BioSenic appoints Dr Carole Nicco as Chief Operating Officer in addition to Chief Scientific Officer

PRESS RELEASE

Dr Nicco's new Chief Operating Officer (COO) position will give her a broader mandate at BioSenic, where she is currently responsible for R&D programs.

Mont-Saint-Guibert, Belgium, January 10, 2024, 7.00 am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, today announces the promotion of Dr Carole Nicco to Chief Operating Officer (COO) in addition to her position as Chief Scientific Officer (CSO).

Dr Carole Nicco will be involved in the strategic planning, decision-making and management of key initiatives, as well as overseeing and enhancing the strategic development of BioSenic's pipelines, targeting treatments with its viscosupplementation, cell therapy and arsenic trioxide platforms. She will work closely with BioSenic's CEO, Prof. François Rieger, to further oversee and enhance BioSenic's strategic decisions.

“BioSenic is very proud to incorporate Dr Carole Nicco - our CSO - deeper into the strategic planning of BioSenic’s development. We have known Dr Nicco for many years and shared fruitful collaboration with her previous academic setting in Paris. Her enthusiasm and dedication to work, together with her wide experience and successes in the continuously growing field of Immunology, and pioneering results in innate and trained immunology, have deep consequences in creating, with the most advanced techniques in molecular and cell biology, the paths to a new area of modern and personalized medicine, applied to pathologies with no actual decisive medical treatments. We welcome her deep involvement and integration into our global project, with an interesting, diversified approach to efficient medications, using both our main platforms, i.e. the arsenic trioxide platform- to treat autoimmune conditions and return to homeostasis - and the cell therapy platform- to encourage tissue repair mechanisms,” said Prof. François Rieger, President and CEO of BioSenic.

"After one year as BioSenic's CSO, I have a better vision of the company's potential” declares Dr Carole Nicco, PhD and supervisor of graduate students for many years at the University Paris Cité. "I knew the scientific and clinical value of BioSenic's technologies and the importance of the arsenic trioxide platform in developing treatments for autoimmune diseases. The very active and interactive last year, 2023, allowed me to meet key players in the health sciences arena, and I particularly appreciate our growing partnership with the Walloon region, combined with the incredibly fruitful biopharma scene in Belgium. I am delighted to take on strategic responsibilities as Chief Operating Officer by BioSenic's Board and get the opportunity to share the strategic objectives of the Deputy CEO, Véronique Pomi, and the CEO, François Rieger, who have placed a great deal of trust in me. I am thrilled to bring my expertise to facilitate efficiency and effective performance, adding my perspectives and ideas to the overall project of the Company. I already have specific plans for the near, medium, and distant future to improve and diversify the use of our main therapeutic platforms, particularly using arsenic trioxide and its various possible formulations, which I'm convinced will address important unmet medical needs for patients heavily affected by certain autoimmune diseases.”

Dr Nicco has already begun to meet and interact with key global players interested in the development of the global BioSenic project or targeted therapeutic innovations. BioSenic wishes her all due success in her new commitments in our company.

About BioSenic

BioSenic is a biotech company specializing in the development of clinical assets issued from: (i) the arsenic trioxide (ATO) platform (with key target indications including Graft-versus-Host Disease (GvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the development of innovative products to meet unmet needs in immune and autoimmune diseases. Following a reverse merger in October 2022, BioSenic combined its strategic positioning and key strengths to develop, separately and in combination, an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO) with its innovative cell therapy platform and strong IP for tissue repair protection.

BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com.

About BioSenic technology platforms

1)   The ATO platform has immunomodulatory properties with fundamental effects on the activated cells of the immune system. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT). BioSenic has been successful in a phase 2 trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The company is heading towards an international phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae and the gastrointestinal tract) in an early phase 2a study. Systemic sclerosis is also part of the clinical pipeline of BioSenic. This serious chronic disease badly affects skin, lungs or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a phase 2 clinical protocol.


2)   ALLOB, an allogeneic cell therapy platform made of differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs), which can be stored at the point of use in hospitals. ALLOB represents a unique and 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. After phase 2 clinical results with contradictory conclusions, BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (between early or late treatment).


The company is currently focusing its present R&D and clinical activities on a selective, accelerated development of its autoimmune (ATO/OATO) platform.

For further information, please contact:

BioSenic SA
François Rieger, PhD, Chief Executive Officer
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com

International Media Enquiries:
IB Communications
Neil Hunter / Michelle Boxall
Tel: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Investor Enquiries:
Seitosei ● Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ggasparetto@actifin.fr

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.

BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, and its subsidiary Medsenic SAS, today announces the promotion of Dr Carole Nicco to Chief Operating Officer (COO) in addition to her position as Chief Scientific Officer (CSO).

 

Dr Carole Nicco will be involved in the strategic planning, decision-making and management of key initiatives, as well as overseeing and enhancing the strategic development of BioSenic's pipelines, targeting treatments with its viscosupplementation, cell therapy and arsenic trioxide platforms. She will work closely with BioSenic's CEO, Prof. François Rieger, to further oversee and enhance BioSenic's strategic decisions.

“BioSenic is very proud to incorporate Dr Carole Nicco - our CSO - deeper into the strategic planning of BioSenic’s development. We have known Dr Nicco for many years and shared fruitful collaboration with her previous academic setting in Paris. Her enthusiasm and dedication to work, together with her wide experience and successes in the continuously growing field of Immunology, and pioneering results in innate and trained immunology, have deep consequences in creating, with the most advanced techniques in molecular and cell biology, the paths to a new area of modern and personalized medicine, applied to pathologies with no actual decisive medical treatments. We welcome her deep involvement and integration into our global project, with an interesting, diversified approach to efficient medications, using both our main platforms, i.e. the arsenic trioxide platform- to treat autoimmune conditions and return to homeostasis - and the cell therapy platform- to encourage tissue repair mechanisms,” said Prof. François Rieger, President and CEO of BioSenic.

"After one year as BioSenic's CSO, I have a better vision of the company's potential” declares Dr Carole Nicco, PhD and supervisor of graduate students for many years at the University Paris Cité. "I knew the scientific and clinical value of BioSenic's technologies and the importance of the arsenic trioxide platform in developing treatments for autoimmune diseases. The very active and interactive last year, 2023, allowed me to meet key players in the health sciences arena, and I particularly appreciate our growing partnership with the Walloon region, combined with the incredibly fruitful biopharma scene in Belgium. I am delighted to take on strategic responsibilities as Chief Operating Officer by BioSenic's Board and get the opportunity to share the strategic objectives of the Deputy CEO, Véronique Pomi, and the CEO, François Rieger, who have placed a great deal of trust in me. I am thrilled to bring my expertise to facilitate efficiency and effective performance, adding my perspectives and ideas to the overall project of the Company. I already have specific plans for the near, medium, and distant future to improve and diversify the use of our main therapeutic platforms, particularly using arsenic trioxide and its various possible formulations, which I'm convinced will address important unmet medical needs for patients heavily affected by certain autoimmune diseases.”

Dr Nicco has already begun to meet and interact with key global players interested in the development of the global BioSenic project or targeted therapeutic innovations. BioSenic wishes her all due success in her new commitments in our company.

About BioSenic

BioSenic is a biotech company specializing in the development of clinical assets issued from: (i) the arsenic trioxide (ATO) platform (with key target indications including Graft-versus-Host Disease (GvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the development of innovative products to meet unmet needs in immune and autoimmune diseases. Following a reverse merger in October 2022, BioSenic combined its strategic positioning and key strengths to develop, separately and in combination, an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO) with its innovative cell therapy platform and strong IP for tissue repair protection.

BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com.

About BioSenic technology platforms

1. The ATO platform has immunomodulatory properties with fundamental effects on the activated cells of the immune system. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT). BioSenic has been successful in a phase 2 trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The company is heading towards an international phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae and the gastrointestinal tract) in an early phase 2a study. Systemic sclerosis is also part of the clinical pipeline of BioSenic. This serious chronic disease badly affects skin, lungs or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a phase 2 clinical protocol.
2. ALLOB, an allogeneic cell therapy platform made of differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs), which can be stored at the point of use in hospitals. ALLOB represents a unique and 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. After phase 2 clinical results with contradictory conclusions, BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (between early or late treatment).

The company is currently focusing its present R&D and clinical activities on a selective, accelerated development of its autoimmune (ATO/OATO) platform.

For further information, please contact:

BioSenic SA
François Rieger, PhD, Chief Executive Officer
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com

International Media Enquiries:
IB Communications
Neil Hunter / Michelle Boxall
Tel: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Investor Enquiries:
Seitosei ● Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ggasparetto@actifin.fr

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.