BioSenic to draw the final tranches of its present Global Tech
Opportunities 15 convertible bonds program and secure runway end of
January 2024
INSIDE INFORMATION
Mont-Saint-Guibert, Belgium, October 18,
2023, 7.00am CEST –
BioSenic to draw the final
tranches of its present Global Tech Opportunities 15 convertible
bonds program and secure runway end of January
2024
Mont-Saint-Guibert, Belgium,
October 18, 2023, 7.00am 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 reached a definitive
agreement with Global Tech Opportunities 15 (GTO15) with respect to
the finalization of the existing convertible bonds
program.
GTO15 will fund two tranches of EUR
300,000 each (minus a commission of 10%) of the existing
convertible bonds program. The EUR 600,000 will be drawn in two
successive tranches of EUR 300,000 – the first this week, and the
second as soon as a new prospectus of BioSenic will be finalized
and approved by FMSA. This will put an end to the convertible bonds
program with GTO15.
In light of the above, BioSenic
anticipates having sufficient cash to carry out its business
objectives until the end of January 2024.
BioSenic is now focusing its efforts in
organizing a fundraising event to allow the initiation of its phase
3 clinical trial with arsenic trioxide (ATO) to treat chronic graft
versus host disease (cGVHD). The initiation is currently scheduled
for Q2 2024.
Under the terms of the present
agreement, GTO15 agrees to voluntarily withdraw its latest
conversion notice for EUR 1,400,000, that would have led to an
issuance of 58 million of shares. In exchange for this withdrawal,
GTO15 will receive from BioSenic a compensation of EUR 125,000 in
convertible bonds under terms comparable to the existing ones.
These convertible bonds will be issued by Company within the
framework of the authorized capital.
BioSenic also obtained a commitment from
GTO15 not to trade more than the higher of 25% of the daily trading
volume of BioSenic's shares, or alternatively 5,000 EUR per day,
until the end of the program. This should efficiently limit the
impact of the termination of the program on BioSenic
stock.
François Rieger, PhD, Chairman
and CEO, BioSenic said: "BioSenic is now establishing new
major financial arrangements with strong commercial partners for
the execution of its long-term clinical programs. These programs
will start with BioSenic’s lead clinical trial in cGvHD with oral
arsenic trioxide as a drug for this disease with high unmet medical
need. BioSenic's pipeline should benefit from its previous
successes in Phase 2 trials in both systemic lupus erythematosus
and chronic graft-versus-host disease. We are on track for 505 b2
(FDA) and Hybrid (EMA) programs, which will allow us to accelerate
access to marketing approvals for related indications in the
autoimmune field. BioSenic needed to secure bridge financing in the
short term and is pleased to have reached a balanced, time-limited,
agreement with GTO15. This make it possible for BioSenic to secure
the long-term future of its ambitious projects.”
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 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 actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 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 2b 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 2b 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 3
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
reached a definitive agreement with Global Tech Opportunities
15 (GTO15) with respect to the finalization of the existing
convertible bonds program.
GTO15 will fund two tranches of EUR 300,000 each
(minus a commission of 10%) of the existing convertible bonds
program. The EUR 600,000 will be drawn in two successive tranches
of EUR 300,000 – the first this week, and the second as soon as a
new prospectus of BioSenic will be finalized and approved by FMSA.
This will put an end to the convertible bonds program with
GTO15.
In light of the above, BioSenic anticipates
having sufficient cash to carry out its business objectives until
the end of January 2024.
BioSenic is now focusing its efforts in
organizing a fundraising event to allow the initiation of its phase
3 clinical trial with arsenic trioxide (ATO) to treat chronic graft
versus host disease (cGVHD). The initiation is currently scheduled
for Q2 2024.
Under the terms of the present agreement, GTO15
agrees to voluntarily withdraw its latest conversion notice for EUR
1,400,000, that would have led to an issuance of 58 million of
shares. In exchange for this withdrawal, GTO15 will receive from
BioSenic a compensation of EUR 125,000 in convertible bonds under
terms comparable to the existing ones. These convertible bonds will
be issued by Company within the framework of the authorized
capital.
BioSenic also obtained a commitment from GTO15
not to trade more than the higher of 25% of the daily trading
volume of BioSenic's shares, or alternatively 5,000 EUR per day,
until the end of the program. This should efficiently limit the
impact of the termination of the program on BioSenic stock.
François Rieger, PhD, Chairman and CEO,
BioSenic said: "BioSenic is now establishing new major
financial arrangements with strong commercial partners for the
execution of its long-term clinical programs. These programs will
start with BioSenic’s lead clinical trial in cGvHD with oral
arsenic trioxide as a drug for this disease with high unmet medical
need. BioSenic's pipeline should benefit from its previous
successes in Phase 2 trials in both systemic lupus erythematosus
and chronic graft-versus-host disease. We are on track for 505 b2
(FDA) and Hybrid (EMA) programs, which will allow us to accelerate
access to marketing approvals for related indications in the
autoimmune field. BioSenic needed to secure bridge financing in the
short term and is pleased to have reached a balanced, time-limited,
agreement with GTO15. This make it possible for BioSenic to secure
the long-term future of its ambitious projects.”
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:
- 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 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 actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 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
2b 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 2b 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 3 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.
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