Bone Therapeutics Provides Third Quarter 2021 Business Update
26 Octobre 2021 - 07:00AM
Bone Therapeutics Provides Third Quarter 2021 Business Update
REGULATED INFORMATION
Recruitment ALLOB tibial fracture Phase IIb trial
slower than anticipated due to pandemic
No statistically significant difference in knee
pain reduction between JTA-004, placebo and active comparator, 3
months after treatment in Phase III knee osteoarthritis study
First tranche of EUR 8.0 million of the EIB
financing received
Signing of research evaluation agreement with
Implant Therapeutics as well as scientific advisory board
appointments latest steps in creating new iMSC platform
Runway until end of Q1 2022 as development of
iMSC platform accelerates
Gosselies, Belgium, 26
October 2021,
7:00 am CEST –
BONE THERAPEUTICS (Euronext Brussels and Paris:
BOTHE), the cell therapy company addressing unmet medical needs in
orthopedics and other diseases, today announces its business update
for the third quarter, ended 30 September 2021.
“Bone Therapeutics is now fully focused on
expanding its allogeneic differentiated MSC based cell therapy
platform, beyond our current orthopedic focus for ALLOB, into other
therapeutic indications,” said Miguel
Forte, MD, PhD, Chief Executive Officer of Bone
Therapeutics. “Our first partnership in this area now
gives us access to vital iPSC technology which is an important step
in the creation of our new iMSC platform. The appointment of Dr.
Anne Leselbaum as our Chief Medical Officer as well as our
scientific advisory board specifically for the development of Bone
Therapeutic’s iMSC platform will also provide crucial support to
achieve this. We look forward to the development of MSC based
therapies to bring options to a wider group of patients.”
Operational
highlights
- On January 12,
2021, Bone Therapeutics initiated the treatment of patients in the
Phase IIb study of its allogeneic cell therapy product, ALLOB, in
patients with difficult tibial fractures. Bone Therapeutics
anticipated finalizing patient recruitment in H1 2022 subject to
evolution of the COVID-19 pandemic and the associated containment
measures. Early recruitment rates were very promising, but the
recruitment rates slowed down in recent month due to short term
pandemic-related factors, such as reduced site activities due to
staff availability, and number of available patients due to less
accidents. The recruitment rate continues to be slower than
anticipated primarily due to the pandemic impact on patient
availability. Several measures (including site expansion, training,
information, best practices sharing and close monitoring of
progress) are being implemented in collaboration with the involved
clinical research organization to improve and facilitate
recruitment. The release of topline data by the end of 2022 is
still currently expected. However, a delay of up to a quarter
cannot be excluded.
- On August 30,
2021, Bone Therapeutics announced topline results from the Phase
III knee osteoarthritis study with its enhanced viscosupplement
JTA-004, its legacy non-MSC product. JTA-004 had a favorable safety
profile. However, the study did not meet the primary and key
secondary endpoints. No statistically significant difference in
pain reduction could be observed between the treatment, placebo and
comparator groups, with all treatment arms showing similar
efficacy. In collaboration with existing and potential partners,
Bone Therapeutics is currently evaluating the options for the
future of JTA-004 development, including potential divestment or
halting.
- On September 28, 2021, Bone
Therapeutics signed a research evaluation agreement with Implant
Therapeutics, the developer of hypoimmunogenic and safe harbor
engineered IPSC derived cells. The agreement enables Bone
Therapeutics to access, evaluate and materially transfer Implant
Therapeutics’ Induced Pluripotent Stem Cell (iPSC) derived,
genetically engineered MSCs, including lines, media,
differentiation protocols and expertise. The iPSCs will be used to
develop Bone Therapeutics’ new next generation induced pluripotent
stem cell-derived mesenchymal stromal cell (iMSC) platform.
Corporate Highlights
- In July 2021,
Bone Therapeutics appointed Dr. Anne Leselbaum as Chief Medical
Officer. Dr. Leselbaum brings three decades of experience in
strategic international clinical development, clinical operations
and medical affairs. As CMO, she has taken responsibility for the
leadership of all clinical development and medical affairs
strategies and activities across the entire Bone Therapeutics’
pipeline and oversees regulatory interactions.
- In September
2021, Bone Therapeutics appointed Lieve Creten, as interim Chief
Financial Officer (CFO), succeeding Jean-Luc Vandebroek. Lieve’s
extensive financial experience gained as Managing Partner at
Deloitte Financial Advisory Belgium will ensure the continued
optimal financial control, oversight and compliance during Bone
Therapeutics strategic refocus on the iMSC platform, which includes
its product ALLOB.
- In October 2021, Bone Therapeutics
appointed key experts to its Scientific Advisory Board (SAB). The
members of the SAB consist of world-recognized scientists and
clinicians in the cell and gene therapy field. The SAB has been
comprised to provide additional expert guidance on the development
of Bone Therapeutics’ novel, next generation induced pluripotent
stem cell-derived mesenchymal stromal cell (iMSC) platform.
Financial highlights
- In July 2021,
Bone Therapeutics secured a loan financing of up to EUR 16.0
million with the European Investment Bank (EIB). The EIB loan
financing is being disbursed in two tranches of EUR 8.0 million
each, subject to conditions precedent. The payment from the EIB for
the first tranche of EUR 8.0 million was received early September
2021, following the approval of the issuance of 800,000 associated
warrants to the EIB at Bone Therapeutics’ General Meetings at the
end of August 2021.
- Bone
Therapeutics also renegotiated 800 convertible bonds issued on May
7, 2020 (for an amount of EUR 2 million) to Patronale Life into a
loan subject to the same repayment terms as the agreement with the
EIB, with the issuance of 200,000 additional warrants
unconditionally subscribed by Patronale Life under the terms and
conditions decided by Bone Therapeutics’ Extraordinary General
Meeting.
- In July 2021,
Bone Therapeutics agreed a final settlement with the Belgian
Financial Services and Markets Authority (FSMA) regarding clinical
studies communication issues in 2016 and 2017 for a settlement
amount of EUR 500,000.
- Net cash and
cash equivalents at the end of September 2021 amounted to EUR 9.3
million (1).
- Disciplined cost and cash
management will remain a key priority. The net cash burn for the
full year 2021 is expected to be in the range of EUR 16-18 million,
assuming normal operation as the effect of the ongoing COVID-19
pandemic cannot be excluded. Due to the accelerated development of
the iMSC platform, Bone Therapeutics anticipates having sufficient
cash to carry out its business objectives till the end of Q1
2022.
Outlook for the remainder of
2021
- Bone
Therapeutics will continue to expand its allogeneic differentiated
MSC based cell therapy platform, beyond ALLOB, into other
therapeutic indications. Bone Therapeutics is also intensifying its
efforts to expand its preclinical and clinical pipeline to
additional indications by enhancing and “professionalizing” the
therapeutic capacity of its cell and gene therapy platform. This
activity includes the development of a next generation of
genetically engineered mesenchymal stromal cells (MSC) and the use
of highly scalable and versatile cell sources such as induced
pluripotent stem cells (iPSC).
- For the ongoing
Phase IIb ALLOB clinical study in difficult tibial fractures, Bone
Therapeutics’ clinical team, in partnership with its clinical
research organization, is continuing to institute corrective
measures to mitigate the impact of the pandemic and will closely
monitor the recruitment progress. Given the initial mitigation
actions, Bone Therapeutics continues to expect to report topline
results as scheduled by the end of 2022. However, a delay of up to
a quarter cannot be excluded. Should the pandemic continue to have
impact on patient availability, Bone Therapeutics may have to
re-evaluate this timeline and, in that eventuality, will
communicate again to the market.
- Bone
Therapeutics will continue its discussions with the US FDA (Food
and Drug Administration) in preparation for the next steps in the
clinical development of ALLOB in the US.
- Bone
Therapeutics will continue to hold discussions with potential
partners to explore business opportunities for ALLOB while it is
being evaluated in a double-blind, placebo-controlled,
proof-of-concept Phase IIb study.
- As alternatives
to on-going discussions including Hybrigenics, Bone Therapeutics is
in the process of mandating a third party organization to explore
partnership and M&A opportunities.
- LinkHealth and Pregene, Bone
Therapeutics’ partners in Asia continue to drive the development of
ALLOB towards the submission of Investigational New Drug
Application (IND) with the Chinese National Medical Products
Administration (NMPA). Following a positive pre-IND meeting with
the NMPA, a successful IND application would result in a new
milestone payment to Bone Therapeutics.
(1) Unaudited number
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 therapies at different stages ranging
from pre-clinical programs in immunomodulation to mid stage
clinical development for orthopedic conditions, targeting markets
with large unmet medical needs and limited innovation.
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. 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 OfficerLieve Creten, Chief
Financial Officer ad interimTel: +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
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