HBM-9027

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, March 28, 2024 /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 immune-oncology and immunology, released annual financial results of full year 2023. "We made progress in two significant undertakings in 2023, the third financial year since listing on the Main Board of the Stock Exchange of Hong Kong: preparing Harbour Therapeutics to operate as a faster, more focused clinical-stage next-generation therapeutics company and initiating Nona Biosciences to leverage our unique global patent-protected technology platforms to empower global therapeutic innovation. We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "We are navigating a fiercely competitive world that is going through rapid changes, facing human being's fundamental quest for longevity and quality of life, and having a greater demand for biotechnological breakthroughs and innovative therapeutics. We've been well-positioned in the new era to achieve results that will propel the Company to new heights and create robust business value." FULL YEAR 2023 FINANCIAL HIGHLIGHTS Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023. This is the first time that the Company has recorded a net profit on its annual financial statements. Other financial highlights include: Revenue: The revenue for the full year 2023 is US$89.5 million, which increased significantly by US$48.8 million, or 119.9%, compared with US$40.7 million for the year ended 31 December 2022. Our revenue primarily consists of molecule license fee, research service fee and technology license fee. The increase is primarily attributed to license out and collaboration agreement with Pfizer, Cullinan Oncology and Kelun-Biotech. Research and development costs: The research and development expenses decreased by 66.6%, from US$135.1 million in 2022 to US$45.1 million in 2023. This decrease was primarily attributable to the combined impact of (i) optimized investments in our clinical programs and our molecule assets in discovery and pre-clinical stages; and (ii) the efficient implementation of cost control measures. Administrative expenses: The administrative expenses decreased by 28.6%, from US$27.3 million in 2022 to US$19.5 million in 2023. ROBUST PORTFOLIO AND DIFFERENTIATED PIPELINE Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is individually responsible for the development of the Company's product pipeline. Focused on oncology and immunology, Harbour Therapeutics has a robust and diversified pipeline of more than ten potentially differentiated drug candidates, four of which are in clinical development stage. Batoclimab (HBM9161), porustobart (HBM4003), HBM7008 and HBM1020 are the main products. Batoclimab, as the clinically most advanced FcRn inhibitor being developed in Greater China, has the potential to be a breakthrough treatment for a wide spectrum of autoimmune diseases in Greater China. Harbour Therapeutics completed the treatment of patients in early 2023 and announced the positive topline results of the phase III clinical trial of batoclimab for the treatment of generalized myasthenia gravis (gMG) in March, which is also the first positive pivotal trial outcome for batoclimab worldwide. This marks a major milestone as it is the Company's first product to complete phase III clinical trial and be poised for commercialization to benefit the gMG patients. The Company also initiated open-label extension clinical trial in 2022 and completed enrolment in March 2023. As the cut-off of open-label extension clinical trial for gMG in November 2023, the data showed sustainable efficacy and safety of batoclimab in long-term disease management. Porustobart (HBM4003) is the next-generation, fully human heavy chain only anti-CTLA-4 antibody generated from the HCAb platform. It is also the first fully human heavy chain only antibody which has entered into clinical development around the world. In 2023, Harbour Therapeutics conducted the global clinical development program of porustobart for multiple types of solid tumors, and positive data of efficacy and safety profile have been read out in the ongoing trials of neuroendocrine neoplasms and hepatocellular carcinoma. Another example demonstrating Harbour Therapeutics' strong research capabilities is the discovery of HBM7008, a novel product targeting B7H4 and 4-1BB. Developed from the immune cell engager platform HBICE®, HBM7008 is the only bispecific antibody against these two targets globally. Leveraging and integrating the expertise in biology and antibody engineering and the unique characteristics of HBICE® platform, HBM7008 showed exciting performance both in efficacy and safety profile at pre-clinical stage. In 2022, the Company conducted the phase I trials in the U.S. and Australia. In February 2023, to maintain a leading position in the development of this first-in-class asset, the Company entered into a co-development collaboration with Cullinan Oncology, to expand its study process in the U.S., Europe and Australia. HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which potentially plays a more important role for tumor cells to escape immune surveillance. HBM1020 is the first product against B7H7 in clinical stage globally. With its excellent product design and target features, HBM1020 presents great potential to address huge unmet medical needs on solid tumors. Driven by the Company's leading drug innovation and discovery engine, new assets are continually being developed, of which HBM1020, HBM1022, HBM1007 and HBM9033 obtained the IND clearance from the U.S. FDA to initiate clinical study in the U.S. in 2023, and HBM9027 obtained the IND clearance from U.S. FDA in the first quarter of 2024. In addition, we have a number of pre-clinical stage products in the pipeline, including HBM7004, HBM1047 and HBM9014, which have shown great potential for development. PLATFORM-VALUE-MAXIMIZED BUSINESS COLLABORATIONS In 2023, the Company continued to expand its business collaborations with leading academic institutions and select industrial partners focusing on innovation and efficiency across the world. The business collaboration model is not only limited to out-licensing, but also to engage with academic institutions or other leading innovative pioneers in the industry for co-development and incubation of joint ventures on next-generation innovative therapy. With flexible business models built around proprietary technologies and platforms, the Company can and will maximize its platform value to address global unmet medical needs. Assets Collaboration of Harbour Therapeutics Harbour Therapeutics has entered into several external collaborations in terms of pipeline licensing and collaborations. In 2023, Harbour Therapeutics has granted the regional out-licensing of HBM7008 in the U.S. to Cullinan Oncology, and HBM7022/AZD5863, which was licensed to AstraZeneca in 2022, has entered into clinical stage. Meanwhile, the three assets which have been licensed the Greater China Rights to Hualan Genetic obtained IND approvals from NMPA to initiate clinical study in China. In addition, HBM9378, which was developed in collaboration with Kelun-Biotech, completed its phase I clinical trial. With these multiple collaborations based on the assets generated from HBICE®, Harbour Therapeutics has shown its strength and unique advantages in building a comprehensive portfolio in immune cell engagers. And the co-development and collaboration of the pipeline is not only the recognition of the industry partners for the Company's products and technology platforms, but will also help the Company to improve the efficiency of portfolio advancement, spread the costs and risks, and make the development of the Company more robust. Multiple Collaborations of Nona Biosciences In addition to collaboration through the molecules and pipeline generated from the platforms, the Company is also focusing the vision on more original and innovative collaborations on early stages. By integrating the industry leading Harbour Mice® and HCAb PlusTM platforms with an experienced therapeutic antibody discovery team, Nona Biosciences provides a one-stop solution for therapeutic antibody discovery, engineering and development from I to ITM (Idea to IND) with flexible business models. From the end of 2022, Nona Biosciences achieved big success in its launch as it has landed several international collaborations in multiple innovative formats. It is worth mentioning that Nona Biosciences has granted the global out-licensing of HBM9033, a potential best-in-class MSLN-targeted ADC, to Pfizer. Until now, Harbour Mice® platforms have been validated by over 50 industry and academic partners. Nona Biosciences has established four leading technology units based on HCAb, including protein engineering, conjugation technology, delivery technology and cell therapy to empower the next-generation therapies. With the multiple collaborations based on the assets generated from HCAb PlusTM, Nona Biosciences has demonstrated its robust capabilities in antibody discovery and development, exploring a new path to expand the collaboration network and maximize the value of the platforms. Incubation on Cutting-Edge Collaborations To give full play to the value of the unique platform technologies, the Company has continued to explore the expandability of platform technology application scenarios which generate impactful values and bring us new value growth points with minimal marginal investment. Representative projects include HBM Alpha Therapeutics, in partnership with Boston Children's Hospital, and Shanghai NK Cell Technology Limited. 2024 OUTLOOK: EXTENSIVE GLOBALIZATION AND BREAKTHROUGH INNOVATION Looking to the future, Harbour BioMed will keep driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences. The former will advance multiple clinical trials of the internal pipeline to fully advance the global clinical development project, and the latter will keep providing integrated discovery solutions for biotechnology and pharmaceutical companies and ultimately create an innovation ecosystem to promote biological advancement. A range of products based on the technology platform and generated from the concept of T-cell engager and NK cell engager, will be pushed forward to clinical stage in the following years. With a combination of in-house development and business collaborations, the Company will continuously form a portfolio of products with a differentiated competitive advantage in immuno-oncology. The platform-valued-maximized business collaborations, driven by Nona Biosciences, will further walk the Company down the path of global development. Positive outcomes have been attained through platform-based collaborations with top institutions around the world and more extensive global collaborations are expected in 2024 as our preclinical products become increasingly mature. 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 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. For further information, please refer to . SOURCE Harbour BioMed

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 23, 2024 /PRNewswire/ -- Harbour BioMed (the "Company", HKEX: 02142) announced that the Company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) of the United States to initiate the first-in-human (FIH) clinical trial in the U.S. for bispecific antibody HBM9027. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors. HBM9027 is generated from Harbour BioMed's proprietary fully human HBICE® platform. It is a novel PD-L1xCD40 bispecific antibody, which is designed to activate CD40 relied on PD-L1 crosslinking for a promising safety profile. PD-L1 is overexpressed on a variety of solid malignancies, and with its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM9027 has shown excellent and promising safety profile with strong anti-tumor efficacy in its pre-clinical studies. "HBM9027, developed through our proprietary HBICE® platform, has demonstrated a promising safety profile and robust anti-tumor efficacy," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "This achievement highlights the capability of our technology platform in developing novel solutions for advanced solid tumors. We firmly believe that our unweaving commitment to innovation will bring about meaningful advancements in cancer treatment." About HBM9027 HBM9027 is a novel PD-L1xCD40 bispecific antibody, developed using the HBICE® bispecific technology and Harbour Mice® Platform. The development of PD-L1xCD40 bispecific HBICE® further expands the Company's bispecific immune cell engager into the cutting-edge DC/myeloid cell engager field and demonstrates HBICE® platform's versatile geometry formats and plug-and-play advantages. 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® 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®, HBICE® with single B cell cloning platform, the antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For more information, please visit . SOURCE Harbour BioMed