Bone Therapeutics to strategically focus on lead cell therapy
product ALLOB
REGULATED INFORMATION
Strategic focus revised and fully focused on
achieving topline results of the ALLOB Phase IIb study in tibial
fractures.
Discussions for ALLOB global partnership still
ongoing.
Board of Directors and Management exploring all
strategic options to protect shareholder value.
Miguel Forte (CEO), Tony Ting (CSO), Stefanos
Theoharis (CBO) and Lieve Creten (CFO) will transition to leave the
company over the coming months.
Mont-Saint-Guibert,
Belgium,
29 March
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 it is redefining
its strategic priorities to concentrate specifically on the
development of its most advanced clinical asset, the allogeneic
cell therapy platform, ALLOB.
ALLOB is currently being evaluated in a
randomized, double-blind, placebo-controlled Phase IIb study in
patients with high-risk tibial fractures. Based on the positive
results of the previous clinical studies of ALLOB undertaken by
Bone Therapeutics and the extensive preclinical data set, Bone
Therapeutics firmly believes that ALLOB has the highest potential
of near-term value creation. Topline results of the Phase IIb trial
are still anticipated in Q1 2023. However, a delay cannot be
excluded.
In order to deliver the results from the Phase
IIb clinical study, Bone Therapeutics has implemented a number of
actions to reduce its cost base to enable completion of its Phase
IIb study. As a result, Bone Therapeutics will focus its R&D
activities to support the clinical development of ALLOB and all
activities related to the development of the pre-clinical iMSCg
platform as well as all other non ALLOB related activities, will be
stopped.
In this context, some members of Bone
Therapeutics' management team will transition to depart Bone
Therapeutics in the coming months in alignment with the focus in
activity. This includes Miguel Forte (CEO), Tony Ting (CSO),
Stefanos Theoharis (CBO) and Lieve Creten (CFO). The CEO, Miguel
Forte, will remain in function for the transition. In addition, all
non-executive members of the Board of Directors have decided to
suspend their compensation for the first quarter of 2022 and until
further notice.
The ongoing completion of ALLOB Phase IIb study
will be supervised by Anne Leselbaum, MD (Chief Medical Officer)
and Anne-Sophie Lebrun, PhD (Chief Operation Officer).
The negotiations for ALLOB, with one of the
current Bone Therapeutics Chinese partners, for the global rights
agreement are still ongoing but are taking longer than anticipated.
The potential completion of a final binding agreement has been
delayed beyond the end of Q1 2022.
Subsequent to some preliminary contacts, the
board of directors of Bone Therapeutics is currently examining
various opportunities to combine certain activities within Bone
Therapeutics, taking into account the interests of its shareholders
and other stakeholders. Further announcements will be made in due
course, if and when circumstances so allow or require.
About ALLOB
ALLOB is Bone Therapeutics’ off-the-shelf
allogeneic cell therapy platform consisting of human allogeneic
bone-forming cells derived from cultured bone marrow mesenchymal
stromal cells (MSC) from healthy adult donors. To address critical
factors for the development and commercialization of cell therapy
products, Bone Therapeutics has established a proprietary,
optimized production process that improves consistency,
scalability, cost effectiveness and ease of use of ALLOB. This
optimized production process significantly increases the production
yield, generating thousands of doses per bone marrow donation.
Additionally, the final ALLOB product is cryopreserved, enabling
easy shipment and the capability to be stored at the point of care
for easy clinical use. The process will therefore substantially
improve product quality, reduce overall production costs, simplify
supply chain logistics, increase patient accessibility and
facilitate global commercialization. The Company has implemented
the optimized production process to produce clinical batches for
the ongoing Phase IIb clinical trial in patients with
difficult-to-heal tibial fractures.
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 OfficerLieve Creten, Chief
Financial Officer ad interimTel: +32 (0)71 12 10
00investorrelations@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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