Neuroplast BV

16 patients have been enrolled in a multicenter international, randomized, placebo-controlled, double-blinded Phase II clinical trial Goal: to determine the effect size of Neuro-Cells ® , a stem-cell treatment for Traumatic Spinal Cord Injury (TSCI) Confirmed excellent safety and tolerability of Neuro-Cells® Preclinical evidence showcases Neuro-Cells ® potential in other indications, including traumatic brain injury Primary outcomes expected in February 2024, full study completion projected in August 2024 GELEEN, The Netherlands, Sept. 7, 2023 /PRNewswire/ -- Neuroplast, a Dutch clinical-stage biotech, focusing on cell-based treatments for neurodegenerative diseases, has successfully completed patient inclusion of its Phase II randomized placebo-controlled double-blinded clinical trial to evaluate the effect size of Neuro-Cells ® for Traumatic Spinal Cord Injury (TSCI). Preliminary data indicate an excellent safety profile due to the complete absence of product related adverse events. Furthermore, p atient feedback confirms excellent tolerability. The trial is conducted in collaboration with Hospital Nacional de Parapléjicos in Toledo, Spain, and Rigshospitalet in Copenhagen, Denmark. The Neuro-Cells® technology platform uses the patient's own bone marrow to create a stem cell treatment that modulates inflammation and improves regeneration potential in the central nervous system. Neuro-Cells® are administered intrathecally to patients in the sub-acute stage. This autologous treatment aims to preserve and restore function, mobility, and therefore independence. Double-blinded, randomized, placebo-controlled multi-center study The trial was conducted by Principal Investigators Antonio Oliviero, MD, PhD and Prof. Jörg Mey from Hospital Parapléjicos in Toledo, Spain, as well as Professor Fin Biering-Sørensen and MD, PhD Claus Andersen from Rigshospitalet in Copenhagen, Denmark. The study is a randomized, double-blinded and placebo-controlled trial, with an early and late intervention cross-over design. The intervention group received Neuro-Cells® in the sub-acute phase after sustaining trauma, with six months follow-up to their primary endpoints. The placebo group received a placebo at first but have been or will be treated with Neuro-Cells® after the initial six-month follow-up period. The multi-faceted follow-up for both groups includes standardized and validated outcome measures on motor and sensory function and multiple blood and cerebrospinal fluid measurements. Next to the absence of product related adverse events, the patients describe the intervention as easy and feasible as it does not require significant changes in daily living or medication intake. Antonio Oliviero, MD, PhD, Principal Investigator at Hospital Nacional de Parapléjicos de Toledo, Spain, states: "In our collaboration with Neuroplast to establish the role of cell transplantation in the recovery of individuals with spinal cord injury, it is great to hear that patients are pleased with the treatment that they experience as easy, feasible and safe." Fin Biering-Sørensen, MD, PhD, Principal investigator at Rigshospitalet, Denmark, adds : "For decades we have been seeking a cure for spinal cord injury. This project may be one step on that road, which is very exciting, due to the fact that so far, we have only been able to treat the symptoms and complications caused by the spinal cord injury." In total, the trial involves 16 patients that were included six to ten weeks after sustaining trauma to the spinal cord. The trial is conducted under official approval from the Spanish and Danish medical ethical committees and competent authorities. Neuroplast CEO Johannes de Munter concludes: "This milestone takes us one step closer to offering an effective treatment for patients suffering from traumatic spinal cord injury. We are especially glad to see further confirmation of the excellent tolerability and safety of our Neuro-Cells® product." Potential relevance to other neurological conditions Preclinical evidence suggests that the Neuro-Cells® treatment may have broader applications in addressing various neurodegenerative diseases. Neuroplast has obtained orphan disease designations for traumatic spinal cord injury and frontotemporal dementia. Ongoing research efforts are actively exploring additional potential applications. Neuroplast is open to discussing investment opportunities aimed at advancing the clinical pathways for addressing a broader range of conditions affecting the central nervous system, including traumatic brain injury. About Traumatic Spinal Cord Injury (TSCI) Acute TSCI causes incurable impairment to the spinal cord, affecting approximately 12,000 people across Europe and 17,000 across the USA annually. The damage or trauma interrupts communication of the brain with the body regions below the site of injury. Spinal cord injuries are mainly caused by accidents and - in most of the cases - result in life-long loss of control of motor functions and sensations. After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient's prognosis. Current treatment approaches for TSCI are only symptomatic, leaving the underlying pathophysiology unchanged. TSCI has a serious impact on the quality of life of patients, with severe implications on mobility and loss of independence. In addition, TSCI creates a lifetime financial burden for patients, payors, healthcare systems and societies at large. About Neuro-Cells® Neuro-Cells® is a transformative platform treatment under GMP. It contains a non-substantially manipulated bone marrow-derived integrated mixture of stem cells including hematopoietic and mesenchymal stem cells, manufactured from a patient's own bone marrow (donor and receiver are the same person). Inflammatory inducing components and pathogens are removed during this process. About Neuroplast Neuroplast is a Dutch stem cell technology company focusing on fast-track development programs using autologous cell products for treatment of neurodegenerative diseases, with the aim of giving back perspective to people who suffer from those conditions. The company was founded in August 2014 by physician Johannes de Munter and neurologist Erik Wolters. Current funders are Lumana Invest, Brightlands Venture Partners, LIOF and the Netherlands Enterprise Agency. Neuroplast is located in The Netherlands. For more information, please visit About Hospital de Parapléjicos, Toledo, Spain Hospital Nacional de Parapléjicos is the reference public hospital in Spain for the treatment of spinal cord injury, recognized by the Ministry of Health of the Government of Spain. About Rigshospitalet, Copenhagen, Spain Rigshospitalet is one of the two Danish national centers offering highly specialized treatment, rehabilitation and care of individuals with spinal cord lesions. About Lumana Invest Investment company Lumana was established by entrepreneurs and unique due to not having a predetermined investment horizon. The Lumana founders showcase strong commitment to their portfolio companies by actively supporting management in strategic decision making. About Brightlands Venture Partners Brightlands Venture Partners (BVP) is the fund manager of Chemelot Ventures and is a so-called ecosystem investor. BVP invests in companies benefiting from and contributing to the Brightlands campuses in the south of The Netherlands. Other funds under management are BVP Fund IV, Brightlands Agrifood Fund and Limburg Ventures. The funds of BVP focus on sustainability and health; together the funds have made 50 investments. About LIOF LIOF is the regional development agency for Limburg and supports innovative entrepreneurs with advice, network and financing. Together with entrepreneurs and partners, LIOF is working towards a smarter, more sustainable and healthier Limburg by focusing on the transitions of energy, circularity, health and digitalization. About The Netherlands Enterprise Agency The Netherlands Enterprise Agency operates under the auspices of the Dutch Ministry of Economic Affairs and Climate Policy. It facilitates entrepreneurship, improves collaborations, strengthens positions and helps realize national and international ambitions with funding, networking, know-how and compliance with laws and regulations. Forward looking statements All statements other than statements of historical facts, including the statements about the clinical and therapeutic potential and future clinical milestones of Neuro-CellsÒ, the indications we intend to pursue and our possible clinical or other business strategies, and the timing of these events, are forward-looking statements. Forward-looking statements can be identified by terms such as "believes", "expects", "plans", "potential", "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management's current beliefs and assumptions about future events and on information currently available to management. Neuroplast B.V. does not make any representation or warranty, express or implied, as to the improper use of this article, accuracy, completeness or updated status of above-mentioned statements. Therefore, in no case whatsoever will Neuroplast B.V. be legally liable or liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages. In case of any further questions, please contact: Neuroplast Johannes de Munter, CEO T: +31 (0)85 076 1000 E: [email protected] LifeSpring LifeSciences Communication, Amsterdam Leon Melens T: +31 6 538 16 427 E: [email protected] SOURCE Neuroplast

Fast-track status is granted for frontotemporal dementia, next to the existing designation for traumatic spinal cord injury An orphan medicinal product designation or orphan disease designation (ODD) grants the holder a fast-track development pathway to market authorization with market exclusivity This second ODD for Frontotemporal Dementia highlights the broader applicability of Neuro-Cells® for both chronic and trauma-induced neurodegenerative diseases; many of which share underlying disease mechanisms. Stem cell biotech Neuroplast already holds an ODD for Traumatic Spinal Cord Injury for which a Phase II clinical trial is ongoing Further applications of Neuro-Cells® are being explored, with targets on both the chronic- and the trauma-induced spectrum. These include ALS, Alzheimer's, Parkinson's Disease and Traumatic Brain Injury GELEEN, Netherlands, Sept. 8, 2022 /PRNewswire/ -- The European Union has granted stem cell biotech Neuroplast an orphan medicinal product designation for the applicability of its stem cell technology platform to frontotemporal dementia (FTD), following a positive opinion from The European Medicines Agency (EMA). With the existing orphan disease designation (ODD) for traumatic spinal cord injury (TSCI), Neuro-Cells® is now approved for a fast-track development pathway with market exclusivity for both a trauma-induced and a chronic degenerative central nervous system disorder. This marks an important milestone in the development roadmap of Neuroplast's Neuro-Cells® platform, as a stepping stone to other chronic neurodegenerative diseases such as Alzheimer's, ALS and Parkinson's Disease. The potential width in therapeutic applicability of the Neuroplast technology gives perspective to millions of people suffering from neurodegenerative diseases that currently have no outlook on effective treatment. One technology addresses underlying mechanisms of multiple acute and chronic neurological disorders Several conditions of the central nervous system, even when they seem unrelated at first and may have distinctive causes, have similar underlying disease mechanisms in common. These include unprogrammed cell death boosted by inflammation. Neuro-Cells®, an autologous, bone-marrow derived Advanced Therapy Medicinal Product, addresses that disease mechanism by moderating inflammation of damaged cells in the central nervous system, to limit further impairment. The treatment objective in acute disorders is to limit impact of sudden injury, where the treatment objective in chronic disorders is to limit progression of the disease. Neuroplast is already running a fast-track development pathway for traumatic spinal cord injury (TSCI), with a Phase II clinical trial in progress. This designation for frontotemporal dementia illustrates the broader applicability of the same technology for acute as well as chronic neurodegenerative disorders, paving the way to explore further applicability to conditions such as ALS, Alzheimer's disease, traumatic brain injury, subarachnoid stroke and Parkinson's Disease. Orphan disease designation for FTD awarded based on pre-clinical evidence Orphan disease designations are restricted to products for rare conditions for which there are no satisfactory methods of treatment authorized. It allows for a faster market authorization pathway and ten-year market exclusivity. Frontotemporal dementia (FTD) is a degenerative condition in the brain that affect approximately 3.8 people in 10,000 persons in the EU. Typical survival rate lies between three and fourteen years from symptom onset, dependent on the FTD variant at play. For this approval, the European Union followed the positive opinion from the EMA after the EMA followed positive recommendations from the Committee for Orphan Medicinal Products (COMP). COMP partly based their conclusions on the availability of pre-clinical evidence in mice, that showed decrease in neuroinflammation markers and rescue of cognitive and social behavioral deficits. Examples include reduction of anxiety, depressive-like behavior and abnormal social behavior. Neuroplast CEO Johannes de Munter states: "This designation for frontotemporal dementia is an important milestone in expanding the Neuro-Cells® development to a wider range of therapeutic areas. Using the same technology platform for traumatic spinal cord injury and frontotemporal dementia, illustrates an unusual range of acute and chronic neurological disorders that could potentially benefit from this." Neuroplast is open to discuss investor opportunities to effectuate the clinical pathways to a wider scope of neurological conditions. About Frontotemporal dementia Frontotemporal dementia (FTD) is a degenerative condition in the brain that is characterized by behavioral and language impairments. Depending on the variant, patients experience changes in personality, emotion, speech or motor functions. Patients may first become indifferent or careless and have difficulty understanding sentences. While the condition progresses, patients may become language impaired, lack initiative and lose executive functions. The typical survival rate lies between three and fourteen years from symptom onset, dependent on the FTD variant at play. FTD affects approximately 3.8 people in 10,000 persons in the EU, for whom there are no effective treatments available. Patients typically receive antipsychotics to limit behavioral symptoms. About Neuro-Cells® Neuro-Cells® is a transformative treatment under GMP. It contains non-substantially manipulated bone marrow-derived hematopoietic and mesenchymal stem cells, manufactured from a patient's own bone marrow (donor and receiver are the same person). Inflammatory inducing components and pathogens are removed during this process. About Neuroplast Neuroplast is a Dutch stem cell technology company focusing on fast-track development programs using autologous cell products for treatment of neurodegenerative diseases, with the aim of giving back perspective to people who suffer from those conditions. The company was founded in August 2014 by physician Johannes de Munter and neurologist Erik Wolters. Current funders are Lumana Invest, Brightlands Venture Partners, LIOF and the Netherlands Enterprise Agency. Neuroplast is located at Brightlands Chemelot Campus in The Netherlands. For more information, please visite About Lumana Invest Investment company Lumana was established by entrepreneurs and unique due to not having a predetermined investment horizon. The Lumana founders showcase strong commitment to their portfolio companies by actively supporting management in strategic decision making. About Brightlands Venture Partners Brightlands Venture Partners (BVP) is the fund manager of Chemelot Ventures and is a so-called ecosystem investor. BVP invests in companies benefiting from and contributing to the Brightlands campuses in the south of The Netherlands. Other funds under management are BVP Fund IV, Brightlands Agrifood Fund and Limburg Ventures. The funds of BVP focus on sustainability and health; together the funds have made over 40 investments. About LIOF LIOF is the regional development agency for Limburg and supports innovative entrepreneurs with advice, network and financing. Together with entrepreneurs and partners, LIOF is working towards a smarter, more sustainable and healthier Limburg by focusing on the transitions of energy, circularity, health and digitalization. About The Netherlands Enterprise Agency The Netherlands Enterprise Agency operates under the auspices of the Dutch Ministry of Economic Affairs and Climate Policy. It facilitates entrepreneurship, improves collaborations, strengthens positions and helps realize national and international ambitions with funding, networking, know-how and compliance with laws and regulations. Forward looking statements All statements other than statements of historical facts, including the statements about the clinical and therapeutic potential and future clinical milestones of Neuro-CellsÒ, the indications we intend to pursue and our possible clinical or other business strategies, and the timing of these events, are forward-looking statements. Forward-looking statements can be identified by terms such as "believes", "expects", "plans", "potential", "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management's current beliefs and assumptions about future events and on information currently available to management. Neuroplast B.V. does not make any representation or warranty, express or implied, as to the improper use of this article, accuracy, completeness or updated status of above-mentioned statements. Therefore, in no case whatsoever will Neuroplast B.V. be legally liable or liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages. In case of any further questions, please contact: Neuroplast Johannes de Munter, CEO T: +31 (0)85 076 1000 E: [email protected] LifeSpring LifeSciences Communication, Amsterdam Leon Melens T: +31 6 538 16 427 E: [email protected] Logo: SOURCE Neuroplast