Bone Therapeutics to start a new Euronext equity story with a
change of name to BioSenic, following the acquisition of a majority
participation of Medsenic valued at EUR 40 million
REGULATED INFORMATION
New company’s pipeline
enriched with serious inflammatory
indications in addition to its
original cell therapy
asset
New
Chairman,
Board
Members and
Management
appointed24,463,421 ALLOB
subscription rights granted to all
existing shareholders
Mont-Saint-Guibert, Belgium,
October 25, 2022, 7am
CEST – BONE THERAPEUTICS (Euronext
Brussels and Paris: BOTHE), the cell therapy company addressing
unmet medical needs in orthopedics and other diseases, today
announces the closing of its acquisition of a majority
participation in Medsenic, a privately held, clinical stage biotech
company incorporated in France and specialized in the development
of optimized formulations of arsenic Trioxide (ATO) and their
applications in serious inflammatory/autoimmune conditions and
other potential new indications in related fields.
The closing follows the realization of all
conditional precedents and the approval of the transaction during
Bone Therapeutics’ extraordinary shareholders meeting (‘ESM’) held
on October 24, 2022.
The ESM has also approved the name change of
Bone Therapeutics into BioSenic. The name change will be
implemented in the next few days. The Company stock ticker symbol
will change from “BOTHE” to “BIOS”. The new corporate website will
be www.biosenic.com.
“The shareholders’ approval of the combination
of Medsenic and Bone Therapeutics will create a diversified and
innovative new company. BioSenic will be able to develop an
expanded product portfolio across multiple therapeutic
indications,” said François Rieger, newly
appointed Chairman and CEO of
BioSenic. “We are excited to bring a new equity
story to the market. Medsenic has been working for a decade on
serious pathologies linked to systemic autoimmune diseases, such as
cGvHD (chronic Graft versus Host Disease), systemic lupus, and
systemic sclerosis. Our programs are well advanced in the clinic
and will bring value to the newly combined portfolio. Our
technologies will now include a dedicated best-in-class autoimmune
disease platform in addition to an allogeneic cell therapy
platform. The widened expertise and IP of the new company will
enable us to target both tissue inflammation and repair, as well as
meet the needs of patients without currently effective
treatments. We are also planning to meet current
shareholders as well as potential new investors in order to present
the new equity story.”
"There continues to be significant unmet medical
needs across immunopathology and tissue repair. Combining Medsenic
and Bone Therapeutics will provide significant opportunity for
cross-pollination and allow therapies to reach patients more
quickly. The combination of development portfolios also enables a
significant derisk for investors and increases the potential for
growth and value creation for all shareholders," said
Jean Stéphenne,
Member of the Board of Directors,
BioSenic. "The new board of directors and
management of BioSenic, under the direction of Prof. François
Rieger, are particularly well placed to lead the merged company to
delivering therapies for unmet medical needs.”
New BioSenic
Board of Directors and Executive
leadership team
The BioSenic’ ESM also approved the appointment
of a new board, consisting of a total of up to seven directors
including Jean Stéphenne and Jean-Luc Vandebroek that are
transitioning to the Biosenic Board, while all other Bone
Therapeutics Board directors have terminated their mandate. Pr.
Francois Rieger, chairman and CEO of Medsenic, has been appointed
as chairman and CEO of BioSenic SA. Other board members are Ms
Véronique Pomi-Schneiter, deputy CEO of Biosenic, formerly in
charge of Medsenic operations, Mr Jean-François Rax, representing
Cap Innovest, Ms Revital Rattenbach, independent director and Mr
Terry Sadler, independent director.
The Executive leadership team now consists of
François Rieger (CEO), Véronique Pomi-Schneiter (deputy CEO), and
Anne Leselbaum (CMO).
Terms of the combination
Further to the ESM, all Medsenic' shareholders
have contributed fifty-one percent (51%) of the total outstanding
share capital of Medsenic, valued at EUR 40,800,207, at a
subscription price per share of EUR 0.45, which values Bone
Therapeutics at EUR 10 million. In exchange for the in-kind
contribution of 51% of Medsenic' shares, 90,668,594 shares were
issued by BioSenic to Medsenic shareholders. The parties have
relied on the valuation carried out by an independent expert in
order to determine the exchange ratio of one for four.
The Medsenic shareholders have agreed to an
initial lock-up of nine months as from the date of the ESM,
provided that on February 28 2023, 2% of the new shares held by
each of Véronique Pomi-Schneiter and François Rieger shall be
released from the lock-up.
BioSenic will maintain its status as a Belgian
listed company, while significantly broadening its diverse
therapeutic portfolio. The ESM also approved the issue of
24,463,421 subscription rights allowing holders to subscribe for a
new share of the company if the ALLOB interim Phase IIB results, a
clinical trial focusing on the regenerative properties of
proprietary ALLOB cells in cases of difficult, in risk of
delayed-union, tibial fractures, are positive at a subscription
price per share of EUR 0.45 (the "ALLOB Subscription Rights"). One
ALLOB Subscription Right was issued and granted to each outstanding
share of BioSenic prior to completion of the transaction.
No offering of the ALLOB Subscription Rights to
the public was made or will be made in the meaning of the
Prospectus Regulation 2017/1129 and no one has taken any action
that would, or is intended to, permit such an offering in any
country or jurisdiction where any such action for such purpose is
required, including in Belgium, France or any other member state of
the European Economic Area to which the Prospectus Regulation
2017/1129 applies. The ALLOB Subscription Rights have also not
been, or will not be, registered under the U.S. Securities Act, or
with any securities regulatory authority of any state or other
jurisdiction in the United States of America, and they may not be
offered, sold, pledged or otherwise transferred in the United
States of America except pursuant to a transaction that is exempt
from, or not subject to, the registration requirements of the U.S.
Securities Act and in compliance with any applicable state
securities laws.
In the contribution agreement, the existing
shareholders of Medsenic have agreed to contribute in kind the
totality of the remaining Medsenic shares held by within the next
24 - 36 months from the completion of the combination, meaning
that, in the medium to long run, all existing pipeline from both
organizations will be directly or indirectly held by BioSenic.
Outlook for the remainder of 2022 and
2023
A Phase III study of cGvHD is currently
anticipated to start in H1 2023 following the Phase II clinical
study with arsenic trioxide in the first-line treatment of cGvHD
(chronic GvH) positive results. A phase IIa clinical trial for
Lupus had previously established proof of concept of safety for the
patient and efficacy on the course of the autoimmune disease: a
Phase IIb clinical trial for severe Lupus is in the planning stage.
Also, positive preclinical work gives good grounds for a Phase II
clinical trial on systemic sclerosis.
The Phase IIb trial of ALLOB, a randomized,
double-blind, placebo-controlled study in patients with high-risk
tibial fractures, is still ongoing and set to report important
interim results in the H1 2023.
About
BioSenic
BioSenic has been formed to be a leading biotech
company, focusing on the development of clinical assets issued
from: (i), the allogeneic cell therapy platform ALLOB and (ii)
through its majority participation in Medsenic, from the Arsenic
TriOxide (ATO platform. kKey programs include Graft versus Host
Disease (GvHD), Systemic Lupus erythematesus (SLE) and Systemic
Sclerosis (SSc).
BioSenic’s technology is based on:
1) The original cutting-edge allogeneic cell and
gene therapy platform from Bone Therapeutics, with differentiated
bone marrow sourced Mesenchymal Stromal Cells (MSCs) which 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 proprietary BioSenic’ scalable
manufacturing process. Following the CTA approval by regulatory
authorities in Europe, the Company has initiated patient
recruitment for the Phase IIb clinical trial with ALLOB in patients
with difficult tibial fractures, using its optimized production
process. ALLOB continues to be evaluated for other orthopedic
indications including spinal fusion, osteotomy, maxillofacial and
dental, and should be of value in new indications when cells will
be further adapted or transformed with additional targeting
properties.
2) The Arsenic TriOxide (ATO) platform from
Medsenic. The immunomodulatory properties of ATO are best described
by 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 soon
eliminated. The second effect is potent immunomodulatory properties
on several pro-inflammatory cytokines involved in inflammatory or
autoimmune cell pathways. One direct application is its use in
immuno-oncology 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-SCT).
GvHD is primarily mediated by the transplanted immune system that
can lead to severe multiorgan damage. Medsenic has been successful
in a Phase II trial with its intravenous formulation which was
granted an orphan drug designation status by FDA and
EMA and is heading towards an international Phase III
confirmatory study, with a new, IP protected, oral
formulation.Moderate to Severe forms of Systemic Lupus
erythematosus (SL)° is another selected target, using the same oral
formulation. ATO has shown in a phase IIa study good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastro-intestinal tract). Systemic Sclerosis is, in
addition, part of the clinical pipeline of BioSenic, as preclinical
studies on pertinent animal models are positive, giving good
grounds to launch a Phase II clinical protocol for this serious
disease that badly affects skin, lungs or vascularization, and with
no actual current effective treatment.
The recent acquisition by BioSenic of a majority
participation in Medsenic brings together the strategic
positionings and strengths of the two companies. As the result of
this merger, Biosenic is adding to its innovative cell therapy
platform and strong IP tissue repair protection an entirely new
arsenal of various anti-inflammatory and anti-autoimmune
formulations, all using the properties mastered by Medsenic of
ATO/OATO with its original compelling immunomodulatory
properties.
BioSenic is based in the Louvain-la-Neuve
Science Park in Mont-Saint-Guibert, Belgium. Further information is
available at http://www.biosenic.com.
For further information, please
contact:
BioSenic
SAFrançois Rieger, PhD, Chief Executive
OfficerTel: +33 (0)671 73 31
59investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicBert BouserieTel: +32 (0)488 40
44 77bert.bouserie@bepublicgroup.be
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor
Enquiries:NewCap Investor Relations &
Financial CommunicationsPierre Laurent, Louis-Victor
Delouvrier and Arthur RouilléTel: +33 (0)1 44 71 94
94bone@newcap.eu
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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