BioSenic provides further update on negotiations with its main creditors
10 7월 2023 - 2:00PM
BioSenic provides further update on negotiations with its main
creditors
INSIDE INFORMATION
Agreement with the main creditors of
BioSenic for a standstill running until October 2023
Mont-Saint-Guibert, Belgium, July 10th,
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 announces a further update on its financial
arrangements with its main historical creditors, Patronale,
Monument and the European Investment Bank. BioSenic aims at
renegotiating its main financial debts, inherited from Bone
Therapeutics. This is required for BioSenic to successfully launch
a new fundraising, in the form of a private placement in Q 3-4
2023.
For the debt renegotiation, our mediator, Yves
Brulard, has achieved a standstill agreement from the main
historical creditors for a period of 3 to 4 months. BioSenic will
therefore be able to keep a good pace to develop its lead projects,
while negotiating a long-term solution to access to the levels of
financing required for all its preclinical and clinical
programs.
Given this agreement with the main creditors and
the one obtained on 30 June 2023 with Global Tech Opportunities 15
to secure short-term financing on the basis of the existing
convertible bond program, BioSenic anticipates having sufficient
cash to carry out its business objectives until October 2023.
Prof. François Rieger, CEO of BioSenic
and President of the Board said: "BioSenic inherited
significant debts from Bone Therapeutics prior to the reverse
merger with Medsenic. Over the first semester of 2023, BioSenic has
invested significant corporate resources in balancing and
developing its programs along the lines set out in last year's
merger terms. A necessary process for a restructuration of the main
debts is now underway and we make sure that all our financial
partners can gather together and contribute to the best conditions
of future success of the company on its present lead programs”.
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from:
(i), the allogeneic cell therapy platform ALLOB and (ii) the
Arsenic TriOxide (ATO) platform. Key target indications for the
platforms include Graft versus Host Disease (GvHD), Systemic lupus
erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial
fractures.Following the merger in October 2022, BioSenic combined
the strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger enables Biosenic to add to its innovative
cell therapy platform and strong IP for tissue repair protection,
an entirely new arsenal of various anti-inflammatory and
anti-autoimmune formulations using the immunomodulatory properties
of ATO/OATO (oral ATO).. 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 allogeneic cell and gene therapy platform, developed by
BioSenic with differentiated bone marrow sourced Mesenchymal
Stromal Cells (MSCs), that can be stored at the point of use in
hospitals. Its current investigational medicinal product, ALLOB,
represents a unique, 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. These cells are produced via a BioSenic's scalable
manufacturing process. Following the CTA (Clinical Trial
Application) approval by regulatory authorities in Europe, BioSenic
had initiated patient recruitment for the Phase IIb clinical trial
with ALLOB in patients with difficult tibial fractures, using its
optimized production process. ALLOB has 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. The patient recruitment has been halted late February 2023
with 57 patients and the new rules permitted for statistical
analysis allowed BioSenic to get the main results of this trial
much earlier than anticipated in the original protocol. In June
2023, BioSenic decided to suspend its interventional trial on
fracture healing using ALLOB, following negative results obtained
for the primary endpoint in the exploratory Phase IIb clinical
trial with ALLOB, focused on safety and treatment timing efficacy
(choice between early or late treatment).
- The Arsenic TriOxide (ATO) platform developed by Medsenic. The
immunomodulatory properties of ATO have demonstrated a double basic
effect on cells of the immune system. The first effect is the
increase of the cell oxidative stress in activated B, T or 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
pro-inflammatory 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. GvHD is one of the most
common and clinically significant complications affecting long-term
survival of allogeneic hematopoietic stem cell transplantation
(allo-HSCT). GvHD is primarily mediated by the transplanted immune
cells that can lead to severe multiorgan damage. Medsenic has been
successful in a Phase II trial with its intravenous formulation,
with orphan drug designation status by FDA and EMA. The
company is heading towards an international Phase III confirmatory
study, with its new, IP protected, oral (OATO) formulation.
Moderate to severe forms of Systemic Lupus erythematosus (SLE) is
another selected target, using the same oral formulation. ATO has
shown good safety and significant clinical efficacy on several
affected organs (skin, mucosae and the gastro-intestinal tract) in
an early Phase IIa study.
Systemic Sclerosis is also part of the clinical
pipeline of BioSenic. Preclinical studies on pertinent animal
models are positive. This gives good grounds to launch a Phase II
clinical protocol. This serious chronic disease badly affects skin,
lungs or vascularization, and has no actual current effective
treatment.
In addition, BioSenic is working on a
next-generation, off-the-shelf, enhanced viscosupplement, JTA, for
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 intend to provide added
lubrication and protection to the cartilage of the arthritic joint
and to alleviate osteoarthritic pain (OA) and inflammation. 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 sub-population. This new post-hoc
analysis drastically changes the therapeutic profile of the
combined components and allows for better patient targeting in
future clinical developments. The company, which does not intend to
allocate R&D resources to support the clinical development of
JTA-004, will focus its R&D and clinical activities on an
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
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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
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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
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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,
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forward-looking statements are based. Neither the Company nor its
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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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