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Partners are investing in high-volume production of electrochemical cells to meet global demand from Steel, Refining, Petrochemical and Chemical sectors HOUSTON, Dec. 12, 2025 /PRNewswire/ -- Utility Global ("Utility"), a U.S.-based global economic industrial decarbonization company, today announced a strategic partnership with Kyocera International, Inc. ("Kyocera") to scale the manufacturing of its proprietary electrochemical cells to support rapid commercial deployments of Utility's H2Gen® systems, enabling economic industrial decarbonization of hard-to-abate industries such as steel, refining, petrochemicals and chemicals. Utility Global and Kyocera Join Forces to Scale H2Gen® Manufacturing Globally for Economic Industrial Decarbonization Under the partnership, Utility's proprietary ceramic-metal electrochemical cell technology will be combined with Kyocera's world-class advanced materials capabilities and diversified global manufacturing footprint. Together, the companies will expand cell manufacturing capacity, enable efficiencies, and accelerate time-to-market for H2Gen systems. "Kyocera is one of the most respected advanced materials manufacturers in the world, and this collaboration marks a pivotal milestone in bringing our proprietary electrochemical cell technology to market faster and at global scale," said Parker Meeks, President and Chief Executive Officer of Utility Global. "By pairing our breakthrough materials technology and ceramic-metal manufacturing and coating know-how with Kyocera's proven manufacturing excellence and global presence, particularly in the regions of high interest to Utility, we can jointly meet our accelerating demand for H2Gen systems." The partnership includes the establishment of high-volume production lines, shared collaboration in advanced materials engineering and automation, and joint quality and durability testing to meet the high standards of Utility's global heavy industry customers, who are committed to reducing emissions of their products and operations so long as it does not negatively affect their core economics, which H2Gen achieves. Utility and Kyocera plan to initially establish a dedicated manufacturing hub at Kyocera's Fine Ceramics manufacturing facility in Hendersonville, North Carolina, with initial production capacity operational in 2026. Further additional manufacturing capabilities are expected to expand globally in sync with the demand for Utility's industrial-scale projects. "The collaboration between our two companies will make this partnership a rapid success and provide high performance, high quality electrochemical cells for Utility," stated Jeff Osmun, Vice President of Kyocera International, Inc., Fine Ceramics Group. "As a global leader and producer of advanced engineered ceramic materials and components, we are seeking to leverage our existing and future capabilities to help enable carbon neutralization. This is in line with Kyocera's philosophy, which aims to solve social issues through its business activities and realize a sustainable society. Partnering with Utility is another major step in that direction." This Agreement builds on Utility's recent commercial momentum and further positions the company as one of the most advanced, disruptive and economic industrial decarbonization companies providing two core products for its customers: namely, clean hydrogen that can be utilized as low-to-negative carbon energy, fuel or feedstock, alongside high purity carbon dioxide (including over 95% pure CO₂ in refining and petrochemical applications) completely reshaping the cost and footprint of carbon capture, utilization and storage (CCUS). Utility's patented H2Gen technology produces clean hydrogen from water by harnessing electrochemical energy from existing industrial processes' off-gases without electricity —eliminating the need for electricity and new grid infrastructure, hence dramatically lowering hydrogen production costs in addition to producing a separate high purity CO2 stream. This unique economic decarbonization value proposition has driven significant commercial traction for Utility in heavy industry globally with steel as a lead sector, including a recently announced project with ArcelorMittal in Brazil, where blast furnace off-gas will be utilized to decarbonize integrated steelmaking. Blast furnace-based steel production accounts for over 70% of steel produced globally today and over 85% of steel industry emissions, presenting a significant market opportunity for economic decarbonization. Utility's commercialization strategy in teaming up with established global manufacturers like Kyocera further strengthens supply chain resilience, enhances product reliability, and supports rapid project deployments across multiple continents and markets. Scalable H2Gen manufacturing and project execution aligns well with major global trends in decarbonizing heavy industries, requiring economic competitiveness in both small-scale projects as well as modular and scalable deployments at industrial scale, with Utility's modular H2Gen technology ready to deliver with active customer projects in development at both ends of that project spectrum. About Utility Global Utility delivers practical solutions that drive economic industrial decarbonization across industries such as steel, mobility, refining, chemicals, and upstream oil & gas. The company's breakthrough H2Gen® technology harnesses energy from industrial off-gases and biogases to produce application-specific high-purity, low-to-negative carbon intensity hydrogen on-site from water, without electricity, using its proprietary electrochemical process. H2Gen also produces a high-concentration carbon dioxide stream, which can eliminate or reduce the cost of carbon capture. H2Gen systems are modular, scalable, and operationally flexible, integrating seamlessly into existing hard-to-abate industrial assets with a record small footprint, enabling practical, economic decarbonization. Utility is a portfolio company of Ara Partners, a global private equity and infrastructure firm that is decarbonizing the industrial economy. For more information, visit www.utilityglobal.com. About Ara Partners Ara Partners is a global private equity and infrastructure investment firm focused on industrial decarbonization. Founded in 2017, Ara Partners seeks to build and scale companies with significant decarbonization impact across the industrial and manufacturing, chemicals and materials, energy efficiency and green fuels, and food and agriculture sectors. The company operates from offices in Houston, Boston, Washington D.C., and Dublin. Ara Partners closed its third private equity fund in December 2023 with over $2.8 billion in capital commitments. As of September 30, 2025, Ara Partners had approximately $6.6 billion of assets under management. For more information about Ara Partners, please visit www.arapartners.com. About Kyocera San Diego-based Kyocera International, Inc. is a wholly-owned subsidiary of Kyocera Corporation. Kyocera Corporation (TOKYO:6971, https://global.kyocera.com/), the parent and global headquarters of the Kyocera Group, was founded in 1959 as a producer of Fine Ceramics (also known as "advanced ceramics"). By combining these engineered materials with metals and integrating them with other technologies, Kyocera has become a leading supplier of industrial and automotive components, semiconductor packages, electronic devices, LCDs, smart energy systems, printers, copiers, and mobile phones. During the year ended March 31, 2025, Kyocera Corporation's consolidated sales revenue totaled 2.0 trillion Japanese yen (approx. US$13.5 billion). Kyocera is ranked #1123 on Forbes magazine's 2025 "Global 2000" list of the world's largest publicly traded companies, and has been named among "The World's 100 Most Sustainably Managed Companies" by The Wall Street Journal. *Conversion based on TTM at March 31, 2025 Photo - https://mma.prnasia.com/media2/2843316/Utility_Kyocera_MOU.jpg?p=medium600Logo - https://mma.prnasia.com/media2/2590736/Utility_Global_2025_Logo.jpg?p=medium600
3 out of 4 Aussies are considering buying a New Energy Vehicle (NEV) but over 53 per cent struggle to understand the differences between hybrid, plug-in hybrid and fully electric models New study, The Road Ahead With Chery: What Australians Know (And Don't Know) About Hybrid & Electric Vehicles key findings: 3 in 4 (75%) Australians would consider buying a New Energy Vehicle (NEV) Over half (53%) are not confident distinguishing between hybrid, plug-in hybrid and fully electric types Women are significantly less confident than men in understanding NEV technology, with 64% of women vs 41% of men saying they are not confident Younger Australians are leading the interest in cleaner cars, as almost 9 in 10 Gen Z drivers (87%) would consider a NEV Top reasons given for considering an NEV are cost (50%), reliability (38%) and fuel efficiency (36%) Top perceived benefits of NEV benefits are lower running costs (82%), reduced emissions (57%), quieter drive (52%) SYDNEY, Dec. 12, 2025 /PRNewswire/ -- Australians are ready to embrace the next generation of driving, but confusion about hybrid and electric technologies is slowing the shift. The Road Ahead With Chery: What Australians Know (And Don't Know) About Hybrid & Electric Vehicles – based on a national survey of 2,010 prospective Aussie car buyers commissioned by Chery Australia – found that while 3 in 4 Australians (74%) would consider a New Energy Vehicle (NEV), more than half (53%) say they are not confident in distinguishing between hybrid, plug-in hybrid and fully electric vehicles. Understanding different types of New Electric Vehicles The report shows that nearly 1 in 4 Australians (23%) say their next car will be a hybrid, while a further 1 in 5 (21%) intend to buy another type of NEV, including plug-in hybrids (7%) or fully electric vehicles (7%). Younger Australians are leading the interest in cleaner cars, even if affordability keeps many of them in petrol vehicles for now. Almost 9 in 10 Gen Z drivers (87%) would consider a NEV, yet 48% still expect their next car to be petrol-powered. This group also shows the highest confidence in driving longer distances in hybrid or electric cars. Among them, Gen Z drivers in Sydney stand out as the most engaged nationally, with 40% saying they are very likely to consider owning a NEV. "Australians clearly want smarter, more efficient cars but many are still wading through jargon," said Lucas Harris, Chief Operating Officer, Chery Australia. "Our job is to make hybrid technology simple and accessible so families can choose with confidence. Younger drivers are curious and environmentally aware; they just need clarity, not complexity." Knowledge gaps remain across the market The research highlights a clear need for education to support the transition to new energy technology, with confidence levels differing greatly by gender. Nearly 2 in 3 women (64%) say they are not confident understanding hybrid and electric models, compared with 2 in 5 men (41%). Among those who lack confidence, the top reasons include limited experience with the vehicles (39%), confusing acronyms (31%) and feeling unfamiliar with the technology (33%). When choosing their next vehicle, Australians focus on practical considerations. Cost and value rank highest (50%), followed by reliability (38%) and fuel efficiency (36%). Among those open to New Energy Vehicles, purchase cost (58%), battery charging time (38%) and driving range (34%) are the most important factors. Confidence in hybrids continues to grow Australians are more confident taking a plug-in hybrid (PHEV) on long road trips than fully electric vehicles, with 55% feeling confident compared with 46% for fully electric vehicles. When asked what would help build their confidence, 63% said longer battery range, 60% called for more charging stations/better infrastructure and 38% said a better understanding of vehicle capabilities. Australians associate NEVs most strongly with lower running and fuel costs (82%), reduced emissions (57%) and a quiet, smoother drive (52%). These perceptions point to an emerging awareness of the practical and environmental benefits of hybrids, even as range and affordability remain front of mind. "This research reinforces that Australians want affordable innovation." said Harris. "Australians are ready to make the switch, but they need clear information and real-world reassurance. Chery commissioned this report to better understand the challenges and barriers consumers face, so we can help tackle them head on through education and by introducing vehicles that genuinely meet the needs of Australian drivers." About the research The Road Ahead with Chery: What Australians Know (and Don't Know) about Hybrid & Electric Vehicles Survey (n = 2,010), was conducted by independent consumer research agency MYMAVINS, nationally among Australians intending to purchase a car within the next three years. The sample was balanced by age, gender and region to reflect the national population. – ENDS – About Chery Chery Australia is a leading automotive brand recognised globally for its commitment to innovation, style, and performance. With a rich history spanning over two decades, Chery has established itself as a pioneer in the industry. Known for producing technologically advanced and visually striking vehicles, Chery offers a diverse range of models that cater to different lifestyles and preferences. Each Chery vehicle embodies the brand's passion for pushing boundaries and redefining the driving experience. For more details on Chery visit www.cherymotor.com.au or Instagram @cheryaustralia
SINGAPORE, Dec. 12, 2025 /PRNewswire/ -- The Lions Club of Singapore Lotusia, in collaboration with MINDS Raintree Special Student Care Centre (SSCC), hosted "Little Hands, Big Joy", a Christmas celebration designed to bring joy, warmth and meaningful connection to 29 students with intellectual disabilities. This marks the second collaboration between the two organizations. Students and volunteers celebrating Christmas together at MINDS Raintree SSCC During the celebration, the students created DIY Christmas socks, a hands-on festive activity designed to encourage enjoyment and self-expression. These socks are now showcased at Fernvale Community Club (CC) as one of the highlights of its 2025 Christmas display. The public showcase runs from 11 to 30 December, giving the students a chance to proudly present their creations and bring their families to view them throughout the festive season. Supported by sponsors Jack Lei, Yu Haixin, Jessica Zheng and Polar Puffs & Cakes, the display celebrates the joy and creativity of the 29 students from MINDS Raintree SSCC. Residents and visitors are encouraged to visit Fernvale CC to enjoy a simple, yet meaningful Christmas moment created by the students themselves. "Christmas is a season of joy, and we want the students to experience the happiness of creating something with their own hands and sharing it with the people who matter to them," said Jacob Tao, President of the Lions Club of Singapore Lotusia and CO-CEO of Lotusia Group. A festive display of 29 handmade Christmas socks by MINDS Raintree SSCC students at Fernvale CC The Little Hands, Big Joy celebration on 5 December included activity stations, a festive gathering and a shared lunch between volunteers and students. All designed to create meaningful moments of connection and holiday cheer. Since its chartering in 2023 under Lions Club International, the Lions Club of Singapore Lotusia has continued to lead community-focused efforts that uplift underserved groups and strengthen social bonds. MINDS Raintree SSCC, a before-and-after school care programme for students from Special Education Schools, provides structured learning, social interaction and caregiver respite. This collaboration reflects the shared belief that every child deserves opportunities to express themselves, participate and be part of the community. As the festive season approaches, Little Hands, Big Joy celebrates what Christmas is truly about: Joy, creativity and inclusion. About Lotusia Group Headquartered in Singapore, Lotusia Group supports high-net-worth individuals, entrepreneurs and businesses across Asia in navigating international growth. With a regional footprint spanning major Asian business hubs including Singapore, Mainland China, Hong Kong SAR, Tokyo, and Bangkok. The group specialises in global expansion, investment migration and cross-border business structuring. By integrating tailored overseas landing services with end-to-end execution, Lotusia Group ensures clients experience a seamless journey across company setup, relocation, and operational compliance. For more information, visit www.lotusiagroup.com or follow Lotusia Group on LinkedIn. About MINDS MINDS has been caring for Persons with Intellectual Disabilities (PWIDs) and their families since 1962. Grounded in the belief that all PWIDs have innate abilities and talents, MINDS is committed to empowering them and enhancing their quality of life, while advocating for greater inclusivity for PWIDs as a nation. Today, MINDS is one of the largest charities in Singapore, serving more than 9,000 PWIDs and caregivers. For media enquiries, please contact: Shermin ChenHead of Marketing, Lotusia groupshermin@lotusia.com.sg+65 9762 7783
阿聯酋迪拜2025年12月12日 /美通社/ -- 12月11日，華為在全球旗艦產品發佈會上，以「Unfold the Moment」為主題推出多款創新產品，開啟智能科技生活新體驗。全新一代HUAWEI Mate X7、HUAWEI FreeClip 2、HUAWEI WATCH Ultimate Design及HUAWEI MatePad 11.5 S震撼亮相。HUAWEI Mate X7輕薄可靠、性能卓越，以旗艦影像記錄生活每一刻；HUAWEI FreeClip 2先鋒創新，打造開放式聆聽體驗新標桿；HUAWEI WATCH Ultimate Design融匯科技與美學，以卓越實力探索未知；HUAWEI MatePad 11.5 S高清護眼，流暢創作，靈感隨手可及。 華為終端 BG Marketing與銷售服務總裁朱平表示：「我們在國際市場上持續與全球用戶同行，讓科技充滿溫度。通過從用戶的真實需求出發，我們希望用科技點亮每一個『此刻』，既為消費者帶來非凡的產品體驗，更讓每一位用戶都能擁抱屬於自己的精彩瞬間。」 HUAWEI Mate X7：大展新篇，開啟心動「此刻」 全新一代折疊屏旗艦HUAWEI Mate X7在輕薄機身基礎上，實現煥新設計、卓越影像和超強可靠等跨越式突破。採用「時空之門」設計，背板首次與傳承1600年的非遺雲錦工藝結合，成就科技與藝術的跨界融合典範。推出納米纖維材質的雲錦白配色，以及寰宇紅、曜石黑兩款素皮版本。 HUAWEI Mate X7 HUAWEI Mate X7首次在輕薄折疊屏手機上實現直板旗艦影像能力。全新升級第二代紅楓原色攝像頭，色彩還原能力提升43%。搭配全新超高動態主攝與長焦微距攝像頭，支持17.5 EV超高動態視頻能力，無論強光暗光都能精準記錄。搭載超可靠折疊玄武架構，配置第二代玄武鋼化崑崙玻璃外屏、玄武水滴鉸鏈、三重複合超韌疊層內屏等五大升級。配備3550mm2超大VC石墨烯跨軸散熱系統和5600mAh大電池，確保續航無憂。 HUAWEI FreeClip 2：美學C位，自由新聲「此刻」 HUAWEI FreeClip 2耳夾耳機憑借獨特開放式形態與現代感設計，不僅是耳機更是時尚配飾。除丹寧藍、羽沙白、摩登黑配色外，海外首發玫瑰金新色，為全球時尚和音樂愛好者提供更多個性佩戴選擇。單耳機僅5.1g，久戴無感、舒適穩固。搭載NPU AI處理器，算力較上一代提升10倍，搭配動能強勁的超澎湃雙擎單元，帶來全場景清晰動感的開放式聆聽和通話體驗。耳機IP57級防塵抗水能力，38小時整機長續航，讓用戶全天候隨心佩戴。 HUAWEI FreeClip 2 HUAWEI WATCH Ultimate Design：探索無界，攀登非凡「此刻」 華為推出HUAWEI WATCH ULTIMATE DESIGN非凡大師紫金款，以「勇於突破，敢於非凡」為理念。採用業界首創復合稀土紫色陶瓷表圈，鑲嵌18K黃金，搭配非晶鋯合金錶殼與鈦合金間金錶帶。基於創新防水系統實現支持音頻功能的150米潛水防水能力，配合獨立海豚聲吶水下通信，讓潛水者潛得更深也更安全。升級版環隙天線帶來更強全域通信能力，支持AI通話降噪、華為向日葵天線精準定位與eSIM先鋒通信等，全方位護航戶外探索。X-TAP智感窗升級玄璣感知系統，讓健康檢測更精準全面[1]。 HUAWEI MatePad 11.5 S：靈感躍然，描繪創意「此刻」 全新HUAWEI MatePad 11.5 S搭載超清護眼雲晰柔光屏，突破性實現「護眼與清晰」雙優突破體驗[2]，解決傳統柔光屏「看不清」痛點，帶來極致清晰、舒適護眼的視覺體驗。聚焦無紙化場景，搭配M-Pencil Pro手寫筆與智能磁吸鍵盤。華為筆記提供豐富筆刷、模板及免費資源；天生會畫App新增動畫功能，讓創作動起來；萬興喵影配合快捷鍵讓視頻剪輯更高效；PC級WPS讓文檔編輯、PPT演示、數據處理一氣呵成。從課堂筆記到創意創作，讓每一種可能觸手可及。 HUAWEI MatePad 11.5 S 此刻，由你。華為新品不僅是一次創新科技的進化，更是對每一位用戶此刻生活的致敬。Now is Yours，去探索，去感受，將每一個平凡瞬間，活成你的非凡時刻。 [1] 本產品非醫療器械，不具備診斷及治療功能。 [2] 本產品非醫療器械，不具備診斷及治療功能。
DUBAI, UAE, Dec. 12, 2025 /PRNewswire/ -- Today, Huawei unveiled a new lineup of flagship innovative devices at a launch event themed "Unfold the Moment". These products included the HUAWEI Mate X7 mobile phone, HUAWEI FreeClip 2 earphones, HUAWEI WATCH ULTIMATE DESIGN smartwatch, and HUAWEI MatePad 11.5 S tablet. Guided by the design philosophy of pushing boundaries, the HUAWEI Mate X7 boasts a slim, yet durable design and powerful performance, including flagship-grade smartphone imaging. The HUAWEI FreeClip 2 claims to set a new benchmark for comfortable open-ear listening experiences. The HUAWEI WATCH ULTIMATE DESIGN blends refined aesthetics with advanced engineering and performance, allowing users to better explore the world. The HUAWEI MatePad 11.5 S is designed for creators, featuring a high-definition, eye-soothing display and a smooth creative experience. Zhu Ping, President of Marketing and Sales Services at Huawei Consumer Business Group, said Huawei will continue to walk alongside users worldwide, bringing warmth to technology. "By understanding and responding to users' real needs, we aim to help the world's consumers use technology to unfold every moment. Our goal is not only to deliver exceptional product experiences, but also to enable every user to embrace the moments that matter most to them." HUAWEI Mate X7: Unfolding a New Chapter The Mate X7 draws design inspiration from the "Time-Space Gate" concept and a 1,600-year-old light-woven brocade tradition, widely regarded as a pinnacle of Chinese silk craftsmanship and part of the country's national intangible cultural heritage. The phone comes in a nano fiber-finished Brocade White, alongside two vegan leather options—Nebula Red and Black. HUAWEI Mate X7 The Mate X7 is also Huawei's first slim foldable smartphone to have the same level of imaging capabilities as a standard flagship phone. Its upgraded second-generation True-to-Color Camera delivers 43% improved color accuracy, and is complemented by a new Ultra Lighting HDR Camera, an Ultra-Wide Camera and a Telephoto Macro Camera. With support for up to 17.5 EV Ultra Lighting HDR Video, the Mate X7 captures vivid details with precision in both bright and low-light environments. Engineered for durability, the device is powered by a proprietary Ultra-Reliable Foldable Architecture, which includes an outer display made of Ultra Durable Crystal Armor Kunlun Glass, Advanced Precision Hinges, and a 3-Layer Composite Ultra-Tough Structure and more. A 3,550 mm² SuperCool Ultra-Large VC & Graphene Heat Dissipation System and a 5,600 mAh battery further ensure stable performance and all-day battery life. HUAWEI FreeClip 2: A Fashion Statement The HUAWEI FreeClip 2 earphones have an ear-clip design that blends open-ear innovation with modern aesthetics, intending to redefine audio products as both listening devices and fashion accessories. HUAWEI FreeClip 2 The FreeClip 2 has been designed to wear all day, and comes in the company's traditional Blue, White and Black colorways, as well as a Rose Gold finish that is brand new for the international market. Each earbud weighs just 5.1 g, ensuring a barely-there feel with long-lasting comfort and a secure fit. The FreeClip 2 provides clear, dynamic audio and call quality across different usage scenarios thanks to its high-energy dual-driver units and NPU AI processor which delivers ten times the computing performance of the previous generation. It also comes with IP57 dust and water resistance and up to 38 hours of total battery life for effortless, all-day wear in any environment. HUAWEI WATCH ULTIMATE DESIGN: Expanding Your Horizons The new HUAWEI WATCH ULTIMATE DESIGN comes in a new Royal Gold Edition which features an industry-first rare-earth purple ceramic bezel with 18K gold, paired with a zirconium-based liquid metal case and a purple-gold titanium alloy strap. The watch offers a range of features tailored for deep-sea divers, including an innovative waterproof system and direct sonar-based underwater communication capabilities. It also features an upgraded antenna for stronger all-scenario connectivity, AI-powered noise cancellation for clear calling, precise positioning enabled by the HUAWEI Sunflower Positioning System, and advanced eSIM communication technologies. The watch's TruSense system additionally comes with the powerful X-TAP technology for more precise and comprehensive health tracking[1]. HUAWEI MatePad 11.5 S: Inspiring Creativity The HUAWEI MatePad 11.5 S is a next-generation tablet designed to seamlessly blend eye comfort with exceptional clarity[2]. Huawei's PaperMatte Display effectively addresses the long-standing issues related to sharpness often associated with traditional matte displays, making the viewing experience on this new device both vividly clear and gentle on the eyes. HUAWEI MatePad 11.5 S The MatePad 11.5 S is designed for paperless productivity, and comes with an M-Pencil Pro stylus and a magnetic keyboard that make transitioning between note-taking, writing, and content creation smoother. The pre-installed Huawei Notes app offers a wide range of brushes, templates, and free resources, and the GoPaint app now comes with a number of new animation tools that help static ideas to come alive. For video creators, the Wondershare Filmora app now offers shortcut key support to streamline editing workflows, while the WPS Office suite provides professional PC-level document editing, presentations, and data processing features. Huawei said that today's launch goes beyond a mere set of technological upgrades — it reflects the company's enduring commitment to putting consumers first. Under the brand proposition "Now Is Yours," Huawei hopes to engage with consumers openly and sincerely, and to build cross-regional and cross-cultural connections with a warm and inclusive attitude, enabling more people worldwide to share the joy of technological progress. [1] This product is not a medical device and should not be used for diagnosis or treatment. [2] This product is not a medical device and should not be used for diagnosis or treatment.
Highlights: FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol This marks the official entry of NUZ-001 as Regimen I in the HEALEY ALS Platform Trial Next steps include obtaining single IRB approval, site initiations and clinical start-up activities ahead of commencement of patient enrollment expected early in 2026 Milestone strengthens Neurizon's pathway toward advancing a potential new treatment for ALS MELBOURNE, Australia, Dec. 12, 2025 /PRNewswire/ -- Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the Sean M. Healey & AMG Center for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) following completion of the FDA's 30-day review. NUZ-001 is officially Regimen I. The FDA's acceptance of the protocol amendment allows the commencement of clinical activities under the Sean M. Healey & AMG Center for ALS Investigational New Drug (IND). It represents another significant regulatory milestone for Neurizon, enabling the Company and the HEALEY ALS Platform Trial team to progress to the next operational phases, including Institutional Review Board (IRB) submissions and approvals, activation of clinical trial sites, and initiation of study start-up activities. The first patients are expected to be enrolled early in 2026. The HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled, adaptive trial for ALS created in partnership with the Network of Excellence for ALS (NEALS). The goal of the HEALEY ALS Platform Trial is to accelerate the development of potential new ALS therapies. The trial tests and evaluates multiple investigational drugs simultaneously, shares infrastructure across trial sites, and improves start-up and enrollment efficiencies, allowing for fast results. NUZ-001 is in development for treating amyotrophic lateral sclerosis (ALS). It aims to address key pathological mechanisms, including TDP-43 protein aggregation and impaired autophagy, which are central features across multiple neurodegenerative diseases. Preclinical and clinical data to date indicate favourable oral bioavailability, central nervous system penetration, an encouraging long‑term safety profile, and early signs of potential clinical benefit. Dr Michael Thurn, Managing Director & CEO, commented: "Receiving the FDA's clearance is a major milestone for Neurizon and a critical step in advancing NUZ-001 as a potential new treatment option for people living with ALS. The HEALEY ALS Platform Trial represents the gold standard for efficient and collaborative clinical development in this field, and we are proud to progress into the next phase of activation. We look forward to working closely with the HEALEY team as we move toward site initiations and study start-up, bringing us one step closer to addressing this significant unmet medical need." Professor Merit Cudkowicz, Principal Investigator, HEALEY ALS Platform Trial & Director, Sean M. Healey & AMG Center for ALS, Mass General Brigham, commented: "We are pleased to welcome Neurizon's NUZ-001 regimen into the HEALEY ALS Platform Trial. The HEALEY ALS Platform Trial Therapy Evaluation Committee previously selected NUZ-001 for inclusion as a new regimen. The FDA's clearance to proceed with the NUZ-001 regimen is an important next step. We look forward to initiating clinical sites and beginning enrollment so we can evaluate the potential of NUZ-001 to benefit people with ALS." Neurizon remains dedicated to developing novel, disease-modifying therapies for ALS and other serious neurodegenerative diseases, leveraging international collaborations and world-leading clinical platforms to accelerate clinical progress. -ENDS- About Neurizon Therapeutics Limited Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the treatment of ALS, which is the most common form of motor neurone disease. Neurizon's strategy is to accelerate access to effective ALS treatments for patients while exploring the potential of NUZ-001 for broader neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is dedicated to creating new horizons for patients and families impacted by complex neural disorders. NUZ-001 is an investigational product and is not approved for commercial use in any jurisdiction. Neurizon® is a registered trademark of Neurizon Therapeutics Limited
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