Bone Therapeutics reports half year 2021 results
REGULATED INFORMATION
The interim financial report is prepared in
accordance with article 13 of the Royal Decree on the obligations
of issuers of financial instruments admitted to trading on a
regulated market and can be accessed on the website of Bone
Therapeutics in the section ‘Financial information’. Bone
Therapeutics publishes its interim financial report in English. A
French translation of the report will also be made available. In
the event of differences between the English and the French version
of the report, the original English version will prevail.
Concentrating focus on the continued development
and expansion of the mesenchymal stromal cell based allogeneic cell
and gene therapy platform
Strengthens financial position with the release
of the first tranche of EUR 8.0 million as part of the financing
agreement with EIB
Management to host conference call today at 5pm
CEST / 11am ET today - details provided below
Gosselies,
Belgium, 8 September 2021,
7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris:
BOTHE), the cell therapy company addressing unmet medical needs in
orthopedics and other diseases, today announces a business update
and its financial results for the six-month period ended 30 June
2021, prepared in accordance with IFRS as adopted by the European
Union, and the outlook for the remainder of the year.
“At the end of the first half of 2021, Bone
Therapeutics has now developed a clear route forward for the
company, with a full focus on expanding its allogeneic
differentiated MSC based cell therapy platform, beyond our current
orthopedic focus for ALLOB, into other therapeutic indications.
This expansion has been built on the evidence of our clinical
progress on orthopedics, and demonstrated a foundation to broaden
our focus to wider indications,” said
Miguel Forte, MD, PhD, Chief Executive Officer of Bone
Therapeutics. “Now we have concluded the
current stage of clinical progress of JTA, this allows all
financial, managerial and scientific resources to be focused on
delivering therapeutic benefit from our core MSC technology. These
resources include our appointments throughout 2021, including the
appointments of stem cell therapy industry veteran, Anthony Ting,
PhD, as Chief Scientific Officer and Dr. Anne Leselbaum as Chief
Medical Officer. We look forward to the development of MSC based
therapies to bring options to a wider group of patients.”
Operational and Corporate
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. Early recruitment rates
were very promising. As across the industry, the rate of
recruitment has temporarily slowed in recent months 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. Bone Therapeutics has taken and will continue to take
actions to intensify the recruitment through increased of number of
sites, training, information and best practices sharing between
different sites. Even though the recruitment rate has been
impacted, Bone Therapeutics continues to expect patient recruitment
to be completed by the end of first half of 2022 and topline
results by the end of 2022. Should the pandemic impact continue,
Bone Therapeutics will have to re-evaluate these timelines and, in
that eventuality, will communicate again to the markets.
- On January 14,
2021, Bone Therapeutics signed an initial agreement for a process
development partnership with the mesenchymal stromal cell (MSC)
specialist, Rigenerand. This first collaboration will focus on
further developing and enhancing Bone Therapeutics’ bone-forming
cells with the potential to broaden therapeutic targets and explore
new mechanisms of action with potential gene modifications for Bone
Therapeutics’ therapeutic portfolio.
- On June 30,
2021, Bone Therapeutics published the positive results of its Phase
I/IIa clinical trial with ALLOB in patients with delayed union
fractures. The results were published in Stem Cell Research &
Therapy, the international peer-reviewed journal focusing on
translational research in stem cell therapies. ALLOB was generally
well-tolerated and that all patients met the primary endpoint.
- 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. Despite JTA’s favorable safety
profile, 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 will evaluate the options for the future of
JTA-004 development.
- On March 30,
2021, Bone Therapeutics appointed the stem cell therapy industry
veteran, Anthony Ting, PhD, as Chief Scientific Officer. Dr. Ting
is now responsible for Bone Therapeutics’ research activities. He
was appointed to lead the expansion of Bone Therapeutics’ pipeline
into new therapeutic indications, leveraging internal know-how and
external collaborations on novel, specialized cell therapy products
with enhanced efficacy, using differentiated and modified
MSCs.
- After 1H 2021,
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 will take
responsibility for the leadership of all clinical development and
medical affairs strategies and activities across the entire Bone
Therapeutics’ pipeline and will oversee the regulatory
interactions.
Financial Highlights
- After 1H 2021,
in July 2021, Bone Therapeutics secured a loan agreement of up to
EUR 16.0 million with the European Investment Bank (EIB). The EIB
loan financing will be disbursed in two tranches of EUR 8.0 million
each, subject to conditions precedent.
- Following the
approval of the issuance of associated warrants by Bone
Therapeutics’ General Meetings at the end of August 2021, Bone
Therapeutics received a payment from the EIB for the first tranche
of EUR 8.0 million and the EIB was granted 800,000 warrants
approved by the Extraordinary General Meeting.
- 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 approved by
the 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.
- During the first
six months of 2021, total operating income amounted to EUR 0.77
million, a slight increase compared to the same period in 2021 (EUR
0.73 million).
- Operating loss
for the period amounted to EUR 5.72 million, compared to EUR 7.38
million in H1 2020.
- The Company
ended the first six months of 2021 with EUR 6.01 million in cash
and cash equivalents. Cash used for the period amounted to EUR 8.64
million, compared to EUR 8.86 million over the same period of
2020.
- 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 epidemic cannot be excluded.
- Based on existing cash resources
and the disbursement of the first tranche of EUR 8.0 million from
EIB in September 2021, Bone Therapeutics anticipates having
sufficient cash to carry out its business objectives into Q2 2022.
To further strengthen its cash position in the near term, the
company is currently evaluating and working on different financing
options and plans to raise new funds with existing and new
investors as well as with strategic partners. Further information
about the going concern is contained in the going concern statement
section of the IFRS reporting.
Outlook for the remainder of
2021
- For the ongoing
Phase IIb ALLOB clinical study in difficult tibial fractures, Bone
Therapeutics’ clinical team, in partnership with the clinical
research organization, has instituted corrective measures to
mitigate the impact of the pandemic. Given the early stage of the
study conduct and recruitment and further to the initial mitigation
actions, Bone Therapeutics continues to expect patient recruitment
to be completed by the end of first half of 2022 and topline
results by the end of 2022. Should the pandemic continue, Bone
Therapeutics may have to re-evaluate these timelines and, in that
eventuality, will communicate again to the market.
- 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 with
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).
- Bone
Therapeutics will continue to hold discussions with potential
partners to explore business opportunities while ALLOB is being
evaluated in a double-blind, placebo-controlled, proof-of-concept
Phase IIb study.
- 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.
- 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). A successful IND application could result in
new milestone payments to Bone Therapeutics.
Conference call
Miguel Forte, MD, PhD, Chief Executive Officer,
and Jean-Luc Vandebroek, Chief Financial Officer, will host a
conference call today at 5pm CEST / 11am ET. To participate in the
conference call, please select your phone number below and use the
conference ID 880 4181 7984#.
Belgium: +32 2 290 9360France: +33 1
7095 0103United Kingdom: +44 208 080 6592United States:
+1 646 876 9923
The conference call will also be webcast and can be
attended via the following link:
https://us06web.zoom.us/j/88041817984
The presentation will be made available on the
Investors section - Presentations of the Bone Therapeutics website
shortly prior the call.
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 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.
- BOTHE_PR_2021-09-08_2021H1_EN_Final