Correction: BioSenic S.A. : Transparency notifications received from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS

 REGULATED INFORMATION

This is a corrected version of the original PR "Transparency notifications received from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS" published on October 17, 2023, 7am CEST. There are two typographical corrections, one in the headline and one in the first paragraph where 2022 was written instead of 2023.

Correction: Transparency notifications received from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS

Article 14 of the Law of 2 May 2007 on disclosure of major holdings

Mont-Saint-Guibert, Belgium, October 17, 2023, 7am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces that it has received transparency notifications from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS. The notifications details can be found below and can be consulted on the website of BioSenic, under the heading “Major shareholders & transparency notices”.

The transparency notification indicates that the shareholdings held by François Rieger have crossed below the threshold of 20% as a result of the issuance of new shares of BioSenic on 10 August 2023. 

The notification received from François Rieger dated 13 October 2023 contains the following information:

• Reason for the notification:
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: François Rieger
• Transaction date: 10 August 2023
• Threshold that is crossed: 20%
• Denominator: 134 014 808
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
François Rieger	26 589 361	26 589 361	19.84%
Total voting rights		26 589 361	19.84%

The transparency notification indicates that the shareholdings held by Véronique Pomi have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 28 August 2023. 

The notification received from Véronique Pomi dated 13 October 2023 contains the following information:

• Reason for the notification:
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Véronique Pomi
• Transaction date: 28 August 2023
• Threshold that is crossed: 10%
• Denominator: 137 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Véronique Pomi	13 306 121	13 306 121	9.69%
Total voting rights		13 306 121	9.69%

The transparency notification indicates that the shareholdings held by FA Dièse 3 SAS have crossed below the threshold of 5% as a result of the issuance of new shares of BioSenic 28 August 2023. 

The notification received from FA DIESE 3 SAS dated 13 October 2023 contains the following information:

• Reason for the notification:
  • Downward crossing of the lowest threshold
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: FA DIESE 3
• Transaction date: 28 August 2023
• Threshold that is crossed: 5%
• Denominator: 137 348 141
• Full chain of controlled undertakings through which the holding is effectively held: FA DIESE 3 is not under control
  
  

The transparency notification indicates that the shareholdings held by Capital Grand Est SAS have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 11 September 2023. 

The notification received from Capital Grand Est SAS dated 16 October 2023 contains the following information:

• Reason for the notification:
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Capital Grand Est SAS
• Transaction date: 11 September 2023
• Threshold that is crossed: 10%
• Denominator: 142 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Capital Grand Est SAS	14 045 094	14 045 094	9.87%
Total voting rights		14 045 094	9.87%

• Full chain of controlled undertakings through which the holding is effectively held: Capital Grand Est SAS is not under control
• Additional information: Capital Grand Est SAS is the management company that can execute the voting rights as it sees fit in the absence of specific instructions

About BioSenic

BioSenic is a leading 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 orthopedics.

Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, 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
BioSenic’s technology is based on two main platforms:

1)   The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and 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 cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. 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). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase II trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase III 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 IIa 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 actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase II clinical protocol.


2)   The allogeneic cell and gene therapy platform developed by BioSenic, with 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. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase IIb clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment).


Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase III JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next-generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation.
The company, will nevertheless focus 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.

 

The transparency notification indicates that the shareholdings held by Véronique Pomi have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 28 August 2023. 

The notification received from Véronique Pomi dated 13 October 2023 contains the following information:

• Reason for the notification:
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Véronique Pomi
• Transaction date: 28 August 2023
• Threshold that is crossed: 10%
• Denominator: 137 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Véronique Pomi	13 306 121	13 306 121	9.69%
Total voting rights		13 306 121	9.69%

The transparency notification indicates that the shareholdings held by FA Dièse 3 SAS have crossed below the threshold of 5% as a result of the issuance of new shares of BioSenic 28 August 2023. 

The notification received from FA DIESE 3 SAS dated 13 October 2023 contains the following information:

• Reason for the notification:
  • Downward crossing of the lowest threshold
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: FA DIESE 3
• Transaction date: 28 August 2023
• Threshold that is crossed: 5%
• Denominator: 137 348 141
• Full chain of controlled undertakings through which the holding is effectively held: FA DIESE 3 is not under control
  
  

The transparency notification indicates that the shareholdings held by Capital Grand Est SAS have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 11 September 2023. 

The notification received from Capital Grand Est SAS dated 16 October 2023 contains the following information:

• Reason for the notification:
  • Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Capital Grand Est SAS
• Transaction date: 11 September 2023
• Threshold that is crossed: 10%
• Denominator: 142 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Capital Grand Est SAS	14 045 094	14 045 094	9.87%
Total voting rights		14 045 094	9.87%

• Full chain of controlled undertakings through which the holding is effectively held: Capital Grand Est SAS is not under control
• Additional information: Capital Grand Est SAS is the management company that can execute the voting rights as it sees fit in the absence of specific instructions

About BioSenic

BioSenic is a leading 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 orthopedics.

Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, 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
BioSenic’s technology is based on two main platforms:

1)   The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and 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 cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. 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). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase II trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase III 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 IIa 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 actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase II clinical protocol.


2)   The allogeneic cell and gene therapy platform developed by BioSenic, with 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. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase IIb clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment).


Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase III JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next-generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation.
The company, will nevertheless focus 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.

REGULATED INFORMATION

 

Article 14 of the Law of 2 May 2007 on disclosure of major holdings

Mont-Saint-Guibert, Belgium, October 17, 2023, 7am CEST – 

Transparency notifications received from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS

Article 14 of the Law of 2 May 2007 on disclosure of major holdings

Mont-Saint-Guibert, Belgium, October 17, 2023, 7am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces that it has received transparency notifications from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS. The notifications details can be found below and can be consulted on the website of BioSenic, under the heading “Major shareholders & transparency notices”.

The transparency notification indicates that the shareholdings held by François Rieger have crossed below the threshold of 20% as a result of the issuance of new shares of BioSenic on 10 August 2023. 

The notification received from François Rieger dated 13 October 2023 contains the following information:

• Reason for the notification: Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: François Rieger
• Transaction date: 10 August 2023
• Threshold that is crossed: 20%
• Denominator: 134 014 808
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
François Rieger	26 589 361	26 589 361	19.84%
Total voting rights		26 589 361	19.84%

The transparency notification indicates that the shareholdings held by Véronique Pomi have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 28 August 2023. 

The notification received from Véronique Pomi dated 13 October 2023 contains the following information:

• Reason for the notification: Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Véronique Pomi
• Transaction date: 28 August 2023
• Threshold that is crossed: 10%
• Denominator: 137 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Véronique Pomi	13 306 121	13 306 121	9.69%
Total voting rights		13 306 121	9.69%

The transparency notification indicates that the shareholdings held by FA Dièse 3 SAS have crossed below the threshold of 5% as a result of the issuance of new shares of BioSenic 28 August 2023. 

The notification received from FA DIESE 3 SAS dated 13 October 2023 contains the following information:

• Reason for the notification: Downward crossing of the lowest threshold Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: FA DIESE 3
• Transaction date: 28 August 2023
• Threshold that is crossed: 5%
• Denominator: 137 348 141
• Full chain of controlled undertakings through which the holding is effectively held: FA DIESE 3 is not under control
  
  

The transparency notification indicates that the shareholdings held by Capital Grand Est SAS have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 11 September 2023. 

The notification received from Capital Grand Est SAS dated 16 October 2023 contains the following information:

• Reason for the notification: Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Capital Grand Est SAS
• Transaction date: 11 September 2023
• Threshold that is crossed: 10%
• Denominator: 142 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Capital Grand Est SAS	14 045 094	14 045 094	9.87%
Total voting rights		14 045 094	9.87%

• Full chain of controlled undertakings through which the holding is effectively held: Capital Grand Est SAS is not under control
• Additional information: Capital Grand Est SAS is the management company that can execute the voting rights as it sees fit in the absence of specific instructions

About BioSenic

BioSenic is a leading 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 orthopedics.

Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, 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
BioSenic’s technology is based on two main platforms:

1)   The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and 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 cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. 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). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase II trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase III 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 IIa 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 actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase II clinical protocol.


2)   The allogeneic cell and gene therapy platform developed by BioSenic, with 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. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase IIb clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment).


Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase III JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next-generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation.
The company, will nevertheless focus 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, today announces that it has received transparency notifications from François Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS.  The notifications details can be found below and can be consulted on the website of BioSenic, under the heading “Major shareholders & transparency notices”.

 

The transparency notification indicates that the shareholdings held by François Rieger have crossed below the threshold of 20% as a result of the issuance of new shares of BioSenic on 10 August 2023. 

The notification received from François Rieger dated 13 October 2023 contains the following information:

• Reason for the notification:
• Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: François Rieger
• Transaction date: 10 August 2023
• Threshold that is crossed: 20%
• Denominator: 134 014 808
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
François Rieger	26 589 361	26 589 361	19.84%
Total voting rights		26 589 361	19.84%

The transparency notification indicates that the shareholdings held by Véronique Pomi have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 28 August 2023. 

The notification received from Véronique Pomi dated 13 October 2023 contains the following information:

• Reason for the notification:
• Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Véronique Pomi
• Transaction date: 28 August 2023
• Threshold that is crossed: 10%
• Denominator: 137 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Véronique Pomi	13 306 121	13 306 121	9.69%
Total voting rights		13 306 121	9.69%

The transparency notification indicates that the shareholdings held by FA Dièse 3 SAS have crossed below the threshold of 5% as a result of the issuance of new shares of BioSenic 28 August 2023. 

The notification received from FA DIESE 3 SAS dated 13 October 2023 contains the following information:

• Reason for the notification:
• Downward crossing of the lowest threshold
• Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: FA DIESE 3
• Transaction date: 28 August 2023
• Threshold that is crossed: 5%
• Denominator: 137 348 141
• Full chain of controlled undertakings through which the holding is effectively held: FA DIESE 3 is not under control

The transparency notification indicates that the shareholdings held by Capital Grand Est SAS have crossed below the threshold of 10% as a result of the issuance of new shares of BioSenic on 11 September 2023. 

The notification received from Capital Grand Est SAS dated 16 October 2023 contains the following information:

• Reason for the notification:
• Passive crossing of a threshold
• Notification by: A person that notifies alone
• Person subject to the notification requirement: Capital Grand Est SAS
• Transaction date: 11 September 2023
• Threshold that is crossed: 10%
• Denominator: 142 348 141
• Notified details:

Voting rights	Previous notification	After the transaction
Holders of voting rights	# of voting rights	# of voting rights	% of voting rights
Capital Grand Est SAS	14 045 094	14 045 094	9.87%
Total voting rights		14 045 094	9.87%

• Full chain of controlled undertakings through which the holding is effectively held: Capital Grand Est SAS is not under control
• Additional information: Capital Grand Est SAS is the management company that can execute the voting rights as it sees fit in the absence of specific instructions

About BioSenic

BioSenic is a leading 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 orthopedics.

Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, 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
BioSenic’s technology is based on two main platforms:

1. The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and 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 cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. 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). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase II trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase III 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 IIa 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 actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase II clinical protocol.
2. The allogeneic cell and gene therapy platform developed by BioSenic, with 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. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase IIb clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment).

Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase III JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next-generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation.
The company, will nevertheless focus 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.