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Centre for Neuro Skills Appoints Curtis Shipman as Chief Information Officer 

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Centre for Neuro Skills Appoints Curtis Shipman as Chief Information Officer 




Centre for Neuro Skills Appoints Curtis Shipman as Chief Information Officer 

Technology leader brings 15+ years of experience in enterprise infrastructure, cybersecurity and digital transformation to national brain injury rehabilitation provider

BAKERSFIELD, Calif., March 12, 2026 (GLOBE NEWSWIRE) — Centre for Neuro Skills (CNS), a national provider of brain injury rehabilitation and neuro-specialty care, today announced the appointment of Curtis Shipman as chief information officer. 

In this role, Shipman will oversee technology strategy, enterprise infrastructure, cybersecurity governance and IT operations to support CNS’s clinical and operational excellence across eight locations in California and Texas. 

“As we continue to expand our services and enhance patient care, having robust, secure technology infrastructure is essential,” said David Harrington, CEO and President of CNS. “Curtis brings a proven track record of aligning technology with organizational mission, and his expertise in cybersecurity and infrastructure modernization will be invaluable as we advance our clinical capabilities and protect sensitive patient information.” 

Shipman brings more than 15 years of experience leading enterprise infrastructure, cybersecurity and global digital transformation initiatives across healthcare, manufacturing and technology sectors. His expertise includes cloud transformation, data governance, regulatory compliance and AI-enabled automation strategies. 

Most recently, Shipman served as director of IT, global infrastructure and IT operations at Electro Rent Corp., where he led global infrastructure modernization initiatives, implemented enterprise device management, standardized network architecture across international regions and developed data integration strategies to support AI-enabled monitoring and predictive alerting. 

Previously, Shipman held senior leadership roles at Harbor Freight Tools, directing large-scale transformation initiatives supporting product development and supply chain operations across the United States and Asia. During his tenure, he led organizational restructuring efforts, implemented ITIL and Scrum frameworks, and improved new product development timelines and on-time delivery performance through process optimization. 

“I’m honored to join Centre for Neuro Skills at such an important time in the organization’s growth,” said Shipman. “CNS’s mission-driven approach to brain injury rehabilitation requires technology systems that are not only secure and reliable, but that also enable clinicians to deliver the highest quality care. I look forward to building on the strong foundation already in place and advancing our technology capabilities to better serve patients and their families.” 

Shipman’s appointment comes as healthcare organizations face increasing cybersecurity threats and evolving regulatory requirements. His experience includes implementing compliance frameworks such as CMMC 2.0 and ISO 27001, as well as developing comprehensive cybersecurity governance programs. 

Shipman holds a Master of Science in cybersecurity and information assurance, a Master of Business Administration and multiple cybersecurity and agile leadership certifications. His leadership approach emphasizes scalable systems, strong governance and secure technology environments that enable mission-driven organizations to operate with confidence. 

About Centre for Neuro Skills 
Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. Recognized as one of America’s Greatest Midsize Workplaces 2025 by Newsweek, CNS covers a full spectrum of advanced care, from residential and assisted living to outpatient and day treatment. Founded by Dr. Mark Ashley in 1980, CNS has eight locations in California and Texas. For more information, visit neuroskills.com, Facebook, X, LinkedIn and YouTube. For a video overview, visit CNS’s YouTube channel. 

Media note: To request an interview with CNS leadership or clinical staff, contact Robin Carr at 415.766.0927 or CNS@landispr.com.

Media Contact: 
Landis Communications Inc. 
Robin Carr 
415.766.0927 
CNS@landispr.com

Merger with impact: MG Health and Canify form an international leading medical cannabis provider

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Issuer: Canify AG

/ Key word(s): Merger/Mergers & Acquisitions

Merger with impact: MG Health and Canify form an international leading medical cannabis provider

12.03.2026 / 11:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

Herrsching, Germany / Maseru, Lesotho (12/03/2026) – Canify AG, a company specializing in the processing and marketing of medical cannabis products, and MG Health Limited, Africa’s first EU-GMP certified producer of medical cannabis flowers and extracts, today announce their planned merger. In a signed Memorandum of Understanding (MoU), both companies have agreed to expand their successful two-year collaboration into a combined holding structure. The group will be a fully vertically integrated medical cannabis platform spanning EU GMP-certified production, pharmaceutical processing, and multi-market distribution, with commercial presence in more than 7 countries including Germany, the United Kingdom, Australia, and Poland, as well a unique global supplier network.

The two companies have worked closely together since Q4 2024, when MG Health began supplying Canify with medical cannabis flower on a consistent basis. That proven supply relationship now forms the operational foundation for a full merger.  “Mutual trust has grown out of our good working relationship – and so it is only logical to take our cooperation to the next level,” says Sascha Mielcarek, CEO of Canify AG. “We share not only quality standards, but also a common attitude: patients are at the center of everything we do. Our shared vision is to create a globally active pharmaceutical company with a clear focus on the highest quality standards and clinical innovation.”

The planned merger will create a vertically integrated structure that is unique in the European medical cannabis market. The combined group will control every critical step in the pharmaceutical value chain: from EU GMP-certified flower cultivation and extraction at MG Health’s facility in Lesotho, through pharmaceutical processing regulatory management, and multi-channel distribution via Canify’s established network of pharmacy partnerships and its direct-to-patient Canify Clinics platform.

MG Health’s production platform provides the combined group with a significant structural cost advantage. Operating at 2,000 metres altitude in the Maluti Mountains of Lesotho, the facility benefits from optimal growing conditions, low energy costs, and year-round natural light, enabling pharmaceutical-grade production at a fraction of the cost of European indoor facilities. Beyond operational efficiency, MG Health has invested meaningfully in the local community, creating hundreds of sustainable jobs, expanding local infrastructure, and delivering education and development programmes for employees, their families, and surrounding communities.

“As a company that puts people first, we don’t see economic success as an end in itself, but as a means to enable positive and sustainable change within our society,” says Andre Bothma, CEO of MG Health. “This principle shapes our daily actions in Lesotho – from responsible, sustainable management and long-term employment prospects to targeted education initiatives. In Canify, we have found a partner who shares these values and will carry them forward with us.”

“The merger gives us the opportunity to align our processes across the entire value chain with expertise and regulatory frameworks—and thus complement each other perfectly,” explains Mielcarek. For example, Canify’s existing international supplier network can be optimally aligned with MG Health’s expanded production and processing capacities. “At the same time, with MG Health, we are strengthening an approach that combines pharmaceutical excellence, social responsibility, and environmental sustainability.”

The combined group will pursue an ambitious international growth strategy. Building on active export supply chains in Australia, the United Kingdom and Poland besides the core market in Germany, the merger memorandum includes planned market expansion into Switzerland and further European markets.

Completion of the merger is subject to the finalisation of definitive agreements, and receipt of all necessary regulatory approvals. However, both parties are convinced that this will be completed timeously and that this first step will lay the foundation for sustainable growth, innovative care concepts, and long-term stable patient care.

About Canify AG:
Canify AG is a licensed pharmaceutical company specializing in medical cannabis. Canify’s products are based on scientific data, cutting-edge technology, and a commitment to helping patients. Canify’s approach is to make the cannabis business as easy and convenient as possible for pharmacies and wholesalers. Canify also offers customized production and market access solutions for third-party providers, setting standards in terms of quality, production capacity, and delivery times. In addition, Canify treats patients with individual cannabis therapy via telemedicine or in medical practices under the Canify Clinics brand. Canify AG consistently meets the highest standards of European GMP guidelines and offers transparency and traceability from cultivation to the patient.

About MG Health Limited:
MG Health is a vertically integrated manufacturer of medical cannabis flowers and extracts. The production facility is located at an altitude of 2,000 meters in the pristine mountainous landscape of the Kingdom of Lesotho in southern Africa. In this pure and untouched environment, MG Health produces safe and effective medical cannabis products of consistently high quality in accordance with the strictest pharmaceutical standards. MG Health is the first EU GMP-certified African medical cannabis company and currently exports its products to the United Kingdom, Australia, Germany, South Africa, and the Czech Republic. MG Health focuses on implementing a plant-to-patient philosophy and building a sustainable future for all.

Further information is also available on our websites:
www.canify.com / www.canify-pharma.de

www.mghealth.com

Contacts for press inquiries:
Kathrin Konyen                                               Luke van der Nest
Press officer Canify AG                                  Commercial Director  MG Health Ltd
press@canify.com                                                          info@mghealth.com
+49(0)173/6790782                                                      +266 5928 3540
 

Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026

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Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026




Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will attend the Stifel 2026 Virtual CNS Forum, from March 17-18, 2026, and will participate in a fireside chat on March 18, 2026, at 10:30am ET.


A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®

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Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®




Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®

FREMONT, Calif.–(BUSINESS WIRE)–Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, “The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease,” showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).


The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.

A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests.

“Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy,” said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. “The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring.”

Key study highlights include:

  • High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
  • Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
  • Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
  • Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.

“We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate,” said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. “The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice.”

The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to the attributes, advantages, sensitivity, and clinical relevance (including prognostic power, risk-stratification capabilities and superiority to traditional metrics) of the NeXT Personal test and the potential impact or expected benefits of the PREDICT-DNA study. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the ability of Personalis to expand reimbursement for, or the rate of adoption and use of, the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future, which may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

Contacts

Investor Relations:
Caroline Corner

investors@personalis.com
415-202-5678

Media Contact:
Patrick Schmidt

pr@personalis.com
630-290-2787

Combat Medical Raises £2.6 Million Series A to Advance Treatment of BCG Unresponsive Bladder Cancer

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Combat Medical Raises £2.6 Million Series A to Advance Treatment of BCG Unresponsive Bladder Cancer




Combat Medical Raises £2.6 Million Series A to Advance Treatment of BCG Unresponsive Bladder Cancer

  • Investment led by T&J Meyer Family Foundation, joined by Varia Ventures, NW Angel Fund and other non-institutional investors
  • Financing advances Combat’s HIVEC® HEAT FDA registration trial to change standard of care in BCG unresponsive NMIBC
  • Future financings to progress patented hyperthermic technology aimed at improving chemotherapy therapeutic efficacy, tolerability and treatment outcomes for advanced bladder and peritoneal cancers

LONDON–(BUSINESS WIRE)–Combat Medical (Combat), a medical device company optimising the delivery and efficacy of cancer therapeutics, today announced it has raised £2.6 million in the first close of a Series A financing to advance its hyperthermic intravesical chemotherapy treatment, HIVEC®, through phase 3 clinical trials and toward FDA registration. The round was led by T&J Meyer Family Foundation, and included investment from Varia Ventures, NW Angel Fund and non-institutional family offices and individuals.


The funding will be used to further fund the ongoing pivotal FDA registration trial, HIVEC HEAT, to investigate the effectiveness of the Company’s HIVEC treatment of BCG unresponsive non-muscle-invasive bladder cancer (NMIBC). The primary objective is to generate phase 3 clinical data to evidence Combat’s patented HIVEC treatment as an effective, safe and tolerable alternative to the current standard of care, which is radical cystectomy.

Combat will use future financings to complete FDA registration, growing operations to scale, expanding its existing clinical programmes for advanced bladder cancer (HIVEC) and peritoneal cancer (HIPEC), with a focus on US market entry.

Edward Bruce-White, Chief Executive Officer of Combat Medical, commented: “Our installed base of over 350 systems and the completion of over 100,000 HIVEC treatments to date demonstrates efficacy and use as a safe and well-tolerated, bladder-sparing alternative to radical cystectomy in BCG-unresponsive, high-risk NMIBC. Setting a new standard for patient care, it also provides clinicians and payers with advanced, affordable options that can easily be built into current treatment pathways. We are proud to have our investors on board as we progress through to FDA approval.”

Balint Nemeth, T&J Meyer Family Foundation, added: “Combat Medical is leading the development and clinical use of device assisted therapies with potential to disrupt current treatment standards. With systems in wide clinical use and already impacting patient outcomes, we are excited to support the company as HIVEC progresses through clinical trials.”

Contacts

Media contacts:
Sarah Jeffery

Zyme Communications

Tel: +44 (0) 7771 730919

Email: sarah.jeffery@zymecommunications.com

Consultation process at Bichsel completed

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On 24 February 2026, Galenica announced its intention to discontinue pharmaceutical production at its subsidiary Bichsel at the end of 2026 for economic reasons and to focus its business on home care services. Bichsel has now completed the consultation process that was initiated as part of this announcement. The Board of Directors and the Executive Committee have carefully reviewed the proposals submitted by the employee representatives during the consultation process. However, the process confirmed that production has been in deficit for years and that the existing facilities and buildings cannot be maintained despite continuous investments in recent years. As a result, continued operation is not economically viable under any scenario. The Board of Directors has therefore decided to close the production division at the end of 2026.

Comprehensive social plan

The originally anticipated reduction of 170 jobs can be reduced slightly by 18 jobs and now affects 152 jobs. In addition, an evaluation will be carried out over the coming weeks to determine how many employees can be employed within the Galenica network. Employees will be informed of their personal situation in the coming days. All affected employees will be supported by a comprehensive social plan. Among other things, the plan takes into account the age and years of service and includes provisions for cases of hardship. In addition, the affected employees will be supported in finding new employment. The constructive proposals submitted by the employee representatives have been incorporated into the social plan and have made a significant contribution to its design.

Supporting customers

Bichsel is in close contact with its customers and will support them during the transition phase as well as the search for alternative suppliers. Production will be continued and planned until the mid-year in such a way that Bichsel will be able to supply its customers with the most important products until approximately the end of the year. The extemporaneous formulations business will be taken over by the Galenica company Laboratoire Golaz in Lausanne. These products are particularly important for doctors and their patients and are sold through pharmacies.

SK pharmteco Announces CGMP Qualification of its Commercial-Scale Viral Vector Manufacturing Facility in France

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SK pharmteco Announces CGMP Qualification of its Commercial-Scale Viral Vector Manufacturing Facility in France




SK pharmteco Announces CGMP Qualification of its Commercial-Scale Viral Vector Manufacturing Facility in France

RANCHO CORDOVA, Calif., March 12, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful CGMP qualification of its manufacturing facility in Corbeil-Essonnes, France. This state-of-the-art plant is now fully operational and prepared to support late-stage and commercial viral vector programs at scale.

Recently, the facility was inspected by the ANSM (French Health Authority) and was successfully approved for operations. It has since produced its first batch using the company’s proprietary AAVelocity™ platform, a cornerstone of SK pharmteco’s extensive history in viral vector manufacturing.

“The qualification of this new facility marks a crucial milestone for SK pharmteco and our partners,” said Joerg Ahlgrimm, CEO of SK pharmteco. “By providing a fully inspected and approved environment that mirrors our development workflows, we eliminate the traditional ‘readiness gap.’ Our clients can now scale from preclinical stages to commercial supply with the same teams, the same platforms, and the same systems, ensuring total continuity and faster speed-to-market.”

Bridging the Gap from Clinical to Commercial
The new infrastructure is specifically designed for reproducibility and scale, offering:

  • Two multiproduct and independent manufacturing facilities
  • Two independent viral vector production suites
  • 5,000 m² purpose-built CGMP facility designed for scalable viral vector manufacturing
  • 12 single-use bioreactors from 50 L to 1,000 L providing a total installed upstream capacity of 5,000 L
  • Capacity for up to 40 cGMP batches per year, supporting parallel processing and reliable supply

By leveraging its established platforms, AAVelocity™ and LentiSure™, SK pharmteco ensures that processes running at a clinical scale remain reliable and steady when scaled up to larger commercial volumes, greatly reducing the risks for cell and gene therapy developers.

Additionally, the expansion directly addresses the critical pain points currently facing the viral vector market, including:

  • Regulatory Confidence: After inspection and approval by health authorities, the facility meets the highest standards of CGMP compliance.
  • Operational Continuity: Clients no longer need to switch CDMOs during scale-up, preventing delays, knowledge loss, and comparability risks related to tech transfers.

When combined with SK pharmteco’s other gene therapy manufacturing location outside of Philadelphia, this expansion enhances SK Pharmteco’s role as a leading global partner in viral vector manufacturing.

About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate. 

Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com

Aplagon Announces First Patient Dosed in Phase 2a Clinical Trial of APAC in Patients with Peripheral Arterial Occlusive Disease / Chronic Limb Threatening Ischemia

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Aplagon Announces First Patient Dosed in Phase 2a Clinical Trial of APAC in Patients with Peripheral Arterial Occlusive Disease / Chronic Limb Threatening Ischemia




Aplagon Announces First Patient Dosed in Phase 2a Clinical Trial of APAC in Patients with Peripheral Arterial Occlusive Disease / Chronic Limb Threatening Ischemia

HELSINKI, March 12, 2026 (GLOBE NEWSWIRE) — Aplagon, a clinical stage biotech pioneering a first-in-class treatment for thrombo-inflammatory diseases, known as APAC, a heparin proteoglycan mimetic with antiplatelet and anticoagulant effects, announced today the first patient has been dosed in its Phase 2a ‘HEALING’ clinical trial in peripheral arterial occlusive disease (PAOD) leading to chronic limb threatening ischemia (CLTI).

The single- and repeat- dose study using an intravenous (IV) administration taking place in Finland, is for up to 42 patients across 4 cohorts and has been designed to provide a preliminary indication of safety and efficacy of APAC in CLTI patients (with and without revascularisation) as well as APAC’s effect on thrombo-inflammatory biomarkers. Atherosclerosis-related thrombo-inflammation lead to CLTI, a severe form of PAOD, with insufficient blood flow in the affected limb, which can indicate limb amputation and has a mortality rate of 25% in the first year. The most important risk factors are diabetes and cigarette smoking.

This new Phase 2a trial received FIMEA approval following the successful completion of an international Phase 1 clinical trial in 30 healthy participants, which demonstrated that APAC was well tolerated, with dose-dependent and transient systemic antithrombotic effects. An associated PET-imaging clinical trial with 89zirconium-labeled APAC in PAOD patients and healthy participants is due to complete in H1 2026.

Aki Prihti, CEO at Aplagon, said, “We’re delighted to have achieved this significant clinical milestone and dosed our first patient in our Phase 2a trial to treat PAOD/CLTI. These are common, serious, thrombo-inflammatory diseases with high morbidity. Our innovative approach, using a heparin proteoglycan mimetic with targeting ability and retention on the vascular injury sites, has potential applications across a broad range of serious vascular diseases caused by thrombo-inflammation. Importantly, our APAC technology can be easily administered locally or intravenously in the hospital setting, supporting its uptake by vascular surgeons or angiologists.”

Maarit Venermo, Professor of vascular surgery, MD, PhD at Helsinki University Hospital, University of Helsinki, commented on the study, “The aim of this study is to improve the current treatment of PAOD/CLTI. APAC has been shown to prevent platelet aggregation and blood clotting. Previous studies have also shown that it reduces the inflammatory response in tissues damaged by oxygen deprivation during short follow-ups. Through these actions, APAC enhances the medical treatment of lower limb arterial atherosclerosis, accelerate the healing of tissue damage caused by ischemia, and prevent restenosis after revascularization procedures, thereby reducing the need for reinterventions.”

PAOD is relatively common and, as it progresses, can lead to limb threatening ischemia, significantly increasing the risk of amputation if arterial perfusion is not improved by a revascularization procedure. Arterial occlusions are often caused by atherosclerotic plaque formation, which may be aggravated by platelet aggregation at sites of severe stenosis, worsening limb ischemia. Current treatments for PAOD do not cure the disease but only alleviate symptoms. Revascularization procedures are often effective; however, particularly after endovascular treatment, restenosis occurs in approximately one-third of treated arteries, even when patients are on antithrombotic medication according to current treatment guidelines. The occurrence of restenosis and microvascular dysfunction represent a significant Achilles’ heel of endovascular treatment, leading to not only suffering for patients but also considerable societal costs.

Aplagon is also planning for 2026 a Phase 2 clinical trial for arteriovenous fistula (AVF) maturation failure in Europe, following the successful completion of its Phase 1 AVF trial. The study demonstrated encouraging early maturation results with no safety concerns.

About Aplagon Oy

Aplagon is a clinical stage biotech company developing a first-in-class therapeutic, called APAC (anti-platelet and anticoagulant), for treating thrombo-inflammatory diseases. The company’s two lead indications are for the prevention of arteriovenous fistula (AVF) maturation failure, to enable lifesaving haemodialysis treatment in end-stage kidney disease patients, and for chronic limb threatening ischemia (CLTI). By mimicking naturally occurring mast cell-derived heparin proteoglycans, APAC targets arterial injury sites providing long-lasting antithrombotic and anti-inflammatory action in situ. APAC is intended for in-hospital use and can be administered either locally or by IV infusion.

APAC is based on the pioneering research on mast cell-derived heparin proteoglycans performed by Prof. Riitta Lassila and associates at Wihuri Research Institute in Helsinki, Finland. Aplagon is backed by a syndicate of leading Nordic investors including FSG Fund, Wihuri Foundation, Innovestor and Serlachius Foundation as well as EIC Fund. The company is headquartered in Helsinki, Finland.

For more information see our website and LinkedIn.

Media Contacts

Aplagon

Aki Prihti, CEO
aki.prihti@aplagon.com

Scius Communications
Katja Stout +44 7789435990
katja@sciuscommunications.com

Daniel Gooch +44 7747875479
daniel@sciuscommunications.com

Cbio A/S Receives European Regulatory Clearance to Begin First-in-Human Clinical Trial of Next-Generation T-Cell Therapy in late-stage Cervical Cancer

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Cbio A/S Receives European Regulatory Clearance to Begin First-in-Human Clinical Trial of Next-Generation T-Cell Therapy in late-stage Cervical Cancer




Cbio A/S Receives European Regulatory Clearance to Begin First-in-Human Clinical Trial of Next-Generation T-Cell Therapy in late-stage Cervical Cancer

COPENHAGEN, Denmark, March 12, 2026 (GLOBE NEWSWIRE) — Cbio A/S today announced that it has received regulatory clearance to begin a first-in-human Phase I/IIa clinical trial of novoleucel, the company’s next-generation T-cell therapy designed to improve immune cell function in cancer patients potentially leading to a more effective treatment.

The study will enroll up to 20 patients with persistent or recurrent cervical cancer at Karolinska University Hospital in Stockholm, with the first patients expected to be treated within the coming months. Initial safety and translational data are expected by the end of 2026.

The milestone marks Cbio’s transition into clinical development and represents a key value inflection point for the company as it advances its strategy to improve the effectiveness of cell-based therapies in solid tumors.

“The regulatory clearance marks a defining milestone for Cbio,” said Ulrik Cordes, Founder and CEO of Cbio. “Patients with recurrent cervical cancer have very limited treatment options once standard therapies fail. We believe that novoleucel has the potential to significantly transform the treatment landscape and are excited to begin evaluating this novel approach in patients.”

Cervical cancer remains a major global health challenge, with more than 660,000 new cases diagnosed and 349,000 dying annually worldwide. The new cell-based therapy addresses a high unmet medical need for more effective treatment options.

Novoleucel is a first-in-class therapy designed to address the central challenge in cancer immunotherapy: oxidative stress within the tumor microenvironment that disables immune cells and limits therapeutic efficacy. The T-cells are armored to cope with this stress, increasing resistance to reactive oxygen species and helping preserve their cancer-killing activity inside tumors.

The therapy is based on discoveries from Professor Rolf Kiessling and Stina Wickström’s research group at Karolinska Institute, pioneers in adoptive cell therapy.

“For many years we have studied how oxidative stress suppresses immune cells in tumors,” said Rolf Kiessling. “By protecting tumor-reactive T-cells through activation of the Nrf-2 pathway, we aim to improve their persistence and anti-tumor activity. It is very gratifying to see this concept now entering clinical testing.”

The therapy will be manufactured at Cbio’s in-house GMP-certified cell therapy production facility in Copenhagen, Denmark, a 1,000 m² production facility dedicated to clinical-grade cell therapy manufacturing.

Cbio is supported by a syndicate of Nordic and international investors and is raising additional capital to support the expansion of the Phase I/IIa clinical program and to further develop its broader cell therapy platform.

“Seeing the program now enter clinical testing is both a proud moment and an important step forward for patients,” said Cecilia Hultén, Co-Founder and CFO in Cbio. “The start of the clinical program represents an important value inflection point for the company,” said Christian Leroy, board member and investor in Cbio. “We believe Cbio is advancing a compelling approach to improving cell therapies for solid tumors and look forward to following the development of novoleucel.”

The ongoing financing will support expansion of the clinical program and the generation of initial safety and translational data expected by the end of 2026.

About the Clinical Trial (EUCT 2024-517594-24)

The Phase I/IIa study will evaluate novoleucel in patients with persistent or recurrent cervical cancer who have progressed after platinum-based chemotherapy and checkpoint inhibitors. The trial will assess safety, feasibility of manufacturing and delivery, persistence of infused T-cells, and early signals of clinical activity.

About Cbio

Cbio A/S is a Nordic biotechnology company developing next-generation cell therapies for solid tumors based on discoveries from the Karolinska Institute, Sweden. The Company operates from Copenhagen and has own production facility for immune cell therapies.

Investor and Media Contact

Cbio A/S
Ulrik Cordes, CEO
ucordes@cbio.dk
+45 31 62 53 33
www.cbio.dk

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a0865d7f-1ea0-4262-80e5-0385fd4e01f1

Allegro’s osteoarthritis hydrogel resolves lameness in animal study

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Allegro’s osteoarthritis hydrogel resolves lameness in animal study




Allegro’s osteoarthritis hydrogel resolves lameness in animal study

  • The hydrogel resolved lameness in 72% of horses treated
  • Horses provide a strong translational model for human osteoarthritis
  • Clinical investigation authorized by Belgian regulatory authority
  • Allegro’s hydrogel is first-in-class potentially disease-modifying osteoarthritis device candidate

Liege, Belgium – 12 March 2026 (08:30 CET) – Allegro NV, a biomedical company developing transformative nanotechnology treatments for degenerative joint disease, has demonstrated that its proprietary injectable hydrogel significantly improved joint mobility in horses with osteoarthritis. In a proof-of-concept study in 40 mature thoroughbred horses with osteoarthritis, 89.6% showed a reduction in lameness after the treatment, while 72.4% demonstrated complete resolution of lameness four weeks later. Allegro plans to publish the results of the study at a leading medical conference in 2026.

The company is also announcing today it has received approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium for an open-label feasibility study with its Hydrocelin hydrogel device candidate in 20 patients with osteoarthritis of the knee. Allegro expects to launch the study in the coming weeks.

“These first efficacy results in horses using Allegro’s osteoarthritis treatment candidate suggest extraordinary promise for use in humans. Osteoarthritis is the leading cause of disability in humans, with no disease-modifying treatment available today. At Allegro, we’re working to demonstrate benefits to patients in our clinical testing this year, and offer better outcomes for the 650 million people affected by the disease,” said Lucas Decuypere, CEO of Allegro.

Horses are a strong translational model for humans in joint disease and Allegro is fully focused on the clinical development of its technology, after signing an exclusive licensing deal for its technology for use in veterinary markets with American Regent, a leading pharmaceutical company in the U.S. specializing in injectables for human and animal health. Allegro will supply American Regent with product from its manufacturing site in Belgium.

In the study, horses received a single injection of the hydrogel in the most affected joint, and hyaluronic acid (Optivisc Single) in the contralateral (healthy) joint as a control.

Among the findings were:

  • After four weeks of treatment with Allegro’s hydrogel, 89.6% of horses (26 out of 29 evaluable horses) showed improvement of the AAEP lameness score, while 72.4% (21 out of 29 evaluable horses) showed complete resolution of lameness.
  • The difference in the AAEP lameness score after 4 weeks of treatment compared with the score before treatment was statistically significant (p<0.05).
  • No adverse effects were observed in pathological joints after the nanogel injection and throughout the 4-week follow-up period.

Hydrocelin contains cross-linked particles designed to act as tiny shock absorbers in the synovial fluid. Restoring the shock-absorbing capacity of the synovial fluid is intended to provide pain relief and protect cartilage in the joints. In April, Allegro presented positive preclinical data demonstrating the satisfactory safety profile of Hydrocelin at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO) in Rome. In addition to this pyrogenicity study, the company has also demonstrated a satisfactory safety profile in preclinical studies assessing irritation, delayed sensitization and systemic toxicity.

Allegro NV (www.allegro.bio) is a clinical-stage biomedical company developing transformative treatments for degenerative joint diseases based on its proprietary nanotechnology platform, INTRICATE. The company’s lead product candidate, Hydrocelin, is a first-in-class, potentially disease-modifying injectable treatment for osteoarthritis, a novel performance biomaterial designed to restore the natural protective mechanics of the joint – rather than merely masking symptoms. By altering the trajectory of the disease at its source we aim to redefine the future of osteoarthritis and its care.

For more information please visit www.allegro.bio.

For further information please contact:

Allegro NV
Lucas Decuypere
Chief Executive Officer
email info@alllegro.bio

 Investor Relations
Mary-Ann Chang
Cohesion Bureau
+44 7483 284 853
mary-ann.chang@cohesionbureau.com

Media Relations
Douwe Miedema
Cohesion Bureau
+352 621 562 764
douwe.miedema@cohesionbureau.com

Important information
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes”, “estimates,” “anticipates”, “expects”, “intends”, “may”, “will”, “plans”, “continue”, “ongoing”, “potential”, “predict”, “project”, “target”, “seek” or “should”, and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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