HanAll Biopharma Reports Third Quarter 2022 Results and Provides Business Update

• Financial results for Q3 2022 ended with revenue of KRW 29.6 billion with continued growth in the pharmaceutical division driven by product portfolio expansion and strong sales in major products
• R&D expenses for the quarter increased by 63%, reflecting the preparation of a Phase 3 study in myasthenia gravis (MG) in Japan, expected to begin in the Q4 2022
• HanAll's licensed partner Immunovant unveiled two new indications for batoclimab, and adds a new FcRn inhibitor, originally developed by HanAll, into its pipeline

SEOUL, South Korea, Nov. 15, 2022 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company developing innovative medicines, today reported financial results for the third quarter of 2022 and provided recent business updates. HanAll sustained a strong growth momentum across the sales performance and progress in the R&D portfolio.

The sales for the third quarter ended with 29.6 billion won, a 16% increase from the previous year, with a net profit of 734 million won. The net cash recorded 66.7 billion won based on the stable cash flow.

"The third quarter delivered strong top-line growth for HanAll, driven by continued sales performance with disciplined operation management. Our late-stage pipeline assets are progressing. Batoclimab Phase 3 study in Myasthenia gravis (MG) is expected to start in Japan later this year. The enrollment to tanfanercept Phase 3 study has been completed, with the topline result expected in the first half of 2023. In addition, Immunovant added the second FcRn molecule developed at HanAll into its pipeline, which is another demonstration of our antibody development expertise," said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Looking forward to the next quarters, HanAll will continue investing in our R&D programs by fully utilizing our own cash flow to bring innovative medicines to patients in need," he added.

THIRD QUARTER 2022 BUSINESS UPDATE

Pipeline Development Highlights  

A comprehensive update on HanAll's pipeline development includes an overview of HanAll's research and a list of compounds in development with targeted indication and the phase of development.

Autoimmune Diseases Programs

Batoclimab (Project Code: HL161BKN)

A novel, fully human monoclonal antibody targeting the FcRn, with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit FcRn, thus blocking the recycling of IgG antibodies.

• HanAll's licensed partner, Immunovant, announced its plans to expand the indication of batoclimab to Chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). A Phase 2b study on CIDP to evaluate batoclimab is planned to be initiated by the end of this year, and a Phase 2 trial on GD is expected to start in early 2023.
• HanAll Biopharma received approval from the Pharmaceuticals and Medical Devices Agency to initiate the Phase 3 study for batoclimab in MG in September 2022. The Phase 3 study to evaluate the safety and efficacy of batoclimab is planned to be initiated in Q4 of 2022.
• Harbour BioMed, another licensed partner of HanAll who is developing batoclimab in China, signed a sub-licensing deal with CSPC NBP Pharmaceutical Co., Ltd. in October. Under the agreement, CSPC will be granted the rights to develop and commercialize batoclimab in Greater China.

HL161ANS

A second novel, fully human, monoclonal antibody molecule inhibiting FcRn-mediated recycling of IgG, designed to deliver maximum lgG reduction while minimizing interference with albumin binding.

• Immunovant announced that it will add a new FcRn inhibitor HL161ANS (Immunovant code name: IMVT-1402), discovered and developed by HanAll, to its pipeline. HL161ANS has been observed to have minimal or no impact on levels of albumin and LDL in animal studies. Immunovant plans to develop HL161ANS in a wide range of therapeutic areas including rheumatology and hematology, with a Phase 1 study expected to initiate in early 2023. The previously announced programs studying batoclimab in Myasthenia gravis (MG), Thyroid eye disease (TED), Chronic inflammatory demyelinatingpolyneuropathy (CIDP), and Graves' disease (GD) will be continued at full speed.

Eye Disease Programs

Tanfanercept (Project Code: HL036)

A novel, topical anti-TNF alpha biologic therapy for eye diseases including dry eye disease (DED) by inhibiting TNF alpha, which is critical in ocular inflammation.

• HanAll Biopharma and Daewoong Pharmaceutical are continuing to conduct the second Phase 3 VELOS-3 study (NCT05109702) in patients with moderate to severe DED to examine the safety and efficacy of tanfanercept, at nine clinical sites located in the U.S. The study enrollment is completed. The topline results from VELOS-3 study are expected in the first half of 2023.
• Results from the previous Phase 3 VELOS-2 study (NCT03846453) in DED have been presented at the World Cornea Congress VIII on Thursday, September 29, 2022 at 10:30 am CDT in Chicago by Dr. Joseph Tauber, MD.
• Harbour BioMed, HanAll's licensed partner in China, announced in early October that they decided to close their Phase 3 study without enrolling new patients to the study. As a result of its observed insufficient efficacy trend, the Independent Data Monitoring Committee recommended to terminate the trial according to the study protocol. The study in China is different from US study (VELOS-3) in key inclusion criteria, primary endpoint and patient demographics reflecting different medical practices and regulatory requirements. HanAll is in discussion with Harbour BioMed regarding the next steps.

Cancer Programs

HL187/ HL186

Novel monoclonal antibodies that respectively target TIM-3 and TIGIT, for the treatment of cancer developed in collaboration with Daewoong Pharmaceutical Co.

• HanAll is continuing with the pre-clinical development of HL187 and plans to submit IND for phase 1 in 2023. HL186 is currently in the discovery phase.

FINANCIAL HIGHLIGHTS (CONSOLIDATED)

Key Highlights

• Sales recorded 29.6 billion won in the third quarter, a 16% increase compared to the same period last year. The sales growth in pharmaceutical division remained strong with additions to the product portfolio including Glucofree, Biotop forte/dual, Abcito, and other major products.
• R&D expenses showed a 63% increase compared to the same period last year, with the record of 4.2 billion won.
• Operating income was 622 million won, a 71% decrease, compared to the same period last year, mainly due to increased investments in R&D.

About HanAll Biopharma Co., Ltd. 

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, 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 areas ranging from endocrine, circulatory, and urologic diseases for more than 49 years. 

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. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hemolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials 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 (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 2022 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 as a result of various important factors our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements, 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 for its technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of its 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. 

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