BioSenic provides third quarter 2023 Business Update
REGULATED INFORMATION
Following the in-principle agreement
reached with its main creditors in the context of ongoing equity
raise process, the focus of BioSenic is now to proceed with
fundraising, allowing to start its phase 3 international clinical
trial with oral arsenic trioxide (ATO) in the first-line treatment
of chronic Graft-versus-Host-Disease (cGvHD).
Mont-Saint-Guibert, Belgium, October 25,
2023, 7.00 am CEST –
BioSenic provides third quarter
2023 Business Update
Following the in-principle
agreement reached with its main creditors in the context of ongoing
equity raise process, the focus of BioSenic is now to proceed with
fundraising, allowing to start its phase 3 international clinical
trial with oral arsenic trioxide (ATO) in the first-line treatment
of chronic Graft-versus-Host-Disease (cGvHD).
Mont-Saint-Guibert, Belgium,
October 25, 2023, 7.00 am CEST – BIOSENIC
(Euronext Brussels and Paris: BIOS), the innovative company
addressing unmet medical needs in the areas of innate immunity,
inflammation and organ/function repair, today provides its business
update for the third quarter, ended 30 September 2023.
Key
highlights
- In July 2023, BioSenic
obtained an agreement with Monument and Patronale for a standstill,
postponing until Q4 any payment to these creditors.
- In September 2023, new
binding term sheets have been signed for the replacement of the
Monument and Patronale bonds and loans, by new unsecured
convertible bonds. New potential terms, subject to formal approval
by the European Investment Bank, have also been formulated for the
long-term extension of the existing loan financing with the
European Investment Bank in the context of ongoing equity raise
process. Implementation of the terms agreed with all three lenders
is subject to the completion of an equity investment in the
Company.
- In August 2023, BioSenic
announced the allowance of a new patent entitled ‘Use of metal ions
to potentiate the therapeutic effects of arsenic’ by the China
National Intellectual Property Administration (CNIPA). This patent
(ZL202080040613.1) covers the use of its ATO platform in
combination with metal ions like copper, allowing further further
potential upon the use of arsenic to improve the treatment of
autoimmune diseases, starting with cGvHD (the European Patent
Office had granted a parallel wide patent protection in eight
countries in Europe - EP3972613 - in April 2023).
- In September 2023, BioSenic
published data in a peer-reviewed international journal “Arthritis
Research & Therapy”, providing additional indications of its
lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO)
to treat systemic sclerosis (SSc). These results give ground to the
proposed clinical relevance of ATO treatment in SSc, and more
generally in autoimmune related pathologies. In September 2023,
BioSenic announced the completion of a post-hoc analysis of its
phase 2 clinical trial of ATO, finding the most adapted scheme for
administration of an efficient treatment for chronic
Graft-versus-Host-Disease (cGvHD). As a result, BioSenic will
further use this 2-cycle treatment in its forthcoming phase 3
clinical trial. This involves the administration of a double
four-week course, separated by a rest period, resulting in the use
of two to four times more doses of ATO.
Financial
highlights
- Net cash
at the end of September 2023 amounted to €0.39 million (1). Upon
receipt of the two final instalments of €300,000 under the existing
convertible bonds program with GTO15, BioSenic anticipates having
sufficient cash to carry out its business objectives until the end
of January 2024. BioSenic will continue to require additional
financing over the last 2023 Quarter and therefore actively
evaluates various options, including a significant fundraising
operation.
Outlook for the remainder of
2023
- BioSenic
is involved in preliminary discussions with Pregene, and other
potential partners, to reach an agreement for the global
development and commercialization of proprietary ALLOB cells,
derived from mesenchymal stem cells.
- Since
BioSenic has obtained new statistical analysis results from the
past Bone Therapeutics JTA-004 Phase 3 clinical trial data, the
therapeutic profile of JTA-004 has significantly changed. The
results allow to specifically target patients severely affected by
osteoarthritis, suggesting to proceed to a new, optimized phase 3
clinical study in this pathologyand possibly other indications.
BioSenic is actively working on new intellectual property rules and
new patent submissions related to a better use of the JTA-004
technology and improved versions.
- The
Medsenic (BioSenic's subsidiary) phase 2 clinical study with ATO in
the first-line treatment of cGvHD has provided additional positive
results, with new data related to the optimal duration of the
treatment. The phase 3 study with oral ATO in the first-line
treatment of cGvHD, for which Medsenic received positive pre-IND
response from the FDA, is indeed anticipated to start in 2024. A
previous phase 2a clinical trial for systemic lupus erythematosus
(SLE) had established safety for the patient and efficacy on the
development of the autoimmune disease. Positive studies on
preclinical models further give good grounds for a phase 2 clinical
trial on systemic sclerosis (SSc). Phase 2b clinical trials for SLE
and SSc are in the planning stage with the synopsis for both
studies ready.
- In 2024
BioSenic expects to use the proceeds of anticipated future
fundraisings in priority for progressing the phase 3 clinical trial
in cGvHD. As a result, it will only be possible to start the SLE
and SSc phase 2b clinical trials if the BioSenic Group succeeds in
concluding a strong partnership with a biopharmaceutical company or
if it manages to successfully out-license some of its technology.
The start of SLE and SSc phase 2 clinical trials is therefore not
envisioned before 2025.
(1) Unaudited numbers
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 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 innovative company addressing unmet medical needs in the areas
of innate immunity, inflammation and organ/function repair, today
provides its business update for the third quarter, ended 30
September 2023.
Key highlights
- In July 2023, BioSenic obtained an agreement with Monument and
Patronale for a standstill, postponing until Q4 any payment to
these creditors.
- In September 2023, new binding term sheets have been signed for
the replacement of the Monument and Patronale bonds and loans, by
new unsecured convertible bonds. New potential terms, subject to
formal approval by the European Investment Bank, have also been
formulated for the long-term extension of the existing loan
financing with the European Investment Bank in the context of
ongoing equity raise process. Implementation of the terms agreed
with all three lenders is subject to the completion of an equity
investment in the Company.
- In August 2023, BioSenic announced the allowance of a new
patent entitled ‘Use of metal ions to potentiate the therapeutic
effects of arsenic’ by the China National Intellectual Property
Administration (CNIPA). This patent (ZL202080040613.1) covers the
use of its ATO platform in combination with metal ions like copper,
allowing further further potential upon the use of arsenic to
improve the treatment of autoimmune diseases, starting with cGvHD
(the European Patent Office had granted a parallel wide patent
protection in eight countries in Europe - EP3972613 - in April
2023).
- In September 2023, BioSenic published data in a peer-reviewed
international journal “Arthritis Research & Therapy”, providing
additional indications of its lead API (Active Pharmaceutical
Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis
(SSc). These results give ground to the proposed clinical relevance
of ATO treatment in SSc, and more generally in autoimmune related
pathologies.
- In September 2023, BioSenic announced the completion of a
post-hoc analysis of its phase 2 clinical trial of ATO, finding the
most adapted scheme for administration of an efficient treatment
for chronic Graft-versus-Host-Disease (cGvHD). As a result,
BioSenic will further use this 2-cycle treatment in its forthcoming
phase 3 clinical trial. This involves the administration of a
double four-week course, separated by a rest period, resulting in
the use of two to four times more doses of ATO.
Financial highlights
- Net cash at the end of September 2023 amounted to €0.39
million (1).
- Upon receipt of the two final instalments of €300,000 under the
existing convertible bonds program with GTO15, BioSenic anticipates
having sufficient cash to carry out its business objectives until
the end of January 2024. BioSenic will continue to require
additional financing over the last 2023 Quarter and therefore
actively evaluates various options, including a significant
fundraising operation.
Outlook for the remainder of
2023
- BioSenic is involved in preliminary discussions with Pregene,
and other potential partners, to reach an agreement for the global
development and commercialization of proprietary ALLOB cells,
derived from mesenchymal stem cells.
- Since BioSenic has obtained new statistical analysis results
from the past Bone Therapeutics JTA-004 Phase 3 clinical trial
data, the therapeutic profile of JTA-004 has significantly changed.
The results allow to specifically target patients severely affected
by osteoarthritis, suggesting to proceed to a new, optimized phase
3 clinical study in this pathologyand possibly other indications.
BioSenic is actively working on new intellectual property rules and
new patent submissions related to a better use of the JTA-004
technology and improved versions.
- The Medsenic (BioSenic's subsidiary) phase 2 clinical study
with ATO in the first-line treatment of cGvHD has provided
additional positive results, with new data related to the optimal
duration of the treatment. The phase 3 study with oral ATO in the
first-line treatment of cGvHD, for which Medsenic received positive
pre-IND response from the FDA, is indeed anticipated to start in
2024. A previous phase 2a clinical trial for systemic lupus
erythematosus (SLE) had established safety for the patient and
efficacy on the development of the autoimmune disease. Positive
studies on preclinical models further give good grounds for a phase
2 clinical trial on systemic sclerosis (SSc). Phase 2b clinical
trials for SLE and SSc are in the planning stage with the synopsis
for both studies ready.
- In 2024 BioSenic expects to use the proceeds of anticipated
future fundraisings in priority for progressing the phase 3
clinical trial in cGvHD. As a result, it will only be possible to
start the SLE and SSc phase 2b clinical trials if the BioSenic
Group succeeds in concluding a strong partnership with a
biopharmaceutical company or if it manages to successfully
out-license some of its technology. The start of SLE and SSc phase
2 clinical trials is therefore not envisioned before 2025.
(1) Unaudited numbers
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 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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