BioSenic and its restructuring practitioner (Me Yves Brulard)
submit a global restructuring plan covering the years 2024-2030 to
the Enterprise Court of Nivelles
PRESS RELEASE - PRIVILEGED INFORMATION
A final circular of the creditors on the
basis of XX 83/23 of the Economic Law Code (ELC) will take place
before the Court grants authorisation, in accordance with article
XX 83/26 of the ELC, to submit the plan to the vote of each class
of creditors and to homologation. The creditors will be aware of
the plan, which by law contains information that could be
privileged.
Mont-Saint-Guibert, Belgium, 11 April
2024, 14:00 CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy announces that it has
finalised a draft plan with the request referred to in Article XX
83/26 ELC with the Enterprise Court of Nivelles. Creditors will be
notified to register their claims in RegSol. They will be able to
consult this plan in order to then vote on the proposals made.
The proposed plan provides for differentiated
treatment of creditors by class:
- The plan does
not affect the recent financing provided through the convertible
bond facilities.
- Some obligators
have been offered to replace their outstanding loans granted to
BioSenic for a total principal amount of EUR 7.5 million with new
convertible bonds to be issued by BioSenic. The convertible bonds
would be unsecured and would have a maturity date of 31 December
2030, which could be further extended by BioSenic for up to 24
months depending on its cash balance. An interest rate of 5% per
year, payable annually, with an additional non-compounding interest
of 3% per year that would be added to the principal amount upon
conversion or repayment of a convertible bond. Under this proposal,
which has already been agreed in principle, 200,000 outstanding
warrants would be cancelled. The plan, if approved, would remove
the conditions precedent previously agreed.
- The plan
provides that an outstanding EUR 8 million principal loan would be
replaced by new convertible bonds to be issued by BioSenic. The
convertible bonds would be unsecured and would have a maturity date
of 31 December 2030, which could be further extended by BioSenic
for up to 24 months depending on its cash balance. An interest rate
of 5% per year, payable annually, with an additional
non-compounding interest of 3% per year that will be added to the
principal amount upon conversion or repayment of a convertible
bond. If the plan is approved, 800,000 outstanding warrants would
also be cancelled.
- With regard to
the ordinary creditors, the plan provides for a payment by BioSenic
of 5% of the claim on the last day of the 5th year of the
plan.
- With respect to
the lessor, the plan provides for the extraordinary part 100%
immediately and the balance in ordinary.
- Regarding the
strategic creditors, the plan provides for 90% over 5 years
depending on cash inflows and no later than the last day of the 5th
year of the plan.
- For the
accessories employee, the plan provides for 99% immediately.
- The plan
provides, for the very useful creditors, for 50% within 2
years.
- Regarding the
InterCos debts, the plan provides for 5% immediately.
- Finally, with
regard to the shareholders, the plan provides for the allocation of
subscription rights, the terms of which will be determined at a
later date by BioSenic.
The plan includes a participation clause at the
reorganisation value, due on the last day of the 5th year following
the homologation of the plan on the basis of the average share
price over the preceding 90 days. This participation amount – to be
deducted from the company's own financing capacity for projects in
the 5th year, with trials to be started or even maintained on new
indications – will be due on the last day of the 5th year following
the homologation of the plan, and will be assessed on the basis of
the average share price over the preceding 90 days: the average
share price will have to reach the level observed for the shares of
BioSenic in 2017 while a Phase III was ongoing (JTA004). At that
time, the share price stood at EUR 10. If this level is reached,
the participation of every creditor will be increased by 10% of the
debt written off. The increase/participation could reach 20 % of
the debt written off if the price reaches EUR 18, 30% if the price
reaches EUR 25 and 50% if the price reaches EUR 50, which is highly
unlikely for a biotech with no turnover, as indicated in a 2022 MIT
study (Singh et al 2022, PloS-ONE, open access article, "The
reaction of sponsor stock prices to clinical trial outcomes: An
event study analysis").
The plan is based on the non-binding offer of
funding from a fund, in particular, to finance a Phase 3 clinical
trial on Graft versus Host disease (as announced by BioSenic, via
press release, on 8 December 2023). BioSenic will announce, by way
of a new press release, the results of the votes of the creditors
and after the terms and conditions that will be decided by the
Court, as well as the Court's decisions as soon as they are known.
This judgement would significantly reduce the debt.
François Rieger, PhD, President of the
Board and CEO of the BioSenic Group, said: "An effort to
reorganise the assets of BioSenic has now been accompanied by a
proposed adjustment to the company's liabilities. This should
enable our biotech to regain momentum by focusing its efforts on
its most promising projects, in particular a Phase 3 clinical trial
for the treatment of chronic Graft versus Host disease. These
projects, now at the clinical trial stage, will generate value for
all those who have invested financially in the adventure that is
now taking shape. We expect decisive results for patients suffering
from chronic diseases of the immune system, for which there is
currently no medical need.".
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from its
Medsenic’s arsenic trioxide (ATO) platform. Key target indications
for the autoimmune platform include graft-versus-host-disease
(GvHD), systemic lupus erythematosus (SLE), and now systemic
sclerosis (SSc).Following the merger in October 2022, BioSenic
combined the strategic positionings and strengths of Medsenic and
Bone Therapeutics. The merger specifically enables
Medsenic/Biosenic to develop an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO).
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 the main Medsenic/BioSenic
technology platform
The ATO platform provides
derived active products with immunomodulatory properties and
fundamental effects on the activated cells of the immune system.
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).
Medsenic has been successful in a phase 2 trial
with its intravenous formulation, Arscimed®, 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). Systemic sclerosis is now
full part of the clinical pipeline of Medsenic/BioSenic. This
serious chronic disease badly affects skin, lungs, or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a phase 2 clinical protocol, using new
immunomodulatory formulations of APIs recognized to be active on
the immune system.
The company is currently focusing its present
R&D and clinical activities on a selective, accelerated
development of its autoimmune platform.
Note: The allogeneic cell therapy
platform-originating from the previous listed company Bone
Therapeutics company, may be of renewed interest by using isolated
and purified differentiated bone marrow Mesenchymal Stromal Cells
(MSCs) as a starting material for further isolation of passive or
active biological subcellular elements. Indeed, these cells may
provide new subcellular vesicles potentially able to deliver a
unique and proprietary approach to organ repair. BioSenic is now
involved in determining new patentable approaches in this complex
area of cell therapy.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
CEOTel: +33 (0)671 73 31 59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsMichelle BoxallTel: +44 (0)20 8943
4685michelle@ibcomms.agency
French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ghislaine.gasparetto@seitosei-actifin.com
Michael
Scholzemichael.scholze@seitosei-actifin.com
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
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disclaims any obligation or undertaking to release any update or
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as a result of any change in expectations or any change in events,
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or any such person’s officers or employees guarantees that the
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future accuracy of the forward-looking statements contained in this
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forward-looking statements, which speak only as of the date of this
press release.
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