• Financial performance for Q2 2022 records revenues of KRW 26.2 billion, a 12% growth from the same period last year, driven by strong sales performance from the pharmaceutical division  
• Operating income turned to profit compared to the last quarter, while investment to R&D continued in the second quarter
• Immunovant initiated Phase 3 clinical study in MG and HanAll completed a meeting with PMDA to initiate a Phase 3 study in MG in Japan in 2H 2022

SEOUL, South Korea, July 29, 2022 /PRNewswire/ -- HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company focusing on delivering breakthrough therapies for patients, reported financial results for the second quarter 2022 as well as an update to its R&D progress.

"The second quarter delivered strong momentum for HanAll Biopharma. Our operating income has turned to profit while we continued our investment in R&D" said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving forward over the next few quarters, we expect to see topline results for the Phase 3 study in dry eye disease in the US, while enhancing our portfolio through open collaborations. HanAll will continue to invest in R&D to bring innovative therapeutics to patients" he added.

SECOND 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.

Batoclimab (Project Code: HL161)

A novel, fully human, anti-FcRn antibody being developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies.

• In March 2022, Harbour BioMed, a licensed partner of HanAll updated full clinical development progress in batoclimab. The company is progressing towards Biologics License Application (BLA) submission in the calendar year of 2022, after obtaining topline results from Phase 3 clinical trial for myasthenia gravis (MG). Harbour is developing batoclimab in a wide range of autoimmune indications in addition to MG, including immune thrombocytopenic purpura (ITP), neuromyelitis optica spectrum disorder (NMOSD) and thyroid eye disease (TED).
• In June 2022, Immunovant, a global licensed partner of HanAll initiated a Phase 3 study to further evaluate the efficacy of batoclimab in MG. Immunovant expects to reveal two new indication programs by August 2022.
• HanAll Biopharma plans to initiate a Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the 2H 2022. 

Tanfanercept (Project Code: HL036)

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

• HanAll Biopharma and Daewoong Pharmaceutical are continuing to conduct their second Phase 3 clinical study (Study name: VELOS-3) in DED to examine the safety and efficacy of the medication, at nine clinical sites located in the U.S. The study design was recently expanded to include a pharmacogenomics component that could deliver more value for patients and prescribers from this study. 
• Harbour BioMed is conducting its pivotal Phase 3 trial on tanfanercept in patients with DED.

HL187/ HL186

HanAll is advancing its development in immuno-oncology therapeutics, that respectively target TIM-3 and TIGIT with Daewoong Pharmaceutical.

• HL187 is in pre-clinical development and antibody screening is ongoing to select the lead molecule in HL186.

Major Development Highlights

HanAll further advanced its partnerships with companies with promising technologies. 

• HanAll supported Neudive, a company developing digital therapeutic solutions to help neurodiverse children. Neudive's platform is expected to deliver individually tailored therapy programs to children with neurodevelopmental disorders by using VR technology.

FINANCIAL HIGHLIGHTS (PROVISIONAL)
Key Highlights

• Sales were 26.2 billion won in the second quarter, a 12% increase compared to the same period last year. Sales growth was mainly driven by continued strong performance from pharmaceuticals sold under the names of Normix, Eligard, Biotop and other major products.
• R&D expenses showed 45.1 % increase compared to the same period last year, recording around 3.6 billion won.
• Operating income was 682 million won, a 56.6% decrease, compared to the same period last year, mainly due to increased investment 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 therapies 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 48 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.