BioSenic S.A. : Transparency notifications received from François
Rieger, Véronique Pomi, FA Dièse 3 SAS and Capital Grand Est SAS
REGULATED INFORMATION
Article 14 of the Law of 2 May 2007 on disclosure
of major holdings
Mont-Saint-Guibert, Belgium, October 17,
2022, 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, 2022, 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
platformsBioSenic’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
SAFrançois Rieger, PhD, Chief Executive
OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media
Enquiries:IB
CommunicationsNeil Hunter / Michelle
BoxallTel: +44 (0)20 8943
4685neil.hunter@ibcomms.agency /
michelle@ibcomms.agency
For French Investor
Enquiries:Seitosei
ActifinGhislaine
GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@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
platformsBioSenic’s technology is based on two main
platforms:
- 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.
- 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 SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@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.
Grafico Azioni Biosenic (EU:BIOS)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Biosenic (EU:BIOS)
Storico
Da Set 2023 a Set 2024