ERRATUM: BioSenic on its way to find the necessary funds to perform
its key clinical trial on chronic Graft-versus-Host Disease
PRESS RELEASE – INSIDE INFORMATION
This is a corrected version of the original PR "
BioSenic on its way to find the necessary funds to perform its key
clinical trial on chronic Graft-versus-Host Disease" published on
December 6, 2023, 7am CEST where TrialCap Pte. Ltd., as part of the
SPRIM Global Investments group (SGI), is named as the lender.
Biosenic signs term sheet with TrialCap
Pte. Ltd. for up to USD 8 million debt financing and USD 800,000
equity investment as a first decisive, financing step towards a
Phase 3 clinical trial for its ground-breaking auto-immune
medication, a first-in-class drug oral arsenic salt.
Mont-Saint-Guibert, Belgium, December 8,
2023, 7.00 am CEST – BIOSENIC (Euronext
Brussels and Paris: BIOS), the clinical-stage company specializing
in serious autoimmune and inflammatory diseases and cell therapy,
and its subsidiary Medsenic SAS, today announces that it has signed
a term sheet with Singapore based TrialCap Pte. Ltd. (the "Term
Sheet") and/or other lenders (the "Lender") for a proposed debt and
equity financing. BioSenic is seeking the funds to continue its
clinical development, backed by previous highly promising Phase 2
and pre-clinical results of arsenic trioxide (ATO). Previous
results show that ATO is a very valuable medication for correcting
dysregulations of the immune system.
In accordance with the Term Sheet, the Lender
will provide two term loan facilities of each up to USD 4,000,000.
The facilities will be structured as a loan note facility
agreement, with each loan to be advanced in cash directly to the
relevant trial service provided or to BioSenic for relevant
expenditures under the Phase 3 clinical study with oral arsenic
trioxide (OATO) in first-line treatment of chronic
Graft-versus-Host Disease (cGvHD). The loan facilities will allow
BioSenic to finance between 25% and 37% of the trial expenses
eligible for an R&D tax credit in France and Australia,
respectively. The loan facilities have a maturity date of 7 years
from the first utilization date, an interest rate of SOFR plus 9.5%
per annum and an upfront fee of an amount equal to 1.0% of the
facility amount, payable on each drawdown.
In addition, under the Term Sheet, the Lender
intends to make an equity investment of USD 800,000 in new shares
of BioSenic. BioSenic will also issue warrants equal to 20% of the
total amounts drawn under the loan facilities. These warrants
become exercisable when 20% of the two loan facilities have been
drawn and the exercise price is equal to the subscription price of
the equity investment.
Completion of the transactions set out in the
Term Sheet is subject to the following conditions: (i) the
satisfactory completion of due diligence by the Lender, (ii) the
signing of the definitive agreements for the debt and equity
financing, (iii) the signing with a Clinical Research Organization
(CRO) and (iv) an equity raise by BioSenic of an amount to be
further determined. BioSenic expects such conditions to be
satisfied in Q1 2024.
François Rieger, PhD, Chairman and Chief
Executive Officer of BioSenic said: "We are very pleased
to announce that we have found ways to set up a decisive financing
for our lead project, an international Phase 3 clinical trial in
chronic Graft versus Host disease, to confirm the remarkable
therapeutic effects of our medication ArsciCor, soon available for
clinical trials as an oral medication. This is a major step forward
in harnessing the unique therapeutic properties of arsenic trioxide
to correct immune dysregulation as seen in various autoimmune
diseases. The success of the present project should lead BioSenic
to progress other important therapeutic approaches related to
abnormalities of the immune system, with chronic detrimental
characteristics affecting the innate, trained and/or adaptative
system, in chronic, serious diseases, and with unmet medical needs.
The involvement of TrialCap Pte. Ltd. is greatly appreciated by the
all BioSenic team, for the benefit of the patients.”
About BioSenic
BioSenic is a 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 immune and autoimmune
diseases. Following a reverse merger in October 2022, BioSenic
combined its strategic positioning and key strengths to develop,
separately and in combination, 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
1) The ATO platform has
immunomodulatory properties with 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).
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 current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a phase 2 clinical protocol.
2) ALLOB, an allogeneic cell therapy platform made
of 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. After phase 2 clinical results with contradictory
conclusions, BioSenic is now focusing on determining the best time
to optimise the efficacy of ALLOB (between early or late
treatment).The company is currently focusing its present R&D
and clinical activities on a selective, accelerated development of
its autoimmune (ATO/OATO) platform.
About TrialCap Pte. Ltd.
:
TrialCap is a specialist debt financier to
companies that provide R&D capabilities to bring life science,
biotech and medtech innovations to patients around the world. As
part of the SPRIM Global Investments group (SGI), TrialCap
leverages SGI’s unique vantage point in clinical stages to invest
in Biotech and in Medtech.
TrialCap is based in Singapore, 79 Science Park
Drive CINTECH IV, Science Park 1Singapore 118264.
For further PR 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
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that could cause actual results or events to differ materially from
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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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future accuracy of the forward-looking statements contained in this
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press release.
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024