Harbour BioMed Announces 2022 Interim Results

Revenue Grows by 1155% with Landmark Acceleration in Core Innovation Strength and Platforms Value

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Aug. 31, 2022 /PRNewswire/ -- Harbour Biomed (“HBM”, or the “Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, today announced its interim results for the six months ended June 30, 2022.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, “In the first half of 2022, Harbour BioMed showcased continued strong growth momentum as the company steadily advanced its strategic upgrades and further strengthened its innovation capabilities. Despite the diverse challenges in the industry, we have leveraged our core innovation power to achieve comprehensive multi-dimensional change including a differentiated global portfolio pipeline, technology platforms and variety of global collaborations.”

“Currently, our in-house R&D engine has entered into a mature stage, with 16 global assets; the continued upgrade of the industry leading fully human antibody platforms to forge ahead into cutting-edge therapeutic areas including next-gen antibodies, ADC, CAR-T, CAR-NK and mRNA; the value of the platform has been realized through diverse global collaborations, including the successful global licensing deal with pharmaceutical giant AstraZeneca, driving high revenue growth.”

“The achievements and growth achieved in the first half of 2022 give us confidence for the future. Harbour BioMed will continue to enhance its global operations and innovations, expand international collaborations, and accelerate the Company’s growth.”

Performance Summary

• Develop global innovative and differentiated products: Global clinical development of porustobart (HBM4003) is progressing steadily, with positive trial data presented at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. HBM7008 is in phase I clinical trials in Australia and approved for phase I clinical trials in China and the U.S. Global development rights for the innovative bispecific antibody HBM7022 licensed to AstraZeneca for a potential total transaction value of US$350 million. HBM1020, HBM1022 and HBM1007 are expected to submit IND applications by the end of 2022.
• Strong R&D capabilities and actively exploring novel therapeutic areas: The Company filed 47 patents during the reporting period, 9 have been granted invention patents by the China National Intellectual Property Administration with 152 in progress. The Company is actively developing ADC therapeutics, carrying out collaborative projects in ADC with LegoChem Biosciences Inc. (LCB) and Duality Biologics, and the internal ADC program HBM9033 is moving forward rapidly. The Company jointly develops novel NK cell therapies with Shanghai NK Cell Technology Limited (NK Cell Tech) which completed its series A financing recently.
• Revenues soared in the first half of 2022, achieving an operating income of US$27.6 million, an 11.55-fold jump year-over-year, demonstrating the value and potential of the core technology platforms and the Company’s innovation capability.

Leveraging industry leading antibody platforms to develop a global innovative and differentiated global portfolio pipeline

Harbour BioMed has three industry leading and globally patented fully human antibody technology platforms, namely HBICE^®, a bispecific platform for immune cell engagers, H2L2, and HCAb (H2L2 and HCAb are collectively known as Harbour Mice^®), which form the basis for the Company to synergize three distinct mechanisms of action in immune-oncology to build differentiated innovative product portfolio. These approaches are:

• HBICE^® based bispecific immune cell engager
• Depletion of Treg
• Modulation of alternative immune evasion pathways

With strong innovation capabilities and efficient antibody platforms, the Company currently has 16 differentiated global programs, with 4 of which in clinical stage, and 3 are expected to apply for IND by the end of the year.

Recent product highlights

Porustobart (HBM4003)

Porustobart is a next-generation fully human heavy chain only anti-CTLA-4 antibody generated from the HCAb platform. It is also the world’s first fully human heavy chain anti-CTLA-4 antibody entered into clinical development. It is expected to break the safety bottleneck of existing treatments and become a flagship product in the field of tumor immunotherapy.

• Phase Ib/II clinical data for porustobart monotherapy was released at the ASCO annual meeting in June 2022, showing strong efficacy and a good safety profile.
• Completed patient enrollment in phase Ib/II trial for combination therapy with PD-1 in melanoma in March 2022; released phase Ia trial data for combination therapy in melanoma at ASCO annual meeting in June 2022.
• Completed the first patient dosing in phase I trial for combination therapy with PD-1 in hepatocellular carcinoma (HCC) in January 2022.
• Completed the first patient dosing in phase I trial for combination therapy with PD-1 in neuroendocrine tumor/carcinoma (NET/NEC) in January 2022; completed the patients enrollment in phase Ib trial for combination therapy in NET/NEC in August 2022.
• The preclinical results were published in the Proceedings of the National Academy of Sciences (PNAS) in August 2022, with its mechanism of action and characteristics having been further recognized by industry experts

HBM7008

HBM7008 is a bispecific antibody against B7H4x4-1BB, developed from the HBICE^® platform, and is the first bispecific antibody against these two targets in the world and is in phase I clinical development worldwide.

• Obtained IRB approval for phase I trial in Australia in February 2022.
• Completed the first patient dosing of the phase I trial in Australia in May 2022.
• Obtained U.S. FDA and NMPA clearance/approval for phase I trial in June 2022.

HBM7022

HBM7022 is a bispecific antibody against Claudin18.2xCD3 based on the HBICE^® platform. Benefiting from its unique 2+1 asymmetric structure, HBM7022 has demonstrated an excellent safety and efficacy profile.

In April 2022, the Company entered into a global out-licensing agreement with AstraZeneca for the development and commercialization of HBM7022 with a potential total deal value of US$350 million. This agreement demonstrates renewed recognition of Harbour BioMed’s technology platforms by a global industry-leading biopharmaceutical company and marks an important milestone in the Company’s global collaborations, validating the Company’s technology platform and innovation capabilities.

HBM9027

The development of HBM9027, a novel PD-L1xCD40 bispecific antibody, further extends the HBICE^® platform’s applications to the frontier of DC/myeloid cell engager field. The characteristics of HBM9027 also demonstrate the versatile geometry formats and plug-and-play advantages of the HBICE^® platform. HBM9027 is currently in preclinical studies and is expected to be submitted for an IND application in 2023.

A number of innovative global programs are expected to file IND by the end of 2022, including HBM1020, HBM1022, and HBM1007.

• HBM1020 is a first-in-class fully human monoclonal antibody against B7H7. The antibody can enhance anti-tumor immunity by blocking the immune checkpoint target.
• HBM1022 (a CCR8 antibody) is cross-reactive with monkey CCR8 and demonstrated its significant tumor growth inhibition efficacy in mouse tumor models.
• HBM1007 is a fully human monoclonal antibody against CD73.

Proactively forging ahead into next-gen therapeutics and continuing to lead antibody drug innovation with ample room for global collaboration

With its unique fully human antibody platforms and professional R&D team, Harbour BioMed continues to engage the optimization, upgrade, and redevelopment of its technology platforms. The Company has established a robust antibody discovery platform including Harbour Mice^® platform, HBICE^® platform, GPCR drug development platform, and ADC platform, values of which have been recognized by more than 50 industry and academic partners. During the reporting period, the Company applied for 47 patents, and 9 patents have been granted invention patent license by the China National Intellectual Property Administration with 152 in process.

The Company continues to explore the value of its core technology platforms, expanding the scope of its R&D efforts and enhancing the potential for commercial returns, particularly in the areas of ADC and NK cell therapy.

HBM9033 is a novel ADC product developed by the Company based on the Harbour Mice^® platform, which specifically targets human Mesothelin (MSLN) and improves its stability and activity utilizing a tumor specific cleavable linker with novel topoisomerase inhibitor. In preclinical studies, HBM9033 has demonstrated superior potency and safety in different tumor models with different MSLN expressing level, and is expected to show a strong therapeutic potential in clinical trials and become a best-in-class therapy worldwide. HBM9033 is in preclinical development and is expected to be submitted for an IND in 2023.

In the first half of 2022, Harbour BioMed commenced collaborations with LCB and Duality Biologics on the development of ADCs, advancing the Harbour Mice^® platform forward in the field.

Harbour BioMed entered into a subscription agreement with NK Cell Tech in 2021, taking the value of the Company’s technology platforms to a whole new level and opening up new directions for the value and translation of the HBM’s technology platforms. Recently, NK Cell Tech has completed its A round financing with over RMB 100 million.

Revenue soared in the first half of 2022, demonstrating the potential of the value of the technology platforms.

For the half-year ended June 30, 2022, the Company reported revenues of US$27.6 million, an 11.55-fold increase over the same period last year.

For the half-year ended June 30, 2022, the Company’s cash balance was US$202.9 million, essentially unchanged from the end of last year, demonstrating excellent value creation, fundraising, and management capabilities.

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 immunology and oncology. 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^® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^®, and HBICE^® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies.

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