Bone Therapeutics to broaden and derisk therapeutic portfolio by
acquiring majority participation in Medsenic
INSIDE INFORMATION
The acquisition will result in the business
combination of Bone Therapeutics and Medsenic to create BioSenic, a
speciality biopharma company
51% of Medsenic shares (valued at ca EUR 40
million) to be contributed at a subscription price per share of EUR
0.45
Each existing share to be entitled to subscribe
to one additional share at EUR 0.45 in case of successful ALLOB
interim results Bone Therapeutics to acquire the remaining
outstanding capital of Medsenic within 36 months
Mont-Saint-Guibert, Belgium,
August 10,
2022, 12:00 AM
CEST – BONE
THERAPEUTICS (Euronext Brussels and Paris: BOTHE),
the cell therapy company addressing unmet medical needs in
orthopedics and Medsenic, a privately held,
clinical stage biopharmaceutical company incorporated in France and
specialized in the development of optimized formulations of arsenic
salts and their application in inflammatory conditions and other
potential new indications, today announces the signature of a
binding contribution agreement to combine the operations of both
companies by means of a share for share exchange, subject to the
approval of the shareholders' meeting.
Background to Medsenic and rationale of
the combinationIntegrating both biopharmaceutical
companies would significantly derisk and broaden Bone Therapeutic's
therapeutic portfolio, targeting a broad array of inflammatory and
orthopedic indications. Both companies currently are running
several mid to advanced stage clinical trials ongoing in lupus,
chronic graft-versus-host disease, tibial fractures and other
indications. As a result, there would be a number of economic,
financial and operational benefits and synergies in combining the
clinical development programs within one organization.
The existing pipeline from both organizations
would continue as planned. The Phase IIb trial of Bone
Therapeutics’ ALLOB, a randomized, double-blind, placebo-controlled
study in patients with high-risk tibial fractures, is still ongoing
and set to report interim results in the first half of 2023. The
Medsenic Phase II clinical study with arsenic trioxide in the
first-line treatment of cGvHD (chronic GvH) is still ongoing, and a
phase IIa clinical trial for Lupus has established proof of concept
of safety for the patient and efficacy on the course of the
autoimmune disease. A Phase 2b clinical trial for severe Lupus is
in the planning stage. A Phase III study of cGvHD is also currently
anticipated to start in the first half of 2023. The new laboratory
facilities in Mont-Saint-Guibert, will become the scientific centre
of the combined entity.
"The addition of Medsenic, particularly with its
dedicated best-in-class autoimmune disease platform, allows the
respective teams of both companies to develop an expanded product
portfolio across multiple therapeutic indications and thus limit
shareholder risk, offer multiple treatments to patients, and
increase the potential for growth and value creation for all
shareholders," said Jean Stéphenne, President of Bone
Therapeutics. "The acquisition of Medsenic fits well with
our strategic priorities and offers substantial financial growth
potential and therapeutic solutions to significantly improve
patient experiences and outcomes for emerging and established
therapies. Bone Therapeutics is well positioned to leverage
Medsenic's value proposition with a strong technology portfolio and
business development experience. It is an honor and I am delighted
to welcome Francois Rieger, a renowned scientist and investor, as
the future President and CEO of the newly created company as a
result of the acquisition, BioSenic. His experience and talent will
undoubtedly enable BioSenic and our talented teams to embark on our
next chapter of accelerating financial growth, maximizing patient
benefits and enhancing value."
"This agreement with Bone Therapeutics
highlights the value of Medsenic's highly complementary businesses,
provides our shareholders with attractive and certain value, and
brings together leading expertise and drug delivery platforms to
accelerate growth and create new opportunities,” said
François Rieger, President and CEO of Medsenic. “As we
remain committed to continuing to serve our stakeholders, I would
like to thank the employees of both organizations for their hard
work and dedication to this mission. I am very proud as the new
President and CEO to work with the Bone Therapeutics team to
successfully complete the transaction and deliver best-in-class
drug therapies and therapeutic solutions under the new name:
‘BioSenic.’”
Terms of the combinationFurther
to the signed contribution agreement, the majority of Medsenic'
shareholders have committed to contribute 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, around
90,668,594 shares would be issued by Bone Therapeutics to Medsenic
shareholders (the "Business Combination"). The
parties have relied on the valuation carried out by an independent
expert in order to determine the exchange ratio of one for
four.
On closing of the Business Combination, Bone
Therapeutics would also issue and automatically allot one
subscription right to each outstanding share of Bone Therapeutics,
allowing the existing shareholders to subscribe for one new share
of Bone Therapeutics in case of statistically positive interim
results of the ALLOB Phase IIb trial, at a subscription price per
share of EUR 0.45.
The transaction is subject to the approval of
the contribution by Bone Therapeutics' shareholders at an
extraordinary shareholders’ meeting (‘ESM’) to be convened by the
Board of Bone Therapeutics in the course of September 2022. The
transaction is also subject to certain other customary conditions
including the confirmation that the proposed Business Combination
would not lead to the necessity, for any subscriber involved to
launch a mandatory takeover bid on Bone Therapeutics.
The Medsenic shareholders have agreed that the
Bone Therapeutics shares to be issued to them in the contribution
will be subject to an initial lock-up of nine months as from the
date of the ESM, provided that on the last day of the four first
calendar month following the month in which the ESM occurs, 2% of
the new shares held by each of Véronique Pomi-Schneiter and
François Rieger shall be released from the lock-up.
If the customary conditions precedent are met
and the shareholders of Bone Therapeutics vote in favor of the
Business Combination, Bone Therapeutics would maintain its status
as a Belgian listed company, and significantly broaden its diverse
therapeutic portfolio.
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
36 months from the completion of the Business Combination, meaning
that, in the medium to long run, all existing pipeline from both
organizations would be directly or indirectly held by Bone
Therapeutics.
Name and Board
ChangesAt the ESM, Bone Therapeutics shareholders will
also be asked to approve the name change of the Company into
‘BioSenic’ and the appointment, with effect as of the completion of
the contribution, of a new board of directors consisting of a total
of up to seven directors including the current chairman Jean
Stéphenne and Jean-Luc Vandebroek at least until the ALLOB Phase
IIb trial results. All other existing director would end their
mandate and Mr. Francois Rieger, chairman and daily manager of
Medsenic, would be appointed as CEO and Chairman of the Company.
Other proposed board members will be Ms Véronique Pomi-Schneiter,
executive director currently in charge of the operations of
Medsenic, Mr Jean-François Rax, representing Cap’Innovest, Ms
Revital Rattenbach, independent director and Mr Terry Sadler,
independent director.
Following the completion of the Business
Combination, it is anticipated that the executive leadership team
consists of François Rieger (CEO), Véronique Pomi-Shneiter (COO),
and Anne Leselbaum (Chief Medical Officer).
The combined group is expected to have a
proforma cash position of at least EUR 5 million at closing. The
Company plans to raise funds in the form of a private placement of
new shares at the end of 2022 in order to finance the combined
activities of Medsenic and the Company. In the meantime, the
Company will make use of the existing EUR 5 million convertible
facility obtained via ABO to finance its activities and to finance
the convertible loan granted to Medsenic for of up to EUR 2 million
to secure the projects of Medsenic during this period.
About Medsenic SAS
Medsenic innovates and exploits the new
possibilities offered by the therapeutic use of arsenic trioxide in
several autoimmune diseases and is currently in clinical trials in
Europe. The company was founded in 2010 by François Rieger, former
Director of Research at the CNRS (French National Centre for
Scientific Research) and author of more than 170 international
scientific publications, and Véronique Pomi-Schneiter, former
founder and manager of a consulting company specializing in human
resources, communication and development strategy. Under the aegis
of a high-level scientific board, chaired by the 2011 Nobel Prize
in Medicine Jules Hoffman, a specialist in innate immunology, and
supported by numerous private investors, Medsenic accelerated its
development in 2016 with the arrival of professional investors.
Further information is available at www.medsenic.com.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company
focused on the development of innovative products to address high
unmet needs in orthopedics and other diseases. Currently Bone
Therapeutics is concentrating specifically on the development of
its most advanced clinical asset, the allogeneic cell therapy
platform, ALLOB.
Bone Therapeutics’ core technology is based on
its cutting-edge allogeneic cell and gene therapy platform with
differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs)
which can be stored at the point of use in the hospital. Its
leading investigational medicinal product, ALLOB, represents a
unique, proprietary approach to bone regeneration, which turns
undifferentiated stromal cells from healthy donors into
bone-forming cells. These cells are produced via the Bone
Therapeutics’ 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.
Bone Therapeutics’ cell therapy products are
manufactured to the highest GMP (Good Manufacturing Practices)
standards and are protected by a broad IP (Intellectual Property)
portfolio covering ten patent families as well as knowhow. The
Company is based in the Louvain-la-Neuve Science Park in
Mont-Saint-Guibert, Belgium. Further information is available
at www.bonetherapeutics.com.
For further information, please contact:
Bone Therapeutics SAMiguel Forte, MD, PhD,
Chief Executive OfficerTel: +32 (0)493 09 73
66investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicBert BouserieTel: +32 (0)488 40
44 77bert.bouserie@bepublicgroup.be
International Media Enquiries:Image Box
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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