Atul Deshpande PhD, MBA
Chief Strategy Officer and Head, US Ops.
March 30, 2021
CAMBRIDGE, Mass., SUZHOU, China, Rotterdam, Netherlands - March 30, 2021
HBM Holdings Limited (“Harbour BioMed”, “HBM” or the "Company”; Stock Code: 02142.HK), a global clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, today reported full year 2020 highlights and financial results.
Dr. Jingsong Wang, Chairman and CEO of Harbour BioMed commented, “Since its inception, the Company has committed to becoming the leader in next generation antibody therapeutics with a strategic focus on immunology and oncology. Through the successful listing on the mainboard of the HK Stock Exchange in 2020 and subsequent inclusion in the Hang Seng Composite Index (HSCI) and Shen Zhen-Hong Kong Stock Connect in early 2021, HBM has truly moved onto a premier capital markets platform which will help to accelerate HBM’s global aspirations and commercialization strategies. The focus now turns towards leveraging our unique, globally patent protected technology platforms and industry experience in order to promote the R&D and commercialization of our differentiated portfolio. We will continue to focus on the clinical-stage products that are expected to fill the gap in the healthcare market, they are strategically important, with clinical value, and in favor of business interest.”
Development Progress of Main Products - Multiple Products Entering Clinical Trials for Registration
A next-generation fully human anti-CTLA4 antibody with the potential to become a cornerstone of immuno-oncology therapy. It is the first molecule generated from Harbour Mice®.
A breakthrough therapy for Immunoglobulin G (IgG) mediated autoimmune diseases with a portfolio-in-a-product approach.
A differentiated therapy that is expected to help solving the growing prevalence of moderate-to-severe dry eye disease.
Other Development Progress - Multiple Projects Entering Clinical Trials
In addition to the above-mentioned products, HBM also developed multiple programs, including HBM1007, HBM7008, HBM1022, HBM9378, HBM1029, HBM7015 and HBM7020. The Company aims to continuously deliver two or more IND submissions generated from its discovery engine each year from 2021 and beyond.
HBM7008 and HBM 1022
HBM1029, HBM7015 & HBM7020
Discovery Engine Upgrade and Optimization for More Novel and Challenging Drug Targets
HBM focuses on innovative next-generation therapies in immunology and oncology areas. Its discovery and pre-clinical research teams conduct drug discovery, formulation development, process development and pre-clinical studies on new candidates.
Collaborations and Strategic Partnerships
In 2020, HBM continued to expand its business collaborations with leading academic institutions and select industrial partners focusing on innovation and efficiency across the world.
Presentations to Scientific Community
Financial Summary of Fiscal Year 2020 – Significant Revenue Growth
Revenue for fiscal year 2020 (FY2020) was $14.1 million as compared to $5.4 million in the fiscal year 2019 (FY2019), primarily due to our molecule license fee of $12.8 million and technology out-license fee of $1.1 million.
Research and development expenses increased from $49.5 million in FY2019 to $55.2 million in FY2020. This increase was primarily attributable to the combined impact of the increase in the number and scale of clinical trials, the increase in headcounts of research and development personnel, and the increase of share-based payment expenses.
IFRS Net loss for the reporting period was $296.5 million or $1.69 per ordinary share versus $67.5 million or $0.57 per ordinary share in FY2019. Non-IFRS adjusted loss for the reporting period was $45.9 million as compared to $54.1 million in FY2019. A non-IFRS measure is not required by or presented in accordance with IFRS. The Company defines adjusted loss for the year as loss for the year adjusted by adding back (i) share-based payment expenses and (ii) loss on fair value change of convertible redeemable preferred shares.
HBM4003 is the next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice®. It is the first molecule generated through our in-house efforts and has entered clinical trial since discovered as a drug candidate only 3 years ago.
HBM4003 is the first fully human heavy chain only anti CTLA-4 antibody entered into clinical development in world history. It shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.
About Tanfanercept (HBM9036)
Tanfanercept (HBM9036) is at the forefront of the Company’s R&D pipeline, it is a modified 19 kDa TNF receptor 1 fragment and is for the treatment of moderate to severe Dry Eye Disease. Tanfanercept has the potential to seize a majority market share in a fast-growing DED drug market.
About Batoclimab (HBM9161)
Batoclimab (HBM9161) is a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). As the first in class FcRn inhibitor being developed in Greater China, it is expected to become a breaking-through therapy to patients with autoimmune diseases conditions.
About Harbour BioMed
Harbour BioMed (HKEX: 02142.HK) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on oncology and immunology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
The Company’s proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICETM) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.
For more information, please visit www.harbourbiomed.com
Atul Deshpande PhD, MBA
Chief Strategy Officer and Head, US Ops.