BioSenic appoints Dr Carole Nicco as Chief Scientific Officer

Dr Nicco will oversee the development of pipeline across BioSenic’s cell therapy and

autoimmune disease platform and will be responsible for R&D programs

Mont-Saint-Guibert, Belgium, January 18, 2023, 7am CET – BioSenic(Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune /inflammatory diseases and cell repair, today announces it is strengthening its scientific team with the appointment of Dr. Carole Nicco, as Chief Scientific Officer (CSO).

Dr Carole Nicco will be responsible for managing BioSenic’s scientific research and development. She will work closely with BioSenic’s CEO, Prof. François Rieger, to further supervise and enhance BioSenic’s strategic pipeline development, targeting treatments with its cell therapy and autoimmune disease platforms.

“BioSenic is completing its C-level team of management to progress driving our cell therapy platform ALLOB to the end of its phase IIb trial and entering the phase III trial for our autoimmune platform. Carole’s experience will be key to foster our research and development activities using allogeneic cell therapy platform and arsenic salts,” said Prof. François Rieger, President and CEO of BioSenic. “The whole team is delighted to take this step with Carole.”

"I am thrilled to join BioSenic, the developer of a robust and diversified therapeutic pipeline for the treatment of chronic inflammatory and autoimmune diseases and the promotion of innovative solutions with great promise for tissue repair. These therapies have high potential to make a considerable difference in a wide range of unmet medical needs. Their combination will bring out major advances and implement new treatments to the market,” said Dr Carole Nicco, CSO of BioSenic. “I am excited to bring new perspectives and ideas to contribute to the development of BioSenic’s next generation of therapies and to be part of the transformative impact of these novel therapeutic approaches for patients across a wide range of diseases who need better and efficient treatment options.”

Dr. Nicco brings more than two decades of expertise in cancer biology and immunology, inflammation, immunity, new target identification and drug discovery. Prior to joining BioSenic, Dr Nicco has actively conducted programs from research all the way through to preclinical trials in collaboration with renown pharma companies (Vertex, BOIRON, IPRAD/GYNOV, Medsenic). Additionally, she has directed dozens of preclinical studies for pathologies ranging from cancer to endometriosis, as well as in autoimmune diseases (SLE, SSc, cGVHD) or pathologies implicating the immune system, including wound healing, uveitis, sepsis, hepatitis and endometriosis.

From 2005 to 2023, Carole was one of the principle investigators and the lab manager of the research team “Pathogeny and innovative treatments for chronic fibro-inflammatory diseases” at Cochin Institute, a biomedical research center affiliated with INSERM (Unit 1016), CNRS (UMR 8104) and Paris Cité University. She was also head of the conventional preclinical structure of the Cochin Institute for the 10 last years. Since 2016, Dr Nicco is a member of the scientific committee and advisory board of four international congresses: Paris Redox, Targeting Mitochondria, Targeting Microbiota and Skin Challenges. In 2023, Dr. Nicco becomes President of the international non-profit organization Redox Medecine Society (previous International Society of Antioxidants in Nutrition and Health). She is the author of 110 articles published in international scientific journals in the fields of autoimmune disorders, inflammation and cancer.

Dr Nicco holds a Ph.D. in human physiology and physiopathology from Denis Diderot University of Paris, France.

About BioSenic

BioSenic is a leading biotech company specializing in the development of clinical assets issued from: (i), the allogeneic cell therapy platform ALLOB and (ii) the Arsenic TriOxide (ATO) platform. Key target indications for the platforms include Graft versus Host Disease (GvHD), Systemic lupus erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial fractures.

Following the merger in October 2022, BioSenic combines the strategic positionings and strengths of Medsenic and Bone Therapeutics. The merger also enables Biosenic to add to its innovative cell therapy platform and strong IP for tissue repair protection with an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/OATO.

BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at .

About BioSenic technology platforms

BioSenic’s technology is based on:

1)   The allogeneic cell and gene therapy platform, developed by Bone Therapeutics with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) that can be stored at the point of use in hospitals. Its current investigational medicinal product, ALLOB, represents a unique, proprietary approach to organ repair and specifically to bone regeneration, by turning undifferentiated stromal cells from healthy donors into bone-forming cells on the site of injury. These cells are produced via a proprietary BioSenic scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental, and should be of value in new indications when cells will be further adapted or transformed with additional targeting properties.

2)    The Arsenic TriOxide (ATO) platform developed by Medsenic. The immunomodulatory properties of ATO have demonstrated a double basic effect on cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T or other cells of the innate/adaptative immune system to the point they will enter a cell death program (apoptosis) and be eliminated. The second effect is potent immunomodulatory properties on several pro-inflammatory cytokines involved in inflammatory or autoimmune cell pathways. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. GvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-SCT). GvHD is primarily mediated by the transplanted immune system that can lead to severe multiorgan damage. Medsenic had been successful in a phase II trial with its intravenous formulation, allowing arsenic trioxide to be granted an orphan drug designation status by FDA and EMA and is heading towards an international Phase III confirmatory study, with a new, IP protected, oral (OATO) formulation.

Moderate to Severe forms of Systemic Lupus erythematosus (SLE)° is another selected target, using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae and the gastro-intestinal tract) in a phase IIa study.

Systemic Sclerosis is, in addition, part of the clinical pipeline of BioSenic. Preclinical studies on pertinent animal models are positive. This gives good grounds to launch a phase II clinical protocol for this serious disease that badly affects skin, lungs or vascularization, and with no actual current effective treatment.

For further information, please contact:

BioSenic SA

François Rieger, PhD, Chief Executive Officer

Tel: +33 (0)671 73 31 59

For Belgian Media and Investor Enquiries:

Bepublic

Bert Bouserie

Tel: +32 (0)488 40 44 77

For International Media Enquiries:

IB Communications

Neil Hunter / Michelle Boxall

Tel: +44 (0)20 8943 4685

cy / cy

For French Media Enquiries:

NewCap Media

Annie-Florence Loyer

Tel: +33 (0)1 44 71 00 12

For French Investor Enquiries:

Seitosei Actifin

Ghislaine Gasparetto

Tel: +33 (0)1 56 88 11 22

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.