Batoclimab

Immunology continues to be one of the most active areas for drug research as the field aims to bring patients new ways to eliminate the antibodies driving autoimmune disease, but in a manner that does not also compromise the immune system. Merida Biosciences, a startup formed by venture capital firm Third Rock Ventures, emerged from stealth Tuesday, revealing $121 million in financing and a lead program for a common autoimmune condition that has not had a new approved therapy in decades. The lead disease target of Cambridge, Massachusetts-based Merida is Graves’ disease, which develops as antibodies produced by the immune system attack the thyroid gland, a butterfly-shaped gland located at the front of the neck. Thyroid hormone regulates functions such as metabolism and growth. In Graves’ disease, the attack on the gland results in excess thyroid hormone production that speeds up the heart rate and weakens bones among other problems. Standard Graves’ treatment includes radioactive iodine therapy to shrink the gland, anti-thyroid medications, or beta blockers that block the effect of thyroid hormone on the body. Each of these treatments introduces complication risks elsewhere in the body. Surgical removal of the thyroid gland is another treatment option, but patients need lifelong hormone replacement therapy afterward. presented by Sponsored Post What Are the Best Medical Coding Outsourcing Companies? Outsourcing your medical coding can help ensure a healthy revenue cycle. Discover the best medical coding outsourcing companies and find the right one for you. By Global Healthcare Resources Merida is developing drugs designed to selectively bind to Fc receptors, receptors on immune cells that regulate immune responses. The company says its protein engineering platform generates unique Fc therapeutics that selectively bind to their antibody targets. The drugs then lead to the elimination of these antibodies by leveraging built-in mechanisms for clearing antibody complexes, which are molecular structures formed when an antibody binds to its specific target antigen. The company says its drugs are designed to eliminate only pathogenic antibodies, sparing healthy components of the immune system. In Graves’ disease, this approach is intended to spare healthy thyroid signaling. The Merida drugs are biotherapeutics that the startup describes as “antibody-like” in the way they move through the body. For example, these drugs could provide longer-lasting effects that enable less frequent dosing compared to some other therapies. The Graves program is currently undergoing the preclinical research that could support an investigational new drug application. Other disclosed Merida programs are in preclinical development for primary membranous nephropathy, which is a chronic inflammatory kidney disease, and food allergies mediated by immunoglobulin E antibodies. “At the heart of Merida is understanding the mechanisms behind antibody-driven diseases like Graves’ at the molecular level, and leveraging these insights to develop precision therapeutics that have thus far evaded the field,” Merida co-founder and Chief Scientific Officer Dario Gutierrez said in a prepared statement. “Our highly differentiated approach has the potential to yield best-in-class treatments by going after the root causes of these devastating diseases.” Merida’s launch comes as other immunology-focused biotech companies, including startups, make headway with their own selective Fc-receptor targeting drugs. Roivant Sciences subsidiary Immunovant is pursuing various immunological indications with IMVT-1402 and batoclimab. Both drug candidates are monoclonal antibodies. The clinical program for IMVT-1402 includes a Phase 2/3 study underway in Graves’. Batoclimab is currently in Phase 2 testing in Graves’. Last September, Immunovant reported preliminary data showing batoclimab achieved a strong response and a lowering of levels of antibodies associated with the disease. The study is expected to post additional data this summer. Sponsored Post Changes in Nurse Staffing Answer Clinician Demands The ongoing nursing shortage facilitates high turnover rates since nurses know they won’t have difficulties finding new jobs. In order to retain and attract staff, it’s in a facility’s best interest to understand what nurses want. By Tomasz Rezik Zenas Biopharma is developing bifunctional antibodies for immunology and inflammation indications. Lead program obexelimab is designed to bind to CD19 and Fc gamma receptor IIb, both of them targets expressed on B cells. A Phase 3 test is underway in immunoglobulin G4-related disease, supported by a $225 million IPO last September. Meanwhile, startup Nuvig Therapeutics is developing proteins engineered to target Fc receptors. Late last year, the Nuvig raised $161 million to support mid-stage clinical development of its lead program, a potential treatment for the rare autoimmune condition chronic inflammatory demyelinating polyneuropathy. Merida received seed financing from Third Rock in 2022, when Gutierrez was an entrepreneur in residence at the firm. The Series A financing announced Tuesday was co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock. The other investors in the new round are GV and Perceptive Xontogeny Venture Funds. The startup is led by CEO Adam Townsend, who was most recently chief operating officer at Apellis Pharmaceuticals, a company that develops drugs that address the complement system, a part of the immune system. Illustration: Sebastian Kaulitzki/Science Photo Library, via Getty Images

Cambridge, MA, Rotterdam, NL, Shanghai, CN — March 31, 2025 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced its financial results for the year ended December 31, 2024. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: “The year 2024 was a pivotal period for Harbour BioMed, marked by significant progress in research and development, strategic business expansion, and operational excellence. Despite a challenging macroeconomic environment, the Company demonstrated remarkable resilience, navigating inflationary pressures, global supply chain disruptions, and geopolitical uncertainties while remaining focused on its long-term growth objectives. Throughout the year, Harbour BioMed advanced its strategic transition toward becoming a sustainably profitable global biotech engine. The Company expanded its research and development pipeline with a strong focus on immunology, autoimmune diseases, and inflammation therapeutics. Several key clinical-stage programs progressed significantly, reinforcing our vision of delivering life-changing medicines to patients worldwide. The Company also made substantial investments in its technology platforms to ensure its core antibody discovery capabilities remain at the forefront of biopharmaceutical innovation. The strategic growth of Nona Biosciences, a subsidiary of Harbour BioMed, further solidified our position as a leading partner in the global biotech ecosystem. Additionally, we strengthened our business collaborations, securing multiple licensing and co-development agreements with top-tier pharmaceutical companies to drive sustainable revenue growth. As we look ahead to 2025, we remain committed to expanding our global presence and delivering breakthrough therapies to patients.” Full Year 2024 Financial Highlights Harbour BioMed reported total revenue of US$38.1 million for the year ended December 31, 2024, with an overall profit of approximately US$2.7 million. The Company has been profitable for two consecutive years, demonstrating the uniqueness and resilience of its business model. Compared to 2023, the Company's revenue sustainability has continued to improve. Annual recurring revenue increased from US$5.7 million to US$16.9 million, reflecting a growth rate of 196.5%. Cash profit[1] reached a record high of US$30.68 million. Meanwhile, Harbour BioMed has maintained a strong financial position. As of December 31, 2024, the company's cash and cash equivalents totaled approximately US$166.8 million, providing a solid financial foundation for future growth. [1] cash profit: operating net cash inflow. Advancing a Robust and Differentiated Pipeline Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is now individually responsible for the development of the Company’s products pipeline. With a growing focus on immunology, inflammation and oncology, Harbour Therapeutics manages a highly differentiated portfolio that includes multiple innovative drug candidates in both clinical and Investigational New Drug (IND)/IND-enabling stages. In inflammation and immunology, the Company has built a robust preclinical pipeline encompassing bispecific and multi-specific antibodies generated using the HCAb-based Bispecific Immune Cell Antagonist (HBICATM) technology, as well as ultra long-acting biotherapeutics for immune-related diseases. In oncology, the Company is leveraging its HBICE® platform to develop bispecific and multi-specific antibodies with novel designs and differentiated mechanisms, such as HBM9027 (PD-L1xCD40) and HBM7004 (B7H4xCD3). In addition, the Company is utilizing its Harbour Mice® and XDC platforms to explore multiple therapeutic modalities, including HBM9033, a mesothelin-targeted ADC, and other ADC/RDC programs in early-stage development. Main products in the clinical stage include: Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the Biologic License Application (BLA) for batoclimab to the National Medical Products Administration of China (NMPA) in June 2024. In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of gMG. HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice® platform. It is a co-development project conducted by the Company and Kelun-Biotech, with both parties equally sharing the rights. HBM9378 has fully human sequences with a lower immunogenicity risk and better bioavailability compared to other TSLP-targeting competitors. Its long half-life optimization and outstanding biophysical properties support favourable dosing and formulation advantages. The Company received IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was approved in February 2025. In January 2025, the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). Currently, Windward Bio is preparing a global Phase II clinical trial for HBM9378. Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice® platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC. HBM1020 is a first-in-class fully human monoclonal antibody generated from the H2L2 Harbour Mice® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found to be non-overlapping with PD-L1 expression in multiple tumor types, potentially playing a more significant role in tumor immune evasion. With its excellent product design and target features, HBM1020 presents great potential to address significant unmet medical needs for solid tumors. In September 2024, the Company presented the latest clinical data for patients with advanced solid tumors at the ESMO Congress 2024. The data demonstrated excellent safety and tolerability profiles for HBM1020. Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%. Main products in IND and IND-enabling stages include: HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE® bispecific technology and Harbour Mice® platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In 2024, the Company restructured its development strategy to target immunological diseases and is currently preparing an IND application. HBM9027 is a novel PD-L1xCD40 bispecific antibody developed using the HBICE® bispecific antibody technology and Harbour Mice® platform. The development of PD-L1xCD40 bispecific antibody further expands the Company’s bispecific immune cell engager into the cutting-edge DC/myeloid cell engager field, showcasing the HBICE® platform’s versatile geometry formats and plug-and-play advantages. In January 2024, HBM9027 obtained IND approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial in the U.S. HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE® bispecific technology and Harbour Mice® platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE® further consolidates the Company’s bispecific immune cell engager platform, demonstrating the HBICE® platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. The Company is currently conducting IND-enabling studies for HBM7004. HBM9014 is a first-in-class, fully human antibody targeting leukemia inhibitory factor receptor (LIFR) for cancer treatment. It was discovered using the Harbour Mice® platform. HBM9014 blocks multiple IL-6 family cytokine pathways via LIFR to inhibit their function in promoting tumor progression, metastasis and chemoresistance. In preclinical studies, HBM9014 showed significant in vivo antitumor efficacy and enhanced efficacy in combination with cisplatin in multiple tumor models. In addition, HBM9014 exhibited strong tolerability in toxicology studies conducted on primates. In 2025, the Company will continue to actively explore drug development strategies and seek collaboration opportunities. Strategic Business Collaborations Maximizing Platform Value Harbour BioMed’s ongoing commitment to global partnerships is critical to driving both scientific and commercial success. In 2024, the Company continued expanding its business collaborations with leading academic institutions and select industrial partners, focused on driving innovation and efficiency worldwide. Leveraging its technological advantages, Harbour BioMed established Nona Biosciences to better empower industry innovators and support collaborators from Idea to IND (I to ITM). Nona Biosciences is a global biotechnology company committed to providing integrated solutions for partners worldwide, across academia, biotechnology startups, and biopharmaceutical giants. Since its launch in late 2022, Nona Biosciences has achieved remarkable success, securing numerous international collaborations across various innovative formats. The subsidiary has established four leading technology units based on HCAb, including protein engineering, conjugation technology, delivery technology, and cell therapy, to accelerate the development of next-generation therapies. Nona Biosciences signed a global out-license and option agreement with AstraZeneca in May 2024 for preclinical monoclonal antibodies to be used in developing targeted oncology therapies. In December 2024, Nona Biosciences entered a research collaboration and license agreement with Candid Therapeutics to discover next-generation T-cell engagers. Over the past year, Nona Biosciences has also formed research collaborations with multiple partners across various therapeutics areas, including Boostimmune, Alaya.bio, Umoja Biopharma, Alkyon Therapeutics, OverT Bio, and Kodiak Sciences. In January 2025, the Company announced a license agreement with Windward Bio for HBM9378, an anti-TSLP fully human antibody for immunological diseases. In February 2025, HBM Alpha Therapeutics, an innovative biotechnology company incubated by the Company, announced a strategic collaboration and license agreement with a business partner to advance novel therapies targeting corticotropin-releasing hormone (CRH) for various disorders. These collaborations further highlight the Company’s unique strengths in pushing technological boundaries and exploring new innovation pathways. With its industry-leading technology platforms and a flexible business model, the Company will continue seeking new opportunities to expand its collaboration network and maximize the value of its platforms. Incubating Breakthrough Collaborations for the Future To fully harness the potential of its unique platform technologies, Harbour BioMed continues to explore the scalability of its platform applications. The Company is incubating several joint ventures focused on next-generation therapeutics, ranging from multivalence antibodies to cell therapies. These ventures aim to broaden the application of platform technologies and create additional value for the Company. This innovative incubation model facilitates the integration of incremental resources for the diversified development of next-generation innovations, requiring minimal marginal investment while offering a high return on value growth. Representative projects include HBM Alpha Therapeutics and Shanghai NK Cell Technology Limited. 2025 Outlook: Expanding Global Presence and Driving Innovation Looking ahead to 2025, Harbour BioMed will continue driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences. Harbour Therapeutic will advance multiple clinical trials of its internal pipeline to fully advance the global clinical development project, while Nona Biosciences will continue providing integrated discovery solutions to biotech and pharmaceutical companies, ultimately fostering an innovation ecosystem that promotes biological advancement. A range of products derived from the Company’s Harbour Mice® technology platform and T-cell engager technology will be advanced in immunology, and the ADC platform will be upgraded to the next generation. Through a combination of in-house development and business collaborations, Harbour BioMed will build a portfolio of products with differentiated competitive advantages both in immunology and immuno-oncology. Maximizing the value of its platform through strategic collaborations will continue to drive the Company’s global expansion. In 2025, as the preclinical product pipeline matures, the company expects to expand its collaboration network even further and enter into broader global partnerships, solidifying its leading position in the global market. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.