Bone Therapeutics agrees final settlement with the FSMA regarding
clinical studies communication issues in 2016 and 2017
Bone Therapeutics to focus in future on the
development of its MSC cell and gene therapy pipeline
Gosselies,
Belgium, 27 July 2021,
7pm CEST – BONE
THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the
cell therapy company addressing unmet medical needs in orthopedics
and other diseases, today announces that it has entered into a
settlement with the Belgian Financial Services and Markets
Authority (FSMA). The settlement brings a final resolution to an
investigation related to communication issues on past clinical
studies dating to 2016 and 2017.
In 2016, Bone Therapeutics decided to direct its
strategic focus to its next-generation, scalable off-the-shelf
allogeneic cell therapy platform, ALLOB. This decision was taken to
maximize value creation and to ensure the best use of available
resources. The development of PREOB for the treatment of
osteoporosis (OP), non-union fractures (NU) and hip osteonecrosis
(ON) was discontinued in subsequent years. Following these
developments, the FSMA started an inquiry in the framework of
Regulation (EU) No. 596/2014 of the European Parliament and of the
Council of 16 April 2014 (Market Abuse Regulation) in 2018. Bone
Therapeutics has fully cooperated with this investigation.
In particular, at the time, Bone Therapeutics
encountered difficulties in the clinical development of three
programs, ALLOB-OP in preparation, PREOB-NU and PREOB-ON. These
difficulties were identified in February and December 2016. The
difficulties included a lack of external partners, recruitment
delays and failures of acceleration programs. According to the
FSMA, Bone Therapeutics, did not clearly communicate on this
information until the press releases announcing the discontinuation
of the clinical development of these three programs respectively in
January 2017, December 2017 and November 2018.
Subsequent to these actions described above, the
board and management of Bone Therapeutics have quasi-totally
changed. To conclude this chapter definitively, the board and
management has taken a number of initiatives to strengthen its
market communication procedures. It has also concluded a settlement
with the FSMA without an acknowledgment of guilt, and has agreed to
a settlement amount of €500,000. This settlement amount has no
lasting impact on Bone Therapeutics’ ongoing activities and the
development of its future programs.
This settlement will allow Bone Therapeutics’
board of directors and management to fully focus in the future on
the development of the modified Mesenchymal Stromal Cell (MSC)
platform including ALLOB and the enhanced viscosupplement
JTA-004.
The settlement was accepted by the FSMA's
Executive Committee on 27 July 2021 and has been published on the
FSMA's website.
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. The Company has a
diversified portfolio of cell and biologic therapies at different
stages ranging from pre-clinical programs in immunomodulation to
mid-to-late stage clinical development for orthopedic conditions,
targeting markets with large unmet medical needs and limited
innovation.
Bone Therapeutics is developing an off-the-shelf
next-generation improved viscosupplement, JTA-004, which is
currently in Phase III development for the treatment of pain in
knee osteoarthritis. Consisting of a unique combination of plasma
proteins, hyaluronic acid - a natural component of knee synovial
fluid, and a fast-acting analgesic, JTA-004 intends to provide
added lubrication and protection to the cartilage of the arthritic
joint and to alleviate osteoarthritic pain and inflammation.
Positive Phase IIb efficacy results in patients with knee
osteoarthritis showed a statistically significant improvement in
pain relief compared to a leading viscosupplement.
Bone Therapeutics’ core technology is based on
its cutting-edge allogeneic cell therapy platform with
differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs)
which can be stored at the point of use in the hospital. Currently
in pre-clinical development, BT-20, the most recent product
candidate from this technology, targets inflammatory conditions,
while the 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 BioPark in Gosselies, Belgium. Further
information is available at www.bonetherapeutics.com.
For further information, please
contact:
Bone Therapeutics SAMiguel
Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief
Financial OfficerTel: +32 (0)71 12 10
00investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicCatherine HaquenneTel: +32
(0)497 75 63 56catherine@bepublic.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.