1 600 mg MAD results for HL161ANS (IMVT-1402) in November 2023. In the study, four once-weekly subcutaneous injections of 600 mg HL161ANS reduced total IgG level by a mean of 74%, demonstrating comparable potency to batoclimab 680 mg, which reduced IgG by 76% after four weekly doses. Overall, HL161ANS consistently demonstrated a significant reduction in IgG levels with potency similar to or greater than that of batoclimab, with no significant decrease in serum albumin or significant increase in LDL-cholesterol levels at day 29 (peak pharmacodynamics impact) from baseline (p-values > 0.05). 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 successfully concluded discussions with the FDA in the second half of 2023, finalizing the Phase 3 VELOS-4 study design and development plan. The anticipated initiation of the VELOS-4 study is set for 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. This improvement, assessed at week 8, demonstrated a highly statistically significant outcome (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 statistically significant (p=0.011) compared to the vehicle group (4%). It is worth mentioning that, according to the FDA's 2020 Draft Guidance on Dry Eye Drug Development, achieving a statistically significant difference in the percentage of patients with a minimum 10 mm increase in the Schirmer test is considered an acceptable primary efficacy endpoint. The FDA has also outlined an alternative approval pathway, requiring the demonstration of a statistically significant difference in an objective predefined sign of dry eye and, additionally, at least one subjective predefined symptom of dry eye. However, this second pathway often involves increased complexity, necessitating additional studies. 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 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 135 billion KRW in 2023, a 22.7% increase compared to 2022. Sales remained strong with its major products including Normix, Eligard, and Biotop. R&D expenses, reported as 24 billion KRW, a 45.1% increase compared to 2022. Operating income was 2.2 billion KRW, a 46.9% increase compared to the same period in 2022. Net income was 3.5 billion KRW, compared to 300 million KRW in 2022. 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 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 myasthenia gravis (MG), 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 China 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 ([email protected], [email protected]). 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. SOURCE HanAll Biopharma