BioSenic raises €500,000 in private placement of new shares with
established new investors
PRESS RELEASE – REGULATED INFORMATION
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Mont-Saint-Guibert, Belgium, 2 February
2024, 17:30 CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, today announces that it
raised €500,000 in gross proceeds through a private placement of
12,195,120 new shares at an issue price of €0,041 per share with
institutional investors, Gestys Santé Biotech and Friedland
Gestion.
BioSenic intends to use the net proceeds of the
placement, together with other sources, to prepare for an IND
application with FDA for the Phase 3 clinical study with oral
arsenic trioxide (OATO) in the first-line treatment of chronic
graft-versus-host disease (cGvHD). They will also cover general
business expenses, mainly related to clinical regulatory
requirements and BioSenic corporate activities.
In line with its financing strategy, the private
placement will allow BioSenic to continue exploring more funding
options in the coming months to further strengthen its balance
sheet and cash position. The payment and delivery of the new shares
are expected to take place on or about 6 February 2024. At the same
time, an application will be made to admit the new shares to
trading on the regulated markets of Euronext Brussels and Euronext
Paris, and a listing prospectus will be published by the
company.
The new shares to be issued will have the same
rights and benefits as, and rank pari passu in all
respects with, the existing and outstanding shares of BioSenic at
the moment of their issuance. A copy of the report prepared by the
board of directors of BioSenic in accordance with the Belgian Code
on Companies and Associations further describing, among others, the
capital increase, the consequences thereof and the justification of
the issue price is made available in the Investors section (under
Regulated financial information – Share and Bond Issues) on
BioSenic's website.
The aggregate dilution for the existing
shareholders resulting from the issuance of the new shares amounts
to 6.95% and upon effective issuance of the new shares, the total
number of shares of BioSenic will amount to 175,376,594.
François Rieger, President of the Board
and CEO of BioSenic Group, declares: "BioSenic is
grateful for the trust in its development projects and capacity to
reach significant milestones, expressed by the shareholding
participations of two well-known funds, Gestys and Friedland
Gestion. The financial conditions of this placement are quite
favorable to BioSenic’s shareholders, as no discount is involved in
the present deal as compared to the last closing price of the
company's shares. Since other funding options are being explored to
cover the necessary long-term budget needs, we needed only a modest
amount of funds at this stage. Our objective this year is to start
patient recruitment for this study, our lead project, as soon as
possible. We expect to confirm and extend the good results obtained
in a recent Phase 2 study for the use of arsenic trioxide using a
patent-protected new oral formulation, OATO, for the treatment of
cGvHD."
Banque Delubac & Cie acted as placement
agent for the private placement.
About BioSenic
BioSenic is a biotech company specializing
in the clinical development of autoimmune disease therapies.
Following a reverse merger in October 2022, BioSenic combined its
strategic positioning, key strengths and strong IP to develop
products along two tracks, separately and in combination. The first
platform leverages immunomodulatory properties of arsenic trioxide
(ATO) for an entirely new arsenal of formulations, including oral
delivery (OATO), for anti-inflammatory and anti-autoimmune
indications such as chronic graft-versus-host disease (cGvHD),
systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). In
parallel, BioSenic develops innovative products through a second
platform that includes cell therapies and strong IP protection for
tissue repair technologies.
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's technology
platforms
The ATO
platform has immunomodulatory properties with
fundamental effects on the activated cells of the immune system.
One direct application is its use in autoimmunity to treat in its
chronic, established stage. Chronic GvHD is one of the most common
and clinically significant complications affecting long-term
survival of allogeneic hematopoietic stem cell transplantation
(allo-HSCT), a curative treatment for patients with serious blood
diseases, including cancers.
BioSenic’s intravenous ATO formulation,
Arscimed®, has orphan drug
designation status by FDA and EMA, and it has shown good safety and
significant clinical efficacy for skin, mucosae, and the
gastrointestinal tract in an early Phase 2a study. The company is
planning a confirmatory international Phase 3 study with its oral
ATO (OATO) formulation. OATO
will also target moderate-to-severe forms of SLE. BioSenic is also
developing a new IP-protected OATO formulation for the treatment of
SSc, a serious chronic disease that affects skin, lungs or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models support the launch
of a Phase 2 clinical trial.
ALLOB is 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 MSCs from healthy donors
into bone-forming cells at the site of injury. BioSenic is studying
the results of a Phase 2 trial to optimise the efficacy of ALLOB by
determining the best timing for therapeutic intervention and
seeking partners to continue the development of the promising
underlying therapy strategies.
The company is also exploring partnerships
at all levels for its JTA-004
viscosupplement for a severe inflammatory subtype of
osteoarthritis, following a positive post hoc analysis of Phase 3
data demonstrating safety and efficacy in support of this
licensing.
For further information, please
contact:
BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
International Media Enquiries:
IB Communications
Michelle Boxall
Tel: +44 (0)20 8943 4685
michelle@ibcomms.agency
French Investor Enquiries:
Seitosei Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ghislaine.gasparetto@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
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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