Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with Amyotrophic Lateral Sclerosis (ALS) at ENCALS 2025 Annual Meeting




Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with Amyotrophic Lateral Sclerosis (ALS) at ENCALS 2025 Annual Meeting

• DAZALS did not meet its primary endpoint of improved outcome in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to patients who received placebo
• DAZALS met its secondary endpoint of improved overall survival at week 24 of the study in patients who received 300 mg of dazucorilant compared to patients who received placebo
• Exploratory analysis at the one-year mark shows continued significant improvement in overall survival between patients who received 300 mg of dazucorilant and those who received placebo only
• Corcept seeking guidance from United States and European regulators on optimum path forward

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting. The presentation can be found here.

DAZALS is a randomized, double-blind, placebo-controlled Phase 2 study in which 249 patients with ALS were randomized to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo, daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in a long-term extension study in which all patients received 300 mg of dazucorilant. The primary endpoint in DAZALS was the difference in ALSFRS-R between patients who received dazucorilant and those who received placebo. Overall survival was a secondary endpoint.

Although DAZALS did not meet its primary endpoint, patient survival significantly improved. At week 24 of the study, no deaths had occurred in the 83 patients who received 300 mg of dazucorilant, while there were five deaths in the 82-patient placebo group (p-value of 0.02).

An exploratory analysis conducted at the one-year mark shows the survival benefit has continued. Patients randomized to 300 mg of dazucorilant lived significantly longer than patients who received placebo and did not switch to 300 mg of dazucorilant in the extension study. The difference between groups was pronounced, with a hazard ratio of 0.16 (p-value: 0.0009). See Figure 1.

A similar survival benefit was observed in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study (hazard ratio: 0.36; p-value 0.02). See Figure 2. The extension study is ongoing.

Dazucorilant has demonstrated an acceptable safety profile, with 92 percent of adverse events being mild to moderate in severity. The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received placebo. Mild to moderate, dose-related, transient abdominal pain was the most common adverse effect.

“The improvement in overall survival, first noted in the DAZALS study at six months, continues to be seen at one-year. This finding deserves our full attention in service to patients with this tragic disease. Progress in the development of new ALS treatments is of critical importance,” said Leonard H. van den Berg, M.D., Ph.D., Professor and Chair in the Department of Neurology, UMC Utrecht Brain Centre, Utrecht, The Netherlands, and Principal Investigator in the DAZALS study.

“Medications that can extend life for patients with ALS are urgently needed. We are working with regulatory authorities to determine the optimal path for advancing dazucorilant,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We would like to thank the patients, their families and care partners, as well as the investigators, doctors and clinic staff involved in this study.”

About the DAZALS Study

DAZALS is a randomized, double-blind, placebo-controlled Phases 2 trial in which 249 patients with ALS were randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in the long-term extension study in which all patients received 300 mg of dazucorilant. Baseline patient characteristics, including the ENCALS risk score, time from diagnosis, ALSFRS-R total score, and bulbar onset, were consistent across study arms.

The DAZALS primary endpoint was the difference in change from baseline during the study’s 24-week treatment period in ALSFRS-R score between patients who received dazucorilant and those who received placebo. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, the United States and Canada.

About Amyotrophic Lateral Sclerosis (ALS)

ALS, also known as Lou Gehrig’s disease or motor neuron disease, is a fatal degenerative neurologic disorder that affects more than 55,000 people in the United States and Europe. ALS causes muscles to weaken and, as the disease progresses, severely impairs patients’ ability to speak, eat, move and breathe. There is increasing evidence that patients with ALS, particularly those with rapid disease progression, exhibit elevated or abnormal cortisol levels. A patient’s life expectancy after diagnosis is two to five years.

About Dazucorilant

Dazucorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but does not bind to the body’s other hormone receptors. Corcept is studying it as a potential treatment for ALS and other neurologic disorders. Dazucorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. The U.S. Food and Drug Administration has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym^®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations, which are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include those concerning the development of dazucorilant as a treatment for patients with ALS, including the pace, conduct, timing and outcome of DAZALS and its associated long-term extension study, as well as oversight or requirements that may be imposed by the FDA or other regulatory authorities. We disclaim any intention or duty to update forward-looking statements made in this press release.

Contacts

Investor inquiries:

ir@corcept.com

Media inquiries:

communications@corcept.com
www.corcept.com

Biocytogen Secures Japan Patent for RenMab Platform, Expands Global Patent Portfolio for RenMice Fully Human Antibody/TCR Platform




Biocytogen Secures Japan Patent for RenMab Platform, Expands Global Patent Portfolio for RenMice Fully Human Antibody/TCR Platform

BEIJING–(BUSINESS WIRE)–#Antibody–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315) today announced that the key technology of its independently developed RenMab™ fully human antibody mouse platform has been granted an invention patent by the Japan Patent Office (JPO). This milestone marks a significant step in strengthening the global intellectual property portfolio of the RenMice^® fully human antibody platform family. It underscores the continued advancement of Biocytogen’s comprehensive global patent strategy and highlights the innovation and international recognition of the company’s proprietary technologies.

RenMab™ mice are a core member of Biocytogen’s independently developed RenMice^® fully human antibody discovery platform family. Using Biocytogen’s proprietary Size-Unlimited and Precise Chromosome Engineering (SUPCE^®) technology, the complete repertoire of murine immunoglobulin heavy chain and light chain variable region genes was precisely replaced in situ with their human counterparts. As a result, RenMab mice have the full repertoire of human antibody heavy chain VDJ and light chain VJ genes. It retains the ability to mount robust immune responses against diverse antigens, comparable to wild-type mice, and can generate fully human antibodies with native-like diversity, significantly improving the efficiency and success rate of discovering high-potential therapeutic candidates. Importantly, antibodies derived from RenMab mice require no additional humanization, effectively minimizing immunogenicity risks and streamlining the antibody drug development process.

With distinct advantages in discovering fully human antibodies and TCRs with low immunogenicity, high diversity, favorable affinity, and excellent physicochemical properties, Biocytogen’s RenMice platform series (RenMab™/RenLite^®/RenNano^®/RenTCR-mimic™/RenTCR™) has gained widespread recognition in the global biotech and biopharmaceutical industry. Licensing agreements have been established with 20+ companies, including Merck KGaA, Darmstadt, Germany, Janssen/ Johnson & Johnson, and BeiGene. Leveraging the RenMice platform, the RenBiologics™ program has generated over 1,000,000 fully human antibody sequences and numerous high-potential preclinical candidates against more than 1,000 therapeutic targets. As of December 31, 2024, approximately 200 agreements encompassing therapeutic antibody co-development, out-licensing, and asset transfers have been executed, highlighting the RenMice platform’s strong global competitiveness and significant commercial value.

With its sustained independent research and cutting-edge technological innovation capabilities, Biocytogen has been actively advancing its global patent portfolio and key technology protections for the RenMice^® platform. To date, the RenMice platform has secured patent grants in nearly 10 countries, including the U.S., China, and Japan, while nearly 40 patent applications are under examination across 15 countries and regions. With the steady progress of the global patent strategy, additional patent grants are anticipated in the near term. This strong intellectual property protection framework will continue to deliver reliable assurance to Biocytogen’s partners worldwide.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab™/ RenLite^®/ RenNano^®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

Fujirebio Announces Strategic Collaboration with Stanford Medicine to Advance Infectious Disease Research




Fujirebio Announces Strategic Collaboration with Stanford Medicine to Advance Infectious Disease Research

TOKYO & SUNNYVALE, Calif.–(BUSINESS WIRE)–#IVD–Fujirebio, a leading innovator in in-vitro diagnostics, today announced a collaboration with Stanford Medicine (Location: Palo Alto, California, USA) to advance research and innovation in the field of infectious disease testing. This collaboration aims to accelerate the adoption of ultrasensitive immunoassays that incorporate single-molecule counting technology developed by Fujirebio’s Silicon Valley wholly-owned subsidiary, Fluxus, Inc. Greater test sensitivity can better inform treatment decisions in the clinic, as well as accelerate studies towards therapeutics and preventive strategies against infectious disease threats worldwide.

“Infectious diseases remain one of the greatest global health challenges of our time,” says Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “By working with the Stanford Clinical Virology Laboratory under the direction of Professor Benjamin Pinsky and the Stanford Clinical Microbiology Laboratory under the direction of Professor Niaz Banaei, we are bringing together world-class scientific expertise, cutting-edge technology, and global health insights. This collaboration underscores our shared vision to create a healthier, more resilient world.”

“This collaboration represents a significant step forward in our mission to improve public health globally, by combining Fujirebio’s global IVD expertise and Fluxus’ ultrasensitive detection systems with Stanford’s world-renowned research,” says Dr. Peter Wagner, President and CEO of Fluxus, Inc. “We are thrilled to be working with Stanford University’s prestigious infectious disease experts.”

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is an R&D-driven company constantly developing new IVD testing technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care. Our global teams located in Japan, Asia, Europe, and the US focus on delivering products with the highest quality standards to our customers and partners. We value partnerships with other leading companies in the industry, sharing knowledge, capabilities, and critical materials to supply, develop, or manufacture diagnostic solutions on a wide variety of platforms. For more information, please visit http://www.fujirebio.com.

About Fluxus

Fluxus is an industry leader and innovator in optofluidic technologies that develops ultrasensitive detection systems and assay solutions to advance the diagnosis, monitoring, and treatment of diseases.

Contacts

H.U. Group Holdings, Inc.

For media:

Public Relations Section, Public Relations/Sustainability Dept.

Phone: +81-3-6279-0884 　

Email: pr@hugp.com

For investors and analysts:

IR/SR Dept.

Phone: +81-3-6279-0926　

Email: ir@hugp.com

Eurofins Consumer Product Testing Announces State-of-the-Art Expansion of Bangalore Laboratory




Eurofins Consumer Product Testing Announces State-of-the-Art Expansion of Bangalore Laboratory

BANGALORE, India–(BUSINESS WIRE)–The Eurofins Consumer Product Testing network of laboratories in India recently unveiled its expanded, state-of-the-art facilities in Hongasandra, Bangalore. This strategic investment doubles the Bangalore laboratory’s footprint and offers enhanced capabilities, enabling a significant leap in compliance and performance testing tailored to the evolving needs of India’s textile, apparel, footwear, and leather goods markets. The expansion directly addresses the growing demand for a one-stop solution for comprehensive quality, safety, and sustainability testing services across India’s rapidly advancing manufacturing supply chain landscape.

The Eurofins Consumer Product Testing network of laboratories in India is a trusted partner for global and domestic brands, retailers, and manufacturers. With these new upgrades, the Bangalore laboratory is well-positioned provide innovative and specialised testing services, including:

• Chemical Smart Testing to provide comprehensive restricted substances list (RSL) analysis for global market compliance;

• Advanced Dry Cleaning Testing Capabilities to ensure textile durability and performance across multiple cleaning methods;
• Comprehensive testing for JIS Standards, in collaboration with KAKEN TEST CENTRE, Japan, reinforcing support to Japanese buyers’ compliance requirements.

With a modern layout, a compliance-first design, and a LEAN-aligned workflow, the enhanced laboratory streamlines operations and delivers a seamless service to clients. Dedicated spaces for innovation and future growth reflect the Eurofins Consumer Product Testing network of laboratories’ commitment to advancing India’s dynamic consumer product ecosystem, meeting future market demands, and offering testing expertise to meet the highest standards.

Backed by a global network of over 85 laboratories and more than 4,000 employees worldwide, the Eurofins network of Consumer Product Testing laboratories provides global clients with a wide array of industry leading testing services across Softlines & Hardlines (S&H), Cosmetics & Personal Care (C&PC), Electrical & Electronics (E&E), and Sustainability Services.

About Eurofins Consumer Product Testing

Backed by a global network of over 85 laboratories and more than 4,000 employees worldwide, the Eurofins Consumer Product Testing network of laboratories provides global clients with a wide array of industry-leading testing services across the Softlines & Hardlines (S&H), Cosmetics & Personal Care (C&PC), Electrical & Electronics (E&E), and Sustainability Services fields.

About Eurofins – the global leader in bio-analysis

Eurofins is Testing for Life. With ca. 63,000 staff across a network of more than 950 laboratories in over 1,000 companies in 60 countries, Eurofins offers a portfolio of over 200,000 analytical methods.

Eurofins Scientific S.E. shares are listed on Euronext Paris Stock Exchange.

Contacts

For further information:
Himanshi Aggarwal

Himanshi.Aggarwal@xoin.eurofinsasia.com

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer




Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI & INDIANAPOLIS–(BUSINESS WIRE)–Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC).

This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. “I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,” says Dr. Antonarakis.

Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development.

The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs.

About ACE-232

ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer.

About Acerand Therapeutics

Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials.

http://acerand.com/

Contacts

Acerand Therapeutics

info@acerand.com

Biocytogen and Nanjing Chia Tai Tianqing Announce IND Approval in China for Co-Developed Anti-IGF-1R Antibody NTB003 (BCG009)




Biocytogen and Nanjing Chia Tai Tianqing Announce IND Approval in China for Co-Developed Anti-IGF-1R Antibody NTB003 (BCG009)

BEIJING & NANJING, China–(BUSINESS WIRE)–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) and Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. (“NJCTTQ”) announced that NTB003 (formerly BCG009), a co-developed injectable drug candidate, has received the Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). The approved indication is Thyroid Eye Disease (TED).

About NTB003 Injection

NTB003 is a second-generation fully human anti-IGF-1R monoclonal antibody co-developed by Biocytogen and Nanjing Chia Tai Tianqing. Antibody discovery and optimization were completed by Biocytogen using its proprietary RenMab™ fully human antibody discovery platform, while Nanjing Chia Tai Tianqing was responsible for CMC process development, GLP-compliant toxicology studies, and IND application. Compared with first-generation approved anti-IGF-1R therapeutics, NTB003 demonstrates enhanced molecular affinity, improved druggability, and an extended half-life. In vitro studies have shown that NTB003 exerts potent signal-blocking activity and effectively inhibits the release of hyaluronic acid (HA), indicating strong potential for further clinical development.

Clinical studies of teprotumumab and other investigational anti-IGF-1R biologics have demonstrated that targeting IGF-1R can deliver significant clinical benefits. These agents have shown rapid onset of therapeutic response and favorable outcomes in reducing proptosis and diplopia, improving quality of life, and lowering clinical activity scores in patients with TED.

Nanjing Chia Tai Tianqing will lead the clinical development and commercialization of NTB003 in China, aiming to provide an improved therapeutic option for Chinese TED patients. Biocytogen will be responsible for the global out-licensing of the product outside China.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab^™/ RenLite^®/ RenNano^®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

Inter Scientific Achieves UK GLP Monitoring Authority Status to Support Regulatory Studies for Medicines, Devices and Novel Products




Inter Scientific Achieves UK GLP Monitoring Authority Status to Support Regulatory Studies for Medicines, Devices and Novel Products

LIVERPOOL, England–(BUSINESS WIRE)–#InterScientific–Inter Scientific Ltd is proud to announce its acceptance onto the UK Good Laboratory Practice (GLP) Monitoring Authority, granting the company official GLP status. This accreditation enables Inter Scientific to conduct fully compliant non-clinical safety studies in accordance with OECD guidelines and GLP standards, supporting the authorisation of regulated products such as pharmaceuticals, medical devices, cosmetics, and products requiring Premarket Tobacco Product Applications (PMTAs).

The GLP status is a major milestone for Inter Scientific and reflects the company’s commitment to delivering the highest standards of scientific and regulatory excellence. It enhances the company’s ability to provide accurate, defensible data for regulatory submissions in the UK and internationally.

“This is a significant step forward for Inter Scientific,” said David Lawson, CEO of Inter Scientific. “Achieving GLP status recognises the quality of our people, systems, and scientific capabilities. It allows us to support clients more comprehensively in bringing safe, effective, and compliant products to market.”

The GLP framework ensures the reliability, integrity, and traceability of data submitted to regulatory bodies. Inter Scientific’s accreditation confirms its laboratories meet the rigorous requirements set out by the UK GLP Monitoring Authority.

Ben Green, Global Technical Specialist for Nicotine-Containing Products at Inter Scientific, added: “Our focus has always been on delivering accurate, impartial regulatory studies that ultimately support public health. GLP accreditation underlines our readiness to contribute to the responsible regulation of a wide range of consumer and healthcare products.”

Inter Scientific’s inclusion on the official UK GLP Compliance Monitoring Programme can be found here: https://assets.publishing.service.gov.uk/media/67c6d137b0bb6528ee866d94/Current-Members_of_the_UK_GLP_Compliance_monitoring_Programme_Version_15.pdf

About Inter Scientific Ltd

Inter Scientific is a regulatory science company specialising in global regulatory compliance and providing laboratory testing and consultancy for medicines, medical devices, cosmetics, and novel nicotine products. With a multidisciplinary team of experts, the company supports clients globally through all stages of product development and regulatory submission.

Contacts

Email: razieh.alipour@inter-scientific.com

Applied Cognition Publishes First-in-Human Study of Glymphatic Function in Nature Biomedical Engineering




Applied Cognition Publishes First-in-Human Study of Glymphatic Function in Nature Biomedical Engineering

Breakthrough enables continuous, non-invasive monitoring of the brain’s waste clearance system, unlocking new drug targets for Alzheimer’s and other neurodegenerative diseases

SAN FRANCISCO–(BUSINESS WIRE)–Applied Cognition, a clinical-stage platform therapeutic company, today announced the publication of a groundbreaking study in Nature Biomedical Engineering demonstrating the first continuous, non-invasive measurement of human glymphatic function—the brain’s system for clearing waste, including Alzheimer’s-associated proteins like amyloid and tau.

Working with researchers at the University of Florida and the University of Washington School of Medicine, the company validated its novel multimodal electrical impedance spectroscopy device using contrast-enhanced MRI. The platform also revealed, for the first time in humans, how EEG and cardiovascular physiology contribute to sleep-active glymphatic activity.

“This work is pivotal in defining the role glymphatic dysfunction plays in Alzheimer’s and discovering therapies to rescue it,” said Dr. Paul Dagum, CEO and co-founder of Applied Cognition. “Our platform has already identified a promising drug candidate that improves glymphatic clearance in early clinical trials.”

Originally characterized in rodents, the glymphatic system plays a vital role in the removal of toxic proteins. Until now, studying its function in humans has been limited to slow, high-cost MRI scans. Applied Cognition’s technology offers a scalable solution that allows real-time, remote, and high-resolution tracking, enabling new avenues for drug discovery.

Co-author on this study was Dr. Jeffrey Iliff, PhD, Psychiatry, University of Washington School of Medicine, who along with Dr. Maiken Nedergaard at the University of Rochester Medical Center characterized the glymphatic system in rodents.

“This unlocks our ability to study glymphatic function in the real world and with high-temporal resolution, not just the MRI suite, giving us new mechanistic insights of its role in neurological and psychiatric conditions,” said Dr. Iliff.

Piyush Jain, Head of New Products at Genentech, added: “Applied Cognition is bridging the gap between lab science and patient care. Their platform is accelerating the discovery of drugs that target the clearance of misfolded proteins at the root of devastating neurological diseases.”

Applied Cognition is advancing its lead drug program for early-stage Alzheimer’s and expanding its pipeline across neurodegenerative and psychiatric disorders.

The paper’s authors include Paul Dagum, Laurent Giovangrandi, Swati Rane Levendovszky, Jake J. Winebaum, Tarandeep Singh, Yeilim Cho, Robert M. Kaplan, Michael S. Jaffee, Miranda M. Lim, Carla Vandeweerd, and Jeffrey J. Iliff.

For the full report, click here. To learn more, visit: www.appliedcognition.com

About Applied Cognition

Applied Cognition is clinical-stage platform therapeutics company advancing the brain’s glymphatic system to drug development. Enhancing glymphatic function is a promising new therapeutic strategy for treating neurodegenerative diseases. Using its first-in-class platform, which enables continuous monitoring of glymphatic activity in humans, the company has successfully identified the first therapeutic target and lead drug candidate to enhance glymphatic clearance of amyloid and tau. Applied Cognition is currently advancing this lead program for early-stage Alzheimer’s and expanding its pipeline to explore treatments for other conditions using its platform.

Contacts

kaylaa@vsc.co

3D Investment Partners Recommends Toho Holdings Shareholders Vote Against the Reappointment of CEO Hiromi Edahiro, and Outside Director Yoshiaki Kamoya and Hidehito Kotani at the Company’s 77th Annual General Meeting




3D Investment Partners Recommends Toho Holdings Shareholders Vote Against the Reappointment of CEO Hiromi Edahiro, and Outside Director Yoshiaki Kamoya and Hidehito Kotani at the Company’s 77th Annual General Meeting

Repeated scandals, an attitude that is suspected as concealment and a lack of succession planning at Toho HD indicate its serious breakdown in corporate governance

The Board of Directors continues to reject reasonable proposals for operational improvement, obstructing the Company’s path to sustainable value creation

The persistent failure to address compliance issues risks alienating its customers and could lead to irreversible damage to corporate value

To resolve these problems, we strongly urge shareholders to vote against the reappointment of Mr. Hiromi Edahiro, Mr. Yoshiaki Kamoya and Mr. Hidehito Kotani at the upcoming Annual General Meeting

TOKYO–(BUSINESS WIRE)–3D Investment Partners Pte. Ltd., the investment manager of 3D Opportunity Master Fund (collectively referred to as “3D” or “we,” meaning either or both of 3D Investment Partners Pte. Ltd. and 3D OPPORTUNITY MASTER FUND), today released a shareholder presentation highlighting the ongoing and serious corporate governance failures at Toho Holdings Co., Ltd. (“Toho HD” or the “Company”) (TOKYO: 8129). The presentation outlines in detail the reasons why 3D recommends shareholders vote against the reappointment of Representative Director, President and CFO Hiromi Edahiro (“Mr. Edahiro”) and, Outside Director Yoshiaki Kamoya (“Mr. Kamoya”) and Hidehito Kotani (“Mr. Kotani”).

Link to presentation: https://www.3dipartners.com/engagement/toho-maximizing-corporate-value-en-202505.pdf

3D has been a shareholder of Toho HD since 2020 and currently holds approximately 22%¹ of the voting rights, making it one of the Company’s largest shareholders. Over the past two years, 3D has engaged in constructive dialogue with Toho HD with the sole aim of enhancing long-term corporate value.

¹ Calculated as: (Number of shares held by us + Number of potential shares from convertible bonds with stock acquisition rights held by us) ÷ (Total number of issued shares – Treasury shares + Number of potential shares from convertible bonds with stock acquisition rights held by us).

Management Issues at Toho HD

3D believes that the fundamental management challenges facing Toho HD—specifically, the low profitability of its core business and an inefficient balance sheet—stem from a serious deficiency in its corporate governance structure. In August 2023, we submitted concrete proposals to address these management issues to Toho HD, which were disclosed in our press release dated March 25, 2025. However, due to Toho HD’s dysfunctional governance, the Board of Directors was unable to objectively evaluate and implement recommendations which would improve the Company’s profitability and value. As a result, the majority of our proposals were dismissed, and the underlying issues remain unresolved.

As long as this governance failure persists, we believe that these management challenges will remain unresolved and long-term corporate value growth will continue to be impaired.

Repeated Scandals and Involvement in the Nihon University Incident

Toho HD has been subject to administrative sanctions for its involvement in bid-rigging on three separate occasions. Nevertheless, the Company has never conducted a thorough investigation of these scandals led by independent experts and has consistently avoided addressing the root causes of its misconduct.

In addition to the bid-rigging incidents, it has recently come to light that Toho HD was involved in a fraudulent scheme related to Nihon University Hospital (the “Nihon University Incident”). In this case, a part of funds that should have been returned from Toho HD as purchase rebates were instead funneled to third parties by the Company through fictitious consulting contracts, and resulting in the illicit payments. The Company was obviously able to notice that the scheme involved such clear compliance violations at the time of execution since another peer company reportedly refused to participate.

An attitude that is suspected as Concealment

Despite the seriousness of the Nihon University Incident, Toho HD has failed to provide any public explanation. Statements made by Mr. Edahiro during media interviews are in conflict with case records, raising serious concerns about the credibility and transparency of his explanations. Moreover, Toho HD has refused our request to establish a third-party investigative committee that is independent from the Company. Furthermore, during meetings we have had with the Company, senior executives (Shikkoyakuin) have asked us to refrain from further inquiries. This response, among others, can only be interpreted as attempts to conceal the truth.

Toho HD’s assertion that “There was no legal violation,” and the decision to take no further action, do not meet the standards of governance required for a listed company. What shareholders are demanding is not the mere absence of illegality, but the presence of sufficient transparency and a sound governance framework necessary for long-term corporate value creation.

Risks of Irreparable Damage to Corporate Value

The Board’s continued failure to address the Company’s compliance issues threatens to erode trust among business partners, potentially leading to revenue losses. This poses the risks of irreparable damage to corporate value. Based on its unwillingness to address these serious issues, we believe the Board of Directors is fundamentally unfit to enhance corporate value.

Our Recommendation Regarding Voting at the General Meeting

In light of the urgent need to rectify Toho HD’s governance failures, we strongly recommend that shareholders vote against the reappointment of Mr. Edahiro (Representative Director, President, and CFO), Mr. Kamoya and Mr. Kotani (Outside Directors) for the following reasons:

Regarding Mr. Edahiro:

• He was centrally involved in the management of the companies, which are Toho HD or its subsidiary involved in two prior bid-rigging scandals as well as the Nihon University Incident, and must be held accountable for the ongoing governance failures.
• His public statements have critically contradicted case records, raising serious concerns about the credibility and transparency of his explanations.
• He was appointed CEO without any external comparison or being held accountable for past scandals, through an internal succession process that lacks transparency.

Regarding Mr. Kamoya:

• Despite being the longest-serving outside director, he is not a member of the Special Committee on Governance Enhancement, reflecting a troubling indifference toward governance and compliance issues.
• Although he should have taken a central role in the Nomination Committee as a previous chairperson thereof, he did not even try to pursue the responsibilities for the past scandals and failed to fulfill his responsibilities of exercising proper oversight in selecting a qualified successor CEO. Furthermore, the internal CEO succession process lacked transparency and, to our knowledge, no attempt was made to look for and evaluate outside candidates.
• He currently serves as an advisor to a company with which Toho HD holds cross-shareholdings, casting significant doubt on his independence.

Regarding Mr. Kotani:

• As a member of the Nomination Committee, he was involved in last year’s process of appointing Mr. Edahiro as CEO.
• Furthermore, this year, regarding the decision to reappoint Mr. Edahiro as CEO, Mr. Kotani has not fulfilled his responsibilities as a chairperson of the Nomination Committee who should play the key role of the committee. The internal CEO succession process lacked transparency and, to our knowledge, no attempt was made to look for and evaluate outside candidates.

To Shareholders

As outlined above, we understand that Toho HD is suffering from a critical failure of governance, which in our view has led to the neglect of pressing management issues, the loss of growth opportunities, and significant risk of value destruction due to unresolved compliance concerns.

We respectfully urge shareholders to review our presentation and support the restoration of sound governance and sustainable long-term value creation at Toho HD by voting against the reappointment of Mr. Edahiro, Mr. Kamoya and Mr. Kotani at the Company’s upcoming Annual General Meeting.

About 3D Investment Partners Pte. Ltd.

3D Investment Partners Pte. Ltd. is an independent Singapore-based Japan focused value investing fund manager founded in 2015. 3D Investment Partners Pte. Ltd. focuses on partnering with management[s] who share its investment philosophy of medium- to long-term value creation through compound capital growth and a common objective of achieving long-term returns.

Disclaimer

This press release, including annexes is provided for informational purposes only and does not constitute an offer to purchase or sell any security or investment product, nor does it constitute professional or investment advice. This press release should not be relied on by any person for any purpose and is not, and should not be construed as investment, financial, legal, tax or other advice.

3D Investment Partners Pte. Ltd. and its affiliates and related persons (“3DIP”) of either believe that the current market price of Toho HD does not reflect its intrinsic value. 3DIP acquired beneficial and/or economic interests based on its own idea that Toho HD securities have been undervalued and provide an attractive investment opportunity and may in the future beneficially own, and/or have an economic interest in, Toho HD securities. 3DIP intends to review its investments in Toho HD on a continuing basis and, depending upon various factors including, without limitation, Toho HD’s financial position and strategic direction, the outcome of any discussions with Toho HD, overall market conditions, other investment opportunities available to 3DIP, and the availability of Toho HD securities at prices that would make the purchase or sale of Toho HD securities desirable, 3DIP may, from time to time (in the open market or in private transactions), buy, sell, cover, hedge, or otherwise change the form or substance of any of its investments (including the investment in Toho HD securities) to any degree in any manner permitted by any applicable law, and expressly disclaims any obligation to notify others of any such changes.

3DIP provides no representation or warranty, either expressed or implied, in relation to the accuracy, completeness, or reliability of the information contained herein (including content or quotes from news coverage or other third-party public sources (“Third-Party Materials”)), nor is it intended to be a complete statement or summary of the securities, markets, or developments referred to herein. 3DIP expressly disclaims any responsibility or liability for any loss whatsoever arising from any use of, or reliance on, this press release or its contents as a whole or in part by any person, or otherwise whatsoever arising in connection with this press release. 3DIP hereby expressly disclaims any obligation to update or provide additional information regarding the contents of this press release or to correct any inaccuracies in the information contained in this press release.

3DIP disclaims any intention or agreement to be treated as a joint holder (kyodo hoyu sha) under the Financial Instruments and Exchange Act of Japan, a closely related party (missetsu kankei sha) under the Foreign Exchange and Foreign Trade Act with other shareholders, or receiving any power or permission to represent other shareholders in relation to the exercise of their voting rights, and has no intention to solicit, encourage, induce or require any person to cause other shareholders to represent such voting rights.

3DIP does not have the intention to make a proposal, directly or through other shareholders of Toho HD, to transfer or abolish the business or assets of Toho HD and/or Toho HD group companies at the general shareholders meeting of Toho HD. 3DIP does not have the intention or purpose to engage in any conduct which constricts the continuing and stable implementation of business of Toho HD and/or Toho HD group companies.

This press release may include Third-Party Materials. Permission to quote from Third-Party Materials in this press release may neither have been sought nor obtained. The content of the Third-Party Materials has not been independently verified by 3DIP and does not necessarily represent the views of 3DIP. The authors and/or publishers of the Third-Party Materials are independent of, and may have different views to 3DIP. Quoting Third-Party Materials in this press release does not imply that 3DIP endorses or concurs with any part of the content of the Third-Party Materials or that any of the authors or publishers of the Third-Party Materials endorses or concurs with any views which have been expressed by 3DIP on the relevant subject matter. The Third-Party Materials may not be representative of all relevant news coverage or views expressed by other third parties on the stated issues.

In respect of information that has been prepared by 3DIP (and not otherwise attributed to any other party) and which appears in the English language version of this press release, in the event of any inconsistency between the English language version and the Japanese language version of this press release, the meaning of the Japanese language version shall prevail unless otherwise expressly indicated.

Contacts

KRIK (PR Agent)

Koshida: +81-70-8793-3990

Sugiyama: +81-70-8793-3989

World-Leading Cancer Center, The Royal Marsden NHS Foundation Trust, Using AI to Push Boundaries of Cancer Research With NTT DATA and CARPL.ai




World-Leading Cancer Center, The Royal Marsden NHS Foundation Trust, Using AI to Push Boundaries of Cancer Research With NTT DATA and CARPL.ai

• This partnership launches a large-scale, AI-powered service designed to accelerate cancer detection and treatment using medical imaging in the UK’s National Health Service (NHS)
• The Royal Marsden NHS Foundation Trust is ranked among world’s top cancer research centers
• Marks a milestone in the application of artificial intelligence for cancer research and clinical innovation

LONDON–(BUSINESS WIRE)–The Royal Marsden NHS Foundation Trust, a world-leading specialist cancer center, has today announced a pioneering partnership with NTT DATA, a global leader in digital business and technology services, and CARPL.ai, a leading enterprise imaging artificial intelligence (AI) and machine learning operations (MLOps) platform. Together, they have designed and built an advanced AI-powered radiology analysis service for the development and evaluation of AI in medical imaging, designed to transform cancer research and, ultimately, improve patient outcomes.

AI’s potential to enhance the speed and accuracy of identifying imaging biomarkers has long been recognized. Funded by a three-year grant from the UK’s National Institute for Health and Care Research (NIHR), the service will be used for research at The Royal Marsden and the Institute of Cancer Research (ICR), including projects in collaboration with other research teams. This research initiative will focus on developing and evaluating AI algorithms to improve the accuracy of cancer evaluation, including sarcoma, lung, breast, brain and prostate cancers. This will lead to faster response times, more accurate diagnoses and better-targeted treatments.

The service runs on a MLOps clinical imaging platform, built and operated by NTT DATA. To enable this, NTT DATA developed a bespoke AI computing solution leveraging high-performance Dell servers and utilizing the latest GPU processing capacity orchestrated by the CARPL.ai platform, which helps test and manage AI algorithms and includes a large collection of radiology AI models.

NTT DATA is also providing specialist imaging AI consulting services, helping researchers at The Royal Marsden test and evaluate emerging AI tools in real clinical settings, while extracting maximum insight and value from both in-house and commercial algorithms.

“AI has immense potential to support clinicians in diagnosing and treating cancer earlier and more precisely,” said Professor Dow-Mu Koh, Professor in Functional Cancer Imaging and Consultant Radiologist in Functional Imaging at The Royal Marsden. “By working with NTT DATA and CARPL.ai, we’ve created a scalable research environment that allows us to explore the full potential of AI safely and in a way that could one day transform cancer diagnosis and treatment across the NHS.”

Minister of State for Health, Karin Smyth, said: “Our 10 Year Health Plan will modernize the NHS, replacing outdated systems with cutting-edge digital solutions. While this trial is in its early stages, it represents exactly the kind of collaboration between the NHS, industry and academia that will help build a health service fit for the future. Early detection saves lives, and innovations like AI will transform how cancer is diagnosed and treated – helping patients receive faster and more effective care.”

Professor Mike Lewis, NIHR Scientific Director for Innovation, said: “Cancer is one of the biggest killers in the UK. That must change. This three-year grant will help researchers push the boundaries of AI-driven technology for cancer detection and diagnosis.

“This AI-powered service represents the cutting edge of cancer research and it is going to transform treatment, better support NHS staff and ultimately change patients’ lives. It is another great example of how NIHR-funded and supported research will ensure the best care is there when patients need it.”

Tom Winstanley, Chief Technology Officer at NTT DATA UK & Ireland, commented: “This service is a great example of responsible innovation in practice, showing the ethical, secure use of AI in healthcare. We are very proud to support The Royal Marsden in pushing the boundaries of cancer research.”

Once the service is live, research teams at The Royal Marsden will be able to evaluate a range of AI models across several cancer types. These studies will generate critical insights into how AI can support clinical decision-making and shape future approaches to diagnosis and treatment. Through CARPL.ai’s centralized interface and built-in monitoring tools, the research teams will also be able to track model performance over time, enabling faster feedback loops between development and deployment – a crucial step towards clinical translation. NTT DATA will continue to work closely with The Royal Marsden to support this next phase of research which will ultimately improve cancer care and patient outcomes.

About NTT DATA

NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. As a Global Top Employer, we have experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, and industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are also one of the world’s leading providers of digital and AI infrastructure. NTT DATA is part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future.

Visit us at https://uk.nttdata.com/

About The Royal Marsden NHS Foundation Trust

The Royal Marsden opened in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education. Today it operates as a specialist cancer center and the Trust was delighted to welcome Her Royal Highness The Princess of Wales, who became Joint Patron with His Royal Highness The Prince of Wales, in January this year.

Together with its principal academic partner, The Institute of Cancer Research (ICR), The Royal Marsden is designated as the UK’s only National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) dedicated solely to cancer.

The Royal Marsden and the ICR are recognized as one of the top four comprehensive cancer centers in the world for the impact of their research, influencing cancer treatment and care for all cancer patients. It is a center of excellence, pioneering the very latest in cancer treatments and technologies, as well as leading the way in innovative cancer diagnosis and education.

The Royal Marsden operates from three centers, in Chelsea, Sutton and Cavendish Square in central London. It also has a Medical Day Unit in Kingston, and is the founder and host of RM Partners West London Cancer Alliance, which includes St George’s University Hospitals NHS Foundation Trust, Imperial Healthcare NHS Trust, and other healthcare partners across north west and south west London.

Driven by the fundamental principle that patients, entrusting their lives to The Royal Marsden, deserve the very best, The Royal Marsden is committed to delivering excellent research‑led cancer care for patients, accelerating early diagnosis, and ensuring treatment and care is personalized for the needs of each individual.

Contacts

Hotwire Global

nttdata@hotwireglobal.com