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- HanAll will expand R&D investments to advance its late-stage pipeline assets​

HanAll Biopharma(KRX: 009420.KS), a global biopharma company committed to deliver innovative and impactful therapeutics to address severe unmet medical needs, today reported the financial results for the first quarter of 2022. 

“In the first quarter, our team focused on enhancing our R&D capabilities by appointing Almira Chabi, an acknowledged industry leader, as our Chief Medical Officer and Chief Development Officer. In addition, we are seeking open collaboration opportunities to expand our areas of focus by investing in Turn Biotechnologies,” said Sean Jeong, M.D., CEO of HanAll Biopharma.

“HanAll is primed to accelerate clinical studies on late-stage pipeline assets by further expanding R&D investment to serve our patients,” he continued. “We are expecting to initiate a Phase 3 trial of HL161(INN: batoclimab) in myasthenia gravis(MG) in Japan as well as presenting topline results from a second Phase 3 of HL036 in dry eye disease in the U.S., later this year. We also plan to expand the indication of HL036(INN: tanfanercept) into new inflammatory eye disorders and advance HL187, an immuno-oncology antibody therapy targeting TIGIT, into first-in human studies by 2023.” 

FIRST QUARTER 2022 BUSINESS UPDATE 

HL161(INN: batoclimab): A novel, fully human, anti-FcRn antibody developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies. It is being developed in the US and China respectively by global license partners Immunovant and Harbour BioMed.

Harbour BioMed is developing batoclimab in six autoimmune indications including myasthenia gravis(MG), immune thrombocytopenia(ITP), neuromyelitis optica spectrum disorder(NMOSD), thyroid eye disease(TED), chronic inflammatory demyelinating polyneuropathy(CIDP), and pemphigus vulgaris(PV). Harbour is undergoing a pivotal Phase 3 trial in MG, and is progressing towards Biologics License Application(BLA) submission. The clinical trial on TED is currently in its Phase 2 study.  

Immunovant announced plans for a Phase 3 trial in myasthenia gravis(MG) as well as for other clinical trial plans for 2022, through its quarterly reports revealed on February this year. The Phase 3 in MG is planned to be initiated in the first half of 2022, and two additional pivotal clinical trials are expected in 2022. Moreover, with the addition of two new indication programs, HL161 is planned to be developed in five autoimmune diseases in the US and Europe.

HanAll Biopharma plans to initiate Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the second half of the year.

HL036(INN: tanfanercept): A novel, topical anti-TNF biologic therapy for dry eye disease jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, tanfanercept aims to treat inflammatory eye diseases by inhibiting TNF, which is critical in ocular inflammation.

November 2021, the first patient first dose in the second Phase 3 clinical trial(study name: VELOS-3) has started in the US and the trial is currently progressing. The VELOS-3 clinical trial aims to replicate the efficacy seen in VELOS-2(the first Phase 3 trial), and is proceeding at nine clinical sites in the US with patients who have moderate to severe dry eye disease.

HanAll’s partner for Chinese market Harbour BioMed is currently conducting a pivotal Phase 3 trial of tanfanercept(also referred to as HBM9036) for dry eye disease and is progressing towards BLA submission. 

HL187/ HL186: Novel immuno-oncology antibodies that respectively target TIM-3 and TIGIT, being developed in collaboration with Daewoong Pharmaceutical. 

HL187 has an enhanced mechanism of action that reinforces the effector function of the antibody, which activates the immune cells to fight cancer by inhibiting the action of regulatory T cells. 

Last year HL187 was nominated as participant of government-led R&D support program, by Korea Drug Development Fund(KDDF), and is proceeding toxicity study. HanAll plans to initiate Phase 1 clinical trial in 2023. 

HL186 targeting TIM-3, is currently under its pre-clinical study. 

Tanfanercept new indication programs: HanAll Biopharma is exploring the options to expand the indications of tanfanercept to new inflammatory eye disorders and finalize a new indications development plan in 2022.

FIRST QUARTER 2022 FINANCIAL HIGHLIGHTS

Key Highlights(Consolidated, KRW million)

Sales in Pharmaceuticals division remained a strong sales driver, with double digit sales growth on major products such as Normix, an antibiotic for gastrointestinal infection, Eligard, a prostate cancer treatment, and Biotop, a probiotics product. The total sales in Q1 2022 has been reduced by the base effect from the one-time license and collaboration revenue in Q1 2021. 

Research and development investment was up by 24.9 percent compared to the same period last year to 3.1 billion won for the three months ended March 31, 2022. The year-on-year increase reflected higher costs related to clinical studies including VELOS-3 and clinical research. 

Net Loss recorded 83 million won for three months ended March 31, 2022, due to an increase in COGS and R&D expenses. The increase in COGS was due to an extraordinary cost incurred by manufacturing suspension from December 2021 to February 2022. The rise in COGS is temporary and is expected to decrease in Q2 2022.   

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 hymolytic 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.