HanAll Biopharma Reports Full-Year 2022 Results and Provides Business Update

• Full year 2022 net revenue 110 billion wonan increase of 8% compared to 2021, a record high
• Batoclimab Enters Multiple Pivotal Trials, First Phase 3 Data China Scheduled for 2023
• Topline data from tanfanercept Phase 3 dry eye trial expected in 1H 2023

Seoul, South Korea, February 1, 2023 /PRNewswire/ — HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to the discovery and development of innovative medicines for patients, has announced 2022 financial results of reported and provided business updates.

Total revenue in 2022 is 110 billion wonincreased 8% year-over-year, primarily driven by continued strong sales from core products and milestone income from licensing partners. $10 million Milestone payments from Immunovant for initiation of MG Phase 3 trials.Net income for the full year is 2 billion wonwas offset by higher R&D spending.

“HanAll continued its transformation into an innovative global biopharmaceutical company in 2022 by enhancing its clinical development capabilities and expanding its open collaboration network, and continued to deliver solid sales performance. We were able to initiate a stock buyback program to return value to our shareholders.” Chung SeanMD, CEO of HanAll Biopharma.

“Transition to 50^th Since its inception, 2023 will be a pivotal year for HanAll with the reading of top-line data for Tanfanercept and advances in its anti-FcRn program. We will continue to do our best to contribute to patients.”

2022 Full Year Business Update

Pipeline development highlights

A comprehensive update on HanAll’s pipeline development below includes an overview of HanAll’s research and a list of compounds, targeted indications and stages of development.

autoimmune disease program

batoclimab (codename: HL161BKN)

Novel fully human subcutaneous antibody targeting FcRn with potential to address multiple IgG-mediated autoimmune diseases.batoclimab is designed to selectively bind to and inhibit FcRn, which is involved in IgG recycling, thus reducing IgG antibodies.

• In late 2022, HanAll Biopharma received approval from the US Pharmaceuticals and Medical Devices Agency to initiate a Phase 3 trial of vatoclimab in myasthenia gravis (MG). Japanand plans to start research in the first half of 2023. HanAll to market batoclimab in thyroid eye disease (TED) Japan.
• HanAll’s licensed partner, Immunovant, is conducting global Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED).Key Phase Key Results 2b A trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is planned for early 2024. In Graves’ disease (GD), a Phase 2 trial is expected to begin in his early 2023. Immunovant finalizes trial design in warm autoimmune hemolytic anemia. In early 2023 (WAIHA), based on recent FDA interactions.
• Harbor BioMed, another licensing partner of HanAll, which is developing vatoclimab in Chinasigned a sublicensing agreement with CSPC NBP Pharmaceutical Co., Ltd. October 2022Under this agreement, CSPC has been granted the rights to develop and commercialize vatoclimab. Greater ChinaThe company is developing vatoclimab in a range of autoimmune diseases including myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP). Topline data from the ongoing Phase 3 trial in MG are expected in the first half of 2023.

HL161ANS (Immunovant codename: IMVT-1402)

A second novel fully human subcutaneous antibody molecule that inhibits FcRn-mediated IgG recycling is designed to maximize IgG depletion with minimal interference with albumin binding.

• of September 2022, Immunovant announced a new FcRn inhibitor, HL161ANS (Immunovant codename: IMVT-1402), originally discovered and developed by HanAll. Immunovant expects to initiate a Phase 1 trial of his HL161ANS in early 2023, with the first data readout in mid-2023.

eye disease program

Tanfanercept (codename: HL036)

A novel topical biologic therapy for ocular diseases, including dry eye disease (DED), by inhibiting TNFα, a key mediator of ocular inflammation.

• HanAll Biopharma and Daewoong Pharmaceutical are conducting a Phase 3 VELOS-3 study in patients with moderate to severe DED to investigate the safety and efficacy of tanfanercept at nine US clinical sites. increase. Study enrollment has been completed and the top-line results of the VELOS-3 trial are expected to be announced in the first half of his 2023.
• Harbor BioMed, a licensing partner of HanAll Chinaannounced in October 2022they followed recommendations from the Independent Data Monitoring Committee (IDMC) for the review of the inadequate efficacy trends observed during the second interim analysis, followed by a first trial in DED without enrolling additional patients into the study. It was decided to terminate the three-phase study. China The ongoing US study (VELOS-3) differs from the primary inclusion criteria, primary endpoint, and patient demographics reflecting different medical practices and regulatory requirements. HanAll is in discussions with Harbor BioMed about next steps in the development of Tanfanercept. China.

Oncology program

HL187/HL186

Monoclonal antibodies targeting TIM-3 and TIGIT, respectively, have potential cancer treatments and are being developed in collaboration with Daewoong Pharmaceutical Co.

• HanAll continues preclinical development of HL187 and is preparing for 2023 IND submission. HL186 is currently in the discovery stage.

financial highlights (Linking)

major highlights

• sale Recorded 110 billion won 2022 represents an 8.3% increase compared to 2021. Pharmaceutical sales continued to be strong with key products such as Normix, Eligard and Biotop.
• R&D expenses representing a 58% increase compared to 2021, 16 billion won.
• net income was 2 billion wondown 78% compared to the same period in 2021, mainly due to increased investment in R&D.

About Han-Or BioPharma

Han-Ur BioPharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, dedicated to the introduction of innovative and impactful medicines to address critical unmet medical needs. Our mission is to make a meaningful contribution to patients’ lives. During his 50 years, HanAll has managed a portfolio of pharmaceuticals in areas ranging from endocrinology, cardiovascular and urology.

HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Our lead pipeline asset, HL161 (INN: vatoclimab), is an anti-FcRn antibody drug indicated for the treatment of rare autoimmune diseases such as myasthenia gravis, thyroid eye disease, and warm autoimmune hemolytic anemia. Phase 3 and 2 trials are ongoing worldwide. Neuromyelitis optica, and immune thrombocytopenia. Another major asset, HL036 (INN: tanfanercept), is an anti-TNF-α protein drug that is undergoing Phase 3 clinical trials in the United States. China For the treatment of dry eye disease.

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Disclaimer

This announcement contains statements that are or may be deemed to be “forward-looking statements.” These forward-looking statements “believe,” “estimate,” “forecast,” “expect,” “intend,” “may,” “will,” or “should.” and include statements made by HANALL (company, us) regarding business and finances for 2022. clinical data, including outlook and related plans, therapeutic potential of product candidates, their strategies and intended outcomes of the company and its alliance partners, projected clinical development, data readouts, regulatory milestones and planning timing; Readout of trials and prospective data, design of future clinical trials, timing and results of regulatory submissions and regulatory approval. By their nature, forward-looking statements involve risks and uncertainties. Readers are cautioned that such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those projected in the forward-looking statements. This reflects our expectations, our reliance, our collaboration with third parties, our product Estimated commercial potential of candidate, Company’s ability to obtain and maintain intellectual property protection for its technology and pharmaceuticals, Company’s limited operational history, and acquisition of additional funding to complete development our ability to develop and commercialize our product candidates; A detailed list and description of these risks, uncertainties and other risks can be found in the Korea Stock Exchange (KRX) filings and reports. This includes our most recent annual report and subsequent filings and reports that the company has filed with his KRX. Given these uncertainties, readers are advised not to place 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 information in this press release, including forward-looking statements, except as required by Korean laws and regulations.

Source: HanAll Biopharma