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.

 

• Revenue for fiscal year 2020 was $14.1 million, increased by 160% year-on-year
• Successfully listed on the HK Stock Exchange on December 10, 2020, raising net proceeds of $214 million
• Major progress in clinical trials of HBM4003, Batoclimab (HBM9161), Tanfanercept (HBM9036)
• Multiple research programs entering clinical trial stage, including HBM1007, HBM7008, HBM1022, HBM9378, HBM1029, HBM7015 and HBM7020
• Established strategic partnerships with worldwide industry partners to fully leverage HBM’s technology platforms, including out-licensing the global rights of SARS-CoV-2 antibody to AbbVie, and collaborating with Vir Biotechnology and Hualan Genetic

 

 

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

 

HBM4003

 

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®.

• Obtained U.S. FDA approval for monotherapy clinical trial in February 2020
• Obtained People’s Republic of China’s (PRC) National Medical Products Administration (NMPA) approval for monotherapy clinical trial in September 2020
• Obtained approval for combination therapy with PD-1 clinical trial for Melanoma and other advanced solid tumors in China in September 2020
• Obtained approval for combination therapy with PD-1 clinical trial for non-small cell lung cancer (NSCLS) and other advanced solid tumors in China in February 2021
• On-going Phase I clinical trial in Australia
• Completed first dosing of Phase I clinical trial of combination therapy for melanoma and other advanced solid tumors in China in March 2021

 

 

Batoclimab (HBM9161)

 

A breakthrough therapy for Immunoglobulin G (IgG) mediated autoimmune diseases with a portfolio-in-a-product approach.

• Completed greater China Phase I first clinical trial in February 2020
• Completed first dosing of acute neuromyelitis optica spectrum disorder (NMOSD) Phase Ib/IIa clinical trial in April 2020
• Obtained approval for clinical Phase II/III of immune thrombocytopenia (ITP) from the NMPA in April 2020
• Obtained approval for clinical Phase II/III of graves ophthalmopathy (GO) from NMPA in June 2020
• Completed first dosing of Phase II clinical trial of myasthenia gravis (MG) in September 2020
• Completed last patient’s first dosing of Phase II clinical trial of ITP in January 2021
• The China Center for Drug Evaluation (CDE) granted “Breakthrough Therapy Designation” (BTD) to MG therapy in January 2021

 

 

Tanfanercept (HBM9036)

 

A differentiated therapy that is expected to help solving the growing prevalence of moderate-to-severe dry eye disease.

• Published Phase II clinical trial data in China in November 2020
• Completed first dosing of Phase III clinical trial in March 2021

 

 

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.

 

 

HBM9022

 

• In December 2020, the Company and Utrecht University jointly announced a deal to out-license the global rights of development and commercialization for a fully human antibody ABBV-47D11 (HBM9022) to AbbVie and authorized it to initiate clinical trials.

 

 

HBM1007

 

• Expects to file an IND in 2021

 

 

HBM7008 and HBM 1022

 

• Expects to file an IND in 2022

 

 

HBM9378

 

• HBM9378 is in pre-clinical trials as part of the Company’s in-house technology platforms to co-develop fully human monoclonal antibody drugs of new targets 
• Expects to file an IND by the end of 2022 and drive global clinical development

 

 

HBM1029, HBM7015 & HBM7020

 

• In 2020, HBM authorized the Greater China rights of 3 pre-clinical products (HBM1029, HBM7015 and HBM7020) developed by its in-house technology platform to Hualan Genetic, a Chinese biopharmaceutical corporation. The two companies will work together to drive the R&D of these products
• Expects to file an IND for HBM1029 in 2021
• Expects to file an IND for HBM7015 in 2022
• Expects to file an IND for HBM7020 in 2022

 

 

HBM9302

 

• Expects to file an IND in the first half of 2021

 

 

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.

 

• Applied for nearly 20 patents during the Reporting Period, of which 4 have been granted invention patent license by the China National Intellectual Property Administration. These patent applications have further strengthened the protection of intellectual property rights of the Company’s core products and technology platforms.
• The discovery of the fully human antibody 47D11 (HBM9022) by UU, Erasmus MC and the Company was reported in Nature Communications. Three separate manuscripts with data around the unique characteristics have been published so far.
• Developed an innovative monoclonal antibody against the GPCR target, CCR8, a novel GPCR target, and presented the antibody (HBM1022) at the 16th PEGS.
• Optimized and upgraded the HCAb technology platform and developed HBICE^TM (an HCAb platform based immune cell engagers) bispecific platform with HBM7015 and HBM7020 generated from the platform. The data for this project was reported at the 16th PEGS in August 2020. The related patent has been applied. Early-stage projects based on the HBICE^TM platform entered the CMC phase gradually.

 

 

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.

 

• HBM entered into a strategic collaboration with AbbVie Inc. (NYSE: ABBV) for the co-development of a fully human antibody which could effectively block infection by the SARS-CoV-2 and SARS-CoV viruses. The Company has authorized AbbVie the global rights of the product and AbbVie has initiated a Phase I clinical trial and completed first dosing in December 2020.
• HBM entered a strategic partnership with Vir Biotechnology, a clinical stage immunology company, for the early discovery, development, and commercialization of innovative therapeutic molecules in the field of oncology and infectious diseases.
• HBM entered into a strategic collaboration with Hualan Genetic Engineering Co., Ltd. (“Hualan Genetic”) to develop three innovative monoclonal antibody and bispecific antibody drugs independently developed by the Company for treatments in various oncology indications.

 

 

Presentations to Scientific Community

 

• Presented results from Phase I clinical trial with batoclimab (HBM9161) in Chinese patients at the 6th European Academy of Neurology (EAN)
• Presented pre-clinical data on HBM1007 at the American Association for Cancer Research (AACR)
• Presented newly discovered BCMA x CD3 bispecific antibody (HBM7020) at Cell Engager Summit 2020.
• Presented newly discovered anti-human CCR8 novel monoclonal antibody (HBM1022) at the 16th Protein Engineering & Cell Therapy Summit (PEGS)
• Presented new platform HBICE™ (Heavy chain only antibody (HCAb) based Immune Cell Engager) at the 16th PEGS
• Presented results from Phase II clinical trial with tanfanercept (HBM9036) in Chinese patients with moderate-to-Severe Dry Eye Disease (DED) at the 25^th Congress of Chinese Ophthalmological Society

 

 

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.

 

 

About HBM4003

 

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) 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 (HBICE^®) 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